头孢匹胺无菌检查方法的建立  

Establishment of the sterility test method for cefpiramide

作　　者：李趣嫦[1] 李文靖[1] Li Qu-chang;Li Wen-jing(Guangdong Institute for Drug Control,Guangzhou 510663)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《中国抗生素杂志》2020年第12期1242-1245,共4页Chinese Journal of Antibiotics

摘　　要：目的建立抗生素类固体原料药头孢匹胺的无菌检查方法。方法以碳酸钠溶液作为稀释液,采用薄膜过滤法去除头孢匹胺的抗菌活性,按照《中国药典》2015年版无菌检查法进行方法的建立和验证。结果药典规定的6种标准菌株均在规定时间内正常生长。结论该方法能有效去除头孢匹胺的抗菌活性,对其相关产品的无菌检查起到较好的参考作用。Objective To establish the sterility test method for antibiotic solid raw materials of cefpiramide. Methods The antibacterial activity of cefpiramide was removed by the membrane filtration method, using sodium carbonate solution as the diluent, and the sterility test method was established and validated according to the Chinese Pharmacopoeia 2015. Results The six standard strains stipulated in Pharmacopoeia grew normally within the specified time. Conclusion Our developed method possess the ability for removing the antibacterial activity of cefpiramide, and it can be used as a reference for the sterility test of cefpiramide and related products.

关 键 词：头孢匹胺 无菌检查 方法适用性 

分 类 号：R978.1[医药卫生—药品]