冠脉宁片(胶囊)现行薄层鉴别标准比较研究  

Comparative study on the current thin-layer identification standard for Guanmaining tablets(capsules)

作　　者：汪祺[1] 郑笑为[1] 刘燕[1] 姚令文[1] 戴忠[1] 马双成[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2014年第9期1692-1700,共9页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:统一冠脉宁片(胶囊)的薄层鉴别方法。方法:归纳总结冠脉宁16个现行标准中10项薄层鉴别方法。通过实验比较不同处理方法及薄层展开条件,最终确定适宜方法。结果:经实验研究,最终统一葛根、丹参、延胡索薄层鉴别项,合并血竭、冰片及何首乌、二苯乙烯薄层鉴别项。结论:本实验确定的7项薄层鉴别方法为16家生产企业提供了统一、切实可行的薄层执行标准,可有效控制该产品质量,建议取消原儿茶醛鉴别项,可统一增订当归、鸡血藤鉴别项。Objective：To unify the method of thinlayer chromatography（ TLC） for Guanmaining tablets（ capsules）. Methods：The TLC methods for 10 items in 16 current standards for Guanmaining tablets（ capsules） were summarized. The appropriate method was eventually determined through comparison of different processing methods and TLC conditions in experiments. Results：The TLC identification items for Puerariae Radix,Salviae Miltiorrhizae Radix and Corydalis Rhizoma were unified. The items for Draconis Sanguis,borneol and stilbene glycoside,Polygoni Multiflori Radix were consolidated. Conclusion：The TLC methods for seven items determined in this experiment provide a uniformed and practical TLC executive standard for 16 manufacturers,which can effectively control the quality of Guanmaining tablets（ capsules）. It is suggested to abolish the identification item for protocatechualdehyde and add the identification item for Angelicae Sinensis Radix and Spatholobi Caulis.

关 键 词：冠脉宁 葛根 丹参 延胡索 血竭 冰片 何首乌 儿茶醛 当归 鸡血藤 薄层鉴别 中成药质量标准 

分 类 号：R917[医药卫生—药物分析学]