消脂通脉颗粒的质量标准研究

Study on Quality Standard for Xiaozhi Tongmai Granule

目的：建立消脂通脉颗粒的质量标准。方法：采用薄层色谱（TLC）法定性鉴别制剂中的半夏、大黄、白术、莪术;以高效液相色谱法测定陈皮中橙皮苷的含量：色谱柱为YWG-C18（150 mm×4.6 mm,5μm）,流动相为甲醇-6.15%醋酸溶液（29∶71,V/V）,检测波长为283 nm。结果：半夏、大黄、白术、莪术均可在TLC图中检出,阴性对照无干扰。橙皮苷的进样量在0.466~2.796μg范围内与其峰面积积分值呈良好的线性关系（r=0.999 9）;平均加样回收率为99.47%,RSD=0.99%（n=6）。结论：所建立的定性鉴别方法专属性强、重复性好,定量方法简便、准确、可靠,可用于消脂通脉颗粒的质量控制。

OBJECTIVE：To establish the quality standard of Xiaozhi tongmai granule.METHODS：Pinellia ternata,Rhei Radix et Rhizoma,Atractylodes macrocephala and Curcumae Rhizoma were identified by TLC qualitatively.The content of hesperidi was determined by HPLC.The separation was performed on YWG-C18（150 mm×4.6 mm,5 μm）with mobile phase consisted of methanol-6.15% acetic acid（29∶71,V/V）.The detection wavelength was 283 nm.RESULTS：P.ternata,Rhei Radix et Rhizoma,A.macrocephala and Curcumae Rhizoma could be identified by TLC without interference from negative control.The linear range of hesperidi were 0.466-2.796 μg（r=0.999 9）with average recovery of 99.47%（RSD=0.99%,n=6）.CONCLUSIONS：The qualitative identification is specific and reproducible,and quantitative method is simple,accurate and reliable,which can be used for the quality control of Xiaozhi tongmai granule.