乙肝解毒胶囊质量标准的研究

Study on Quality Standard of Yigan Jiedu Capsules

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Phenomenex Luna5μC18（2）（250×4．6mm），流动相：甲醇-0．05mol·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：276nm；柱温：30℃。结果盐酸小檗碱在0．02056～0．2056μg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0．04056～0．4056μg范围内线性关系良好，r=0．9999；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。

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 C18 column （250×4.6 mm,5μm） 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 rale 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 6μg 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.