Creation of an efficient and safe medication is based on the knowledge of the world＇s best achievements in medicine and pharmacy. Development of new original medications and dosage forms, study of their specific medi...Creation of an efficient and safe medication is based on the knowledge of the world＇s best achievements in medicine and pharmacy. Development of new original medications and dosage forms, study of their specific medicinal properties, application and advantages over well-known brands are important for achieving a high quality medical assistance. The innovative product----original Ukrainian substance Flurenizide served as the basis for new dosage forms （solid, semisolid and liquid） intended for preventive care and treatment of dangerous and controlled infectious diseases for human and veterinary medicine.展开更多
Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Ag...Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Agkistrodon decoction, agkistrodon powder, and agkistrodon wine were administered daily starting from the onset of arthritis. Paw swelling degree was measured by using a volume-measuring instrument every 7 days after primary immunization. Arthritis index was measured and calculated using the ＂five scoring method＂ every 7 days. The levels of serum interleukin-1β（IL-1β） and type Ⅱ collagen Ig G antibodies were detected by enzyme-linked immunosorbent assay. Finally, all ankles were removed, and X-ray radiography was performed with In-vivo Imaging System FX. Samples were counterstained with hematoxylin and eosin for analysis. Results： Among the various dosage formulations of agkistrodon, high-dose powder, which was equivalent to an amount of 6 g/day in adults, showed better effects on the inhibition of joint swelling and reduction of arthritis index score. The relatively low levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, as well as the X-ray radiography and pathology results, further proved the superiority of the high-dose powder over the other formulations. The effect of decoction on inhibiting joint swelling was inversely proportional to the dosage. Other effects, such as reduction of arthritis index score and the levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, were directly proportional to the dosage. While the use of large dose agkistrodon wine led to negative effects. Conclusions： These data highlight the potential function of high-dose agkistrodon powder, which was equivalent to an amount of 6 g/day in adults. The powder can quickly relieve the symptoms of rheumatoid arthritis and prevent aggravation of disease, especially during the early period.展开更多
Two simple and sensitive spectrophotometric methods for the determination of cefetamet in either pure form or in its pharmaceutical formulations were described. The method Ⅰ is based on the interaction of 3-methylben...Two simple and sensitive spectrophotometric methods for the determination of cefetamet in either pure form or in its pharmaceutical formulations were described. The method Ⅰ is based on the interaction of 3-methylbenzo[d]- thiazolin-2-one hydrazone （MBTH） with cefetamet in the presence of freshly prepared ferric chloride in a neutral medium. The resulting blue colored product has λmax at 628 nm. The method Ⅱ describes the reduction of ferric ion by the drug to ferrous ion followed by a complex formation reaction with 1,10-phenanthroline （1,10-phen） to form an orange red colored chromogen exhibiting 2max at 510 nm. The products are stable for more than 5 and 8 h respectively. Common excipients used as additives in pharmaceutical preparations do not interfere in the proposed methods. Both methods are highly reproducible and have been applied to a wide variety of pharmaceutical preparations and the results are comparable with those of official methods.展开更多
Accurate application of dosage of Chinese herbs based on differentiation of symptoms and signs is an important link for a better therapeutic result with less adverse effects. Some of the experiences are briefly in... Accurate application of dosage of Chinese herbs based on differentiation of symptoms and signs is an important link for a better therapeutic result with less adverse effects. Some of the experiences are briefly introduced in the following aspects. ……展开更多
This study reviewed clinical evidence of probiotics-mediated effects on constipation.Four databases were used in the literature searches,namely Cochrane Library,Embase,Pubmed,and Web of Science.The last retrieval time...This study reviewed clinical evidence of probiotics-mediated effects on constipation.Four databases were used in the literature searches,namely Cochrane Library,Embase,Pubmed,and Web of Science.The last retrieval time was March 2021.Collected data were analyzed by Review Manager(version 5.3)and Stata(version 14).The primary search retrieved 8418 articles after removing duplicates.Eventually,26 studies were included in the meta-analysis.Administration of probiotics signifi cantly increased stool frequency(MD:1.15 times/week;95%CI:0.59 to 1.70;P<0.0001),improved bloating(MD:-0.48;95%CI:-0.89 to-0.07;P=0.02),reduced abdominal pain(MD:-0.71;95%CI:-1.25 to-0.16;P=0.01),and improved quality of life(MD:-0.73;95%CI:-1.37 to-0.10;P=0.02).However,the clinical effect of intake of probiotics on stool consistency was non-signifi cant(MD:0.07;95%CI:-0.34 to 0.48;P=0.73).Based on our analysis,probiotic supplements were effective in relieving constipation through symptom improvement.The effectiveness of dosage forms of intervention ranked:capsules>others(tablets,powder)>fermented milk.展开更多
