山梨醇是一种D-葡萄糖醇，不仅是一种常用的药用辅料，还广泛用于化妆品和食品行业。不同企业生产的山梨醇中还原糖含量存在一定差异。残留的还原糖在制剂过程和药品贮存过程中，可能会与含氨基的药物活性成分（API）发生美拉德反应，产生一些与还原性糖偶联的降解产物，影响产品的质量。对山梨醇的生产工艺、各国药典对山梨醇的质量控制、还原糖残留的测定方法进行了总结，对山梨醇中还原糖与API发生美拉德反应所产生的杂质的控制进行了分析，以期为新产品开发和药品质量控制研究提供借鉴。

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.

R284