Study on Chromatographic Detection Methods of Intermediates and Preparations of Xiaochaihu Capsules（1）—Method for Quantitative Fingerprint of Preparations

DING Feng; WU Ge-lin; XING Leng; QU Hai-bin; LI Dao-chao; ZHOU Peng; GONG Xing-chu

doi:10.12452/j.fxcsxb.24021102

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Study on Chromatographic Detection Methods of Intermediates and Preparations of Xiaochaihu Capsules（1）—Method for Quantitative Fingerprint of Preparations

Scientific Papers | 更新时间：2024-11-26

- Study on Chromatographic Detection Methods of Intermediates and Preparations of Xiaochaihu Capsules（1）—Method for Quantitative Fingerprint of Preparations
- Journal of Instrumental Analysis Vol. 43, Issue 11, Pages: 1754-1763(2024)
- 作者机构：
  
  1.浙江大学药学院，浙江杭州 310058
  2.浙江赞生药业有限公司，浙江台州 318000
  3.杭州赞生医药有限公司，浙江杭州 310052
  4.浙江大学金华研究院，浙江金华 321016
  5.现代中药创制全国重点实验室，浙江杭州 310058
- 作者简介：
- 基金信息：
- DOI：10.12452/j.fxcsxb.24021102
  CLC： O657.7;R284
- Published：15 November 2024，
  
  Received：11 February 2024，
  
  Revised：14 March 2024，
- 稿件说明：
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丁丰,吴革林,邢冷,瞿海斌,李道超,周鹏,龚行楚.小柴胡胶囊中间体和制剂的色谱检测方法研究（1）—制剂的定量指纹图谱方法[J].分析测试学报,2024,43(11):1754-1763.

DING Feng,WU Ge-lin,XING Leng,QU Hai-bin,LI Dao-chao,ZHOU Peng,GONG Xing-chu.Study on Chromatographic Detection Methods of Intermediates and Preparations of Xiaochaihu Capsules（1）—Method for Quantitative Fingerprint of Preparations[J].Journal of Instrumental Analysis,2024,43(11):1754-1763.
丁丰,吴革林,邢冷,瞿海斌,李道超,周鹏,龚行楚.小柴胡胶囊中间体和制剂的色谱检测方法研究（1）—制剂的定量指纹图谱方法[J].分析测试学报,2024,43(11):1754-1763. DOI： 10.12452/j.fxcsxb.24021102.

DING Feng,WU Ge-lin,XING Leng,QU Hai-bin,LI Dao-chao,ZHOU Peng,GONG Xing-chu.Study on Chromatographic Detection Methods of Intermediates and Preparations of Xiaochaihu Capsules（1）—Method for Quantitative Fingerprint of Preparations[J].Journal of Instrumental Analysis,2024,43(11):1754-1763. DOI： 10.12452/j.fxcsxb.24021102.

摘要

以小柴胡胶囊为研究对象，建立了甘草苷、党参炔苷、黄芩苷、汉黄芩苷、黄芩素、甘草皂苷G

、甘草酸、汉黄芩素、柴胡皂苷B

、柴胡皂苷B

共10种成分的定量分析及指纹图谱方法。采用超高效液相色谱（UHPLC）进行分析，采用Waters HSS T3色谱柱（100 mm×2.1 mm，1.8 μm）以0.05%磷酸水溶液-乙腈为流动相进行梯度洗脱，利用光电二极管阵列检测器（DAD）在215、254 nm波长下进行检测，指纹图谱中含22个共有峰。利用超高效液相色谱-三重四极杆-飞行时间质谱（UHPLC-Q-TOF MS）推断了色谱共有峰中化合物的结构，指纹图谱方法学（精密度、重复性、稳定性）结果的相对标准偏差（RSD）均小于6.0%。10种成分在一定质量浓度范围内线性关系较好，

＞0.999，进样精密度和方法重复性结果的RSD不超过6.0%，供试品溶液在24 h内稳定性良好，各成分的平均加标回收率为91.9%~104%。利用所建方法对12批小柴胡胶囊进行检测，结果表明不同批次之间小柴胡胶囊的一致性良好。该方法稳定、准确、可靠，能够检测小柴胡胶囊中不同饮片中的指标成分，更加全面地反映小柴胡胶囊的质量。

Abstract

A quantitative method and a fingerprint method were established for a total of 10 components in Xiaochaihu Capsules，including liquiritin，lobetyolin，baicalin，wogonoside，baicalein，licoricesaponin G

，glycyrrhizin，wogonin，saikosaponin B

and saikosaponin B

. They were analyzed by ultra high performance liquid chromatography（UHPLC）. Waters HSS T3 chro

matographic column（100 mm×2.1 mm，1.8 μm） was used. The mobile phase was consisted of 0.05% phosphoric acid solution and acetonitrile. The elution mode was gradient elution. The detection wavelength was set at 215 nm and 254 nm by diode-array detector（DAD）. There were 22 common peaks in the fingerprints. The ultra high performance liquid chromatography quadrupole time of flight mass spectrometry（UHPLC-Q-TOF MS） was used to infer the structure of the compounds in the common peaks. The relative standard deviations（RSDs） of precision，repeatability and stability were all less than 6.0%. The linear relationship of 10 components was good within the quantitative range. The determination coefficients（

） were higher than 0.999. RSDs of injection precision and method repeatability were less than 6.0%. The sample solution was stable within 24 hours，and the recoveries of each component were 91.9%-104%. 12 batches of Xiaochaihu Capsules from different batches were analyzed using the established analytical method. The results showed good consistence of Xiaochaihu Capsules among different batches. The established analytical method is stable，accurate and reliable. It can be used to detect the index components in Xiaochaihu Capsules. The detection results can reflect the quality of Xiaochaihu Capsules more comprehensively.

关键词

小柴胡胶囊指纹图谱含量测定超高效液相色谱双波长检测

Keywords

Xiaochaihu Capsulesfingerprintcontent determinationUHPLCdual-wavelength detection

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