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The detection method of the purity of interleukin-12 injection

A detection method and injection technology, applied in the fields of medical testing and drug analysis, can solve problems such as poor stability, achieve reliable detection results, broad application prospects, and improve specificity

Active Publication Date: 2022-06-21
KANGLITAI BIOMEDICAL (QINGDAO) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Biopharmaceuticals usually have defects such as poor stability, so the purity of their injections is one of the quality indicators that need to be paid attention to

Method used

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  • The detection method of the purity of interleukin-12 injection
  • The detection method of the purity of interleukin-12 injection
  • The detection method of the purity of interleukin-12 injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] (1) Reagents: trifluoroacetic acid (TEDIA, chromatographically pure), acetonitrile (Fisher, chromatographically pure);

[0058] (2) Instruments: Agilent 1260 liquid chromatograph (Agilent, USA), Agilent 1260DAD detector and OpenLAB processing software (Agilent, USA), AUW220 electronic balance (SHIMADZU, Japan).

[0059] (3) Preparation of samples to be tested

[0060] The concentration of interleukin-12 injection was 15μg / ml.

[0061] (4) Preparation of mobile phase

[0062] Mobile phase A: Pipette 0.5mL of trifluoroacetic acid into a 1L volumetric flask, add water to make the volume, stand for 5min, and then test on the machine;

[0063] Mobile phase B: Pipette 0.5mL of trifluoroacetic acid into a 1L volumetric flask, add acetonitrile to the volume, put it into ultrasonic treatment for degassing for 20min, and set aside.

[0064] (5) Chromatographic conditions

[0065] Chromatographic column: YMC C4 liquid chromatography column (250mm×4.6mm I.D.S-5μm);

[0066] Co...

Embodiment 2

[0072] (1) Reagents: trifluoroacetic acid (TEDIA, chromatographically pure), acetonitrile (Fisher, chromatographically pure);

[0073] (2) Instruments: Agilent 1260 liquid chromatograph (Agilent, USA), Agilent 1260DAD detector and OpenLAB processing software (Agilent, USA), AUW220 electronic balance (SHIMADZU, Japan).

[0074] (3) Preparation of samples to be tested

[0075] The concentration of human interleukin-12 injection is 15 μg / ml.

[0076] (4) Preparation of mobile phase

[0077] Mobile phase A: Pipette 0.5mL of trifluoroacetic acid into a 1L volumetric flask, add water to make the volume, stand for 5min, and then test on the machine;

[0078] Mobile phase B: Pipette 0.5mL of trifluoroacetic acid into a 1L volumetric flask, add acetonitrile to the volume, put it into ultrasonic treatment for degassing for 20min, and set aside.

[0079] (5) Chromatographic conditions

[0080] Chromatographic column: YMC C4 liquid chromatography column (250mm×4.6mm I.D.S-5μm);

[00...

Embodiment 3

[0086] Example 3: Specificity, Column Efficiency, Resolution, Precision Verification Experiment

[0087] S1: Specificity verification experiment:

[0088] (S1-1) Solvent blank interference experiment

[0089] Experimental method: Use a pipette to suck up 1000 μl of mobile phase A and mobile phase B, and inject them into the liquid chromatograph respectively. The chromatographic conditions are the same as those in Example 1, and record the chromatogram to investigate whether the blank mobile phase has any interference effect on the chromatographic measurement results. , the experiment uses mobile phase A as the loading sample, and the chromatogram is obtained. figure 1 ; Take mobile phase B as the loading sample to obtain a chromatogram figure 2 .

[0090] (S1-2) Preparation Buffer Interference Experiment

[0091] Experimental method: Use a pipette to suck up 1000 μl of the preparation Buffer and inject it into a liquid chromatograph. The chromatographic conditions are the...

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Abstract

The invention provides a method for detecting the purity of interleukin-12 injection, which belongs to the field of medical inspection and drug analysis. The detection method provided by the present invention mainly includes the steps of sample preparation, mobile phase preparation, and chromatographic detection. By optimizing the mobile phase ratio, adjusting the sample loading method, adjusting detection time, detection wavelength and column temperature, etc. The specificity, detection limit and durability of the detection are improved, and the detection data with higher accuracy and reliability can also be obtained by using this method. The detection method provided by the invention has very broad application prospects in the fields of medical inspection and drug analysis, and has great practical application value.

Description

technical field [0001] The invention belongs to the field of medical testing and drug analysis, in particular to a method for detecting the purity of interleukin-12 injection. Background technique [0002] Interleukin-12 injection is a cell growth factor with a wide range of biological activities and belongs to biological drugs. Biological drugs usually have defects such as poor stability, so the purity of their injections is one of the quality indicators that needs to be paid attention to. [0003] The solid phase carrier of reversed-phase high performance liquid chromatography has hydrophobicity, which can interact with different strengths and weaknesses according to the different hydrophobicity of the separated substances in the mobile phase, so that different molecules can be separated from each other in the reversed-phase column. However, when the above-mentioned reversed-phase high performance liquid chromatography method is used to determine the purity of human inter...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 刘忠凯魏文王彦娜王媛媛
Owner KANGLITAI BIOMEDICAL (QINGDAO) CO LTD