Stabilizer, thrombin time test reagent, preparation method of thrombin time test reagent and kit

A thrombin time and stabilizer technology, applied in the field of medical inspection, can solve the problems of spatial structure change, inconvenient operation, poor stability, etc., and achieve the effects of reducing mutual collision, strengthening hydrophobic interaction, and increasing stability

Active Publication Date: 2022-02-18
SHENZHEN DYMIND BIOTECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, most of the TT test reagents on the market are freeze-dried powders, which need to be reconstituted before use. The operation is inconvenient, and the precision between bottles cannot be guaranteed. However, liquid reagents can overcome the defects caused by freeze-dried powders and improve the precision of the reagents.
However, the main component of liquid reagents is thrombin, which is a multifunctional serine protease. Like most proteases, its stability is relatively poor, and it is easily affected by pH, temperature, ionic strength, etc., resulting in enzyme Changes in the spatial structure of the reagent affect the accuracy and sensitivity of the test results of the reagent

Method used

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  • Stabilizer, thrombin time test reagent, preparation method of thrombin time test reagent and kit
  • Stabilizer, thrombin time test reagent, preparation method of thrombin time test reagent and kit
  • Stabilizer, thrombin time test reagent, preparation method of thrombin time test reagent and kit

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preparation example Construction

[0029] The preparation method of the above thrombin time test reagent, characterized in that the following steps are included:

[0030] 1) When the buffer is prepared, the buffer is dissolved with deionized water to the buffer solution, and the pH of the buffer solution is 6.8 to 8.

[0031] 2) Add stabilizers, preservatives, calcium supplements, and thrombin to the buffer solution, mix well, to obtain TT test reagents.

[0032] The present invention also discloses a kit comprising the above-described stabilizer or the above thrombin time test reagent.

Embodiment 1

[0035] 1) Terfe 8.5 g of Tris is added to deionized water, continuously stirring, and adjusting the pH at 1 M HCl at 7.60, and the buffer is fixed to 1000 ml.

[0036] 2) Add polyethylene glycol 6,000 1.5 g, calcium chloride 1.1g, bovine serum albumin, 20g of protein 胨 15g, xanthan gum 0.5 g, PROCLIN 300 2.0 mL, stirred after 30min, then add 12 IU / mL thrombin, TT test reagents were obtained uniform.

[0037] Detection method:

[0038] Using Stago's original normal quality control plasma, measurement at Stago Emo Express automatic blood glossy instrument, recording plasma coagulation time, TT measurement, its normal value range: 14.0 S ~ 20.0S.

[0039] Continuously produce three batch kits, each batch of randomly extracts the TT value, 10 times each bottle, the test results are shown in Table 1: S is the standard deviation, X is TT average, error CV = S / X .

[0040] Table 1: TT value test data for three batch kits

[0041]

Embodiment 2

[0043] The present embodiment differs from the first embodiment in that the stabilizer only includes a yellowla gum.

[0044]1) Weigh 8.5g Tris was added to deionized water, stirring was continued, the pH is adjusted with 1M HCl in 7.60, constant volume buffer to a 1000mL.

[0045] 2) were added 1.1 g of calcium chloride, xanthan gum 0.5g, Proclin 300 2.0mL, stirred for 30min and then add thrombin 12IU / mL, and stirred to obtain a uniform TT test agent.

[0046] Detection method is the same as in Example 1.

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Abstract

The invention discloses a stabilizer, a thrombin time test reagent, a preparation method of the thrombin time test reagent and a kit. The stabilizer comprises xanthan gum, and the thrombin time test reagent comprises thrombin, a buffer solution and the stabilizer. The stabilizer comprises xanthan gum, the concentration of the xanthan gum in the thrombin time test reagent is 0.1g/L to 10g/L, and the enzyme activity of thrombin is 1IU/mL to 50IU/mL. The stability of the liquid thrombin time test reagent is remarkably improved by utilizing a network structure of xanthan gum macromolecules.

Description

Technical field [0001] The present invention relates to the field of medical examination, and more particularly to a stabilizer, a prothrombin time test reagent, and a preparation method thereof, a kit. Background technique [0002] Thrombin Time, TT) is an important indicator for determining the detection of coagulation, and is also an important indicator of preoperative inspections. TT assay is to check the ability of plasma fibrinogen transformation into fibrin and how much heparinous substances in plasma. Exception is seen in the progression of Dic fibrous activity, low (none) fibrinogen, abnormal hemogloboxemia, fibrin (original) degradation product is increased; reduced no clinical significance. [0003] At present, most of the TT test reagents are lyophilized. It is necessary to recall before use, and the operation is inconvenient. The premium in the bottle cannot be guaranteed. . However, the most important components of liquid type reagents are thrombin, thrombin is a mu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/56
CPCC12Q1/56
Inventor 韩学娉何圣侠
Owner SHENZHEN DYMIND BIOTECH
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