国产乳酸环丙沙星滴眼液质量分析

目的评价国产乳酸环丙沙星滴眼液的质量现状。方法采用现行法定标准检验结合探索性研究结果,对市场上3家企业生产的36批乳酸环丙沙星滴眼液的质量进行比较分析,通过对含量测定、有关物质及抑菌剂合理性等项目的考察,结合稳定性试验,分析不同企业产品的质量差异。结果法定标准检验36批乳酸环丙沙星滴眼液,合格率为100%;探索性研究显示,该品种现行标准多个安全性检查项目缺失、检验方法专属性差、标准不统一。结论国内乳酸环丙沙星滴眼液整体质量一般,现行质量标准有待提高。

Quality analysis of domestic ciprofloxacin lactate eye drops

Objective To evaluate the quality of domestic ciprofloxacin lactate eye drops. Method Using statutory testing methods combining with the exploratory research, the quality of 36 batches of ciprofloxacin lactate eye drops produced by three enterprises on the market was compared systematically. Through the investigation of the component, related substances, the rationality of bacteriostat and other items, combining with the stability test, quality differences among different enterprise products were analyzed. Results 36 batches of ciprofloxacin lactate eye drops were inspected according to the legal standard, and the qualified rate was 100%. The exploratory research showed that the current standard of ciprofloxacin lactate eye drops was lack of several safety inspection items, poor specificity of inspection methods, and inconsistent standards, which lead to inadequate quality control. Conclusion The quality of domestic ciprofloxacin lactate eye drops is generally acceptable, and the current quality standard needs to be