中国药业2026，Vol.35Issue(8)：81-87,7.DOI:10.3969/j.issn.1006-4931.2026.08.015
小儿吐泻宁(散)质量标准提升研究
Study on the Quality Standard Improvement of Xiao'er Tuxiening(Powder)
摘要
Abstract
Objective To improve the quality standard of Xiao'er Tuxiening(Powder).Methods Thin-layer chromatography(TLC)method was used for the qualitative identification of Pogostemonis Herba,Citri Reticulatae Pericarpium and Atractylodis Macrocephalae Rhizoma in the preparation.Gas chromatography(GC)method in constant pressure mode was employed for the content determination of patchouli alcohol in the preparation.High-performance liquid chromatography(HPLC)method was adopted for the simultaneous determination of the content of hesperidin,ammonium glycyrrhizinate,honokiol and magnolol in the preparation.Results The characteristic spots in the TLC chromatograms of Pogostemonis Herba,Citri Reticulatae Pericarpium and Atractylodis Macrocephalae Rhizoma were clear with good resolution,and no interference from the negative control.The linear ranges of hesperidin,ammonium glycyrrhizinate,honokiol and magnolol were 3.205 4-128.216 2 µg/mL,7.290 0-364.500 0 µg/mL,5.652 7-282.633 6 µg/mL,3.816 4-190.818 0 µg/mL and 3.579 1-178.956 8 µg/mL,respectively(r=1.000 0).The limits of detection were 0.27 µg/mL,0.02 µg/mL,0.05 µg/mL,0.17 µg/mL and 0.10 µg/mL,respectively;the limits of quantitation were 0.91 µg/mL,0.05 µg/mL,0.16 µg/mL,0.56 µg/mL and 0.33 µg/mL,respectively.The RSDs of precision,stability and repeatability tests results were all lower than 2.0%.The average recoveries were 101.96%,97.71%,96.43%,98.54% and 97.90%,respectively,with RSDs of 1.32%,1.47%,2.62%,1.05%,0.54%,respectively(n=9).The transfer rates were≥90%.Conclusion The established method is highly operable and reliable,which can be used for the quality control of Xiao'er Tuxiening(Powder).关键词
小儿吐泻宁(散)/质量标准/薄层色谱法/气相色谱法/高效液相色谱法Key words
Xiao'er Tuxiening(Powder)/quality standard/TLC/GC/HPLC分类
医药卫生引用本文复制引用
喻悦,余平,范晓磊..小儿吐泻宁(散)质量标准提升研究[J].中国药业,2026,35(8):81-87,7.基金项目
国家药典委员会药品标准制修订研究课题[2023Z029]. （）
