氨基葡萄糖类药物的来源、结构及其鉴别技术研究  

Research on the sources,structures and identification technology of glucosamine drugs

作　　者：但晓梦 刘晓锋 郭江红 姜红 DAN Xiaomeng;LIU Xiaofeng;GUO Jianghong;JIANG Hong(Hubei Institute for Drug Control,Wuhan 430073,China;NMPA Key Laboratory for Quality Control of Blood Products,Wuhan 430073,China)

机构地区：[1]湖北省药品监督检验研究院,武汉430073 [2]国家药品监督管理局血液制品质量控制重点实验室,武汉430073

出　　处：《中国药师》2024年第4期551-556,共6页China Pharmacist

基　　金：国家药典委员会标准提高项目(2019H080);湖北省药品监督管理局青年项目(20200117)。

摘　　要：目的对氨基葡萄糖类药物的来源、结构及其鉴别技术相关研究进行梳理与归纳,为该类药物的开发与研究提供参考。方法通过稳定同位素比值检查法鉴别氨基葡萄糖类药物的来源,采用X射线粉末衍射技术鉴别氨基葡萄糖类药物的晶型结构。结果碳同位素θ比值在-11‰~-13‰区间内的氨基葡萄糖原料属于微生物发酵θ来源;碳同位素比值在-17‰~-24‰区间内的氨基葡萄糖原料属于动物来θ源。盐酸氨基葡萄糖的最强衍射峰232.124°、19.035°,硫酸氨基葡萄糖氯化钠/钾原料药的最强衍射峰2酸氨基葡萄糖+硫酸钠/钾混合物(2:1)的最强衍射峰2θ角为12.391°,通过X射线粉末衍射技术,一定程度上可以区分硫酸氨基葡萄糖氯化钠/钾共晶体复盐与盐酸氨基葡萄糖+硫酸钠/钾物理混合物。结论该研究能准确鉴别氨基葡萄糖类药物的来源和结构,方法简便、准确、专属性强,为氨基葡萄糖类药物的监督管理提供了技术支撑。Objective To sort out and summarize the researches of source,structures and identification technologies of glucosamine drugs,and provide a reference for the development and research of this kind of drugs.Methods The sources of glucosamine drugs was identified by stable isotope ratio test,and the crystal structures of glucosamine drugs was identified by X-ray powder diffraction.Results When the carbon isotope ratio was between-11‰and-13‰,the source of glucosamine was from microbial fermentation.When the carbon isotope ratio was between-17‰and-24‰,the source of glucosamine was from microbial animals.The 2θangles of the strongest diffraction peak of hydrochloric glucosamine were 16.525°,12.360°and 17.330°,the 2θangles of the strongest diffraction peak of sodium sulfate were 32.124°and 19.035,the 2θangle of the strongest diffraction peak of the glucosamine sulfate potassium chloride/sodium was 27.036°,and the 2θangle of the strongest diffraction peak of the physical mixture of glucosamine hydrochloride and chloride/sodium sulfate(2∶1)was 12.391°.Through X-ray powder diffraction technology,the glucosamine sulfate potassium chloride/sodium eutectic complex salt and the physical mixture of glucosamine hydrochloride and chloride/sodium sulfate.can be distinguished.Conclusion The research can effectively identify the sources and structures of glucosamine drugs,which is simple,accurate and reliable,and provides technical support for the supervision and management of glucosamine drugs.

关 键 词：盐酸氨基葡萄糖 硫酸氨基葡萄糖 来源 结构 鉴别 

分 类 号：R927.1[医药卫生—药学]