Views on Key Technical Problems in Research and Development of Famous Classical Formulas
10.13422/j.cnki.syfjx.20211852
- VernacularTitle:关于经典名方研发的一些重要关键信息和科学问题的几点看法
- Author:
Zhi-min WANG
1
;
Ju-yan LIU
2
;
De-qin WANG
3
;
Chun LI
1
;
Li-hua YAN
1
;
Xiao-qian LIU
1
;
Wei-hong FENG
1
;
Hui-min GAO
1
;
Yan TONG
1
;
Jing-jing ZHU
1
;
Yan-hui KUANG
3
;
Liang-mian CHEN
1
Author Information
1. National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines， Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. Guangzhou Pharmaceutical Holdings Co. Ltd.，Guangzhou 510103，China
3. Guangzhou Baiyunshan Hutchison Whampoa Chinese Medicine Co. Ltd.，Guangzhou 510515，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine;
famous classical formulas;
reference sample;
ancient and modern dose conversion;
quality consistency evaluation;
processing methods
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(1):212-217
- CountryChina
- Language:Chinese
-
Abstract:
In this paper， the key technical problems in the research and development of famous classical formulas are analyzed. Firstly， the puzzled problem for a long-time， which is conversion relationship from medicinal metrology of Han dynasty （HD） to that of modern （gram，g）， is comprehensively expounded that one Liang （两） of HD=3 g is more appropriate. Secondly， the model and principles of quality consistency evaluation are given for the transformation from the quality of authoritative basic sample prepared by casserole （ABS-C） to the quality consistency in Laboratory process， pilot-scale process and industrial production. The consistency evaluation model is ξABS-X=K1（Q1ABS-X/Q1ABS-C）+K2（Q2ABS-X/Q2ABS-C）+……+Ki（QiABS-X/QiABS-C）=∑Ki（QiABS-X/QiABS-C）（i=1，2，3……n）. In the formula， ABS-X means laboratory reference sample ABS-C （ABS-L）， pilot-scale ABS-C （ABS-mP） or industrial production ABS-C （ABS-P）， ξABS-X means the quality consistency rate or similarity degree of ABS-L， ABS-mP and ABS-P processes with ABS-C， Ki means the weight of each quality evaluation index （i）， QiABS-X is the data of i in ABS-L， ABS-mP， ABS-P samples， and QiABS-C is the data （or mean） of i in ABS-C sample. Thirdly， in order to control the quality of the herbal medicines whose active ingredients were unknown， their chemical constituents should be studied deeply， and if necessary， the bioassay research should be carried out according to the main efficacy or indication of famous classical formulas. Finally， for the special processing of some herbal medicines， it is difficult to formulate the processing method， technology and standard of prepared slices. It is suggested that the scientific connotation and historical evolution of the special processing method should be thoroughly sorted out， and its technological characteristics are summarized， the modern processing technology and production processes are simulated， and then the corresponding processing methods and quality standards are formulated.