Redox behavior of midazolam was studied at a glassy carbon electrode in various buffer systems,supporting electrolytes and pH using differential paise,square-wave and cyclic voltammetry.Based on its reduction behavior...Redox behavior of midazolam was studied at a glassy carbon electrode in various buffer systems,supporting electrolytes and pH using differential paise,square-wave and cyclic voltammetry.Based on its reduction behavior,a direct differential pulse voltammetric method has been developed and validated for the determination of midazolam in parenteral dosage.Three welldefined peaks were observed in 0.1％ SLS,Britton-Robinson (BR) buffer of pH 2.5.The effect of surfaetants like sodium lauryl sulfate (SLS),cetyl trimethyl ammonium bromide (CTAB) and Tween 20 was studied.Among these surfactants SLS showed significant enhancement in reduction peak.The cathodic peak currents were directly proportional to the concentration of midazolam with correlation coetfficient of 0.99.展开更多
Tadalafil(TAD)and dapoxetine HCl(DAP)are recently co-formulated and both show native fluorescence.Therefore,a novel,accurate,specific and sensitive reversed-phase high performance liquid chromatographic method with fl...Tadalafil(TAD)and dapoxetine HCl(DAP)are recently co-formulated and both show native fluorescence.Therefore,a novel,accurate,specific and sensitive reversed-phase high performance liquid chromatographic method with fluorescence detection was developed and validated for their separation and quantitation in dosage form and human plasma using avanafil as an internal standard(IS).Separation was achieved using isocratic elution within 7.0 min on C18column and acetonitrile-0.15%triethylamine(40∶60,v/v;pH 4)as a mobile phase.The flow rate was 1.0 mL/min and the detection was time-programmed at 330,410 and 370 nm for TAD,DAP and IS,respectively,after excitation at 236 nm.The linear ranges from 0.01 to 30.00μg/mL for each drug with the limits of detection of 4.20 and 7.20 ng/mL for TAD and DAP,respectively.The method was validated in accordance to the International Conference on Harmonization(ICH)guidelines and was successfully applied to spiked human plasma with mean recoveries of 98.17%and 98.83%for TAD and DAP respectively.展开更多
Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western ...Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.展开更多
Among the various research works going on nowadays, designing of controlled release dosage form is of great importance. For the development of suitable controlled release dosage form, a proper matrix needs to be forme...Among the various research works going on nowadays, designing of controlled release dosage form is of great importance. For the development of suitable controlled release dosage form, a proper matrix needs to be formed from which the drug release generally occur by polymer swelling, polymer erosion, drug dissolution/diffusion mechanism. HPMC （hydroxy propyl methyl cellulose）, also known as hypromellose, is one of the best known cellulosic polymers used in the development of controlled released drug delivery. It is available in various grades. Cellulosic polymers are ingredients that contain units linked together which help to retain water. Due to its high water absorptive capacity, it acts as an excellent hydrophilic gel forming polymer. HPMC generally hydrates on the outer surface to form a gelatinous layer which is critical to prevent wetting and rapid drug release from the matrices. If the drug is sparingly soluble in the system, the release of drug from the system is slow and helps in formulation of controlled release dosage form. In the ophthalmic dosage form, HPMC is used as a matrix that swells and expands after absorbing water and expand the thickness of the tear film.展开更多
Traditional Chinese medicine ointment is the main component of Chinese national medicine. Compared with traditional Chinese medicine decoction, ointment has great advantages, and the dosage is small and simple, which ...Traditional Chinese medicine ointment is the main component of Chinese national medicine. Compared with traditional Chinese medicine decoction, ointment has great advantages, and the dosage is small and simple, which can reduce the trouble of conventional decoction, and the taste will not change greatly. Because the ointment has the effects of moisturizing and strengthening the body, protecting internal organs and expelling disease pathogens, it is clinically suitable for patients with physical weakness, chronic disease and physical deficiency. In recent years, with the improvement of our understanding of the health of traditional Chinese medicine ointment, more and more people regard it as a manifestation of health preservation. The cream prescription, a brilliant pearl in Chinas ancient health culture, has also become an important symbol of modern human advocating a high-quality lifestyle. In autumn and winter, health preservation with plaster has become our tradition, so it is favored and respected by consumers.展开更多
