培根胶囊的质量标准研究

目的:建立培根胶囊质量标准。方法:采用薄层色谱(TLC)法对大豆异黄酮和淫羊藿进行定性鉴别;用高效液相色谱法测定淫羊藿苷、大豆苷、大豆黄苷、染料木苷的含量。结果:TLC斑点清晰、分离度好,阴性无干扰;淫羊藿苷、大豆苷、大豆黄苷、染料木苷进样量分别在0.04～0.80(r=0.9998)、0.03～0.60(r=0.9998)、0.0076～0.1520(r=0.9996)、0.01～0.20(r=0.9997)μg范围内与其峰面积积分值呈良好的线性关系;淫羊藿苷、大豆苷、大豆黄苷、染料木苷的平均回收率分别为99.22%、97.61%、98.25%、98.46%,RSD分别为0.21%、1.64%、1.00%、1.32%(n均为9)。结论:所建标准可用于培根胶囊的质量控制。

Study on the Quality Standard of Peigen Capsules

OBJECTIVE:To establish a method for the quality control of Peigen capsules.METHODS:Soybean isoflavone and Epimedii Folium were identified by TLC qualitatively.The contents of icariin,daidzin,glycitin and genistin in the Peigen capsules were determined by HPLC.RESULTS:TLC spots were clear and well-separated without interference from negative sample.The linear ranges were 0.04～0.80 μg for icariin(r=0.999 8),0.03～0.60 μg for daidzin(r=0.999 8),0.007 6～0.152 0 μg for glycitin(r=0.999 6) and 0.01～0.20 μg for genistin(r=0.999 7),respectively.The average recoveries of four components were 99.22%,97.61%,98.25% and 98.46%.RSD were 0.21%,1.64%,1.00% and 1.32%,respectively(n=9).CONCLUSION:Established standard is suitable for quality control of Peigen capsules.