Different dosage forms can significantly impact pharmacokinetics in vivo,leading to varied effects and potential adverse reactions.This study aimed to evaluate the efficacy,safety,and cost-effectiveness of isosorbide ...Different dosage forms can significantly impact pharmacokinetics in vivo,leading to varied effects and potential adverse reactions.This study aimed to evaluate the efficacy,safety,and cost-effectiveness of isosorbide mononitrate sustained-release capsules(IMSRC)combined with conventional treatments,compared to isosorbide mononitrate tablets(IMT)combined with conventional treatments,for managing angina pectoris in patients with coronary heart diseases.A network meta-analysis(NMA)was conducted to assess the efficacy and safety of IMSRC and IMT.Relevant literature was sourced from databases,including PubMed,Embase,Cochrane Library,ScienceDirect,Web of Science,CNKI,Wanfang,and VIP,covering publications up to July 2023.The cost-effectiveness analysis(CEA)was performed from the perspective of China’s healthcare system,utilizing inputs derived from the NMA.The analysis included 15 studies.The NMA results revealed no significant difference in efficacy and safety between IMSRC plus conventional treatments and IMT plus conventional treatments.However,both combinations were more effective than conventional treatments without isosorbide mononitrate.No differences in safety were observed among the three groups.The surface under the cumulative ranking(SUCRA)of the NMA indicated that IMT had a slight edge over IMSRC in the total effective rate of angina pectoris,whereas IMSRC showed higher probabilities for markedly effective rate and ECG effective rate compared to IMT.The incidence of adverse events was ranked as IMT>conventional preparation>IMSRC.The CEA results highlighted that the incremental cost-effectiveness ratios(ICERs)for the markedly effective and total effective rates of angina pectoris were-133.41 and-260.20,respectively.The ICERs for ECG effective rates were-83.34 and-234.24,respectively.In conclusion,while IMSRC combined with conventional treatments and IMT combined with conventional treatments were similar in efficacy and safety,IMSRC proved to be more economical.展开更多
Encapsulation of water-soluble cargoes in millimeter-sized capsules has enabled major advances in various fields,including pharmaceuticals,food,cosmetics,packaging,and materials.However,because of the lack of fabricat...Encapsulation of water-soluble cargoes in millimeter-sized capsules has enabled major advances in various fields,including pharmaceuticals,food,cosmetics,packaging,and materials.However,because of the lack of fabrication precision,low cargo retention,suboptimal mechanical properties,and difficulty in preventing water evaporation,this technique is more challenging than microencapsulation techniques.In this study,we developed a surfactant-free and organic solvent-free water-in-oil in-air emulsification approach for synthesizing double-layered“milli-capsules”for the precise encapsulation,enhanced retention,and force-triggered burst release of water-soluble bioactive cargoes.In particular,we synthesized milli-capsules with a first shell of poly(ethylene glycol dimethacrylate)for the efficient encapsulation of bioactive cargoes and a second shell of beeswax to prolong the retention of the entrapped bioactive compounds.Unlike traditional milli-capsules,which exhibit poor shape uniformity and mechanical stability,we introduced metallic ions to stabilize the interfacial tension and employed constant rotation to balance the gravity,buoyancy,inertial,and viscous forces imposed on the droplets,resulting in uniform and rigid milli-capsules with narrow rupture forces.Furthermore,additional hydrophobic beeswax coating prevented water volatilization and substantially prolonged the shelf life of the encapsulated compounds from a few days to a few months while maintaining their bioactivities.The proposed milli-capsule system addresses the challenge of precise fabrication of large carriers for water-soluble cargoes,representing a significant step toward the long-term storage and controlled release of bioactive cargoes for various industrial applications.展开更多
Objective:To explore the effect of sustained-release recombinant human bone morphogenetic protein-2(rhBMP-2) on ectopic osteogenesis in the muscle pouches of rats through preparing rhBMP-2 sustained-release capsules b...Objective:To explore the effect of sustained-release recombinant human bone morphogenetic protein-2(rhBMP-2) on ectopic osteogenesis in the muscle pouches of rats through preparing rhBMP-2 sustained-release capsules by wrapping morphogenesis protein bones-2(BMP-2)using chitosan nanoparticles,and compositing collagen materials.Methods:Twenty four SpragueDawley rats were randomly divided into four groups with six rats in each group,that is Group A(control group),Group B(only treated with collagen),Group C(rhBMP-2+collagen treated group) and Group D(rhBMP-2/cs+collagen treated group).The composite materials for each group were implanted in the bilateral peroneal muscle pouches in rats.The peroneal muscles were only separated without implanting any materials in control group.Rats were sacrificed 2 weeks and 4 weeks post treatment and samples were cut off for general observation,Micro CT scans and histological observation.Results:General observation showed no new bone formation in Groups A and B mice,while new bones were formed in Groups C and D mice.Two weeks after treatment Micro CT scans showed that The bone volume fraction(BVF),trabecular thickness(Tb. Th),bone mineral density(BMD) in Group C mice were all higher than that in Group D(P<0.05). At the fourth week,the BVK,Tb.Th and BMD were significantly higher than that at the second week(P<0.01).Conclusions:The slow-release effect of rhBMP-2/cs sustained-release capsules can significantly promote ectopic osteogenesis.Its bone formation effect is better than that of rhBMP-2 burst-release group.展开更多
Ins paper describes the development and validation of a liquid chromatography mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hy...Ins paper describes the development and validation of a liquid chromatography mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hydrochloride sustained-release capsule (SR-test), as an instant-release tablet (IR-reference) and as the market leader sustained-release capsule (Rythmod SR-reference) in male beagle dogs (n= 8). In Study A comparing SR-test with IR-reference in a crossover design T-max and t(1/2) of propafenone for SR-test were significantly higher than those for IR-reference while C-max and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed C and A TIC of propafenone for SR test (124.5 +/- 140.0 ng/mL and 612.0 +/- 699.2 ng.h/mL, respectively) were higher than for SR-reference (78.52 +/- 72.92 ng/mL and 423.6 +/- 431.6 ng.h/mL, respectively) although the differences were not significant. Overall, the new formulation has as good if not better sustained release characteristics to the market leader formulation. (C) 2015 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier By All rights reserved.展开更多
Objective: To explore the therapeutic effect of Huoxue Tongmai capsule combined with edaravone right camphor on patients with acute cerebral infarction (Acute Cerebral Infarction) and the effect of combination therapy...Objective: To explore the therapeutic effect of Huoxue Tongmai capsule combined with edaravone right camphor on patients with acute cerebral infarction (Acute Cerebral Infarction) and the effect of combination therapy on serum inflammatory factors. Methods: In this study, 90 patients with acute cerebral infarction hospitalized in Zhuji People’s Hospital from December 2023 to December 2024 were selected and divided into two groups of 45 patients in each group. The control group used standard medical treatment, and the treatment group compared the changes of serum inflammatory factors IL-CRP, TNF-α, and Hcy with Huoxue Tongmai capsule for 7 days, 14 days and 30 days, and discussed the changes of the modified Rankin scale score (mRS) and National Institutes of Health Stroke Scale (NIHSS) score. Results: At 7 days, 14 days, and 30 days of treatment, the NIHSS score, mRS score, hs-CRP, IL-6, TNF-α, and Hcy levels were statistically significant (P α, and Hcy levels in the treatment group were significantly lower than those in the control group (P Conclusion: Patients with acute cerebral infarction received Huoxue Tongmai capsule combined with edaravone right camphor, which can reduce the inflammatory reaction, improve the nerve function and improve the prognosis.展开更多
