醒脑苏胶囊的质量标准研究

Quality control standard for Xingnaosu capsules

目的:建立醒脑苏胶囊质量标准。方法:色谱柱为Kromasil C18柱(4.6mm×250mm,5μm),以乙腈-水(32∶68)为流动相(流速:0.6mL.min-1),采用蒸发光散射检测器(ELSD),漂移管温度为100℃,N2流速为2.4L.min-1,对3批中试样品中的黄芪甲苷进行含量测定。采用薄层层析法,对胶囊中的主要药味进行定性鉴别研究。结果:3批中试样品中,黄芪甲苷的平均含量分别为0.176 6,0.178 6,0.180 6mg/粒。结论:每粒胶囊中含黄芪以黄芪甲苷(C41H68O14)计,不得少于0.14mg(取3批平均含量的80%为其下限)。定性鉴别方法简单易行、专属性强。

OBJECTIVE To establish the quality control standard for Xingnaosu capsules. METHODS The contents of Astragaloside IV in three batches of pilot sample were determined by HPLC ELSD. Kromasil C18 column（4. 6 mm × 250 mm,5 μm）was used. The mobile phase was acetonitrile-water（32：68） at a flow rate of 0. 6mL/min. The flow rate N2 in EI.SD was 2.-4 L·min^-1. The temperature of drift tube was 100 ℃. The main ingredients in the prescription were identified by TLC. RESULTS The average contents of astragaloside Ⅳ in this three batches of pilot sample were 0. 176 6 mg/capsule, 0. 178 6 mg/ capsule, 0. 1806 mg/capsule respectively. Qualitative identification by TLC for five ingredients in the prescription including astragalus membranaceus, Radix Paeoniae Rubra, Flos Carthami, Semen Persicae, Rhizoma Chuanxiong were established successfully. CONCLUSION According to the results of determination, the tentative contents of astragaloside Ⅳ （C41H68 O14） in each capsule, should not be less than 0. 14 mg （taking 80% of the average content of three batches to be the lower limit）. The experimental results indicated that the qualitative identification method is simple, scientific, objective, and specific.