基于组分结构理论的胆木注射液多维结构质量控制技术体系

胆木为黎族民间常用药之一,具有清热解毒、抗菌消炎等作用,以胆木药材开发的中药制剂胆木注射液已经进入临床使用多年,疗效确切。目前已有不少研究对胆木化学成分进行了详细解析,但是其与疾病防治相关的药效物质基础并未得到明确,而且胆木及其制剂的质量控制方法依然局限于单一指标成分,并且存在一定的不合理性,无法很好地保证它们的内在质量。该文在总结以往研究成果的基础上,基于物质基础“组分结构理论”,构建能够反映胆木注射液作用整体性以及组分结构层次性的“多维结构质量控制技术体系”,对药材到制剂成品进行工艺全程动态监控,从而保证胆木注射液的内在品质。

Multi-dimensional structure quality control technology system of Danmu injection based on component structural theory

Danmu is one of common medicines in folks of Li nationality, with such effects in clearing heat and removing toxicity, antisepsis and anti-inflammation. Danmu injection, which is developed with Danmu herbs, has been clinically applied for years and showed curative efficacy. Currently, though many studies have been conducted to analyze chemical constituents in Danmu in details, its pharmacodynamic material basis related to disease prevention and treatment has not been defined. Furthermore, as the quality control methods for Danmu and its preparations remain restricted to single index component and irrational to some extent, it fails to ensure their inherent quality. On the basis of the summary of previous study results, as well as the "component structural theory" of the material basis, we established a "multi-dimensional structure quality control technology system" that is capable of reflecting the integrity of effects of Danmu injection and component structure hierarchy, and performed a dynamic monitoring over the whole process from medicinal materials and preparation products, so as to ensure the inherent quality of Danmu injection.