Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas

Yan LIU; Jun ZHANG; Lin-yong YANG; Guo-yuan ZHANG; Shu-yu XU; Ling-mei KONG; Xiao-dan QI; Yun GONG; Feng-yan NI; Yan TONG; An LIU

doi:10.13422/j.cnki.syfjx.20192150

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Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas

Classic Prescriptions | 更新时间：2021-02-09

- Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 26, Issue 1, Pages: 1-9(2020)
- 作者机构：
  
  1.中国中医科学院　中药研究所，北京　 100700
  2.盛实百草药业有限公司，天津　 300301
  3.厦门中药厂有限公司，福建厦门　 361100
  4.东阿阿胶股份有限公司，山东聊城　 252201
  5.株洲千金药业股份有限公司，湖南株洲　 412003
  6.江西中医药大学，南昌　 330004
- 作者简介：
- 基金信息：
- DOI：10.13422/j.cnki.syfjx.20192150
  CLC： R22; R28; R94; R931
- Received：19 June 2019，
  
  Published Online：18 July 2019，
  
  Published：05 January 2020
- 稿件说明：
移动端阅览
Yan LIU, Jun ZHANG, Lin-yong YANG, et al. Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(1): 1-9.
DOI：

Yan LIU, Jun ZHANG, Lin-yong YANG, et al. Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas[J]. Chinese journal of experimental traditional medical formulae, 2020, 26(1): 1-9. DOI： 10.13422/j.cnki.syfjx.20192150.

摘要

随着国家针对经典名方的相关政策不断出台，全国各地经典名方研究开展的如火如荼。与其他新药的研发不同，经典名方复方制剂开发是先有“标准”后有产品，其“物质基准”的研制具有重要意义。笔者在结合本课题组前期经典名方开发的工作基础上，针对国家药品监督管理局2018年5月发布的《古代经典名方中药复方制剂简化注册审批管理规定》中涉及的“经典名方物质基准”内容进行分析，阐述其研制的意义，提出涵盖处方考证及历史沿革研究、药味收集和质量评价、饮片炮制方法和质量评价、物质基准的制备和质量研究、物质基准质量标准的起草和制定的五阶段研究策略，同时针对经典名方复方制剂开发的可行性、处方药味资源评估实施的难度、药材质量相关研究中不合理性提出建议，以期为经典名方物质基准研制和政策落地提供参考和启示。

Abstract

With continuous introduction of relevant national policies on famous classical formulas

the research of famous classical formulas is popular all over the country. Different from other new drugs

in the research and development process of famous classical formulas

substance benchmark is earlier than the product

suggesting that the research and development of substance benchmark is of great significance. Based on previous work of the authors

content of substance benchmark of famous classical formulas was analyzed

which was included in the document

The Management Regulation of Simplified Registration and Approval over Chinese Herbal Medicine Compound Preparations of Ancient Famous Classical Formulas

released by the National Medical Products Administration in May 2018. In this paper

the significance of substance benchmark development was described

a five-stage of research strategy was proposed

covering the prescription textual research and historical evolution

the collection and quality evaluation of medicinal materials

the processing method and quality evaluation of decoction pieces

the preparation and quality research of substance benchmark

the drafting and formulating of quality standard over substance benchmark. At the same time

some suggestions were put forward to the feasibility of compound preparations development over famous classical formulas

the implementation difficulty of resource evaluation over Chinese medicinal materials

and the irrationality on the quality correlation of Chinese medicinal materials. All of these are expected to provide reference and enlightenment for the development and policy officially landed over ancient famous classical formulas.

关键词

Keywords

references

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Shanghai Huanghai Pharmaceutical Co. Ltd.

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