Multinomial liquid quality control material and preparation method thereof

A technology of quality control substances and liquids, applied in the field of medical inspection quality control, can solve the problems of pathogenic microorganisms, difficulty in meeting actual needs, and few quality control components, and achieve a wide range of applications

Active Publication Date: 2013-08-21
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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  • Multinomial liquid quality control material and preparation method thereof
  • Multinomial liquid quality control material and preparation method thereof
  • Multinomial liquid quality control material and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Step 1: Collect blood waste from clinical tests, which requires normal liver function, negative HBsAg, no hemolysis and jaundice;

[0052] Step two, separate the serum from the blood;

[0053] Step 3: Analyze and determine the content of each quality control component in the serum according to conventional methods;

[0054] Step 4: Adjust the content of each analytical component according to the requirements of the quality control substance, and add the corresponding substances to achieve the required concentration;

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

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

[0057] Step 7, analyze the content of ...

Embodiment 2

[0061] Step 1: Collect fresh pig blood;

[0062] Step two, separate the serum from the blood;

[0063] Step 3: Analyze and determine the content of each quality control component in the serum according to conventional methods;

[0064] Step 4: Adjust the content of each analytical component according to the requirements of the quality control substance, and add the corresponding substances to achieve the required concentration;

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

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

[0067] Step 7, analyze the content of each quality control component in the quality control and determine its value;

[0068] Step 8, fi...

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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 plurality of liquid quality control substances and a preparation method thereof. Background technique [0002] Quality control is an important subject in inspection work. At present, the quality control materials used in most medical tests are freeze-dried quality control materials. Because the freeze-dried quality control material will produce errors in the process of aliquoting, freeze-drying and reconstitution, and is unstable to enzymes, it is unstable at room temperature or 4℃ after reconstitution, and there are various potential pathogenic microorganisms. Deviations in the quality control process. [0003] Liquid quality control materials are gradually being used because they can solve the problem of reconstitution error. However, the storage stability of liquid quality control materials is difficult to guarantee. For this reason, some studies have proposed ad...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/96
Inventor 明德松林振忠
Owner 明德松
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