UPLC-Q-Exactive-MS 同时测定三臣丸中六种活性成分的药代动力学研究

doi:10.5246/jcps.2019.11.077

中国药学(英文版) ›› 2019, Vol. 28 ›› Issue (11): 812-824.DOI: 10.5246/jcps.2019.11.077

• 【研究论文】 • 上一篇

UPLC-Q-Exactive-MS 同时测定三臣丸中六种活性成分的药代动力学研究

张玲玲, 张慧文, 武世奎, 刘宏, 李静媛, 董馨, 夏慧敏, 王焕芸^*

内蒙古医科大学药学院药物分析教研室, 内蒙古呼和浩特 010110

收稿日期:2019-08-19 修回日期:2019-09-23 出版日期:2019-12-01 发布日期:2019-10-11
通讯作者: Tel.: +86-18647116320; Fax: +86-0471-6653116, E-mail: whuanyun999@163.com
基金资助:
Natural Science Foundation of Inner Mongolia (Grant No. 2017BS0806) and Science Fund of Inner Mongolia Education Department (Grant No. NJZZ19089).

Simultaneous determination of the pharmacokinetics of the active components of San-Chen-pill by UPLC-Q-Exactive-MS

Lingling Zhang, Huiwen Zhang, Shikui Wu, Hong Liu, Jingyuan Li, Xin Dong, Huimin Xia, Huanyun Wang^*

Department of Pharmaceutical Analysis, College of Pharmacy, Inner Mongolian Medical University, Huhhot 010110, China

Received:2019-08-19 Revised:2019-09-23 Online:2019-12-01 Published:2019-10-11
Contact: Tel.: +86-18647116320; Fax: +86-0471-6653116, E-mail: whuanyun999@163.com
Supported by:
Natural Science Foundation of Inner Mongolia (Grant No. 2017BS0806) and Science Fund of Inner Mongolia Education Department (Grant No. NJZZ19089).

摘要/Abstract

摘要：

建立三臣丸药代动力学的UPLC-Q-Exactive-MS检测方法, 同时测定大鼠血浆中胆酸、猪胆酸、羟基红花黄色素A、山奈酚-3-O-芸香糖苷、脱水红花黄色素B和紫丁香苷6种活性成分的含量。HPLC分离采用SHIMADZU GIST C₁₈色谱柱, 流动相为乙腈–0.1%甲酸溶液梯度洗脱。质谱检测采用HESI离子源负离子检测模式。6种活性成分的线性范围0.50–1280 ng/mL, r均大于0.99; 日内及日间精密度(RSD)均小于12.7%; 提取回收率、基质效应和稳定性的计算值均符合FDA生物分析方法验证准则。该文中的三臣丸为传统的蒙药复方, 由牛黄、红花和天竺黄三味药材等量组成。该方法为首次报道, 并且已成功应用于三臣丸的药代动力学研究。

关键词: 三臣丸, 药代动力学, UPLC-Q-Exactive-MS

Abstract:

In the present study, we developed a rapid, sensitive and efficient ultra high-performance liquid chromatography-tandemmass spectrometric (UPLC-Q-Exactive-MS) method, and six bioactive constituents in San-Chen-pill (SCP), including cholic acid (CA),hyodeoxycholic acid (HDCA), hydroxysafflor yellow A (HSYA), kaempferol-3-O-rutinoside (KFR), anhydrosafflor yellow B (AHSYB) and syringin (SRG), in rat plasma after oral administration of San-Chen-pill, were simultaneously determined. Plasma samples were pretreated with methanol for protein precipitation. Chromatography separation was performed on a SHIMADZU of shim-pack GIST C₁₈ column using a gradient mobile phase consisting of acetonitrile and 0.1% formic acid aqueous solution. A tandem mass spectrometric detection with an electrospray ion source (HESI) interface was conducted in negative ionization mode. For all the six analytes of interest, the calibration curves were linear within the concentration rage of 0.50–1280 ng/mL with r≥0.99. The intra-day and inter-day precisions (in terms of relative standard deviation, RSD) were all below 12.7% for all six analytes. Extraction recovery, matrix effect and stability data all met the acceptance criteria of FDA guideline for bioanalytical method validation. In addition, San-Chen-pill is a traditional Mongolian herbal medicine that has been prepared with three medicinal herbs,Calculus bovis, Carthamus tinctorius L. and Concretio silicea bambusae, and it shows potent anti-anginal activity in all preparationswith in a ratio of 1:1:1. The pharmacokinetic parameters of San-Chen-pill were reported herein for the first time, and this developed method was successfully used in a pharmacokinetic study for San-Chen-pill.

