The current quality control（QC） pattern for Chinese materia medica（CMM） lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this...The current quality control（QC） pattern for Chinese materia medica（CMM） lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this review, main problems of the current QC pattern for CMM, principally focused on the content determination of constituents,were summarized and the inspiration from the QC of biological products was introduced. With the aim at introducing a suitable tool to the QC of CMM, biopotency assay and its feasibility in the QC pattern for CMM were analyzed and confirmed by relevant researches with years of practice. From the applications of biopotency assays in the QC of CMM in the last 10 years, we propose that biopotency assays should be an integral part of the QC pattern for CMM, for these assays can make the QC indicators related to the clinical safety and efficacy, supplementing the existed QC system of CMM.展开更多
Quality evaluation is a bottleneck restricting the modernization and internationalization of Chinese materia medica (CMM). Due to characteristics of multi-component, multi-efficacy, multi-target, the existing quality ...Quality evaluation is a bottleneck restricting the modernization and internationalization of Chinese materia medica (CMM). Due to characteristics of multi-component, multi-efficacy, multi-target, the existing quality evaluation system still cannot fully meet quality control needs of CMM. Hence, the author put forward “Bio-characteristic profiling related to clinic, BPRC” academic concept, meanwhile, fully take the advantage of analysis method with clinical monitoring superiority or profiling characteristics, build up “BPRC” new technology platform, in order to realize “real-time, dynamic and full-range monitoring” new technologies of CMM quality evaluation system and promote the further development of CMM industry.展开更多
Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CM...Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and validated.Therefore,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.展开更多
New sensor technologies play an important role in quality evaluation of Chinese materia medica(CMM) and include near-infrared spectroscopy,chemical imaging,electronic nose and electronic tongue.This review on quality ...New sensor technologies play an important role in quality evaluation of Chinese materia medica(CMM) and include near-infrared spectroscopy,chemical imaging,electronic nose and electronic tongue.This review on quality evaluation of CMM and the application of the new sensors in this assessment is based on studies from 2010 to 2015,with prospects and opportunities for future research.展开更多
The development of HKCMM standards is one of the achievements of developing Hong Kong into an intemational centre for Chinese medicine. In order to enable more people concerned to have an intimate knowledge of this st...The development of HKCMM standards is one of the achievements of developing Hong Kong into an intemational centre for Chinese medicine. In order to enable more people concerned to have an intimate knowledge of this standard, the author was invited to introduce the development of HKCMM standards to readers, including： 1） the history of the project and the basis for legislative supports; 2） the composition and operation of the regulatory division, the research institution and the evaluation committee; 3） the progress of HKCMM standards; 4） the contents and features of HKCMM standards.展开更多
目的系统评价中药联合贝前列素钠治疗下肢动脉硬化闭塞症的临床疗效及安全性。方法计算机检索PubMed、Web of Science、Cochrane Library、MEDLINE、中国生物医学文献服务系统、知网、万方和维普等数据库采用中药联合贝前列素钠治疗下...目的系统评价中药联合贝前列素钠治疗下肢动脉硬化闭塞症的临床疗效及安全性。方法计算机检索PubMed、Web of Science、Cochrane Library、MEDLINE、中国生物医学文献服务系统、知网、万方和维普等数据库采用中药联合贝前列素钠治疗下肢动脉硬化闭塞症的临床对照研究。检索时限均为从建库至2023年3月15日。由2名研究者独立筛选文献并评价,运用Rev-Man统计软件分析。结果共纳入12篇文献,共计1129例。meta分析结果显示,中药联合贝前列素钠治疗下肢动脉硬化闭塞症在临床有效率方面优势明显[RR=1.20,95%CI(1.13,1.27),P<0.00001],改善患者踝肱指数[SMD=0.15,95%CI(0.01,0.29),P=0.03],增加足背动脉血流量[MD=5.31,95%CI(1.08,9.54),P=0.01]、行走距离[MD=72.49,95%CI(30.39,114.60),P=0.0007]。结论中药内服联合贝前列素钠可提高下肢动脉硬化闭塞症临床疗效优于单独使用贝前列素钠。展开更多
基金National Natural Science Foundation of China (81274026)China Scholarship Council,Open Research Fund of the State Key Laboratory Breeding Base of Systematic Research,Development and Utilization of Chinese Medicinal Resources,China Postdoctoral Science Foundation(2013M532130)
文摘The current quality control（QC） pattern for Chinese materia medica（CMM） lacks suitable methods and indicators to evaluate their safety and efficacy effectively, which impedes the smooth development of CMM. In this review, main problems of the current QC pattern for CMM, principally focused on the content determination of constituents,were summarized and the inspiration from the QC of biological products was introduced. With the aim at introducing a suitable tool to the QC of CMM, biopotency assay and its feasibility in the QC pattern for CMM were analyzed and confirmed by relevant researches with years of practice. From the applications of biopotency assays in the QC of CMM in the last 10 years, we propose that biopotency assays should be an integral part of the QC pattern for CMM, for these assays can make the QC indicators related to the clinical safety and efficacy, supplementing the existed QC system of CMM.
