近红外漫反射光谱结合相关系数法快速检测制川乌中双酯型生物碱的限量

Rapid Determination of Diester-type Alkaloids in Radix Aconiti Preparata by Near Infrared Correlation Coefficient Method

目的:建立快速检测制川乌中双酯型生物碱限量的近红外漫反射光谱结合相关系数法。方法:选择制川乌、生川乌,分析双酯型生物碱的近红外特征区间,同时测定每批次样品中双酯型生物碱的含量,采用OPUS软件中相关系数法分析每批次样品与生川乌的相关系数,确定方法阈值。结果:炮制充分的样品,相关系数均≤25%;未炮制充分的样品,相关系数均为60%~70%。当定义阈值为40%时,能准确地对样品进行初筛。结论:近红外漫反射光谱结合相关系数法可以对制川乌样品中双酯型生物碱的限量进行初筛,用于该类药品的质量控制,同时可以应用于药品监管机构进行快速筛查和监督抽样。

OBJECTIVE： To establish rapid identification on biogerm limit of diester-type alkaloids in radix aconiti preparata by near infrared diffuse spectroscopy combined with correlation coefficient method. METHODS： Samples of radix aconitum preparata and radix aconitum were selected to analyze the near-infrared characteristic range of diestertype alkaloids. The content of diester-type alkaloids in each batch was also determined. The correlation coefficient method was used to analyze the correlation coefficient between samples of each batch and standard control of radix aconiti,and the method threshold was determined. RESULTS： The correlation coefficient of fully processed samples were ≤ 25%; yet the correlation coefficient of not fully processed samples were 60%-70%. Samples could be accurately screened when the defined thresholds were set at 40%. CONCLUSIONS： Near-infrared diffuse reflectance spectroscopy combined with correlation coefficient method can be used to determine the limit of diester-type alkaloids in radix aconiti preparata for the quality control of drugs purchased in the hospital. Meanwhile,the method can be applied to screening and supervision of sampling in drug regulatory agencies.