摘要
目的;研究阿司匹林(Asp)锌肠溶片在正常人体内的药物动力学与生物利用度.方法:采用HPLC法测定8名健康志愿者po Asp锌肠溶片和Asp肠溶片后血清中水杨酸浓度;以MCPKP药物动力学软件处理测定结果,计算药物动力学参数;用双单侧t检验对主要药物动力学参数进行统计分析,评价两者的生物等效性.结果:两者的药-时曲线符合单室开放模型,Asp锌肠溶片和Asp肠溶片的AUC_o-oo分别是34.21和31.69[(μg·h)/ml];c_(max)分别是4.41和4.18μg/ml;t(max)分别是 3.89和3.94h,双人侧t检验前二项参数有显著性差异,后一项无显著性差异.结论:两者为生物不等效制剂,以Asp肠溶片为参比,Asp锌肠溶片的相对生物利用度为137.77%.
AIM: To study the pharmacokinetics and relative bioavailability of aspirin zinc enteric-coated tablet. METHODS: The concentration of salicylic acid in serum was assayed by high performance liquid chromatography method following a single oral dose of aspirin zinc enteric-coated tablet and aspirin enteric-coated tablet respectively given to 8 volunteers in an open randomized cross-over test. RESULTS: The data were fitted by MCPKP program. The pharmacokinetics of aspirin zinc enteric-coated tablet and aspirin enteric-coated tablet be described by an open single compartment model. The AUC_(0→∞), c_(max) and t_(max) of 2 products were 34.21 and 31.69 (μg · h)/ml, 4.41 and 4.18μg/ml, 3.89 and 3.94 h, respectively. CONCLUSION : There are significant differences between aspirin zinc enteric-coated tablet and aspirin enteric-coated tablet in the AUC_(0→∞) c_(max) . The bioavailability of aspirin zinc enteric-coated tablet is 137.77%.
出处
《中国临床药学杂志》
CAS
1999年第5期290-294,共5页
Chinese Journal of Clinical Pharmacy
关键词
阿司匹林
锌肠溶片
药物动力学
相对生物利用度
aspirin zinc enteric-coated tablet
aspirin enteric-coated tablet
pharmacokinetics
relative bioavailability
