Discussion on Technical Characteristics of National Drug Standards for Traditional Chinese Medicine Dispensing Granules
10.13422/j.cnki.syfjx.20250963
- VernacularTitle:中药配方颗粒国家药品标准技术特点探讨
- Author:
Shengjun CHEN
1
;
Song LI
1
;
Kejia GUO
1
;
Yuntian ZHANG
1
;
Haiqin ZHOU
1
;
Xianglan PU
1
Author Information
1. Jiangyin Tianjiang Pharmaceutical Co. Ltd.，Jiangyin 214400，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine dispensing granules;
national standards;
technical requirements;
technical characteristics;
quality control;
specific chromatogram
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(10):256-264
- CountryChina
- Language:Chinese
-
Abstract:
On the premise of respecting the objective law of the occurrence and development of traditional Chinese medicine（TCM） dispensing granules， relevant national departments have gradually formed the research and formulation ideas of national drug standards for dispensing granules based on the experiences and lessons learned in the development process of quality standards， as well as the formation mechanism of national standards for dispensing granules. This has certain reference significance for the formulation path of TCM quality standards. Combined with the general situation of the published standards and specific cases， the research concepts of the national standards for dispensing granules were analyzed and summarized in this paper， and the analysis of the technical characteristics of the issued national standards was focused， including the introduction of standard decoction， the overall quality control of TCM， the whole process quality control and other research ideas. At the same time， it summarized the industry common problems in the research and development process of national standards for dispensing granules， such as the source and process control of medicinal materials， and strived to solve them together， encouraging the demonstration and application of new technological means in the field of TCM dispensing granules. Finally， based on the literature analysis， the shortcomings of the current national standards were discussed， and relevant suggestions were put forward to further improve the national standards for dispensing granules. Through the overall analysis， it is helpful to comprehensively understand the technical characteristics of the national standards for TCM dispensing granules， and provide reference for the scientific exploration and practice of quality control methods for TCM.
