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目的:建立肾衰康颗粒质量标准。方法:采用薄层色谱(TLC)法对制剂中黄芪、大黄进行定性鉴别。采用高效液相色谱法测定制剂中大黄素和大黄酚的含量:色谱柱为Agilent HC-C_(18),流动相为甲醇-0.1%磷酸(85∶15,V/V),流速为1.0 ml/min,检测波长为254 nm,柱温为30℃,进样量为10μl。结果:黄芪、大黄的TLC图斑点清晰,分离度好。大黄素和大黄酚检测质量浓度线性范围分别为1.9~60.8、1.6~51.2μg/ml(r均为0.999 9);精密度、稳定性、重复性试验的RSD<3%;加样回收率分别为95.76%~103.66%(RSD=2.83%,n=9)、97.24%~104.34%(RSD=2.65%,n=9)。结论:所建标准可用于肾衰康颗粒的质量控制。
Objective: To establish the quality standard of Shenshuaikang granules. Methods: TLC (TLC) method was used to qualitatively identify astragalus and rhubarb in the preparation. The content of emodin and chrysophanol in the preparation was determined by HPLC: Agilent HC-C 18 column with a mobile phase of methanol-0.1% phosphoric acid (85:15, V / V) at a flow rate of 1.0 ml / min, the detection wavelength was 254 nm, the column temperature was 30 ℃, and the injection volume was 10μl. Results: Astragalus, rhubarb TLC map spots clear, good resolution. The linear range of emodin and chrysophanol was 1.9 ~ 60.8,1.6 ~ 51.2μg / ml (r = 0.999 9) respectively. The RSDs of precision, stability and repeatability were less than 3% Were 95.76% ~ 103.66% (RSD = 2.83%, n = 9) and 97.24% ~ 104.34% (RSD = 2.65%, n = 9). Conclusion: The established standards can be used for the quality control of Shenshenkang granules.