Research on Preparation Process and Quality Evaluation of Traditional Chinese Medicine Dispensing Granules and Its Consistency with Traditional Decoction： A Review
10.13422/j.cnki.syfjx.20220653
- VernacularTitle:中药配方颗粒制备工艺、质量评价、与传统汤剂一致性的研究现状分析
- Author:
Henian YANG
1
;
Jincheng ZHANG
2
;
Suhui WU
1
;
Hanbing LI
1
Author Information
1. Henan Zhongjing's Prescription Healthy Aging Industry Engineering Research Center， Henan University of Chinese Medicine，Zhengzhou 450046，China
2. Beijing University of Chinese Medicine，Beijing 100029，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine dispensing granules;
traditional decoction;
preparation technology;
quality evaluation;
consistency evaluation;
structural Chinese medicine;
quality marker（Q-Marker）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(8):266-274
- CountryChina
- Language:Chinese
-
Abstract:
Traditional Chinese medicine dispensing granules（TCMDGs）is the new type of decoction pieces with the development of modernization of TCM， which has received mixed opinions since its practical application. In 2021， the national departments issued Announcement on Ending the Pilot Work of TCMDGs， marking the end of the 28-year pilot work of TCMDGs， and eligible TCM enterprises can produce TCMDGs after filing. However， this does not mean that the preparation process， quality standard and efficacy research of TCMDGs have been developed and matured， on the contrary， there are still some problems that need to be solved and gradually improved. For example， in the production process， there are problems such as unclear， unified and non-standardized preparation parameters. In terms of quality control， there are some problems such as lack of producing area regulation， variety selection and processing specification. In terms of consistency evaluation with traditional decoction， there are problems such as unclear relationship between the chemical constituents and pharmacological effects of the two. Therefore， in view of some prominent problems of TCMDGs at present， this paper takes the published literature as the main data source and combines the specific requirements of the code or technical standards such as the 2020 edition of Chinese Pharmacopoeia， Publicity of the Unified Standard on the Varieties of TCMDGs， Quality Control and Standard Formulation Technical Requirements of TCMDGs. The production process of TCMDGs， the origin and variety of raw materials， the processing of decoction pieces， the quality control standard and the consistency evaluation of formula granules and traditional decoction were sorted out and visualized by literature mining， data analysis and list comparison. Based on the analysis results， the following suggestions were made. In terms of preparation process， the completeness and standardization of process parameters should be strengthened. In terms of quality evaluation， attention should be paid to the relationship between the authenticity， variety， processing and quality of medicinal materials. In the consistency evaluation of formula granules and traditional decoction， the deep difference and mechanism between TCMDGs and traditional decoction were discussed by combining structural Chinese medicine， quality marker（Q-Marker） theory and physicochemical characterization， so as to provide reference for the application and development of TCMDGs.
