Brockmeier D, Grigoleit H G, Leonhardt H
Eur J Clin Pharmacol. 1985;29(2):193-7. doi: 10.1007/BF00547421.
In a study of eight volunteers and six patients, glibenclamide was placed at different sites of the gastro-intestinal tract under visual control. The dose was instilled once into the stomach and once into the duodenum of the eight volunteers in a randomized crossover design. The six patients underwent diagnostic colonoscopy, and the dose was placed into the ascending colon if pathological findings were not present. The area under the concentration-time curve, completed by extrapolation, and the mean residence time of the drug in the body were calculated. These pharmacokinetic characteristics were examined using a Jonckheere test for ordered alternatives and a Wilcoxon signed rank pair test. The means of the areas under the curve were 477 +/- 131 ng . h ml-1 for the stomach, 475 +/- 142 ng . h ml-1 for the duodenum and 486 +/- 301 ng . h ml-1 for the colon. The mean residence time changed from 2.67 +/- 0.35 h for the stomach to 2.42 +/- 0.48 h for the duodenum and 3.55 +/- 0.68 h for the colon. These results indicate that although glibenclamide is absorbed from all three sites of the gastro-intestinal tract to the same extent, the rates of absorption are different. It is discussed whether these findings really confirm the pH-partition hypothesis in drug absorption. Since glibenclamide--a weak acid--has a pK-value of about 6.5, these data seem to confirm the pH-partition hypothesis of drug absorption.
在一项针对8名志愿者和6名患者的研究中,在可视控制下将格列本脲放置于胃肠道的不同部位。采用随机交叉设计,将剂量分别一次注入8名志愿者的胃和十二指肠。6名患者接受了诊断性结肠镜检查,若未发现病理结果,则将剂量注入升结肠。通过外推法完成浓度-时间曲线下面积以及药物在体内的平均驻留时间的计算。使用Jonckheere有序替代检验和Wilcoxon符号秩对检验来检查这些药代动力学特征。曲线下面积的平均值分别为:胃477±131 ng·h/ml -1,十二指肠475±142 ng·h/ml -1,结肠486±301 ng·h/ml -1。平均驻留时间从胃的2.67±0.35小时变为十二指肠的2.42±0.48小时以及结肠的3.55±0.68小时。这些结果表明,尽管格列本脲从胃肠道的所有三个部位吸收程度相同,但吸收速率不同。文中讨论了这些发现是否真的证实了药物吸收中的pH分配假说。由于格列本脲(一种弱酸)的pK值约为6.5,这些数据似乎证实了药物吸收的pH分配假说。