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Thrombin time detection reagent and preparation method thereof

A thrombin time and detection reagent technology, applied in the biological field, can solve the problems of unstable detection results and poor stability

Pending Publication Date: 2019-09-06
SHENZHEN GOLDSITE DIAGNOSTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The main purpose of the present invention is to provide a thrombin time detection reagent and its preparation method, to solve the problem that the current thrombin time detection reagents generally have poor stability, resulting in unstable detection results

Method used

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  • Thrombin time detection reagent and preparation method thereof
  • Thrombin time detection reagent and preparation method thereof
  • Thrombin time detection reagent and preparation method thereof

Examples

Experimental program
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preparation example Construction

[0028] The preparation method of thrombin time detection reagent provided by the invention comprises the following steps:

[0029] Preparation of buffer:

[0030] Weigh the following raw materials: 4-hydroxyethylpiperazineethanesulfonic acid (HEPES), bovine serum albumin, proclin300 preservative, inorganic sodium salt, nonpolar amino acids, sugar alcohols and polysaccharides, add water to the weighed raw materials and mix Obtain mixed solution, described mixed solution can directly be used as buffer solution, wherein, each raw material mass percent in described buffer solution is respectively 0.24wt%~1.2wt% of 4-hydroxyethylpiperazineethanesulfonic acid (10mmol / L~ 50mmol / L), bovine serum albumin 0.5wt% ~ 2wt%, proclin300 preservative 0.1wt% ~ 0.3wt%, inorganic sodium salt 0.3wt% ~ 2wt%, non-polar glycine 0.8wt% ~ 2wt%, sugar alcohol 0.2wt%-2wt%, polysaccharide 0.2wt%-0.5wt%, the balance is water, the inorganic sodium salt includes one of sodium chloride and sodium sulfate, an...

Embodiment 1

[0046] Weigh 4.0g HEPES, 15g bovine serum albumin, 1ml proclin300 preservative, 9g sodium chloride, 20g glycine, 20g mannitol and 3g trehalose, add water to the above raw materials to 1L, adjust the pH to 7.5±0.1, then Filter through a 0.22um filter membrane, take the filtrate to obtain buffer solution 1, and store buffer solution 1 at 4°C until use.

[0047] Add bovine thrombin freeze-dried powder into buffer 1, control the active concentration of bovine thrombin to 4 U / mL, and obtain thrombin time detection reagent 1.

[0048] The prepared thrombin time detection reagent 1 was subpackaged in XX plastic bottles.

[0049] The thrombin time detection reagent 1 prepared in this example includes the following components: bovine thrombin 4U / mL, HEPES 0.4wt%, bovine serum albumin 1.5wt%, proclin300 preservative 0.1wt%, sodium chloride 0.9wt%, glycine 2wt%, mannitol 2wt%, trehalose 0.3wt%, and the balance is water.

[0050] Performance testing:

[0051] (1) Repeatability test

...

Embodiment 2

[0070] Weigh 12g HEPES, 5g bovine serum albumin, 1ml proclin300 preservative, 20g sodium sulfate, 8g alanine, 2g sorbitol and 5g sucrose, add water to the above raw materials to 1L, adjust the pH to 7.5±0.1, and pass Filter through a 0.22um filter membrane, take the filtrate to obtain buffer solution 2, and store buffer solution 2 at 4°C until use.

[0071] Store at 4°C until use.

[0072] Add bovine thrombin freeze-dried powder to the buffer solution 2, control the active concentration of bovine thrombin to 1 U / mL, and obtain thrombin time detection reagent 2.

[0073] The prepared thrombin time detection reagent 2 is divided into polyvinyl chloride plastic bottles.

[0074] The thrombin time detection reagent 2 prepared in this example includes the following components: bovine thrombin 1U / mL, HEPES 1.2wt%, bovine serum albumin 0.5wt%, proclin300 preservative 0.1wt%, sodium sulfate 2wt% %, alanine 0.8wt%, sorbitol 0.2wt%, sucrose 0.5wt%, and the balance is water.

[0075] ...

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Abstract

The invention discloses a thrombin time detection reagent. The thrombin time detection reagent comprises components with the following contents: 1U / mL to 10U / mL of bovine thrombin, 0.24wt% to 1.2wt% of 4-hydroxyethylpiperazine ethane sulfonic acid, 0.5wt% to 2wt% of bovine serum albumin, 0.1wt% to 0.3wt% of a proclin300 preservative, 0.3wt% to 2wt% of inorganic sodium salt, 0.8wt% to 2wt% of non-polar glycine, 0.2wt% to 2wt% of sugar alcohol, 0.2wt% to 0.5wt% of polysaccharide and the remaining amount of water. The invention also discloses a preparation method of the thrombin time detection reagent. The thrombin time detection reagent prepared by the invention is good in reproducibility and high in stability, also has high correlation with the listed thrombin time detection reagent, and can improve the stability of the thrombin time detection results.

Description

technical field [0001] The invention relates to the field of biotechnology, in particular to a thrombin time detection reagent and a preparation method thereof. Background technique [0002] Thrombin time (TT) is the time required for coagulation by adding a certain amount of thrombin reagent to the plasma to be tested, and fibrinogen becomes insoluble fibrin. TT is a simple test to detect the function of coagulation, anticoagulation and fibrinolysis system. It is widely used in the monitoring and treatment of high molecular weight heparin and fibrinolysis treatment, screening of fibrinogen disorders and some serious fibrinogen deficiency diseases. The diagnosis of diseases is of great significance. [0003] The principle of thrombin time (TT) detection is that an appropriate amount of thrombin converts the fibrinogen in the plasma sample into fibrin, thereby causing the plasma to coagulate, and the time required for coagulation is the thrombin time (TT). The quality of re...

Claims

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Application Information

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IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 郑琳陈明峰郑筱雯余嘉陵
Owner SHENZHEN GOLDSITE DIAGNOSTICS
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