[Objectives]To optimize the forming process of Yi medicine Tongfeng Granules.[Methods]The forming process of Yi medicine Tongfeng Granules was optimized,with paste density,ethanol volume fraction,and type and proporti...[Objectives]To optimize the forming process of Yi medicine Tongfeng Granules.[Methods]The forming process of Yi medicine Tongfeng Granules was optimized,with paste density,ethanol volume fraction,and type and proportion of excipient as influencing factors,and granule formability,solubility,moisture absorption,and angle of repose as evaluation indicators.Critical relative humidity(CRH)was investigated to select optimal storage conditions.[Results]Maltodextrin was selected as the excipient,and the best process parameters was the ratio of drug to excipient at 1∶2(g/g),under which the forming rate,solubility,moisture absorption rate,and angle of repose were 81.38%,98.90%,8.81%,and 27.5°,respectively.The critical relative humidity was 72%.[Conclusions]The forming process adopted is reasonable and feasible,and can provide a reference for large-scale production of Yi medicine Tongfeng Granules.展开更多
Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious...Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.展开更多
基金National Key R&D Program(2018YFC1708005)Sichuan Provincial Key R&D Project(2021YFS0043)Fundamental Research Funds for the Central Universities(2020NGD01).
文摘[Objectives]To optimize the forming process of Yi medicine Tongfeng Granules.[Methods]The forming process of Yi medicine Tongfeng Granules was optimized,with paste density,ethanol volume fraction,and type and proportion of excipient as influencing factors,and granule formability,solubility,moisture absorption,and angle of repose as evaluation indicators.Critical relative humidity(CRH)was investigated to select optimal storage conditions.[Results]Maltodextrin was selected as the excipient,and the best process parameters was the ratio of drug to excipient at 1∶2(g/g),under which the forming rate,solubility,moisture absorption rate,and angle of repose were 81.38%,98.90%,8.81%,and 27.5°,respectively.The critical relative humidity was 72%.[Conclusions]The forming process adopted is reasonable and feasible,and can provide a reference for large-scale production of Yi medicine Tongfeng Granules.
基金supported by the Clinical Research Plan of SHDC(No.SHDC2020CR4053SHDC2022CRS053)+14 种基金Research Project of Shanghai Municipal Health Care Commission(No.20204Y0312)Shanghai Municipal Health Commission Health Industry Clinical Research Special Project(No.20234Y0075)Health Young Talents of Shanghai Municipal Health Commission(No.2022YQ026)the Clinical Research Program of Shanghai Municipal Health Commission(No.202240371)Shanghai Clinical Key Specialty Construction Project(No.shslczdzk05001)Three-year Action Plan of Shanghai to Further Accelerate the Inheritance and Innovation of Traditional Chinese Medicine(No.ZY[2021-2023]-0302)Jiangxi Provincial Natural Science Foundation(No.20224BAB216096)Shanghai Dermatology Research Center(No.2023ZZ02017)Shanghai Dermatology Hospital Demonstration Research Ward Project(No.SHDC2023CRW009)Xinglin Youth Scholar of Shanghai University of Traditional Chinese Medicine(No.RY411.33.10)Youth Talent Promotion Project of China Association of Traditional Chinese Medicine(2021–2023)Category A(No.CACM-2021-QNRC2-A10)‘‘Chen Guang”project supported by Shanghai Municipal Education Commission and Shanghai Education Development Foundation(No.22CGA50)High-level Chinese Medicine Key Discipline Construction Project(Integrative Chinese and Western Medicine Clinic)of National Administration of TCM(No.zyyzdxk-2023065)Shanghai Talent Development Fund(No.2021073)Shanghai Sailing Program(No.20YF1450500)。
文摘Background:Acute gouty arthritis(AGA)is an inflammatory joint disease with a high prevalence.Typical medical interventions,including nonsteroidal anti-inflammatory drugs,colchicine and glucocorticoids,can have serious adverse reactions.Huzhang Granule(HZG),a compound Chinese herbal medicine,has been used to treat AGA for more than 30 years with satisfactory effects and no significant adverse reactions.However,the efficacy and safety of HZG in AGA patients remains unknown.Objective:The present investigation was designed to examine the efficacy and safety profile of HZG in managing AGA patients.Design,setting,participants and interventions:The current study was conducted as a noninferiority,randomized controlled clinical trial on 180 eligible enrolled participants.Participants were randomly assigned into the HZG and etoricoxib groups.Treatments were administered for 5 d,during which the HZG group received HZG and placebo etoricoxib,while the etoricoxib group received etoricoxib and placebo HZG in the same ratio(1:1).Main outcome measures:The primary outcome was pain experienced by the patient in the gout-afflicted joint from days 2 to 5 of the treatment window.The pain level was measured via a visual analogue scale,ranging from 0 mm to 100 mm.The secondary outcomes comprised joint tenderness and swelling,reduction of inflammatory biomarkers,and the patient’s and investigator’s global evaluations of therapeutic response.Results:The mean reduction in pain was-51.22 mm(95%confidence interval[CI],[-53.42,-49.03]mm)for the HZG and-52.00 mm(95%CI,[-54.06,-49.94]mm)for the etoricoxib groups.The mean difference between the two groups was 0.78 mm(95%CI,[-2.25,3.81]mm).All additional efficacy endpoints,covering decreased inflammation and pain relief,yielded compelling proof of noninferiority.Patients in the HZG group exhibited a comparatively lower rate of adverse events compared to those in the etoricoxib group(4.44%vs 13.33%;P≤0.05).Conclusion:HZG and etoricoxib groups demonstrated similar levels of analgesic effectiveness.The safety and efficacy of HZG indicates that it can be used as a potential therapeutic option for treating AGA.
文摘目的观察痛风清消颗粒的急性毒性反应,评价其临床用药的安全性。方法采用清洁级昆明种小鼠40只,随机分为2组,分别给予痛风清消颗粒混悬液和生理盐水0.78 ml/次灌胃,24小时内3次,连续观察小鼠的体重、饮食、毒性反应和死亡情况14天。结果 2组小鼠在第1天、第7天和第14天的体重无显著性差异(P>0.05),小鼠一次性口服痛风清消颗粒的最大耐受量为86.88 g durg·kg-1,为成人每日临床常用量的253倍。结论痛风清消颗粒口服临床常用剂量安全。
