刺五加注射液近红外含量预测模型谱段选择规律和消除溶剂干扰方法的探讨

目前中药制剂生产过程中缺乏全过程参数检测和质量控制技术手段,不同生产批次药品化学成分差异较大、质量不够稳定、临床使用疗效和安全性不理想,因此,建立其完善的质量评价体系及其准确快速的质量评价方法,成为中药质量控制的重中之重.通过对刺五加注射液近红外(near infrared,NIR)含量预测模型的谱段选择规律和消除溶剂干扰方法的探讨,发现采用表征混合物结构差异的结构相关谱段结合含量相关谱段作为NIR组分预测模型谱段,用基于水为参比光谱的样本光谱建立含量预测模型,并利用水作为参比光谱识别和提取待分析组分的光谱信息,可以得到较理想的NIR含量预测结果.通过对刺五加注射液中绿原酸、紫丁香苷和刺五加苷E组分的近红外光谱结构相关谱段和含量相关谱段的归属,分别建立了绿原酸、紫丁香苷和刺五加苷E组分的含量预测模型,可用于快速分析刺五加注射液中不同组分的含量.

Discussion on spectral wavelength selection principles and the strategy for eliminating the solvent interference in the near infrared quantitative models for determination of Acanthopanax senticosus injection

Currently,most of the Traditional Chinese Medicine（TCM） has problems regarding to the quality consistence and clinical efficacy safety due to lack of adequate manufacturing process analytical technology. Therefore,the first priorities for the quality control of TCM is to establish the quality evaluation system and specified analytical methods with high accuracy.Through the study of spectral wavelength selection and the research on the method of eliminating solvent interference in the near infrared quantitative models for the determination of Acanthopanax senticosus injection,relatively desired assay results could be predicted by NIR module with the water＇s spectrum as the reference spectrum to identify and abstract the sample＇s spectrum information.The NIR module were established by combining the structural relevant spectrum bands with content relevant spectrum bands and using sample＇s spectrum which was formed by using water＇s spectrum as the reference spectrum.Universal quantitative models for the determination of chlorogenic acid,syringin and eleutheroside E in Acanthopanax senticosus injection were constructed by assigning the structure and content related bands for the spectrum profile of Acanthopanax senticosus injection.The result showed that this method could rapidly test the different components of Acanthopanax senticosus injection.