清热安宫丸质量标准研究

Study on Quality Standard for Qingre Angong Pills

目的:研究完善清热安宫丸的质量标准。方法:薄层色谱法鉴别制剂中的黄连、黄芩,HPLC法测定制剂中黄芩苷的含量,采用Waters C_(18)色谱柱(250mm×4.6mm,5μm);流动相为甲醇-0.2%磷酸(45:55),流速为1.0ml·min^(-1);检测波长为315nm,柱温为30℃,进样量为10μl。用滴定法测定朱砂的含量。结果:鉴别阴性对照均无干扰;含量测定方法中黄芩苷的线性范围为0.029~0.870μg(r=0.9999),回收率为99.2%(RSD=0.67%,n=6),朱砂的含量测定平均回收率为100.5%(RSD=0.45%,n=6)。结论:所建方法简单、可靠,可作为清热安宫丸的质量控制标准。

Objective ： To establish a method for the quality standard of Qingre Angong pills. Method ： The TLC methods were es- tablished for Rhizoma Coptidis and Radix ScuteUariae, and an HPLC method was established for the determination of baiealin on a Wa- ters C18 analytical column （250 mm×4.6 mm,5 μm） with methanol -0.2% phosphoric acid （45：55 ） as the mobile phase at the flow rate of 1.0 ml ·min^- 1 and the detection wavelength of 315nm. The column temperature was 30℃ , and the sample volume was 10 μl. A titrimetric method was used for the content determination of cinnabaris. Result： There was no interference from the negative controls in TLC identification. In the content detelxnination of baicalin, the linear response range was 0. 029-0. 870 μg（ r = 0. 999 9 ）, and the average recovery was 99.2% （RSD = 0.67% , n = 6 ）. In the content determination of cinnabaris, the average recovery was 100.5% （ RSD = 0.45 % , n = 6）. Conclusion： The method is convenient and reliable, and suitable for the quality assessment of Qingre Angong pills.