The Study Of Rapid Detection Of Human Albumin Stoste Protein Content By Using Near Infrared Spectroscopy

Human albumin is extracted from healthy human plasma, which is separated and purified by low temperature ethanol or other approved methods, and finally prepared by inactivated virus for 10 hours at 60 ?. The human serum albumin formulation was composed of suitable stabilizer, human serum albumin, without any antiseptic and antibiotic. It is only used for intravenous infusion. The albumin is the main component, and the purity is higher than 96.0%. Human serum albumin is an ideal clinical blood volume expansion agent with the property of good stability, easy storage and transportation.In recent years, the raw material of plasma which is relatively scarce resources has always been the bottleneck of enterprise development. At the same time, patients of human blood albumin blood products such as security requirements are also gradually increase, how to improve the quality and safety of human serum albumin, further reduce the risk of product contamination and et al. become a research hotspot. The human serum albumin content during our production process was determined by Kjeldahl method. The Kjeldahl method will take 2 to 3 hours which could increase the risk of contamination and production time. The main advantages of NIRS are as follows:easy operation, fast analysis (2-3 minutes), no destructive, no pollution, and on-line real-time monitoring. So NIRS is applied to detect the protein content of the human albumin, expecting to shorten the testing time, and reducing the risk to the quality of the human albumin.At first, the microbial content before and after detection of human serum albumin protein by kjeldahl method was determined in order to evaluate the risks on the human serum albumin quality.Then, the laboratory type NIR was used. This study established the NIRS quantitative analysis model of human serum albumin Stoste protein's content in laboratory conditions. In the process, first derivative Savitzky-Golay smoothing and Mean Center was selected as the best pre-processing method. Forward iPLS method was introduced to select the regions. And determination coefficient of calibration(Rc2), determination coefficient of prediction (Rp2),root mean square error of calibration (RMSEC), root mean square error of prediction (RMSEP),root mean square error of cross validation (RMSECV) were 0.997,0.987,0.1394%,0.2560%,0.1831%, respectively.And next, studying the feasibility of portable type NIR. The MicroNIR1700 near infrared spectrometer was used to investigate the feasibility for determining the human serum albumin content with portable near infrared spectrometer. And determination coefficient of calibration(Rc2), determination coefficient of prediction (Rp2),root mean square error of calibration (RMSEC), root mean square error of prediction (RMSEP),root mean square error of cross validation (RMSECV) were 0.977,0.958,0.3983%,0.5653%,0.5334%, respectively. The results show that the MicroNIR1700 near infrared spectrometer also can be used in rapid detection of human serum albumin semi-finished protein contention.Finally, combining with the production process, the human blood albumin contrast near infrared spectrum test and semi-micro kjeldahl determination time differences, analyses the NIRS detection technology to product quality and company saving energy and reducing consumption (water, electricity, gas, etc) and the positive influence the production benefit and value.The study demonstrated that NIRS was suitable for human serum albumin rapid detection, meanwhile NIRS could save the analytical time, decrease the quality risk and improve the quality of products.