摘要
本文报道８例健康志愿者交叉口服两个药厂生产的布洛芬的人体生物利用度及药代动力学研究，用反相高效液相色谱法测定人血清中布洛芬浓度。单剂量空腹口服布洛芬颗粒剂和糖衣片剂４００ｍｇ后，体内过程符合单室模型．达峰时间为１．８５±０．４０ｈ和２７．４４±７．３５ｈ；峰浓度为２５．６５±５．２７ｍｇＬ（－１）和２７．４４±７．３５ｍｇＬ（－１）；曲线下的面积为１３６．０８±２７．１３ｍｇＬ（－１）ｈ和１４２．７４±３２．１３ｍｇＬ（－１）ｈ；消除半衰期为１．９８±０．３５ｈ和１．９８±０．３０ｈ。以对照制剂为标准，样品制剂的相对生物利用度为９５．３３％，两药的主要药代动力学参数无显著性差异（ｐ＞０．０５）。
A study on bioavailability and pharmacokin etics of ibuprofen was performed in 8 young healthy volunteers.According to the cross-over design, each volunteer was given two different products of ibuprofen granule and sugar coated tablet producted by different pharmaceutical factories in single dose of 400mg altern atively.The serum concertrations were ditermined by RP-HPLC method.The pharmacokinetics of ibuprofen could be des cribed by single compartment model.The Tmax Cmax AUC0～∞ of two products were 1.85±0.40h and 27.44±7.35h;25.65±5.27mgL(-1)and 27.44±7.35mgL(-1);136.08±27.13mgL(-1)h and 142.74±32.13mgL(-1)h,respectively,The elimination half life was 1.98 ± 0.35h,1.98±0.30h respectively. The relative bioaveilability of sample preparation was 95.33% compared with standard preparation.The pharmacokinetics parameters showed no significant difference between two different products(p>0.05).
出处
《中国药房》
CAS
CSCD
1995年第6期29-30,共2页
China Pharmacy
关键词
布洛芬颗粒剂
人体生物利用度
药代动力学
ibuprofen granule bioavailability in human body pharmacokinetics RP-HPLC
