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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 a method for quality control of children’s chewable tablets. Methods: Hippophae rhamnoides, Malt, Smilax glabra and Chrysanthemum were qualitatively identified by TLC in children’s chewable tablet. The contents of trigonelline were determined by normal-phase high performance liquid chromatography. Results: The results showed that there was a good linear relationship between the content of trigonelline and the peak area in the range of 50 ~ 300μg. The recovery rate was 97.16% and the RSD was 1.94%. Conclusion: The method is simple, reproducible and specific, and can be used for the quality control of chewable tablets in children.