Method for determining content of high molecule weight substance in injection

A technology of high molecular weight and substance content, applied in the direction of measuring device, material separation, analysis material, etc., to achieve the effect of less interference, saving first aid time, and high sensitivity

Active Publication Date: 2006-07-26
MUDANJIANG YOUBO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the skin test can only predict the immediate type I allergic reaction, and the positive coincidence rate is only 30%. Even if the skin test is negative, it cannot explain that no allergic reaction will occur in the future. There are also II and III allergic reactions that may occur clinically. , type IV allergy, which is not predictable by skin test

Method used

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  • Method for determining content of high molecule weight substance in injection
  • Method for determining content of high molecule weight substance in injection
  • Method for determining content of high molecule weight substance in injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1: Determination of high molecular weight substance content by high performance liquid chromatography

[0026] 1. Test materials and instruments

[0027] name

[0028] 2. Instrument

[0029] Visible ultraviolet spectrophotometer (Hitachi U-3210, Japan)

[0030] High performance liquid chromatography Waters 600 system

[0031] High performance liquid chromatography Agilent Hp1100

[0032] 3. Reagents

[0033] Chemically pure trifluoroacetic acid (School of Chemical Engineering and Materials, Polytechnic University)

[0034] Chromatographically pure acetonitrile (Dima Company)

[0035] 2. Chromatographic conditions

[0036] Chromatographic column: gel chromatography column (TSK GEL 2000 SWxl 7.8mm×300mm);

[0037] Mobile phase: trifluoroacetic acid-acetonitrile-water, the volume ratio is 0.025:30:70;

[0038] Ultraviolet detector, the detection wavelength is 214±1nm;

[0039] The flow rate was 0.7ml / min.

[0040] 3. Determination

[0041] T...

Embodiment 2

[0044] Embodiment 2: repeatability test

[0045] Take an appropriate amount of human insulin standard, add mobile phase to dilute to 3 different concentrations, measure 3 times respectively, the results are shown in Table 2.

[0046] concentration

[0047] The test results show that the method of the present invention has very good repeatability.

Embodiment 3

[0048] Embodiment 3: Determination of high molecular weight substance content in Shuxuetong injection by high performance liquid chromatography

[0049] Preparation of test product solution: get test product Shuxuetong injection (batch numbers 0212031 and 0212051, specification 2ml / support, produced by Mudanjiang Youbo Pharmaceutical Co., Ltd.), add mobile phase to dilute 5 times, shake well, and use as test product solution .

[0050] Preparation of reference substance solution: take an appropriate amount of human insulin (molecular weight 5800), and use mobile phase to make a solution containing 0.1 mg in every 1 ml, as the reference substance solution.

[0051] Determination: Take 20ul each of the reference substance solution and the test solution and inject them into the high-performance liquid chromatograph respectively, record the chromatogram, regard the peak prior to the insulin peak retention time as the high molecular weight substance peak, and calculate according to...

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Abstract

The invention provides a method for measuring the content of high molecular weight matter in an injection. Particularly provides a method which measures content of high molecular weight matter in Shuxuetong injection with high efficiency liquid chromatography, taking human insulin as reference, measures the content of which molecular weight greater then human insulin as high molecular weight matter content. The inventive method has the advantages of being quick, accurate and of have high sensibility.

Description

technical field [0001] The invention relates to a method for determining the content of high-molecular-weight substances in injections, in particular to high-performance liquid chromatography for determining the content of high-molecular-weight substances in injections. Background technique [0002] For injection products containing high molecular weight substances, from the perspective of safety, patients need to undergo skin tests when applying them. However, the skin test can only predict the immediate type I allergic reaction, and the positive coincidence rate is only 30%. Even if the skin test is negative, it cannot explain that no allergic reaction will occur in the future. There are also II and III allergic reactions that may occur clinically. , Type IV allergy, which cannot be predicted by the skin test. [0003] Therefore, in order to ensure the safety and effectiveness of clinical medication, the content of high-molecular-weight substances in injection products is...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 李振国
Owner MUDANJIANG YOUBO PHARMA CO LTD
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