摘要
目的：研究国产吗氯贝胺片剂与进口同种产品的生物利用度及其药动学特征。方法：健康志愿者12人，随机、交叉、单剂量po300mg吗氯贝胺片剂，采用反相高效液相色谱法，测定不同时间血药浓度，用3P87程序处理数据。结果：国产药品的cmax，tsub>1/2和AUC分别为(1.499±0.453)μg·ml-1，(3.359±1.315)h，(9.460±2.492)h·μg·ml-1。结论：国产品与进口品比较，高峰血药浓度，达峰时间虽有显著性差异(P<0.05)，但曲线下面积经统计学分析无显著性差异(P<0.05)，其相对生物利用度为92.07%。po该药24h尿排出原型药物为给药量的1.19%。
Abstract
OBJECTIVE: Pharmacokinetics and bioavailability of domestic and imported moclobemide tablets were compared in 12 healthy volunteers after single dose oral administration. METHOD: The blood levels of moclobemide were determined by RP-HPLC. The 3P87 program was used for the calculation of pharmacokinetic parameters. RESULTS: The cmax,tsub>1/2 , and AUC of the domestic product was (1.499±0.453)μg·ml-1, (3.359±1.315)h, and (9.460± 2.492)h·μ·ml-1, respectively. CONCLUSIONS: The statistical analyss for the AUC showed that there was no significant difference (P>0.05) between the two products. The relative bioavailability of domestic moclobemide tablet was 92.07% . The urine cumulative excretion of the domestic product was 1.19%.
关键词
吗氯贝胺 /
生物利用度 /
反相高效液相色谱法 /
药动学
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Key words
moclobemide /
bioavailability /
RP HPLC /
pharmacokinetcs
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孙培红;李荣;崔一民;孙忠民.
国产吗氯贝胺在健康志愿者体内生物利用度研究[J]. 中国药学杂志, 1998, 33(06): 354-356
Sun Peihong.
Study on the relative bioavailability of moclobemide tablets in healthy volunteers [J]. Chinese Pharmaceutical Journal, 1998, 33(06): 354-356
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参考文献
1 Raaflaub J，Haefelfinger P．Single-dose pharmacokineties of the MAO-inhibitor moclobemide in Man Drug Res，1980，34(I)：80．
2 朱荣华，赵靖平．周北雁，等．高效液相色谱法测定人血清中吗氯贝胺浓度．中国临床药理学杂志，1996，12(2)：104．
3 安国升，林令华．吗氯贝胺在大鼠体内的药物动力学研究．中国医院药学杂志，1996，16(7)：305．
4 Geschke R．Korner J．Determination of the new monoamine oxidase inhibitor moclobemide and three of its metabolites in biological fluids by highperformance liquid chromatography，J Chromatography，1987，420：111．
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脚注
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