门冬氨酸钾镁注射液无菌检查方法验证  

Methodology Study on Sterility Test for Potassium Aspartate and Magnesium Aspartate Injection

作　　者：郑国锋 

机构地区：[1]安徽阜阳市食品药品检验检测中心,阜阳236015

出　　处：《海峡药学》2014年第11期67-69,共3页Strait Pharmaceutical Journal

摘　　要：目的建立门冬氨酸钾镁注射液的无菌检查方法。方法依据《中国药典》2010版二部附录ⅪH无菌检查法的要求进行验证试验。结果门冬氨酸钾镁注射液对5株阳性代表菌株有不同程度的抗菌活性,采用薄膜过滤法可建立针对门冬氨酸钾镁注射液的无菌检查方法。结论此法用于门冬氨酸钾镁注射液的无菌检查,方法准确、可靠。OBJECTIVE To establish a method on sterility test for Potassium Aspartate and Magnesium Aspartate Injection. METHODS Validation test was carried accouding to the requirements of sterile test in 《Chinese Pharmacopoeia》2010 edition of Appendix ⅪH. RESULTS Potassium Aspartate and Magnesium Aspartate Injection on five representative strains with different degrees of positive antibacterial activity can be created using the membrane filtration method for Potassium Aspartate and Magnesium Aspartate Injection sterility test methods. CONCLUSION This method is accurate and reliable which can be used to check the sterility of Potassium Aspartate and Magnesium Aspartate Injection.

关 键 词：门冬氨酸钾镁注射液 无菌检查法 方法验证 

分 类 号：R927.2[医药卫生—药学]