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Application of recombinant human hyaluronidase preparation

A technology of human hyaluronidase and hyaluronic acid, which is applied in the application field of recombinant human hyaluronidase preparations, can solve the problems of ineffective treatment, low risk of allergy, poor curative effect, etc., and achieves high concentration of active protein and effective treatment. Good results

Pending Publication Date: 2022-07-01
SHANGHAI BAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Treatment is ineffective if clinically used doses are reduced to avoid hypersensitivity
[0007] Therefore, in view of the problems of large dosage, poor curative effect and high safety hazards in the treatment of thrombus caused by hyaluronic acid at present, there is an urgent need for a hyaluronidase preparation containing hyaluronidase with low allergic risk and good use effect

Method used

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  • Application of recombinant human hyaluronidase preparation
  • Application of recombinant human hyaluronidase preparation
  • Application of recombinant human hyaluronidase preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0236] Example 1 Preparation of human hyaluronidase protein

[0237] The CHO cells were cultured in suspension in the self-developed serum-free medium, and the self-developed serum-free feed medium was used for fed-feed controlled culture, which was gradually expanded to a 30L reactor scale through shake flask culture.

[0238] When cultured for 3-4 days, the daily amount of feed medium added to the bioreactor is 2%-5% of the actual culture volume in the bioreactor. The culture temperature was controlled at 35°C to 37°C by adding 10% Na 2 CO 3 and CO 2 The pH is controlled at 7.0; the ventilation volume of the reactor is controlled at 0.015-0.15vvm; the rotational speed is controlled at 80-150rpm; the dissolved oxygen value is controlled at 20%-40%. During cell culture, samples were taken every day to monitor temperature, pH, glucose concentration, lactate concentration, osmolality and protein expression; when the CHO cell viability was lower than 80% or the culture period ...

Embodiment 2

[0240] Example 2 Research on the liquid preparation of recombinant human hyaluronidase

[0241]The recombinant human hyaluronidase stock solution obtained in Example 1 was exchanged into liquid preparations with different compositions, and the concentration of the recombinant human hyaluronidase was adjusted to the expected concentration. All liquid formulations were sterile filtered through 0.22 μm low protein adsorption filters and filled under sterile conditions into sterile 5 ml glass vials, stoppered with fluororesin layered butyl rubber stoppers and aluminum / plastic lift-off type (flip-off) Seal and cap. The fill volume is 2ml. These formulations were stored at different temperatures and samples were taken at specified time intervals to investigate formulation stability, and the stability data for different liquid formulations were summarized. The samples were set out at 25°C for accelerated experiments, and samples were taken at different times to analyze the protein ...

Embodiment 3

[0248] Example 3 Study on the freeze-dried preparation of recombinant human hyaluronidase

[0249] Different recombinant human hyaluronidase liquid preparations were prepared first, and then freeze-dried according to Table 1, and the stability of different freeze-dried preparations was studied after freeze-drying.

[0250] Table 1

[0251]

[0252]

[0253] like Figure 7 Buffers indicated were 5 mM and 50 mM phosphate buffer, histidine buffer, acetate buffer, citrate buffer and Tris buffer, pH 5.0, 6.0, 6.5, 7.0, 8.0 conditions provided The lyophilized preparation of recombinant human hyaluronidase has better stability.

[0254] like Figure 8 As shown, the lyophilized formulations containing recombinant human hyaluronidase in the range of 5, 10 and 50 mM methionine were more stable.

[0255] like Figure 9 As shown, the lyophilized preparation of recombinant human hyaluronidase containing the protective agent sodium chloride concentration of 50-170 mM, trehalose 2...

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Abstract

The invention discloses an application of a recombinant human hyaluronidase preparation. The recombinant human hyaluronidase preparation is prepared from recombinant human hyaluronidase, a buffering agent, a stabilizing agent and a nonionic surfactant, wherein the enzyme activity of the recombinant human hyaluronidase is 45 to 450,000 units / ml; the concentration of the buffering agent is 5-50 mM; the concentration of the stabilizer is 1-500mM, and the stabilizer is selected from one or more of trehalose, cane sugar, mannitol, sodium chloride and methionine; the concentration of the nonionic surfactant is 0.01%-0.1% (w / v); the pH value of the recombinant human hyaluronidase preparation is 5.0 to 8.0. The problems that when an existing clinically-used hyaluronidase extraction product is used for treating, correcting or preventing side reactions such as vascular embolism, excessive filling or uneven filling caused by hyaluronic acid filling, the intravenous administration dosage is too large, the effect is poor, and subcutaneous local treatment is poor in safety and curative effect can be solved.

Description

technical field [0001] The invention belongs to the field of corrective treatment in plastic surgery and beauty, in particular to the application of a recombinant human hyaluronidase preparation. Background technique [0002] Hyaluronic acid (HA), also known as uronic acid, hyaluronic acid or hyaluronic acid, is a linear polymer glycosaminoglycan composed of two disaccharide units, D-glucuronic acid and N-acetylglucosamine, which are repeatedly connected. Glycans are widely present in the connective tissue, mucous tissue, lens of the eyeball and skin of vertebrates, especially in embryos, cartilage, synovial fluid, vitreous body, umbilical cord, cockscomb and other tissues. Hyaluronic acid is the most widely distributed acidic mucopolysaccharide in human tissue matrix. It has various functions in the body, such as forming a variety of matrices, limiting the diffusion of water and other extracellular substances, regulating osmotic pressure, and regulating macromolecular subst...

Claims

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Application Information

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IPC IPC(8): A61K38/47A61K47/02A61K47/20A61K47/26A61M5/178A61P7/02A61P29/00A61P31/00A61P37/08
CPCA61K38/47A61K47/26A61K47/20A61K47/02C12Y302/01035A61P7/02A61P37/08A61P31/00A61P29/00A61M5/178
Inventor 王征陆琳
Owner SHANGHAI BAO PHARM CO LTD
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