Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of thes...Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of these Chinese patent medicines varies greatly among different forms,but there were few studies on the difference comparison and quality control of them.In order to improve the effectiveness and safety in its clinical application,an idea combining high performance liquid chromatography(HPLC)and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.Methods:The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis(OPLS-DA),principal component analysis(PCA),and hierarchical cluster analysis(HCA).Finally,the quantitative analysis method of related components was established by HPLC.Results:A quality control method for HMYG and HMYC was established.Firstly,the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting.Further exploration showed that there were 20 characteristic peaks and 57 common peaks.Then,the potential differential markers between HMYG and HMYC were explored by chemometrics,and the differential markers were screened after intersection with the 20 characteristic peaks.Finally,HPLC quantitative analysis methods for nine components were established,including seven differential markers(neochlorogenic acid,protocatechualdehyde,chlorogenic acid,cryptochlorogenic acid,caffeic acid,rosmarinic acid and salvianolic acid A).The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different.According to the above results,the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms.Conclusion:The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC.This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.展开更多
目的:对滑膜炎颗粒治疗膝关节骨关节炎(KOA)的随机对照试验(RCT)进行Meta分析,旨在评估滑膜炎颗粒治疗KOA的有效性和安全性。方法:全面检索8个主要中英文数据库,收集滑膜炎颗粒治疗KOA的RCT。使用Cochrane偏倚风险评估工具对纳入研究的...目的:对滑膜炎颗粒治疗膝关节骨关节炎(KOA)的随机对照试验(RCT)进行Meta分析,旨在评估滑膜炎颗粒治疗KOA的有效性和安全性。方法:全面检索8个主要中英文数据库,收集滑膜炎颗粒治疗KOA的RCT。使用Cochrane偏倚风险评估工具对纳入研究的质量进行评定,利用RevMan 5.3软件进行统计分析,计数变量采用比值比(odds ratio,OR)为效应量,计量变量采用加权均数差为效应量(WMD,Weight Mean Difference),各效应量均提供其95%CI。结果:纳入的7个RCT研究质量偏低。Meta分析结果显示,滑膜炎颗粒组治疗有效率高于安慰剂组,滑膜炎颗粒联合玻璃酸钠关节腔注射及塞来昔布胶囊口服的VAS评分变化大于单纯玻璃酸钠关节腔注射联合塞来昔布胶囊口服。与酮基布洛芬相比,滑膜炎颗粒组不良反应率低,与安慰剂相比较滑膜炎颗粒并没有增加不良反应的发生。结论:滑膜炎颗粒治疗KOA有效,未增加不良反应的发生。受纳入研究数量和质量限制,需要开展大样本的真实世界研究以获取更高质量的证据。展开更多
基金supported by Shineway Pharmaceutical Group Ltd.(No.2020110031006073).
文摘Objective:Huamaoyan Granules(HMYG)and Huamaoyan Capsules(HMYC)are Chinese patent medicines with different dosage forms of the same prescription.Due to the different preparation process,the chemical composition of these Chinese patent medicines varies greatly among different forms,but there were few studies on the difference comparison and quality control of them.In order to improve the effectiveness and safety in its clinical application,an idea combining high performance liquid chromatography(HPLC)and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.Methods:The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis(OPLS-DA),principal component analysis(PCA),and hierarchical cluster analysis(HCA).Finally,the quantitative analysis method of related components was established by HPLC.Results:A quality control method for HMYG and HMYC was established.Firstly,the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting.Further exploration showed that there were 20 characteristic peaks and 57 common peaks.Then,the potential differential markers between HMYG and HMYC were explored by chemometrics,and the differential markers were screened after intersection with the 20 characteristic peaks.Finally,HPLC quantitative analysis methods for nine components were established,including seven differential markers(neochlorogenic acid,protocatechualdehyde,chlorogenic acid,cryptochlorogenic acid,caffeic acid,rosmarinic acid and salvianolic acid A).The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different.According to the above results,the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms.Conclusion:The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC.This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.
文摘目的:对滑膜炎颗粒治疗膝关节骨关节炎(KOA)的随机对照试验(RCT)进行Meta分析,旨在评估滑膜炎颗粒治疗KOA的有效性和安全性。方法:全面检索8个主要中英文数据库,收集滑膜炎颗粒治疗KOA的RCT。使用Cochrane偏倚风险评估工具对纳入研究的质量进行评定,利用RevMan 5.3软件进行统计分析,计数变量采用比值比(odds ratio,OR)为效应量,计量变量采用加权均数差为效应量(WMD,Weight Mean Difference),各效应量均提供其95%CI。结果:纳入的7个RCT研究质量偏低。Meta分析结果显示,滑膜炎颗粒组治疗有效率高于安慰剂组,滑膜炎颗粒联合玻璃酸钠关节腔注射及塞来昔布胶囊口服的VAS评分变化大于单纯玻璃酸钠关节腔注射联合塞来昔布胶囊口服。与酮基布洛芬相比,滑膜炎颗粒组不良反应率低,与安慰剂相比较滑膜炎颗粒并没有增加不良反应的发生。结论:滑膜炎颗粒治疗KOA有效,未增加不良反应的发生。受纳入研究数量和质量限制,需要开展大样本的真实世界研究以获取更高质量的证据。
