Quantitative And Qualitative Analysis Of Drugs By Near Infrared Spectroscopy Technology

It is very important for drug quality control in the pharmaceutical field. Near infrared spectroscopy (NIRS) technology as a new "green" analysis method has been applied in the determination of raw materials and accessories, the distribution of particle size, fake identification, product distinguishing, online quality control and reformation of manufacturing technique.This thesis focuses on drug process of quantitative and qualitative analysis based on near infrared spectral technology, especially in information extraction and analysis process. According to near infrared spectrum of four drugs, using multivariate linear regression, partial least squares and artificial neural network, Quantitative ananlysis of active ingredients were developed for different drugs and qualitative discrimination was set up for different formula and technic production.The spectroscopies of nateglinide, rabdosia rubescens tablets, gliclazide tablets and ranitidine hydrochloride capsules were collected in the range of 12000 cm-1～4000 cm-1. Compared with the results of pharmacopoeia method, quantitative model and qualitative discrimination model were developed by different pretreatment methods, optimization of the best principal component count in their optimal range respectively. It was shown that the two drugs quantitative models were established for different specifications of nateglinide and ranitidine hydrochloride capsules by partial least squares (PLS) and artificial neural network (ANN). The results were satisfactory. The quantitative and qualitative models were established by PLS and discriminant analysis for the rabdosia rubescens tablets, gliclazide tablets and ranitidine hydrochloride capsules. The quantitative model can accurately predict active ingredients of content. And using various qualitative models, we can distinguish the productions of different manufacturers. These models were expected to provide an important tool and basis for the prediction of active ingredients, technic reform and quality control.From these results, it is shown that near infrared analysis technology can qualify for quality control and discriminant analysis for complex of different manufacturer without complicated pretreatment. The method is a new type of drug content determination way. It is rapid, non-destructive and accurate. Through continuous optimization of model, the model of drug can be applied to drug quality control. The NIRS analysis methods can play an important role in pharmaceutical analysis.