利咽润喉含片的制备与质量控制

Preparation and Quality Control of Liyan Runhou Lozenge

目的:对利咽润喉含片的制备工艺和质量标准进行研究。方法:采用水提、喷雾干燥法制备利咽润喉含片;采用化学方法对游离羟基蒽醌、薄层色谱法对大黄素和熊果酸分别进行定性鉴别;采用HPLC法对虎杖中大黄素进行定量分析,色谱柱为Hedera ODS-2 C18(250 mm×4.6 mm,5μm),流动相为甲醇-水(78∶22),流速为1.0 mL·min-1,检测波长为254 nm。结果:制备工艺简便可行;薄层色谱斑点清晰,专属性强;大黄素进样量在0.204-2.04μg范围内线性关系良好(r=1.0000),平均回收率为99.61%,RSD%为0.78%。结论:所建立的定性定量方法简便、准确、重复性好,可作为利咽润喉含片的质量控制方法。

Objective To study the preparative technique and quality standard of Liyan Runhou lozenge. Methods： The waterextraction and spray drying methods were adopted to prepare Liyan Runhou lozenge. Ursolic acid and rheum emodin were iden-tified by TLC, and hydroxyanthraquinone was identified by chemical process,respectively. The contents of rheum emodin inPolygonum Cuspidatum were determined simultaneously by HPLC. The chromatographic column was Hedera ODS-2 Cs col-umn（250mmx4.6 mm,5 μm）; the mobile phase was methyl alcohol-water（78：22） at the flow rate of 1.0mL＇min-l,and the detect-ing wavelength was 254 nm. Results： The preparative technique is simple and feasible. The TLC identification was highly specificand spots were clear. Rheum emodin showed a good linear relationship at a range of 0.204-2.04 μg （r=1.0000）,and the averagerecovery was 99.61% with RSD of 0.78%. Conclusion： The qualitive and quantitative methods established is simple, accurate andreproducible, and can be used for the quality control of Liyan Runhou lozenge.