肾安泰胶囊的质量标准研究

STUDY OF QUALITY STANDARD FOR SHENANTAI CAPSULE

目的探讨肾安泰胶囊的薄层色谱法(thin layer chromatography,TLC)和高效液相色谱法(highpreformance liquid chromatography,HPLC)的质量控制方法。方法分别用冷浸和加热回流提取法对肾安泰胶囊处方中黄芪和地黄进行TLC定性鉴别,并采用HPLC法对牡丹皮中的丹皮酚进行含量测定。结果在供试品色谱中,与对照品色谱相应的位置上,黄芪和地黄都显现出相同颜色的斑点。丹皮酚在0.019 86～0.496 50μg线性关系良好,r^2=0.999 9,平均回收率为98.96%,相对标准偏差为0.32%。结论该方法能准确可靠地进行定性、定量检测,能有效控制肾安泰胶囊制剂的质量。

Objective To establish the thin layer chromatography （TLC） and high preformance liquid chromatography （HPLC） quality control method for Shenantai capsule. Methods Radix Astragali and Rehmannia Root were extracted by cold soaked method and heated refluxed method and then were identified by TLC method. The content of paeonol in Cortex Moutan Radicis was determined by HPLC method. Results Radix Astragali and Rehmannia Root in the chromatograms of sample showed the same color spot with the chromatograms of standard. And paeonol showed a good linear relationship at a range of 0.019 86 - 0.496 50p, g with r^2 of 0. 999 9. The average recovery was 98.96%, and relative standard deviation was 0.32%. Conclusion The method is accurate and reliable, and can be used to control the quality shenantai capsule effectively.