Analysis of Formulation and Characteristics of Provincial Standards for Traditional Chinese Medicine Dispensing Granules
10.13422/j.cnki.syfjx.20221248
- VernacularTitle:中药配方颗粒省级标准的制定情况及其特点分析
- Author:
Yan MIAO
1
;
Lu LU
1
;
Lu ZHANG
2
;
Fuguo HOU
1
;
Di ZHANG
1
;
Xuehua FAN
1
;
Xinjing GUI
2
;
Qingxiao WANG
3
;
Haibo WANG
3
;
Ruixin LIU
2
Author Information
1. Henan University of Chinese Medicine，Zhengzhou 450046，China
2. The First Affiliated Hospital of Henan University of Chinese Medicine，Zhengzhou 450000，China
3. Henan Institute for Drug and Medical Device Inspection，Zhengzhou 450018，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine dispensing granules;
provincial standards;
national pharmaceutical standards;
dry extract rate;
index components;
specifications;
equivalence ratio
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2023;29(14):157-163
- CountryChina
- Language:Chinese
-
Abstract:
In order to standardize the quality control of traditional Chinese medicine（TCM） dispensing granules， the Chinese Pharmacopoeia Commission has promulgated and implemented 200 national drug standards for TCM dispensing granules， but there are still varieties of TCM dispensing granules without unified standards. Many provinces have actively invested in the formulation of provincial standards for TCM dispensing granules to make up for the gaps in standards for varieties of traditional Chinese medicine dispensing granules other than the national standards. By the end of July 2022， 29 provincial-level administrative regions have successively promulgated and implemented a total of 5 602 provincial standards for TCM dispensing granules， involving more than 400 varieties. In order to better understand the formulation and characteristics of provincial standards， this study took 105 provincial standards that have been promulgated and implemented in Henan province as an example， and comprehensively analyzed the formulation and characteristics through quality control indicators such as dry extract rate of raw materials， contents of index components and their transfer rates， specifications and so on. The formulation and characteristics of the same TCM dispensing granules in the provincial standards of different provinces were further analyzed， in order to provide reference for the formulation of provincial standards of TCM dispensing granules and the implementation of national standards.
