不更换介质计算溶出曲线的计算机电子表格的开发和验证

Imad Osman Abu Reid
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引用次数: 0

摘要

用于生成溶出度剖面数据的计算是复杂的,而且人工执行时容易出错,此外,由于溶出度测试实验的重复性,有必要创建一个经过验证的电子表格来取代和克服与人工计算相关的问题。我们编写了一个简单的、用户友好的电子表格来计算溶解实验的溶解曲线,其中容器溶解介质的体积随时间而变化,因为在每个时间点移除的溶解介质都没有被新的溶解介质所取代。使用手持计算器验证了电子表格的计算与人工计算的对比;两种方法的结果具有可比性。开发的电子表格可以很容易地适应在受监管的环境中使用后,激活微软Excel软件中嵌入的安全功能,如公式隐藏,单元格块和密码保护。
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Development and Validation of Computer Spreadsheet Used to Calculate Dissolution Profiles without Media Replacement
Calculations carried out to generate dissolution profile data are complicated and subject to error to be performed manually, moreover and due to the repetitive nature of the dissolution testing experiments it is necessary to create a validated spreadsheet to replace and overcome the problems associated with manual calculations. A simple, user friendly spreadsheet was written to calculate dissolution profiles for a dissolution experiment where the volume of the dissolution medium for the vessel varies with time as the removed dissolution medium is not replaced with fresh one at each time point. The calculations of the spreadsheet were validated against manual calculations using a hand-held calculator; the results of the two methods were found to be comparable. The developed spreadsheet can be easily adapted for use in regulated environment after activating the security features embedded in Microsoft Excel software such as formula hiding, cell block and password protection.
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