The aroma sustained-release cotton fabric was prepared by finishing rose fragrance nanocapsules directly on cotton.The structure and properties of nanocapsules were demonstrated by transmission electron microscope(TEM...The aroma sustained-release cotton fabric was prepared by finishing rose fragrance nanocapsules directly on cotton.The structure and properties of nanocapsules were demonstrated by transmission electron microscope(TEM),dynamic light scattering(DLS),fourier transform infrared spectrometer(FTIR),X-ray diffraction (XRD),gas chromatography-mass spectrometry(GC-MS)and electronic nose.The results showed that the spherical nanocapsule dispersed evenly and the average diameter kept 51.4 nm.The existence of COO peak(1741 cm? 1)in the FTIR curve of the finished cotton fabric and the decrease of crystallinity demonstrated that rose fragrance nanocapsules have been incorporated into the cotton fabrics.The washing resistance of the cotton fabrics finished by 51.4 nm nanocapsules was much better than that by rose fragrance alone.Besides,the loss of fragrance from the cotton fabrics finished by 51.4 nm nanocapsules was obviously lower than that by 532 nm nanocapsules and rose fragrance.The smaller the nanocapsule size,the better the sustained release property.Electronic nose analysis also displayed that the aroma released from the cotton fabrics finished by nanocapsules after washing has no obvious variety in contrast to that without washing.The cotton fabrics finished by nanocapsules has the excellent sustained release property.展开更多
Docetaxel-loaded sustained-release preparation based on 2-Hydroxyethyl methacrylate(HEMA)and Methyl methacrylate(MMA)cross-linked copolymer(P(HEMA-co-MMA))was prepared to examine the potential use for preventing poste...Docetaxel-loaded sustained-release preparation based on 2-Hydroxyethyl methacrylate(HEMA)and Methyl methacrylate(MMA)cross-linked copolymer(P(HEMA-co-MMA))was prepared to examine the potential use for preventing posterior capsule opacification(PCO).The preparations were prepared by polymerizing the mixture of HEMA,MMA,cross-linking agent(EGDMA),initiator(AIBN)and docetaxel.The influence factors and mechanism of drug release were studied in the experiments.FT-IR,X-RD and SEM methods were used to characterize the polymer(P(HEMA-co-MMA))and docetaxel-loaded sustained-release preparations.Biocompatibility of P(HEMA-co-MMA)and in-vitro effect of docetaxel-loaded sustained-release preparations were also evaluated.The results showed that docetaxel could release sustainedly from these preparations prepared by cross-linking polymerization.And the release rate could be accelerated by increasing the MMA ratio or EGDMA ratio of the polymer.Release mechanism of docetaxel fitted the Higuchi model well.The results of IR and X-RD showed that only a hydrogen bond was formed between docetaxel and P(HEMA-co-MMA).Docetaxel dispersed in P(HEMA-co-MMA)in amorphous form.The elution test showed that P(HEMA-co-MMA)had good biocompatibility and the in-vitro pharmacodynamics study proved that docetaxel could release stably from the preparations and inhibit HLECs’proliferation.The docetaxel-loaded sustained-release preparations proved to be a promising therapy for preventing PCO.These results also lay a theoretical and experimental foundation for the future.展开更多
This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagl...This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.展开更多
Naturally degradable capsule provides a platform for sustained fragrance release.However,practical challenges such as low encapsulation efficiency and difficulty in sustained release are still limited in using fragran...Naturally degradable capsule provides a platform for sustained fragrance release.However,practical challenges such as low encapsulation efficiency and difficulty in sustained release are still limited in using fragranceloaded capsules.In this work,the natural materials sodium alginate and gelatine are dissolved and act as the aqueous phase,lavender is dissolved in caprylic/capric triglyceride(GTCC)as the oil phase,and SiO_(2) nanoparticles with neutralwettability as a solid emulsifier to form O/W Pickering emulsions simultaneously.Finally,multi-core capsules are prepared using the drop injection method with emulsions as templates.The results show that the capsules have been successfully prepared with a spherical morphology and multi-core structure,and the encapsulation rate of multi-core capsules can reach up to 99.6%.In addition,the multi-core capsules possess desirable sustained release performance,the cumulative sustained release rate of fragrance at 25℃over 49 days is only 32.5%.It is attributed to the significant protection of multi-core structure,Pickering emulsion nanoparticle membranes,and hydrogel network shell for encapsulated fragrance.This study is designed to deliver a new strategy for using sustained-release technology with fragrance in food,cosmetics,textiles,and other fields.展开更多
Oseltamivir phosphate(OP),renowned as one of the most effective drugs for influenza treatment,encounters several challenges,including poor stability,difficulty in swallowing,and a bitter taste,thereby limiting its com...Oseltamivir phosphate(OP),renowned as one of the most effective drugs for influenza treatment,encounters several challenges,including poor stability,difficulty in swallowing,and a bitter taste,thereby limiting its compliance,particularly among children.Consequently,this study aimed to devise a novel sustained-release suspension of OP employing an ion exchange resin as a carrier to address these challenges.The OP-drug resin complex(OP-DRC)was synthesized utilizing ion exchange technology,while OP-coated microcapsules(OP-CM)were fabricated via the emulsion-evaporation method.The optimization of the formulation process for the OP sustained-release suspension was achieved through a combination of single-factor experimentation and orthogonal experimental design.Furthermore,the drug release kinetics and pharmacokinetic properties of the sustained-release suspension were thoroughly evaluated both in vitro and in vivo.Scanning electron microscopy(SEM),X-ray diffraction(XRD),and attenuated total reflectance Fourier-transform infrared spectroscopy(ATR-FTIR)analyses confirmed the formation of drug-resin complexes via ionic bonding.The in vitro cumulative release rates were found to be 16%(1 h),53%(6 h),and 84%(24 h),respectively.Notably,the self-made sustained-release suspension exhibited an extended half-life(21.518 h),delayed time to peak concentration(T_(max))(6 h),and reduced maximum plasma concentration(C_(max))(0.397μg/mL)in comparison to commercial granules(half-life=8.466 h;T_(max)=2 h;C_(max)=0.631μg/mL).Additionally,the area under the curve(AUC)indicated that the bioavailability of the self-made OP suspension surpassed that of the commercial OP granules by 101%.These findings underscored the successful development of an oral OP sustained-release suspension characterized by stability,tastelessness,ease of swallowing,convenient administration,and sustained-release properties,thereby potentially enhancing drug compliance among children.展开更多
