肾衰康颗粒的质量标准研究

Study on the Quality Standard of Shenshuaikang Granule

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-C18,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 standards for Shenshuaikang granule. METHODS： TLC was used for the qualitative identification of Astragali Radix and Rhei Radix et Rhizoma in the preparation. HPLC was used for the contents determination of emodin and chrysophanol, the column was Agilent HC-C18 with 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 10 μl. RESULTS：TLC showed clear spots and good separation. The linear range was 1.9-60.8 μg/ml for emodin（r=0.999 9, n=6） and 1.6-51.2 μg/ml for chrysophanol （r=0.999 9）, RSDs of precision, stability and reproducibility tests were lower than 3%, recoveries were 95.76%-103.66% （RSD=2.83% ,n=9） and 97.24%-104.34% （RSD=2.65% ,n=9）, respectively. CONCLUSIONS： The standard can be used for the quality control of Shenshuaikang granule.