黄蒲胃宁颗粒的质量标准提高研究

Study on the Improvement of Quality Standard of Huangpu Weining Granule

目的：完善和提高黄蒲胃宁颗粒的质量标准。方法：采用薄层色谱（TLC）法对制剂中黄芪、蒲公英、黄连、白及、柴胡、陈皮、炙甘草进行定性鉴别。采用高效液相色谱法测定制剂中盐酸小檗碱的含量：色谱柱为Dikma Diamonsil C18,流动相为乙腈-0.05 mol/L磷酸二氢钾（50∶50,V/V）（每100 ml中含0.4 g十二烷基硫酸钠,磷酸调pH至4.0）,流速为1.0 ml/min,检测波长为345 nm,柱温为30℃,进样量为10μl。结果：黄芪、蒲公英、黄连、白及、柴胡、陈皮、炙甘草的TLC图斑点清晰,分离度好。盐酸小檗碱检测质量浓度线性范围为2.03-81.2μg/ml（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈1%;加样回收率为99.67%-103.04%（RSD=1.14,n=9）。结论：完善和提高的标准有利于黄蒲胃宁颗粒的质量控制。

OBJECTIVE：To optimize and improve the quality standards of Huangpu weining granule. METHODS：TLC was used for qualitative identification of Coptis chinensis,Pericarpium citri,Leguminosae,Herba taraxaci,Bletilla striata,Bupleurum chinense and Radix glycyrrhizae. HPLC was used for the content determination of berberine hydrochloride. Column was Dikma Diamonsil C18 with mobile phase of acetonitrile-0.05 mol/L Potassium dihydrogen phosphate solution（50 ∶ 50,V/V）（per 100 ml was added sodium lauryl sulfate 0.4 g,and then adjusted the p H to 4.0 with phosphoric acid）at a flow rate of 1.0 ml/min,the detection wavelength was 345 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. RESULTS：The TLC of C.chinensis,P.citri,Leguminosae,H. taraxaci,B. striata,B. chinense and R. glycyrrhizae showed clear spots and good separation.The linear range of berberine hydrochloride was 2.03-81.2 μg/ml（r=0.999 9）;RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.67%-103.04%（RSS=1.14,n=9）. CONCLUSIONS：The optimized and improved method is helpful for the quality control of Huangpu weining granule.