肾康片质量标准的研究

Study on quality standard for Shenkang tablets(Radix astragall,fructus corni,etc.)

目的 :研究肾康片的质量标准并控制该制剂的质量。方法 :用薄层色谱法鉴别了肾康片中的黄芪、山茱萸、桑寄生及丹参 ,用薄层色谱法限量检查了该制剂中的乌头碱 ,用双波长薄层扫描法测定了该制剂中黄芪甲苷的含量。结果 :乌头碱限量符合中国药典规定 ,黄芪甲苷的平均回收率为 97.5% ,其RSD为 1 .4 3 % (n =5)。结论 :本文的结果显示出这些方法可用于控制该制剂的质量 ,方法灵敏、简便、专属。

OBJECTIVE:To study quality standard of shenkang tablets and to control its quality.METHODS:Radix Astragali、Fructus、Corni、Herba Taxilli and Radix Salviae Miltiorrhizae in Shenkang tablets were identified with TLC;The amount of aconitine in Radix Aconiti Lateralis Preparata was also limited with TLC;Astragaloside in Shenkang tablets was determined with Dual Wavelength TLCS.RESULTS:Limit of the amount of aconitine accorded with general rule of Chinese pharmacopoeia.The average recovery of astragaloside was 97.5% with RSD 1.43%(n=5).CONCLUSION:The results show that these methods could be used in controlling quality of Shenkang tablets and these methods are sensitive,simple,specific and accurate.