海峡药学2024,Vol.36Issue(10) :29-31.

滋肾育胎丸质量标准提升的研究

Study on Quality Standard Improving for ZiShen YuTai Pills

陈隽 徐丹洋 耿婷 张丽 周利贤
海峡药学2024,Vol.36Issue(10) :29-31.

滋肾育胎丸质量标准提升的研究

Study on Quality Standard Improving for ZiShen YuTai Pills

陈隽 1徐丹洋 1耿婷 2张丽 2周利贤1
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作者信息

  • 1. 南通市食品药品监督检验中心,江苏南通 226006
  • 2. 南京中医药大学翰林学院,江苏泰州 225300
  • 折叠

摘要

目的 基于滋肾育胎丸的现行质量标准,结合生产实际存在问题以及绿色节能的环保要求,从薄层鉴别、指纹图谱等方面对其质量标准进行提升研究.方法 使用薄层色谱法(TLC)鉴别其中的艾叶、白术.采用高效液相色谱-二极管阵列检测器法(HPLC-DAD)建立指纹图谱.结果 艾叶、白术的薄层斑点清晰,分离良好,阴性无干扰,所建立的方法适用性良好.通过对10批样品的指纹图谱采集,确定了 12个共有色谱峰,10批样品指纹图谱的相似度均良好.所建立的指纹图谱测定方法色谱分离度良好,精密度、重复性及稳定性均能够满足要求.结论 方法的重复性及稳定性好,方法便捷、准确,设备设施及试剂大众化,易于推广,可以更全面、更系统地提高滋肾育胎丸的的质量控制水平.

Abstract

OBJECTIVE Based on the current quality standard of ZiShen YuTai Pills,combined with the actual problems in production and the environmental protection requirement of green energy conservation,the improvement research of the current quality standard was studied from the aspects of thin layer identification and finger-print.METHODS Artemisiae argyi Folium and Atractylodis macrocephalae Rhizoma in ZiShen YuTai Pills were in-dentified by TLC,and high performance liquid chromatography diode array detection(HPLC-DAD)was used for fin-gerprint determination.RESULTS The TLC characteristic spots were clear and the nagitive control had no interfer-ence.The established method could be effectively applied to the identification.The established method of fingerprint had good chromatographic separation,and the precision,repeatability and stability could meet the detection require-ments.12 common chromatographic peaks were identified by collecting the fingerprints of 10 batches of sam-ples.CONCLUSION The method has good repeatability,is convenient,accurate,and easy to promote,which can comprehensively and systematically improve the quality control level of ZiShen YuTai Pills.

关键词

滋肾育胎丸/薄层色谱法/高效液相色谱/指纹图谱

Key words

ZiShen YuTai Pills/Thin layer chromatography/High performance liquid chromatography/Fingerprint

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出版年

2024
海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
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