Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination

CHEN Song; LI Yunrong; NONG Luwei; LI Li; JIANG Xianzai; ZENG Cuiqiong; WANG Liuping

doi:10.6039/j.issn.1001-0408.2024.22.04

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Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination

更新时间：2024-11-26

- Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination
- ZHONGGUO YAOFANG Vol. 35, Issue 22, Pages: 2726-2731(2024)
- 作者机构：
  
  1.广西中医药大学附属国际壮医医院壮瑶药研发中心，南宁　530201
  2.广西中医药大学药学院，南宁　530200
  3.广西中医药大学中药学国家级实验教学示范中心，南宁　530200
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.22.04
  CLC： R917;R284.1
- Published：30 November 2024，
  
  Received：16 April 2024，
  
  Revised：23 July 2024，
- 稿件说明：
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陈松,李运容,农璐蔚等.基于HPLC指纹图谱和多成分含量综合评价扶正胶囊的质量 ^Δ[J].中国药房,2024,35(22):2726-2731.

CHEN Song,LI Yunrong,NONG Luwei,et al.Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination[J].ZHONGGUO YAOFANG,2024,35(22):2726-2731.
陈松,李运容,农璐蔚等.基于HPLC指纹图谱和多成分含量综合评价扶正胶囊的质量 ^Δ[J].中国药房,2024,35(22):2726-2731. DOI： 10.6039/j.issn.1001-0408.2024.22.04.

CHEN Song,LI Yunrong,NONG Luwei,et al.Quality evaluation of Fuzheng capsules based on HPLC fingerprint and multi-ingredient content determination[J].ZHONGGUO YAOFANG,2024,35(22):2726-2731. DOI： 10.6039/j.issn.1001-0408.2024.22.04.

摘要

目的

建立壮药制剂扶正胶囊指纹图谱和多指标成分含量的测定方法，并对其进行质量评价。

方法

采用高效液相色谱（HPLC）法，结合《中药色谱指纹图谱相似度评价系统（2004A）》建立12批扶正胶囊样品的指纹图谱，并进行相似度评价、共有峰确认；以指纹图谱共有峰峰面积为变量，采用SPSS 20.0软件进行聚类分析和主成分分析。采用同一HPLC法测定12批样品中甘草苷、特女贞苷、3，6′-二芥子酰基蔗糖、甘草酸铵的含量。

结果

12批扶正胶囊样品共有22个共有峰，相似度均大于0.91；指认出甘草苷（峰8）、特女贞苷（峰10）、3，6′-二芥子酰基蔗糖（峰11）、甘草酸铵（峰21）4个共有峰；12批样品可聚为3类，200801、200802、200803为Ⅰ类，样1～样8为Ⅱ类，221101为Ⅲ类；200802的综合得分（2.540）最高。12批样品中，甘草苷、特女贞苷、3，6′-二芥子酰基蔗糖、甘草酸铵的含量分别为0.44～0.73、1.28～2.47、0.08～0.12、1.31～1.81 mg/粒。

结论

12批扶正胶囊样品的主要成分相似但含量有所差别，以200802的质量最优；所建指纹图谱和多指标成分含量测定方法专属性强、准确度高，结合化学模式识别分析可用于扶正胶囊的质量评价。

Abstract

OBJECTIVE

To establish the fingerprint of the Zhuang medicine preparation Fuzheng capsules and a method for the determination of multi-ingredient content for quality evaluation.

METHODS

High-performance liquid chromatography （HPLC） was used in conjunction with the

Similarity Evaluation System for Chromatographic Fingerprints of Traditional Chinese Medicine

（2004A edition） to establish the fingerprint of 12 batches of Fuzheng capsules， evaluate their similarity and confirm the common peaks. Cluster analysis and principal component analysis were performed using SPSS 20.0 software with the peak areas of the common peaks in the fingerprint as variables. The same HPLC method was adopted to determine the content of liquiritin， sp

ecnuezhenide， 3，6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples.

