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Study on a noninvasive method for rapid screening Human Serum albumin injectables by Raman spectroscopy

Journal of Innovative Optical Health Sciences 2017年第1期10卷 34-42页

作者： Yu Zhao Nan Ji Xiuji Li Jifeng Hou Min Li Yongjian Yang Ping Tian Xinmei Sun Xinyue Xiao Lihui Yin National Institutes of Food and Drug Control(NIFDC)No.2 Tiantan Xi Li BeijingP.R.China tSichuan Vspec Technologies Co.Ltd.Beijing Office No.2 BeiTaiPingZhuang RoadBeijingP.R.China Shanghai Institute for Food and Drug Control(SIFDC)No.1500 Zhangheng Road ShanghaiP.R.China

Human serum albumin(HSA)injectable product is a severely afflicted area on drug safety due to its high price and restricted *** spectroscopy performances high specificity on HSA detection and it is even possible to determine HSA injectable products *** this study,we developed a noninvasive rapid screening method for of HSA injectable products by using portable Raman *** models were established by using principal component analysis combined with classical least squares(PCA-CLS)algorithm,while quanti-tative model was established by using partial least squares(PLS)*** transfer in different instruments of both the same and different apparatus modules was further discussed in this paper.A total of 34 HSA injectable samples collected from markets were used for *** identification results showed 100%accuracy and the predicted concentrations of those identified as true HSA were consistent with their labeled *** quantitative results also indicated that model transfer was excellent in the same apparatus modules of Raman spectrometer at all concentration levels,and still good enough in the different apparatus modules although the relative standard deviation(RSD)value showed a little increasing trend at low HSA concentration *** conclusion,the method was proved to be feasible and efficient for screening HSA injections,especially on its screening speed and the consideration of glass ***,with inspiring results on the model transfer,the method could be used as a universal screening mean to different Raman instruments.

关键词： Human serum albumin Raman noninvasive rapid screening method principal component analysis combined with classical least squares partial least squares model transfer.

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