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Preparation method of plasma and serum endogenous small molecule compound quality control material

A preparation method, endogenous technology, applied in the field of testing

Pending Publication Date: 2022-05-13
HANGZHOU BAICHEN MEDICAL INSTR CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] The purpose of the present invention is to solve the defects of the existing quality control product preparation method, and provide a kind of plasma and serum endogenous small molecule compound quality control product preparation method, the quality control product configured by the method of the present invention is suitable for clinical reference Range and measurement range of liquid chromatography tandem mass spectrometry detection method, and can be stored for a long time

Method used

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  • Preparation method of plasma and serum endogenous small molecule compound quality control material
  • Preparation method of plasma and serum endogenous small molecule compound quality control material
  • Preparation method of plasma and serum endogenous small molecule compound quality control material

Examples

Experimental program
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Embodiment 1

[0033] The present embodiment provides a dialysis method. First, the collected plasma or serum is dialyzed. The dialysis bag is first boiled with 50% ethanol for 1 hour, and then successively with 50% ethanol, 0.01mol / L sodium bicarbonate and 1mmol / L EDTA ( pH=8.0) solution, and finally rinsed twice with distilled water. Add 10mL of plasma or serum to the dialysis bag, put the dialysis bag into 100ml of water at 4°C and dialyze 3 times, 1 hour each time.

[0034] After the dialysis, an appropriate amount of dialysis serum or plasma was taken to detect whether the dialysis was successful by liquid chromatography tandem mass spectrometry. The results are shown in Table 1-Table 4 respectively.

[0035] Table 1 Amino acid concentration before and after dialysis

[0036]

[0037]

[0038] Table 2 Concentration of trimethylamine oxide and its metabolic profile before and after dialysis

[0039]

[0040]

[0041] Table 3 Concentrations of 11 steroid hormones before and ...

Embodiment 2

[0048] This embodiment provides the preparation method of amino acid low and high quality control:

[0049] Low amino acid, high quality control preparation method, take the dialyzed plasma in Example 1, add the amino acid mixture according to the clinical reference range and analysis measurement range, mix well, the ratio of plasma to amino acid mixture is 1:1-100:1, The theoretical concentration of each amino acid quality control is shown in Table 5.

[0050] Table 5 amino acid quality control concentration

[0051]

[0052]

[0053]

Embodiment 3

[0055] This example provides a preparation method for trimethylamine oxide and its metabolic profile with low and high quality control: take the dialyzed plasma in Example 1, add trimethylamine oxide and its metabolic profile mixture according to the clinical reference range and analysis measurement range, and mix well , the ratio of plasma to trimethylamine oxide and its metabolic profile mixture is 1-100:1, and the theoretical concentration of trimethylamine oxide and its metabolic profile for quality control is shown in Table 6.

[0056] Table 6 Trimethylamine oxide and its metabolic profile quality control concentration

[0057]

[0058]

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Abstract

The invention provides a preparation method of a plasma and serum endogenous small molecule compound quality control product, which comprises the following steps: collecting mixed plasma and serum, dialyzing by using a dialysis bag to remove various free amino acids, trimethylamine oxide and metabolites thereof, steroid hormones, water-soluble vitamins and other endogenous small molecule compounds in the plasma; adding low-concentration and high-concentration amino acids, trimethylamine oxide and metabolites thereof, steroid hormones and water-soluble vitamins which are suitable for a clinical reference range and a measurement range of a liquid chromatography-tandem mass spectrometry detection method, and uniformly mixing for low-quality control and high-quality control of endogenous small molecular compound plasma and serum; and storing at-80 DEG C under low quality control and high quality control. The quality control product obtained by the method is suitable for a clinical reference range and a measurement range of a liquid chromatography-tandem mass spectrometry detection method, can be stored and used for a long time, and does not need to be frequently prepared.

Description

technical field [0001] The invention belongs to the technical field of testing, and in particular relates to a method for preparing quality control products of plasma and serum endogenous small molecule compounds. Background technique [0002] Liquid chromatography tandem mass spectrometry is used to clinically detect the concentration of small molecule compounds in plasma or serum, and appropriate quality control substances are needed to evaluate the stability of the detection method and the reliability of the results. The existing preparation methods of quality control products are as follows: 1. Screen low-concentration or high-concentration plasma or serum and mix them as low-quality control and high-quality control respectively; 2. Collect mixed plasma samples, dilute several times to obtain low-quality control, and add A high quality control is obtained at a certain concentration; 3, a low quality control and a high quality control are prepared with a matrix containing...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/86
CPCG01N30/06G01N30/8665
Inventor 高强薛建有吴超超李鸣晖杨利娜
Owner HANGZHOU BAICHEN MEDICAL INSTR CO LTD
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