中药注射剂中安全性相关物质5-羟甲基糠醛的研究进展  

Research progress of 5-hydroxymethylfurfural,a safety-related substance in traditional Chinese medicine injections

作　　者：潘卓[1] 邵禾欣 刘婷[1] 陆晓燕[1] 范骁辉[1] 

机构地区：[1]浙江大学药学院中药科学与工程学系,浙江杭州310058

出　　处：《中国中药杂志》2017年第10期1842-1846,共5页China Journal of Chinese Materia Medica

基　　金：国家中药标准化项目(ZYBZH-C-ZJ-60)

摘　　要：筛查出安全性相关物质进而建立相应的限量标准是提高中药注射剂安全性的重要研究内容。5-羟甲基糠醛(5-hydroxymethylfurfural,5-HMF)广泛存在于含糖类中药注射剂中,被认为是重要安全性相关物质。该文综述了5-HMF毒副作用的研究现状,并总结了其在中药注射剂中含量及限度的研究进展。文献综述及分析结果表明,尽管多项研究证实5-HMF及其代谢产物具有潜在毒性,但中药注射剂中5-HMF及其代谢产物的安全性研究仍十分匮乏;且不同中药注射剂甚至不同厂家的同一中药注射剂产品中5-HMF含量相差极大。为确保中药注射剂的临床疗效,亟待全面、系统地开展中药注射剂中5-HMF的毒副作用研究,建立相对统一的限量标准及过程质控方法。Screening out the safety-related substances and establishing the corresponding standard has been a key research issue to improve the safety of traditional Chinese medicine injections（TCMIs）. 5-HMF which widely exists in sugar-containing TCMIs has long been considered as an important safety-related substance. In this review, we summarizes the research progress on the toxicology of 5-HMF as well as the content and standards of 5-HMF in TCMIs.Therein, both literature summary and analysis results indicate that there are lack of toxicology researches of 5-HMF and its metabolites in TCMIs, although the potential toxicity of 5-HMF and its metabolites has been reported. Moreover, the content of 5-HMF largely varies from TCMIs to TCMIs, and even in the same TCMIs from different factories. To ensure the clinical efficacy of TCMIs, it urgent to carry out the study of the toxicology of 5-HMF in TCMIs comprehensively and systematically, so as to set up a relatively uniform standard as well as to develop process quality control method.

关 键 词：中药注射剂 5-羟甲基糠醛 毒副作用 限量标准 

分 类 号：R285.5[医药卫生—中药学]