基金The National Natural Science Foundation of China (grant number 81773891)the National Great New Drugs Development Project of China (grant number 2017ZX09301-040)+1 种基金the Beijing Municipal Science and Technology Commission (grant number XMLX201704, 2018-2-2242, 7194280)the Open Research Fund of the State Key Laboratory Breeding Base of Systematic Research, Development and Utilization of Chinese Medicinal Resources.
文摘Quality evaluation is a bottleneck restricting the modernization and internationalization of Chinese materia medica (CMM). Due to characteristics of multi-component, multi-efficacy, multi-target, the existing quality evaluation system still cannot fully meet quality control needs of CMM. Hence, the author put forward “Bio-characteristic profiling related to clinic, BPRC” academic concept, meanwhile, fully take the advantage of analysis method with clinical monitoring superiority or profiling characteristics, build up “BPRC” new technology platform, in order to realize “real-time, dynamic and full-range monitoring” new technologies of CMM quality evaluation system and promote the further development of CMM industry.
基金the National Natural Science Foundation of China(81773891)the National Great New Drugs Development Project of China(2017ZX09301-040)+3 种基金the Beijing Natural Science Foundation(7162092)Beijing Talents Project(2017A19)Beijing Municipal Science&Technology Commission(XMLX201704,Z161100000516074)the Open Research Fund of the State Key Laboratory Breeding Base of Systematic Research,Development and Utilization of Chinese Medicinal Resources.
文摘Quality marker(Q-marker)of Chinese materia medica(CMM)plays an important role in quality control of CMM products.However,its research strategy and technique remain unclear.Based on the fact that quality standard of CMM should be associated with clinical efficacy,taking Jinqi Jiangtang tablet treating type 2 diabetes as an example,the Q-marker related to activity via the reverse analysis of drug metabolism in clinic and traceability of botanic biosynthetic pathways is discovered and validated.Therefore,we proposed a new research strategy of Q-marker of CMM with"Discovery of clinical active constituents as guidance,Reverse analysis of metabolic transformations as link,and Traceability of biosynthesis pathways as key",to improve quality control of CMM products.
基金Financial support of this work from the National Natural Science Foundation of China(81303218)Doctoral Fund of Ministry of Education of China(20130013120006)+1 种基金Beijing Nova Program of China(xx2016050)Science Fund for Distinguished Young Scholars in Beijing University of Chinese Medicine(2015-JYBXYQ-003)
文摘New sensor technologies play an important role in quality evaluation of Chinese materia medica(CMM) and include near-infrared spectroscopy,chemical imaging,electronic nose and electronic tongue.This review on quality evaluation of CMM and the application of the new sensors in this assessment is based on studies from 2010 to 2015,with prospects and opportunities for future research.
文摘The development of HKCMM standards is one of the achievements of developing Hong Kong into an intemational centre for Chinese medicine. In order to enable more people concerned to have an intimate knowledge of this standard, the author was invited to introduce the development of HKCMM standards to readers, including： 1） the history of the project and the basis for legislative supports; 2） the composition and operation of the regulatory division, the research institution and the evaluation committee; 3） the progress of HKCMM standards; 4） the contents and features of HKCMM standards.
文摘目的系统评价中药联合贝前列素钠治疗下肢动脉硬化闭塞症的临床疗效及安全性。方法计算机检索PubMed、Web of Science、Cochrane Library、MEDLINE、中国生物医学文献服务系统、知网、万方和维普等数据库采用中药联合贝前列素钠治疗下肢动脉硬化闭塞症的临床对照研究。检索时限均为从建库至2023年3月15日。由2名研究者独立筛选文献并评价,运用Rev-Man统计软件分析。结果共纳入12篇文献,共计1129例。meta分析结果显示,中药联合贝前列素钠治疗下肢动脉硬化闭塞症在临床有效率方面优势明显[RR=1.20,95%CI(1.13,1.27),P<0.00001],改善患者踝肱指数[SMD=0.15,95%CI(0.01,0.29),P=0.03],增加足背动脉血流量[MD=5.31,95%CI(1.08,9.54),P=0.01]、行走距离[MD=72.49,95%CI(30.39,114.60),P=0.0007]。结论中药内服联合贝前列素钠可提高下肢动脉硬化闭塞症临床疗效优于单独使用贝前列素钠。
