Improvement of high-quality evaluation criteria of Chinese patent medicines based on whole process control.
10.19540/j.cnki.cjcmm.20221108.302
- Author:
Yan LIU
1
;
Cong GUO
1
;
Jun ZHANG
1
;
Qing-Xia XU
1
;
An-Yi ZHAO
1
;
Yong-Zhen LAO
2
;
Jiang-Min SU
1
;
Zhi-Guang WANG
3
;
Yu-Zhen LIU
3
;
Sha CHEN
1
;
An LIU
1
Author Information
1. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China Shandong University of Traditional Chinese Medicine Jinan 250355, China.
3. Pharmaceutical Chamber of Commerce,All China National Industry and Commerce Association Federation Beijing 100101, China.
- Publication Type:Journal Article
- Keywords:
Chinese patent medicine;
efficacy evaluation;
high-quality;
quality control;
raw materials;
whole process control
- MeSH:
Medicine, Chinese Traditional;
Drugs, Chinese Herbal/therapeutic use*;
Nonprescription Drugs;
Chlorobenzenes;
China
- From:
China Journal of Chinese Materia Medica
2023;48(6):1700-1704
- CountryChina
- Language:Chinese
-
Abstract:
Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.