The aim of the present study was to develop and characterize a gastroretentive dosage form suitable for controlled drug release.It consists of a drug loaded polymeric film made up of a bilayer of immediate(IR)and cont...The aim of the present study was to develop and characterize a gastroretentive dosage form suitable for controlled drug release.It consists of a drug loaded polymeric film made up of a bilayer of immediate(IR)and controlled release(CR)layers folded into a hard gelatin capsule.Gast roretention results from unfolding and swelling of the film and its bioadhesion to the gastric.mucosa.Furosemide,a drug with a narrow absorption window,was selected as the model drug.Inclusion of hydroxypropyl β-cyclodextrin in both layers and Carbopol■ 971P NF in the CR layer of the bilayer film resulted in optimum drug release,bioadhesion and mechanical properties.The film with zig-zag folding in the capsule was shown to unfold and swell under acidic conditions and provide IR of drugover 1 hand CR for up to 12 h in acidic medium.X-ray diffraction,differential scanning calorimetry and scanning electron microscopy revealed uniform dispersion of furosemide in the polymeric matrices.The results indicate the dosage form is gastroretentive and can provide controlled release of drugs with narrow therapeutic wind ows.展开更多
Nuclear radiation exposure events and tumor radiotherapy are highly susceptible to a range of psychological,physiological and other health problems,which can seriously affect patients'quality of life.It has been s...Nuclear radiation exposure events and tumor radiotherapy are highly susceptible to a range of psychological,physiological and other health problems,which can seriously affect patients'quality of life.It has been shown that 87.5%of tumor patients are exposed to varying degrees of radiation injury during radiotherapy.The treatment of radiation injury(RI)in modern medicine is limited to drug therapy,cell therapy,etc.Among them,the most chemical drugs cause many adverse reactions including fatigue,nausea,vomiting,etc.,and there are very few drugs dedicated to the treatment of RI.Traditional Chinese medicine(TCM)is a rich natural medicinal resource,which has a wide range of pharmacological activities,multiple targets of action and minimal toxic side effects.Many studies have demonstrated that TCM and its compound preparations have enormous potential in the treatment of radiation induced comprehensive diseases.However,TCM is limited in clinical application due to its slow onset of action,complex active ingredients,and low bioavailability.Therefore,the article reviews the application,molecular mechanisms,and new dosage forms of TCM in the prevention and treatment of RI.On this basis,we will focus on discussing the development advantages and application prospects of the combination of traditional Chinese and Western medicine to achieve highly efficient treatment of RI.This review aims to provide scientific and effective drug delivery strategies and basic theoretical support for the clinical effective treatment of RI with TCM,and further promote the innovative development of TCM.展开更多
Ionic liquid(IL)salts of active pharmaceutical ingredients(API)represent promising formulations for poorly-soluble APIs as they eliminate polymorphism commonly associated with conventional API salts.Being highly visco...Ionic liquid(IL)salts of active pharmaceutical ingredients(API)represent promising formulations for poorly-soluble APIs as they eliminate polymorphism commonly associated with conventional API salts.Being highly viscous liquid,oral dosage formulation of API-ILs is challenging,necessitating immobilization onto particulate carriers,typically by spray-drying.This study developed an alternative oral dosage formulation of API-ILs by incorporating them into soft gelatin-alginate pellets,where the alginate’s role was to improve storage stability of hygroscopic and thermally-sensitive gelatin.Poorly-soluble ibuprofen(IBU)and 1-butyl-3-methylimidazolium(BMIM)was used as the model API-IL.The impacts of alginate inclusion at varying gelatin-to-alginate ratios on quality attributes of IBU-BMIM-loaded pellets were investigated.The evaluated attributes included physical appearance,IBU-BMIM payload,dosage uniformity,flowability,IBU-BMIM release,and IBU solubility enhancement.The results showed IBU-BMIM remained in its liquid-like amorphous form upon incorporation into the pellets,thereby preserving its solubility enhancement capability,albeit at a lower degree due to slower IBU-BMIM release upon alginate inclusion.Alginate inclusion also influenced the pellets’physical appearance,thickness,flowability,and gelatin’s secondary structures,while having minimal impacts on payload and dosage uniformity.Importantly,the pellets remained stable after one-month of accelerated storage(40℃ and 75% relative humidity)with minimal variations in their quality attributes.展开更多
