注用达托霉素粉针剂无菌检查方法验证

Establish Sterility Test for Injection Daptomycin

建立了注用达托霉素粉针剂的无菌检查方法。参考中国药典2010年版无菌检查验证试验方法,采用薄膜过滤法对人工污染的6种菌株进行试验,以pH=7.0氯化钠-蛋白胨缓冲液作为稀释液和冲洗液,供试品先用450 mL缓冲液进行稀释,然后用700 mL缓冲液分若干次冲洗,消除其抑菌作用。结果表明:本试验建立的注用达托霉素粉针剂无菌检查方法准确、可靠,避免了该药品无菌检查结果出现假阴性。

To establish sterility testing method for injection daptomycin.The experiment was conducted according to the method of the Chinese Phaemacopoeia 2010 edition.The result was tested by the membrane-filter method to six kinds of artificial contamination strain.The sample was atternated in 450 mL of pH=7.0 sodium chloride-alburninous peptone,washed many times with 700 mL of the same buffer damping fluid.The method provided an effective standard operation process in sterility test and that could eliminate the pseudo-negative results.