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Method for detecting glucose degradation product in compound electrolyte injection

A compound electrolyte and degradation product technology, applied in the field of analytical chemistry, can solve problems such as the absence of glucose degradation products, and achieve the effects of easy separation and analysis, reduced impurities, and guaranteed quality and safety

Inactive Publication Date: 2021-01-26
青岛力腾医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no technical requirement related to glucose degradation products in the drug standard of this product

Method used

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  • Method for detecting glucose degradation product in compound electrolyte injection
  • Method for detecting glucose degradation product in compound electrolyte injection
  • Method for detecting glucose degradation product in compound electrolyte injection

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Embodiment 1

[0031] A method for the detection of glucose degradation products in compound electrolyte injection

[0032] This product is a sterilized aqueous solution of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and glucose. Containing sodium acetate (CH3COONa 3H2O), anhydrous glucose (C6H12O6) should be 90.0% ~ 110.0% of the labeled amount; containing sodium chloride (NaCl), potassium chloride (KCl), calcium chloride (CaCl2 2H2 O ), magnesium chloride (MgCl2 6H2 O) should be 93.0% to 107.0% of the marked amount.

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Abstract

The invention discloses a method for detecting a glucose degradation product in a compound electrolyte injection. The method comprises the following steps: S1, mixing the compound electrolyte injection with a derivatization reagent, and carrying out derivatization reaction at room temperature in a dark place to obtain a test solution; S2, taking a reference substance, and carrying out a derivativereaction according to the method in the step S1 to obtain a comparison solution; S3, taking water, and carrying out a derivative reaction according to the method in the step S1 to obtain a blank solution; S4, carrying out liquid chromatographic analysis on the obtained test solution, the comparison solution and the blank solution, taking octadecylsilane chemically bonded silica as a filler for achromatographic column, and calculating the number of theoretical plates according to the peak of a reference substance to be not less than 2000; and S5, calculating the content of the reference substance in the compound electrolyte injection according to the obtained peak area standard curve of the reference substance and the peak area of the compound electrolyte injection. According to the detection method disclosed by the invention, impurities in the derivative are obviously reduced, the peak shape and the separation degree are improved, meanwhile, the peak appearance time is shortened, andthe detection process is shortened.

Description

technical field [0001] The invention belongs to the technical field of analytical chemistry, in particular to a method for detecting glucose degradation products in compound electrolyte injections. Background technique [0002] During the preparation of the dextrose aqueous solution, glucose degradation products will be produced. The content of glucose in the solution is different, the pH value of the solution is different, and the specific method of sterilization is different, which will lead to different types and contents of glucose degradation products produced in the solution sterilization process. [0003] The present invention is directed to aqueous solutions with low glucose content, the concentration of glucose being lower than 20.0 g / 1000 ml. Specifically, the compound electrolyte injection targeted by the present invention is a sterilized aqueous solution of sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate and glucose, whi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34
CPCG01N30/02G01N30/06G01N30/34G01N2030/067
Inventor 王文彦孙建
Owner 青岛力腾医药科技有限公司
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