Testing reagent for activated partial thromboplastin time and preparation method of testing reagent

An activator and reagent technology, applied in the field of activated partial thromboplastin time assay reagents and its preparation, can solve the problems of reducing accuracy, increasing the use of raw materials, and difficulty in control, etc., to achieve improved accuracy, strong stability, and production High safety effect

Active Publication Date: 2015-12-30
QINGDAO GUGAO BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among these commonly used stabilizers, butylated hydroxytoluene has certain toxicity and is relatively less toxic, while sodium azide is more toxic and is easy to detonate when it comes into contact with copper pipes, etc. Therefore, the use of raw materials in the production process is increased. and control difficulty
In addition, in addition to adding butylated hydroxytoluene or butylated hydroxyanisole, sodium azide, in order to further improve the stability of the activated partial thrombin assay reagent, polysaccharide or polyol polymers are added to the reagent (JP2994557B2, JP3330685B2) , the addition of such substances can improve the dispersibility and uniformity of the composition contained in APTT, especially the activator, or as a suspending agent, increase the viscosity of the solution, so that the colloidal particles can be suspended in the solution for a long time without sedimentation, However, the addition of this type of polymer compound will reduce the accuracy of the APTT value measured by the optical method while increasing the viscosity of the mixed liquid.

Method used

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  • Testing reagent for activated partial thromboplastin time and preparation method of testing reagent
  • Testing reagent for activated partial thromboplastin time and preparation method of testing reagent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Weigh 1.5g of hydroxyethylpiperazine ethylsulfuric acid, add it into a glass bottle with a volume of 1.5L, add deionized water to 500mL, stir to dissolve, adjust the pH to 7.3 with dilute sodium hydroxide solution, add 15g of sodium chloride , 0.2g nano silicon dioxide. After stirring and mixing, add 0.3g mixed phospholipids (0.1g phosphatidylserine and 0.2g phosphatidylglycerol), after thorough mixing, add 0.4g butyl hydroxytoluene, 0.5g polyethylene glycol and 0.5g azide Sodium, dilute to 1L. After stirring and mixing and filtering, the filtrate is the liquid APTT assay reagent.

Embodiment 2

[0023] Weigh 1.5g of hydroxyethylpiperazine ethylsulfuric acid, add it into a glass bottle with a volume of 1.5L, add deionized water to 500mL, stir to dissolve, adjust the pH to 7.3 with dilute sodium hydroxide solution, add 15g of sodium chloride , 0.2g nano silicon dioxide. After stirring and mixing, add 0.3g mixed phospholipids (0.1g phosphatidylserine and 0.2g phosphatidylglycerol), after thorough mixing, add 0.4g butyl hydroxytoluene, 0.5g polyethylene glycol, 12g alanine , 1.5mM catechin, dilute to 1L. After stirring and mixing and filtering, the filtrate is the liquid APTT assay reagent.

[0024] The preparation composition of embodiment 1 and embodiment 2 is basically the same, but in embodiment 2, replace the sodium azide added in embodiment 1, and change corresponding alanine and catechin into.

[0025] The APTT assay reagent prepared in Example 1 and Example 2 was combined with 25 mM calcium chloride, and the activated partial thrombin time of normal human fresh ...

Embodiment 3

[0030] Effect of Alanine Amount on Activated Partial Thrombin Time Reagent

[0031] Weigh 1.7g of hydroxyethylpiperazine ethylsulfuric acid, add it into a glass bottle with a volume of 1.5L, add deionized water to 500mL, stir to dissolve, adjust the pH to 7.3 with dilute sodium hydroxide solution, add 10g of sodium chloride , 0.6g nano silicon dioxide. After stirring and mixing, add 0.4g mixed phospholipids (0.1g each of phosphatidylethanolamine, phosphatidylserine, phosphatidylcholine and phosphatidylglycerol), and after thorough mixing, add 1g polyethylene glycol, 0.4g butyl Hydroxytoluene, 1g ascorbic acid, 1.5mM catechin, and alanine were added in different amounts, and the mixed solution was dilute to 1L with deionized water. After stirring and mixing and filtering, the filtrate is the liquid APTT assay reagent.

[0032] Combine the obtained activated partial thrombin time reagent with 25mM calcium chloride, and use a CA1500 automatic coagulation analyzer to measure the...

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Abstract

The invention relates to a testing reagent for activated partial thromboplastin time. The testing reagent is prepared from phospholipids, activator and stabilizer. The stabilizer is prepared from, by mass, 1%-4% of alanine and 0.5-5 mM of catechin. A preparation method of the testing reagent includes the steps that an HEPES buffer solution is prepared, the pH value of the buffer solution is adjusted to be neutral, and sodium chloride is added; the activator is added to the buffer solution, phospholipids and other components are added after stirring and even mixing are conducted, and then the testing reagent for APTT is obtained after even mixing, stirring and filtering are conducted. According to the testing reagent for activated partial thromboplastin time, stabilizer components with high toxicity are removed, so that production and use processes are safer; meanwhile, the stability and detection accuracy of the testing reagent for APTT are greatly improved.

Description

technical field [0001] The invention relates to a coagulation reagent and a preparation method thereof, in particular to an activated partial thromboplastin time determination reagent and a preparation method thereof. Background technique [0002] Activated partial thromboplastin time (APTT) can be used to judge the state of endogenous coagulation activity, and is one of the main clinical coagulation performance test indicators. The main components of the activated partial thromboplastin time assay reagent are activator and phospholipids, which are lipids containing phosphoric acid and belong to complex lipids. As platelet substitutes, phospholipids participate in the intrinsic coagulation pathway. As one of the main components of activated partial thromboplastin time assay reagents, phospholipids are rich in unsaturated fatty acids, which are easily oxidized to produce a series of lipid peroxidation, which affects its physiological activity. Taking phosphatidylcholine as ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 胡小伟王华高军
Owner QINGDAO GUGAO BIOTECH CO LTD
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