注射用甲磺酸培氟沙星无菌检查法的确定  

Confirmation study on the steriality method of the pefloxacin mesylate for injection

作　　者：李昊 李旭 张亚杰 

机构地区：[1]辽宁省药品检验检测院,沈阳110036

出　　处：《中国抗生素杂志》2017年第6期531-533,共3页Chinese Journal of Antibiotics

摘　　要：目的建立可行的适合所有生产单位的注射用甲磺酸培氟沙星无菌检查方法。方法采用含0.05%硫酸锰的0.1%蛋白胨水溶液作为溶剂和冲洗液进行无菌检查。结果对30批次样品进行无菌检查,均符合规定。结论该方法适用于所有厂家的注射用甲磺酸培氟沙星的无菌检查。Objective To establish the sterile examination method for every company. Methods Add 0.05% manganese sulfate into the 0.1% peptone solution for dissolving and washing. Results The sterile examination of the thirty batches all meets the specification. Conclusion The method of the sterile examination is appropriate for all companies.

关 键 词：注射用甲磺酸培氟沙星 无菌检查 冲洗液 

分 类 号：R917[医药卫生—药物分析学] R978.1[医药卫生—药学]