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阿那曲唑在中国男性志愿者体内的药代动力学
引用本文:袁静,王平全,戈升荣,安富荣,施安国,陈钧,梁建英. 阿那曲唑在中国男性志愿者体内的药代动力学[J]. Acta pharmacologica Sinica, 2001, 22(6): 573-576
作者姓名:袁静  王平全  戈升荣  安富荣  施安国  陈钧  梁建英
作者单位:上海第二医科大学附属仁济医院临床药学药理研究室,国家药品临床研究基地,上海第二医科大学附属仁济医院临床药学药理研究室,国家药品临床研究基地,上海第二医科大学附属仁济医院临床药学药理研究室,国家药品临床研究基地,上海第二医科大学附属仁济医院临床药学药理研究室,国家药品临床研究基地,上海第二医科大学附属仁济医院临床药学药理研究室,国家药品临床研究基地,上海医科大学药物分析教研室,上海医科大学药物分析教研室 上海,中国 200001,上海,中国 200001,上海,中国 200001,上海,中国 200001,上海,中国 200001,上海,中国 200032,上海,中国 200032
摘    要:目的:比较国产和进口阿那曲唑片在健康人体内的药代动力学。方法:二十名志愿者交叉随机分成两组,单剂量口服1mg,用GC-ECD测定血药浓度,通过方差分析和双单侧t检验比较两种制剂的药-时曲线下面积。结果:阿那曲唑的体内分布符合二室模型。国产和进口阿那曲唑的药动学参数C_(max)分别为(10±3)和(10.2±2.5)μg·L~(-1);T_(max)分别为(1.2±0.5)和(1.3±0.4)h;T_(1/2β)分别为(42±14)和(41±26)h;AUC_(0-∞)分别为(443±141)和(429±121)μg·h·L~(-1),两者无显著性差别(P>0.05)。结论:两种制剂为生物等效,国产阿那曲唑片的相对生物利用度为100%±9%。

关 键 词:阿那曲唑  药物动力学  气相色谱法  生物利用度

Pharmacokinetics of anastrozole in Chinese male volunteers
YUAN Jing,WANG Ping-Quan,GE Sheng-Rong,AN Fu-Rong,SHI An-Guo. Pharmacokinetics of anastrozole in Chinese male volunteers[J]. Acta pharmacologica Sinica, 2001, 22(6): 573-576
Authors:YUAN Jing  WANG Ping-Quan  GE Sheng-Rong  AN Fu-Rong  SHI An-Guo
Affiliation:Base for Drug Clinical Trial of SDA, Department of Clinical Pharmacology and Pharmacy, Renji Hospital, Shanghai Second Medical University, Shanghai 200001, China yuan_jing88@hotmail.com
Abstract:AIM: To compare pharmacokinetics of domestic and imported tablets of anastrozole. METHODS: Twenty male Chinese volunteers were enrolled in a randomized crossover study with a single oral dose of 1 mg of the two formulations respectively. The anastrozole in plasma was measured by gas chromatography with electron-captured detector. Area under the drug concentration-time curve was evaluated by variance analysis and two one-side t-test. RESULTS: A two-compartment model was adopted in anastrozole plasma concentration-time data analysis. The paramaters such as Cmax, Tmax, T1/2beta, and AUC(0-infinity) were (10 +/- 3) and (10.2 +/- 2.5) microg/L, (1.2 +/- 0.5) and (1.3 +/- 0.4) h, (42 +/- 14) and (41 +/- 26) h, (443 +/- 141) and (429 +/- 121) microg . h . L-1, respectively, and there were no significant differences between the two formulations. CONCLUSION: Domestic and imported anastrozole were of bioequivalence. The relative bioavailability of the domestic tablet was 100 % +/- 9 %.
Keywords:anastrozole  pharmacokinetics  gas chromatography  biological availability
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