Design Of Uniformity Monitoring System Of Penicillin Products Exclusive Online Mixing

Drug is a special commodity, which is directly related to the safety and quality of people’s life, the quality of drugs is much stricter than other goods. Quality is produced, not inspected. The key process parameters and the key physicochemical index control in the production process is of the most important.. Near infrared spectroscopy provided a fast, nondestructiveonline analysis method for quality control of pharmaceutical intermediates. In this paper, based on this idea, the near infrared spectroscopy analysis to the uniformity technology for the rapid detection of penicillin products online mixing were studied.Mixing is a key link in the process of drug production, only the drug mixing evenly can guarantee to produce high quality product. The mixing process is composed of three different forms of movement, including diffusion, convection and shear. The purpose is to ensure the mixing is completed, the content of each component is to achieve uniform distribution. The mixing time is too short or too long which is not^conducive to different components mixed evenly. In this paper, we used mezlocillin sodium and Sulbactam Sodium as for the samples, to study the changes of the NIR absorbance in the mixed operation, and the spectral data of different mixture based chemometrics, establishing the quantitative mathematical model by partial least squares method, the main contents are as follows1near infrared spectroscopy analysis technique is used for mixing uniformity monitoringThis study used Antaris II Fourier transform near infrared spectrometer to collect original NIR spectra of mezlocillin sodium and sulbactam sodium with different ratios, established the quantitative mezlocillin sodium and Sulbactam sodium mixed process analysis model. In the study, we firstly prepared samples with sulbactam sodium content in the range of0-100%, and then the original NIR spectra was collected by the Antaris Ⅱ Fourier transform NIR spectroscopy. Secondly we chose different spectra pretreatment methods, the final choice was SG5smooth derivative, SNV as the optimal preprocessing method, finally we sellected the whole spectral range model with good results. The quantitative parameter model eventually established mezlocillin sodium and sulbactam sodium raw material mixing process monitoring as PCs=2, Rc=0.9983, RMSEV=1.88, RMSEP=1.66, with the RPD value of evaluation index to evaluate the model, the result shows the model has a strong predictive ability, which can effectively carry out monitoring on the composite end point.2near infrared spectroscopy analysis technique is used for online mixing uniformity endpoint monitoringThis study used Antaris Ⅱ Fourier transform near infrared spectrometer of mezlocillin sodium, sulbactam sodium mixed process online monitoring. In the study, qualitative analysis model was established respectively by MBSD and quantitative sulbactam sodium percentage content analysis based on Antaris Ⅱ, and Fourier transform infrared spectrometer diffuse sampling spectra collected in the way of mixing process, for real-time monitoring of the mixing process. Through online mixing process in three parallel experiments, the results can effectively monitor the mixing process of MBSD method and sulbactam percent content determination method, effectively proved that NIR spectroscopy analysis technology for the feasibility of mezlocillin sodium and sulbactam sodium, mixed online monitoring. In addition, the MBSD method, there is no need for a class of data collection, method is simple and easy to understand, at present used in blending process online monitoring.This study confirmed the feasibility analysis of the application of effective technology in sulbactam sodium and mezlocillin sodium sample online mixing process of NIR spectroscopy, it has great application value and important application prospect in the online monitoring of mixed samples. Disadvantages of this technology can overcome the traditional method which was time consuming and tedious, real-time online monitoring can realize the process, allowing producers to fully understand the change of parameters of the whole production process.3MicroNIR1700near infrared spectrometer was used for the feasibility study of solid mixture uniformity monitoringThis research has carried on the analysis to the Micro type NIR1700micro spectrometer for the feasibility of mezlocillin sodium, sulbactam sodium mixed degree of uniformity of monitoring. In the study, the samples were prepared mezlocillin sodium content in the range of0-100%, and then use the Micro NIR1700spectrometer NIR original spectrum acquisition. Separately select different spectra pretreatment methods, in order to study the different pretreatment methods, selecting SG7smooth derivative, SNV as the optimal preprocessing method; respectively using iPLS method, SPA method, CARS method three spectral intervals of different selection methods, in order to get the best modeling spectral interval, the final choice of18variables obtained by CARS method for the quantitative analysis model was established, with the percent content of mezlocillin sodium monitoring in the mixing process, to achieve duality of solid powder mixing process quantitative monitoring purpose. The results showed that the specific parameters of the model for the PCs=4, R2=0.999,RMSEC=1.2216, RMSECV=1.5792, RMSEP=0.8560, experimental results showed that the Micro NIR1700type micro spectrometer can achieve the mixed degree of uniformity of the end-point objective.