复方补肾颗粒的质量标准研究

quality standard for Compound Bushen Granule

目的 :建立复方补肾颗粒 (黄芪 ,补骨脂 ,菟丝了 ,枸杞子 ,等 )的质量标准。方法 :采用TLC法对处方中的黄芪、菟丝子、枸杞子进行定性鉴别 ,用HPLC法测定补骨脂中补骨脂素和异补骨脂素的含量。结果 :在TLC色谱中均能检出黄芪、菟丝子、枸杞子 ;补骨脂素在 0 .0 1 53μg～0 .2 30 μg范围呈良好的线性关系 ,r =0 .9999,平均回收率 1 0 2 .4% ,RSD为2 .7% ;异补骨脂素在 0 .0 1 83μg～0 .2 75μg范围呈良好的线性关系 ,r =0 .9999,平均回收率 1 0 2 .4% ,RSD为 2 .7%。 结论 :该法简单可行 ,结果准确 。

Objective: To establish the quality control standards for Compound Bushen Granule (CBG) (Radix Astagali, Fructus Psoraleae Semen Cuscutae, Fructus Lycii, etc.). Methods: Radix Astragali, Semen Cuscutae, Fructus Lycii in CBG were identified by TLC, and the content of psoralen and isopsoralen were determined by HPLC. Results: Radix Astragali, Semen Cuscutae, Fructus Lycii could be identified by TLC, the psoralen showed a good linear relationship at a range of 0.0153μg～0.230μg, r=0.9999 , the average recovery was 102.4%, and RSD was 2.7%, respectively; the isopsoralen showed a good linear relationship at a range of 0.0183μg～0.275μg, r=0.9999, the average recovery was 102.4%, and RSD was 2.7% , respectively. Conclusion: The method is accurate and can be used for the quality control of Compound Bushen Granule.