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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 study and improve the quality standard of Qingre An Gong Wan. Methods: The content of baicalin in the preparation was identified by TLC. The content of baicalin in the preparation was determined by TLC. The mobile phase consisted of methanol - 0.2% phosphoric acid (250 mm × 4.6 mm, 5 μm) 45:55), the flow rate was 1.0ml · min -1, the detection wavelength was 315nm, the column temperature was 30 ℃, and the injection volume was 10μl. Determination of cinnabar content by titration. Results: There was no interference in the identification of negative control. The linear range of baicalin was 0.029-0.870μg (r = 0.9999), the recovery was 99.2% (RSD = 0.67%, n = 6) The recovery was 100.5% (RSD = 0.45%, n = 6). Conclusion: The established method is simple and reliable, which can be used as the quality control standard of Qingre An Gong Wan.