ISO 18662-1:2017,Traditional Chinese medicine--Vocabulary--Part 1:Chinese Materia Medica(CMM)was officially released recently.The standard is the first terminology standard published by ISO/TC 249,Traditional Chinese ...ISO 18662-1:2017,Traditional Chinese medicine--Vocabulary--Part 1:Chinese Materia Medica(CMM)was officially released recently.The standard is the first terminology standard published by ISO/TC 249,Traditional Chinese medicine,which provides an important basis to standardize and uniform the terminology of traditional Chinese medicine in the展开更多
Medicinal plants or Chinese materia medica(CMM)are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare.Since the 1990s,World Health...Medicinal plants or Chinese materia medica(CMM)are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare.Since the 1990s,World Health Organization(WHO)and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine(ISO/TC 249)have carried out the development of quality standards on medicinal plants or CMMs respectively,and a considerable number of monographs and international standards have been published.Since the two international organizations adhere to different principles,the standards they develop naturally have different emphasis.Driven by market demand and international trade,ISO mainly takes quality,efficacy and safety into consideration when developing standards,while WHO pays more attention to clinical practice,quality control and medication guidance.Up to now,there is a lack of comparative analysis on the records,background,principles,basic content,and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO.Therefore,based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants,this paper systematically compares the purposes,selected principles,standard-developing process,basic content,and main quality requirements to summarize their similarities and differences,and find their merits,aiming to serve as a reference to the development of international standards for CMMs that helps them go global.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 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
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ISO 18662-1:2017,Traditional Chinese medicine--Vocabulary--Part 1:Chinese Materia Medica(CMM)was officially released recently.The standard is the first terminology standard published by ISO/TC 249,Traditional Chinese medicine,which provides an important basis to standardize and uniform the terminology of traditional Chinese medicine in the
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.
基金Supported by the National Social Science Fund of China(No.19CGJ037)Three-Year Action Plan for Development of Traditional Chinese Medicine in Shanghai[No.ZY(2021-2023)-0212)Shanghai Association for Science and Technology(No.20DZ2200800)。
文摘Medicinal plants or Chinese materia medica(CMM)are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare.Since the 1990s,World Health Organization(WHO)and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine(ISO/TC 249)have carried out the development of quality standards on medicinal plants or CMMs respectively,and a considerable number of monographs and international standards have been published.Since the two international organizations adhere to different principles,the standards they develop naturally have different emphasis.Driven by market demand and international trade,ISO mainly takes quality,efficacy and safety into consideration when developing standards,while WHO pays more attention to clinical practice,quality control and medication guidance.Up to now,there is a lack of comparative analysis on the records,background,principles,basic content,and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO.Therefore,based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants,this paper systematically compares the purposes,selected principles,standard-developing process,basic content,and main quality requirements to summarize their similarities and differences,and find their merits,aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
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.
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.
