稳态下吲哚美辛缓释胶囊与普通胶囊的血清浓度波动及生物利用度比较
Serum concentration fluctuation and bioavailability comparison between indomethacin sustained-release and conventional capsules during steady state.
作者信息
Wang J P, Liu L, Liu X, Yang X Y, Li D, Ge G Q, Huang Q W
机构信息
Department of Pharmacology, School of Pharmacy, Shanghai Medical University, China.
出版信息
Zhongguo Yao Li Xue Bao. 1992 Jul;13(4):298-301.
The comparison between indomethacin conventional capsule (CC) po 25 mg q 8 h or 25 mg tid and indomethacin sustained-release capsule (SRC) po 25 mg bid in human by crossover design showed that both maximal serum concentration (Cmax) and fluctuation index (FI%) of SRC were significantly lower than those of CC during steady state (P < 0.01). No practical differences were observed between the 2 preparations in the trough serum concentration (Cmin) and area under serum concentration-time profiles (AUC0-tau) (P > 0.05). The time period reaching maximal serum concentration (Tmax) of SRC was much more delayed than that of CC (P < 0.01). It suggested that SRC possesses a better controlled release property and could avoid a higher serum peak concentration of CC.
采用交叉设计对人体口服25毫克吲哚美辛常规胶囊（CC）、每8小时一次或每日三次，与口服25毫克吲哚美辛缓释胶囊（SRC）、每日两次进行比较，结果显示，在稳态时，SRC的最大血清浓度（Cmax）和波动指数（FI%）均显著低于CC（P<0.01）。两种制剂在谷浓度（Cmin）和血清浓度-时间曲线下面积（AUC0-tau）方面未观察到实际差异（P>0.05）。SRC达到最大血清浓度的时间（Tmax）比CC延迟得多（P<0.01）。这表明SRC具有更好的控释性能，可避免CC的血清峰值浓度过高。
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