中药资源评估的背景及总体设计
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摘要
该文全面分析了原国家食品药品监督管理总局颁布的《中药资源评估技术指导原则》背景和意义,指出以保障中药资源可持续供应能力为目的的中药资源评估是新药开发的前提;以质量保证为核心的中药资源评估是促进中药工业固定产地且质量管理前移的重要举措;以实现全程可追溯为抓手的中药资源评估是现代中药优质品牌打造的关键;以经典名方制剂为切入点的中药资源评估是中药资源保护和监管国际化视野的体现,为相关企业开展中药资源评估理清了思路。全文在分析国家开展中药资源评估中要确保中药资源"总量不减,保障供应"的总体思路的基础上,明确了中药资源评估的2个方法:基于"总量不减"的中药资源"家底评估"和基于"保障供应"的中药资源"供需平衡评估"。提出了开展基于"保障供应"的中药资源"供需平衡评估"的基本策略,认为资源评估将导致中药材生产布局面临重大调整,全面提升中药产品质量、品牌建设、建立优质优价机制已成为各类中药生产企业发展的必由之路。
This paper comprehensively analyses the background and meaning of The Technological Guiding Principle for Assessment of Chinese Medicine Resources enacted by the former CFDA(China Food and Drug Administration),moreover,it also points out that the Chinese medicine resources assessment with the purpose of guaranteeing the sustainable supplying capacity of Chinese medicine resources is the premise of new drug development; the Chinese medicine resources assessment which takes quality guarantee as the core is a significant action to promote the fixing of place of origin and quality-management antedisplacement for the traditional Chinese medicine industry; in this regard,the Chinese medicine resources assessment which aims at realizing the whole-process traceability is the key to building the high-quality modern traditional Chinese medicine brand. The Chinese medicine resources assessment which takes the classical prescription as the entry point is the embodiment of the protection of traditional Chinese medicine resources and international vision of regulation,which aims at clarifying the thinking for the relevant enterprises to carry out the Chinese medicine resources assessment. Base on the general thinking of ensuring that the " total amount of Chinese medicine resources is fixed and the supply is guaranteed",this paper clarifies two methods of Chinese medicine resources assessment: " family property assessment" of Chinese medicine resources based on " fixed total amount", " supply and demand balance assessment" of Chinese medicine resources based on " supply guarantee". In this regard,the basic strategy of " supply and demand balance assessment" of Chinese medicine resources based on " guaranteed supply" is put forward and it is believed that the resources assessment will lead to the significant adjustment of traditional Chinese medicinal materials production. It becomes the only way for the development of various Chinese medicine production enterprises to realize the comprehensive improvement of Chinese medicine quality,brand construction,the establishment of preferential price mechanism.
This paper comprehensively analyses the background and meaning of The Technological Guiding Principle for Assessment of Chinese Medicine Resources enacted by the former CFDA(China Food and Drug Administration),moreover,it also points out that the Chinese medicine resources assessment with the purpose of guaranteeing the sustainable supplying capacity of Chinese medicine resources is the premise of new drug development; the Chinese medicine resources assessment which takes quality guarantee as the core is a significant action to promote the fixing of place of origin and quality-management antedisplacement for the traditional Chinese medicine industry; in this regard,the Chinese medicine resources assessment which aims at realizing the whole-process traceability is the key to building the high-quality modern traditional Chinese medicine brand. The Chinese medicine resources assessment which takes the classical prescription as the entry point is the embodiment of the protection of traditional Chinese medicine resources and international vision of regulation,which aims at clarifying the thinking for the relevant enterprises to carry out the Chinese medicine resources assessment. Base on the general thinking of ensuring that the " total amount of Chinese medicine resources is fixed and the supply is guaranteed",this paper clarifies two methods of Chinese medicine resources assessment: " family property assessment" of Chinese medicine resources based on " fixed total amount", " supply and demand balance assessment" of Chinese medicine resources based on " supply guarantee". In this regard,the basic strategy of " supply and demand balance assessment" of Chinese medicine resources based on " guaranteed supply" is put forward and it is believed that the resources assessment will lead to the significant adjustment of traditional Chinese medicinal materials production. It becomes the only way for the development of various Chinese medicine production enterprises to realize the comprehensive improvement of Chinese medicine quality,brand construction,the establishment of preferential price mechanism.
