儿童排铅咀嚼片的质量标准研究

Study on Quality Standard of Lead-removing Tablets for Children

目的:建立儿童排铅咀嚼片的质量控制方法。方法:采用薄层层析法对儿童排铅咀嚼片中的沙棘、麦芽、土茯苓、菊花等进行定性鉴别,采用正相高效液相色谱法对制剂中胡芦巴碱进行含量测定。结果:胡芦巴碱在50～300μg范围内与峰面积积分值呈良好的线性关系;回收率为97.16%,RSD为1.94%。结论:本方法简单、重复性好、专属性强,可用于儿童排铅咀嚼片的质量控制。

Objective： To establish the quality standard method of lead-removing tablets for children.Method： ShaJi,MaiYa,TuFuLing,JuHua in lead-removing tablets were distinguished qualitatively with TCL,the content of trigonelline in the preparations was measured with HPLC.Result： Trigonelline showed better linear relationship at the range of 50-300 μg and integral value of peak area;the recovery rate was 97.16%,RSD was 1.94%.Conclusion： The method,simple,with good repeatability and specificity,could be used to quality control for lead-removing tablets.