不同厂家酒石酸长春瑞滨软胶囊质量对比研究  

Quality evaluation of vinorelbine tartrate soft capsules from different manufacturers

作　　者：王彪[1] 张翠莲[1] 杜博冉[2] 赵彬[1] 张鹏霄[1] 刘新月[3] 梅丹[1] 

机构地区：[1]中国医学科学院北京协和医学院北京协和医院药剂科,北京100730 [2]首都医科大学附属北京妇产医院药剂科,北京100026 [3]美国佛罗里达大学药学院,盖恩斯维尔32603

出　　处：《临床药物治疗杂志》2017年第8期15-20,共6页Clinical Medication Journal

基　　金：北京市2013-2014年度国家临床重点专科建设项目

摘　　要：目的:对不同厂家酒石酸长春瑞滨软胶囊进行质量对比研究,评价不同厂家制剂的质量差异。方法:参考国家食品药品监督管理总局进口药品注册标准JX20130256,选择含量、有关物质、溶出度及不同贮藏温度下的稳定性等指标进行比较和评价。结果:不同厂家酒石酸长春瑞滨软胶囊制剂存在质量差异。结论:不同厂家制剂存在一定质量差异,建议有关厂家从制剂原辅料、制剂工艺等方面入手,不断提高制剂质量。Objective：To compare the quality of vinorelbine tartrate soft capsules form different pharmaceuticals,and evaluate the quality differences of products from different manufacturers.Methods：Comparison and evaluation of the quality were performed on content,related substances,dissolution and stability when storing in different temperature,according to the strict standards No.JX20130256.Results：There were some differences among the vinorelbine tartrate soft capsules from different manufacturers.Conclusion：There are differences in quality among products from different manufactures.We suggest that manufacturers should promote their quality from raw materials and production process.

关 键 词：质量 评价 酒石酸长春瑞滨软胶囊 

分 类 号：R927[医药卫生—药学]