马波沙星注射液无菌检查方法的建立

Validation on Sterility Test Method for Marbofloxacin Injection

对马波沙星注射液的无菌检查方法进行适用性研究。按《中国兽药典》2015年版一部附录1101进行试验,采用薄膜过滤法对马波沙星注射液进行无菌检查。结果:马波沙星注射液经用0.1%无菌蛋白胨水溶液冲洗滤膜,每膜每次100 mL,冲洗6次后,试验组菌生长良好,与阳性对照组一致。结果表明,薄膜过滤法可用于马波沙星注射液的无菌检查。

To analyze the applicability of sterility test method for marbofloxacin injection,according to the Chinese Veterinary Pharmacopoeia(2015 Edition One Appendix 1101),the sterility test for marbofloxacin injection was conducted by membrane filtration.The microbes in the test group grew well after marbofloxacin injection washed with 0.1%sterile peptone aqueous solution at 100 mL/membrane,after washing for 6 times,which was consistent with the results of positive control group.The results indicated that the membrane filtration method could be used for sterility test for marbofloxacin injection.