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贝沙罗汀软胶囊在复发难治性皮肤T细胞淋巴瘤患者中的药代动力学研究
引用本文:董梅,高晶,韩晓红,邢鐠元,石远凯. 贝沙罗汀软胶囊在复发难治性皮肤T细胞淋巴瘤患者中的药代动力学研究[J]. 中国新药杂志, 2011, 0(20)
作者姓名:董梅  高晶  韩晓红  邢鐠元  石远凯
作者单位:中国医学科学院肿瘤医院;天津药物研究院新药评价中心;
基金项目:国家“重大新药创制”科技重大专项——抗肿瘤新药的临床评价研究技术平台建设(2008ZX09312-020)
摘    要:目的:评价贝沙罗汀在复发难治性皮肤T细胞淋巴瘤患者中的药物代谢动力学。方法:建立荧光液相色谱法,以乙腈、乙酸铵、乙酸等为流动相成分,在激发波长260 nm、发射波长430 nm的色谱条件下进行方法学考察及血药浓度测定。所得到的血药浓度以DAS 2.0药代动力学参数计算程序进行参数计算。皮肤T细胞淋巴瘤患者接受贝沙罗汀口服300 mg.m-2,qd,连用4周,进行单剂量和多剂量药代动力学分析。结果:建立的荧光液相色谱法在10~1 000 ng.mL-1之间线性关系良好(r=0.999 7),在空白血浆中20,100和800 ng.mL-1浓度的提取回收率分别为79.49%8,7.06%和78.56%。血药浓度测定结果显示,5例皮肤T-细胞淋巴瘤患者口服贝沙罗汀软胶囊300 mg.m-2,服药d 1和连续服药d 28的Cmax分别为366.31和652.44 ng.mL-1;Tmax分别为1.80和1.88 h;t1/2分别为2.56和3.18 h;AUC0~t分别为1 680.96和2 133.34ng.mL-1.h。结论:建立的荧光液相色谱法稳定,敏感性高。皮肤T-细胞淋巴瘤患者口服300 mg.m-2的贝沙...

关 键 词:贝沙罗汀  皮肤T细胞淋巴瘤  药代动力学  

Pharmacokinetics of bexarotene soft capsules in patients with relapsed or refractory cutaneous T-cell lymphoma
DONG Mei,GAO Jing,HAN Xiao-hong,XING Pu-yuan,SHI Yuan-kai. Pharmacokinetics of bexarotene soft capsules in patients with relapsed or refractory cutaneous T-cell lymphoma[J]. Chinese Journal of New Drugs, 2011, 0(20)
Authors:DONG Mei  GAO Jing  HAN Xiao-hong  XING Pu-yuan  SHI Yuan-kai
Affiliation:DONG Mei1,GAO Jing2,HAN Xiao-hong1,XING Pu-yuan1,SHI Yuan-kai1(1 Department of Medical Oncology,Cancer Institute and Hospital,Chinese Academy of Medical Science and Peking Union Medical College,Beijing 100021,China,2 Center for Drug Evaluation and Research,Tianjin Institute of Pharmaceutical Research,Tianjin 300193,China)
Abstract:Objective: To evaluate the pharmacokinetics(PKs) of bexarotene in patients with relapsed or refractory early-and advanced-stage cutaneous T-cell lymphoma(CTCL).Methods: We developed a liquid chromatographic method with fluorescence detector for determination of bexarotene in human plasma.The mobile phase was consisted of acetonitrile,acetic acid and ammonium acetate.The drug was analyzed with a fluorescence detector using an exciting wavelength at 260nm and an emission wavelength at 430nm.DAS 2.0 pharmacoki...
Keywords:bexarotene  cutaneous T-cell lymphoma  pharmacokinetics  
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