A method for rapid determination of water content in finished products of human coagulation factor VIII
A technology for the rapid determination of human coagulation factors, which is applied in measurement devices, analysis materials, and material analysis by optical means.
Active Publication Date: 2017-09-26
SHANDONG UNIV
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Problems solved by technology
[0004] In order to solve the time-consuming, labor-intensive and destructive problems in the existing moisture content determination methods, the present invention provides a method for rapidly determining the moisture content in the finished product of human blood coagulation factor VIII. The moisture content of the sample can be measured without destroying the sample, which can realize all the inspections of the outgoing drugs
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Embodiment 1
[0024] (1) Preparation of FVIII freeze-dried samples with different water content: take FVIII freeze-dried agent, add 10mL water for injection to each bottle to dissolve completely, put in -80°C ultra-low temperature refrigerator for more than 2 hours, and freeze-dry at -20°C for 12h-48h Different, take some samples that have been freeze-dried for more than 24 hours, and analyze and dry them in a vacuum oven at a temperature of 32°C and a vacuum of 10Pa for 5-24 hours, and obtain 88 freeze-dried samples with different moisture contents.
[0025] (2) Antaris II Fourier transform near-infrared spectrometer integrating sphere diffuse reflectance analysis module is used to collect near-infrared spectra. The working parameters of the instrument are: the spectral scanning range is 10000cm -1 -4000cm -1 , with a resolution of 8cm -1 , the number of spectral scans is 32, and 3 spectra are collected for each sample. The absorption intensity of the near-infrared diffuse reflectance sp...
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Disclosed is a method for rapid determination of the water content in a human coagulation factor VIII final product, comprising the following steps of: (1) preparing human coagulation factor VIII preparation products with different water contents; (2) using a near-infrared spectrometer to collect a near infrared spectrum directly, and determining the water content in a sample; (3) dividing sample sets of different water contents, to obtain a calibration set for establishing a model and a validation set for validating the ability of a model to carry out prediction; (4) comparing evaluation parameters of models under different pretreatment methods and model wavelengths to obtain an optimal pretreatment method and model wavelength, so as to establish a PLS quantitative analysis model for determining the water content; (5) taking a sample to be tested, collecting a near infrared spectrum, fitting the spectrum obtained against a model, and obtaining the water content value in a human coagulation factor VIII preparation product. The method is simple and practicable, quick and non-destructive, green and environmentally friendly, and in particular, is suitable for determining the water content in a lyophilized human coagulation factor VIII lyophilized product.
Description
technical field [0001] The invention relates to a method for quickly measuring the water content in finished products of human coagulation factor VIII by a near-infrared spectrum analysis technique. Background technique [0002] Human coagulation factor VIII (human coagulation factor VIII, FVIII) is an important coagulation factor in the intrinsic coagulation pathway, participates in the activation of coagulation factor X, and plays an irreplaceable role in the normal coagulation process. The hereditary deficiency of human blood coagulation factor VIII will lead to hemophilia A, so regular intravenous injection of human blood coagulation factor VIII preparation is the main treatment for hemophilia A. At present, due to the serious shortage of raw material sources and the limitation of production technology, there is a serious shortage of human coagulation factor VIII preparations in my country. [0003] The human blood coagulation factor VIII preparations currently on the m...
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IPC IPC(8): G01N21/359
CPCG01N21/359
Inventor 臧恒昌庞广礼仲立军王斐姜玮李连张惠李灿
Owner SHANDONG UNIV