Research Strategies for Quality Standards of Famous Classical Formula Based on Standard Decoction (Material Reference)
10.13422/j.cnki.syfjx.20200244
- VernacularTitle:基于标准汤剂(物质基准)的经典名方制备工艺和质量标准研究
- Author:
Yun-tao DAI
1
;
Ru-na JIN
1
;
Zhi-li WU
1
;
An LIU
1
;
Tie-jun ZHANG
2
;
Shi-lin CHEN
1
Author Information
1. Institute of Chinese Materia Medica, China Academy of Chinese Medicinal Science, Beijing 100700, China
2. Research Center for New Drug Evaluation, Tianjin Institute of Pharmaceutical Research, Tianjin 300193, China
- Publication Type:Research Article
- Keywords:
famous classical formulae;
standard decoction(materia reference);
production process;
quality standard;
consistency evaluation
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2020;26(2):164-174
- CountryChina
- Language:Chinese
-
Abstract:
The inheritance of traditional clinical value of famous classical formulae is an important direction for the development of traditional Chinese medicine industry.Compared with the previous research and development of new drugs, the management requirement of " material reference" was introduced into the famous classical formulae research, which is used as the reference of process optimization and quality control.The characteristics of compound preparation of famous classical formulae are also reflected in the core concept of " quality inheritance of classics" in the road of industrial development.How to implement the above requirements and concepts into product development and industrial production? There are many specific common problems to be solved in practical research.How to effectively establish the " material reference" of famous classical formulae of different dosage forms? How to use " material reference" to guide the process optimization of compound preparation of famous classical formulae? How to determine the daily dose of famous classical formulae? How to take effective measures in the selection of raw material to reduce quality fluctuation range? This paper discusses the key issues such as production process and quality evaluation from the following aspects.Firstly, the management regulations and research and development guidelines are analyzed, and the specific implementation methods are given.Then, the possible problems in the Requirements for Declaration Documents (Draft for Opinions) are pointed out, and relevant suggestions are given.Finally, based on the research experience of standard decoction and famous classical formulae in the laboratory, an example is given to provide reference for the development of compound preparation of famous classical formulae.
