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Lipid quality control product and preparation method thereof

A technology for quality control substances and lipids, applied in the field of clinical medical testing, can solve the problems of matrix effects, inconvenient quality control, and incomplete inclusion of items, and achieve the effects of stable channel sources, wide application range, and reduced matrix effects.

Pending Publication Date: 2020-04-21
郑州标源生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the lipid quality control products used in clinical laboratories have the following defects: ① Most of them are imported brands, which are expensive and have a long purchase cycle; ② The validity period is short; ③ The items included are not complete, which can no longer meet the clinical needs; ④ Must be combined with reagents Supporting the use of
Moreover, at present, the source of lipid quality control matrix solution is usually animal serum, which is less consistent with the test results of clinical samples and has matrix effects, which brings a lot of inconvenience to the daily quality control of the laboratory.

Method used

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  • Lipid quality control product and preparation method thereof
  • Lipid quality control product and preparation method thereof
  • Lipid quality control product and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: lipid quality control product of the present invention

[0031] The matrix solution is composed of the following components: normal human serum, 50mmol / LHEPES buffer, 50g / L trehalose, 0.2%NaN 3 ;

[0032] The content of the lipid component:

[0033] 1) The content of each lipid component in the high-level lipid quality control product is total cholesterol (TC) 8.0mmol / L, triglyceride (TG) 4.0mmol / L, high-density lipoprotein cholesterol (HDL-C) 1.6mmol / L, low-density lipoprotein cholesterol (LDL-C) 5.0mmol / L, apolipoprotein A1 (ApoA-1) 2.5g / L, apolipoprotein B (ApoB) 1.6g / L, lipoprotein a( Lp(a)) 300mg / L, small and dense low-density lipoprotein cholesterol (sd LDL-C) 2.5mmol / L;

[0034] 2) The content of each lipid component in the middle-level lipid quality control product is: total cholesterol (TC) 5.5mmol / L, triglyceride (TG) 2.5mmol / L, high-density lipoprotein cholesterol (HDL-C ) 1.3mmol / L, low-density lipoprotein cholesterol (LDL-C) 3.5mmol / L, apo...

Embodiment 2

[0036] Embodiment 2: lipid quality control product of the present invention

[0037] The matrix solution is composed of the following components: normal human serum, 25mmol / L HEPES buffer, 100g / L sucrose, 0.15% Proclin300;

[0038] The content of the lipid component:

[0039] 1) The content of each lipid component in the high-level lipid quality control product is total cholesterol (TC) 8.3mmol / L, triglyceride (TG) 4.5mmol / L, high-density lipoprotein cholesterol (HDL-C) 1.5mmol / L, low-density lipoprotein cholesterol (LDL-C) 4.8mmol / L, apolipoprotein A1 (ApoA-1) 2.3g / L, apolipoprotein B (ApoB) 1.5g / L, lipoprotein a ( Lp(a)) 280mg / L, small and dense low-density lipoprotein cholesterol (sd LDL-C) 2.4mmol / L;

[0040] 2) The content of each lipid component in the middle-level lipid quality control product is: total cholesterol (TC) 5.8mmol / L, triglyceride (TG) 2.6mmol / L, high-density lipoprotein cholesterol (HDL-C ) 1.3mmol / L, low-density lipoprotein cholesterol (LDL-C) 3.6mmol / ...

Embodiment 3

[0042] Embodiment 3: lipid quality control product of the present invention

[0043] The matrix solution is composed of the following components: normal human serum, 75mmol / LHEPES buffer, 50g / L pentaerythritol, 0.2%NaN 3 ;

[0044] The content of the lipid component:

[0045] 1) The content of each lipid component in the high-level lipid quality control product is total cholesterol (TC) 7.5mmol / L, triglyceride (TG) 4.2mmol / L, high-density lipoprotein cholesterol (HDL-C) 1.5mmol / L, low-density lipoprotein cholesterol (LDL-C) 4.5mmol / L, apolipoprotein A1 (ApoA-1) 2.2g / L, apolipoprotein B (ApoB) 1.5g / L, lipoprotein a ( Lp(a)) 310mg / L, small and dense low-density lipoprotein cholesterol (sd LDL-C) 2.3mmol / L;

[0046] 2) The content of each lipid component in the middle-level lipid quality control product is: total cholesterol (TC) 5.5mmol / L, triglyceride (TG) 2.5mmol / L, high-density lipoprotein cholesterol (HDL-C ) 1.1mmol / L, low-density lipoprotein cholesterol (LDL-C) 3.2mmol...

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Abstract

The invention belongs to the field of clinical medicine detection, and discloses a lipid quality control product and a preparation method thereof. The lipid quality control product disclosed by the invention consists of a matrix liquid and lipid components, wherein the matrix liquid is prepared from the following components: a matrix, 10 to 80 mmol / L of a HEPES buffer solution, 5 to 200 g / L of sugar and 0.001 to 0.5 percent of a preservative; a lipid marker comprises total cholesterol, triglyceride, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, apolipoprotein A1, apolipoprotein B, lipoprotein a and small and dense low-density lipoprotein cholesterol. The lipid quality control product disclosed by the invention contains eight lipids, and can achieve quality control of different detection items by detecting one quality control sample, so that combined detection of different lipid items is realized. The lipid quality control product disclosed by the inventionis good in product uniformity, long-term storage stability and stability after redissolution and wide in application range, and the shelf life of the lipid quality control product at 2-8 DEG C is 24 months.

Description

technical field [0001] The invention belongs to the field of clinical medical testing, and in particular relates to a lipid quality control product and a preparation method thereof. Background technique [0002] Blood lipids are the general term for neutral fats (triglycerides and cholesterol) and lipids (phospholipids, glycolipids, sterols, steroids) in plasma. They are widely present in the human body and are essential substances for the basic metabolism of living cells. The main components of blood lipids are triglycerides and cholesterol, of which triglycerides participate in energy metabolism in the human body, and cholesterol is mainly used for the synthesis of cell membranes, steroid hormones and bile acids. Since triglycerides and cholesterol are hydrophobic substances, they cannot be transported directly in the blood, and they cannot directly enter tissue cells. They must form a hydrophilic substance together with special proteins and lipids (such as phospholipids) ...

Claims

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Application Information

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IPC IPC(8): C12Q1/60C12Q1/61G01N33/68
CPCC12Q1/60C12Q1/61G01N33/68
Inventor 赵晓转郭利杰王新明刘功成
Owner 郑州标源生物科技有限公司
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