Pharmaceutical cocrystals are multicomponent systems in which at least one component is an active pharmaceutical ingredient and the others are pharmaceutically acceptable ingredients.Cocrystallization of a drug substa...Pharmaceutical cocrystals are multicomponent systems in which at least one component is an active pharmaceutical ingredient and the others are pharmaceutically acceptable ingredients.Cocrystallization of a drug substance with a coformer is a promising and emerging approach to improve the performance of pharmaceuticals,such as solubility,dissolution profile,pharmacokinetics and stability.This review article presents a comprehensive overview of pharmaceutical cocrystals,including preparation methods,physicochemical properties,and applications.Furthermore,some examples of drug cocrystals are highlighted to illustrate the effect of crystal structures on the various aspects of active pharmaceutical ingredients,such as physical stability,chemical stability,mechanical properties,optical properties,bioavailability,sustained release and therapeutic effect.This review will provide guidance for more efficient design and manufacture of pharmaceutical cocrystals with desired physicochemical properties and applications.展开更多
Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the...Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.展开更多
Derived from dry powder coating of metals, electrostatic powder coating for pharmaceuticals is a technology for coating drug solid dosage forms. In this technology, coating powders, containing coating polymers, pigmen...Derived from dry powder coating of metals, electrostatic powder coating for pharmaceuticals is a technology for coating drug solid dosage forms. In this technology, coating powders, containing coating polymers, pigments, and other excipients, are directly sprayed onto the surface of the solid dosage forms through an electrostatic gun without using any organic solvent or water. The deposited coating powders are further cured to form a coating film. Electrostatic powder coating technology has many advantages compared to other pharmaceutical coating methods. It can eliminate the limitations caused by the organic solvent in solvent coating such as environmental issues and health problems. And electrostatic powder coating technology also surpasses aqueous coating due to its shorter processing time and less energy consumption, leading to a lower overall cost. Furthermore, the utilization of electrical attraction can promote the movement of coating powders towards the substrate, leading to an enhanced coating powder adhesion and coating efficiency, which make it more promising compared to other dry coating technologies. The objective of this review is to summarize the coating principles, apparatus, and formulations of different electrostatic powder coating technologies, giving their advantages and limitations and also analyzing the future application in the industry for each technology展开更多
文摘Creation of an efficient and safe medication is based on the knowledge of the world＇s best achievements in medicine and pharmacy. Development of new original medications and dosage forms, study of their specific medicinal properties, application and advantages over well-known brands are important for achieving a high quality medical assistance. The innovative product----original Ukrainian substance Flurenizide served as the basis for new dosage forms （solid, semisolid and liquid） intended for preventive care and treatment of dangerous and controlled infectious diseases for human and veterinary medicine.
基金Supported by the Traditional Chinese Medicine Scientific Research Fund of Zhejiang Province,China(No.2013ZA063 and No.2012ZB062)the Key Scientific and Technological Innovation Team Plan of Zhejiang Province,China(No.2009R50042-002)the Third Level of 151 Talents Project of Zhejiang Province,China
文摘Objectives： To determine the effective dosage and formulation of agkistrodon in collagen-induced arthritis（CIA） rats. Methods： CIA was induced by injection of collagen in complete/incomplete Freund＇s adjuvant. Agkistrodon decoction, agkistrodon powder, and agkistrodon wine were administered daily starting from the onset of arthritis. Paw swelling degree was measured by using a volume-measuring instrument every 7 days after primary immunization. Arthritis index was measured and calculated using the ＂five scoring method＂ every 7 days. The levels of serum interleukin-1β（IL-1β） and type Ⅱ collagen Ig G antibodies were detected by enzyme-linked immunosorbent assay. Finally, all ankles were removed, and X-ray radiography was performed with In-vivo Imaging System FX. Samples were counterstained with hematoxylin and eosin for analysis. Results： Among the various dosage formulations of agkistrodon, high-dose powder, which was equivalent to an amount of 6 g/day in adults, showed better effects on the inhibition of joint swelling and reduction of arthritis index score. The relatively low levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, as well as the X-ray radiography and pathology results, further proved the superiority of the high-dose powder over the other formulations. The effect of decoction on inhibiting joint swelling was inversely proportional to the dosage. Other effects, such as reduction of arthritis index score and the levels of serum IL-1 and anti-type Ⅱ collagen Ig G antibodies, were directly proportional to the dosage. While the use of large dose agkistrodon wine led to negative effects. Conclusions： These data highlight the potential function of high-dose agkistrodon powder, which was equivalent to an amount of 6 g/day in adults. The powder can quickly relieve the symptoms of rheumatoid arthritis and prevent aggravation of disease, especially during the early period.
