單劑量與多劑量口服單硝酸異山梨酯緩釋膠囊的人體生物等效性研究
發(fā)布時間：2018-12-28 14:40
【摘要】：目的評價2種單硝酸異山梨酯緩釋膠囊在中國健康男性體內(nèi)的生物等效性。方法單劑量給藥24名、多劑量給藥26名健康男性受試者隨機分為2組,根據(jù)交叉試驗設(shè)計方案,單劑量給予50 mg和多劑量給予50 mg(1天1次,連續(xù)6 d)兩種單硝酸異山梨酯緩釋膠囊,用液相色譜串聯(lián)質(zhì)譜法測定其血藥濃度,并計算藥代動力學(xué)參數(shù)。結(jié)果單劑量給藥受試藥物和參比藥物的主要藥代動力學(xué)參數(shù):Cmax為(554.18±117.84)和(526.29±91.58)μg·L-1;AUC0-t為(7834.21±1227.70)和(7658.86±927.74)h·μg·L-1,以Cmax和AUC0-t計算,受試藥物90%的置信限分別為參比藥物的99.82%~113.03%和99.13%~106.43%。多劑量給藥受試藥物和參比藥物的主要藥代動力學(xué)參數(shù):Cmax為(612.96±171.32)和(527.12±114.36)μg·L-1;AUC0-t為(8408.71±1321.91)和(7781.88±1325.12)h·μg·L-1,以Cmax和AUC0-t計算,受試藥物90%的置信限分別為參比藥物的108.44%~122.17%和105.35%~111.57%。單劑量給藥、多劑量給藥受試藥物Cmax90%的置信限均在參比藥物的70%~143%;AUC0-t的90%置信限均在參比藥物的80%~125%。結(jié)論受試藥物和參比藥物具有生物等效性。
[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 鹵117.84) 渭 g / L ~ (-1) and (526.29 鹵91.58) 渭 g / L, respectively. AUC0-t was (7834.21 鹵1227.70) h and (7658.86 鹵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 鹵171.32) 渭 g / L ~ (-1) and (527.12 鹵114.36) 渭 g / L ~ (-1); AUC0-t was (8408.71 鹵1321.91) h and (7781.88 鹵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.
【作者單位】： 沈陽藥科大學(xué)藥學(xué)院;首都醫(yī)科大學(xué)附屬北京安貞醫(yī)院臨床藥理中心;
【分類號】：R969
本文編號：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 鹵117.84) 渭 g / L ~ (-1) and (526.29 鹵91.58) 渭 g / L, respectively. AUC0-t was (7834.21 鹵1227.70) h and (7658.86 鹵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 鹵171.32) 渭 g / L ~ (-1) and (527.12 鹵114.36) 渭 g / L ~ (-1); AUC0-t was (8408.71 鹵1321.91) h and (7781.88 鹵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.
【作者單位】： 沈陽藥科大學(xué)藥學(xué)院;首都醫(yī)科大學(xué)附屬北京安貞醫(yī)院臨床藥理中心;
【分類號】：R969
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