摘要
目的研究7个生产企业的65批盐酸左氧氟沙星滴眼液的现行质量标准以及苯扎溴铵、苯扎氯铵、羟苯乙酯、三氯叔丁醇4种抑菌剂的添加状况和包装材料的相容性,为提高其质量标准提供参考。方法对盐酸左氧氟沙星滴眼液的现行6个质量标准及常用的苯扎溴铵、苯扎氯铵、羟苯乙酯、三氯叔丁醇4种抑菌剂的测定方法进行研究,建立HPLC法对抑菌剂苯扎溴铵、苯扎氯铵、羟苯乙酯的含量进行测定,并对不同包装材料相容性进行考察。结果现行6个质量标准不统一,有的未对抑菌剂进行控制,包装材料对抑菌剂三氯叔丁醇存在吸附作用,有些抑菌剂与其包装材料搭配存在缺陷。结论现行质量标准有待统一,应加强对抑菌剂的控制,建议改进包装材料。
Objective To study the condition of the existing quality standard of Levofloxacin Hydrochloride Eye Drops, the 4 kinds of antibacterial agent additions -- benzalkonium bromide, benzalkonium chloride, ethylparaben and tert butyl alcohol three chloro, as well as the compatibility of additions with packaging materials by testing 65 batches of samples from 7 manufacturers. The results can provide a reference to improve its quality standards. Methods Levofloxacin Hydroehloride Eye Drops of 6 existing quality standards and 4 common antibacterial agents （benzalkonium bromide, benzalkonium chloride, ethylparaben and tert butyl alcohol three chloro） were studied, the HPLC method was used to inspect the content of antibacterial agents benzalkonium bromide, benzalkonium chloride, ethylparaben, and to test their compatibility with different packaging materials. Results The 6 existing quality standards are not uniform, some lack a control over antibacterial agents, as the packaging has sorption of ehlorobutanol; some contain defects in the collocation between antibacterial agents and packaging materials. Conclusion The existing quality standards need to be unified. The antibacterial agent should be controlled strictly. It is suggested to improve packaging materials.
出处
《中国药事》
CAS
2014年第5期479-484,共6页
Chinese Pharmaceutical Affairs
关键词
盐酸左氧氟沙星
抑菌剂检测
苯扎溴铵
苯扎氯铵
羟苯乙酯
三氯叔丁醇
包装材料相容
性
质量标准比较
Levofloxacin Hydrochloride
antibacterial agent testing
benzalkonium bromide
benzalkonium chloride
ethylparaben
tert butyl alcohol three chloro
compatibility of packaging materials
comparison of quality standards
