Analysis on Technical Problems and Countermeasures of Standard Formulation of Traditional Chinese Medicine Formula Granules
10.13422/j.cnki.syfjx.20220453
- VernacularTitle:中药配方颗粒标准制定技术问题和对策分析
- Author:
Dongxiao GUO
1
;
Shanshan YU
2
;
Yanheng GUO
3
;
Xiaofei CUI
4
;
Huan QIN
5
;
Weiliang CUI
1
;
Yongqiang LIN
1
;
Hongchao LIU
1
Author Information
1. Key Laboratory for Quality Evaluation of Gelatin Products，National Medical Products Administration，Shandong Engineering Laboratory for Standard Innovation and Quality Evaluation of Traditional Chinese Medicine （TCM），Shandong Engineering Research Center for Generic Technologies of TCM Formula Granules，Shandong Institute for Food and Drug Control，Jinan 250101，China
2. Jinan Supervision and Inspection Center for Food and Drug Control，Jinan 250102，China
3. Heze Institute for Food and Drug Control，Heze 274000，China
4. Yantai Supervision and Inspection Center for Food and Drug Control，Yantai 264000，China
5. Taian Institute for Food and Drug Control，Taian 271000，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine formula granules;
standard formulation;
quality control;
production technology;
whole process supervision;
technical problems;
countermeasure analysis
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(17):188-194
- CountryChina
- Language:Chinese
-
Abstract:
After the completion of the pilot work of traditional Chinese medicine formula granules （TCMFGs）， the national and provincial medical products administrations have published and implemented about 440 varieties of TCMFGs standards. Based on the previous work， this paper analyzed technical problems encountered in the review and evaluation of Shandong TCMFGs standards， mainly involving the executive standards and distinguishing technologies of raw materials， the adding process of excipients in the procedure item， the rationality of quality control methods， the information content and reproducibility of characteristic chromatograms， the nomenclature and accessibility of reference materials， etc. The common problems such as the coverage of standards， specification differences， and the integrity of quality control items of current TCMFGs standards were discussed deeply. It is proposed to promote the upgrading of provincial standards to national standards， accelerate the research and development of reference materials， advocate the use of high-quality raw materials， explore the evaluation methods of high-quality products， and strengthen the quality supervision of the whole process. Suggestions of this paper is hoped to provide references for the formulation of national and provincial TCMFGs standards， promote the continuous improvement of TCMFGs standard system， and ensure the healthy and orderly development of the TCMFGs industry.
