| 摘要: |
| 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100ml，冲洗6次后，试验组菌生长良好，与阳性对照组一致。结论：薄膜过滤法可用于马波沙星注射液的无菌检查。 |
| 关键词: 马波沙星注射液 无菌检查 方法适用性试验 薄膜过滤法 |
| DOI： |
| 投稿时间：2021-05-10修订日期：2021-12-30 |
| 基金项目: |
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| Validation on sterility test method for Marbofloxacin Injection |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| Objective: To analyze the applicability of sterility test method for marbofloxacin injection .Method:According to the Chinese Veterinary Pharmacopoeia (2015 Edition One Appendix 1101 ),the sterility test for marbofloxacin injection was conducted by membrane filtration. Results: 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. Conclusion:This method can be used for the sterility test for marbofloxacin injection. |
| Key words: marbofloxacin injection sterility test method applicability test membrane filtration |
