Analysis and Discussion on Quality Standard of TCM Preparation in Guangdong Provincial Medical Institution Preparation Specification
- VernacularTitle:《广东省医疗机构制剂规范》中的中药制剂质量标准的分析与探讨
- Author:
Xiaoxiao LIU
1
;
Ying LONG
1
;
Zhong DAI
2
;
Hua LI
1
;
Shuangcheng MA
2
;
Zhuoya LUO
1
Author Information
1. Guangdong Institute for Drug Control，Guangzhou 510633，China
2. National Institute for Food and Drug Control，Beijing 100050，China
- Publication Type:Journal Article
- Keywords:
Guangdong provincial medical institution preparation specification;
TCM preparations;
Medical institution;
Quality standard;
Problems and suggestions
- From:
China Pharmacy
2019;30(15):2027-2030
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE： To provide reference for perfecting the quality standard revision of TCM preparations in medical institutions， and improving the quality standard of TCM preparations in medical institutions. METHODS： By sorting out the quality standards of TCM preparations in Guangdong provincial medical institution preparation specification， this paper summarized the main problems and put forward suggestions for improvement. RESULTS & CONCLUSIONS： There are 897 kinds of TCM preparations included in the Guangdong provincial medical institution preparation specification. The recent quality standards （2017 edition） have been greatly improved compared with those of the first edition （1985 edition）； however， there are still some problems in the overall quality control of preparations， quantitative control of indicative components， project specificity， source control of medicinal materials， control of medicinal materials not included in the Chinese Pharmacopoeia and quality standards of the same series of varieties. It is suggested that on the premise of considering both advancement and applicability， the quality control of the whole， local and toxic preparations of TCM hospitals should be strengthened， the detection methods with good specificity and reproducibility should be properly updated， the control of key parameters of production process should be strengthened， the quality standard of TCM preparations in medical institutions should be fully improved， so as to provide the products with safe， effective and controllable in quality products in medical institutions.
