低脂、低热量餐后胃内 pH 值的个体内和个体间变异性。

Intra- and inter-subject variability in gastric pH following a low-fat, low-calorie meal.

机构信息

Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, Butler University, IN 46208, USA.

Gastroenterology and Hepatology Unit, Department of Medical Sciences, Uppsala University, Uppsala University Hospital, Uppsala SE-75185, Sweden.

出版信息

Int J Pharm. 2022 Sep 25;625:122069. doi: 10.1016/j.ijpharm.2022.122069. Epub 2022 Jul 30.

DOI:10.1016/j.ijpharm.2022.122069

PMID:35917873

Abstract

Food can alter drug bioavailability through gastric pH changes. Time spent at gastric pH ranges is reported here, including variability data following ingestion of a light, mixed, 260 kcal meal. pH data was obtained for 20 healthy subjects undergoing SmartPill™ wireless motility capsule investigations on three separate visits. Gastric phase pH was sorted into pH < 2, 2-3, 3-4, 4-5 and > 5. All visits and all subjects were pooled to determine median time (25-75th percentiles) in minutes. Gastric emptying time was 176 (137-205) min with the majority of time, 111 (67 - 163), spent at pH < 2. Times spent at pH 2-3 and 3-4 were similar: 17 (5.7 - 35.6) and 18 (7.2-29.3). Time spent at pH 4-5 was 9 (1.3-20.6) and at pH > 5 was 0.7 (0-4.4). Intra-subject variability as determined by robust coefficient of variation (RCV)% was 30 % for pH < 2, 57 % for pH 2-3, 71 % for pH 3-4, 106 % for pH 4-5 and 144 % for pH > 5. Inter-subject variability RCV% was 49 % for pH < 2, 89 % for pH 2-3, 54 % for pH 3-4, 97 % for pH 4-5 and 148 % for pH > 5. Inter-subject variability can be up to approximately twofold higher than intra-subject variability at the lower pH ranges.

摘要

食物可通过改变胃内 pH 值来影响药物的生物利用度。本研究报告了不同时间内胃内 pH 值的范围，包括摄入 260 卡路里轻食后出现的变异性数据。对 20 名健康受试者进行了 SmartPill™无线动力胶囊研究，在 3 次不同访问中获得了 pH 值数据。胃期 pH 值被分为 pH 值<2、2-3、3-4、4-5 和>5。将所有访问和所有受试者进行汇总，以确定分钟中位数（25-75 百分位数）。胃排空时间为 176（137-205）min，大部分时间（111（67-163））在 pH 值<2 时。pH 值为 2-3 和 3-4 的时间相似：17（5.7-35.6）和 18（7.2-29.3）。pH 值为 4-5 的时间为 9（1.3-20.6），pH 值>5 的时间为 0.7（0-4.4）。通过稳健变异系数（RCV）%确定的个体内变异性为 pH 值<2 时为 30%，pH 值为 2-3 时为 57%，pH 值为 3-4 时为 71%，pH 值为 4-5 时为 106%，pH 值>5 时为 144%。个体间变异性 RCV%为 pH 值<2 时为 49%，pH 值为 2-3 时为 89%，pH 值为 3-4 时为 54%，pH 值为 4-5 时为 97%，pH 值>5 时为 148%。个体间变异性在较低的 pH 值范围内可能是个体内变异性的两倍左右。