Establishment of quality control method for biological activity of Honghua injection
10.3969/j.issn.1001-1978.2020.05.026
- Author:
Tian-Hong GAO
1
Author Information
1. Shanxi Institute for Food and Drug Control
- Publication Type:Journal Article
- Keywords:
Biological activity;
Honghua injection;
Limit value determination method;
Orthogonal test;
Quality control of traditional Chinese medicine;
Thrombus method in mice
- From:
Chinese Pharmacological Bulletin
2020;36(5):727-731
- CountryChina
- Language:Chinese
-
Abstract:
Aim To establish a method for determining the antithrombotic biological activity of Honghua injection, which can be used to evaluate and control its quality. Methods Collagen-adrenalin was used to induce mouse acute cerebral thrombosis model and hemiplegic protection rate of Honghua injection in mice as an index to investigate the antithrombotic activity of Honghua injection. The experimental conditions of the administration dosage, inducer dosage, and different strains of mice were investigated, and the experimental conditions were optimized by orthogonal design. Results Honghua injection which was made by 5. 0 g crude drug · kg-1and continuously ip for 3 d, had obvious protective effect on collagen-adrenalin-induced acute cerebral thrombosis in mice. The established biological activity limit method showed a good repeatability, intermediate precision, and reproducibility. Each sample showed different degrees of differences in biological activity. Conclusions The thrombus test in mice can be used as a method for measuring the biological activity of Honghua injection. It is recommended to use 5. 0 g crude drug · kg-1dose as the limit for bioactive process optimization and product quality controlment of Honghua injection.
