近红外光谱在天舒胶囊提取工艺过程中的应用  

Application Research on Near-infrared Spectroscopy Monitoring of Water Extraction Process of Tianshu Capsules

作　　者：杨绪芳[1,2] 孙永成[2] 米慧娟[2] 王秀海[2] 李峰[2] 吴云[2] 萧伟[1,2] 

机构地区：[1]南京中医药大学药学院,南京210000 [2]江苏康缘药业股份有限公司,中药制药过程新技术国家重点实验室,江苏连云港222047

出　　处：《中国实验方剂学杂志》2015年第23期28-32,共5页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家“重大新药创制”科技重大专项(2012ZX09201201-002)

摘　　要：目的:采用近红外(NIR)光谱技术建立天舒胶囊水提取工序中天麻素含量和含固量2个质量控制指标的快速定量分析方法,实时获得二者在该制剂2次水提过程中的动态变化情况,实现水提液浓缩过程关键指标的质量控制。方法:收集天麻、川芎2次水提取过程中样品,通过异常点去除、光谱预处理方法确定及最优波段选择,运用偏最小二乘法(PLS)分别建立NIR光谱与天麻素含量和含固量之间的定量校正模型,采用未知样品对定量校正模型进行验证,判断其准确性。结果:天麻素含量和含固量校正模型的相关系数分别为0.968 0,0.977 2,验证模型的相关系数分别为0.965 9,0.978 6,校正均方差(RMSEC)分别为4.686,0.053,预测均方差(RMSEP)分别为3.698,0.034,预测相对偏差(RSEP)分别为4.85%,3.07%。结论:近红外光谱分析技术操作简便、分析速度快且准确度高,可用于天舒胶囊水提取过程天麻素含量及含固量的快速监测。Objective： To realize quality control of water extracting process,near-infrared（ NIR）spectroscopy was used to establish a rapid quantitative analysis model for the content of gastrodin and total solid content in the second water extracting process of Tianshu capsules,which could timely reflect its state. Method：Samples of the second water extracting process of Tianshu capsules were collected,after rejection of abnormal samples,pretreatment of spectra and choice of corresponding wave band, multivariate calibration models were respectively established by partial least squares（ PLS） algorithm between spectra and the content of gastrodin or total solid content. Samples in the concentrating process,which did not participate in modeling were used to test performance of models. Result： Correlation coefficients of the content of gastrodin and total solid content were0. 968 0 and 0. 977 2; predicted coefficients of them were 0. 965 9 and 0. 978 6, root mean square error of calibration（ RMSEC） were 4. 686 and 0. 053,root mean square error of prediction（ RMSEP） were 3. 698 and0. 034, and the relative standard errors of predictions（ RSEP） were 4. 85% and 3. 07%, respectively.Conclusion： The method mentioned above is proved to be convenient,rapid,accurate and applicable for fast analysis and monitoring of active components in the second water extraction process of Tianshu capsules.

关 键 词：近红外光谱 天舒胶囊 水提取 天麻素 含固量 

分 类 号：R283.6[医药卫生—中药学] R284.1[医药卫生—中医学]