Chiral coordination molecular cages/capsules with discrete nanoconfined chiral cavities demonstrate significant potential applications across various fields.In this study,we utilized Tr?ger's base as the building ...Chiral coordination molecular cages/capsules with discrete nanoconfined chiral cavities demonstrate significant potential applications across various fields.In this study,we utilized Tr?ger's base as the building block to design and synthesize two pairs of enantiopure ligands.These ligands were then self-assembled with Pd(II)ions through chiral self-sorting coordination,resulting in the formation of two pairs of homochiral M2L4-type coordination molecular capsules.Notably,due to differences in the substitution positions on the Tr?ger's base,these two pairs of enantiomeric coordination molecular capsules exhibited distinct levels of cavity closures,cavity sizes,and host-vip recognition properties.This research offers valuable insights into the construction of novel chiral molecular capsules and the regulation of confined cavities.展开更多
Objective:To analyze the efficacy of Tongxinluo Capsules in treating coronary heart disease(CHD)with angina pectoris.Methods:A total of 98 patients with CHD and angina pectoris admitted between May 2022 and May 2025 w...Objective:To analyze the efficacy of Tongxinluo Capsules in treating coronary heart disease(CHD)with angina pectoris.Methods:A total of 98 patients with CHD and angina pectoris admitted between May 2022 and May 2025 were enrolled and randomly divided into a control group and an experimental group,with 49 cases each.The control group was treated with atorvastatin+clopidogrel,while the experimental group received atorvastatin+clopidogrel+Tongxinluo Capsules.Clinical efficacy,cardiac function,angina attack frequency and duration,and adverse reactions were compared between the two groups.Results:The experimental group showed higher clinical efficacy than the control group(P<0.05).Cardiac function in the experimental group was superior to that of the control group(P<0.05).The duration and frequency of angina attacks in the experimental group were lower than those in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The use of Tongxinluo Capsules in the clinical treatment of CHD with angina pectoris can improve various clinical indicators,enhance therapeutic efficacy,and promote faster patient recovery.展开更多
Objective:To explore the clinical efficacy of sodium oligomannate capsules combined with memantine hydrochloride and donepezil hydrochloride in the treatment of moderate Alzheimer’s disease(AD)and analyze its impact ...Objective:To explore the clinical efficacy of sodium oligomannate capsules combined with memantine hydrochloride and donepezil hydrochloride in the treatment of moderate Alzheimer’s disease(AD)and analyze its impact on cognitive function.Methods:Eighty patients with moderate AD admitted to the neurology outpatient clinic of our hospital from June 2021 to December 2022 were selected as the study subjects and randomly divided into a study group and a control group,each with 40 patients.The control group was treated with oral memantine hydrochloride and donepezil hydrochloride,while the study group was additionally treated with oral sodium oligomannate capsules for 24 weeks.The scores of neuropsychological scales[Montreal Cognitive Assessment(MoCA)and Mini-Mental State Examination(MMSE)],and Activities of Daily Living(ADL)scale were compared before and after treatment.Additionally,the levels of homocysteine(Hcy),central nervous system-specific protein(S100-β),interleukin(IL)-6,and tumor necrosis factor(TNF)-αwere measured in both groups,and the treatment effects and adverse reactions were compared.Results:After 24 weeks of treatment,the MMSE,MoCA,and ADL scores of both groups were significantly higher than those before treatment(P<0.05).Compared with the control group after 24 weeks of treatment,the study group had significantly higher MMSE,MoCA,and ADL scores(P<0.05),and significantly lower levels of Hcy,IL-6,and TNF-α(P<0.05).Both the study group and the control group showed reduced levels of Hcy,IL-6,and TNF-αafter 24 weeks of treatment compared to before(P<0.05),but there was no significant change in S100-βlevels(P>0.05).Conclusion:The combination of sodium oligomannate capsules,memantine hydrochloride,and donepezil hydrochloride is effective in the treatment of moderate AD.It can improve the cognitive function and daily living abilities of patients with dementia,enhancing their quality of life.展开更多
This article presents a case study of a 20-year-old male patient diagnosed with dilated cardiomyopathy(DCM)(NYHA IV).This condition was diagnosed as"heart failure disease"(water overflowing due to yang defic...This article presents a case study of a 20-year-old male patient diagnosed with dilated cardiomyopathy(DCM)(NYHA IV).This condition was diagnosed as"heart failure disease"(water overflowing due to yang deficiency,intermingled phlegm and stasis)in traditional Chinese medicine(TCM).The treatment approach employed a combination of TCM and Western medicine.Western medicine involved the administration of sacubitril valsartan sodium tablets to inhibit ventricular remodeling,in conjunction with diuretics and cardiotonic agents.Initially,TCM utilized a static infusion of Shenfu injection,which was subsequently supplemented with Qiliqiangxin capsules to invigorate qi,warm yang,activate blood circulation,and promote diuresis.After a follow-up period of 3 years,the patient's ejection fraction(EF)improved from 23%to 51%,and the left ventricular end diastolic diameter(LVed)decreased from 68 to 52 mm,accompanied by a significant alleviation of symptoms.These findings indicate that the combined treatment of TCM and Western medicine can synergistically enhance cardiac function and impede the progression of the disease,thereby offering valuable insights for the optimal management of DCM.展开更多
Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observat...Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observational study of brain trauma patients who met the inclusion criteria between March 2023 and June 2024 and who could be treated with citicoline sodium capsules after being evaluated by the investigator.The Glasgow Coma Scale(GCS)and Mini-Mental State Examination(MMSE),the incidence of adverse drug reactions/adverse events during treatment,and the abnormalities of safety tests with clinical evaluation significance were observed at 1 month and 2 months after treatment.Results:A total of 2806 patients,63.1%of whom were male,with an average age of 58.85 years old.The GCS and MMSE scores of the patients at 1 month and 2 months after treatment were significantly improved and were statistically significant,indicating that citicoline sodium had a significant effect on improving the state of consciousness and cognitive function of patients with TBI.Only 8 adverse reactions were reported in the study,all of which were mild gastrointestinal reactions and anaphylaxis,and did not lead to treatment interruption or serious consequences.Conclusion:Citicoline sodium has a significant therapeutic effect on patients with TBI and has good safety.展开更多
To evaluate the subchronic and chronic toxicity of Fuyanxiao capsules,Sprague-Dawley(SD)rats were used in toxicity studies.In the subchronic toxicity study,50 female rats were randomly divided into a high-dose group(5...To evaluate the subchronic and chronic toxicity of Fuyanxiao capsules,Sprague-Dawley(SD)rats were used in toxicity studies.In the subchronic toxicity study,50 female rats were randomly divided into a high-dose group(5.4g/kg/day)and a control group,with 15 rats in each,and medium(2.7g/kg/day)and low(1.35g/kg/day)dose groups,with 10 rats in each.The test substance was administered orally(mixed with feed,twice daily)for 90 consecutive days.In the chronic toxicity study,40 female rats were randomly divided into high,medium,and low dose groups and a control group,with 10 rats in each.The test substance was administered orally in the same manner for 180 consecutive days.Clinical signs,body weight,and food consumption were observed and recorded daily.At the end of the terminal phase(the first 10 rats from each group,1 day after the last dose)and the recovery phase(the last 5 rats from the control group and the high-dose group,observed for an additional 28 days after the last dose),blood and urine samples,as well as organs,were collected.Organ coefficients were calculated,and various hematological and urinary indicators were detected,followed by pathological analysis.The results showed that there were no significant differences in body weight,food consumption,or organ coefficients between any of the dose groups and the control group in both subchronic and chronic toxicity studies(P>0.05).Histopathological examination revealed no lesions,suggesting no tissue or organ damage in any of the dose groups.The rats exhibited good mental status,and hematological and urinary physiological indicators were within normal ranges,indicating stable liver and kidney function,hematopoietic system of the bone marrow,and internal environment in all dose groups.Therefore,Fuyanxiao capsule has no obvious subchronic or chronic toxicity in SD rats,and it is safe and reliable to use at reasonable dosage in clinical practice.展开更多