文摘Two simple and sensitive spectrophotometric methods for the determination of cefetamet in either pure form or in its pharmaceutical formulations were described. The method Ⅰ is based on the interaction of 3-methylbenzo[d]- thiazolin-2-one hydrazone （MBTH） with cefetamet in the presence of freshly prepared ferric chloride in a neutral medium. The resulting blue colored product has λmax at 628 nm. The method Ⅱ describes the reduction of ferric ion by the drug to ferrous ion followed by a complex formation reaction with 1,10-phenanthroline （1,10-phen） to form an orange red colored chromogen exhibiting 2max at 510 nm. The products are stable for more than 5 and 8 h respectively. Common excipients used as additives in pharmaceutical preparations do not interfere in the proposed methods. Both methods are highly reproducible and have been applied to a wide variety of pharmaceutical preparations and the results are comparable with those of official methods.
文摘 Accurate application of dosage of Chinese herbs based on differentiation of symptoms and signs is an important link for a better therapeutic result with less adverse effects. Some of the experiences are briefly introduced in the following aspects. ……
基金supported by the National Natural Science Foundation of China(31922071)the Natural Science Foundation of Inner Mongolia Autonomous Region of China(2021ZD08)Science Fund for Distinguished Young Scholars of Inner Mongolia Agricultural University(BR220301).
文摘This study reviewed clinical evidence of probiotics-mediated effects on constipation.Four databases were used in the literature searches,namely Cochrane Library,Embase,Pubmed,and Web of Science.The last retrieval time was March 2021.Collected data were analyzed by Review Manager(version 5.3)and Stata(version 14).The primary search retrieved 8418 articles after removing duplicates.Eventually,26 studies were included in the meta-analysis.Administration of probiotics signifi cantly increased stool frequency(MD:1.15 times/week;95%CI:0.59 to 1.70;P<0.0001),improved bloating(MD:-0.48;95%CI:-0.89 to-0.07;P=0.02),reduced abdominal pain(MD:-0.71;95%CI:-1.25 to-0.16;P=0.01),and improved quality of life(MD:-0.73;95%CI:-1.37 to-0.10;P=0.02).However,the clinical effect of intake of probiotics on stool consistency was non-signifi cant(MD:0.07;95%CI:-0.34 to 0.48;P=0.73).Based on our analysis,probiotic supplements were effective in relieving constipation through symptom improvement.The effectiveness of dosage forms of intervention ranked:capsules>others(tablets,powder)>fermented milk.
文摘Redox behavior of midazolam was studied at a glassy carbon electrode in various buffer systems,supporting electrolytes and pH using differential paise,square-wave and cyclic voltammetry.Based on its reduction behavior,a direct differential pulse voltammetric method has been developed and validated for the determination of midazolam in parenteral dosage.Three welldefined peaks were observed in 0.1％ SLS,Britton-Robinson (BR) buffer of pH 2.5.The effect of surfaetants like sodium lauryl sulfate (SLS),cetyl trimethyl ammonium bromide (CTAB) and Tween 20 was studied.Among these surfactants SLS showed significant enhancement in reduction peak.The cathodic peak currents were directly proportional to the concentration of midazolam with correlation coetfficient of 0.99.
