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Liquid-type prothrombin time detection reagent and preparation method thereof

A technology for thrombin time and detection reagents, applied in biological testing, material inspection products, etc., can solve the problems of high price, poor quality stability, large differences between bottles, etc., and achieve simple production equipment, high reagent stability, and production process. Simplified effect

Inactive Publication Date: 2015-04-29
SHANGHAI LONG ISLAND BIOTEC CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The process of thrombin time detection and determination is affected by many factors, among which the quality of reagents is the key factor. Due to the problems of unstable product quality and poor sensitivity of domestic coagulation reagents, the test results are unstable, and different clinical tests It is difficult to compare the results measured between laboratories, so most of the reagents used in clinical laboratories are imported products, which are expensive
On the other hand, due to the poor stability of thrombin, an important component in the reagent, almost all thrombin reagents at home and abroad are in the form of freeze-dried powder, which needs to be reconstituted before use. The operation is troublesome and the difference between bottles is large. And the quality stability of the reagent is poor after reconstitution
Although liquid-type reagents can be used directly, they are convenient to operate, and the difference between bottles is small, which is more suitable for the operation of automated instruments, but their application is limited due to their unsatisfactory stability during long-term storage.

Method used

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  • Liquid-type prothrombin time detection reagent and preparation method thereof
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  • Liquid-type prothrombin time detection reagent and preparation method thereof

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preparation example Construction

[0035] refer to figure 1 , a method for preparing a liquid thrombin time detection reagent, comprising the following steps:

[0036] Dissolving amino acid, polyethylene glycol, mannitol, bovine serum albumin, and gelatin in water to obtain a thrombin protection solution, adjusting the pH value to 6.0-8.0;

[0037] The thrombin freeze-dried powder is dissolved in the thrombin protection solution to obtain the liquid thrombin time detection reagent, and the thrombin enzyme activity in the liquid thrombin time detection reagent is 5-80 IU / mL.

[0038] Such as figure 2 Shown, a kind of preparation method of liquid thrombin time detection reagent comprises the following steps:

[0039] Dissolving amino acid, polyethylene glycol, mannitol, bovine serum albumin, and gelatin in water to obtain a thrombin protection solution, adjusting the pH value to 6.0-8.0;

[0040] Dissolving thrombin freeze-dried powder in the thrombin protection solution to obtain thrombin mother liquor, the ...

Embodiment 1

[0046] The preparation method of embodiment 1 thrombin time detection reagent

[0047] 1 Thrombin protection solution preparation: weigh Tris6.06g (50mmol / L), glycine 12g (mass fraction is 1.2%), PEG200005g (mass fraction is 0.5%), BSA 35g (mass fraction is 3.5%), gelatin 2g ( The mass fraction is 0.2%), mannitol 40g (mass fraction is 0.4%), sodium azide 1g (mass fraction is 0.1%), add 1L of purified water, stir to make it fully dissolve, adjust the pH with 0.1mol / L NaOH is 7.0.

[0048] 2 Sterilization by filtration: Wet 0.45 μm cellulose triacetate with water, put it close on the sand core of the suction filter to filter the protection solution, collect the filtrate to obtain the filtered thrombin protection solution, and remove a small amount of the prepared thrombin protection solution. Insolubles.

[0049] 3 Preparation of thrombin mother solution: Take a 1mL thrombin freeze-dried product with a specification of 50,000IU / mL, add 1mL thrombin protection solution, keep it...

Embodiment 2

[0067] The thermostability detection of embodiment 2 thrombin time detection reagent

[0068] 1 Reagent preparation: Prepare various thrombin protection solutions according to the combination in Table 3, and then dilute the thrombin mother solution at a ratio of 1:200 to obtain various thrombin time detection reagents.

[0069] Table 3 Composition of each thrombin protection solution

[0070]

[0071] Thermal stability test at 237°C: test each thrombin time detection reagent prepared above and contrast reagent 1 in parallel, pack 4mL each into 7mL clean glass bottles, cover and seal, and heat 30 of them in an oven at 37°C. Destroyed, take a pair of newly reconstituted Siemens hemagglutination normal level quality control product Ci-Trol 1 of the same batch every day for detection, and the detection method is the same as above. The results are shown in Table 4 below:

[0072] Table 4 Thrombin time detection reagent 37 ℃ thermal stability detection results (unit: second)

...

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Abstract

The invention discloses a liquid-type prothrombin time detection reagent and a preparation method thereof. The preparation method comprises the following steps: dissolving amino acid, polyethylene glycol, mannitol, bovine serum albumin, and gelatin in water so as to obtain a prothrombin protective fluid, and adjusting the pH value of the prothrombin protective fluid to 6.0-8.0; and dissolving prothrombin freeze-dried powder in the prothrombin protective fluid so as to obtain the liquid-type prothrombin time detection reagent, wherein the enzymatic activity of the liquid-type prothrombin time detection reagent is 5-80 IU / mL. The liquid-type prothrombin time detection reagent contains prothrombin, amino acid, polyethylene glycol, mannitol, bovine serum albumin and gelatin, and takes water as a solvent. The production process of the reagent disclosed by the invention is simplified, production facilities are simple, no freeze-drying process is performed, and the production cost is low; the reagent is used in an out-of-the-box mode; the variation among bottles is small; and the reagent is high in stability.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic reagents, in particular to a liquid-type coagulation time (TT) detection reagent and a preparation method thereof. Background technique [0002] 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). [0003] Thrombin time is a simple test to detect the function of coagulation, anticoagulation and fibrinolysis system, and its detection has important value for clinical disease diagnosis. [0004] The process of thrombin time detection and determination is affected by many factors, among which the quality of reagents is the key factor. Due to the problems of unstable product quality and poor sensitivity of domestic coagulation reagents, the test results are unstable, and different clinical test...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/86
CPCG01N33/86
Inventor 艾峰肖国伟潘仁斌
Owner SHANGHAI LONG ISLAND BIOTEC CO LTD
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