国产马普替林片剂的人体相对生物利用度研究  

RELATIVE BIOAVAILABILITY OF MAPROTILINE IN HEALTHY VOLUNTEERS

作　　者：张岱[1] 刘家良[1] 管振全[1] 孙丽丽[1] 

机构地区：[1]北京医科大学精神卫生研究所

出　　处：《中国临床药理学杂志》1998年第3期170-173,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：８名青年健康志愿者随机分为两组，间隔两周交叉口服５０ｍｇ国产和进口马普替林片剂，用高效液相色谱荧光检测法测定血浆马普替林浓度，进行相对生物利用度研究。该实验结果表明国产与进口马普替林片剂的体内过程均符合一室动力学模型，Ｔｐｅａｋ分别为９．６±１．４ｈ和１０．４±１．５ｈ，Ｃｍａｘ分别２９．７±１．９μｇ·Ｌ－１和３０．４±２．１μｇ·Ｌ－１，ＡＵＣ分别为２２３２．４±３９７．７μｇ·ｈ·Ｌ－１和２２０５．７±２９６．４μｇ·ｈ·Ｌ－１。统计分析结果表明国产和进口制剂的药代动力学参数均无显著性差异（Ｐ＞０．０５）。以进口制剂为标准，国产马普替林的相对生物利用度为１０１．２％。The bioavailability of domestic product of maprotiline produced by Beijing YI-Min Pharmaceutical Factory was studied in eight healthy adult volunteers. A single oral dose of 50mg maprotiline tablets made in China and Swiss were given according to a cross over design. Plasma concentrations of maprotiline were measured by HPLC. The concentration-time curves of the two products of maprotiline fitted to one compartment open model. There were no significant difference in each pharmacokinetic parameters between the two products (P>0.05). Tpeak of maprotiline (China) and Tpeak of maprotiline (Swiss) were 9.6±1.4 h and 10.4±1.5 h, Cmax were 29.7±1.9 (μg/L and 30.4±2.1 μg·L-1, AUC were 2232.4±397.7 μg·h·L-1 and 2205.7±296.4 μg·h·L-1, respectively. The relative bioavailability of domestic maprotiline was 101.2%.

关 键 词：马普替林 高效液相色谱法 生物利用度 国产药 

分 类 号：R971.43[医药卫生—药品] R969.1[医药卫生—药学]