国家药品抽检滴眼剂质量状况研究  

Quality Research on Eye Drops for National Drug Sampling Inspection

作　　者：朱嘉亮[1] 庄珊珊 陆爽 李睿 王翀[1] 徐苗[1] ZHU Jialiang;ZHUANG Shanshan;LU Shuang;LI Rui;WANG Chong;XU Miao(National Institutes for Food and Drug Control,Beijing 102629,China;Fujian Institutes for Food and Drug Quality Control,Fuzhou 350012,China;Jiangsu Institutes for Food and Drug Control,Nanjing 210019,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]福建省食品药品质量检验研究院,福州350012 [3]江苏省食品药品监督检验研究院,南京210019

出　　处：《中国现代应用药学》2024年第23期3408-3414,共7页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的评价国内滴眼剂的抽检质量现状及存在的质量风险,并提出完善建议。方法回顾中国抽检滴眼剂历年质量现状,按照国家药品抽检计划总体要求,采用法定标准检验方法结合探索性研究对2018年、2020年、2021年样品进行检验,对发现的主要质量问题进行分析。结果滴眼剂抽检合格率呈现逐年向好趋势,但通过研究发现在质量标准、处方设计、生产工艺以及包材相容性等方面仍存在一定问题。结论目前滴眼剂仍存在部分产品处方不合理、抑菌效力不符合规定等问题。建议完善并统一质量标准,优化处方和包装材料,规范产品标签。OBJECTIVE To evaluate the current quality status and existing quality risks of domestic eye drops sampling,and provide suggestions for improvement.METHODS Reviewing the current status of sampling quality of eye drops across the country over the years,and in accordance with the overall requirements of the national evaluative sampling plan,using legal standard inspection methods combined with exploratory research to inspect samples in 2018,2020 and 2021,and analyzing the main quality problems discovered.RESULTS The pass rate of eye drops sampling inspections had shown an improving trend year by year,but research had found that there were still certain problems in quality standards,prescription design,production technology,and packaging material compatibility.CONCLUSION At present,eye drops still have problems such as unreasonable prescriptions and substandard bacteriostatic efficacy of some products.It is recommended to improve and unify quality standards,optimize prescriptions and packaging materials,and standardize product labels.

关 键 词：滴眼剂 处方合理性 抑菌剂 质量分析 

分 类 号：R917[医药卫生—药物分析学]