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应中央军委要求,2022年9月起,《药学实践杂志》将更名为《药学实践与服务》,双月刊,正文96页;2023年1月起,拟出版月刊,正文64页,数据库收录情况与原《药学实践杂志》相同。欢迎作者踊跃投稿!

生物技术药物药代动力学研究进展

何晓波 朱佳慧 高方圆

何晓波, 朱佳慧, 高方圆. 生物技术药物药代动力学研究进展[J]. 药学实践与服务, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
引用本文: 何晓波, 朱佳慧, 高方圆. 生物技术药物药代动力学研究进展[J]. 药学实践与服务, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
Citation: HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003

生物技术药物药代动力学研究进展

doi: 10.3969/j.issn.1006-0111.2019.05.003
基金项目: 国家自然科学基金(81703676)

Progress on pharmacokinetics of biotechnology drugs

  • 摘要: 生物技术药物作为现代药物研发热点而备受关注,它具有和传统小分子药物截然不同的理化性质,因此其药动学呈现出独特性和复杂性。阐述生物技术药物的概念;总结4种主要的生物技术药物分析方法;进一步综述生物技术药物在体内吸收、分布、代谢和排泄的药动学特点;最后以生物技术药物主流之一的单克隆抗体药物为代表,通过相关数据对比单克隆抗体药物与传统小分子药物在药动学方面的差异。以期为充分了解生物技术药物的药动学特征以及形成机制、研发和筛选新型生物技术药物提供强有力的支持,同时为药物安全性评价和临床用药提供重要参考。
  • [1] 韩迎.生物技术药物的优势与前景展望[J].中国医院药学杂志,2013,33(13):1083-1085.
    [2] KESIK-BRODACKA M.Progress in biopharmaceutical development[J].Biotechnol Appl Biochem,2018,65(3):306-322.
    [3] 刘昌孝.我国药物代谢动力学研究的发展及其对创新药物研发的重要作用[J].中国药理学与毒理学杂志,2015,29(5):686-687.
    [4] 张振清.我国药物代谢与药代动力学学科发展与展望[J].中国药理学与毒理学杂志,2015,29(5):752-754.
    [5] PARR M K,MONTACIR O,MONTACIR H.Physicochemical characterization of biopharmaceuticals[J].J Pharm Biomed Anal,2016,130:366-389.
    [6] 斯琴朝克图,黄玲利,袁宗辉.放射性同位素标记药物在药物代谢与处置研究中的应用[J].中国新药杂志,2016,25(13):1475-1484.
    [7] 林立红,余洋,李晓磊,等.放射性同位素示踪法研究2-氟-6-三氟甲基吡啶在大鼠体内的吸收、分布和排泄[J].中国药理学与毒理学杂志,2017,31(6):670-674.
    [8] 赵小亮,刘曦,杨忆,等.利用活体成像技术研究海茸β-1,3/1,6-葡聚糖在小鼠体内的分布[J].高等学校化学学报,2017,38(8):1368-1374.
    [9] MU LL,LI SW,ZHOU R,et al. The application of immunoassay in bioanalysis[J].中国药学(英文版),2015,24(4):205-216.
    [10] LIU C C,FANG G Z,DENG Q L,et al. Determination of metolcarb in food by capillary electrophoresis immunoassay with a laser-induced fluorescence detector[J].Electrophoresis,2012,33(9-10):1471-1476.
    [11] WANG J,ZHU X H,KOLLI S,et al. Plasma pharmacokinetics and bioavailability of verticillin A following different routes of administration in mice using liquid chromatography tandem mass spectrometry[J].J Pharm Biomed Anal,2017,139:187-192.
    [12] FRANZONI S,VEZZELLI A,TURTORO A,et al. Development and validation of a bioanalytical method for quantification of LNA-i-miR-221,a 13-mer oligonucleotide,in rat plasma using LC-MS/MS[J].J Pharm Biomed Anal,2018,150:300-307.
    [13] LIAN D S,ZHAO S J.Highly sensitive analysis of nucleic acids using capillary gel electrophoresis with ultraviolet detection based on the combination of matrix field-amplified and head-column field-amplified stacking injection[J].J Chromatogr B,2015,978-979:29-42.
    [14] YU R Z,GRUNDY J S,GEARY R S.Clinical pharmacokinetics of second generation antisense oligonucleotides[J].Expert Opin Drug Metab Toxicol,2013,9(2):169-182.
    [15] BURKI U,KEANE J,BLAIN A,et al. Development and application of an ultrasensitive hybridization-based ELISA method for the determination of peptide-conjugated phosphorodiamidate morpholino oligonucleotides[J].Nucleic Acid Ther,2015,25(5):275-284.
    [16] THWALA L N,PRÉAT V,CSABA N S.Emerging delivery platforms for mucosal administration of biopharmaceuticals:A critical update on nasal,pulmonary and oral routes[J].Expert Opin Drug Deliv,2017,14(1):23-36.
    [17] WALLIS L,KLEYNHANS E,TOIT T,et al. Novel non-invasive protein and peptide drug delivery approaches[J].PPL,2014,21(11):1087-1101.
    [18] UENO H,MIZUTA M,SHⅡYA T,et al. Exploratory trial of intranasal administration of glucagon-like peptide-1 in japanese patients with type 2 diabetes:figure 1[J].Dia Care,2014,37(7):2024-2027.
    [19] RICHTER W F,JACOBSEN B.Subcutaneous absorption of biotherapeutics:knowns and unknowns[J].Drug Metab Dispos,2014,42(11):1881-1889.
    [20] VUGMEYSTER Y.Pharmacokinetics and toxicology of therapeutic proteins:advances and challenges[J].World J Biol Chem,2012,3(4):73.
    [21] ZHAO L,REN T H,WANG D D.Clinical pharmacology considerations in biologics development[J].Acta Pharmacol Sin,2012,33(11):1339-1347.
    [22] LENE H S,PETERSEN L C,LAURITZEN B,et al. Target-mediated clearance and bio-distribution of a monoclonal antibody against the Kunitz-type protease inhibitor 2 domain of Tissue Factor Pathway Inhibitor[J].Thromb Res,2014,133(3):464-471.
    [23] XIAO G Q,GAN L S.Receptor-mediated endocytosis and brain delivery of therapeutic biologics[J].Int J Cell Biol,2013,2013:1-14.
    [24] DENG R,JIN F,PRABHU S,et al. Monoclonal antibodies:what are the pharmacokinetic and pharmacodynamic considerations for drug development[J].Expert Opin Drug Metab Toxicol,2012,8(2):141-160.
    [25] SHI S J.Biologics:an update and challenge of their pharmacokinetics[J].Curr Drug Metab,2014,15(3):271-290.
    [26] BAUMANN A.Early development of therapeutic biologicspharmacokinetics[J].Curr Drug Metab,2006,7(1):15-21.
    [27] PYZIK M,RATH T,LENCER W I,et al. FcRn:the architect behind the immune and nonimmune functions of IgG and albumin[J].J Immunol,2015,194(10):4595-4603.
    [28] WILCOX C R,HOLDER B,JONES C E.Factors affecting the FcRn-mediated transplacental transfer of antibodies and implications for vaccination in pregnancy[J].Front Immunol,2017,8:1294.
    [29] ROBBIE G J,CRISTE R,DALL'ACQUA W F,et al. A novel investigational fc-modified humanized monoclonal antibody,motavizumab-YTE,has an extended half-life in healthy adults[J].Antimicrob Agents Chemother,2013,57(12):6147-6153.
    [30] EZAN E,BECHER F,FENAILLE F.Assessment of the metabolism of therapeutic proteins and antibodies[J].Expert Opin Drug Metab Toxicol,2014,10(8):1079-1091.
    [31] KAPLON H,REICHERT J M.Antibodies to watch in 2018[J].mAbs,2018,10(2):183-203.
    [32] KAPLON H,REICHERT J M.Antibodies to watch in 2019[J].mAbs,2019,11(2):219-238.
    [33] DOSTALEK M,GARDNER I,GURBAXANI B M,et al. Pharmacokinetics,pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies[J].Clin Pharmacokinet,2013,52(2):83-124.
    [34] KAMATH A V.Translational pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].Drug Discov Today Technol,2016,21-22:75-83.
    [35] LIN J.Pharmacokinetics of biotech drugs:peptides,proteins and monoclonal antibodies[J].Curr Drug Metab,2009,10(7):661-691.
    [36] MOULD D R,GREEN B.Pharmacokinetics and pharmacodynamics of monoclonal antibodies[J].BioDrugs,2010,24(1):23-39.
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  • 收稿日期:  2018-12-11
  • 修回日期:  2019-03-22

