不同生产厂家乳酸环丙沙星注射液质量考察

Investigation on Quality of Ciprofloxacin Lactate Injection from Different Manufacturers

目的:比较不同厂家乳酸环丙沙星注射液的质量。方法:对国内、外4厂家产品的不溶性微粒、乳酸含量、乙二胺及有关物质、容器内表面吸附性能进行测定或观察。结果:所有被测产品各项指标均符合《中国药典》要求,除不溶性微粒外,其余指标不同厂家产品之间存在差异。结论:有必要对乳酸环丙沙星注射液中部分项目进行限量规定。

OBJECTIVE： To compare the quality of ciprofloxacin lactate injections from different manufactories. METH- ODS： The determination of ciprofloxacin lactate injections from 4 different manufacturers was performed from several aspects： particulate matter, lactic acid content, ethanediamine, the related substance and the superficial adsorption property within container was determined. RESULTS： The determined indexes of all ciprofloxacin lactate injection products manufactured by 4 different manufacturers were all in line with the specification of China Pharmacopoeia, with all of the indexes except the index of particulate matter showing no difference. CONCLUSION： The results suggest that it is necessary to define a limited dose for some items in ciprofloxacin lactate injection.