摘要
本文比较了吲哚拉新控释片和普通胶囊在人体内生物利用度，吲哚拉新血浆浓度用高效液相色谱法（HPLC）测定。结果表明，在6名受试者中．两种制剂的吸收程及基本一致；但控释片的峰药浓度（Cmax）显著低于普通胶囊（P＜0.01），其达峰时间（Tmax）也明显延迟（P＜0.01）。给予单剂量（250mg）控释片后．在给药后4h至24h其血浆浓度显著高于普通胶囊（P＜0．05）。说明该控释片可避免普通制剂初期的高峰血药浓度，从而降低副作用并延长了给药间隔时间。
The comparison of a crossover bioavailability in 6 adult health volunteers between the controlled release indolacin tablet and a commercially available capsule were examined. The indolacin in plasma samples were assayed by HPLC. The in vivo bioavailability of two preparations, although their absorped degree(AUC。~24 h)were almost the same,Cmax and Tmax of controlled release tablet were significantly lower and latter .than that of the commercially available capsule (P<0.01). The controlled release tablet demonstrated a higher and smooth concentration-time curves than that of the commercially available capsule from 4 ~ 24 h following a single dose (250 mg )of indolacin, and their plasma level significantly higher than that of the latter (P<0.05). The results suggest that the controlled release indolacin tablet can avoid high initialpeak of the commercially available capsule and increase the interval between dosage.
出处
《海峡药学》
1999年第2期54-55,共2页
Strait Pharmaceutical Journal
