Research Strategies and Key Problems Analysis over Substance Benchmark of Famous Classical Formulas
10.13422/j.cnki.syfjx.20192150
- VernacularTitle:经典名方物质基准研制策略及关键问题分析
- Author:
Yan LIU
1
;
Jun ZHANG
1
;
Lin-yong YANG
2
;
Guo-yuan ZHANG
1
;
Shu-yu XU
3
;
Ling-mei KONG
4
;
Xiao-dan QI
4
;
Yun GONG
5
;
Feng-yan NI
6
;
Yan TONG
1
;
An LIU
1
Author Information
1. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
2. China Medico Technology Co. Ltd., Tianjin 300301, China
3. Xiamen Traditional Chinese Medicine (TCM) Co. Ltd., Xiamen 361100, China
4. Dong-e E-jiao Co. Ltd., Liaocheng 252201, China
5. Qianjin Pharmaceutical Co. Ltd., Zhuzhou 412003, China
6. Jiangxi University of TCM, Nanchang 330004, China
- Publication Type:Research Article
- Keywords:
traditional Chinese medicine;
famous classical formulas;
substance benchmark;
research and development strategies;
prescription textual research;
resource evaluation;
processing
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2020;26(1):1-9
- CountryChina
- Language:Chinese
-
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.