RESULTS

A total of 22 common peaks were identified in the fingerprints of the 12 batches of Fuzheng capsules， with the similarities greater than 0.91. Four common peaks were identified as liquiritin （peak 8）， specnuezhenide （peak 10）， 3，6′-disinapoyl sucrose （peak 11）， and ammonium glycyrrhizinate （peak 21）. The 12 batches of samples could be clustered into 3 categories， with 200801， 200802 and 200803 as category Ⅰ， samples 1 to 8 as category Ⅱ， and 221101 as category Ⅲ. The sample 200802 had the highest comprehensive score （2.540）. The contents of liquiritin， specnuezhenide， 3，6′-disinapoyl sucrose and ammonium glycyrrhizinate in the 12 batches of samples were 0.44 to 0.73， 1.28 to 2.47， 0.08 to 0.12， and 1.31 to 1.81 mg per capsule， respectively.

CONCLUSIONS

The main components of the 12 batches of Fuzheng capsules were similar， but the content varied， with the sample 200802 indicating the highest quality. The established fingerprint and multi-ingredient content determination method were highly specific and accurate， which can be used for the quality evaluation of Fuzheng capsules in combination with chemical pattern recognition analysis.

关键词

扶正胶囊指纹图谱含量测定化学模式识别分析质量评价高效液相色谱法

Keywords

fingerprintcontent determinationchemical pattern recognition analysisquality evaluationHPLC

references

广西壮族自治区药品监督管理局. 医疗机构中药民族药制剂再注册批件[Z]. 2018-09-03.

Guangxi Zhuang Autonomous Region Medical Products Administration. Re-registration approval for traditional Chinese medicine and ethnic medicine preparations in medical institutions[Z].2018-09-03.

陈霞，阳长明，陈浩，等. 基于中药复方制剂特点的中药复方制剂生产工艺研究[J]. 中草药，2021，52（19）：5807-5813.

CHEN X，YANG C M，CHEN H，et al. Research of preparation process of Chinese materia medica compound preparation based on characteristics of Chinese materia medica compound preparation[J]. Chin Tradit Herb Drugs，2021，52（19）：5807-5813.

杨冰，封亮，贾晓斌. 基于“组分结构” 特征的中药制剂质量评价策略[J]. 中草药，2019，50（17）：4003-4007.

YANG B，FENG L，JIA X B. Quality evaluation strategy of Chinese materia medica preparation based on characte-ristics of “structural composition of multi-components”[J]. Chin Tradit Herb Drugs，2019，50（17）：4003-4007.

叶婷，梁文仪，梁林金，等. HPLC指纹图谱在中药制剂质量研究中的应用[J]. 世界科学技术-中医药现代化，2017，19（11）：1794-1800.

YE T，LIANG W Y，LIANG L J，et al. Application of HPLC fingerprint in quality of traditional Chinese medicine preparations[J]. Mod Tradit Chin Med Mater Med World Sci Technol，2017，19（11）：1794-1800.

赵桉熠，倪凤燕，陈彭月，等. 以一致性为核心的中成药质量研究现状及优质评价新模式探讨[J]. 中国中药杂志，2020，45（15）：3740-3748.

ZHAO A Y，NI F Y，CHEN P Y，et al. Current studies on quality of Chinese patent drugs with consistency as core and discussions on new high-quality evaluation model[J]. China J Chin Mater Med，2020，45（15）：3740-3748.

张佳，杨怀瑾，马丽霞，等. 中药品质传递过程评价技术与方法研究进展[J]. 中草药，2021，52（15）：4711-4721.

ZHANG J，YANG H J，MA L X，et al. Research progress on evaluation technology and method of quality delivery process of traditional Chinese medicine[J]. Chin Tradit Herb Drugs，2021，52（15）：4711-4721.

农璐蔚，陈松. 黄花倒水莲研究进展[J]. 亚太传统医药，2022，18（7）：227-231.

NONG L W，CHEN S. Research progress of Polygala fallax hemsl[J]. Asia Pac Tradit Med，2022，18（7）：227-231.

赵润清，胡园，李牧函，等. 3，6′-二芥子酰基蔗糖联合tenuifoliside A协同抗抑郁作用及其机制的研究[J]. 中国药理学通报，2016，32（5）：716-722.

ZHAO R Q，HU Y，LI M H，et al. Study on synergistic antidepressant effect of 3，6′-disinapoyl sucrose combined with tenuifoliside A and its possible mechanism[J]. Chin Pharmacol Bull，2016，32（5）：716-722.

