摘要
目的评价国内不同企业生产的酮康唑洗剂的质量。方法采用法定标准结合探索性研究对2024年国家药品抽检的45批(40个批号)酮康唑洗剂进行综合评价,包括有关物质、抗氧剂含量、包装透氧量、体外透皮、黏度、抑菌效力、刺激性、微观结构等。结果法定标准检验合格率100.0%,经探索性研究后发现多批次样品存在问题。相关性分析发现影响酮康唑洗剂质量的主要因素为处方工艺和包装。结论建议生产企业尽快进行处方工艺优化,并注意选择合适的包材,有效提高酮康唑洗剂的质量。
Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.
作者
寻延滨
多凯
信长颖
韩小旭
赵霞
王斯文
王春雨
肖宇
赵龙山
王常禹
于新颖
XUN Yanbin;DUO Kai;XIN Changying;HAN Xiaoxu;ZHAO Xia;WANG Siwen;WANG Chunyu;XIAO Yu;ZHAO Longshan;WANG Changyu;YU Xinying(Heilongjiang Institute for Drug Control,Harbin 150088,China;School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Institute for the Testing of Packaging Materials and Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100061,China)
出处
《医药导报》
北大核心
2025年第10期1595-1600,共6页
Herald of Medicine
基金
2024年国家药品抽检中央补助地方经费项目(编号:44)。
关键词
酮康唑洗剂
国家药品抽检
法定标准
探索性研究
处方工艺
Ketoconazole lotion
National drug sampling and testing
Legal standards
Exploratory research
Prescription process
