Discussion about re-evaluation of compound preparation of Chinese-Western medicine on post-marketing drug
10.7501/j.issn.1674-6376.2017.05.001
- VernacularTitle:中西药复方制剂再评价的有关问题探讨
- Author:
Xia LI
;
Shengbing XU
- Keywords:
compound preparation of Chinese-Western medicine;
quality control;
safety evaluation;
drug re-evaluation;
drug supervision
- From:
Drug Evaluation Research
2017;40(5):577-585
- CountryChina
- Language:Chinese
-
Abstract:
In this paper,the management process of Chinese-Western medicine compound preparation is briefly reviewed.the existing problems were analyzed from the perspective of registration supervision and quality control.It is pointed out that there are still some types of management in the registration of supervision,such as the weak basic research,approval number of multiple pecifications,not uniform name,and not standardized specification.In the area of quality control,correlation analysis between the lack of key items (such as related substances,uniformity of contents,and dissolution test items) and the hidden dangers in medical security of preparations was performed.To explore the need for reevaluation,and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.
