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Position: Home > Articles > Study on the Sterility Test Method for Gamithromycin Injection Chinese Journal of Veterinary Medicine 2018 (12) 110-113

加米霉素注射液无菌检查方法的试验

作  者:
赵梅仙;宋敏;张国栋;张传良;徐金雷;葛辛玫;马佳颖;王楠
单  位:
中牧实业股份有限公司
关键词:
加米霉素注射液;薄膜过滤法;无菌检查
摘  要:
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。
译  名:
Study on the Sterility Test Method for Gamithromycin Injection
作  者:
ZHAO Mei-xian;SONG Min;ZHANG Guo-dong;ZHANG Chuan-liang;XU Jin-lei;GE Xin-mei;MA Jia-ying;WANG Nan;Zhongmu Institute of China Animal Husbandry Industry Co.,LTD.;
单  位:
ZHAO Mei-xian%SONG Min%ZHANG Guo-dong%ZHANG Chuan-liang%XU Jin-lei%GE Xin-mei%MA Jia-ying%WANG Nan%Zhongmu Institute of China Animal Husbandry Industry Co.,LTD.
关键词:
gamithromycin injection;;membrane filitration method;;sterility test
摘  要:
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.

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