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禁食条件下微丸的胃排空:一种数学模型。

Gastric emptying of pellets under fasting conditions: a mathematical model.

作者信息

Locatelli Igor, Mrhar Ales, Bogataj Marija

机构信息

Faculty of Pharmacy, University of Ljubljana, Askerceva cesta 7, 1000 Ljubljana, Slovenia.

出版信息

Pharm Res. 2009 Jul;26(7):1607-17. doi: 10.1007/s11095-009-9869-3. Epub 2009 Apr 1.

Abstract

PURPOSE

To develop a mathematical model that would adequately describe human gastric emptying of pellets under fasting conditions of healthy subjects.

METHODS

Scintigraphic profiles representing the gastric emptying of pellets were obtained from the literature. Altogether 19 individual and three mean scintigraphic profiles were collected. Three mathematical models namely; the lag-time exponential (two parameters), the Weibull (two parameters), and the double Weibull (five parameters) model were proposed and fitted to the gastric emptying profiles.

RESULTS

Different patterns of gastric emptying (immediate and rapid, delayed but rapid, delayed and slow, and interruptive emptying) were observed, with the emptying time varied from approximately 15 min to more than 3 h. The best model for fitting to the individual profiles was the double Weibull model. This model also provided an insight into the mechanism of interruptive emptying of pellets, observed for some patients. In addition, mean gastric emptying of pellets was calculated using the Weibull model.

CONCLUSIONS

Mean gastric emptying of pellets was adequately described by the Weibull model (eta = 61.9 min, beta = 0.895), which could be applied in the design of in vitro dissolution experiments for pellet formulations with pH dependent dissolution.

摘要

目的

建立一个能充分描述健康受试者禁食条件下人体胃内微丸排空情况的数学模型。

方法

从文献中获取代表微丸胃排空情况的闪烁扫描曲线。共收集了19条个体闪烁扫描曲线和3条平均闪烁扫描曲线。提出了三种数学模型,即滞后时间指数模型(两个参数)、威布尔模型(两个参数)和双威布尔模型(五个参数),并将其拟合到胃排空曲线上。

结果

观察到不同的胃排空模式(即刻快速、延迟但快速、延迟且缓慢以及间歇性排空),排空时间从约15分钟到超过3小时不等。拟合个体曲线的最佳模型是双威布尔模型。该模型还揭示了一些患者观察到的微丸间歇性排空机制。此外,使用威布尔模型计算了微丸的平均胃排空率。

结论

威布尔模型(η = 61.9分钟,β = 0.895)能充分描述微丸的平均胃排空情况,可应用于具有pH依赖性溶解的微丸制剂体外溶出实验的设计。

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