氨金黄敏颗粒的盐酸金刚烷胺薄层鉴别方法的修订  

Revision of identification of amantadine hydrochloride in paracetamol,anantadine hydrochloride,artificid cow-bezar and chlorphenamine maleate granules by TLC

作　　者：李美芳 刘敏 董继胜 肖丽和 LI Meifang;LIU Min;DONG Jisheng;XIAO Lihe(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen 518057,China;Heilongjiang Dilong Pharmaceutical Co.,Ltd.,Suihua 151400,China)

机构地区：[1]深圳市药品检验研究院,深圳药品质量标准研究重点实验室,深圳518027 [2]黑龙江迪龙制药有限公司,绥化151400

出　　处：《中国药品标准》2021年第2期113-118,共6页Drug Standards of China

摘　　要：目的:修订氨金黄敏颗粒的盐酸金刚烷胺薄层色谱鉴别方法。方法:以盐酸金刚烷胺对照品为对照,采用硅胶G薄层板,以三氯甲烷-甲醇-丙酮-浓氨溶液(9∶1.5∶1∶0.05)为展开剂,展开后晾干,喷以显色剂,可见光检视。结果:修订的盐酸金刚烷胺薄层鉴别方法,斑点清晰易辨,分离度和重现性均良好。结论:修订的薄层鉴别方法为国内5家生产企业提供了统一、切实可行的薄层鉴别方法,有效控制本品质量。Objective:To revise the TLC identification method of amantadine hydrochloride in paracetamol,anantadine hydrochloride,artificid cow-bezar and chlorphenamine maleate granules.Methods:Amantadine hydrochloride reference substance was used as the control,the silica G plate was used.The plate was developed with a mixture of chloroform,methanol,acetone and strong ammonia solution(9∶1.5∶1∶0.05)and allowed to air-dry,then sprayed with chromogenie reagent.The spots were observed under visible light.Results:The revised identification method of amantadine hydrochloride had the good resolution and reproducibility,and the obtained spots were clear.Conclusion:The revised TCL method provides a uniform and practicable identification method for five domestic manufacturers,and it can control the quality of this product effectively.

关 键 词：氨金黄敏颗粒 盐酸金刚烷胺 薄层色谱鉴别 

分 类 号：R921.2[医药卫生—药学]