Quality Management

Analysis of the Difficulties and Discussion of Strategies in the Development of Reference Medicinal Materials of Ethnic Drugs

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  • National Institutes for Food and Drug Control, Beijing 100050, China

Online published: 2019-01-19

Abstract

Objective: To provide strategies for development of reference medicinal materials of ethnic drugs. Methods: The difficulties during the development of reference medicinal materials of ethnic drugs, including difficulties of raw material collection and identification, imperfect standards, weak researches etc were analyzed. Results: The development scheme of reference medicinal materials of ethnic drugs was proposed, including raw material collection and selection mehods, pharmacognostical identification, physical and chemical inspection, uniformity and stability test according to the requirements of the development of national drug reference materials. Conclusion: Although the research and development of reference medicinal materials of ethnic drugs had weak foundation with many difficulties, and started late, this work is of great significance to the quality evaluation and supervision of ethnic drugs, and can also lay the foundation for the research and development of ethnic drugs.

Cite this article

Gao Yan, Guo Linong, Ma Shuangcheng, Liu Jie, Zheng Jian, Zan Ke . Analysis of the Difficulties and Discussion of Strategies in the Development of Reference Medicinal Materials of Ethnic Drugs[J]. Chinese Pharmaceutical Affairs, 2020 , 34(1) : 53 -57 . DOI: 10.16153/j.1002-7777.2019.01.008

References

[1] 中华人民共和国药品管理法[S]. 2019.
[2] 国家食品药品监督管理局.国家食品药品监督管理局令第28号药品注册管理办法[S]. 2002.
[3] 国家药典委员会.中国药典:一部[S]. 2015.
[4] 中华人民共和国卫生部.卫生部药品标准:蒙药分册[S]. 1998.
[5] 朱根华,熊耀坤,钟国跃.少数民族医药产业发展面临的困境及改革策略研究——以蒙,藏,维民族医药为例[J].西南民族大学学报:人文社会科学版,2015,36(8):147-151.
[6] 李佳川,何晓磊,徐新,等.蒙药的现代研究概况与发展思考[J].西南民族大学学报(自然科学版):2019,45(3):272-277.
[7] 中华人民共和国卫生部.卫生部药品标准:藏药分册[S]. 1998.
[8] 中国科学院中国植物志编辑委员会.中国植物志[M].北京:科学出版社,1989.
[9] 陈平,张杰,章云勇.云南省民族医药产业发展的困境与对策[J].卫生软科学,2019,33(5):17-20,45.
[10] 国家食品药品监督管理局.WS-11164(ZD-1164)-2002-2011Z国家药品标准[S]. 2012.
[11] 梁正海,辛丽平.略论少数民族传统医药知识的生产性保护[J].贵州民族研究,2017,38(11):143-148.
[12] 刘伟,马骏麒,伊河山·伊明,等.新疆维吾尔自治区中医药和民族医药传统知识的调查研究[J].西部中医药,2018,31(10):50-52.
[13] 袁媛,陈媞颖,黄璐琦,等.对照道地药材的研究策略与应用探讨[J].中国中药杂志,2017,42(13):2623-2626.
[14] 严华,麻思宇,程显隆,等.中药对照药材的稳定性及期间核查[J].中国药事,2017,31(9):1012-1016.
[15] 昝珂,袁红,马双成,等.民族药材青阳参对照品的制备及质量标准提高研究[J].中国药事,2018,32(4):469-475.
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