BACKGROUND Rheumatic immune diseases are a group of chronic inflammatory diseases charac-terized by joint and systemic multi-organ involvement,including rheumatoid arthritis,systemic lupus erythematosus,and Sjogren’s...BACKGROUND Rheumatic immune diseases are a group of chronic inflammatory diseases charac-terized by joint and systemic multi-organ involvement,including rheumatoid arthritis,systemic lupus erythematosus,and Sjogren’s syndrome,among others.The pathogenesis of these diseases is related to the abnormal activation and regulatory imbalance of the immune system.The prevalence and morbidity of rheumatic immune diseases are high,imposing a significant burden on patients'quality of life and socio-economic costs.Currently,the treatment of rheumatic immune diseases mainly relies on Western medicine,such as non-steroidal anti-inflammatory drugs,glucocorticoids,disease-modifying antirheumatic drugs,and biologics.However,the therapeutic effects of Western medicine are not ideal,some patients poorly respond or are resistant to Western medicine,and long-term use often causes various adverse reactions.AIM To systematically evaluate the efficacy and safety of Tripterygium wilfordii gly-cosides tablets combined with Western medicine in the treatment of patients with rheumatic immune diseases.METHODS This study conducted a meta-analysis to systematically evaluate the efficacy and safety of Tripterygium wilfordii glycosides tablets combined with Western medicine for patients with rheumatic immune diseases.Chinese and English databases were searched for randomized controlled trials(RCTs)on the treatment of rheumatic immune diseases with Tripterygium wilfordii glycosides tablets combined with Western medicine.The quality of the included studies was assessed using the Cochrane risk of bias assessment tool.Meta-analysis was performed using RevMan 5.4 software.RESULTS The meta-analysis included 11 RCTs involving 1026 patients with rheumatic immune diseases.The combined treatment significantly reduced the risk of disease recurrence(relative risk=1.07,95%confidence interval:1.01-1.15,P<0.05)and showed no significant heterogeneity(I2=0%,P=0.53),indicating that Tripterygium wilfordii glycosides tablets combined with Western medicine is an effective method to reduce the possibility of postoperative recurrence in patients with rheumatic immune diseases.However,due to the limited number and quality of the studies included,these results should be interpreted with caution.CONCLUSION Tripterygium wilfordii glycosides tablets combined with Western medicine is an effective and safe treatment option for patients with rheumatic immune diseases and can be considered a clinical choice.However,more high-quality research is needed to validate this conclusion and provide more solid evidence for clinical practice.展开更多
Objective:To evaluate the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease,in order to provide a more scientific basis for the application of the drug in Parkinson’s disease.Methods:...Objective:To evaluate the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease,in order to provide a more scientific basis for the application of the drug in Parkinson’s disease.Methods:This study is a single-arm,prospective,observational study.The trial collected patients with primary Parkinson’s disease who met the inclusion and exclusion criteria after being assessed by the investigator to evaluate the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease patients through UPDRSIII and UPDRSII scales,and evaluated the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease patients.Results:A total of 3560 patients were included in this study.44.1%of patients had early Parkinson’s disease,52.4%had intermediate Parkinson’s disease,and 3.5%had advanced Parkinson’s disease.The UPDRSIII(exercise capacity)score was 26.76 at baseline,25.47 at 1 month,24.18 at 2 months,and 23.39 at 3 months after treatment,and scores significantly improved over time(P<0.001).The UPDRSII(ability to perform daily living)score was an average of 23.60 at baseline,22.49 at 1 month,21.53 at 2 months,and 21.09 at 3 months after treatment,with statistically significant differences in scores between months(P<0.001).A total of 18 adverse events/reactions occurred in this study,and adverse symptoms eventually disappeared or resolved,without termination due to adverse events/reactions or patient discharge.Conclusion:Rasagiline tablets have significant efficacy in improving daily exercise capacity and living ability in patients with Parkinson’s disease,and have a certain safety,which supports the effectiveness of rasagiline as a treatment for Parkinson’s disease and provides new evidence for its clinical application.展开更多
Objective:To evaluate the clinical effect of combined therapy with Diosmin Tablets and Mayinglong Musk Hemorrhoids Ointment for patients with acute hemorrhoids.Methods:A total of 50 patients with acute hemorrhoids who...Objective:To evaluate the clinical effect of combined therapy with Diosmin Tablets and Mayinglong Musk Hemorrhoids Ointment for patients with acute hemorrhoids.Methods:A total of 50 patients with acute hemorrhoids who visited the hospital from January 2023 to January 2025 were selected as samples and randomly divided into two groups.Group A was treated with Diosmin Tablets combined with Mayinglong Musk Hemorrhoids Ointment,while Group B was treated with Mayinglong Musk Hemorrhoids Ointment only.The efficacy,wound recovery time,perianal pain score,hemorrhoid symptom score,and stress indicators were compared between the two groups.Results:The efficacy of Group A was higher than that of Group B(P<0.05).The postoperative perianal edema time and wound healing time in Group A were shorter than those in Group B,and the Visual Analog Scale(VAS)score was lower than that in Group B(P<0.05).The hemorrhoid symptom score in Group A was lower than that in Group B(P<0.05).The stress level in Group A was lower than that in Group B(P<0.05).Conclusion:The combination therapy of Diosmin Tablets and Mayinglong Musk Hemorrhoids Ointment for postoperative treatment of acute hemorrhoids can effectively relieve perianal pain,shorten the duration of hemorrhoids,and is highly feasible.展开更多
