摘要
目的评价国内不同厂家生产的盐酸洛美沙星滴眼液的质量现状及存在问题。方法按照国家评价性抽验计划总体要求,采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果。结果共抽取样品153批次,按国家标准检验不合格率0.7%。探索性研究建立了有关物质检查方法,对光降解杂质的来源与结构进行了确证;考察了盐酸洛美沙星滴眼液处方合理性,发现多家企业处方不合理。结论目前国内盐酸洛美沙星滴眼液总体质量一般;现行标准有待统一和提高;建议企业优化处方,加强内包装材料遮光性。
Objective To evaluate the suitability of the statutory standard and the quality status of lomefloxacin hydrochloride eye drops of different domestic manufacturers. Methods According to the general requirements of national assessment programs, the statutory standard methods combined with exploratory researches were used to evaluate the quality of lomefloxacin hydrochloride eye drops. Results According to the statutory standards for the examination of the 153 batches, the unqualified rate was 0.7%. The method of related substances test was optimized. This paper also researched the structures and sources of major photodegradation impurities. The formulation rationality of domestic lomefloxacin hydrochloride eye drops was evaluated and most of the formulation was not reasonable. Conclusion The quality of lomefloxacin hydrochloride eye drops was generally good. On the one hand, the statutory standards needs to be integrated and improved. On the other hand, exploratory research results suggested that the formulation should be optimized, and the obscuration of inner packing material should be improved.
出处
《中国抗生素杂志》
CAS
CSCD
2018年第3期307-312,共6页
Chinese Journal of Antibiotics
关键词
盐酸洛美沙星滴眼液
有关物质
处方合理性
质量分析
Lomefloxacin hydrochloride eye drops
Related substances
Formulation rationality
Quality evaluation
