抗疏健骨颗粒质量标准研究

目的研究抗疏健骨颗粒的质量标准,为有效控制该制剂的质量提供实验依据。方法采用薄层色谱法对淫羊藿、杜仲、牛膝、丹参、白术进行定性鉴别,采用高效液相色谱法对淫羊藿苷进行定量分析。结果淫羊藿、杜仲、牛膝、丹参、白术的薄层鉴别结果良好,阴性对照均无干扰;含量测定淫羊藿苷在0.1μg~1.2μg范围内有良好的线性关系（r=0.9999）,平均加样回收率为100.66%,RSD为1.31%（n=6）。结论所建立的TLC法和HPLC法对淫羊藿、杜仲、牛膝、丹参、白术和淫羊藿苷含量可准确地进行定性、定量测定,专属性强、重现性好,可用于抗疏健骨颗粒的质量控制。

Quality Standard Research of Kangshu Jiangu Granule

Objective to study the quality standard of Kangshu Jiangu granule, to provide the experimental basis for the effective quality control of the preparation. Methods TLC was used for qualitative identification of epimodium, eucommia, Achyranthes root, salvia, Atraetylodes, using high performance liquid chromatography method for the quantitative analysis of icariin. Results the TLC results of epimedium, eucommia, Achyranthes root, salvia, Atractylodes macrocephala are good, the negative control showed no interference; the content determination of icariin between 0.11μg - 1.2μg range has a good linear relationship （ r = 0.9999）, the average recovery was 100.66%, RSD was 1.31% （ n = 6）. Conclusion the determination of TLC method and HPLC method of epimedium, eucommia, Achyranthes root, salvia, Rhizo- ma Atractylodis Macrocephalae and icariin contents can be accurately qualitative, quantitative, strong specificity, good reproducibility, and can be used for quality control of Kangshu Jiangu granule.