Objective:To analyze the efficacy of Bifidobacterium triple viable bacteria tablets on neonatal necrotizing enterocolitis(NEC)and its impact on serum factors of the patients.Methods:From January 2021 to May 2025,88 ne...Objective:To analyze the efficacy of Bifidobacterium triple viable bacteria tablets on neonatal necrotizing enterocolitis(NEC)and its impact on serum factors of the patients.Methods:From January 2021 to May 2025,88 neonates with NEC admitted to our hospital were selected as study subjects.During the study,these 88 patients were evenly divided into two groups,namely the observation group and the control group,with 44 patients in each group based on the random number table method.In terms of treatment,the control group was treated with meropenem,while the observation group received additional treatment with Bifidobacterium triple viable bacteria powder based on the treatment plan of the control group.The clinical efficacy and differences in serum inflammatory factor levels between the two groups were compared.Results:The efficacy of the observation group(90.91%)was better than that of the control group(72.73%)(P<0.05).After treatment,the levels of C-reactive protein(CRP)and procalcitonin(PCT)in both groups decreased compared to those before treatment,and the values of the above indicators in the observation group were lower than those in the control group(P<0.05).Conclusion:Based on conventional treatment for NEC neonates,the use of Bifidobacterium triple viable bacteria tablets has significant efficacy and can effectively reduce serum inflammatory factor levels.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:To analyze the therapeutic efficacy of Shexiang Baoxin Pill combined with Rosuvastatin Calcium Tablets(ROS)in patients with angina pectoris due to coronary atherosclerotic heart disease(CHD-AP).Methods:Eight...Objective:To analyze the therapeutic efficacy of Shexiang Baoxin Pill combined with Rosuvastatin Calcium Tablets(ROS)in patients with angina pectoris due to coronary atherosclerotic heart disease(CHD-AP).Methods:Eighty CHD-AP patients admitted for treatment from January 2023 to December 2024 were selected and evenly divided using a random number table.The combined group(40 cases)received treatment with Shexiang Baoxin Pill combined with ROS,while the reference group(40 cases)received ROS monotherapy.The overall response rate,frequency and duration of AP attacks,blood lipid levels,and cardiac function indicators were compared between the two groups.Results:The combined group exhibited a higher overall response rate than the reference group.After treatment,the frequency and duration of AP attacks were lower in the combined group than in the reference group.Additionally,blood lipid levels and cardiac function indicators were superior in the combined group(p<0.05).Conclusion:The combination of Shexiang Baoxin Pill and ROS demonstrates favorable therapeutic effects in CHD-AP patients,effectively preventing AP attacks,regulating blood lipid levels,protecting cardiac function,and reducing disease risk.展开更多
Confucius’imminent birth is heralded by the appearance of the qilin.The mythical one-horned animal came to his mother at the door and cast out of its mouth a jade tablet bearing an inscription saying that she would g...Confucius’imminent birth is heralded by the appearance of the qilin.The mythical one-horned animal came to his mother at the door and cast out of its mouth a jade tablet bearing an inscription saying that she would give birth to“the son of the refinement of water,and that he would succeed the Zhou Dynasty,but as a king without a throne(su wang).”Stunned,Yan Zhengzai–Confucius’mother–tied an embroidered ribbon around the horn of the qilin,and the animal stayed for two nights.展开更多
Aim To establish a reversed phase liquid chromatographic method forsimultaneous determination of three main medicinal constituents, baicalin, berberine and rhein, inSanhuang tablets. Methods The separation was perform...Aim To establish a reversed phase liquid chromatographic method forsimultaneous determination of three main medicinal constituents, baicalin, berberine and rhein, inSanhuang tablets. Methods The separation was performed on a Kromasil C_(18) column with TEA-adjusted0.02 mol·L^(-1) H_3PO_4 (pH 6.78)-acetonitrile-methanol (40 : 9 : 7) as mobile phase at aflow-rate of 1.0 mL·min^(-1), with detection at 254 ran. Considering interaction between acidic andalkaline compounds, three standard markers were added respectively and the volume of samplesolution was doubled in recovery experiments. Results Three regression equations revealed excellentlinear relationship between the peak areas and concentrations and the correlation coefficients allsurpassed 0.999 8. The average recovery was 96.1% (RSD = 2.1%) baicalin, 98.5% (RSD = 2.4%) forberberine, and 101.5% (RSD =1.3%) for rhein. Conclusion The method developed can be used to controlthe quality of Sanhuang tablets comprehensively.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
