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Neuron-specific enolase calibration product and preparation method thereof

An enolase-specific technology, which is applied in the field of neuron-specific enolase calibrator and its preparation, can solve the problems of unstandardized production, large batch-to-batch variation, and high cost of calibrator, and achieve easy standardized production and long-term validity Long-lasting, low-cost effects

Inactive Publication Date: 2019-07-09
DIRUI MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the problems of high cost, large batch-to-batch variation and inability to standardize production of the existing calibrator, the present invention provides a neuron-specific enolase calibrator and its preparation method

Method used

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  • Neuron-specific enolase calibration product and preparation method thereof
  • Neuron-specific enolase calibration product and preparation method thereof
  • Neuron-specific enolase calibration product and preparation method thereof

Examples

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preparation example Construction

[0026] A preparation method of a neuron-specific enolase calibrator of the present invention specifically comprises the following steps:

[0027] (a) prepare buffer solution;

[0028] (b) adding a protective agent and different concentrations of neuron-specific enolase to the buffer obtained in step (a);

[0029] (c) freeze-drying the buffer mixture obtained in step (b) to obtain a neuron-specific enolase calibrator.

[0030] Preferably, the buffer is one or more of MOPSO, Tris, borate buffer; more preferably, the buffer is MOPSO or Tris or a mixture of MOPSO and Tris.

[0031] Preferably, the pH of the buffer is 7.0-7.5; more preferably, the pH of the buffer is 7.2-7.4.

[0032] Preferably, the concentration of the buffer is 10-30 mM; more preferably, the concentration of the buffer is 10-20 mM.

[0033] Preferably, the protective agent is a mixture of proteins, sugars, antioxidants and bacteriostatic agents; wherein, the proteins are preferably ovalbumin or human serum al...

Embodiment 1

[0040] Example 1 Preparation of neuron-specific enolase calibrator

[0041] Prepare 100 mL of MOPSO buffer solution with a pH of 7.0 and a concentration of 10 mM, add 0.5 g of human serum albumin, 4 g of trehalose, 1 g of sodium thiosulfate and 0.05 g of sodium azide, and filter through a 0.22 μm filter membrane; NSE was added to the matrix of the calibration substance; the prepared neuron-specific enolase calibration substance was weighed 1g ± 0.005g / bottle, put into a freeze dryer, and freeze-dried; the prepared neuron-specific enolase Add 1g ± 0.005g of purified water to the lyophilized powder of the calibration product, redissolve at room temperature for 15 minutes, and perform the test. According to the NSE concentration and the corresponding light value, a dose-response curve is drawn.

Embodiment 2

[0042] Example 2 Preparation of Neuron-specific Enolase Calibrator

[0043] Prepare 100 mL of Tris buffer solution with a pH of 7.4 and a concentration of 20 mM, add 0.5 g of ovalbumin, 4 g of trehalose, 1 g of sodium thiosulfate and 0.05 g of sodium azide to it, and filter through a 0.22 μm filter membrane; Add NSE to the prepared calibrator matrix; weigh the prepared neuron-specific enolase calibrator 1g ± 0.005g / bottle, put it into a freeze dryer, and freeze-dry; add the prepared neuron-specific enolase Add 1g±0.005g of purified water to the freeze-dried powder of the alcoholase calibrator, redissolve at room temperature for 15 minutes, and conduct the test. According to the NSE concentration and the corresponding light value, draw a dose-response curve, such as figure 1 shown.

[0044] The pH buffers, proteins, sugars, antioxidants and preservatives used in the above examples can also be replaced by any one or a combination of the aforementioned definitions, and the prepa...

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Abstract

The invention discloses a neuron-specific enolase calibration product and a preparation method thereof. The problems that an existing calibration product is high in cost and large in batch-to-batch difference, and cannot achieve standardized production are solved. The preparation method of the neuron-specific enolase calibration product comprises the following steps: (a) a buffer solution is prepared; (b) a protective agent and neuron-specific enolase of different concentrations are added into the buffer solution obtained in the step (a); and (c) a buffer solution mixture obtained in the step(b) is frozen and dried, and the neuron-specific enolase calibration product is obtained. The buffer solution serves as a matrix, and by screening the type of the buffer solution and the protective agent, the neuron-specific enolase calibration product is prepared, wherein as for the neuron-specific enolase calibration product, the cost is low, the batch-to-batch difference is controllable, standardized production is easy, and performance is stable.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnosis, and in particular relates to a neuron-specific enolase calibrator and a preparation method thereof. Background technique [0002] Neuron-specific enolase (NSE) is a kind of enolase, which is an acidic protease with a molecular weight of 78KD. Enolase isoenzymes are composed of α, β, and γ subunits in the form of dimers, and there are five forms of αα, αβ, ββ, αγ, and γγ. Among them, the dimer αγ and γγ are called NSE, and NSE plays an important regulatory role in the growth, differentiation, survival and death of neurons. Under normal circumstances, serum and cerebrospinal fluid contain a small amount of NSE, and abnormally increased NSE is often accompanied by brain injury or other neurological diseases and tumor-related diseases, such as cerebral hemorrhage, cerebral ischemia, traumatic brain injury, Alzheimer's disease, neuroblastoma, etc. cell tumors, neuroendocrine diseases, and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N1/28
CPCG01N1/28
Inventor 赵妍
Owner DIRUI MEDICAL TECH CO LTD
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