小儿奇应丸质量标准的研究

Study on Quality Standard of Xiaoer Qiying Pills

目的建立小儿奇应丸的质量标准。方法采用薄层色谱法对处方中牛黄、黄连进行定性鉴别;采用高效液相色谱法,以C18化学键合硅胶为固定相,乙腈-0.05 mol/L磷酸二氢钾-十二烷基磺酸钠(45∶55∶0.1)为流动相,检测波长:265 nm,测定盐酸小檗碱的含量。结果薄层色谱均检出牛黄与黄连的特征斑点,其阴性无干扰;含量测定盐酸小檗碱的平均回收率为98.7%(n=6),RSD=0.8%,在0.156μg^0.936μg范围内,进样量与吸收峰面积积分值呈良好的线性关系。结论该方法简便、快速、结果准确、重现性好,可有效控制小儿奇应丸的质量。

Objective To establish the quality standards for Xiaoer Qiying pills. Methods Calculus and Rhizoma Coptidis were identified by TLC and determination of Berberine hydrochloride contents by HPLC. Results TLC spots of Calculus and Rhizoma Coptidis were fairly clear, negative samples were no interference. And the average recovery rate of Berberine hydrochloride was 98.7% （ n = 6 ） and the RSD was 0.8% . There was a good linear relationship between the quantity of samples and the absorption area value within a range of 0. 156 μg - 0. 936 μg of Berberine hydrochloride. Conclusion This method was convenient, rapid and accurate, it was efficient for control of the product quality.