文摘Tadalafil(TAD)and dapoxetine HCl(DAP)are recently co-formulated and both show native fluorescence.Therefore,a novel,accurate,specific and sensitive reversed-phase high performance liquid chromatographic method with fluorescence detection was developed and validated for their separation and quantitation in dosage form and human plasma using avanafil as an internal standard(IS).Separation was achieved using isocratic elution within 7.0 min on C18column and acetonitrile-0.15%triethylamine(40∶60,v/v;pH 4)as a mobile phase.The flow rate was 1.0 mL/min and the detection was time-programmed at 330,410 and 370 nm for TAD,DAP and IS,respectively,after excitation at 236 nm.The linear ranges from 0.01 to 30.00μg/mL for each drug with the limits of detection of 4.20 and 7.20 ng/mL for TAD and DAP,respectively.The method was validated in accordance to the International Conference on Harmonization(ICH)guidelines and was successfully applied to spiked human plasma with mean recoveries of 98.17%and 98.83%for TAD and DAP respectively.
基金supported by Mitacs,Canada(Mitacs Accelerate:IT13686)and JRC Pharmaceuticals Inc,Canada。
文摘Objective:Traditional Chinese medicine(TCM)has been widely used throughout China to prevent and cure diseases for thousands of years,and now it is a part of the integrative medicine field that is available in Western societies.To ensure the safety and quality of the herbal medicines that are a major part of the TCM tradition,they must be held to modern pharmaceutical standards.Erzhi pill(EZP)is a Chinese Pharmacopeia-listed herbal preparation that is used in the long-term clinical management of postmenopausal symptoms,osteoporosis and menstrual disorders.Until now,whether the drug release mechanism of EZP is in line with its intended TCM usage has not been studied.Methods:The release of specnuezhenide from three EZPs(self-made,Leiyunshang and Renhe)in simulated gastric fluid(SGF),acetate buffer(p H 4.5 buffer)and simulated intestinal fluid(SIF)was investigated in a dissolution test.The water uptake capacity and erosion extent of the three EZPs were investigated using swelling and erosion studies.The drug release mechanism was further assessed through statistical model fitting,using DDSolver software.Results:The release of specnuezhenide from all three EZPs in SGF was less than 50%within a 4 h period.However,over 70%of the specnuezhenide was released from each EZP in both p H 4.5 buffer and SIF in the same time.Analysis of the swelling and erosion behaviors and the drug release mechanism of the three EZPs confirmed that the release rate from EZP followed a sustained release profile,which was an interactive combination of swelling and erosion.Conclusion:This study showed that the release pattern from the pills was in line with the intended TCM use of EZP.TCM had not only theoretically considered sustained release from the pills,but also formulated them to achieve this release pattern.When establishing quality control standards for pills,the theoretical TCM usage and the actual release patterns need to be considered.
文摘Among the various research works going on nowadays, designing of controlled release dosage form is of great importance. For the development of suitable controlled release dosage form, a proper matrix needs to be formed from which the drug release generally occur by polymer swelling, polymer erosion, drug dissolution/diffusion mechanism. HPMC （hydroxy propyl methyl cellulose）, also known as hypromellose, is one of the best known cellulosic polymers used in the development of controlled released drug delivery. It is available in various grades. Cellulosic polymers are ingredients that contain units linked together which help to retain water. Due to its high water absorptive capacity, it acts as an excellent hydrophilic gel forming polymer. HPMC generally hydrates on the outer surface to form a gelatinous layer which is critical to prevent wetting and rapid drug release from the matrices. If the drug is sparingly soluble in the system, the release of drug from the system is slow and helps in formulation of controlled release dosage form. In the ophthalmic dosage form, HPMC is used as a matrix that swells and expands after absorbing water and expand the thickness of the tear film.
文摘Traditional Chinese medicine ointment is the main component of Chinese national medicine. Compared with traditional Chinese medicine decoction, ointment has great advantages, and the dosage is small and simple, which can reduce the trouble of conventional decoction, and the taste will not change greatly. Because the ointment has the effects of moisturizing and strengthening the body, protecting internal organs and expelling disease pathogens, it is clinically suitable for patients with physical weakness, chronic disease and physical deficiency. In recent years, with the improvement of our understanding of the health of traditional Chinese medicine ointment, more and more people regard it as a manifestation of health preservation. The cream prescription, a brilliant pearl in Chinas ancient health culture, has also become an important symbol of modern human advocating a high-quality lifestyle. In autumn and winter, health preservation with plaster has become our tradition, so it is favored and respected by consumers.
