前列安通胶囊质量标准研究

目的制订前列安通胶囊简便、快捷的质量标准。方法在同一块薄层板上鉴别黄柏、赤芍药和丹参。采用反相高效液相法,以乙腈-甲醇-0.1%磷酸(17∶13∶70)和乙腈-甲醇-甲酸-水(10∶30∶1∶59)为流动相,分别测定了样品中盐酸小檗碱和丹酚酸B的含量。结果盐酸小檗碱进样量在0.025 2～0.252 0μg(r=0.999 999)、丹酚酸B进样量在0.108 6～1.629μg(r=0.999 99)分别与峰面积呈良好的线性关系。盐酸小檗碱与丹酚酸B平均回收率分别为99.60%、99.12%,RSD分别为0.69%、0.48%。薄层色谱图鉴别阴性无干扰。结论该质量标准可快速控制前列安通胶囊质量。

Studies of quality standards for Qianlie Antong Capsules

Objective To establish a simple and rapid quality standard for Qianlie Antong Capsules. Methods Cortex phellodendri, Radix paeoniae rubra and Salvia mihiorrhiza were identified by TLC at same thin - layer chromatographic plates. The contents of berberine hydrochloride and salvianolic acid B in the Qianlie Antong Capsules was determinated respectively using a mixture of acetonitrile -methanol -0.1% phosphoric （17： 13：70）and a mixture of acetonitrile - methanol - formic acid - water （ 10： 30：1 ： 59 ） as the mobile phase by Rp - HPLC. Results The methodological study showed that a good linear correlation existed in the range 0. 025 2 - 0. 252 μg （ r = 0. 999 999） of berberine hydrochloride and 0. 108 6 - 1. 629 μg （ r = 0. 999 99） of salvianolic acid B. The average recovery of berberine hydrochloride and salvianolic acid B was 99.60% and 99.12% respectively ; RSD （n = 9） was 0.69% and 0.48% respectively. The negative sample has not interference on TLC identification. Conclusion This quality standard can be rapidly used to control quality of Qianlie Antong Capsules.