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10名健康志愿者,随机交叉口服单剂量(60 mg)格列喹酮胶囊或 片剂,采用HPLC法测定血浆中药物浓度。结果tmax分别为 2.60±0.20 h和2.70± 0.24 h;血药浓度峰值Cmax分别为1315.9±206.2 ng/ml和1211.8±177.3 ng/ml; 两种制剂的消除相半衰期t1/2分别为1.86±0.13 h和1.86±0.15 h; 血药曲线 下面积AUC分别为5443.1±583.5 ng·h/ml和5440.8±662.0 ng·h/ml。药-时曲线符合一 房室线性模型。以北京第六制药厂的格列喹酮片为标准, 算得格列喹酮胶囊的相对生物利用 度为100.7％±10.1％, 经方差分析和双单侧t检验证明, 两种制剂吸收程度一致。
Ten healthy volunteers were randomized to receive a single dose (60 mg) of gliquidone capsules or tablets at randomized crossover intervals. The plasma concentration of the drug was determined by HPLC. Results The tmax were 2.60 ± 0.20 h and 2.70 ± 0.24 h, respectively. The peak plasma concentration Cmax was 1315.9 ± 206.2 ng / ml and 1211.8 ± 177.3 ng / ml, respectively. The elimination half-lives t1 / 2 of the two preparations were 1.86 ± 0.13 h and 1.86 ± 0.15 h respectively. The area under the curve of plasma metabolites were 5443.1 ± 583.5 ng · h / ml and 5440.8 ± 662.0 ng · h / ml, respectively. Drug-time curve in line with a room linear model. The relative bioavailability of gliquidone was calculated as 100.7% ± 10.1% based on the standard of gliquidone tablets in Beijing No. 6 Pharmaceutical Factory. The variance analysis and double unilateral t test showed that the absorption of the two preparations was consistent .