文摘The aim of the present study was to develop and characterize a gastroretentive dosage form suitable for controlled drug release.It consists of a drug loaded polymeric film made up of a bilayer of immediate(IR)and controlled release(CR)layers folded into a hard gelatin capsule.Gast roretention results from unfolding and swelling of the film and its bioadhesion to the gastric.mucosa.Furosemide,a drug with a narrow absorption window,was selected as the model drug.Inclusion of hydroxypropyl β-cyclodextrin in both layers and Carbopol■ 971P NF in the CR layer of the bilayer film resulted in optimum drug release,bioadhesion and mechanical properties.The film with zig-zag folding in the capsule was shown to unfold and swell under acidic conditions and provide IR of drugover 1 hand CR for up to 12 h in acidic medium.X-ray diffraction,differential scanning calorimetry and scanning electron microscopy revealed uniform dispersion of furosemide in the polymeric matrices.The results indicate the dosage form is gastroretentive and can provide controlled release of drugs with narrow therapeutic wind ows.
基金supported by the Central Guidance on Local Science and Technology Development Fund of Sichucan(No.2023ZYD0053,China)Central Nervous System Drug Key Laboratory of Sichuan Province(No.230014-01SZ,China)+1 种基金Special research project of the Sichuan Provincial Administration of TCM(No.2023MS621,China)the Southwest Minzu University Research Startup Funds(No.RQD2023005,China).
文摘Nuclear radiation exposure events and tumor radiotherapy are highly susceptible to a range of psychological,physiological and other health problems,which can seriously affect patients'quality of life.It has been shown that 87.5%of tumor patients are exposed to varying degrees of radiation injury during radiotherapy.The treatment of radiation injury(RI)in modern medicine is limited to drug therapy,cell therapy,etc.Among them,the most chemical drugs cause many adverse reactions including fatigue,nausea,vomiting,etc.,and there are very few drugs dedicated to the treatment of RI.Traditional Chinese medicine(TCM)is a rich natural medicinal resource,which has a wide range of pharmacological activities,multiple targets of action and minimal toxic side effects.Many studies have demonstrated that TCM and its compound preparations have enormous potential in the treatment of radiation induced comprehensive diseases.However,TCM is limited in clinical application due to its slow onset of action,complex active ingredients,and low bioavailability.Therefore,the article reviews the application,molecular mechanisms,and new dosage forms of TCM in the prevention and treatment of RI.On this basis,we will focus on discussing the development advantages and application prospects of the combination of traditional Chinese and Western medicine to achieve highly efficient treatment of RI.This review aims to provide scientific and effective drug delivery strategies and basic theoretical support for the clinical effective treatment of RI with TCM,and further promote the innovative development of TCM.
基金Ministry of Education Singapore for funding this work(grant No.AcRF Tier 1 Fund RG4/24)and for the postgraduate scholarship awarded to Liu Han Ng.
文摘Ionic liquid(IL)salts of active pharmaceutical ingredients(API)represent promising formulations for poorly-soluble APIs as they eliminate polymorphism commonly associated with conventional API salts.Being highly viscous liquid,oral dosage formulation of API-ILs is challenging,necessitating immobilization onto particulate carriers,typically by spray-drying.This study developed an alternative oral dosage formulation of API-ILs by incorporating them into soft gelatin-alginate pellets,where the alginate’s role was to improve storage stability of hygroscopic and thermally-sensitive gelatin.Poorly-soluble ibuprofen(IBU)and 1-butyl-3-methylimidazolium(BMIM)was used as the model API-IL.The impacts of alginate inclusion at varying gelatin-to-alginate ratios on quality attributes of IBU-BMIM-loaded pellets were investigated.The evaluated attributes included physical appearance,IBU-BMIM payload,dosage uniformity,flowability,IBU-BMIM release,and IBU solubility enhancement.The results showed IBU-BMIM remained in its liquid-like amorphous form upon incorporation into the pellets,thereby preserving its solubility enhancement capability,albeit at a lower degree due to slower IBU-BMIM release upon alginate inclusion.Alginate inclusion also influenced the pellets’physical appearance,thickness,flowability,and gelatin’s secondary structures,while having minimal impacts on payload and dosage uniformity.Importantly,the pellets remained stable after one-month of accelerated storage(40℃ and 75% relative humidity)with minimal variations in their quality attributes.
