基于HPLC指纹图谱、多指标成分含量测定及化学计量学的复方保泰松鸡血藤片质量评价

doi:10.11669/cpj.2020.22.008

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摘要目的建立HPLC指纹图谱和多指标成分定量测定与化学计量学相结合的复方保泰松鸡血藤片质量评价方法。方法以Waters Symmetry C₁₈柱为色谱柱,柱温30 ℃;乙腈-甲醇(4∶1)与0.05 mol·L^-1磷酸二氢钾溶液为流动相,梯度洗脱,流速1.0 mL·min^-1;检测波长分别为280 nm(检测儿茶素、表儿茶素和美迪紫檀素)、215 nm(检测奇壬醇、豨莶苷和豨莶精醇)和240 nm(检测保泰松、6-姜辣素和8-姜酚)。利用中药色谱指纹图谱相似度评价系统(2012.130723版)建立复方保泰松鸡血藤片HPLC指纹图谱并进行相似度评价;采用SPSS26.0软件聚类分析、主成分分析等化学计量学方法对不同厂家生产的复方保泰松鸡血藤片进行质量评价。结果复方保泰松鸡血藤片HPLC指纹图谱确认了17个共有峰,指认出9个共有峰,3个厂家生产的10批复方保泰松鸡血藤片样品相似度均大于0.95。儿茶素、表儿茶素、美迪紫檀素、奇壬醇、豨莶苷、豨莶精醇、保泰松、6-姜辣素和8-姜酚分别在2.596～259.6、3.148～314.8、0.284 0～28.40、3.876～387.6、0.928 0～92.80、0.512 0～51.20、0.356 0～35.60、2.268～226.8和0.432 0～43.20 μg·mL^-1内线性关系良好(r≥0.999 1),平均加样回收率分别为99.69%、100.02%、96.91%、100.06%、98.94%、98.42%、97.88%、99.32%和97.32%,RSD分别为0.78%、0.67%、1.24%、0.84%、1.03%、1.36%、1.15%、0.94%和1.46%。10批复方保泰松鸡血藤片样品聚为3类,主成分分析结果显示,主成分1～6是影响复方保泰松鸡血藤片质量评价的主要因子。结论该方法操作简便、重复性好,可用于复方保泰松鸡血藤片的质量控制和综合评价。

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关键词 ：复方保泰松鸡血藤片, 指纹图谱, 儿茶素, 表儿茶素, 奇壬醇, 豨莶苷, 质量评价

Abstract：OBJECTIVE To establish a quality evaluation method of Compound phenylbutazone and spatholobus stem tablets based on HPLC fingerprint, determination of multi-index components and chemometrics analysis. METHODS The chromatographic column was Waters Symmetry C₁₈ column, and the column temperature was set at 30 ℃.The mobile phase was composed of acetonitrile-methanol (4∶1) and 0.05 mol·L^-1 potassium dihydrogen phosphate solution flowing at 1.0 mL·min^-1 in a gradient elution manner. The detection wavelength were set at 280 nm for (+)-catechin, epicatechin and medicarpin,215 nm for kirenol, darutoside and darutigenol, 240 nm for phenylbutazone, 6-gingerol and 8-gingerol. RESULTS The fingerprint of Compound phenylbutazone and spatholobus stem tablets was established. Seventeen common peaks were confirmed and nine of them were identified.The similarity of fingerprints of 10 batches of Compound phenylbutazone and spatholobus stem tablets from 3 different manufacturers was more than 0.95. (+)-Catechin, epicatechin, medicarpin, kirenol, darutoside, darutigenol, phenylbutazone, 6-gingerol and 8-gingerol showed good linear relationships within the ranges of 2.596-259.6, 3.148-314.8, 0.284 0-28.40, 3.876-387.6, 0.928 0-92.80, 0.512 0-51.20, 0.356 0-35.60, 2.268-226.8 and 0.432 0-43.20 μg·mL^-1(r≥0.999 1), whose average recoveries were 99.69%, 100.02%, 96.91%, 100.06%, 98.94%, 98.42%, 97.88%, 99.32% and 97.32% with the RSDs of 0.78%, 0.67%, 1.24%, 0.84%, 1.03%, 1.36%, 1.15%, 0.94% and 1.46%, respectively. The results of cluster analysis showed that 10 batches of Compound phenylbutazone and spatholobus stem tablets were clustered into three groups, and the results of principal component analysis showed that the principal components 1-6 were the main factor affecting the quality evaluation of Compound phenylbutazone and spatholobus stem tablets. CONCLUSION The method is simple and repeatable, and it can be used to quality control and hensive evaluation of Compound phenylbutazone and spatholobus stem tablets.