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo(TXL)capsule to treat atherosclerosis.However,clinical evidence of the effects of TXL treatment on coronary ...Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo(TXL)capsule to treat atherosclerosis.However,clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable.In response,we developed this study to investigate the hypothesis that on the basis of statin therapy,treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome(ACS).The TXL-CAP study was an investigator-initiated,randomized,double-blind clinical trial conducted across 18 medical centers in China.Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness(FCT)<100μm and lipid arc>90°as defined by optical coherence tomography(OCT)were recruited.A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL(n=110)or placebo(n=110)for a duration of 12 months.The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up.Secondary endpoints included:(1)changes of the maximum lipid arc and length of the target plaque,and the percentage of lipid,fibrous,and calcified plaques at the end of the12-month period;(2)the incidence of composite cardiovascular events and coronary revascularization within the 12 months;(3)changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society(CCS)grading system and Seattle angina questionnaire(SAQ)score,respectively;and(4)changes in hs-CRP serum levels.The results of the TXLCAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.展开更多
AIM:To assess the visual acuity and visual quality of cataract patients who received femtosecond laser-assisted cataract surgery(FLACS)and multifocal intraocular lens(MIOL)implantation with an improved polishing techn...AIM:To assess the visual acuity and visual quality of cataract patients who received femtosecond laser-assisted cataract surgery(FLACS)and multifocal intraocular lens(MIOL)implantation with an improved polishing technique during a 1-year follow-up period.METHODS:This study included 74 eyes from 37 patients,comprising 17 males and 20 females,with a mean age of 51.74±7.80 years.Using a coin toss method,one eye per patient was randomly selected for improved anterior capsular polishing,while the other eye received standard irrigation/aspiration(I/A)polishing.The polishing group consisted of 37 eyes,including 21 right and 16 left eyes,while the control group comprised the contralateral fellow eyes of the same individuals in the polishing group.Visual acuity and quality of the patients were evaluated before surgery and at 1 wk,1,6,and 12 mo after surgery.The OPD-Scan III was utilized to assess high-order aberrations,while the optical quality analysis system(OQAS)was employed to evaluate modulation transfer function(MTF cutoff),Strehl ratio(SR),and objective scatter index(OSI)for the purpose of visual quality assessment.Paired t-tests and repeated measures analysis of variance(ANOVA)were utilized to compare the results,and the SNK-q post hoc test was applied to identify significant differences.RESULTS:The polishing group’s uncorrected distant visual acuity(UDVA)and uncorrected near visual acuity(UNVA)significantly improved 1-week post-surgery(all P<0.05).At 12-months,UDVA,UNVA,and corrected distant visual acuity(CDVA)were better than the control group(P<0.05).The MTF cutoff,SR,OSI,and high-order aberrations in the polishing group also showed significant improvements compared to the control group at 12 mo(P<0.05).CONCLUSION:The improved capsular polishing method has been demonstrated to effectively maintain visual acuity and visual quality in patients with MIOL after FLACS within 1 a.展开更多
Aim To establish a LC-MS method for determining the concentration of nifedipine in human plasma and to evaluate the pharmacokinetic characteristics of nifedipine sustained-release tablets. Methods A XB-C18 （5 μm, 4....Aim To establish a LC-MS method for determining the concentration of nifedipine in human plasma and to evaluate the pharmacokinetic characteristics of nifedipine sustained-release tablets. Methods A XB-C18 （5 μm, 4.6 mm ×150 mm） column and a mobile phase of methanol： 0.01 mol·L^-1ammonium acetate （60：40, V/V） were used to separate nifedipine, the detections was accuracy under atmosperic pressure electronic spray ionization （AP-ESI） mode and ion mass spectrum （m/z） of 314.9 [M＋H]^＋ for nifedipine, and 320.8 [M＋H]^＋ for lorazepam （Internal Standard, IS）. Results The linear range of nifedipine was 0.3 - 80 ng·mL^-1 （ r = 0.9997）, and the limit of quantitation （LOQ） was 0.3 ng·mL^-1. The nifedipine pharmacokinetic parameters after a single dose of 20 mg nifedipine sustained-release tablets test （T） or reference （R） were as the followings, t1/2 （6.73 ± 2.00） h and （7.04 ± 2.18） h, Tmax （4.28 ± 0.70） h and （4.48 ± 0.70） h, Cmax（39.66 ± 10.58） ng·mL^-1 and （40.19 ± 10.97） ng·mL^-1, AUC0-36 （391.63 ± 108.55） ng·mL^-1·h and （387.57 ± 121.51） ng·mL^-1·h, and AUC0-∞ （408.28 ± 121.16） ng·mL^-1·h and （406.15 ± 133.13） ng·mL^-1·h. The relative bioavailability of nifedipine sustained-release tablets （test） was （103.02 ± 13.93） %. Conclusion LC-MS method for the determination of concentrations of nifedipine in human plasma was sensitive and accurate, and could be used in nifedipine bioavailability and pharmacokinetic studies.展开更多
Fufang Zhenzhu Tiaozhi capsules （FTZc）, which is consisted of eight traditional Chinese herbal medicines and contains multiple bioactive ingredients, is a patented and clinically approved herbal formulation for the ...Fufang Zhenzhu Tiaozhi capsules （FTZc）, which is consisted of eight traditional Chinese herbal medicines and contains multiple bioactive ingredients, is a patented and clinically approved herbal formulation for the treatment of dyslipidemia. A feasible HPLC-DAD-ELSD method was developed to simultaneously determine 15 bioactive compounds （salidroside, specneuzhenide, magnoflorine, rosmarinic acid, salvianolic acid B, columbamine, jatrorrhizine, epiberberine, coptisine, palmatine, berberine, 5,7-dimethoxycoumarin, ginsenoside Rgl, ginsenoside Rbl and oleanic acid ） in FTZc for its quality control. The multiple wavelength detection mode of DAD was used. The chromatographic separation was performed on an Ultimate XB Cls column with gradient elution. The mobile phase A （acetonitrile） and B （0.25% glacial acetic acid and 0.13% triethylamine in water, v/v） were run at a flow rate of 0.8 mL/min. The developed method showed good precision and accuracy with overall intra- and inter-day variations of 0.7%-1.9% and 0.6%-3.0%, respectively. The recoveries measured at three concentration levels, varied from 95.5% to 103.8%. The validated method was successfully applied for the simultaneous determination of 15 bioactive compounds in three batches of FTZc. The results suggested that the developed method was convenient and reliable, particularly suitable for the routine quality control of FTZc.展开更多
基金The 2022 Ministry of Education General Project for Humanities and Social Sciences Research(Grant No.22YJAZH147)the General Subject of Guangzhou Philosophy and Social Science Development“14th Five-Year Plan”in 2023(Grant No.2023GZYB68)+2 种基金China University Industry-Academia-Research Innovation Fund-Huatong Guokang Medical Research Special Project(Grant No.2023HT017)2024 Guangdong Province General Project for the Planning of Philosophy and Social Sciences(Grant No.GD24CGL29)the Innovation Team Project of Colleges and Universities in Guangdong Province(Grant No.2022WCXTD011).