张洁. 远志中3，6′-二芥子酰基蔗糖酯的抗焦虑作用及药代动力学研究[D].北京：北京中医药大学，2022.

ZHANG J. Study on the anti-anxiety effect and pharmacokinetics of 3，6′-disinapoyl sucrose ester in Polygala tenuifolia[D]. Beijing：Beijing University of Chinese Medicine，2022.

徐志宏，代爽，刘静雅，等. 3，6′-二芥子酰基蔗糖在制备治疗2型糖尿病的药物中的应用：CN113082038A[P]. 2021-07-09.

XU Z H，DAI S，LIU Y J，et al. Application of3，6′-disinapoyl sucrose in the preparation of drugs for the treatment of type 2 diabetes：CN113082038A[P]. 2021-07-09.

余思萍. 特女贞苷改善2型糖尿病小鼠胰岛素抵抗的机制研究[D]. 广州：广东药科大学，2022.

YU S P. Mechanism of Ligustrum lucidum Ait in impro-ving insulin resistance in type 2 diabetic mice[D]. Guangzhou：Guangdong Pharmaceutical University，2022.

顾闻，刘特，陈久林，等. 特女贞苷对血管内皮细胞氧化损伤的作用研究[J]. 中国中西医结合杂志，2018，38（9）：1093-1098.

GU W，LIU T，CHEN J L，et al. Effect of specnuezhenide reducing the oxidative damage of vascular endothelial cells[J]. Chin J Integr Tradit West Med，2018，38（9）：1093-1098.

杨倩倩，孟子盈，王晓禹，等. 甘草苷的提取纯化和药理作用研究进展[J]. 中国野生植物资源，2023，42（4）：12-17.

YANG Q Q，MENG Z Y，WANG X Y，et al. Extraction and purification of glycyrrhizin and its pharmacological effects：a review[J]. Chin Wild Plant Resour，2023，42（4）：12-17.

吴凤爱，逯青霞，侯贵明，等. 甘草苷对血管紧张素Ⅱ诱导的心肌细胞肥大的影响[J]. 中国临床药理学杂志，2023，39（19）：2780-2784.

WU F A，LU Q X，HOU G M，et al. Effect of liquiritin on angiotensin Ⅱ-induced cardiomyocyte hypertrophy[J]. Chin J Clin Pharmacol，2023，39（19）：2780-2784.

邵杨，安丹蔷，杨杨，等. 脊髓损伤小鼠中甘草苷通过抑制MAPK通路抑制炎症和神经元凋亡[J]. 中国医科大学学报，2022，51（6）：518-523，547.

SHAO Y，AN D Q，YANG Y，et al. Liquiritin suppresses inflammation and apoptosis in a mouse model of spinal cord injury via inhibiting the MAPK signaling pathway[J]. J China Med Univ，2022，51（6）：518-523，547.

黄娇，罗杰伟，韩丽，等. 甘草酸铵调控IL-33/ST2通路对特应性皮炎小鼠肥大细胞活化的影响[J]. 药物评价研究，2020，43（11）：2181-2186.

HUANG J，LUO J W，HAN L，et al. Effect of ammonium glycyrrhizinate regulation of IL-33/ST2 pathway on mast cell activation in atopic dermatitis mice[J]. Drug Eval Res，2020，43（11）：2181-2186.

常成，宋燕. 甘草酸铵对带状疱疹后遗神经痛大鼠GLP-1R/IL-10/β-内啡肽通路及脊髓背角小胶质细胞活化的影响[J]. 免疫学杂志，2022，38（1）：81-87.

CHANG C，SONG Y. Effects of ammonium glycyrrhi-zinate on GLP-1R/IL-10/β-endorphin pathway and microglia activation in spinal dorsal horn of rats with postherpetic neuralgia[J]. Immunol J，2022，38（1）：81-87.

赵慧，吕佳，曹燕妮，等. 甘草酸铵对对乙酰氨基酚致人肝细胞损伤的保护作用研究[J]. 中南药学，2017，15（3）：301-304.

ZHAO H，LYU J，CAO Y N，et al. Protective effect of ammonium glycyrrhizinate on injured human hepatocytes by acetaminophen[J]. Cent South Pharm，2017，15（3）：301-304.

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