Method for detecting anhydrous dextrose bacteria endotoxin content by spectrophotometry

An anhydrous glucose, bacterial endotoxin technology, applied in the field of analytical chemistry, can solve the problems of the specific value of endotoxin cannot be accurately known, wrong judgment, misleading production and so on

Inactive Publication Date: 2009-03-18
XIWANG GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The specific value of the endotoxin content in the sample cannot be accurately known
And when the content of endotoxin is less than 0.03EU / mL, it is easy to produce false positives with the gel method, which makes the result wrongly judged, misleads the production, and causes unnecessary losses to the enterprise.

Method used

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Experimental program
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Embodiment Construction

[0011] The detection method of the present invention is established and confirmed through the following tests.

[0012] 1. Preparation and investigation of the standard curve

[0013] 1. Preparation of standard curve

[0014] First, dissolve the bacterial endotoxin working standard with 1mL of bacterial endotoxin test water, mix on a vortex mixer for 15 minutes, and then prepare 2EU / mL, 1EU / mL, 0.5EU / mL, 0.125EU / mL, 0.0325EU / mL for later use, and then the reconstituted photometric limulus reagent was divided into 10 special test tubes for quantitative analysis. For parallel tubes, add 0.2ml to each tube, and add 0.2ml of BET water (water for bacterial endotoxin testing) to each of the remaining two tubes as a negative control.

[0015] 2. Validation of the standard curve

[0016] pipe number Endotoxin (EU / ml) Response time (seconds) coefficient of variation Measured endotoxin 1 0 >7200 0 2 0 >7200 3 2.0 790 0.36％ 2.0118 4 2...

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Abstract

The invention relates to a method for using luminous intensity to test the bacterial endotoxin content of glucosum anhydricum, belonging to the analytical chemistry technical field. The technical scheme is that: using luminous intensity to test the reaction time from the reaction of limulus polyphemus agent and the endotoxin to the turbidity of the mixture reaching a preset absorbency; finding the endotoxin content of the object glucosum anhydricum sample. According to the scheme, the method dilutes an endotoxin operation standard sample of known content into operation standard sample series of different contents, tests the times of different endotoxin content standards reaching the preset absorbency, and draws a standard curve; and tests the time of the object glucosum anhydricum sample reaching the preset value, to find the content of the endotoxin of the glucosum anhydricum sample.

Description

Technical field [0001] The invention belongs to the field of analytical chemistry and relates to a photometric method for measuring the content of anhydrous glucose bacterial endotoxin. Background technique [0002] A class of substances that cause fever in mammals and hot bodies due to injection are collectively referred to as heat sources. The heat source of injection contamination produced under GMP (Government Manufacturing Practice) conditions is bacterial endotoxin. Bacterial endotoxin is a lipopolysaccharide structure (hairless) embedded in the cell wall of G-bacteria, which can cause fever in mammals and humans. Therefore, many infusion manufacturers using anhydrous glucose pay great attention to the content of bacterial endotoxin in the sugar, so as to avoid the infusion reaction of the human body. In the current national pharmacopoeia, only the endotoxin content of glucose infusion is regulated, but there is no definition for anhydrous glucose raw materials. [0...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/579G01N21/82
Inventor 王勇王岩刘剑侠张全刚程平王非何玉梅
Owner XIWANG GROUP
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