Cardiovascular and cerebrovascular and diabetes related four-high index composite quality control product and preparation method thereof

A technology for cardiovascular and cerebrovascular and quality control products, applied in the field of medical diagnosis, to achieve the effect of long storage time, ensuring consistency and improving accuracy

Active Publication Date: 2021-01-05
SINOCARE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Combining multiple quality control substances at the same time needs to fully consider the stability after compounding and the matrix effect during detection. However, none of the current products or processes involve all of them.

Method used

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  • Cardiovascular and cerebrovascular and diabetes related four-high index composite quality control product and preparation method thereof
  • Cardiovascular and cerebrovascular and diabetes related four-high index composite quality control product and preparation method thereof
  • Cardiovascular and cerebrovascular and diabetes related four-high index composite quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Embodiment 1: Preparation of composite quality control product of the present invention

[0035] Take 1L of healthy mixed human plasma and place it at 37 degrees to thaw, add 10 mL of protamine sulfate with a concentration of 2-10 mg / mL, stir at 37 degrees for 30 minutes, incubate at room temperature for 2 hours, and then place it at 2-8 degrees for 40 hours to promote fibrin The original degradation product is formed, centrifuged at 10,000rpm for 15min, retaining the supernatant, and filtering with a 0.22μm filter membrane, and the filtered liquid is the matrix fluid with four high indicators.

[0036] Sodium sulfite, bovine serum albumin, sodium heparin, glycerol, uric acid, homocysteine, glucose, low-density lipoprotein cholesterol and preservatives were added to the matrix solution after treatment. The specific composition is shown in Table 1 below.

[0037] Table 1

[0038]

Embodiment 2

[0039] Example 2: Effects of different anticoagulants, reducing agents and polyols on the stability of composite quality control products

[0040] The mixture of disodium EDTA, citric acid and trisodium citrate, which belong to the same anticoagulant as sodium heparin, was selected as the control; Mannitol and sorbitol, which belong to polyols, were used as controls, and the stability comparison of composite quality control products was carried out under the condition that other conditions remained unchanged;

[0041] 1. The influence of different anticoagulants

[0042] Table 2

[0043]

[0044] Prepare three composite quality control products according to the above table 2. After freeze-drying, test the accelerated stability at 37 degrees and the stability of reconstitution and storage in a refrigerator at 2-8 degrees for different days, and test the stability of Glu, Hcy, UA, and LDL-C and observe the appearance after reconstitution, the results are shown in Table 3; ...

Embodiment 3

[0068] Embodiment 3: Comparison of matrix effects of different matrix fluids

[0069] The matrix solutions of quality control products sold in the market are mainly buffer matrix and human blood matrix. In this example, the influence of different matrix solutions on the stability of composite quality control products is compared according to the grouping in Table 8. The results are shown in Table 9.

[0070] Table 8

[0071]

[0072]

[0073] The accelerated stability result of table 9 matrix liquid screening

[0074]

[0075]

[0076] It can be seen from Table 9 that the buffer solution and human serum matrix were used to prepare four high-quality control products, and the matrix was quite different from the clinical samples. The lyophilized powder was accelerated at 37 degrees for 7 days, and the glucose concentration decreased significantly; the stability was poor; However, the matrix solution of the present invention ensures that the matrix is ​​consistent wit...

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Abstract

The invention relates to the technical field of medical diagnosis, and discloses a cardiovascular and cerebrovascular and diabetes related four-high index composite quality control product and a preparation method thereof. The composite quality control product comprises a matrix liquid, a reducing agent, bovine serum albumin, an anticoagulant, polyol, uric acid, homocysteine, glucose, low-densitylipoprotein cholesterol and a preservative. The composite quality control product which can be used for testing four cardiovascular and cerebrovascular and diabetic indexes of Glu, Hcy, UA and LDL-C at the same time can be prepared at a time, healthy human plasma is selected as a matrix liquid raw material, the components are basically consistent with those of serum after treatment, and the matrixeffect is reduced to the maximum extent; meanwhile, by matching with other components, the prepared four-high quality control product has good uniformity and stability, stable performance, long preservation time and simplicity and convenience in use, meanwhile, the accuracy of quality control during joint inspection is greatly improved, and a more accurate basis is provided for clinical diagnosisof cardiovascular and cerebrovascular diseases and diabetes related diseases.

Description

technical field [0001] The invention relates to the technical field of medical diagnosis, in particular to a composite quality control product with four high indicators related to cardiovascular and cerebrovascular diseases and diabetes and a preparation method thereof. Background technique [0002] The glucose content in serum reflects the real-time blood sugar control situation, and strict control of blood sugar level is very necessary in the prevention and treatment of diabetes and other blood sugar disorders. [0003] Homocysteine ​​is one of the independent risk factors for stroke, coronary atherosclerosis and myocardial infarction, and its concentration is directly proportional to the degree of risk of the disease. At the same time, according to the metabolic characteristics of homocysteine, its concentration is also a sensitive indicator of vitamin B12 and folic acid deficiency. [0004] Uric acid (urine acid, UA) is one of the important components of non-protein nit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/92G01N33/66G01N33/50
CPCG01N33/6893G01N33/92G01N33/66G01N33/5002G01N2333/765G01N2800/042G01N2800/32G01N2800/2871G01N2400/40
Inventor 李宗祥赵利旦彭琳戴斌杨赛男
Owner SINOCARE
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