扶正固本颗粒的质量标准研究

Quality Standard of Fuzheng Guben Granules

目的:建立扶正固本颗粒的质量标准。方法:采用薄层色谱(TLC)法对扶正固本颗粒中黄芩、女贞子、何首乌、淫羊藿和茜草进行定性鉴别,用高效液相色谱法测定制剂中淫羊藿苷的含量。结果:TLC斑点清晰、分离度好;淫羊藿苷进样量在20.2～404.0μg范围内与峰面积积分值呈良好线性关系(r=0.9999),平均回收率为98.1%,RSD=1.21%(n=6)。结论:所建鉴别方法专属性强、重现性好,定量方法简便、准确,可用于控制扶正固本颗粒的质量。

OBJECITVE：To establish the quality standard for Fuzheng guben granules.METHODS：The qualities of Scutellaria baicalensis,Ligustrum lucidum,Polygonum multiflorum,Epimedii folium and Rubiae Radix ET Rhizoma in prescription were identified with TLC method.The content of icariin was determined by HPLC.RESULTS：TLC spots were clear and well-separated.The linear range of icariin was 20.2～404.0 μg（r=0.999 9） with an average recovery of 98.1%（RSD=1.21%,n=6）.CONCLUSION：The method is specific,reproducible,simple and accurate.It can be used for the quality control of Fuzheng guben granules.