文摘Different dosage forms can significantly impact pharmacokinetics in vivo,leading to varied effects and potential adverse reactions.This study aimed to evaluate the efficacy,safety,and cost-effectiveness of isosorbide mononitrate sustained-release capsules(IMSRC)combined with conventional treatments,compared to isosorbide mononitrate tablets(IMT)combined with conventional treatments,for managing angina pectoris in patients with coronary heart diseases.A network meta-analysis(NMA)was conducted to assess the efficacy and safety of IMSRC and IMT.Relevant literature was sourced from databases,including PubMed,Embase,Cochrane Library,ScienceDirect,Web of Science,CNKI,Wanfang,and VIP,covering publications up to July 2023.The cost-effectiveness analysis(CEA)was performed from the perspective of China’s healthcare system,utilizing inputs derived from the NMA.The analysis included 15 studies.The NMA results revealed no significant difference in efficacy and safety between IMSRC plus conventional treatments and IMT plus conventional treatments.However,both combinations were more effective than conventional treatments without isosorbide mononitrate.No differences in safety were observed among the three groups.The surface under the cumulative ranking(SUCRA)of the NMA indicated that IMT had a slight edge over IMSRC in the total effective rate of angina pectoris,whereas IMSRC showed higher probabilities for markedly effective rate and ECG effective rate compared to IMT.The incidence of adverse events was ranked as IMT>conventional preparation>IMSRC.The CEA results highlighted that the incremental cost-effectiveness ratios(ICERs)for the markedly effective and total effective rates of angina pectoris were-133.41 and-260.20,respectively.The ICERs for ECG effective rates were-83.34 and-234.24,respectively.In conclusion,while IMSRC combined with conventional treatments and IMT combined with conventional treatments were similar in efficacy and safety,IMSRC proved to be more economical.
基金supported by the National Natural Science Foundation of China(Nos.52273102,31870957,and 52302344)the Fundamental Research Funds for the Central Universities(Nos.DUT24YG155,DUT20YG103,and DUT22LAB601)Liaoning Provincial Science and Technology Plan Joint Plan(No.2023JH2/101700341)。
文摘Encapsulation of water-soluble cargoes in millimeter-sized capsules has enabled major advances in various fields,including pharmaceuticals,food,cosmetics,packaging,and materials.However,because of the lack of fabrication precision,low cargo retention,suboptimal mechanical properties,and difficulty in preventing water evaporation,this technique is more challenging than microencapsulation techniques.In this study,we developed a surfactant-free and organic solvent-free water-in-oil in-air emulsification approach for synthesizing double-layered“milli-capsules”for the precise encapsulation,enhanced retention,and force-triggered burst release of water-soluble bioactive cargoes.In particular,we synthesized milli-capsules with a first shell of poly(ethylene glycol dimethacrylate)for the efficient encapsulation of bioactive cargoes and a second shell of beeswax to prolong the retention of the entrapped bioactive compounds.Unlike traditional milli-capsules,which exhibit poor shape uniformity and mechanical stability,we introduced metallic ions to stabilize the interfacial tension and employed constant rotation to balance the gravity,buoyancy,inertial,and viscous forces imposed on the droplets,resulting in uniform and rigid milli-capsules with narrow rupture forces.Furthermore,additional hydrophobic beeswax coating prevented water volatilization and substantially prolonged the shelf life of the encapsulated compounds from a few days to a few months while maintaining their bioactivities.The proposed milli-capsule system addresses the challenge of precise fabrication of large carriers for water-soluble cargoes,representing a significant step toward the long-term storage and controlled release of bioactive cargoes for various industrial applications.
基金supported by Guangdong Province Science and Technology Foundation,Guangdong,China(No:2011B080701053)
文摘Objective:To explore the effect of sustained-release recombinant human bone morphogenetic protein-2(rhBMP-2) on ectopic osteogenesis in the muscle pouches of rats through preparing rhBMP-2 sustained-release capsules by wrapping morphogenesis protein bones-2(BMP-2)using chitosan nanoparticles,and compositing collagen materials.Methods:Twenty four SpragueDawley rats were randomly divided into four groups with six rats in each group,that is Group A(control group),Group B(only treated with collagen),Group C(rhBMP-2+collagen treated group) and Group D(rhBMP-2/cs+collagen treated group).The composite materials for each group were implanted in the bilateral peroneal muscle pouches in rats.The peroneal muscles were only separated without implanting any materials in control group.Rats were sacrificed 2 weeks and 4 weeks post treatment and samples were cut off for general observation,Micro CT scans and histological observation.Results:General observation showed no new bone formation in Groups A and B mice,while new bones were formed in Groups C and D mice.Two weeks after treatment Micro CT scans showed that The bone volume fraction(BVF),trabecular thickness(Tb. Th),bone mineral density(BMD) in Group C mice were all higher than that in Group D(P<0.05). At the fourth week,the BVK,Tb.Th and BMD were significantly higher than that at the second week(P<0.01).Conclusions:The slow-release effect of rhBMP-2/cs sustained-release capsules can significantly promote ectopic osteogenesis.Its bone formation effect is better than that of rhBMP-2 burst-release group.
文摘Ins paper describes the development and validation of a liquid chromatography mass spectrometric assay for propafenone and its application to a pharmacokinetic study of propafenone administered as a new propafenone hydrochloride sustained-release capsule (SR-test), as an instant-release tablet (IR-reference) and as the market leader sustained-release capsule (Rythmod SR-reference) in male beagle dogs (n= 8). In Study A comparing SR-test with IR-reference in a crossover design T-max and t(1/2) of propafenone for SR-test were significantly higher than those for IR-reference while C-max and AUC were lower demonstrating the sustained release properties of the new formulation. In Study B comparing SR-test with SR-reference the observed C and A TIC of propafenone for SR test (124.5 +/- 140.0 ng/mL and 612.0 +/- 699.2 ng.h/mL, respectively) were higher than for SR-reference (78.52 +/- 72.92 ng/mL and 423.6 +/- 431.6 ng.h/mL, respectively) although the differences were not significant. Overall, the new formulation has as good if not better sustained release characteristics to the market leader formulation. (C) 2015 Chinese Pharmaceutical Association and Institute of Materia Medica, Chinese Academy of Medical Sciences. Production and hosting by Elsevier By All rights reserved.
文摘Objective: To explore the therapeutic effect of Huoxue Tongmai capsule combined with edaravone right camphor on patients with acute cerebral infarction (Acute Cerebral Infarction) and the effect of combination therapy on serum inflammatory factors. Methods: In this study, 90 patients with acute cerebral infarction hospitalized in Zhuji People’s Hospital from December 2023 to December 2024 were selected and divided into two groups of 45 patients in each group. The control group used standard medical treatment, and the treatment group compared the changes of serum inflammatory factors IL-CRP, TNF-α, and Hcy with Huoxue Tongmai capsule for 7 days, 14 days and 30 days, and discussed the changes of the modified Rankin scale score (mRS) and National Institutes of Health Stroke Scale (NIHSS) score. Results: At 7 days, 14 days, and 30 days of treatment, the NIHSS score, mRS score, hs-CRP, IL-6, TNF-α, and Hcy levels were statistically significant (P α, and Hcy levels in the treatment group were significantly lower than those in the control group (P Conclusion: Patients with acute cerebral infarction received Huoxue Tongmai capsule combined with edaravone right camphor, which can reduce the inflammatory reaction, improve the nerve function and improve the prognosis.
