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A kind of lyophilization auxiliary preparation and lyophilization method of thyroid stimulating hormone receptor

A thyroid-stimulating hormone and freeze-drying technology, applied in the field of immunoassay, can solve the problems of poor resolubilization, decreased biological activity, decreased solubility of thyroid-stimulating hormone receptor, etc. good melting effect

Active Publication Date: 2022-05-03
AUTOBIO DIAGNOSTICS CO LTD
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  • Abstract
  • Description
  • Claims
  • 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, which will still lead to problems such as reduced solubility of TSH receptors, poor resolubility, and decreased biological activity.

Method used

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  • A kind of lyophilization auxiliary preparation and lyophilization method of thyroid stimulating hormone receptor
  • A kind of lyophilization auxiliary preparation and lyophilization method of thyroid stimulating hormone receptor
  • A kind of lyophilization auxiliary preparation and lyophilization 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 immune analysis, 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 composed of non-reducing disaccharide, glycine, serum albumin, polyethylene glycol and buffer; the contents of each component are: non-reducing disaccharide 2wt%-20wt%; glycine 5-30mmol / L; Serum albumin 2wt%-10wt%; polyethylene glycol 0.5wt%-2wt%; buffer balance. The thyroid-stimulating hormone receptor freeze-drying auxiliary preparation provided by the present invention can effectively assist the thyroid-stimulating hormone receptor to freeze-dry, make the shape of the thyroid-stimulating hormone receptor stable after freeze-drying, the effect of freeze-drying and redissolving is good, no precipitation occurs, and the biological activity is low. Affected.

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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Patent Type & Authority Patents(China)
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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