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Multinomial liquid quality control material and preparation method thereof

A technology for quality control substances and liquids, applied in the field of medical inspection quality control, can solve the problems of pathogenic microorganism hazards, restrict the application of liquid quality control substances, and few quality control components, and achieve a wide range of applications.

Active Publication Date: 2010-06-30
明德松
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after using ethylene glycol or glycerol as a stabilizer, the liquid quality control substance still cannot be stored at room temperature or the storage time is short, which limits the application of this type of liquid quality control substance
[0004] Not only that, but the existing liquid quality control substances still have pathogenic microorganism hazards caused by the existence of various potential pathogenic microorganisms, and the existing liquid quality control substances usually have less quality control components, which is difficult to meet actual needs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Step 1, collecting waste blood for clinical examination, requiring normal liver function, negative HBsAg, no hemolysis and jaundice;

[0052] Step 2, separating the serum in the blood;

[0053] Step 3, analyzing and determining the content of each quality control component in the serum according to a conventional method;

[0054] Step 4, according to the requirements of the quality control substance, adjust the content of each analysis component, and add the corresponding substance to make it reach the required concentration;

[0055] Step 5, using methylene blue photosensitive inactivation method to inactivate various potential pathogenic microorganisms;

[0056] Step 6, adding a composite protective agent composed of ethylene glycol and glycerol in a volume ratio of 1:1, accounting for 30% of the total volume of the quality control substance, is prepared into a quality control substance, wherein ethylene glycol and glycerol are analytically pure;

[0057] Step 7, an...

Embodiment 2

[0061] Step 1, collecting fresh pig blood;

[0062] Step 2, separating the serum in the blood;

[0063] Step 3, analyzing and determining the content of each quality control component in the serum according to a conventional method;

[0064] Step 4, according to the requirements of the quality control substance, adjust the content of each analysis component, and add the corresponding substance to make it reach the required concentration;

[0065] Step 5, using methylene blue photosensitive inactivation method to inactivate various potential pathogenic microorganisms;

[0066]Step 6, adding a composite protective agent composed of ethylene glycol and glycerol in a volume ratio of 1:1, accounting for 40% of the total volume of the quality control substance, is prepared into a quality control substance, wherein ethylene glycol and glycerol are analytically pure;

[0067] Step 7, analyzing and determining the content of each quality control component in the quality control subst...

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PUM

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Abstract

The invention relates to the field of the medical test quality control, in particular to a multinomial liquid quality control material and a preparation method thereof. The preparation method comprises the following steps: collecting waste blood of a blood bank; carrying out clinical examination on a waste blood sample or mammal blood; separating serum or blood plasma; analyzing the content of each quality control components in the serum or the blood plasma; adjusting each analysis component; adopting a methylene blue photosensitive inactivation method to inactivate various potential pathogenic microorganisms; and adding a composite protective agent to prepare the quality control material. As the invention adds the composite protective agent consisting of glycol and glycerol into the quality control material, each analysis component in the quality control material is stable, can be stable for one month at room temperature, can be stable for 2 to 4 months at a temperature of 4 DEG C, and can be stable for 12 months at a temperature of minus 20 DEG C. Moreover, the quality control material of the invention adopts the methylene blue photosensitive inactivation method to inactivate various potential pathogenic microorganisms, thereby having no potential pathogenic microorganism harmfulness.

Description

technical field [0001] The invention relates to the field of medical inspection quality control, in particular to a multiple liquid quality control substance and a preparation method thereof. Background technique [0002] Quality control is an important topic in the inspection work. At present, the quality control substances used in most medical laboratories are freeze-dried quality control substances. Because the lyophilized quality control substance will produce errors in the process of subpackaging, lyophilization and reconstitution, and it is unstable for enzyme storage, unstable at room temperature or 4°C after reconstitution, and there are various potential pathogenic microorganisms, so that the whole Quality control process produces deviations. [0003] Liquid quality control substances are gradually being used because they can solve the problem of reconstitution errors, but the storage stability of liquid quality control substances is difficult to guarantee. For th...

Claims

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Application Information

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IPC IPC(8): G01N33/96
Inventor 明德松林振忠
Owner 明德松
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