基金the financial support to this work from the National Natural Science Foundation of China(Nos.81872813)the Outstanding Youth Fund of Jiangsu Province of China(BK20190029)+2 种基金Natural Science Foundation of Jiangsu Province(BK 20200576,China)Fundamental Research Funds for the Central Universities(No.2632020PY04)the Program of State Key Laboratory of Natural Medicines-China Pharmaceutical University(No.SKLNMZZ202031)
文摘Pharmaceutical cocrystals are multicomponent systems in which at least one component is an active pharmaceutical ingredient and the others are pharmaceutically acceptable ingredients.Cocrystallization of a drug substance with a coformer is a promising and emerging approach to improve the performance of pharmaceuticals,such as solubility,dissolution profile,pharmacokinetics and stability.This review article presents a comprehensive overview of pharmaceutical cocrystals,including preparation methods,physicochemical properties,and applications.Furthermore,some examples of drug cocrystals are highlighted to illustrate the effect of crystal structures on the various aspects of active pharmaceutical ingredients,such as physical stability,chemical stability,mechanical properties,optical properties,bioavailability,sustained release and therapeutic effect.This review will provide guidance for more efficient design and manufacture of pharmaceutical cocrystals with desired physicochemical properties and applications.
基金financially supported by The National Natural Science Foundation of China(81904052)The 13th Five-Year Plan for National Key R&D Program of China(2018YFC1705401)。
文摘Objective:Traditional Chinese medicines(TCMs)are efficacious against ulcerative colitis(UC).In recent years,the number of randomized clinical trials(RCTs)of TCM has increased.Thus,it is very important to summarize the basic characteristics,quality,and types of TCM interventions in published RCTs.This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC.Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching.Materials and Methods:A scoping review was conducted according to the PRISMA extension for scoping reviews.We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020.Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated.Selection and characterization were performed by two independent reviewers using predefined forms.All discrepancies were resolved by consensus discussion with a third reviewer.Microsoft Excel 2010 was used to extract the following data from the included studies:(1)basic information of the included studies including research ID,article title,publication language,journal,year of publication,and funding information;(2)patient information including gender,age,disease course,disease stage,severity,sample size;and(3)information on intervention measures,types of intervention measures,drug dosage forms,and treatment courses.Results:The search identified 2225 RCTs published between1987 and 2020.These studies covered 36 provinces in China.The time frame of the RCTs was<28 days in approximately one-third of the RCTs(647,29.08%).Only one RCT was published in English.Nearly three-quarters of RCTs(1665,74.83%)did not report the severity of the disease.Three types of interventions were included in the RCTs:pharmacotherapy(2028,91.15%),nonpharmacotherapy(57,2.56%),and a combination of the two(140,6.29%).The administration modes of the intervention groups were evaluated.Drug therapy involved 12types of TCM dosage forms,which were decoctions,troches,powders,capsules,granules,pills,suppositories,ointments,injections,gels,oral liquids,and substitute tea according to the frequency of use.Nondrug intervention measures involved 10 treatment options,namely,acupuncture,moxibustion,hemospasia,auricular point,acupoint catgut embedding,acupoint injection,scrapping,tuina,acupoint application,and five-tone therapy according to the frequency of use.Most studies included in this review were low in quality.This underscores the need for improvement in the quality of trial methodology in TCM RCTs.
文摘Derived from dry powder coating of metals, electrostatic powder coating for pharmaceuticals is a technology for coating drug solid dosage forms. In this technology, coating powders, containing coating polymers, pigments, and other excipients, are directly sprayed onto the surface of the solid dosage forms through an electrostatic gun without using any organic solvent or water. The deposited coating powders are further cured to form a coating film. Electrostatic powder coating technology has many advantages compared to other pharmaceutical coating methods. It can eliminate the limitations caused by the organic solvent in solvent coating such as environmental issues and health problems. And electrostatic powder coating technology also surpasses aqueous coating due to its shorter processing time and less energy consumption, leading to a lower overall cost. Furthermore, the utilization of electrical attraction can promote the movement of coating powders towards the substrate, leading to an enhanced coating powder adhesion and coating efficiency, which make it more promising compared to other dry coating technologies. The objective of this review is to summarize the coating principles, apparatus, and formulations of different electrostatic powder coating technologies, giving their advantages and limitations and also analyzing the future application in the industry for each technology