引文
[1]国家食品药品监督管理总局.中药资源评估技术指导原则[EB/OL].(2017-12-25)[2018-04-10].http://www.sda.gov.cn/WS01/CL0087/220232.html.
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[4]黄璐琦,彭华胜,肖培根.中药资源发展的趋势探讨[J].中国中药杂志,2011,36(1):1.
[5]郭兰萍,王铁霖,杨婉珍,等.生态农业——中药农业的必由之路[J].中国中药杂志,2017,42(2):231.
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[7]郭兰萍,周利,王升,等.《中医药——中药材重金属限量》ISO国际标准下中药材重金属污染现状与分析[J].科技导报,2017,35(11):91.
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[10]郭兰萍,黄璐琦,Christian W Huck,等.近红外光谱技术及其在中药道地性研究中的应用[J].中国中药杂志,2009,34(14):1751.
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[12]国家食品药品监督管理总局.总局办公厅公开征求《中药经典名方复方制剂简化注册审批管理规定(征求意见稿)》及申报资料要求(征求意见稿)意见[EB/OL].(2017-10-09)[2018-04-10].http://samr.cfda.gov.cn/WS01/CL0778/178324.html.
[13]全国人民代表大会.中华人民共和国中医药法[EB/OL].(2016-12-25)[2018-04-10].http://www.npc.gov.cn/npc/xinwen/2016-12/25/content_2004972.htm.
[14]US Department of Health and Human Services Food and Drug Administration.Environmental Assessment of Human Drug and Biologics Applications[EB/OL].(1998-07)[2018-04-10].https://www.fda.gov/cber/guidelines.htm.
[15]黄璐琦,孙丽英,张小波,等.全国中药资源普查(试点)工作进展情况简介[J].中国中药杂志,2017,42(22):4256.
[2]中华人民共和国工业和信息化部.2017年1月至9月医药工业主要经济指标完成情况[EB/OL].(2017-11-23)[2018-04-10].http://www.miit.gov.cn/newweb/n1146312/n1146904/n1648366/n1648370/c5920776/content.html.
[3]程蒙,辛敏通,郭兰萍,等.我国中药产品国际贸易现状及结构特征[J].中国现代中药,2017,19(7):1030.
[4]黄璐琦,彭华胜,肖培根.中药资源发展的趋势探讨[J].中国中药杂志,2011,36(1):1.
[5]郭兰萍,王铁霖,杨婉珍,等.生态农业——中药农业的必由之路[J].中国中药杂志,2017,42(2):231.
[6]杨婉珍,康传志,纪瑞锋,等.中药材残留农药情况分析及其标准研制的思考[J].中国中药杂志,2017,42(12):2284.
[7]郭兰萍,周利,王升,等.《中医药——中药材重金属限量》ISO国际标准下中药材重金属污染现状与分析[J].科技导报,2017,35(11):91.
[8]华国栋,郝庆秀,格小光,等.中药材质量变异概述[J].中国现代中药,2014,16(6):510.
[9]郭兰萍,黄璐琦,胡娟,等.基于生物信息分析的苍术挥发油成分变异及其化学型的划分[J].资源科学,2008,30(5):770.
[10]郭兰萍,黄璐琦,Christian W Huck,等.近红外光谱技术及其在中药道地性研究中的应用[J].中国中药杂志,2009,34(14):1751.
[11]国家食品药品监督管理总局.药品注册管理办法(局令第28号)[EB/OL].(2007-10-01)[2018-04-10].http://www.sda.gov.cn/WS01/CL0053/24529.html?from=timeline.
[12]国家食品药品监督管理总局.总局办公厅公开征求《中药经典名方复方制剂简化注册审批管理规定(征求意见稿)》及申报资料要求(征求意见稿)意见[EB/OL].(2017-10-09)[2018-04-10].http://samr.cfda.gov.cn/WS01/CL0778/178324.html.
[13]全国人民代表大会.中华人民共和国中医药法[EB/OL].(2016-12-25)[2018-04-10].http://www.npc.gov.cn/npc/xinwen/2016-12/25/content_2004972.htm.
[14]US Department of Health and Human Services Food and Drug Administration.Environmental Assessment of Human Drug and Biologics Applications[EB/OL].(1998-07)[2018-04-10].https://www.fda.gov/cber/guidelines.htm.
[15]黄璐琦,孙丽英,张小波,等.全国中药资源普查(试点)工作进展情况简介[J].中国中药杂志,2017,42(22):4256.