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Detection and control method of glucose degradation products in compound electrolyte injection

A technology for compound electrolytes and degradation products is applied in the field of detection and control of glucose degradation products in electrolyte injections, which can solve problems such as influence of drug quality control, toxic and side effects, and achieve the effects of ensuring safe medication and controllability.

Inactive Publication Date: 2018-06-29
青岛力腾医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These glucose degradation products themselves have different degrees of toxic and side effects, and will be further derivatized to form more toxic polymers, which have a huge impact on the quality control of drugs.

Method used

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  • Detection and control method of glucose degradation products in compound electrolyte injection
  • Detection and control method of glucose degradation products in compound electrolyte injection
  • Detection and control method of glucose degradation products in compound electrolyte injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] The HPLC determination of embodiment 1 glucose degradation product—3-DG, glyoxal and methylglyoxal

[0056] 1) Preparation of reference substance solution: Prepare a solution containing 3-deoxyglucosone, glyoxal and methylglyoxal at a concentration of 20 μg / ml, accurately measure 1.0ml, place them in 10ml measuring bottles, add water to the mark, and shake well Standby; take 1ml of reference substance solution (3-deoxyglucosone, glyoxal and methylglyoxal concentration is 2μg / ml), add water 1ml, then add o-phenylenediamine solution (4mg / ml) 1.2ml, mix well, adjust When the pH value reached 7.0, it was obtained by filtering at room temperature for 1 hour in the dark.

[0057] 2) Preparation of the test solution: Take 1ml of the glucose-containing electrolyte injection for children to be tested, add 0.6ml of o-phenylenediamine solution (4mg / ml), mix well, adjust the pH value to 7.0, and place it at room temperature for 1h Filter and serve.

[0058] 3) HPLC detection: C...

Embodiment 2

[0061] The methodological investigation of the HPLC detection of embodiment 2 3-DG, glyoxal and methylglyoxal

[0062] 1) Limit of detection and limit of quantitation

[0063] According to the method of Example 1, quantitatively dilute each impurity solution until the signal-to-noise ratio of each impurity peak is about 3, the calculated detection concentration of 3-deoxyglucosone is 0.2 μg / ml, the injection volume is 20 μl, and the detection limit is 4ng; The detection concentration of glyoxal was 0.2μg / mL, the injection volume was 15μl, and the detection limit was 3ng; the detection concentration of methylglyoxal was 0.2μg / mL, the injection volume was 20μl, and the detection limit was 4ng.

[0064] 2) Linearity and range

[0065] According to the method of Example 1, prepare a solution containing 3-deoxyglucosone, glyoxal and methylglyoxal at a concentration of 20 μg / ml, accurately measure 0.25, 0.5, 1.0, 2.0, 4.0ml, and place them in 10ml measuring bottles Add water to ...

Embodiment 3

[0100] Embodiment 3 Degradation products of glucose—5-hydroxymethylfurfural, furfural, levulinic acid determination

[0101] 1) Preparation of reference solution: Precisely prepare a solution containing 2 μg / ml of 5-hydroxymethylfurfural and furfural and 200 μg / ml of levulinic acid.

[0102] 2) Test solution: 1ml of glucose-containing electrolyte injection sample for children to be tested.

[0103] 3) HPLC detection:

[0104] Mobile phase: 0.015mol / L sodium dihydrogen phosphate (adjust pH2.60 with phosphoric acid): acetonitrile (90:10 volume ratio)

[0105] Detection wavelength: 283nm

[0106] Flow rate: 0.8ml / min

[0107] Column temperature: 30°C

[0108] Injection volume: 20μl

[0109] 4) Determination method: draw respectively 20 μ l of reference substance solution and need testing solution, inject high performance liquid chromatograph, measure, obtain high performance liquid chromatogram ( image 3 with Figure 4 ), measure the peak areas of the components to be t...

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Abstract

The invention provides a detection and control method of glucose degradation products in a compound electrolyte injection for children. The glucose degradation products is prepared from various othersubstances including 5-hydroxymethylfurfurale 5-HMF; the quality controllability of the child medicine is ensured, so that the safe medication is ensured.

Description

technical field [0001] The invention belongs to the field of drug analysis and production, in particular to a method for detecting and controlling glucose degradation products in glucose-containing electrolyte injections for children. Background technique [0002] This product involves a compound electrolyte injection for children that has been marketed outside of China. According to its published prescription composition, its pH range is set within the range of 5.0 to 7.0. According to the nature of glucose and the content of industrial production The experience of glucose injection is that it is unstable at higher pH or lower pH conditions, especially when the pH is greater than 5.0, glucose will easily undergo degradation reactions and produce a series of degradation products, thus Therefore, the pH of the glucose-containing injections of various drug manufacturers is usually controlled between 3.5 and 5.0. These glucose degradation products themselves have varying degre...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 宋明非孙建王文彦
Owner 青岛力腾医药科技有限公司
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