天芪气血口含片质量标准研究

Study on Quality Standards for Tiqiqixue Mouth lozenge

目的:建立天芪气血口含片的质量标准。方法:采用TLC法对天芪气血口含片中的红景天、黄芪、当归进行鉴别;采用苯酚—硫酸显色法和HPLC法对制剂中的总多糖及红景天苷的含量进行测定。结果:薄层色谱中,红景天和黄芪供试品溶液色谱在与对照药材或对照品相应位置上出现相同颜色的斑点,阴性对照无干扰;葡萄糖在检测浓度范围内与吸光度呈良好的线性关系;高效液相色谱中,红景天苷在0.8304～8.3040μg范围内相关性良好,回收率为97.7%。结论:通过TLC实验可对制剂中红景天、黄芪进行鉴别,该方法专属性强;苯酚硫酸法对制剂中总多糖进行测定并控制其它药效成分的含量,高效液相色谱法对制剂中专属成分红景天苷进行测定,可有效控制该制剂的质量。

Objective：To establish the quality standard for Tiqiqixue mouth lozenge.Methods：TLC was adopted to identify Rhodiola,Astragalus,Angelica in Tiqiqixue mouth lozenge.HPLC and phenol-sulfuric acid colorimetric method were applied to determine the contents of Salidroside and total polysaccharides in this preparation.Results：The chromatography for the test solution of Rhodiola and Astragalus appear the same color as the spots of the control medicines or the reference substance.Negative substance do not have interference.The content of glucose showed a good linear relationship with the absorbance in the detection range of concentration.In HPLC,Salidroside has excellent correlation in the range of 0.8304μg～8.304μg.The average recovery was 97.7%.Conclusion：TLC method to identify Rhodiola and Astragalus in this method is highly specific.Phenol-sulfuric acid colorimetric method determine polysaccharides in this preparation to control other efficacy component content.HPLC determine proprietary component of Salidroside. These methods can control this preparation effectively.