Kenyon A S, Flinn P E, Layloff T P
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Analysis, St. Louis, MO 63101-2045.
J AOAC Int. 1995 Jan-Feb;78(1):41-9.
A method for rapidly screening pharmaceuticals by thin-layer chromatography has been designed for use in areas with limited resources and by operators with limited training. An apparatus for performing the analysis in a plastic bag under equilibrium conditions was designed. Results can be reproduced by different operators and in different locations. The analysis can be performed without electricity or in a remote area, away from a laboratory. It is especially suited for field use in developing countries. The method is low cost, maintenance-free, fast, and reliable; it also uses limited volumes of solvents. The analyses can be performed without weighing if reference materials can be supplied in tablet form, provided the drug content is listed and only one unit is required for each analysis. All procedures were developed for the analysis of drugs from a partial list of essential drugs established by the World Health Organization. Three drugs were selected and prepared in the form of reference tablets. Comparisons with the analyses of the drugs in standard dosage forms were made by using reference tablets and primary USP standards. Comparable results were obtained, proving that the screening process can be conducted by using reference tablets and without weighing either the sample or the reference. The method has been successfully demonstrated and used in Swaziland, by high school teachers in the United States, and by personnel from the Ministry of Health in Saudi Arabia. Personnel can be trained in a short time to perform screening analysis of drugs.
一种通过薄层色谱法快速筛选药品的方法已被设计出来，供资源有限地区的人员和培训有限的操作人员使用。设计了一种用于在塑料袋中于平衡条件下进行分析的仪器。不同操作人员在不同地点均可重现结果。该分析无需电力即可进行，也可在远离实验室的偏远地区进行。它特别适合在发展中国家的现场使用。该方法成本低、无需维护、快速且可靠；它还使用有限量的溶剂。如果参考物质可以制成片剂形式提供，且列出了药物含量且每次分析仅需一个单位，那么无需称重即可进行分析。所有程序都是为分析世界卫生组织确定的部分基本药物清单中的药物而开发的。选择了三种药物并制成参考片剂。通过使用参考片剂和美国药典主要标准，对标准剂型药物的分析进行了比较。获得了可比结果，证明可以通过使用参考片剂且无需称取样品或参考物质来进行筛选过程。该方法已在斯威士兰成功演示并使用，美国的高中教师以及沙特阿拉伯卫生部的人员也使用过。人员可以在短时间内接受培训以进行药物筛选分析。
