一种基于指纹图谱分析技术的中药生产工艺稳定性评价方法  

A chromatographic fingerprinting-based approach to evaluating the stability of production process of traditional Chinese medicine

作　　者：胡楚楚[1] 李云飞[1] 程翼宇[1] 

机构地区：[1]浙江大学中药科学与工程学系,浙江杭州310027

出　　处：《中国中药杂志》2006年第14期1151-1154,1162,共5页China Journal of Chinese Materia Medica

基　　金：国家"十五"科技攻关计划重大项目(2001BA701A01);国家重点基础研究发展规划项目(G1999054405)

摘　　要：目的:提出一种基于指纹图谱分析技术的中药提取工艺稳定性评价方法。方法:通过单因素实验,获取实验条件(如溶剂倍数、溶剂浓度、提取时间和提取次数等)变化时的红参提取液色谱指纹图谱。比较并选取基于欧式距离计算方法的相似性测度计算指纹图谱相似度值,并且在所得实验数据的基础上,应用三次样条函数对相似度-工艺参数特性曲线进行拟合。结果:提取液指纹图谱相似度随工艺参数变化呈现一定规律,表明以指纹图谱相似度为指标可定量考察样品色谱指纹图谱与工艺参数之间的关系。结论:本方法较灵敏地表征了提取工艺参数波动导致的药材提取物整体质量变化情况,并可用于指导工艺参数的调整,优于传统的以单一化学成分含量为指标的工艺评价方法。extracts produced with fluctuating processing factors, i.e. ratio of solvent to liquid, solvent concentration, extraction durations and extraction times, were acquired. Meanwhile, the similarity of fingerprinting based on Euclidean distance was calculated and each fingerprint was fit with cubic spline. Result： Similarities of fingerprints of the extracts responded to the fluctuation of processing factors, and it showed that taking similarity as index, quantitative relation between chromatographic fingerprints and processing factors could be established. Conchusion： The method proposed in the paper was able to describe the quality of products resulting from fluctuating conditions in extracting process, and therefore, can be developed as a practicable strategy to evaluate the stability Traditional Chinese Medicines in production process.

关 键 词：色谱指纹图谱 工艺稳定性评价 中药 红参 

分 类 号：TQ461[化学工程—制药化工]