Comparison of Applicability Test of Sterile Examination Method for Artemether Injection
- VernacularTitle:蒿甲醚注射液无菌检查方法的适用性试验比较
- Author:
Qin LIU
1
;
Hongyu ZHANG
;
Lu WANG
;
Xiuping LUO
Author Information
1. 云南省食品药品监督检验研究院 昆明650000
- Keywords:
Artemether injection;
Sterility test;
Membrane filtration;
Direct inoculation;
Method applicability;
Comparative anal-ysis
- From:
China Pharmacist
2017;20(10):1874-1876
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a more suitable sterile examination method for artemether injection in order to control its quality better. Methods:The direct inoculation and the membrane filtration was respectively used for the sterile examination of artemether in-jection. Results:In the direct inoculation method, Staphylococcus aureus, Bacillus subtilis and Clostridium perfringens grew well in the test tubes containing artemether injection in 24 h, and Escherichia coli, Aspergillus niger and Candida albicans grew well in 48 h. In the membrane filtration method, Staphylococcus aureus grew well in 24 h in the test group containing artemether injection, and the other 5 strains grew well in 48 h. Conclusion:The positive strains can grow well in the applicability test of both methods. However, due to the simpler operation and higher accuracy of membrane filtration method, it is recommended to be used for the sterile test of artemether injection.