Ahn To develop a high resolution HPLC method for the determination of ondansetron in human plasma and to study the pharmacokinetics of ondansetron in orally disintegrating tablets. Methods HPLC determination involved ...Ahn To develop a high resolution HPLC method for the determination of ondansetron in human plasma and to study the pharmacokinetics of ondansetron in orally disintegrating tablets. Methods HPLC determination involved liquid-liquid extraction, separation on a CN column and ultraviolet detection at 310 ran with granisetron as an internal standard. Pharmacokinetics and bioequivalence of ondansetron in orally disintegrating tablets by direct compression and conventional 8 mg tablets were evaluated and compared in 20 healthy human male volunteers after a single oral dose in a randomized cross-over study. Results The limit of quantification was 0.25 ng· mL^-1. The recovery was about 85 % or over for ondan setron and about 90% for internal standard. Linearity was good within the concentration range of 0.5 - 50 ng·mL^-1 with r^2 ranging from 0.997 1 to 0.999 9. Intra- and inter-assay coefficients of variation ranged from 1.78% to 2.38% and 3.88% -5.19%, respectively. Accuracies for spiked concentrations of 2.0, 10.0, and 30.0 ng·mL^-1 were 104.7% ±4.4%, 102.2% ± 1.1%, and99.51% ±2.34%, respectively. Pharmacokinetic parameters of AUCo-t, AUCo-∞ , Cmax, Tmax, and T1/2 were 230.2 ± 78.0 ng·h·L^-1 , 265.2± 101.5 ng·h·mL^-1, 35.67 ± 8.94 ng·mL^-l, 1.51 ±0.79 h, and 5.00± 1.41 h for orally disintegrating tablets, respectively. The analysis of variance did not show any significant difference between orally disintegrating tablets and conventional tablets, and 90% confidence intervals fell within the acceptable range for bioequivalence. Conclusion High resolution HPLC method has been set up and applied in pharmacokinetic evaluation of ondansetron in orally disintegrating tablets.展开更多
A qualitative and quantitative test method of fingerprint of Wuji gastric floating sustained-release tablets was established. High performance liquid chromatography （HPLC） was adopted, using Agilent ZORBAX SB-C18 co...A qualitative and quantitative test method of fingerprint of Wuji gastric floating sustained-release tablets was established. High performance liquid chromatography （HPLC） was adopted, using Agilent ZORBAX SB-C18 column （250 mm×4.6 mm, 5 μm） as the chromatographic column, and acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution as the mobile phase in a gradient elution with the flow rate of 1.0 mL/min. Sample solution （10 μL） was injected and was tested at the wavelength of 225 nm for 75 min at the column temperature of 30 ℃, Fingerprint similarity software （2004A version） was used to conduct data analysis. A total of 11 batches of Wuji gastric floating sustained-release tablets were tested and analyzed with HPLC fingerprint. Seventeen common peaks were found and the similarity of the 11 batches of agents was greater than 0.9, indicating that the production process of the agent is stable and feasible. The method is operable and could effectively control the quality of Wuji gastric floating sustained-release tablets.展开更多
Aim In this study, compound metformin/glipizide bilayer extended release tablets were formulated with hydroxypropyl methylcellulose （HPMC） by wet granulation technique in order to tackle the problems associated with...Aim In this study, compound metformin/glipizide bilayer extended release tablets were formulated with hydroxypropyl methylcellulose （HPMC） by wet granulation technique in order to tackle the problems associated with the muhidrug therapy of non-insulin dependent diabetes mellitus. Me^ls High-dose metformin is difficult to formulate into a tablet dosage form due to its poor compressibility and compactibility. In this study, the way to overcome the difficulty was to utilize stearic alcohol to prepare the tablet formulation. The influences of viscosity, amount of HPMC, and weight of fillers were investigated. The optimal formulation had acceptable physicochemical properties and released metformin and glipizide over 10 h. Results The data of metformin obtained from in vitro release fitted Higuchi kinetics best, while the release of glipizide in vitro was found to follow zero kinetics. Conclusion Compound metformin/glipizide bilayer extended release tablets have been successfully developed.展开更多
The objectives of this present investigation were to develop and formulate nimesulide bilayer tablets by using different polymer combinations and fillers, to optimize the formulations for different drug release variab...The objectives of this present investigation were to develop and formulate nimesulide bilayer tablets by using different polymer combinations and fillers, to optimize the formulations for different drug release variables by orthogonal design and central composite design-surface methodology and to evaluate drug release pattern of the optimized product. The bilayer tablet containing a fast release layer（FRL） and a sustained release layer（SRL） provided an initial burst release of nimesulide, followed by the sustained release for a period of time. The optimal formulation obtained was as follows：（I） the formulation of FRL： nimesulide, 50 mg; lactose, 92 mg; starch, 22 mg; CCMC-Na, 14 mg; PVP K30, 1 mg; micronized silica gel, 1 mg; magnesium stearate, 0.9 mg; and iron oxide red, 0.1 mg; and（II） the formulation of SRL： nimesulide, 150 mg; HPMC K100LV, 26 mg; HPMC K4M, 33 mg; lactose, 54 mg; PVP K30, 1 mg; micronized silica gel, 1 mg; and magnesium stearate, 0.9 mg. According to the optimal formulation, the biphasic type of release was identified. The in vitro drug dissolution from the bilayer tablets was sustained for about 16 h after releasing 15% of drug in the first 10 min. The developed nimesulide bilayer tablets with improved efficacy can perform therapeutically better than the conventional tablets.展开更多
