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Analysis method for quickly detecting and judging albumin products

A technology of albumin and analysis device, applied in the field of rapid detection and judgment of albumin product analysis

Inactive Publication Date: 2013-10-23
SHANGHAI INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no research report on the quantitative analysis of human serum albumin solution by Raman spectroscopy

Method used

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  • Analysis method for quickly detecting and judging albumin products
  • Analysis method for quickly detecting and judging albumin products
  • Analysis method for quickly detecting and judging albumin products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0110] The establishment of embodiment 1 human serum albumin standard curve

[0111] 1. Sample Preparation

[0112] Since the standard substance of human serum albumin cannot be obtained, commercially available human serum albumin solution (determined its protein content by the first method (Kjeldahl method) of the three appendix VIB of the Chinese Pharmacopoeia 2010 edition) is used as a mother liquor to prepare a series of concentrations standard solution. The concentrations of genuine human serum albumin were 24.30% (A) and 4.88% (B), respectively, diluted with each other, mixed evenly, and filled into standard bottles. The specific configuration and concentration distribution are shown in Table 1.

[0113] Table 1, configuration of human serum albumin standard solution

[0114] Numbering

Volume of A / (ml)

Volume of B / (ml)

Concentration / (%)

1

0

10

4.88

2

1

9

6.82

3

2

8

8...

Embodiment 2

[0125] The concentration prediction of embodiment 2 test sample

[0126] The PLS model established above was used to measure the commercially available human serum albumin solution samples, and the results are shown in Table 3.

[0127] table 3

[0128]

[0129]

[0130] Prediction of 17 human serum albumin samples from 6 manufacturers of Oct Pharma, Shanghai Institute of Biological Products, Shanghai RAAS, Shanghai Xinxing Pharmaceutical, Jiangxi Boya Pharmaceutical, and Baxter, covering commercially available human serum albumin samples Three different concentrations of protein: 5%, 20%, 25%. The prediction results show that the maximum deviation is within 3.5%, which proves that the method has high accuracy.

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Abstract

The invention relates to a quick nondestructive testing method of albumin products and particularly relates to an analysis method used for predicting albumin concentration through the characteristic spectrum segment of albumin and further verifying the identity of albumin products. The invention further relates to an analysis device executing the analysis method and an analysis system comprising the analysis device. The method, the device and the system provided by the invention combine a laser Raman spectrum with a partial least squares method to predict albumin contents in the albumin products, and compared with other quantitative techniques, the method, the device and the system have the advantages of simplicity in operation, rapid analysis, and the like.

Description

technical field [0001] The present invention relates to a non-destructive and rapid detection method for albumin products, in particular to a method for predicting the concentration of albumin by using the characteristic spectrum of albumin and further identifying the authenticity and inferiority of albumin products, especially human albumin products. Analytical method. Background technique [0002] Human albumin solution is a clear, slightly viscous liquid, almost colorless, or yellow, brownish yellow or green, derived from human venous plasma, and prepared through a series of steps such as precipitation, centrifugation, filtration, and sterilization. The drug has always been known as "life product" and "life-saving drug". It is mainly used to treat acute and intensive care patients caused by insufficient blood volume expansion, including malnutrition, burns, severe injuries, infections, major operations, bleeding, and renal excretion. It is a special medicine for clinical...

Claims

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Application Information

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IPC IPC(8): G01N21/65
Inventor 杨永健毛丹卓翁欣欣王彦
Owner SHANGHAI INST FOR FOOD & DRUG CONTROL
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