溃平宁颗粒质量标准的研究及确定

Quality Standard for Kuipingning Granules

目的研究溃平宁颗粒的质量标准。方法增加TLC法鉴别延胡索、白及及RP-HPLC法测定大黄浸膏的含量。含量采用Waters C18色谱柱(200 mm×4.6 mm,5μm);流动相为甲醇-0.1%磷酸溶液(85:15),流速1 ml·min-1;检测波长:440 nm;用外标法定量。结果鉴别、含量:阴性对照均无干扰;含量:大黄素0.003 824～0.152 96μg(r=0.999 9)、大黄酚0.007 168～0.286 72μg(r=0.999 7)范围内有良好的线性关系,平均加样回收率为97.8%(n=6)。结论所建方法简单、可靠,可用于溃平宁颗粒的质量控制。

Objective To establish a method for the quality standard of Kuipingning Granules.Methods The TLC methods were established for Rhizoma Corydalis,Rhizoma Bletillae and an RP-HPLC method was established for the determination of Rhubarb extract performed on waters C18 analytical column（200 mm×4.6 mm,5 μm） with methanol-0.1%phosphoric acid（85∶15） as the mobile phase flow rate of 1.0 ml·min-1.The detection wavelength was 440nm.Results Negative control had no interference.The linear range was within the range of 0.003 824～0.152 96 μg（r=0.999 9） for rhein and 0.007 168～0.286 72 μg（r=0.999 7） for chrysopharol,and the average recovery（n=6）was 97.8%.Conclusion The method is convenient,reliable and suitable for quality assessment of Kuipingning Granules.