A rapid, accurate and sensitive HPLC method for the determination of bupropion hydrochloride in a new tablet formulation is described. Chromatographic separation of bupropion hydrochloride is achieved using a mobile p...A rapid, accurate and sensitive HPLC method for the determination of bupropion hydrochloride in a new tablet formulation is described. Chromatographic separation of bupropion hydrochloride is achieved using a mobile phase consisting of methanol -0.01 mol·L -1 ammonium dihydrogen phosphate (80:20, v/v, pH 4.8) at a flow rate of 1.0 mL·min -1 on a Hypersil BDS C18 column. Absorbance is monitored at 251 nm where bupropion hydrochloride has maximum absorption in the mobile phase. The linear range of determination for bupropion hydrochloride is between 2.12 and 21.2 μg·mL -1. The proposed method was validated with respect to accuracy, precision, limits of detection and quantification and robustness, etc.展开更多
The clinical pharmacokinetics of osmotic pump controlled release tablets of terazosin hydrochloride in healthy volunteers was studied.A sensitive and rapid HPLC method was used to determine the terazosin plasma concen...The clinical pharmacokinetics of osmotic pump controlled release tablets of terazosin hydrochloride in healthy volunteers was studied.A sensitive and rapid HPLC method was used to determine the terazosin plasma concentrations,and single and multiple doses of terazosin hydrochloride regular tablets（reference tablets）and osmotic pump controlled release tablets were orally administrated in randomized crossover design.The results showed that the C_（max）of the reference tablets after single oral dose（（120.56±23.15）ng/mL）in 20 healthy volunteers was significantly higher than that of controlled release tablets （（95.27±16.35）ng/mL）.The T_（max）of the controlled release tablets（（2.65±0.82）h）was significantly longer than that of reference tablets（（1.27±0.61）h）（P0.05）.The relative bioavailability of the controlled release tablets was found to be（105.85±6.12）%. The multiple oral dose pharmacokinetic parameters of the regular tablets and controlled release tablets were as follows：AUC_（SS） were（1275.17±175.35）and（1382.65±205.31）ng·h/mL respectively,C_（max）were（128.15±22.37）and（98.57±18.16）ng/mL respectively,T_（max）were（1.35±0.71）and（2.76±0.85）h respectively,C_（av）were（53.13±9.12）and（57.61±9.25）ng/mL respectively, and DF were（2.25±0.26）%and（1.62±0.25）%respectively.The relative bioavailability of the controlled release tablets to the reference tablets was（108.43±6.26）%.The controlled release tablet of terazosin hydrochloride was bioequivalent to the reference tablet.The controlled release tablet exhibited a sustained-release property with a significantly longer T_（max）and lower C_（max）.展开更多
To investigate the pharmacokinetic characteristics of moclobemide sustainedrelease tablets after multiple oral dose administration in healthy Chinese volunteers. MethodsMoclobemide sustained release tablets were given...To investigate the pharmacokinetic characteristics of moclobemide sustainedrelease tablets after multiple oral dose administration in healthy Chinese volunteers. MethodsMoclobemide sustained release tablets were given as a multiple oral dose regimen of 300 mg oncedaily for five consecutive days to 12 healthy volunteers. The concentrations of moclobemide inplasma were determined by reversed-phase high performance liquid chromatography. The partialpharmacokinetic parameters were calculated using 3p97 pharmacokinetic program. Results Theconcentration-time profile fitted an one-compartment model best. The steady-state pharmacokineticparameters of moclobemide sustained release tablets after multiple oral doses were as follows:C_(max) was (1 950 +- 156) μg· L^(-1), T_(max) was (6.00 +-1.55) h, T_(1/2(kel)) was (3.14 +-0.12)h, AUC_(ss 0-24) was (22 836 +- 1 842) μg·h· L^(-1), MRT was (7.68+-0.36) h, CL/F_((s)) was(20.2+-2.1) L·h^(-1), and V/F_((c)) was (91.4+-9.4) L, respectively. No marked adverse events werenoted during this study. Conclusion The formulation has a sustained-release effect and goodtolerance in the healthy volunteers, which provides useful information for clinical practice.展开更多
The pharmacokinetics of morphine sulphate was studied in 10 Chinese healthy volunteers after a single oral dose. Blood samples were collected before and after administration of controlled release tablets (CRMS, 30 mg)...The pharmacokinetics of morphine sulphate was studied in 10 Chinese healthy volunteers after a single oral dose. Blood samples were collected before and after administration of controlled release tablets (CRMS, 30 mg) and immediate release tablets (IRMS, 20 mg). The plasma concentration of morphine was determined by GC MS. The pharmacokinetic parameters of controlled release tablets and immediate release tablets were calculated∶ C max was 19.38±3.80 and 21.27±6.21 ng/ml, t max was 2.36 ±0.37 h and 0.56±0.16 h, t 1/2β was 3.53±0.87 and 3.03±0.74 h, AUC was 145.15±17.65 and 93.08±16.65 ng/ml, respectively. The steady state plasma concentration of morphine sulphate in cancer patients after multiple doses was achieved, C max of CRMS and IRMS was 27.43±0.33 ng/ml and 22.68±0.16 ng/ml, C min of CRMS and IRMS was 19.45±1.44 ng/ml and 18.14±0.49 ng/ml, respectively.展开更多
AIM: To compare efficacy, patient compliance, acceptability, satisfaction, safety, and adenoma detection rate of sodium phosphate tablets (NaP, CLICOLON<sup>TM</sup>) to a standard 4 L polyethylene glycol ...AIM: To compare efficacy, patient compliance, acceptability, satisfaction, safety, and adenoma detection rate of sodium phosphate tablets (NaP, CLICOLON<sup>TM</sup>) to a standard 4 L polyethylene glycol (PEG) solution for bowel cleansing for adults undergoing colonoscopy.展开更多
