加米霉素注射液无菌检查方法的试验

Study on the Sterility Test Method for Gamithromycin Injection

本文建立了加米霉素注射液的无菌检查方法。采用薄膜过滤法,根据《中国兽药典》2015年版一部附录要求进行试验,以0.1%无菌蛋白胨的0.1%聚山梨酯80溶液冲洗,冲洗量为500 mL/膜,验证试验结果显示,各验证菌生长良好,各供试品管均未见细菌生长。本试验成功建立了可靠、准确、可用于加米霉素注射液的无菌检查法。

To establish the sterility test for gamithromycin injection, the membrane filitration method was used and verified on the basis of the appendix to Veterinary Pharmacopoeia of the People’s Republic of China(2015 edition). The results showed that the antibacterial activity of various strains could be eliminated with 500 ml 0.1% sterility peptone-0.1%polysorbate 80 solution as flushing fluid.In validation test, all the test strains grew well and bacteria were not found in the tube of test sample.The results showed that the method was reliable and accurate and could be used for sterility test of gamithromycin injection.