Study On Rapid Determination Of Several Powder Mixtures Blending Uniformity By Near-Infrared Spectroscopy

Drug is a special kind of commodity which has direct relationship with people’s life safety. The quality requirements of drug are more strict than other products, and drug production process direct influences drug quality, therefore the production process control in this field is particularly important. Near-infrared spectroscopy provides pharmaceutical production process control with a rapid and nondestructive online analysis method which can be applied to optimize each link of the production process. Based on the concept above, this paper applies near-infrared spectroscopy to the issue of fast detection of solid powder mixed uniformity for a more in-depth research.Powder blending is the key unit operation for the production of drug. In order to ensure the production quality of pharmaceutical preparations, we must make the drugs fully mixed. The blending process is consisted by three different forms of exercise comprehensively. A. Diffusion, the movement between the particles. B. Convection, the movement between amount of particles c. shear, redistribution of material layers. Its purpose is to make sure that the whole process of mixing is completed and achieve a uniform content distribution of various components. Blending time too short or too long can create uneven drug combinations. This paper uses microcrystalline cellulose, polyvinylpyrrolidone and five different types of medicinal lactose as the samples to study the changes of binary mixture on the near infrared absorption. We combine spectrum data with chemical metrology to build up the quantitative mathematical model with PLS. Specific methods are as followsFirst, solid medicinal lactose in gradient content must be accurately prepared and collect the diffuse near infrared spectra.Second, we use RMSEP, RMSECV, Rc, RMSEC, PCs as the referencing factors to choose an optimal spectrum pretreatment method.Third, iPLS method is used to select appropriative spectral absorption bands so that we can establish specific quantitative model. Ultimately ten quantitative models which have characteristic absorption band of medicinal lactose were built.Fourth, a miniaturization of the near infrared spectrometer was designed. The optical system applies the blazed grating which is integrated by microelectromechanical system technology as a core component. Control system consists of signal acquisition, amplification, analog-to-digital conversion, data buffer, data transfer and so on, which is controlled by a micro control unit. The shape of the instrument is small and the internal parts are fixe, therefore it is more suitable for online analysis.