Method for quickly measuring potency of crude heparin sodium by using near infrared spectral analysis technology
A technology of near-infrared spectroscopy and analysis technology, which is applied in the field of potency determination of crude heparin sodium, can solve the problems of long cycle and consumption of reagents, etc., and achieve the effect of simple and easy method and rapid technical data support
Inactive Publication Date: 2010-08-11
山东万邦赛诺康生化制药股份有限公司
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[0003] The purpose of the present invention is to solve the problems of reagent consumption and long period of the existing heparin sodium crude product potency determination method, and to provide a green, pollution-free, simple and easy-to-operate near-infrared spectrum that can effectively measure the potency of heparin sodium crude product analytical skills
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[0030] First, different batches of crude heparin sodium were heated and dried at 65°C for 3 hours, ground through a 60-mesh sieve, and at a room temperature of 21°C, the original near-infrared spectra of different batches of crude heparin sodium were obtained by using a near-infrared spectrometer. The potency value of the crude heparin sodium obtained by conventional technology is correlated with the near-infrared spectrum in the spectral range of 1300-2500nm to establish a mathematical model to form a near-infrared analysis mathematical model of the crude heparin potency, and then by comparing different spectral pretreatment methods And the impact of spectral region on modeling, determine the best spectral preprocessing method and spectral region, and finally verify the predictive ability of the mathematical model.
[0031] this invention figure 1 The original transmission spectrum of the heparin sodium crude product collected for the present invention. figure 2 The spectru...
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The invention discloses a method for quickly measuring the potency of crude heparin sodium by using near infrared spectral analysis technology. The method is characterized by comprising the following steps of: a, pre-processing the crude heparin sodium, namely, drying, grinding and sieving the crude heparin sodium; b, collecting original near infrared spectrums of the crude heparin sodium by using a near infrared spectrum analyzer; c, associating the obtained near infrared spectrums with a potency value obtained by conventional chemical analysis so as to establish a mathematical model; d, comparing influences of different spectrum pre-processing methods and different spectral regions on modeling; and e, verifying the predictive capacity of the mathematical model. The method of the invention is simple and easy to implement, is suitable for quickly detecting the potency of the crude heparin sodium without causing damage and pollution and provides a quick technical data support for the purchasing and subsequent processing of the crude heparin sodium.
Description
technical field [0001] The invention relates to a method for measuring the potency of crude heparin sodium, in particular to a method for measuring the potency of crude heparin sodium using a near-infrared spectrum analysis technique. Background technique [0002] The existing method for determining the titer of crude heparin sodium is generally the sheep plasma method. Its shortcomings: consumption of reagents, time and effort, and slow speed, which cannot meet the needs of rapid analysis. Contents of the invention [0003] The purpose of the present invention is to solve the problems of reagent consumption and long period of the existing heparin sodium crude product potency determination method, and to provide a green, pollution-free, simple and easy-to-operate near-infrared spectrum that can effectively measure the potency of heparin sodium crude product analytical skills. [0004] To achieve the above object, the technical solution adopted in the present invention is...
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IPC IPC(8): G01N21/35G01N21/3563G01N21/359
Inventor 臧恒昌孙春晓丛义国张允华魏杰刘清凉孙中春石滨刘建芬
Owner 山东万邦赛诺康生化制药股份有限公司