Freeze-drying auxiliary preparation and freeze-drying method of thyroid stimulating hormone receptor

A thyroid-stimulating hormone and freeze-drying technology, which is applied in the field of immune analysis, can solve the problems of decreased solubility of thyroid-stimulating hormone receptor, decreased biological activity, and poor resolubility, and achieves good freeze-dried reconstitution effect, stable shape, and biological activity. unaffected effect

Active Publication Date: 2020-05-05
AUTOBIO DIAGNOSTICS CO LTD
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

Freeze-drying auxiliary preparations of other biologically active substances are not suitable for lyophilization of TSH receptors,

Method used

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  • Freeze-drying auxiliary preparation and freeze-drying method of thyroid stimulating hormone receptor
  • Freeze-drying auxiliary preparation and freeze-drying method of thyroid stimulating hormone receptor
  • Freeze-drying auxiliary preparation and freeze-drying method of thyroid stimulating hormone receptor

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Embodiment 1～15

[0029] Thyrotropin receptor protein was combined with buffer, non-reducing disaccharide, bovine serum albumin, polyethylene glycol and glycine in different ratios at a volume ratio of 1:24 according to the ratios described in Table 1, and then the same Procedures (freeze-drying curves are all used: -80°C pre-cooling for 2h, first-stage sublimation -40°C to -15°C, 12h, second-stage drying -15°C to 25°C, 8h.) for freeze-drying. The evaluation indicators of freeze-dried products include: molding, reconstitution (equal volume reconstitution with deionized water), clarity, potency evaluation before and after freeze-drying. Wherein, the potency evaluation before and after drying is expressed by the recovery rate of the signal value before and after freeze-drying.

[0030] Kit construction: the solid phase is the antibody of thyroid-stimulating hormone receptor coated with magnetic beads; the marker is the receptor labeled with the marker that only binds to the thyroid-stimulating ho...

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Abstract

The invention relates to the technical field of immunoassay, in particular to a freeze-drying auxiliary preparation and a freeze-drying method of a thyroid stimulating hormone receptor. The freeze-drying auxiliary preparation is prepared from non-reducing disaccharide, glycine, serum albumin, polyethylene glycol and a buffer solution, the content of each component is as follows: 2wt%-20wt% of non-reducing disaccharide, 5-30 mmol/L of glycine, 2wt%-10wt% of serum albumin, 0.5wt%-2wt% of polyethylene glycol, and the balance being buffer. The freeze-drying auxiliary preparation of the thyroid stimulating hormone receptor provided by the invention can effectively assist in freeze-drying of the thyroid stimulating hormone receptor, so that the thyroid stimulating hormone receptor is stable in form after freeze-drying, good in freeze-drying redissolution effect, free of precipitation and free of influence on biological activity.

Description

technical field [0001] The invention relates to the technical field of immune analysis, in particular to a freeze-drying auxiliary preparation and a freeze-drying method of a thyroid stimulating hormone receptor. Background technique [0002] Autoimmune thyroid disease (Autoimmune thyroid disease, AITD) is a typical organ-specific autoimmune disease. Thyrotropin receptor is a protein-coupled macromolecular glycoprotein expressed on the surface of thyroid follicular cells and is the main antigen that induces AITD. The antigen-antibody reaction model and detection method established with the help of purified thyroid-stimulating hormone receptor antigen are of great significance to the differential diagnosis of AITD diseases. [0003] In clinical immunoassays, the antigen is usually obtained through relatively complicated processes such as cell culture, expression, purification and other methods. Since the antigen obtained by this method is extremely unstable in the liquid st...

Claims

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Application Information

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IPC IPC(8): G01N33/78G01N33/531
CPCG01N33/78G01N33/531
Inventor 徐海娈靳增明赵艳芳
Owner AUTOBIO DIAGNOSTICS CO LTD
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