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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 sterile test method for potassium and magnesium aspartate injection. Methods According to “Chinese Pharmacopoeia” 2010 edition two appendix Ⅺ H sterility test requirements for verification test. Results Potassium and magnesium aspartate injection had different degrees of antibacterial activity against five positive representative strains. Aseptic method for the injection of potassium-magnesium aspartate injection could be established by membrane filtration method. Conclusion This method is used for the sterile examination of potassium and magnesium aspartate injection, the method is accurate and reliable.