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作 者:肖钦钦 陈希 张银花 王杰 刘卫德 段和祥 裴昆 章红 Xiao Qinqin;Chen Xi;Zhang Yinhua;Wang Jie;Liu Weide;Duan Hexiang;Pei Kun;and Zhang Hong(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029)
机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029
出 处:《中国抗生素杂志》2025年第3期304-312,共9页Chinese Journal of Antibiotics
基 金:2023年国家药品抽检资助国药监药管(No.[2023]2号)。
摘 要:目的探讨国产氧氟沙星滴耳液的质量现状与风险点,为仿制药一致性评价提供质量控制参考依据。方法在法定检验结果的基础上,从“质量源于设计”理念出发,重点对关键辅料质量控制、原辅料相容性及杂质谱等方面进行深入研究,综合评价产品的质量现状。结果186批次样品按法定标准检验,合格率为100%。但现行质量标准存在缺失及方法适用性差;部分企业产品存在渗漏;多家企业药品说明书不规范;不同企业之间、同一企业不同批次间的产品质量存在差异。探索性研究结果表明,甘油、乙醇、丙二醇等辅料可加速氧氟沙星降解;尼泊金酯类、三氯叔丁醇等抑菌剂稳定性差;抑菌剂存在过度添加风险;不良反应与产品渗透压摩尔浓度相关;分析了氧氟沙星滴耳液中11个杂质的来源,采用UPLC-QTOF-MS初步推测了4个降解杂质的可能的结构式。结论本品总体质量较好,但多家企业处方设计存在较大风险,建议企业在进行仿制药一致性评价时,重点关注生产工艺过程控制及产品效期内关键辅料质控等方面,从而全面提高产品质量与稳定性。Objective To explore the quality status and risk points of domestic ofloxacin ear drops and provide quality control reference for the consistency evaluation of generic drugs.Methods Based on the results of statutory inspections,in-depth research was conducted on the quality control of key excipients,compatibility of raw and auxiliary materials,impurity profiles,etc.,starting from the concept of“quality by design”,and a comprehensive evaluation of the current quality of the product was made.Results The 186 batches of samples were inspected according to the legal standards,with a 100%qualification rate.However,there were deficiencies in the current quality standards and poor applicability of the methods;some products from enterprises had leakage;the drug instructions from many enterprises were not standardized.There were differences in product quality between different enterprises and different batches from the same enterprise.The exploratory research results showed that excipients,such as glycerin,ethanol and propylene glycol,could accelerate the degradation of ofloxacin;preservatives,such as paraben esters and chlorobutanol,had poor stability;there was a risk of over-addition of preservatives;adverse reactions were related to the osmotic pressure molarity of the product;the sources of 1 impurity in ofloxacin ear drops were analyzed,and the possible structures of 4 degraded impurities were preliminarily inferred by UPLC-QTO-MS.Conclusion The overall quality of this product was good,but there were significant risks in the prescription design of many enterprises.It was recommended that enterprises could focus on control of the production process and the quality control of key excipients within the validity period of the product when conducting a consistency evaluation of generic drugs,so as to comprehensively assess the quality and stability of the product.
关 键 词:氧氟沙星滴耳液 原辅料相容性 杂质谱 抑菌剂 仿制药一致性评价
分 类 号:R917[医药卫生—药物分析学]
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