The aim of the study was to develop actarit double-layered osmotic pump tablets to overcome the weak points of actarit common tablets, such as short half-life and large plasma concentration fluctuations. Single factor...The aim of the study was to develop actarit double-layered osmotic pump tablets to overcome the weak points of actarit common tablets, such as short half-life and large plasma concentration fluctuations. Single factor experiment and orthogonal test were applied to optimize the formulation;the pharmacokinetic study was performed in beagle dogs adopting actarit common tablets as reference tablets. The optimal formulation was as follows: drug layer: 150 mg actarit, 240 mg PEO-N80, 50 mg NaCl;push layer: 140 mg PEO-WSR303, 20 mg NaCl;coating solution: 30 g cellulose acetate and 6 g PEG 4000 in 1000 ml 94% acetone solution, 60 mg coating weight gain. The pharmacokinetic study showed that T max was prolonged by the contrast of commercial common tablets with constant drug release rate, but the bioavailability was equivalent. And a good in vivo –in vitro correlation of the actarit osmotic pump tablets was also established. The designed actarit osmotic pump tablets can be applied for rheumatoid arthritis, proposing a promising replacement for the marked common products.展开更多
文摘BACKGROUND Rheumatic immune diseases are a group of chronic inflammatory diseases charac-terized by joint and systemic multi-organ involvement,including rheumatoid arthritis,systemic lupus erythematosus,and Sjogren’s syndrome,among others.The pathogenesis of these diseases is related to the abnormal activation and regulatory imbalance of the immune system.The prevalence and morbidity of rheumatic immune diseases are high,imposing a significant burden on patients'quality of life and socio-economic costs.Currently,the treatment of rheumatic immune diseases mainly relies on Western medicine,such as non-steroidal anti-inflammatory drugs,glucocorticoids,disease-modifying antirheumatic drugs,and biologics.However,the therapeutic effects of Western medicine are not ideal,some patients poorly respond or are resistant to Western medicine,and long-term use often causes various adverse reactions.AIM To systematically evaluate the efficacy and safety of Tripterygium wilfordii gly-cosides tablets combined with Western medicine in the treatment of patients with rheumatic immune diseases.METHODS This study conducted a meta-analysis to systematically evaluate the efficacy and safety of Tripterygium wilfordii glycosides tablets combined with Western medicine for patients with rheumatic immune diseases.Chinese and English databases were searched for randomized controlled trials(RCTs)on the treatment of rheumatic immune diseases with Tripterygium wilfordii glycosides tablets combined with Western medicine.The quality of the included studies was assessed using the Cochrane risk of bias assessment tool.Meta-analysis was performed using RevMan 5.4 software.RESULTS The meta-analysis included 11 RCTs involving 1026 patients with rheumatic immune diseases.The combined treatment significantly reduced the risk of disease recurrence(relative risk=1.07,95%confidence interval:1.01-1.15,P<0.05)and showed no significant heterogeneity(I2=0%,P=0.53),indicating that Tripterygium wilfordii glycosides tablets combined with Western medicine is an effective method to reduce the possibility of postoperative recurrence in patients with rheumatic immune diseases.However,due to the limited number and quality of the studies included,these results should be interpreted with caution.CONCLUSION Tripterygium wilfordii glycosides tablets combined with Western medicine is an effective and safe treatment option for patients with rheumatic immune diseases and can be considered a clinical choice.However,more high-quality research is needed to validate this conclusion and provide more solid evidence for clinical practice.
文摘Objective:To evaluate the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease,in order to provide a more scientific basis for the application of the drug in Parkinson’s disease.Methods:This study is a single-arm,prospective,observational study.The trial collected patients with primary Parkinson’s disease who met the inclusion and exclusion criteria after being assessed by the investigator to evaluate the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease patients through UPDRSIII and UPDRSII scales,and evaluated the efficacy and safety of rasagiline tablets in the treatment of Parkinson’s disease patients.Results:A total of 3560 patients were included in this study.44.1%of patients had early Parkinson’s disease,52.4%had intermediate Parkinson’s disease,and 3.5%had advanced Parkinson’s disease.The UPDRSIII(exercise capacity)score was 26.76 at baseline,25.47 at 1 month,24.18 at 2 months,and 23.39 at 3 months after treatment,and scores significantly improved over time(P<0.001).The UPDRSII(ability to perform daily living)score was an average of 23.60 at baseline,22.49 at 1 month,21.53 at 2 months,and 21.09 at 3 months after treatment,with statistically significant differences in scores between months(P<0.001).A total of 18 adverse events/reactions occurred in this study,and adverse symptoms eventually disappeared or resolved,without termination due to adverse events/reactions or patient discharge.Conclusion:Rasagiline tablets have significant efficacy in improving daily exercise capacity and living ability in patients with Parkinson’s disease,and have a certain safety,which supports the effectiveness of rasagiline as a treatment for Parkinson’s disease and provides new evidence for its clinical application.
