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Multi-level blood coagulation nano quality control product based on nano-enzyme coagulation method and preparation method of multi-level blood coagulation nano quality control product

A technology of quality control products and nanozymes, which is applied in the field of quality control products of thromboelastography, can solve the problems that quality control products cannot tolerate room temperature transportation and storage, and achieve the effect of low product maintenance and operation costs and low product maintenance costs

Pending Publication Date: 2022-05-27
重庆康巨全弘生物科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention intends to provide a multi-level blood coagulation nano-quality control product based on nano-enzyme coagulation method to solve the technical problem that the quality control product in the prior art cannot withstand room temperature transportation and storage, thereby improving the stability of the quality control product and reducing the Expensive product maintenance and operating costs

Method used

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  • Multi-level blood coagulation nano quality control product based on nano-enzyme coagulation method and preparation method of multi-level blood coagulation nano quality control product
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  • Multi-level blood coagulation nano quality control product based on nano-enzyme coagulation method and preparation method of multi-level blood coagulation nano quality control product

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1: Preparation of coagulation nanometer quality control product

[0024] (1) Overview of the performance of coagulation nano-quality control products

[0025] The coagulation nano-quality control product in this scheme includes two levels, which are the coagulation nano-quality control product level I and the coagulation nano-quality control product level II. The assignment range of blood coagulation nano quality control substance level I should satisfy: 0min≤R≤6min, 0min<K≤3min, 60°≤Angle≤90°, 0mm≤MA<60mm. The assignment range of blood coagulation nano quality control substance level II should satisfy: 0min≤R≤6min, 0min<K≤3min, 60≤Angle≤90°, 60≤MA<90mm.

[0026]Among them, R(min) refers to the time (min) from the time when the sample is placed in the thromboelastography instrument to the first fibrin clot is formed (the trace amplitude reaches 2mm), which reflects the participation in the coagulation process (endogenous, external origin and common pathway) co...

experiment example 1

[0070] Experimental Example 1: Evaluation of the homogeneity (precision) of the quality control product

[0071] Detection method: Return all reagents to room temperature; take 1 piece of quality control product and add 1 mL of purified water, invert and mix, place for 5 minutes, fully shake after mixing and test immediately.

[0072] Inspection steps: load the sample cup; add 20 μL calcium chloride solution to the sample cup; add 340 μL of the mixed quality control substance I to the sample cup; test according to the requirements of the thromboelastography until the MA (blood clot strength) value is determined . Typical detection image of blood coagulation nano quality control substance level I such as figure 1 As shown, the typical measurement image of blood coagulation nanometer quality control substance level II is as follows figure 2 shown.

[0073] Homogeneity (precision) determination

[0074] Randomly select 10 bottles of quality control products from the same bat...

experiment example 2

[0092] Experimental example 2: Research on the assignment of quality control products

[0093] According to the clinical reference interval and the actual detection value of the quality control product, the assignment range of the two-level quality control products is initially limited. There are certain differences between each batch of quality control products, so each batch of quality control products needs to be assigned. The specific assignment method is as follows:

[0094] Randomly select 20 bottles of quality control products from the same batch for testing, repeat 20 times, and calculate the average value of the 20 test results according to formula (1) and formula (2). Standard deviation (SD), and then calculate the assignment range of the quality control product according to formula (4). Thromboelastometry (Chongqing Dingrun Medical Devices Co., Ltd., DRNX-III) was used to assign the quality control materials respectively. The experimental results are shown in Table...

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Abstract

The invention relates to the technical field of thromboelastography quality control products, in particular to a multi-level blood coagulation nanometer quality control product based on a nanometer enzyme coagulation method and a preparation method of the multi-level blood coagulation nanometer quality control product. The multi-level blood coagulation nanometer quality control product based on the nanometer enzyme coagulation method comprises a quality control product body and a coagulation auxiliary component, and the quality control product body comprises a coagulation component, a stabilizer and nanometer enzyme. According to the technical scheme, a freeze-drying system is regulated by using nano-enzyme, so that the technical problem of poor storage and transportation stability of a quality control product under a room temperature condition in the prior art is solved. The product of the scheme has the advantages of being capable of being stored and transported at room temperature, low in product maintenance cost, good in stability performance and the like.

Description

technical field [0001] The invention relates to the technical field of thrombelastograph quality control products, in particular to a multi-level coagulation nanometer quality control product based on a nanoenzyme coagulation method and a preparation method thereof. Background technique [0002] Normal blood coagulation or fibrinolysis is a natural response of the body for self-protection, which can effectively prevent excessive blood loss or excessive blood clots in the body; while abnormal blood clots and bleeding can lead to a series of clinical diseases, such as ischemic heart disease, stroke, traumatic injury, coagulation Therefore, timely and effective diagnosis of coagulation function is particularly important for disease diagnosis and treatment, risk management and antithrombotic and anti-bleeding drug treatment. Thromboelastography, invented by German Hartert in 1948, can monitor the whole process from the beginning of coagulation to clot formation and fibrinolysis ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28G01N1/38G01N1/42G01N33/48
CPCG01N1/28G01N1/38G01N1/42G01N33/48G01N2001/2893
Inventor 陈渝峰陈鑫孙文
Owner 重庆康巨全弘生物科技有限公司
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