Pan Zhuo, Shao He-Xin, Liu Ting, Lu Xiao-Yan, Fan Xiao-Hui
Department of Chinese Medicine Science & Engineering, College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, China.
Zhongguo Zhong Yao Za Zhi. 2017 May;42(10):1842-1846. doi: 10.19540/j.cnki.cjcmm.2017.0074.
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.
筛选出与安全性相关的物质并建立相应标准，一直是提高中药注射剂安全性的关键研究问题。广泛存在于含糖中药注射剂中的5-羟甲基糠醛（5-HMF）长期以来被视为一种重要的与安全性相关的物质。在本综述中，我们总结了5-HMF的毒理学研究进展以及其在中药注射剂中的含量和标准。其中，文献综述和分析结果均表明，尽管已有报道称5-HMF及其代谢产物具有潜在毒性，但在中药注射剂中缺乏对5-HMF及其代谢产物的毒理学研究。此外，不同中药注射剂中5-HMF的含量差异很大，甚至同一中药注射剂不同厂家生产的产品之间也存在差异。为确保中药注射剂的临床疗效，迫切需要全面、系统地开展5-HMF在中药注射剂中的毒理学研究，以便建立相对统一的标准并制定过程质量控制方法。
