海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2014年
11期
67-69
,共3页
门冬氨酸钾镁注射液%无菌检查法%方法验证
門鼕氨痠鉀鎂註射液%無菌檢查法%方法驗證
문동안산갑미주사액%무균검사법%방법험증
Potassium Aspartate and Magnesium Aspartate Injection%Sterility test method%Method validationx
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。
目的：建立門鼕氨痠鉀鎂註射液的無菌檢查方法。方法依據《中國藥典》2010版二部附錄ⅪH無菌檢查法的要求進行驗證試驗。結果門鼕氨痠鉀鎂註射液對5株暘性代錶菌株有不同程度的抗菌活性，採用薄膜過濾法可建立針對門鼕氨痠鉀鎂註射液的無菌檢查方法。結論此法用于門鼕氨痠鉀鎂註射液的無菌檢查，方法準確、可靠。
목적：건립문동안산갑미주사액적무균검사방법。방법의거《중국약전》2010판이부부록ⅪH무균검사법적요구진행험증시험。결과문동안산갑미주사액대5주양성대표균주유불동정도적항균활성，채용박막과려법가건립침대문동안산갑미주사액적무균검사방법。결론차법용우문동안산갑미주사액적무균검사，방법준학、가고。
OBJECTIVE To establish a method on sterility test for Potassium Aspartate and Magnesium Aspar-tate 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 Injec-tion 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 meth-ods.CONCLUSION This method is accurate and reliable which can be used to check the sterility of Potassium As-partate and Magnesium Aspartate Injection.
