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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。
The ibuprofen suspension was developed, and HPLC and HPLC were used to determine the content of the product and plasma concentration. Advil suspension as a control to compare the quality of the product. Ibuprofen tablets as a control, the product of 10 healthy volunteers in vivo pharmacokinetics. The results showed that the relative density of this product and Advil suspension were 1.15 and 1.18, respectively. The kinetics of this product in human body was - atrioventricular model. The relative bioavailability of this product was 107.16% ± 8.32%. This product absorption fast, peak time is short, peak concentration, and ibuprofen tablets were significantly different. The LnAUC values were validated by double unilateral and equivalence tests and (1-12d) confidence intervals, and the results showed that the two preparations were bioequivalent.