基金Supported by the State Key Development Program for Basic Research of China(2009CB226104)the National Natural ScienceFoundation of China(20876097,21076125)+1 种基金Shanghai Chenguang Foundation(10CG60)Shanghai Excellent Talents(yyy10071)
文摘The aroma sustained-release cotton fabric was prepared by finishing rose fragrance nanocapsules directly on cotton.The structure and properties of nanocapsules were demonstrated by transmission electron microscope(TEM),dynamic light scattering(DLS),fourier transform infrared spectrometer(FTIR),X-ray diffraction (XRD),gas chromatography-mass spectrometry(GC-MS)and electronic nose.The results showed that the spherical nanocapsule dispersed evenly and the average diameter kept 51.4 nm.The existence of COO peak(1741 cm? 1)in the FTIR curve of the finished cotton fabric and the decrease of crystallinity demonstrated that rose fragrance nanocapsules have been incorporated into the cotton fabrics.The washing resistance of the cotton fabrics finished by 51.4 nm nanocapsules was much better than that by rose fragrance alone.Besides,the loss of fragrance from the cotton fabrics finished by 51.4 nm nanocapsules was obviously lower than that by 532 nm nanocapsules and rose fragrance.The smaller the nanocapsule size,the better the sustained release property.Electronic nose analysis also displayed that the aroma released from the cotton fabrics finished by nanocapsules after washing has no obvious variety in contrast to that without washing.The cotton fabrics finished by nanocapsules has the excellent sustained release property.
基金(Lab of Drug Metabolism and Pharmacokinetics,Sun Yat-sen University,Guangzhou,China)for the help and technical assistance.
文摘Docetaxel-loaded sustained-release preparation based on 2-Hydroxyethyl methacrylate(HEMA)and Methyl methacrylate(MMA)cross-linked copolymer(P(HEMA-co-MMA))was prepared to examine the potential use for preventing posterior capsule opacification(PCO).The preparations were prepared by polymerizing the mixture of HEMA,MMA,cross-linking agent(EGDMA),initiator(AIBN)and docetaxel.The influence factors and mechanism of drug release were studied in the experiments.FT-IR,X-RD and SEM methods were used to characterize the polymer(P(HEMA-co-MMA))and docetaxel-loaded sustained-release preparations.Biocompatibility of P(HEMA-co-MMA)and in-vitro effect of docetaxel-loaded sustained-release preparations were also evaluated.The results showed that docetaxel could release sustainedly from these preparations prepared by cross-linking polymerization.And the release rate could be accelerated by increasing the MMA ratio or EGDMA ratio of the polymer.Release mechanism of docetaxel fitted the Higuchi model well.The results of IR and X-RD showed that only a hydrogen bond was formed between docetaxel and P(HEMA-co-MMA).Docetaxel dispersed in P(HEMA-co-MMA)in amorphous form.The elution test showed that P(HEMA-co-MMA)had good biocompatibility and the in-vitro pharmacodynamics study proved that docetaxel could release stably from the preparations and inhibit HLECs’proliferation.The docetaxel-loaded sustained-release preparations proved to be a promising therapy for preventing PCO.These results also lay a theoretical and experimental foundation for the future.
文摘This study pharmacokinetically examined the lovastatin sustained-release tablet and sustained-release capsule in Beagle dogs. An reversed-phase HPLC method was established for the determination of lovastatin in Beagle dog plasma. Pharmacokinetic findings were compared among three preparation(lovastatin sustained-release tablet,T p; sustained-release capsule,T J and conventional capsule). Our results showed that the pharmacokinetic parameters in 6 dogs after single-dose oral administration of three perparations were calculated. T max, C max and MRT revealed significant difference (P<0.05). Relative bioavailability was 111.5±16.9 % (T P) and 110.4%±9.6 % (T J). The pharmacokinetic parameters in the 6 dogs after multiple-dose oral administration of three perparations, T max, C max MRT and DF had significant difference (P<0.05); C av , C min and AUC 0-24 h displayed no significant difference (P>0.05). It is concluded that the lovastatin sustained-release tablet and sustained-release capsule are able to maintain a sustained-release for 24 h.
文摘Naturally degradable capsule provides a platform for sustained fragrance release.However,practical challenges such as low encapsulation efficiency and difficulty in sustained release are still limited in using fragranceloaded capsules.In this work,the natural materials sodium alginate and gelatine are dissolved and act as the aqueous phase,lavender is dissolved in caprylic/capric triglyceride(GTCC)as the oil phase,and SiO_(2) nanoparticles with neutralwettability as a solid emulsifier to form O/W Pickering emulsions simultaneously.Finally,multi-core capsules are prepared using the drop injection method with emulsions as templates.The results show that the capsules have been successfully prepared with a spherical morphology and multi-core structure,and the encapsulation rate of multi-core capsules can reach up to 99.6%.In addition,the multi-core capsules possess desirable sustained release performance,the cumulative sustained release rate of fragrance at 25℃over 49 days is only 32.5%.It is attributed to the significant protection of multi-core structure,Pickering emulsion nanoparticle membranes,and hydrogel network shell for encapsulated fragrance.This study is designed to deliver a new strategy for using sustained-release technology with fragrance in food,cosmetics,textiles,and other fields.
基金2023 Nantong Jianghai Talents Project2023 Nantong Social Livelihood Science and Technology Plan+4 种基金2021 Jurong Social Development Science&Technology Program(Grant No.ZA42109)2022 New Drugs and Platform Enhancement Project of the Yangtze Delta Drug Advanced Research InstituteChina Postdoctoral Science Foundation(Grant No.2020M681532)Jiangsu Planned Projects for Postdoctoral Research Funds(Grant No.2020Z209)Natural Science Research Projects of Universities in Jiangsu Province(Grant No.20KJD350001)。
文摘Oseltamivir phosphate(OP),renowned as one of the most effective drugs for influenza treatment,encounters several challenges,including poor stability,difficulty in swallowing,and a bitter taste,thereby limiting its compliance,particularly among children.Consequently,this study aimed to devise a novel sustained-release suspension of OP employing an ion exchange resin as a carrier to address these challenges.The OP-drug resin complex(OP-DRC)was synthesized utilizing ion exchange technology,while OP-coated microcapsules(OP-CM)were fabricated via the emulsion-evaporation method.The optimization of the formulation process for the OP sustained-release suspension was achieved through a combination of single-factor experimentation and orthogonal experimental design.Furthermore,the drug release kinetics and pharmacokinetic properties of the sustained-release suspension were thoroughly evaluated both in vitro and in vivo.Scanning electron microscopy(SEM),X-ray diffraction(XRD),and attenuated total reflectance Fourier-transform infrared spectroscopy(ATR-FTIR)analyses confirmed the formation of drug-resin complexes via ionic bonding.The in vitro cumulative release rates were found to be 16%(1 h),53%(6 h),and 84%(24 h),respectively.Notably,the self-made sustained-release suspension exhibited an extended half-life(21.518 h),delayed time to peak concentration(T_(max))(6 h),and reduced maximum plasma concentration(C_(max))(0.397μg/mL)in comparison to commercial granules(half-life=8.466 h;T_(max)=2 h;C_(max)=0.631μg/mL).Additionally,the area under the curve(AUC)indicated that the bioavailability of the self-made OP suspension surpassed that of the commercial OP granules by 101%.These findings underscored the successful development of an oral OP sustained-release suspension characterized by stability,tastelessness,ease of swallowing,convenient administration,and sustained-release properties,thereby potentially enhancing drug compliance among children.
