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两种电子舌在药物制剂开发中的比较研究。

A comparative study on two electronic tongues for pharmaceutical formulation development.

机构信息

Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Duesseldorf, Universitaetsstr. 1, 40225 Duesseldorf, Germany.

出版信息

J Pharm Biomed Anal. 2011 May 15;55(2):272-81. doi: 10.1016/j.jpba.2011.02.002. Epub 2011 Feb 24.

Abstract

Electronic tongues are sensor array systems which are able to determine single substances as well as complex mixtures of various substances. They are increasingly used for taste assessment of pharmaceutical formulations. Two systems are available on the market, the AlphaMOS electronic tongue Astree2 and the Insent taste sensing system TS-5000Z. Both systems measure based on potentiometry but sensor technologies are different. Therefore, these electronic tongue systems were compared to each other with respect to general aspects like software handling, sensors, and measurement procedure, but also on the basis of analytical experiments in order to figure out the applicability and limitations for use in the pharmaceutical field. By investigation of substances with different ionic character, like sodium saccharin, acetaminophen, ibuprofen, quinine, and caffeine, it was shown for both systems that ionic substances are easier to detect than neutral ones. Further, the performance qualification could only be done for the TS-5000Z, whereas the validation step, a correlation to human taste assessment, was passed by both systems. The results were even more reproducible than those from the panel. Taste masking by complexation of ibuprofen and quinine hydrochloride by maltodextrin, could be evaluated by both systems. Data from the Astree2 system have to be normalized in order to compare inter-day results, while the Insent taste sensing system refers each measurement to a standard solution and therefore reaches better inter-day results. Both systems offer the opportunity to be used for the development of taste-masked pharmaceutical formulations.

摘要

电子舌是一种传感器阵列系统,能够确定单一物质以及各种物质的复杂混合物。它们越来越多地用于药物制剂的味觉评估。市场上有两种系统,即 AlphaMOS 电子舌 Astree2 和 Insent 味觉感应系统 TS-5000Z。这两种系统都基于电位法进行测量,但传感器技术不同。因此,这两种电子舌系统在软件处理、传感器和测量程序等一般方面进行了比较,同时也根据分析实验进行了比较,以确定其在制药领域的适用性和局限性。通过对具有不同离子特性的物质(如糖精钠、对乙酰氨基酚、布洛芬、奎宁和咖啡因)的研究,结果表明,对于这两种系统,离子物质比中性物质更容易检测。此外,仅对 TS-5000Z 进行了性能资格认证,而通过了与人类味觉评估相关联的验证步骤的则是这两种系统。结果比专家组的结果更具可重复性。通过麦芽糊精对布洛芬和盐酸奎宁的络合作用进行的味觉掩蔽,也可以用这两种系统进行评估。为了比较日间结果,需要对 Astree2 系统的数据进行归一化处理,而 Insent 味觉感应系统则将每次测量与标准溶液进行比较,因此可以获得更好的日间结果。这两种系统都为开发具有味觉掩蔽功能的药物制剂提供了机会。

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