注射用甲磺酸加贝酯无菌检查方法的验证

Sterility Test Method Validation of Gabexate Mesylate for Injection

目的:建立注射用甲磺酸加贝酯无菌检查方法。方法:参照中国药典2005年版二部附录XIH进行试验。结果:采用薄膜过滤法,以0.1%无菌蛋白胨水溶液为冲洗液,选择冲洗量为300ml,即可消除样品对各菌株的抑菌活性。结论:故注射用甲磺酸加贝酯可按照此方法进行无菌检查。

Objectlve：To establish a Sterility test method of Cabexate Mesylate for Injection. Methods：To test according to Chinese pharmacopoeia 2005 edition appendix XIH. Results：The antibacterial activity of various sample strains can be eliminated with membrane filtration method ,300ml 0. 1% sterile peptone aqueous solution as flushing fliud. Conclusion：This method can be used as the sterility test method for Gabexate Mesylate for Injection.