Key words: San-Chen-pill, Pharmacokinetics, UPLC-Q-Exactive-MS

中图分类号:

R944

Supporting:

张玲玲, 张慧文, 武世奎, 刘宏, 李静媛, 董馨, 夏慧敏, 王焕芸. UPLC-Q-Exactive-MS 同时测定三臣丸中六种活性成分的药代动力学研究[J]. 中国药学(英文版), 2019, 28(11): 812-824.

Lingling Zhang, Huiwen Zhang, Shikui Wu, Hong Liu, Jingyuan Li, Xin Dong, Huimin Xia, Huanyun Wang. Simultaneous determination of the pharmacokinetics of the active components of San-Chen-pill by UPLC-Q-Exactive-MS[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(11): 812-824.

参考文献

[1] Ministry of health pharmacopoeia committee. Ministry of health of the People’s Republic of China drug standards- Mongolian medicine standards. 1988, 59.

[2] Peng, C.; Tian, J.X.; Lv, M.; Huang, Y.; Tian, Y.; Zhang, Z.J. Development and validation of a sensitive LC-MS-MS method for the simultaneous determination of multicomponent contents in artificial Calculus Bovis. J. Chromatogr. Sci. 2014, 52, 128-136.

[3] Chang, Z.R.; Di, F.; Zhou, F.R. Study on determination of cholic acid in natural bezoar by TLC chromatography. China J. Tradit. Chin. Med. 1999, 24, 684.

[4] Zhan, R.M.; Cui, F.M.; Wang, A.M.; et al. In vitro cultivate of cholic acid and its components in wild boar. Chin. Herb. Med. 1995, 26, 592.

[5] Zhang, X.H.; Zheng, W.; Xu, H.L.; Huang, X.; Ren, P.; Zou, H.; Liu, G.H.; Wang, J.; Ma, X.L. Pharmacokinetic study of representative anti-oxidative compounds from Denshen-Chuanxiong-Honghua following oral administration in rats. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2017, 1052, 82-90.

[6] Jin, Y.; Tang, Y.P.; Zhu, Z.H.; Shang, E.X.; Pang, H.Q.; Shi, X.Q.; Chen, Y.Y.; Wang, J.; Chang, X.; Kang, A.; Zhou, G.S.; Shi, Y.J.; Sun, J.; Tang, Z.S.; Li, S.P.; Duan, J.N. Pharmacokinetic comparison of seven major bio-active components in normal and blood stasis rats after oral administration of herb pair danggui-honghua by UPLC-TQ/MS. Molecules. 2017, 22, E1746.

[7] Li, F.; He, Z.S.; Ye, Y. Flavonoids from carthamus tinctorius. Chin. J. Chem. 2010, 20, 699-702.

[8] Zhou, X.D.; Tang, L.Y.; Xu, Y.L.; Zhou, G.H.; Wang, Z.J. Towards a better understanding of medicinal uses of Carthamus tinctorius L. in traditional Chinese medicine: a phytochemical and pharmacological review. J. Ethnopharmacol. 2014, 151, 27-43.

[9] Zan, T.; Piao, L.; Wei, Y.T.; Gu, Y.; Liu, B.H.; Jiang, D.Q. Simultaneous determination and pharmacokinetic study of three flavonoid glycosides in rat plasma by LC-MS/MS after oral administration of Rubus chingii Hu extract. Biomed. Chromatogr. 2018, 32.

