国家药品抽检滴眼剂质量状况研究

Special Quality Research on Eye Drops for National Drug Sampling Inspection

关键词:  滴眼剂  处方合理性  抑菌剂  质量分析

Key words:  eye drops  prescription rationality  antibacterial agent  quality analysis

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：回顾我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、2020、2021年样品检验,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。

Abstract:

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 has shown an improving trend year by year, but research has found that there are 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.