摘要
红曲为传统曲类中药,在我国有近千年的使用史。近年来因红曲的降脂作用使得红曲的药用价值和保健功效日益引人关注,其中他汀类成分作为红曲主要的调脂成分成为科研热点和红曲产业发展的重点。然而2015年版《中国药典》等目前国内现有的红曲质量标准大多只以内酯式洛伐他汀作为指标成分并规定其检测方法。红曲降脂成分复杂,起主要降脂作用的是酸式洛伐他汀,其他的他汀类成分也起协同降脂作用,仅以内酯式洛伐他汀作为降脂作用的指标成分,存在一定的片面性。红曲降脂指标成分规定的不科学性导致其质量参差不齐,不利于红曲的质量监控,并影响其临床使用的安全性和有效性。更严重的是红曲质量标准的不合理性为红曲中非法添加外源性洛伐他汀的检测带来了不便。为此,笔者在前人的研究基础上,通过查阅近年国内外红曲的文献报道,对红曲降脂成分他汀类物质的检测方法进行了分析和归纳,并提出了增加质量控制指标成分的设想,以期为红曲内在质量的综合评价及标准完善提供参考。
Fermentum Rubrum is a traditional Chinese fermented medicine and has been used for nearly 1 000 years in China. In recent years, its lipid-reducing effect has attracted attentions to its medicinal value and health care effect. In particular, its statins ingredients with the main lipid-reducing effect have become the focus of science research and development of Fermentum Rubrum industry. At present, only lactone-type lovastatin is recognized as an index component in the most of current domestic quality standards of Fermentum Rubrum. Lipid- reducing ingredients in Fermentum Rubrum are complex. Its acid-type lovastatin has the main lipid-reducing effect, and other statins also have a synergistic lipid-reducing effect. It is unreasonable to regard lactone-type lovastatin as the only index component, which leads to varying qualities and impacts quality monitoring, safety and effectiveness of clinical medication. More seriously, it is difficult to detect the adulteration of lovastatin in Fermentum Rubrum, because of the unreasonable quality standard. Based on the previous studies, the authors collected, analyzed and summarized the literatures for Fermentum Rubrum at home and abroad in recent years, and systemically reviewed the research advances in detection methods of lipid-reducing ingredients of Fermentum Rubrum. This paper puts forward the suggestion of adding the quality control index components, in the hope of providing a theoretical reference for the comprehensive quality evaluation and standard improvement of Fermentum Rubrum.
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2017年第23期228-234,共7页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局公益性行业科研专项(201507004)
四川省科技厅苗子工程项目(2016RZ0037)
关键词
红曲
降脂成分
内酯式洛伐他汀
酸式洛伐他汀
他汀类物质
检测方法
Fermentum Rubrum
lipid-reducing ingredient
lactone-type lovastatin
acid-type lovastatin
statins ingredient
detection method
