影響生體相等性因素的電腦模擬評估

Computer Simulation to Evaluate the Factors Affecting Bioequivalence

郭浩雲(Kao Hau-Yun)

指導教授 ： 許明照

臺北醫學大學/藥學院/藥學研究所/碩士(1998年)

摘要

在難溶性藥物的生體可用率試驗中，最有可能產生差異的是藥物溶解的過程。 在成份處方差異不大的情況下往往可能影響溶解速率的因素是出現在藥品粒度 大小與分布的不同，本研究就是想探討藥品粒度的變化對生體相等性的影響。 利用電腦程式模擬溶解吸收的過程以描繪出血中濃度曲線。使粒度變化對不同 藥物的影響可以經由電腦模擬而有效率的得到結果。生體相等性試驗的受試者 抽樣也經由程式模擬出可能的影響。研究結果顯示雖然有以下明顯趨勢：藥品 溶解度愈大、受試者差異越小、粒度差異越小則通過生體相等性試驗機會愈大 。但並非單純比例關係﹐而是在某些範圍內有顯著影響。這也顯示出在尋求生 體相等性試驗通過的機會提高的過程中﹐最好方式是先經由程式模擬確定在試 驗條件下各可調整的設定值基本方向﹐以減少試誤機會。

關鍵字

電腦模擬 ； 生體相等性

並列摘要

In the bioequivalence test of insoluble drug, differences have the biggest chance to come out in the process of drug dissolving. The small diversity of treatments affects dissolution rate by particle size and distribution. The influence that the change of particle size has on bioequivalence is the theme of this research. We design a computer program to simulate the procedure of dissolution and absorption so that we can plot the plasma concentration curve and by this way achieve the objective of this research. The sampling of volunteers is also completed by the computer program. The result reveals that it has more opportunity to pass the bioequivalence test when we have more solubility, less diversity of volunteers and less diversity of particle size. But they are only significant on some ranges instead of having liner relationship. We also conclude that the program simulating is the better method to find the direction of all adjustable parameters and to reduce trial and error when we try to raise the probability of passing bioequivalence tests.

並列關鍵字

Computer Simulation ； Bioequivalence