基金supported by the National Natural Science Foundation of China(No.22271164)the Fundamental Research Funds for the Central UniversitiesNankai University(NKU)。
文摘Chiral coordination molecular cages/capsules with discrete nanoconfined chiral cavities demonstrate significant potential applications across various fields.In this study,we utilized Tr?ger's base as the building block to design and synthesize two pairs of enantiopure ligands.These ligands were then self-assembled with Pd(II)ions through chiral self-sorting coordination,resulting in the formation of two pairs of homochiral M2L4-type coordination molecular capsules.Notably,due to differences in the substitution positions on the Tr?ger's base,these two pairs of enantiomeric coordination molecular capsules exhibited distinct levels of cavity closures,cavity sizes,and host-vip recognition properties.This research offers valuable insights into the construction of novel chiral molecular capsules and the regulation of confined cavities.
文摘Objective:To analyze the efficacy of Tongxinluo Capsules in treating coronary heart disease(CHD)with angina pectoris.Methods:A total of 98 patients with CHD and angina pectoris admitted between May 2022 and May 2025 were enrolled and randomly divided into a control group and an experimental group,with 49 cases each.The control group was treated with atorvastatin+clopidogrel,while the experimental group received atorvastatin+clopidogrel+Tongxinluo Capsules.Clinical efficacy,cardiac function,angina attack frequency and duration,and adverse reactions were compared between the two groups.Results:The experimental group showed higher clinical efficacy than the control group(P<0.05).Cardiac function in the experimental group was superior to that of the control group(P<0.05).The duration and frequency of angina attacks in the experimental group were lower than those in the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The use of Tongxinluo Capsules in the clinical treatment of CHD with angina pectoris can improve various clinical indicators,enhance therapeutic efficacy,and promote faster patient recovery.
文摘Objective:To explore the clinical efficacy of sodium oligomannate capsules combined with memantine hydrochloride and donepezil hydrochloride in the treatment of moderate Alzheimer’s disease(AD)and analyze its impact on cognitive function.Methods:Eighty patients with moderate AD admitted to the neurology outpatient clinic of our hospital from June 2021 to December 2022 were selected as the study subjects and randomly divided into a study group and a control group,each with 40 patients.The control group was treated with oral memantine hydrochloride and donepezil hydrochloride,while the study group was additionally treated with oral sodium oligomannate capsules for 24 weeks.The scores of neuropsychological scales[Montreal Cognitive Assessment(MoCA)and Mini-Mental State Examination(MMSE)],and Activities of Daily Living(ADL)scale were compared before and after treatment.Additionally,the levels of homocysteine(Hcy),central nervous system-specific protein(S100-β),interleukin(IL)-6,and tumor necrosis factor(TNF)-αwere measured in both groups,and the treatment effects and adverse reactions were compared.Results:After 24 weeks of treatment,the MMSE,MoCA,and ADL scores of both groups were significantly higher than those before treatment(P<0.05).Compared with the control group after 24 weeks of treatment,the study group had significantly higher MMSE,MoCA,and ADL scores(P<0.05),and significantly lower levels of Hcy,IL-6,and TNF-α(P<0.05).Both the study group and the control group showed reduced levels of Hcy,IL-6,and TNF-αafter 24 weeks of treatment compared to before(P<0.05),but there was no significant change in S100-βlevels(P>0.05).Conclusion:The combination of sodium oligomannate capsules,memantine hydrochloride,and donepezil hydrochloride is effective in the treatment of moderate AD.It can improve the cognitive function and daily living abilities of patients with dementia,enhancing their quality of life.
文摘This article presents a case study of a 20-year-old male patient diagnosed with dilated cardiomyopathy(DCM)(NYHA IV).This condition was diagnosed as"heart failure disease"(water overflowing due to yang deficiency,intermingled phlegm and stasis)in traditional Chinese medicine(TCM).The treatment approach employed a combination of TCM and Western medicine.Western medicine involved the administration of sacubitril valsartan sodium tablets to inhibit ventricular remodeling,in conjunction with diuretics and cardiotonic agents.Initially,TCM utilized a static infusion of Shenfu injection,which was subsequently supplemented with Qiliqiangxin capsules to invigorate qi,warm yang,activate blood circulation,and promote diuresis.After a follow-up period of 3 years,the patient's ejection fraction(EF)improved from 23%to 51%,and the left ventricular end diastolic diameter(LVed)decreased from 68 to 52 mm,accompanied by a significant alleviation of symptoms.These findings indicate that the combined treatment of TCM and Western medicine can synergistically enhance cardiac function and impede the progression of the disease,thereby offering valuable insights for the optimal management of DCM.
文摘Objective:This study aimed to evaluate the prognostic impact of citicoline sodium capsules on patients with traumatic brain injury(TBI)and its safety.Methods:This study is a multicenter,single-arm,prospective,observational study of brain trauma patients who met the inclusion criteria between March 2023 and June 2024 and who could be treated with citicoline sodium capsules after being evaluated by the investigator.The Glasgow Coma Scale(GCS)and Mini-Mental State Examination(MMSE),the incidence of adverse drug reactions/adverse events during treatment,and the abnormalities of safety tests with clinical evaluation significance were observed at 1 month and 2 months after treatment.Results:A total of 2806 patients,63.1%of whom were male,with an average age of 58.85 years old.The GCS and MMSE scores of the patients at 1 month and 2 months after treatment were significantly improved and were statistically significant,indicating that citicoline sodium had a significant effect on improving the state of consciousness and cognitive function of patients with TBI.Only 8 adverse reactions were reported in the study,all of which were mild gastrointestinal reactions and anaphylaxis,and did not lead to treatment interruption or serious consequences.Conclusion:Citicoline sodium has a significant therapeutic effect on patients with TBI and has good safety.
