摘要
２０名健康志愿者分成两组，分别单次口服两种不同规格的国产兰索拉唑胶囊（１５ｍｇ和３０ｍｇ）和进口品，进行药代动力学和相对生物利用度研究，血药浓度用ＨＰＬＣ测定。结果表明：口服国产和进口两种制剂的药时曲线均符合一室模型。１０名健康志愿者单剂量口服１５ｍｇ×２国产兰索拉唑胶囊后，其血药峰浓度为１．３４±０．６６ｍｇ·Ｌ－１，消除半衰期为１．０２±０．２２ｈ，药时曲线下面积为３．５８±１．１８ｍｇ·ｈ·Ｌ－１；单剂量口服１５ｍｇ×２进口兰索拉唑胶囊后，其血药峰浓度为１．１９１±０．３７７２ｍｇ·Ｌ－１，消除半衰期为１．４１０±０．４２５７ｈ，药时曲线下面积为３．６２±１．０５ｍｇ·ｈ·Ｌ－１；单剂量口服３０ｍｇ×１国产品与进口品后测得参数与上述结果类似。对国产品与进口品的血药峰浓度、消除半衰期和药时曲线下面积等主要药代动力学参数进行比较，除１５ｍｇ×２组消除半衰期外，其余参数的差别均无统计学意义（Ｐ＞０．０５）。与进口兰索拉唑胶囊比较，国产兰索拉唑胶囊的相对生物利用度为９８．７０±２４．６０％（１５ｍｇ胶囊剂）和１１１．４０±３４．２０％（３０ｍｇ胶囊剂）。
The bioavailabilities of 15 mg and 30 mg domestic lansoprazole capsules were studied in 20 healthy volunteers. A single dose oral of 15 mg ×2(or 30 mg×1) lansoprazole capsule made in China or Japan was given according to a crossover design. The concentrations in plasma were determined by HPLC. Both concentration-time curves of domestic and imported products fitted to an one-compartment open model. The i.v main pharmacokinetics parameters of 15 mg domestic group and imported group were as following: Cmax 1.343±0.6663 and 1.191±0.3772 mg·L-1, T1/2ke 1.023 ±0.2240 and 1.410±0.4257 h, AUC 3.583±1.189 and 3.629±1.052 mg·h·L-1, respectively. The domestic and imported products in 30mg capsules have similar results. The main pharmacokinetics parameters obtained from our studies showed no significant difference between two products, except the T1/2 in 15 mg group. The relative bioavailabilities of 15 mg and 30 mg domestic to imported capsules were 98.7±24.6%(15 mg) and 111.4±34.2%(30 mg). The results showed that two forms of domestic and imported formulations were bioequivalent.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
1998年第2期104-108,共5页
The Chinese Journal of Clinical Pharmacology
