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目的:建立小儿健脾温通贴的质量标准。方法:采用薄层色谱法对处方中白术、砂仁、艾叶进行定性鉴别;采用高效液相色谱法测定凝胶贴膏剂中苍术素含量;按《中国药典》(2015年版4部)方法考察凝胶贴膏剂的含膏量、赋形性、黏附力。结果:薄层色谱斑点清晰、分离度好、专属性强、阴性对照无干扰;同时对3批凝胶贴膏剂进行含量测定,苍术素含量分别为:4.1298、4.1106、4.0587μg/g;苍术素的平均回收率为99.49%,RSD为1.46%;其含膏量、赋形性符合要求。结论:该法简便、准确、重复性好,可作为小儿健脾温通贴的质量控制标准。
Objective: To establish the quality standard of pediatric spleen and invigorating. Methods: The prescriptions of Atractylodes, Amomum villosum and Citrus grandis were identified by TLC. The contents of atractylodes macrocephala were determined by high performance liquid chromatography. Adhesive paste containing paste, formability, adhesion. Results: The TLC spots were clear, the resolution was good, the specificity was strong, and the negative control had no interference. At the same time, the contents of the three batches of gel patches were determined as follows: 4.1298,4.1106,4.0587μg / g, The average recovery rate was 99.49%, RSD was 1.46%; its cream content and formability meet the requirements. Conclusion: The method is simple, accurate, reproducible, and can be used as a quality control standard for pediatric spleen and warm through.