乙肝解毒胶囊质量标准的研究

目的建立乙肝解毒胶囊(黄柏、黄芩、大黄等)的质量标准。方法采用薄层色谱法鉴别乙肝解毒胶囊中的黄柏、黄芩、大黄;用HPLC法同时对制剂中的盐酸小檗碱、黄芩苷进行了定量分析,色谱柱Phe-nomenex Luna 5μC18(2)(250×4.6 mm),流动相:甲醇-0.05 mol.L-1磷酸二氢钾溶液-冰醋酸(38∶62∶1);流速:1.0mL.min-1;检测波长:276 nm;柱温:30℃。结果盐酸小檗碱在0.020 56~0.205 6μg范围内线性关系良好,r=0.9999;平均回收率为100.2%,RSD为1.89%(n=6);黄芩苷在0.0405 6~0.405 6μg范围内线性关系良好,r=0.999 9;平均回收率为99.7%,RSD为2.22%(n=6)。结论本方法操作简便,结果准确、可靠,能有效地控制制剂的质量。

Study on Quality Standard of Yigan Jiedu Capsules

Objective To establish the quality standard for Yigan Jiedu Capsules(Cortex Phellodendri;Radix Scutellariae;Radix et Rhizoma Rhei,etc.) Methods Cortex Phellodendri,Radix Scutellariae,Radix et Rhizoma Rhei in Yigan Jiedu capsules were identified by TLC.Berberine hydrochloride and baiclin in capsules were determined by HPLC.Phenomenex luna C_(18) column(250×4.6 mm,5 μm) was used,the methanol-0.05 mol·L~(-1) potassium dihydrogen phosphate-acetic acid glacial solution(38∶62∶1) was used as the mobile phase.The flow rate was 1.0 mL·min~(-1),the detection wavelength was set at 276 nm,column temperature was at 30 ℃.Results The linear range of berberine hydrochloride was 0.020 6～0.205 6ug and the correlation coefficient was 0.999 9.,the average recovery rate was 100.2%,RSD was 1.89%(n=6),respectively.The linear range of baiclin was 0.040 6～0.405 6 ug and the correlation coefficient was 0.999 9.,the average recovery rate was 99.7%,RSD was 2.22%(n=6),respectively.Conclusion The method was simple.The result was reliable and accurate.The method can be used for quality of Yigan Jiedu capsules.