布洛芬泡腾片药代动力学及相对生物利用度的研究  

PHARMACOKINETICS AND RELATIVE BIOAVAILITY OF IBUPROFEN EFFERVESCENT TABLES

作　　者：丁晨光[1] 贺蕊[1] 陈雨安[1] 钟红玲 

机构地区：[1]解放军大连医学高等专科学校

出　　处：《中国临床药理学杂志》1997年第2期102-105,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：８名健康受试者，随机自身交叉口服单剂量布洛芬泡腾片和颗粒剂后，采用ＨＰＬＣ法对其药代动力学及相对生物利用度进行了研究。结果表明，内含赖氨酸的布洛芬泡腾片，比颗粒剂具有较快的吸收速率和较高的血浆峰浓度，但二者的药时曲线下面积基本相等。泡腾片与颗粒剂的达峰时间Ｔｍａｘ分别为０．６８±０．２６和１．５９±０．３４ｈ；峰浓度Ｃｍａｘ分别为５２．１８±９．１３和３０．５２±４．５２ｍｇ／Ｌ；ＡＵＣ分别为１３７．６±２５．８和１３６．７６±１９．４５ｍｇ·ｈ·Ｌ－１；消除半衰期Ｔ１／２β分别为２．６６±０．４８和２．４２±０．６７ｈ；经ｔ检验，两种剂型的达峰时Ｔｍａｘ和峰浓度Ｃｍａｘ差异非常显著，二者的ＡＵＣ值经等价性检验，确认二者生物等效，泡腾片对颗粒剂的相对生物利用度为１００．４％。A single 600 mg oral dose of ibuprofen effervescent tablets and granules was given to 8 healthy volunteers in a randomized crossover design. Pharmacokinetics and relative bioavailability was determined by HPLC. The results indicated that there was a faster absorption and higher plasma concentration in effervescent tablets but the AUC of two formulations is similar. The Tmax of effervescent tablets and granules were 0.68±0.28 and 1.59±0.34 h, Cmax were 52.18±9.31 and 30.52±4.52 mg/L, T1/2β were 2.66±0.48 and 2.24±0.67h and AUC were 137.6±25.8 and 136.76±19.45 mg·h·L-1)respectively.There were significant difference in Tmax andCmax between effervescent tablets and granules by t test. The AUC of equivalency test showed that two formulations were bioequivalent. The relative bioavailability of effervescert tablets was 100.4%.

关 键 词：布洛芬 泡腾片 药代动力学 生物利用度 

分 类 号：R971.1[医药卫生—药品]