摘要
目的：测定吲哚美辛控释制剂的相对生物利用度。方法：采用反相高效液相色谱法。流动相为甲醇－ ０．０３５ｍｏｌ·Ｌ－１ 磷酸（７７∶２３） 。结果：两种胶囊剂血药浓度数据经３Ｐ８７ 药动学程序拟合为一室模型， ＡＵＣ分别为２９．７９ｍｇ·ｈ·Ｌ－１ 和２７．０８ｍｇ·ｈ·Ｌ－ １；Ｔｍａｘ 分别为３．７８ｈ 和３ ．５６ｈ；Ｃｍａｘ 分别为２．８２ｍｇ·Ｌ－ １和３．２１ｍｇ·Ｌ－１ 。结论：经双单侧ｔ 检验结果表明，两种胶囊剂为生物等效制剂，艾狄多辛胶囊的相对生物利用度为１１０ ．７６ ±５．５１％ 。
AIM To investigate the relative bioavailability of the control release preparation of indomethacin,AIDIDUOXIN capsule and ETIDOCINE capsule.METHODS The plasma level of indomethacin was detected by RP-HPLC method.The chromatography consisted of Alltima RP-C 18 (5μ) column (4.6mm I.D.),methanol-0.035mol·L -1 phosphoric acid (77∶23) as the mobile phase at the flow rate of 1.0ml·min -1 .RESULTS One-compartment model with first-order absorption was fitted to the concentration-time profiles of the two capsules of indomethacin through 3P87 program.Pharmacokinetic parameters of AIDODUOXIN and ETIDOCINE CAPSULE were AUC 29.79mg.h·L -1 and 27.08mg·h·L -1 ;T max 3.78h and 3.56h;C max 2.82mg·L -1 and 3.21mg·L -1 .CONCLUSIONS The two capsules were bioequivalence determined by the two one-side tests.The relative bioavailability of AIDIDUOXIN capsule was 110.76±5.51%
出处
《解放军药学学报》
CAS
1999年第4期16-19,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
