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健康受试者中不崩解片剂的结肠转运特征

Characterization of colonic transit of nondisintegrating tablets in healthy subjects.

作者信息

Price J M, Davis S S, Wilding I R

机构信息

Department of Pharmaceutical Sciences, University of Nottingham, UK.

出版信息

Dig Dis Sci. 1993 Jun;38(6):1015-21. doi: 10.1007/BF01295715.

DOI:10.1007/BF01295715
PMID:8389686
Abstract

The transit of pharmaceutical dosage forms through the colon has been shown to be highly variable. The amount of fiber in the diet is known to alter gastrointestinal transit; however, the dietary intake of the subjects in previous studies was not adequately controlled. Using the technique of gamma scintigraphy, we have therefore characterized the variability in the colonic transit of nondisintegrating tablets, by strictly controlling the dietary fiber intake of the subjects. Eight healthy male subjects followed a diet containing 25 g dietary fiber per day, for six days prior to dosing. Each subject received five 6-mm nondisintegrating tablets on three consecutive days. Mouth-to-anus transit times exhibited a high degree of variability. Regional differences in colonic transit were evident. Tablet stasis appeared to occur mainly in the ascending colon and hepatic flexure. Despite the diets of the volunteers being identical, colonic transit was still observed to be highly variable, which suggests that this variability is intrinsic.

摘要

药物剂型在结肠中的转运已被证明具有高度变异性。已知饮食中的纤维量会改变胃肠道转运;然而,以往研究中受试者的饮食摄入量并未得到充分控制。因此,我们采用γ闪烁显像技术,通过严格控制受试者的膳食纤维摄入量,对不崩解片剂在结肠中的转运变异性进行了表征。八名健康男性受试者在给药前六天遵循每天摄入25克膳食纤维的饮食。每位受试者连续三天每天服用五片6毫米的不崩解片剂。口腔到肛门的转运时间表现出高度变异性。结肠转运的区域差异很明显。片剂停滞似乎主要发生在升结肠和肝曲。尽管志愿者的饮食相同,但仍观察到结肠转运具有高度变异性,这表明这种变异性是内在的。

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