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目的:建立小儿汗停颗粒的质量标准。方法:采用TLC法对制剂中黄芪、白术(炒)、防风进行定性鉴别。采用HPLC法对制剂中毛蕊异黄酮葡萄糖苷含量进行测定,Cosmosil C_(18)柱(250 mm×4.6 mm,5μm)分离,以乙腈-0.2%甲酸溶液(16∶84)为流动相;流速为1.0 ml·min~(-1),检测波长为260 nm。结果:TLC色谱分别检出黄芪中的黄芪甲苷,与白术、防风对照药材有相同清晰斑点且阴性无干扰。毛蕊异黄酮葡萄糖苷对照品在0.061~0.613μg范围内与峰面积呈良好的线性关系(r=0.999 9),平均加样回收率结果为99.4%,RSD为1.29%(n=6)。结论:该方法准确、快速、稳定、可靠,重复性好,可用于小儿汗停颗粒的质量控制及评价。
Objective: To establish the quality standard of Khan’s granule in children. Methods: TLC method was used for the qualitative identification of Astragalus, Atractylodes (fried), windproof. HPLC method was used to determine the content of calycosin glucoside in Cosmosil C_ (18) column (250 mm × 4.6 mm, 5 μm) using acetonitrile-0.2% formic acid solution (16:84) as the mobile phase at a flow rate of 1.0 ml · min ~ (-1) and the detection wavelength was 260 nm. Results: Astragaloside IV in Astragalus membranaceus was detected by TLC, respectively. The calibration curve of curculent isoflavone glucoside showed a good linear relationship with the peak area in the range of 0.061 ~ 0.613 μg (r = 0.999 9). The average recovery was 99.4% and the RSD was 1.29% (n = 6). Conclusion: The method is accurate, rapid, stable, reliable and reproducible. It can be used for the quality control and evaluation of Khan.