小儿汗停颗粒质量标准研究

Study on the Quality Standard for Xiao'er Hanting Granule

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 for Xiao＇ er Hanting granule. Methods ： Astragali Radix, Rhizoma Atrac- tylodis Macrocephalae （baked） and Saposhnikoviae Radix were qualitatively identified by a TLC method. The contents of calycosin-7- O-β-D-glycoside in the preparation were determined by an HPLC method. The chromatographic column was Cosmosil C18 （ 250 mm × 4.6 mm,5 μm） ;the mobile phase was acetonitrile-0.2% methanoicacid（ 16 ： 84） ; the flow rate was 1.0 ml·min-1; the detection wavelength was 260 nm. Results： Astragaloside A in Astragali Radix was detected by the TLC method, and Rhizoma Atractylodis Macrocephalae （baked）, Saposhnikoviae Radix and saposhnkoviae standard crude drug had the same clear spots without any negative interference. The linear range of calycosin- 7-O-β-D-glycoside was 0. 061-0. 613μg （ r = 0.999 9 ）. The average recovery was 99.4% （RSD = 1.29%, n = 6）. Conclusion： The method is accurate, rapid, stable and reliable with good reproducibility, which is suitable for the quality control of Xiao＇ er Hanting granule.