金柏胶囊的质量标准研究

Study on the Quality Standard of Jinbo Capsule

目的：为建立金柏胶囊的质量标准提供参考。方法：采用薄层色谱（TLC）法对制剂中黄柏、川楝子进行定性鉴别,采用高效液相色谱（HPLC）法对制剂中盐酸小檗碱进行含量测定。色谱柱为Diamonsil C18,流动相为乙腈-0.1%磷酸溶液（50∶50,V/V）,流速为1 ml/min,检测波长为265 nm,柱温为25℃,进样量为10μl。结果：制剂中黄柏、川楝子的TLC斑点清晰、分离度好。盐酸小檗碱检测质量浓度线性范围为0.044～0.154 mg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD≤2.0%;加样回收率为98.36%～102.15%,RSD为1.11%（n=9）。结论：该方法操作简便、结果准确、重复性好,可用于金柏胶囊的质量控制。

OBJECTIVE： To provide reference for the establishment of quality standard for Jinbo capsule. METHODS： TLC was conducted for the qualitative identification of Phellodendron chinense and Melia toosendan in preparation; HPLC was used for the content determination of berberine hydrochloride in preparation; the column was Diamonsil C18 with mobile phase of acetoni- trile -0.1% phosphoric acid （50 ： 50, V/V） at flow rate of 1 ml/min, detection wavelength was 265 nm, column temperature was 25 ℃ and volume injection was 10 μl. RESULTS： TLC spots of P. chinense and M.. toosendan in preparation were clear and well-separated. The linear range of berberine hydrochloride was 0.044-0.154 mg/ml （r=0.999 9）; RSDs of precision, reproducibili- ty and stability tests were no more than 2.0%, recovery was 98.36%-102.15%（RSD=1.11% ,n=9）. CONCLUSIONS： The meth- od is simple, accurate and reproducible, and can be used for the quality control of Jinbo capsule.