低密度聚乙烯药用滴眼剂瓶质量状况分析

Quality Analysis of Low-Density Polyethylene Bottles for Eye Drops

目的:分析我国低密度聚乙烯药用滴眼剂瓶的质量状况,为其生产和检验提出建议与对策。方法:在法定检验项目基础上,通过对国内外检验标准现状的比较分析及探索性研究,探讨低密度聚乙烯药用滴眼剂瓶工艺的可控性、产品的安全性、阻隔性和与药物的相容性。结果:我国法定标准与国外药典相比,鉴别性状项目尚未采用专属性极强的DSC方法,红外光谱法可操作性欠缺但密度指标范围相对合理,安全性方面的收载项目各异且部分项目指标相对宽松;而阻隔性和相容性研究表明低密度聚乙烯滴眼剂瓶不适合作为含冰片等挥发性成分以及用三氯叔丁醇和硫柳汞钠作为防腐剂的滴眼剂药物的包装。结论:质量标准方面应规范样品名称,增加修订试验方法,提高限度要求,建立统一的红外对照图谱;企业监管方面应规范生产,严格控制配方与工艺的一致性,加强相容性研究。

Objective： To analyze the quality status of low-density polyethylene （LDPE） bottles for eye drops in China and to put forward countermeasures and suggestions for manufacture and testing. Methods： The controllability, safety, barrier properties and compatibility with drugs of LDPE bottles for eye drops were discussed on the basis of statutory inspection items through comparative analysis and exploratory research on the current status of the domestic and international testing standards. Results： Compared with international pharmacopoeia, trait identification of the legal standard in our country has not adopted DSC method. Infrared spectroscopy is less operational but the density range is relatively reasonable. Security part contains different items and some of the item indicators are relatively loose. The barrier properties and compatibility studies have shown that LDPE bottles are not suitable for drug packaging of eye drops containing volatile ingredients such as bomeol and preservatives, like, trichlorobutanol and sodium thimerosal. Conclusion： it is suggested that sample names be standardized, revised testing methods be added, the limit requirements be enhanced and the atlas of infrared spectra be established. For manufacturer regulation, it is suggested that production be regulated, the consistency of the formula and process be strictly controlled and the compatibility study be strengthened.