注射用七叶皂苷钠无菌检查方法学验证

Methodology Validation of Test for Sterility of Sodium Aescinate for Injection

目的建立注射用七叶皂苷钠的无菌检查方法,并对方法进行验证。方法按《中国药典》2010年版二部附录ⅪH无菌检查法进行方法学验证。结果用0.1%蛋白胨水溶液作稀释剂进行稀释,采用薄膜过滤法进行过滤,加相应的培养基进行培养,六株试验菌供试品阳性对照与阳性对照比较均生长良好,符合验证要求。结论验证所建立的方法可用于注射用七叶皂苷钠的无菌检查,结果准确、可靠。

0bjective To establish and validate a method for sterility test of Sodium Aescinate for Injection.Methods Perform methodology validation for sterility test according to Appendix XIH,Chinese Pharmacopeia（Edition 2010 Vol ）.Resu Its The drug is diluted by 0.1% peptone solution,filtered by membrane filtration,and cultured with nutrient medium.All six testing strains compared product positive control with positive control grow well,the method could meet the requirement of the validation. Conclusion This method can be used for sterility test of Sodium Aescinate for Injection. The testing results are accurate and reliable.