Key words： Compound phenylbutazone and spatholobus stem tablets fingerprints (+)-catechin epicatechin kirenol darutoside quality evaluation

收稿日期: 2020-06-12

PACS:

R917

基金资助:国家自然科学基金面上项目资助(8157150733);安徽省教育厅高校自然科学研究项目资助(KJ2017A770)

通讯作者: 焦伟杰,男,硕士,副主任药师研究方向:药物质量控制及药事管理等医院药学研究 Tel:15038053837 E-mail:jie696688@hotmail.com

作者简介: 张洁,女,本科,主管药师研究方向:药物质量控制及药物临床应用研究

引用本文:

张洁, 焦伟杰, 雷震, 张格艳, 高咏莉, 孙自学, 马灵珍. 基于HPLC指纹图谱、多指标成分含量测定及化学计量学的复方保泰松鸡血藤片质量评价[J]. 中国药学杂志, 2020, 55(22): 1873-1882. ZHANG Jie, JIAO Wei-jie, LEI Zhen, ZHANG Ge-yan, GAO Yong-li, SUN Zi-xue, MA Ling-zhen. Quality Evaluation of Compound Phenylbutazone and Spatholobus Stem Tablets Based on HPLC Fingerprint,Determination of Multi-index Components and Chemometrics Analysis. Chinese Pharmaceutical Journal, 2020, 55(22): 1873-1882.

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http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/10.11669/cpj.2020.22.008 或 http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/Y2020/V55/I22/1873

[1]	WS-1001-(HD-0637)-2002. National Drug Standards: Local Standards of Chemical Drugs Rise to National Standards[S]. 2002:145.
[2]	YANG R R, SUO Y R, QIAO Y H, et al. Simultaneous determination of formononetin, medicarpin and other 4 flavonoidsin Spatholobi Caulis by HPLC[J]. Chin J Pharm Anal(药物分析杂志), 2017, 37(12):2139-2144.
[3]	ZHANG L, LIU J, YU J, et al. Determination of fingerprint of Herba Siegesbeckiae and 3 kinds of active ingredients[J]. Shaanxi J Tradit Chin Med(陕西中医), 2015, 36(12):1674-1676.
[4]	MENG X C. Content determination of 3 gingerols in dried ginger, baked ginger and fresh ginger by RP-HPLC[J]. J China Pharm(中国药房), 2011, 22(23):2182-2184.
[5]	DU J S, WU L Q, MA H Y. Determination of four flavonoids in Coprinus chinensis by quantitative analysis of multi-components with a single-marker(QAMS)[J]. J Chin Med Mater(中药材), 2017, 40(4):881-883.
[6]	KONG F Y, HU H H, TIAN Z H, et al. Study on index components and fingerprints of crude and processed Siegesbeckia Herbs[J]. China J Chin Mater Med(中国中药杂志), 2014, 39(15):2907-2911.
[7]	HAO W S, FAN Z Q, XI J Q. A comparative analysis of the composition of the stem, branch and lear from Herba Siegesbeckiae[J]. Chin J Pharm(中国医药工业杂志), 2019, 50(9):987-992.
[8]	LI L, CHEN N J, JIANG Y. HPLC method for content determination of Phenylbutazone Tablets[J]. China Med Pharm(中国医药科学), 2015, 5(17):61-63.
[9]	SUN T, ZHANG J. Content determination of phenylbutazone in Phenylbutazone Tablets by improved HPLC[J]. China Pharm(中国药业), 2018, 27(1):38-40.
[10]	LI P H, YAN H, ZHU S Q, et al. Establishment of HPLC fingerprint of dried ginger and determination of 5 components[J]. Chin Tradit Pat Med(中成药), 2019, 41(9):2246-2251.
[11]	LONG Q J, LI W T, ZHANG Y, et al. Comparative study on HPLC fingerprint of dry ginger(Zingiberis Rhizoma) slices and their processed products with different processing methods[J]. Gansu Univ Chin Med(甘肃中医药大学学报), 2019, 36(2):23-27.
[12]	XU F Q, LIU J Q, WANG J T, et al. Simultaneous determination of darutosidein and kirenol in Herba Siegesbeckiae by HPLC[J]. Chin Tradit Pat Med(中成药), 2011, 33(8):1444-1446.