文摘Objective:To evaluate the clinical effect of combined therapy with Diosmin Tablets and Mayinglong Musk Hemorrhoids Ointment for patients with acute hemorrhoids.Methods:A total of 50 patients with acute hemorrhoids who visited the hospital from January 2023 to January 2025 were selected as samples and randomly divided into two groups.Group A was treated with Diosmin Tablets combined with Mayinglong Musk Hemorrhoids Ointment,while Group B was treated with Mayinglong Musk Hemorrhoids Ointment only.The efficacy,wound recovery time,perianal pain score,hemorrhoid symptom score,and stress indicators were compared between the two groups.Results:The efficacy of Group A was higher than that of Group B(P<0.05).The postoperative perianal edema time and wound healing time in Group A were shorter than those in Group B,and the Visual Analog Scale(VAS)score was lower than that in Group B(P<0.05).The hemorrhoid symptom score in Group A was lower than that in Group B(P<0.05).The stress level in Group A was lower than that in Group B(P<0.05).Conclusion:The combination therapy of Diosmin Tablets and Mayinglong Musk Hemorrhoids Ointment for postoperative treatment of acute hemorrhoids can effectively relieve perianal pain,shorten the duration of hemorrhoids,and is highly feasible.
基金Project Name:Correlation Analysis between Intestinal Flora and Differential Proteins in Intestinal Tissue of Neonatal Necrotizing Enterocolitis(Project No.:FYX202336)。
文摘Objective:To analyze the efficacy of Bifidobacterium triple viable bacteria tablets on neonatal necrotizing enterocolitis(NEC)and its impact on serum factors of the patients.Methods:From January 2021 to May 2025,88 neonates with NEC admitted to our hospital were selected as study subjects.During the study,these 88 patients were evenly divided into two groups,namely the observation group and the control group,with 44 patients in each group based on the random number table method.In terms of treatment,the control group was treated with meropenem,while the observation group received additional treatment with Bifidobacterium triple viable bacteria powder based on the treatment plan of the control group.The clinical efficacy and differences in serum inflammatory factor levels between the two groups were compared.Results:The efficacy of the observation group(90.91%)was better than that of the control group(72.73%)(P<0.05).After treatment,the levels of C-reactive protein(CRP)and procalcitonin(PCT)in both groups decreased compared to those before treatment,and the values of the above indicators in the observation group were lower than those in the control group(P<0.05).Conclusion:Based on conventional treatment for NEC neonates,the use of Bifidobacterium triple viable bacteria tablets has significant efficacy and can effectively reduce serum inflammatory factor levels.
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:To analyze the therapeutic efficacy of Shexiang Baoxin Pill combined with Rosuvastatin Calcium Tablets(ROS)in patients with angina pectoris due to coronary atherosclerotic heart disease(CHD-AP).Methods:Eighty CHD-AP patients admitted for treatment from January 2023 to December 2024 were selected and evenly divided using a random number table.The combined group(40 cases)received treatment with Shexiang Baoxin Pill combined with ROS,while the reference group(40 cases)received ROS monotherapy.The overall response rate,frequency and duration of AP attacks,blood lipid levels,and cardiac function indicators were compared between the two groups.Results:The combined group exhibited a higher overall response rate than the reference group.After treatment,the frequency and duration of AP attacks were lower in the combined group than in the reference group.Additionally,blood lipid levels and cardiac function indicators were superior in the combined group(p<0.05).Conclusion:The combination of Shexiang Baoxin Pill and ROS demonstrates favorable therapeutic effects in CHD-AP patients,effectively preventing AP attacks,regulating blood lipid levels,protecting cardiac function,and reducing disease risk.
文摘Confucius’imminent birth is heralded by the appearance of the qilin.The mythical one-horned animal came to his mother at the door and cast out of its mouth a jade tablet bearing an inscription saying that she would give birth to“the son of the refinement of water,and that he would succeed the Zhou Dynasty,but as a king without a throne(su wang).”Stunned,Yan Zhengzai–Confucius’mother–tied an embroidered ribbon around the horn of the qilin,and the animal stayed for two nights.
基金Innovation Fund of Chinese Academy of Sciences(KGCX2 SW 213 05)
文摘Aim To establish a reversed phase liquid chromatographic method forsimultaneous determination of three main medicinal constituents, baicalin, berberine and rhein, inSanhuang tablets. Methods The separation was performed on a Kromasil C_(18) column with TEA-adjusted0.02 mol·L^(-1) H_3PO_4 (pH 6.78)-acetonitrile-methanol (40 : 9 : 7) as mobile phase at aflow-rate of 1.0 mL·min^(-1), with detection at 254 ran. Considering interaction between acidic andalkaline compounds, three standard markers were added respectively and the volume of samplesolution was doubled in recovery experiments. Results Three regression equations revealed excellentlinear relationship between the peak areas and concentrations and the correlation coefficients allsurpassed 0.999 8. The average recovery was 96.1% (RSD = 2.1%) baicalin, 98.5% (RSD = 2.4%) forberberine, and 101.5% (RSD =1.3%) for rhein. Conclusion The method developed can be used to controlthe quality of Sanhuang tablets comprehensively.
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.
