Coupe A J, Davis S S, Wilding I R
Department of Pharmaceutical Sciences, University of Nottingham, U.K.
Pharm Res. 1991 Mar;8(3):360-4. doi: 10.1023/a:1015849700421.
The variability in the gastrointestinal transit of a multiple-unit and single-unit dosage form was investigated following a light breakfast in six, healthy, male volunteers after repeated weekly administration. The dosage forms were labeled with gamma-emitting radionuclides and the transit of the formulations was monitored on 4 separate study days using the technique of dual-isotope gamma scintigraphy. Gastric emptying times and small intestinal transit times were calculated and compared statistically within and between subjects using the standard deviation and coefficient of variance. The variability in gastric emptying of single- and multiple-unit systems was large; the intrasubject variation being less than the intersubject. There was less variation in small intestinal transit times for the single- and multiple-unit formulations than in gastric emptying, intrasubject variation again being less than intersubject variation.
在六名健康男性志愿者每周重复给药后，于清淡早餐后研究了多单元和单单元剂型在胃肠道转运中的变异性。剂型用发射γ射线的放射性核素标记，并在4个独立的研究日使用双同位素γ闪烁扫描技术监测制剂的转运。计算胃排空时间和小肠转运时间，并使用标准差和变异系数在受试者内和受试者间进行统计学比较。单单元和多单元系统的胃排空变异性很大；受试者内变异小于受试者间变异。单单元和多单元制剂的小肠转运时间变异小于胃排空变异，受试者内变异同样小于受试者间变异。
