Study on Quantitative Fingerprints for Raw Medicinal Materials， Intermediates and Preparations of Yuanhu Zhitong Koufuye

XIE Jia-le; LAN Jing; CAO Zhi-ming; GUAN Jian-li; WANG Yi; GONG Xing-chu

doi:10.19969/j.fxcsxb.23030303

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Study on Quantitative Fingerprints for Raw Medicinal Materials， Intermediates and Preparations of Yuanhu Zhitong Koufuye

Scientific Papers | 更新时间：2023-10-24

- Study on Quantitative Fingerprints for Raw Medicinal Materials， Intermediates and Preparations of Yuanhu Zhitong Koufuye
- Journal of Instrumental Analysis Vol. 42, Issue 8, Pages: 984-991(2023)
- 作者机构：
  
  1.浙江大学药学院，浙江杭州 310058
  2.浙江大学智能创新药物研究院，浙江杭州 310018
  3.河南福森药业有限公司，河南南阳 474450
  4.组分中药国家重点实验室浙江大学交叉创新中心，浙江杭州 310058
- 作者简介：
- 基金信息：
- DOI：10.19969/j.fxcsxb.23030303
  CLC：
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颉佳乐,兰婧,曹智铭等.元胡止痛口服液药材、中间体及制剂的定量指纹图谱方法研究[J].分析测试学报,2023,42(08):984-991.

XIE Jia-le,LAN Jing,CAO Zhi-ming,et al.Study on Quantitative Fingerprints for Raw Medicinal Materials， Intermediates and Preparations of Yuanhu Zhitong Koufuye[J].Journal of Instrumental Analysis,2023,42(08):984-991.
颉佳乐,兰婧,曹智铭等.元胡止痛口服液药材、中间体及制剂的定量指纹图谱方法研究[J].分析测试学报,2023,42(08):984-991. DOI： 10.19969/j.fxcsxb.23030303.

XIE Jia-le,LAN Jing,CAO Zhi-ming,et al.Study on Quantitative Fingerprints for Raw Medicinal Materials， Intermediates and Preparations of Yuanhu Zhitong Koufuye[J].Journal of Instrumental Analysis,2023,42(08):984-991. DOI： 10.19969/j.fxcsxb.23030303.

摘要

建立了适用于元胡止痛口服液原料药材、中间体及制剂中若干生物碱类成分的定量指纹图谱方法。采用DIKMA Diamonsil Plus C,18,－A色谱柱（4.6 mm × 250 mm，5 μm），以0.04%乙酸铵溶液（冰醋酸调至pH 4.0，A）－乙腈（B）为流动相进行梯度洗脱，在280 nm下进行检测。指纹图谱中含共有峰7个，其精密度、重复性、稳定性的相对标准偏差（RSD）均小于5.0%。对延胡索乙素、去氢延胡索甲素进行定量分析，其分别在6.15 ~ 123 µg/mL和10.15 ~ 203 µg/mL范围内线性关系良好，相关系数（,r,2,） ,>, 0.999，进样精密度、方法重复性的RSD均小于5.0%，供试品溶液在24 h内稳定。延胡索乙素、去氢延胡索甲素在低、中、高3个加标水平下的平均回收率为89.6% ~ 107%，RSD小于3.0%。所建立的分析方法稳定、准确、可靠，能够对药材、中间体及制剂中的中等极性成分进行检测，可用于考察工业生产中元胡成分的量值传递情况，从而为改进元胡止痛口服液制药过程控制水平提供技术支持。

Abstract

A quantitative fingerprint method was established for several alkaloids in the raw medicinal materials，intermediates and preparations of Yuanhu Zhitong Koufuye．A DIKMA Diamonsil Plus C,18,－A chromatographic column（4.6 mm × 250 mm，5 μm） was used for separation with gradient elution.The mobile phase was consisted of solvent A（0.04% ammonium acetate solution，glacial acetic acid was used to regulate the pH value to 4.0） and solvent B（acetonitrile）．The detection wavelength was 280 nm．There were 7 common peaks in the fingerprint．The relative standard deviations（RSDs） of precision，repeatability and stability were all less than 5.0%．The linear relationships of tetrahydropalmatine and dehydrocorydaline were good within the range of 6.15－123 µg/mL and 10.15－203 µg/mL，respectively．The correlation coefficients（,r,2,） were more than 0.999，and RSDs for injection precision and method repeatability were less than 5.0%．The sample solution was stable within 24 h．The average recoveries for tetrahydropalmatine and dehydrocorydaline at low，medium and high levels ranged from 89.6% to 107%，with RSDs less than 3.0%．The established method is stable，accurate and reliable，and could be used to detect the medium polar components in the medicinal materials，intermediates and preparations，investigating the quantity and measure value transfer of the components in Corydalis Rhizoma during industrial production．The method provides a technical support for improving the control level for pharmaceutical process of Yuanhu Zhitong Koufuye.

关键词

定量指纹图谱含量测定元胡止痛口服液延胡索乙素去氢延胡索甲素

Keywords

quantitative fingerprintcontent determinationYuanhu Zhitong Koufuyetetrahydropalmatinedehydrocorydaline

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Related Institution

School of Pharmacy， Shanghai University of Traditional Chinese Medicine

National Medical Products Administration Key Laboratory for Quality Control of Traditional Chinese Medicine，Shanghai Institute for Food and Drug Control

Department of Pharmaceutical Analysis，College of Pharmacy，China Pharmaceutical University

Pharmaceutical Research Institute，China Pharmaceutical University

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