小儿健脾温通贴的质量标准研究

Quality standard for Xiaoer Jianpi Wentong patch

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 for Xiaoer Jianpi Wentong patch. Methods： Thin-layer chromatography（ TLC） was used for qualitative identification of Atractylodes macrocephala Koidz.,Amomum villosum,and folium artemisiae argyi in prescription,and high-performance liquid chromatography was used to measure the content of atractylodin in gel patch. Ointment content,shape-forming ability,and adhesion of gel patch were evaluated according to the methods in Chinese Pharmacopoeia（ 2015 edition,4 volumes）. Results： TLC spots were clear and had good resolution and specificity,with no interference in negative control. The content of atractylodin in three batches of gel patch was 4. 1298,4. 1106,and 4. 0587 μg/g,respectively. The average recovery rate of atractylodin was 99. 49%（ relative standard deviation = 1. 46%）. Ointment content and shape-forming ability of gel patch met related requirements. Conclusion： This method is simple,convenient,and accurate and has good repeatability. It can be used as the quality control standard for Xiaoer Jianpi Wentong patch.