[10] Liang, S.P.; Liu, F.; Du, F.F.; Niu, W.; Sun, Y.; Li, C.; Guo, M.L. A new method for determination of kaempferol-3-O-rutinoside in plasma: Application to pharmacokinetic study in Sprague-Dawley rats. Chin. J. Clin. Pharmacol. Therap. 2006, 11, 491-49

[11] Liu, R.; Ma, R.; Yu, C.Y.; Bi, C.W.; Yin, Y.D.; Xu, H.R.; Shang, H.W.; Bi, K.S.; Li, Q. Quantitation of eleven active compounds of Aidi injection in rat plasma and its application to comparative pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 2016, 1026, 105-113.

[12] Guideline on Bioanalytical Method Validation. http://www.ema.europa.eu/docs/en GB/document library/Scientific guideline/2011/08/WC500109686.

[13] Sun, Y.W.; He, Y.; Liu, W.H.; Xiang, H.; Tang, Y.H.; Jin, Z. Study on pharmacokinetics of hydroxysafflor yellow A and anhydrosafflor yellow B from safflower extract in rats. China J. Tradit. Chin.Med. Pharm. 2015, 30, 4287-4291.

[14] Shi, X.H.; Tang, Y.H.; Chen, J.Z.; Shi, S.L.; He, Y. Pharmacokinetics of hydroxysafflor yellow A in Guhong Injection in rats. Chin. Tradit. Pat. Med. 2015, 37, 2387-2391.

[15] Qi, J.P.; Jin, X.F.; Huang, L.S.; Ping, Q.N. Simultaneous determination of hydroxysafflor yellow A and ferulic acid in rat plasma after oral administration of the co-extractum of Rhizoma chuanxiong and Flos Carthami by HPLC-diode array detector. Biomed. Chromatogr. 2007, 21, 816-822.

[16] Zhao, L.; Qian, X.; Li, W.H.; Lv, L.; Zhang, H.; Chai, Y.F.; Zhang, G.Q. An LC-MS/MS method for the simultaneous determination and pharmacokinetic studies of bergenin, chlorogenic acid and four flavonoids in rat plasma after oral administration of a QingGanSanJie decotion extract. Biomed. Chromatogr. 2014, 28, 1670-1678.

[17] Kim, M.J.; Kwon, S.H.; Jang, C.G.; Maeng, H.J. Determination of isoorientin levels in rat plasma after oral administration of Vaccinum bracteatum Thunb. methanol extract by high-performance liquid chromatography-tandem mass spectrometry. Biomed. Chromatogr. 2018, 32, e4188.

[18] Wang, Y.J.; Wen, J.; Zheng, W.H.; Zhao, L.S.; Fu, X.H.; Wang, Z.Z.; Xiong, Z.L.; Li, F.M.; Xiao, W. Simultaneous determination of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid and geniposide in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study after administration of Reduning injection. Biomed. Chromatogr. 2015, 29, 68-74.

[19] Hofmann, A.F.; Cravetto, C.; Molino, G.; Belforte, G.; Bona, B. Simulation of the metabolism and enterohepatic circulation of endogenous deoxycholic acid in humans using a physiologic pharmacokinetic model for bile acid metabolism. Gastroenterology. 1987, 93, 693-709.

[20] Tian, Y.; Yang, Z.F.; Li, Y.; Qiao, Y.; Yang, J.; Jia, Y.Y.; Wen, A.D. Pharmacokinetic comparisons of hydroxysafflower yellow A in normal and blood stasis syndrome rats. J. Ethnopharmacol. 2010, 129, 1-4.

[21] Tian, Z.M. The development of blood concentration measurement on the syndrome of Chinese formula and efficacy determination. Foreign Med. Sci. 1989, 10, 58-59.