生物技术药物药代动力学研究进展

doi: 10.3969/j.issn.1006-0111.2019.05.003
    基金项目:  国家自然科学基金(81703676)

摘要: 生物技术药物作为现代药物研发热点而备受关注,它具有和传统小分子药物截然不同的理化性质,因此其药动学呈现出独特性和复杂性。阐述生物技术药物的概念;总结4种主要的生物技术药物分析方法;进一步综述生物技术药物在体内吸收、分布、代谢和排泄的药动学特点;最后以生物技术药物主流之一的单克隆抗体药物为代表,通过相关数据对比单克隆抗体药物与传统小分子药物在药动学方面的差异。以期为充分了解生物技术药物的药动学特征以及形成机制、研发和筛选新型生物技术药物提供强有力的支持,同时为药物安全性评价和临床用药提供重要参考。

English Abstract

何晓波, 朱佳慧, 高方圆. 生物技术药物药代动力学研究进展[J]. 药学实践与服务, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
引用本文: 何晓波, 朱佳慧, 高方圆. 生物技术药物药代动力学研究进展[J]. 药学实践与服务, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
Citation: HE Xiaobo, ZHU Jiahui, GAO Fangyuan. Progress on pharmacokinetics of biotechnology drugs[J]. Journal of Pharmaceutical Practice and Service, 2019, 37(5): 394-399. doi: 10.3969/j.issn.1006-0111.2019.05.003
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