蒿甲醚注射液无菌检查方法的适用性试验比较  

Comparison of Applicability Test of Sterile Examination Method for Artemether Injection

作　　者：刘勤 张红宇 王璐 罗秀萍 

机构地区：[1]云南省食品药品监督检验研究院,昆明650000 [2]昆明医科大学药学院

出　　处：《中国药师》2017年第10期1874-1876,共3页China Pharmacist

摘　　要：目的:拟定一个更适用于蒿甲醚注射液的无菌检查方法,以更好地控制其质量。方法:分别采用直接接种法和薄膜过滤法对蒿甲醚注射液进行无菌检查,并对两种方法的试验过程和结果进行比较。结果:直接接种法中,含蒿甲醚注射液的试验组各试管中金黄色葡萄球菌、枯草芽孢杆菌、生孢梭菌24 h均生长良好,大肠埃希菌、黑曲霉、白色念珠菌48 h均生长良好;薄膜过滤法中,含蒿甲醚注射液的试验组各滤瓶中金黄色葡萄球菌24 h均生长良好,其他5个菌在48 h均生长良好。表明该供试品在薄膜过滤法的试验量及检验条件下无抑菌作用或其抑菌作用可以忽略不计,可选择薄膜过滤法作为蒿甲醚注射液的无菌检查方法。结论:两种方法的方法适用性试验阳性菌均生长良好。但由于薄膜过滤法在操作和结果的准确性等方面有较为明显的优势,因此建议蒿甲醚注射液的无菌检查法按薄膜过滤法进行。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.

关 键 词：蒿甲醚注射液 无菌检查 薄膜过滤法 直接接种法 方法适用性 比较分析 

分 类 号：R927.1[医药卫生—药学]