盐酸洛美沙星滴耳液的质量分析与评价  

Quality analysis and evaluation of lomefloxacin hydrochloride ear drops

作　　者：曾红霞 杨盈 周玉平 王建 周霞 朱坤丹 张凤妹 郑金琪 Zeng Hongxia;Yang Ying;Zhou Yuping;Wang Jian;Zhou Xia;Zhu Kundan;Zhang Fengmei;Zheng Jinqi(Zhejiang Institute of Food and Drug Control,Key Laboratory of Key Technologies for Generic Drug Evaluation,Zhejiang Key Laboratory of Quality Control of Drug Contact Materials,Zhejiang Provincial Key Laboratory of Drug Contact Materials,Hangzhou 310052;China Jiliang University,Hangzhou 310018;Zhejiang University of Technology,Hangzhou 310014)

机构地区：[1]浙江省食品药品检验研究院、国家药品监督管理局仿制药评价关键技术重点实验室、浙江省药品接触材料质量控制研究重点实验室,杭州310052 [2]中国计量大学,杭州310018 [3]浙江工业大学,杭州310014

出　　处：《中国抗生素杂志》2024年第4期381-387,共7页Chinese Journal of Antibiotics

摘　　要：目的评价国内不同企业生产的盐酸洛美沙星滴耳液的质量现状。方法采用法定标准结合探索性研究对111批抽验样品进行综合评价,包括杂质分析、抑菌剂、辅料相容性、包装材料、抑菌效力和处方合规性方面,综合评价国内产品质量及现行质量标准对产品质量的可控性。结果法定检验结果显示,111批盐酸洛美沙星滴耳液合格率为100%。但现行法定标准中的有关物质方法重现性、杂质分离和检出能力差,且抑菌剂测定方法未涵盖本品使用的全部抑菌剂种类。探索性研究结果显示,本品的杂质水平主要与处方工艺有关,不同企业的杂质检出情况差异明显。国内厂家的处方和辅料与原研差异较大,光降解杂质含量与处方中有机物含量呈显著负相关。不同企业包装材料的遮光作用存在明显差异。一家厂家的抑菌效力测定结果达《中国药典》2020年版抑菌效力判断B标准,未达A标准。111批次抽样抑菌剂、EDTA和乙醇含量均与处方量一致。结论目前国产盐酸洛美沙星滴耳液总体质量较好;现行标准需要进一步提高;本品处方工艺差别对质量影响很大,且与原研差异大,建议尽快开展质量与疗效一致性评价。Objective This study evaluated the quality status of lomefloxacin hydrochloride ear drops produced by different domestic manufacturers.Methods A comprehensive evaluation of 111 batches of samples was carried out using legal specifications combined with exploratory research,including impurity analysis,bacteriostatic agents,excipient compatibility,packaging materials,bacteriostatic efficacy and formulation compliance.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results The statutory determination results showed that the qualification rate of 111 batches of lomefloxacin hydrochloride ear drops was 100%.However,the reproducibility,impurity separation,and detection ability of the related substance methods in the current specifications were poor,and the bacteriostatic agent determination method did not cover the types used in the products.The exploratory research results showed that the impurity level of the products was mainly related to the formulation process,and the impurity detection situations varied significantly among different manufacturers.There were significant differences between the formulation and excipients of domestic manufacturers and the original drugs,and there was a significant negative correlation between the content of photodegradation impurities and the organic content in their formulation.There were significant differences in the shading effect of packaging materials from different manufacturers.The results of the bacteriostatic efficacy determination of one manufacturer reached the B standard for the judgment in the 2020 edition of the Chinese Pharmacopoeia but did not meet the A standard.The levels of bacteriostatic agents,EDTA and ethanol in 111 batches were consistent with the prescribed amount.Conclusion The overall quality of domestically produced lomefloxacin hydrochloride ear drops was good at present.The current specification should be further improved.The difference in formulation process of the products had a signifi

关 键 词：盐酸洛美沙星滴耳液 质量评价 评价性抽验 一致性评价 杂质分析 

分 类 号：R978.1[医药卫生—药品]