复方银杏通脉胶囊的制备及质量控制  

Preparation and Quality Control of Co Yinxing Tongmai Capsule

作　　者：陈登丰[1] 

机构地区：[1]福建省南平市人民医院,南平353000

出　　处：《光明中医》2012年第3期593-595,共3页GUANGMING JOURNAL OF CHINESE MEDICINE

摘　　要：目的建立复方银杏通脉胶囊制备方法及质量标准。方法采用70%乙醇提取银杏叶黄酮类化合物和振动磨超微粉碎;采用薄层色谱法对制剂中的银杏叶、丹参、川芎进行定性鉴别;采用高效液相色谱法对丹参酮ⅡA进行含量测定。结果该制剂符合《中国药典》2010年版对胶囊剂的要求;TLC鉴别银杏叶、丹参、川芎方法简便易行,斑点清晰,专属性强;高效液相色谱法测定丹参酮ⅡA含量,平均回收率为96.22%,RSD为3.068%(n=5)。结论本制剂制备方法合理,简便;质控方法简单易行,结果准确,可作为该制剂的质量控制标准。Objective To prepare Co Yinxing Tongmai Capsule and establish a method for its quality control.Methods The extraction of the flavonoids from leaves of Ginkgo biloba is 70% ethanol.By vibration mill the technology of ultra-fine pulverization is used for the content of this capsule.Radix Salviae Miltiorrhiza,Ginkgo Biloba,Rhizoma Chuanxiong are identified by TLC.HPLC method is employed to determine tanshinone ⅡA.Results It is up to the standard specified of capsules in Chinese Pharmacopeia（2010 edition）.The TLC spots are distinctive and specific.The average recovery of HPLC for determination of the content of tanshinone ⅡA is 96.22%,with RSD of 3.068%（n=5）.Conclusion This preparation is feasible,and the quality control method is simple,rapid and accurate.They can be used effectively for the quality control of this capsule.

关 键 词：复方银杏通脉胶囊 制备 质量控制 

分 类 号：R283[医药卫生—中药学] R286.0[医药卫生—中医学]