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10名健康志愿者随机自身交叉单次po国产被试格列齐特片80mg和国产标准参比格列齐特片80mg后,应用高效液相色谱法测定血浆格列齐特浓度.格列齐特在健康人体内的血药浓度-时间过程符合二室模型.被试格列齐特片的药物动力学参数分别为:T_(1/2ka)=1.01±0.67h,T_(1/2β)=4.81±1.91h,T_(max)=3.32±0.92h,C_(max)=4.20±1.77μg/ml,AUC=45.89±22.98(μg·h)/ml.参比格列齐特的药物动力学参数分别为:T_(1/2Ka)=0.84±0.42h,T_(1/2β)=6.30±3.22h,T_(max)=3.28±0.79h,C_(max)=3.68±1.89μg/ml,AUC=41.42±19.35(μg·h)/ml.两种格列齐特片剂的各项药物动力学参数经3P87程序及统计学分析处理,被试格列齐特片对标准参比格列齐特片的相对生物利用度为107%.
10 healthy volunteers were randomized to cross their own single po domestic test gliclazide tablets 80mg and domestic standard reference gliclazide tablets 80mg, the application of high performance liquid chromatography determination of plasma gliclazide concentration. The blood concentration-time course of healthy volunteers was in accordance with the two-compartment model.The pharmacokinetic parameters of Gliclazide tablets were as follows: T 1 / 2ka = 1.01 ± 0.67h, T 1 / 2β, = 4.81 ± 1.91 h, T max = 3.32 ± 0.92 h, C max = 4.20 ± 1.77 μg / ml and AUC = 45.89 ± 22.98 μg · h / ml.Pharmacokinetics of reference gliclazide The learning parameters were: T 1 kPa = 0.84 ± 0.42 h, T 1/2 b = 6.30 ± 3.22 h, T max = 3.28 ± 0.79 h, C max = 3.68 ± 1.89 μg / ml, , AUC = 41.42 ± 19.35 (μg · h) / ml.The pharmacokinetic parameters of the two gliclazide tablets by the 3P87 program and statistical analysis, the test gliclazide tablets on the standard reference grid The relative bioavailability of Riezetzan tablets was 107%.