摘要
目的:验证乳酸环丙沙星氯化钠注射液的无菌检查方法。方法:采用中国药典2005年版二部附录无菌检查法项下薄膜过滤法。结果:确定大肠埃希菌为乳酸环丙沙星氯化钠注射液无菌检查的敏感菌株。结论:经方法学验证,该方法准确可靠,可作为乳酸环丙沙星氯化钠注射液的无菌检查方法。
Objective: To verify the sterility test of Ciprofloxacin Lactate and Sodium Chloride Injection. Method: Membrane filtration method in Volume Ⅱ of ChP2005 was used. Result:Escherichia coli was restrained by Ciprofloxacin Lactate and Sodium Chloride Injection. Conclusion:This method is accurate. It can be used for sterility test of Ciprofloxacin Lactate and Sodium Chloride Injection.
出处
《中国药品标准》
CAS
2008年第1期38-40,共3页
Drug Standards of China
关键词
乳酸环丙沙星氯化钠注射液
无菌检查
方法验证
Ciprofloxacin Lactate and Sodium Chloride Injection
Sterility Test
Verification