UPLC-Q-Exactive-MS 同时测定三臣丸中六种活性成分的药代动力学研究

Simultaneous determination of the pharmacokinetics of the active components of San-Chen-pill by UPLC-Q-Exactive-MS

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

本文评价

[1]	杨雁芳, 韦玮, 张雷, 徐嵬, 杨秀伟. UPLC-MS/MS法测定都梁丸中37个成分在大鼠体内的药代动力学[J]. 中国药学(英文版), 2023, 32(7): 560-573.
[2]	李晓娇, 栾树鑫, 张洪, 万洪泉, 陈红, 刘成娇, 刘畅, 丁艳华. 单剂量长效利培酮注射液在中国精神分裂症患者体内的药代动力学、药效学和安全性研究[J]. 中国药学(英文版), 2021, 30(3): 206-217.
[3]	周艳, 宋恒文, 邵志超, 尹博民, 付西美, 谢典佑, 韦利军. 一种新的细胞周期蛋白依赖性激酶(CDK)9抑制剂QHRD107对急性髓系白血病的临床前疗效[J]. 中国药学(英文版), 2021, 30(2): 146-156.
[4]	杨秀伟, 张友波, 徐嵬. 静脉和灌胃给予大鼠茴香酸对羟基苯乙酯的RP-HPLC法测定和药代动力学研究[J]. 中国药学(英文版), 2020, 29(11): 804-812.
[5]	杨辉, 胡小鹏, 杨晓勇, 刘航, 任亮, 王玮, 刘丽宏, 张小东. 肾移植术后糖皮质激素和他克莫司的药代动力学相互作用[J]. 中国药学(英文版), 2019, 28(4): 257-263.
[6]	刘鑫, 张波, 梅丹, 黄凯. HPLC-MS/MS法测定大鼠血浆中异绿原酸B浓度及其在药代动力学研究中的应用[J]. 中国药学(英文版), 2019, 28(3): 167-173.
[7]	欧阳文鹃, 张亚兰, 徐平声, 戴智勇, 马虹英, 秦群. 国产注射用甲磺酸帕珠沙星在健康人体的药代动力学研究[J]. 中国药学(英文版), 2019, 28(1): 40-48.
[8]	常馨予, 郭桂明, 范峥, 王宏蕾, 刘洋, 韩丽娟. UPLC-MS/MS法测定黄芪桂枝五物汤在大鼠血浆中两种活性成分及药代动力学研究[J]. 中国药学(英文版), 2018, 27(4): 263-272.
[9]	姜华, 杨景明, 曹玲, 贾桂枝, 戴红良, 孟祥才. 高温胁迫对防风药材药代动力学和药效的影响[J]. 中国药学(英文版), 2018, 27(2): 109-115.
[10]	代华灵, 高伟祺, 张国顺, 王锐利, 张淑秋. 青蒿素脂质纳米粒的制备及药动学评价[J]. 中国药学(英文版), 2017, 26(3): 180-186.
[11]	崔婷, 周岐新, 张丹, 蒋心惠. 五种大黄蒽醌类化合物在家兔和大鼠体内的分布和药代动力学[J]. 中国药学(英文版), 2017, 26(2): 115-123.
[12]	朱刚直, 易勤, 范志宏, 马岳慧, 王丹丹, 王磊, 程泽能. LC-MS/MS法测定大鼠血浆中PAC-1的新型抗癌衍生物的浓度及其药物动力学研究[J]. 中国药学(英文版), 2017, 26(11): 811-818.
[13]	文周, 冀闪, 谢非凡, 胡高云, 程泽能. 高效液相色谱法测定大鼠血浆中新型抗纤维化药物美氟尼酮的浓度及其药物动力学研究[J]. 中国药学(英文版), 2017, 26(1): 45-52.
[14]	谢湘, 周瑞, 周培根, 余鹏, 高峰. LC-MS-MS法测定人血浆中的替诺福韦[J]. 中国药学(英文版), 2016, 25(9): 676-682.
[15]	黄晓敏, 焦文宣, 孙崎, 王克威. 大鼠血浆中新型α7-烟碱型乙酰胆碱受体正向变构调节剂LD486的液相色谱-质谱串联测定方法学的建立及其药代动力学特征[J]. 中国药学(英文版), 2016, 25(7): 517-525.