摘要
研制了布洛芬混悬液,分别建立了高效液相色谱法测定本品含量和血药浓度。以Advil混悬液为对照比较了本品的质量。以布洛芬片剂为对照,研究了本品在10名健康志愿受试者体内的药物动力学。结果表明:本品和Advil混悬液的相对密度分别为1.15和1.18;本品在人体内的动力学为—房室模型,本品的相对生物利用度为107.16％±8.32％。本品吸收快、达峰时间短、峰浓度高,与布洛芬片剂比较有显著性差异。LnAUC值经双单侧与等效性检验和(1一2d)置信区间等效性试验,结果表明两种制剂为生物等效制剂。
Ibuprofen suspension(100 mg/5 ml) was prepared according to the Children's Advil suspension. Two simple and sensitive high performance liquid chromatographic methods were established and could be seperately used for the analysis of suspension quality and biological samples of ibuprofen. The pharmacokinetics of ibuprofen was determined after a single oral dose of 300 mg was given to 1 0 volunteers in an open randomized crossover study. It was suggested that kinetics of ibuprofen in vivo conformed to a 1 compartment open model. The peak levels in plasma averaged 27. 32 + 3. 28, 19. 93 + 3. 39 ug/ml at 0. 98 + 0. 23 h and 2. 78 + 0. 62 h, t1/2 were 2. 15+0. 46 h and 2. 04 + 0. 32 h for suspension and tablet respectively, and the areas under the.drug concentration-time curve were 118. 78 + 28. 32 h ug/ml and 110. 96 + 24. 96 h ug/ml, the relative bioavailability of ibuprofen suspension was 107. 16%+8. 32/o, compared with the control of ibuprofen tablet. Consequently, the two formulations were bioequivalent.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1997年第3期136-141,共6页
Journal of China Pharmaceutical University
