Studies on the Quality Standard of Qichan Koufu Jiechang Baxiang Tablets

SONG Xiao-hong; HUANG Yu-ye; YU Ye; TIAN Gang

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Studies on the Quality Standard of Qichan Koufu Jiechang Baxiang Tablets

更新时间：2024-01-04

- Studies on the Quality Standard of Qichan Koufu Jiechang Baxiang Tablets
- Chinese Journal of Experimental Traditional Medical Formulae Vol. 18, Issue 11, Pages: 88-93(2012)
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- Published：2012
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SONG Xiao-hong, HUANG Yu-ye, YU Ye, et al. Studies on the Quality Standard of Qichan Koufu Jiechang Baxiang Tablets[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(11): 88-93.
DOI：

SONG Xiao-hong, HUANG Yu-ye, YU Ye, et al. Studies on the Quality Standard of Qichan Koufu Jiechang Baxiang Tablets[J]. Chinese journal of experimental traditional medical formulae, 2012, 18(11): 88-93. DOI：

摘要

目的: 建立芪蟾口服结肠靶向片的质量控制标准。方法: 采用TLC法对制剂中黄芪、干蟾皮、苦参进行定性鉴别;采用UPLC和HPLC法对制剂中黄芪甲苷、酯蟾毒配基和华蟾酥毒基、苦参碱进行定量分析。结果: 薄层色谱主斑点清晰、特征明显、专属性强;黄芪甲苷线性范围为0.233 6~0.817 6 μg(r=0.999 6

n=6)

平均回收率为99.66%(RSD 1.14%);酯蟾毒配基线性范围为0.001 75~0.010 5 μg

(r=1.000 0

n=6)

平均回收率为100.44%(RSD 1.94%);华蟾酥毒基线性范围为0.003 51~0.021 06 μg

(r=1.000 0

n=6)

平均回收率为99.57%(RSD 2.73%);苦参碱线性范围为0.336 8~1.178 8 μg

(r=0.999 8

n=6)

平均回收率为100.30%(RSD 1.11%)。结论: 检测方法简便、可靠、重复性好

可作为芪蟾口服结肠靶向片的质量标准控制方法。

Abstract

Objective: To establish the quality control standard of Qichan Koufu Jiechang Baxiang tablets. Method: Astragalus

corium bufon and flavescens were identified by TLC. The UPLC and HPLC in preparations for astragaloside Ⅳ

resibufogenin and cinobufagin

matrine are quantificationally analyzed. Result: The characteristic for identification by TLC was distinct and highly specific. The linear range of astragaloside Ⅳ was 0.233 6-0.817 6 μg(r=0.999 9)

and the average recovery was 99.66%(RSD 1.14%). The linear range of resibufogenin concentration was 0.001 75-0.010 5 μg(r=1.000 0)

and the average recovery was 100.44%(RSD 1.94%). The linear range of cinobufagin concentration was 0.003 51-0.021 06 μg(r=1.000 0)

and the average recovery was 99.57%(RSD 2.73%). The linear range of Matrine concentration was 0.336 8-1.178 8 μg(r=0.999 8)

and the average recovery was 100.30%(RSD 1.11%). Conclusion: The detection method is simple

reliable

reproducible and can be suitable for quality control of Qichan Koufu Jiechang Baxiang Tablets.

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Related Institution

Henan Engineering Research Center for Quality Control and Evaluation of Traditional Chinese Medicine（TCM），School of Pharmacy，Henan University of Chinese Medicine

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Third Affiliated Hospital of Henan University of Chinese Medicine

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Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences

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