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研制了格列吡嗪缓释胶囊 (SRC) ,释放曲线与国外同类缓释片 (ESRT)基本一致。 10名健康志愿受试者交叉口服SRC和美吡达 (普通片 ,CT)后 ,进行了药物动力学和相对生物利用度的研究。单剂量口服 5mg ,SRC和CT的AUC分别为 5 189.33± 6 2 1.10ng·h/ml和 5 198.5 2± 881.73ng·h/ml,MRT分别为 11.97±2 .30h和 7.46± 0 .82h ,Cmax分别为 5 0 7.34± 114.0 2ng/ml和 834.5± 92 .8ng/ml;Tmax分别为 4.4± 1.3h和2 .0± 0 .4h ,SRC的相对生物利用度为 (99.8± 10 ) %。多剂量口服SRC(每日 1次 ,每次 10mg)和CT(每日 2次 ,每次 5mg)研究 ,Cmin分别为 6 8.1± 38.9ng/ml和 5 8.4± 44 .8ng/ml,Cmax分别为 5 6 5 .9± 10 4.6ng/ml和5 5 8.5± 181.3ng/ml,波动系数FI分别为 1.5 7± 0 .2 5和 1.6 4± 0 .4。表明日服一次SRC与日服 2次CT生物等效。
Developed glipizide sustained-release capsules (SRC), release curve and similar foreign sustained-release tablets (ESRT) basically the same. Pharmacokinetics and relative bioavailability of 10 healthy volunteers after oral administration of SRC and pyridostigmine (plain film, CT) were studied. AUC of 5 189.33 ± 6 2 1.10 ng · h / ml and 5 198.5 2 ± 881.73 ng · h / ml for SRC and CT respectively with a single oral dose of 5 mg and MRT of 11.97 ± 2.30 h and 7.46 ± 0.82 h respectively, The relative bioavailability of SRC was (99.8 ± 10)% for Cmax of 50 ± 7.34 ± 114.0 ng / ml and 834.5 ± 92 .8 ng / ml, respectively; for Tmax of 4.4 ± 1.3 h and 2.0 ± 0.4 h, respectively. Cmax was 6 8.1 ± 38.9 ng / ml and 5 8.4 ± 44 .8 ng / ml, respectively, for multiple doses of oral SRC (10 mg once daily) and CT (2 mg daily) Were 56.59 ± 10 4.6ng / ml and 55.5 ± 181.3ng / ml, respectively, and the volatility coefficients FI were 1.57 ± 0.52 and 1.6 4 ± 0.4 respectively. That once served on the SRC with the Japanese serving 2 times CT bioequivalence.