文摘Ahn To develop a high resolution HPLC method for the determination of ondansetron in human plasma and to study the pharmacokinetics of ondansetron in orally disintegrating tablets. Methods HPLC determination involved liquid-liquid extraction, separation on a CN column and ultraviolet detection at 310 ran with granisetron as an internal standard. Pharmacokinetics and bioequivalence of ondansetron in orally disintegrating tablets by direct compression and conventional 8 mg tablets were evaluated and compared in 20 healthy human male volunteers after a single oral dose in a randomized cross-over study. Results The limit of quantification was 0.25 ng· mL^-1. The recovery was about 85 % or over for ondan setron and about 90% for internal standard. Linearity was good within the concentration range of 0.5 - 50 ng·mL^-1 with r^2 ranging from 0.997 1 to 0.999 9. Intra- and inter-assay coefficients of variation ranged from 1.78% to 2.38% and 3.88% -5.19%, respectively. Accuracies for spiked concentrations of 2.0, 10.0, and 30.0 ng·mL^-1 were 104.7% ±4.4%, 102.2% ± 1.1%, and99.51% ±2.34%, respectively. Pharmacokinetic parameters of AUCo-t, AUCo-∞ , Cmax, Tmax, and T1/2 were 230.2 ± 78.0 ng·h·L^-1 , 265.2± 101.5 ng·h·mL^-1, 35.67 ± 8.94 ng·mL^-l, 1.51 ±0.79 h, and 5.00± 1.41 h for orally disintegrating tablets, respectively. The analysis of variance did not show any significant difference between orally disintegrating tablets and conventional tablets, and 90% confidence intervals fell within the acceptable range for bioequivalence. Conclusion High resolution HPLC method has been set up and applied in pharmacokinetic evaluation of ondansetron in orally disintegrating tablets.
基金The National Natural Science Foundation of China(Grant No.81460609)
文摘A qualitative and quantitative test method of fingerprint of Wuji gastric floating sustained-release tablets was established. High performance liquid chromatography （HPLC） was adopted, using Agilent ZORBAX SB-C18 column （250 mm×4.6 mm, 5 μm） as the chromatographic column, and acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution as the mobile phase in a gradient elution with the flow rate of 1.0 mL/min. Sample solution （10 μL） was injected and was tested at the wavelength of 225 nm for 75 min at the column temperature of 30 ℃, Fingerprint similarity software （2004A version） was used to conduct data analysis. A total of 11 batches of Wuji gastric floating sustained-release tablets were tested and analyzed with HPLC fingerprint. Seventeen common peaks were found and the similarity of the 11 batches of agents was greater than 0.9, indicating that the production process of the agent is stable and feasible. The method is operable and could effectively control the quality of Wuji gastric floating sustained-release tablets.
文摘Aim In this study, compound metformin/glipizide bilayer extended release tablets were formulated with hydroxypropyl methylcellulose （HPMC） by wet granulation technique in order to tackle the problems associated with the muhidrug therapy of non-insulin dependent diabetes mellitus. Me^ls High-dose metformin is difficult to formulate into a tablet dosage form due to its poor compressibility and compactibility. In this study, the way to overcome the difficulty was to utilize stearic alcohol to prepare the tablet formulation. The influences of viscosity, amount of HPMC, and weight of fillers were investigated. The optimal formulation had acceptable physicochemical properties and released metformin and glipizide over 10 h. Results The data of metformin obtained from in vitro release fitted Higuchi kinetics best, while the release of glipizide in vitro was found to follow zero kinetics. Conclusion Compound metformin/glipizide bilayer extended release tablets have been successfully developed.
基金Important National Science & Technology Specific Projects of China(Grant No.2012ZX09301003-001-009)
文摘The objectives of this present investigation were to develop and formulate nimesulide bilayer tablets by using different polymer combinations and fillers, to optimize the formulations for different drug release variables by orthogonal design and central composite design-surface methodology and to evaluate drug release pattern of the optimized product. The bilayer tablet containing a fast release layer（FRL） and a sustained release layer（SRL） provided an initial burst release of nimesulide, followed by the sustained release for a period of time. The optimal formulation obtained was as follows：（I） the formulation of FRL： nimesulide, 50 mg; lactose, 92 mg; starch, 22 mg; CCMC-Na, 14 mg; PVP K30, 1 mg; micronized silica gel, 1 mg; magnesium stearate, 0.9 mg; and iron oxide red, 0.1 mg; and（II） the formulation of SRL： nimesulide, 150 mg; HPMC K100LV, 26 mg; HPMC K4M, 33 mg; lactose, 54 mg; PVP K30, 1 mg; micronized silica gel, 1 mg; and magnesium stearate, 0.9 mg. According to the optimal formulation, the biphasic type of release was identified. The in vitro drug dissolution from the bilayer tablets was sustained for about 16 h after releasing 15% of drug in the first 10 min. The developed nimesulide bilayer tablets with improved efficacy can perform therapeutically better than the conventional tablets.
文摘A rapid, accurate and sensitive HPLC method for the determination of bupropion hydrochloride in a new tablet formulation is described. Chromatographic separation of bupropion hydrochloride is achieved using a mobile phase consisting of methanol -0.01 mol·L -1 ammonium dihydrogen phosphate (80:20, v/v, pH 4.8) at a flow rate of 1.0 mL·min -1 on a Hypersil BDS C18 column. Absorbance is monitored at 251 nm where bupropion hydrochloride has maximum absorption in the mobile phase. The linear range of determination for bupropion hydrochloride is between 2.12 and 21.2 μg·mL -1. The proposed method was validated with respect to accuracy, precision, limits of detection and quantification and robustness, etc.
