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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 preparation technology and quality standard of Liyan Throat lozenge tablets. Methods: The tablets of Liyan Throat were prepared by water-extraction and spray-drying method. The chemical methods were used to qualitatively identify emodin and ursolic acid by HPLC. The contents of emodin Quantitative analysis was performed on a Hedera ODS-2 C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-water (78:22) at a flow rate of 1.0 mL · min-1 and a detection wavelength of 254 nm. Results: The preparation process was simple and feasible. The TLC spots were clear and specific. The emodin injection showed good linearity (r = 1.0000) within the range of 0.204-2.04 μg with an average recovery of 99.61% and RSD% of 0.78% . Conclusion: The established qualitative and quantitative method is simple, accurate and reproducible. It can be used as a quality control method for the livers and throat lozenge tablets.