文摘To evaluate the subchronic and chronic toxicity of Fuyanxiao capsules,Sprague-Dawley(SD)rats were used in toxicity studies.In the subchronic toxicity study,50 female rats were randomly divided into a high-dose group(5.4g/kg/day)and a control group,with 15 rats in each,and medium(2.7g/kg/day)and low(1.35g/kg/day)dose groups,with 10 rats in each.The test substance was administered orally(mixed with feed,twice daily)for 90 consecutive days.In the chronic toxicity study,40 female rats were randomly divided into high,medium,and low dose groups and a control group,with 10 rats in each.The test substance was administered orally in the same manner for 180 consecutive days.Clinical signs,body weight,and food consumption were observed and recorded daily.At the end of the terminal phase(the first 10 rats from each group,1 day after the last dose)and the recovery phase(the last 5 rats from the control group and the high-dose group,observed for an additional 28 days after the last dose),blood and urine samples,as well as organs,were collected.Organ coefficients were calculated,and various hematological and urinary indicators were detected,followed by pathological analysis.The results showed that there were no significant differences in body weight,food consumption,or organ coefficients between any of the dose groups and the control group in both subchronic and chronic toxicity studies(P>0.05).Histopathological examination revealed no lesions,suggesting no tissue or organ damage in any of the dose groups.The rats exhibited good mental status,and hematological and urinary physiological indicators were within normal ranges,indicating stable liver and kidney function,hematopoietic system of the bone marrow,and internal environment in all dose groups.Therefore,Fuyanxiao capsule has no obvious subchronic or chronic toxicity in SD rats,and it is safe and reliable to use at reasonable dosage in clinical practice.
基金National Key Research and Development Program of China(2017YFC1700502)Ministry of Science and Technology of China。
文摘Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo(TXL)capsule to treat atherosclerosis.However,clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable.In response,we developed this study to investigate the hypothesis that on the basis of statin therapy,treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome(ACS).The TXL-CAP study was an investigator-initiated,randomized,double-blind clinical trial conducted across 18 medical centers in China.Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness(FCT)<100μm and lipid arc>90°as defined by optical coherence tomography(OCT)were recruited.A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL(n=110)or placebo(n=110)for a duration of 12 months.The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up.Secondary endpoints included:(1)changes of the maximum lipid arc and length of the target plaque,and the percentage of lipid,fibrous,and calcified plaques at the end of the12-month period;(2)the incidence of composite cardiovascular events and coronary revascularization within the 12 months;(3)changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society(CCS)grading system and Seattle angina questionnaire(SAQ)score,respectively;and(4)changes in hs-CRP serum levels.The results of the TXLCAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.
文摘AIM:To assess the visual acuity and visual quality of cataract patients who received femtosecond laser-assisted cataract surgery(FLACS)and multifocal intraocular lens(MIOL)implantation with an improved polishing technique during a 1-year follow-up period.METHODS:This study included 74 eyes from 37 patients,comprising 17 males and 20 females,with a mean age of 51.74±7.80 years.Using a coin toss method,one eye per patient was randomly selected for improved anterior capsular polishing,while the other eye received standard irrigation/aspiration(I/A)polishing.The polishing group consisted of 37 eyes,including 21 right and 16 left eyes,while the control group comprised the contralateral fellow eyes of the same individuals in the polishing group.Visual acuity and quality of the patients were evaluated before surgery and at 1 wk,1,6,and 12 mo after surgery.The OPD-Scan III was utilized to assess high-order aberrations,while the optical quality analysis system(OQAS)was employed to evaluate modulation transfer function(MTF cutoff),Strehl ratio(SR),and objective scatter index(OSI)for the purpose of visual quality assessment.Paired t-tests and repeated measures analysis of variance(ANOVA)were utilized to compare the results,and the SNK-q post hoc test was applied to identify significant differences.RESULTS:The polishing group’s uncorrected distant visual acuity(UDVA)and uncorrected near visual acuity(UNVA)significantly improved 1-week post-surgery(all P<0.05).At 12-months,UDVA,UNVA,and corrected distant visual acuity(CDVA)were better than the control group(P<0.05).The MTF cutoff,SR,OSI,and high-order aberrations in the polishing group also showed significant improvements compared to the control group at 12 mo(P<0.05).CONCLUSION:The improved capsular polishing method has been demonstrated to effectively maintain visual acuity and visual quality in patients with MIOL after FLACS within 1 a.
文摘Aim To establish a LC-MS method for determining the concentration of nifedipine in human plasma and to evaluate the pharmacokinetic characteristics of nifedipine sustained-release tablets. Methods A XB-C18 （5 μm, 4.6 mm ×150 mm） column and a mobile phase of methanol： 0.01 mol·L^-1ammonium acetate （60：40, V/V） were used to separate nifedipine, the detections was accuracy under atmosperic pressure electronic spray ionization （AP-ESI） mode and ion mass spectrum （m/z） of 314.9 [M＋H]^＋ for nifedipine, and 320.8 [M＋H]^＋ for lorazepam （Internal Standard, IS）. Results The linear range of nifedipine was 0.3 - 80 ng·mL^-1 （ r = 0.9997）, and the limit of quantitation （LOQ） was 0.3 ng·mL^-1. The nifedipine pharmacokinetic parameters after a single dose of 20 mg nifedipine sustained-release tablets test （T） or reference （R） were as the followings, t1/2 （6.73 ± 2.00） h and （7.04 ± 2.18） h, Tmax （4.28 ± 0.70） h and （4.48 ± 0.70） h, Cmax（39.66 ± 10.58） ng·mL^-1 and （40.19 ± 10.97） ng·mL^-1, AUC0-36 （391.63 ± 108.55） ng·mL^-1·h and （387.57 ± 121.51） ng·mL^-1·h, and AUC0-∞ （408.28 ± 121.16） ng·mL^-1·h and （406.15 ± 133.13） ng·mL^-1·h. The relative bioavailability of nifedipine sustained-release tablets （test） was （103.02 ± 13.93） %. Conclusion LC-MS method for the determination of concentrations of nifedipine in human plasma was sensitive and accurate, and could be used in nifedipine bioavailability and pharmacokinetic studies.
基金Guangdong Administration of Traditional Chinese Medicine Research Projects China (Grant No. 2010200)a cooperation Project in Industry, Education and Research of Guangdong Province and Ministry of Education of China (Grant No. 2009B090300349)+1 种基金a cooperation project of National Science Foundation of Guangdong Province (Grant No. 10351022401000000)a Guangzhou City Science and Technology Support Program (Grant No. 2009Z1-E361)
文摘Fufang Zhenzhu Tiaozhi capsules （FTZc）, which is consisted of eight traditional Chinese herbal medicines and contains multiple bioactive ingredients, is a patented and clinically approved herbal formulation for the treatment of dyslipidemia. A feasible HPLC-DAD-ELSD method was developed to simultaneously determine 15 bioactive compounds （salidroside, specneuzhenide, magnoflorine, rosmarinic acid, salvianolic acid B, columbamine, jatrorrhizine, epiberberine, coptisine, palmatine, berberine, 5,7-dimethoxycoumarin, ginsenoside Rgl, ginsenoside Rbl and oleanic acid ） in FTZc for its quality control. The multiple wavelength detection mode of DAD was used. The chromatographic separation was performed on an Ultimate XB Cls column with gradient elution. The mobile phase A （acetonitrile） and B （0.25% glacial acetic acid and 0.13% triethylamine in water, v/v） were run at a flow rate of 0.8 mL/min. The developed method showed good precision and accuracy with overall intra- and inter-day variations of 0.7%-1.9% and 0.6%-3.0%, respectively. The recoveries measured at three concentration levels, varied from 95.5% to 103.8%. The validated method was successfully applied for the simultaneous determination of 15 bioactive compounds in three batches of FTZc. The results suggested that the developed method was convenient and reliable, particularly suitable for the routine quality control of FTZc.
