健胃灵颗粒的质量控制项目研究

Studies on the quality control method of Jianweiling granules

目的:研究健胃灵颗粒的质量控制方法。方法:采用硅胶 G 薄层色谱法对健胃灵颗粒中2种主要成分黄芪和当归进行定性鉴别;用 RP-HPLC 法对芍药苷进行含量测定,以 Ultimate^(TM)XB-C_(18)(5 μm,4.6 mm×250 mm)为色谱柱,甲醇-乙腈-0.05 mol·L^(-1)。磷酸二氢钾溶液(22:15:63)为流动相;流速0.6 mL·min^(-1);检测波长为230 nm;进样量为10 μL。结果:芍药苷浓度在9.64～96.4 μg·mL^(-1)范围内与峰面积呈良好的线性关系,相关系数 r=1.000,日内、日间精密度 RSD 分别为1.0%和1.8%(n:3)。高、中、低3个浓度平均加样回收率(n=3)分别为101.2%,100.8%,101.1%;RSD 分别为1.3%,1.0%,0.58%(n=3)。结论:方法重复性好,操作简单,结果准确可靠。

Objective：To establish a quality control method for Jianweiling granules. Methods：The two main ingre- dient of Radix Astragali and Radix Angelicae Sinensis were identified by silical gel G thin layer chromatography and the paeoniflorin was determined by RP - HPLC with a UltimateTM XB - Cls （5 μm ,4. 6 mm × 250 mm） column. The mobile phase was methanol - acetonitrile - potassium dihydrogen phosphate（ 22： 15：63 ）. The flow rate was 0. 6 mL·min^-1. The detection wavelength was 230 nm. Results： The calibration curve was linear in the range of 9. 64 - 96. 4 μg · mL^-1 for paeoniflorin with r = 1. 000. Within - day RSD and between - day RSD were 1.0% and 1.8% （n = 3 ）. The average recoveries of high, middle and low concentrations of sample were 101.2% , 100. 8%, 101.1% with RSD = 1.3%, 1.0% ,0. 58% （ n = 3 ）. Conclusions： The methods are simple, reproducible, accurate and relia- ble,which is used for the quality control of the Jianweiling granules.