文摘The clinical pharmacokinetics of osmotic pump controlled release tablets of terazosin hydrochloride in healthy volunteers was studied.A sensitive and rapid HPLC method was used to determine the terazosin plasma concentrations,and single and multiple doses of terazosin hydrochloride regular tablets（reference tablets）and osmotic pump controlled release tablets were orally administrated in randomized crossover design.The results showed that the C_（max）of the reference tablets after single oral dose（（120.56±23.15）ng/mL）in 20 healthy volunteers was significantly higher than that of controlled release tablets （（95.27±16.35）ng/mL）.The T_（max）of the controlled release tablets（（2.65±0.82）h）was significantly longer than that of reference tablets（（1.27±0.61）h）（P0.05）.The relative bioavailability of the controlled release tablets was found to be（105.85±6.12）%. The multiple oral dose pharmacokinetic parameters of the regular tablets and controlled release tablets were as follows：AUC_（SS） were（1275.17±175.35）and（1382.65±205.31）ng·h/mL respectively,C_（max）were（128.15±22.37）and（98.57±18.16）ng/mL respectively,T_（max）were（1.35±0.71）and（2.76±0.85）h respectively,C_（av）were（53.13±9.12）and（57.61±9.25）ng/mL respectively, and DF were（2.25±0.26）%and（1.62±0.25）%respectively.The relative bioavailability of the controlled release tablets to the reference tablets was（108.43±6.26）%.The controlled release tablet of terazosin hydrochloride was bioequivalent to the reference tablet.The controlled release tablet exhibited a sustained-release property with a significantly longer T_（max）and lower C_（max）.
文摘To investigate the pharmacokinetic characteristics of moclobemide sustainedrelease tablets after multiple oral dose administration in healthy Chinese volunteers. MethodsMoclobemide sustained release tablets were given as a multiple oral dose regimen of 300 mg oncedaily for five consecutive days to 12 healthy volunteers. The concentrations of moclobemide inplasma were determined by reversed-phase high performance liquid chromatography. The partialpharmacokinetic parameters were calculated using 3p97 pharmacokinetic program. Results Theconcentration-time profile fitted an one-compartment model best. The steady-state pharmacokineticparameters of moclobemide sustained release tablets after multiple oral doses were as follows:C_(max) was (1 950 +- 156) μg· L^(-1), T_(max) was (6.00 +-1.55) h, T_(1/2(kel)) was (3.14 +-0.12)h, AUC_(ss 0-24) was (22 836 +- 1 842) μg·h· L^(-1), MRT was (7.68+-0.36) h, CL/F_((s)) was(20.2+-2.1) L·h^(-1), and V/F_((c)) was (91.4+-9.4) L, respectively. No marked adverse events werenoted during this study. Conclusion The formulation has a sustained-release effect and goodtolerance in the healthy volunteers, which provides useful information for clinical practice.
文摘The pharmacokinetics of morphine sulphate was studied in 10 Chinese healthy volunteers after a single oral dose. Blood samples were collected before and after administration of controlled release tablets (CRMS, 30 mg) and immediate release tablets (IRMS, 20 mg). The plasma concentration of morphine was determined by GC MS. The pharmacokinetic parameters of controlled release tablets and immediate release tablets were calculated∶ C max was 19.38±3.80 and 21.27±6.21 ng/ml, t max was 2.36 ±0.37 h and 0.56±0.16 h, t 1/2β was 3.53±0.87 and 3.03±0.74 h, AUC was 145.15±17.65 and 93.08±16.65 ng/ml, respectively. The steady state plasma concentration of morphine sulphate in cancer patients after multiple doses was achieved, C max of CRMS and IRMS was 27.43±0.33 ng/ml and 22.68±0.16 ng/ml, C min of CRMS and IRMS was 19.45±1.44 ng/ml and 18.14±0.49 ng/ml, respectively.
文摘AIM: To compare efficacy, patient compliance, acceptability, satisfaction, safety, and adenoma detection rate of sodium phosphate tablets (NaP, CLICOLON<sup>TM</sup>) to a standard 4 L polyethylene glycol (PEG) solution for bowel cleansing for adults undergoing colonoscopy.
文摘The aim of the study was to develop actarit double-layered osmotic pump tablets to overcome the weak points of actarit common tablets, such as short half-life and large plasma concentration fluctuations. Single factor experiment and orthogonal test were applied to optimize the formulation;the pharmacokinetic study was performed in beagle dogs adopting actarit common tablets as reference tablets. The optimal formulation was as follows: drug layer: 150 mg actarit, 240 mg PEO-N80, 50 mg NaCl;push layer: 140 mg PEO-WSR303, 20 mg NaCl;coating solution: 30 g cellulose acetate and 6 g PEG 4000 in 1000 ml 94% acetone solution, 60 mg coating weight gain. The pharmacokinetic study showed that T max was prolonged by the contrast of commercial common tablets with constant drug release rate, but the bioavailability was equivalent. And a good in vivo –in vitro correlation of the actarit osmotic pump tablets was also established. The designed actarit osmotic pump tablets can be applied for rheumatoid arthritis, proposing a promising replacement for the marked common products.
