单剂量与多剂量口服单硝酸异山梨酯缓释胶囊的人体生物等效性研究
发布时间：2018-12-28 14:40
【摘要】：目的评价2种单硝酸异山梨酯缓释胶囊在中国健康男性体内的生物等效性。方法单剂量给药24名、多剂量给药26名健康男性受试者随机分为2组,根据交叉试验设计方案,单剂量给予50 mg和多剂量给予50 mg(1天1次,连续6 d)两种单硝酸异山梨酯缓释胶囊,用液相色谱串联质谱法测定其血药浓度,并计算药代动力学参数。结果单剂量给药受试药物和参比药物的主要药代动力学参数:Cmax为(554.18±117.84)和(526.29±91.58)μg·L-1;AUC0-t为(7834.21±1227.70)和(7658.86±927.74)h·μg·L-1,以Cmax和AUC0-t计算,受试药物90%的置信限分别为参比药物的99.82%~113.03%和99.13%~106.43%。多剂量给药受试药物和参比药物的主要药代动力学参数:Cmax为(612.96±171.32)和(527.12±114.36)μg·L-1;AUC0-t为(8408.71±1321.91)和(7781.88±1325.12)h·μg·L-1,以Cmax和AUC0-t计算,受试药物90%的置信限分别为参比药物的108.44%~122.17%和105.35%~111.57%。单剂量给药、多剂量给药受试药物Cmax90%的置信限均在参比药物的70%~143%;AUC0-t的90%置信限均在参比药物的80%~125%。结论受试药物和参比药物具有生物等效性。
[Abstract]:Objective to evaluate the bioequivalence of two isosorbide mononitrate sustained release capsules in healthy Chinese men. Methods Twenty-four healthy male subjects were randomly divided into two groups. According to the design of cross experiment, the single dose of 50 mg and the multiple dose of 50 mg (once a day) were given. For 6 days, two kinds of isosorbide mononitrate sustained release capsules were determined by liquid chromatography-tandem mass spectrometry (LC-MS) and pharmacokinetic parameters were calculated. Results the main pharmacokinetic parameters were (554.18 卤117.84) 渭 g / L ~ (-1) and (526.29 卤91.58) 渭 g / L, respectively. AUC0-t was (7834.21 卤1227.70) h and (7658.86 卤927.74) h 渭 g L ~ (-1). Calculated by Cmax and AUC0-t, the confidence limit of 90% was 99.82% and 99.136.43% of the reference drug, respectively. The main pharmacokinetic parameters of multidose drug and reference drug were (612.96 卤171.32) 渭 g / L ~ (-1) and (527.12 卤114.36) 渭 g / L ~ (-1); AUC0-t was (8408.71 卤1321.91) h and (7781.88 卤1325.12) h 渭 g L ~ (-1). Calculated by Cmax and AUC0-t, the confidence limit of 90% was 108.44% and 105.35% respectively. The confidence limit of Cmax90% was 90% of the reference drug 70 ~ 143AUC _ 0-t, and the confidence limit of the reference drug was 80 ~ 125. Conclusion the tested drugs and reference drugs are bioequivalent.
【作者单位】： 沈阳药科大学药学院;首都医科大学附属北京安贞医院临床药理中心;
【分类号】：R969
本文编号：2394083
[Abstract]:Objective to evaluate the bioequivalence of two isosorbide mononitrate sustained release capsules in healthy Chinese men. Methods Twenty-four healthy male subjects were randomly divided into two groups. According to the design of cross experiment, the single dose of 50 mg and the multiple dose of 50 mg (once a day) were given. For 6 days, two kinds of isosorbide mononitrate sustained release capsules were determined by liquid chromatography-tandem mass spectrometry (LC-MS) and pharmacokinetic parameters were calculated. Results the main pharmacokinetic parameters were (554.18 卤117.84) 渭 g / L ~ (-1) and (526.29 卤91.58) 渭 g / L, respectively. AUC0-t was (7834.21 卤1227.70) h and (7658.86 卤927.74) h 渭 g L ~ (-1). Calculated by Cmax and AUC0-t, the confidence limit of 90% was 99.82% and 99.136.43% of the reference drug, respectively. The main pharmacokinetic parameters of multidose drug and reference drug were (612.96 卤171.32) 渭 g / L ~ (-1) and (527.12 卤114.36) 渭 g / L ~ (-1); AUC0-t was (8408.71 卤1321.91) h and (7781.88 卤1325.12) h 渭 g L ~ (-1). Calculated by Cmax and AUC0-t, the confidence limit of 90% was 108.44% and 105.35% respectively. The confidence limit of Cmax90% was 90% of the reference drug 70 ~ 143AUC _ 0-t, and the confidence limit of the reference drug was 80 ~ 125. Conclusion the tested drugs and reference drugs are bioequivalent.
【作者单位】： 沈阳药科大学药学院;首都医科大学附属北京安贞医院临床药理中心;
【分类号】：R969
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