扶肾颗粒质量标准研究

Study on quality standard of Fushen granule

关键词:  扶肾颗粒  薄层色谱法  高效液相色谱法  黄芪  当归  丹参  大黄  陈皮  淫羊藿

Key words:  Fushen granule  TLC  HPLC  icariine  Radix Astragali  Radix Angelicae Sinensis  Radix Salviae Miltiorrhizae  Radix et Rhizoma Rhei  Pericarpium Citri Reticulatae

摘要:

[目的]建立扶肾颗粒的质量标准。[方法]采用薄层色谱(TLC)法鉴别制剂中黄芪、当归、丹参、大黄、陈皮药材,用高效液相色谱(HPLC)法测定制剂中淫羊藿苷的含量。[结果]TLC斑点清楚,专属性强。淫羊藿苷0.048 5～0.97μg范围内与峰面积积分值呈良好线性关系(r分别为0.999 9);平均回收率分别为97.0%,相对标准偏差(RSD)分别为0.7%。[结论]所建标准可用于扶肾颗粒的质量控制。

Abstract:

[Objective] To establish the quality standard of Fushen granule.[Methods] Radix Astragali,Radix Angelicae Sinensis,Radix Salviae Miltiorrhizae,Radix et Rhizoma Rhei and Pericarpium Citri Reticulatae in some preparations were identified qualitatively by TLC and the content of icariine in Herba Epimedii was determined by HPLC.[Results] The TLC spots were distinctive and specific.The linear range of quercetin,kaempferide, isorhamnetin was 0.048 5～0.97μg(r=0.999 9).The average recovery rate was 97.0%(RSD=0.7%).[Conclusion] The method is reliable,accurate,and reproducible for the quality control of Fushen granule.