山梨醇是一種D-葡萄糖醇，不僅是一種常用的藥用輔料，還廣泛用于化妝品和食品行業(yè)。不同企業(yè)生產(chǎn)的山梨醇中還原糖含量存在一定差異。殘留的還原糖在制劑過(guò)程和藥品貯存過(guò)程中，可能會(huì)與含氨基的藥物活性成分（API）發(fā)生美拉德反應(yīng)，產(chǎn)生一些與還原性糖偶聯(lián)的降解產(chǎn)物，影響產(chǎn)品的質(zhì)量。對(duì)山梨醇的生產(chǎn)工藝、各國(guó)藥典對(duì)山梨醇的質(zhì)量控制、還原糖殘留的測(cè)定方法進(jìn)行了總結(jié)，對(duì)山梨醇中還原糖與API發(fā)生美拉德反應(yīng)所產(chǎn)生的雜質(zhì)的控制進(jìn)行了分析，以期為新產(chǎn)品開(kāi)發(fā)和藥品質(zhì)量控制研究提供借鑒。

Sorbitol is a D-glucose alcohol, which is not only a commonly used medicinal excipient, but also widely used in cosmetics and food industry. There are certain differences in reducing sugar in sorbitol from different manufacturers. In the preparation process and drug storage process, the residual reducing sugar may occur Maillard react with the amino-containing active pharmaceutical ingredient (API) to produce some degradation products coupled with reducing sugar, which will affect the quality of the product. This paper summarizes the production process of sorbitol, the quality control for sorbitol in pharmacopoeia of various countries, and the determination method of reducing sugar residue, and analyzes the control of impurities produced by the Maillard reaction of reducing sugar and API in sorbitol, in order to provide reference for development of new products and study of drug quality control.

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