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Bevacizumab eye drop and preparation method thereof

A technology of bevacizumab and eye drops, applied in the direction of antibodies, pharmaceutical formulations, medical preparations with inactive ingredients, etc., can solve the problems of difficult preservation, easy deterioration and failure, allergic reactions, etc., to avoid pollution, strengthen biological The effect of utilization and increased comfort

Active Publication Date: 2013-11-27
SCHOOL OF OPHTHALMOLOGY & OPTOMETRY WENZHOU MEDICAL COLLEGE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In addition, bevacizumab is a monoclonal antibody, which is not easy to store under normal conditions, and it is very easy to deteriorate and fail, and even cause allergic reactions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Bevacizumab eye drops components:

[0043] Bevacizumab 25mg;

[0044] Sodium Hyaluronate 10mg;

[0045] Glycerin 10mg;

[0046] Human albumin 2.5mg;

[0047] Sodium chloride 250mg;

[0048] Sodium dihydrogen phosphate 50mg;

[0049] Disodium hydrogen phosphate 125mg;

[0050] Add water for injection to 100ml

[0051] A total of 250 sticks were produced

[0052] The measured pH was 6.8.

[0053] The preparation method steps of above-mentioned bevacizumab eye drops are as follows:

[0054] (1) Disperse the prescribed amount of sodium hyaluronate in an appropriate amount of sterile water for injection to fully swell, autoclave at 121°C, and cool to 40°C for use;

[0055] (2) Dissolve the prescribed amount of bevacizumab, human serum albumin, sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate in an appropriate amount of sterile water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0056] (3) Mix the solution obtained...

Embodiment 2

[0059] Bevacizumab eye drops components:

[0060] Bevacizumab 250mg;

[0061] Sodium Hyaluronate 500mg;

[0062] Glycerin 500mg;

[0063] Human albumin 12.5mg;

[0064] Sodium chloride 500mg;

[0065] Sodium dihydrogen phosphate 45mg;

[0066] Disodium hydrogen phosphate 100mg;

[0067] Add water for injection to 100ml

[0068] A total of 250 sticks were produced

[0069] The measured pH was 7.0.

[0070] The preparation method steps of above-mentioned bevacizumab eye drops are as follows:

[0071] (1) Disperse the prescribed amount of sodium hyaluronate in an appropriate amount of sterile water for injection to fully swell, autoclave at 121°C, and cool to 35°C for use;

[0072] (2) Dissolve the prescribed amount of bevacizumab, human serum albumin, sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate in an appropriate amount of sterile water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0073] (3) Mix the solution ob...

Embodiment 3

[0076] Bevacizumab eye drops components:

[0077] Bevacizumab 2.5g;

[0078] Polyvinyl alcohol 2.5g;

[0079] Glycerin 2.5g;

[0080] Human serum albumin 0.1g;

[0081] Sorbitol 1.25g;

[0082] Sodium dihydrogen phosphate 0.1g

[0083] Disodium hydrogen phosphate 0.25g

[0084] Add water for injection to 100ml

[0085] A total of 250 sticks were produced

[0086] The measured pH was 7.0.

[0087] The preparation method steps of above-mentioned bevacizumab eye drops are as follows:

[0088] (1) Disperse the prescribed amount of polyvinyl alcohol in an appropriate amount of sterile water for injection, autoclave at 121°C, and cool to 30°C for use;

[0089] (2) Dissolve the prescribed amount of bevacizumab, human serum albumin, sorbitol, sodium dihydrogen phosphate and disodium hydrogen phosphate in an appropriate amount of sterile water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0090] (3) Mix the solution obtained in step (1) and the solut...

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PUM

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Abstract

The invention relates to a bevacizumab eye drop and a preparation method thereof. The bevacizumab eye drop comprises the following components: 0.25-25 g / L of bevacizumab, 0.1-25 g / L of thickening agent, 0.1-25 g / L glycerol, 0.025-1.0 g / L of protein protecting agent and 2.5-12.5 g / L of osmotic pressure regulator, and the PH of the eye drop is adjusted to 5.0-7.5. The eye drop provided by the invention can prevent medicine from overflow and loss, enables medicine to remain in the focal zone for a long time, can perform the function of lubricating the cornea, and increases the bioavailability of bevacizumab. In addition, glycerol is added to prolong the storage time of the bevacizumab eye drop.

Description

Technical field [0001] The present invention involves the field of biological products, especially a Bevar Midurate eye fluid and its preparation methods. Background technique [0002] Corneal Neovascularization (CNV) is a common pathological characteristics of multiple eye meter diseases such as severe chemical and heat burn, degeneration, or trauma.It can reduce corneal transparency, lead to significant visual decline, corneal scar, lipid deposition, and change the "immune pardon" function of the cornea, and increase the rejection reaction after corneal transplantation, leading to the failure of penetrating corneal transplantation.There are many methods for treatment, but the effect is not ideal.In recent years, studies have shown that vascular endothelial growth factor (VEGF) plays an important role in corneal new blood vessels.Animal experiments have found that VEGF in the corneal of inflammation and hemorrhale is significantly up.Experiments of Lai et al. Confirmed that spec...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K47/36A61P27/02
Inventor 宋宗明李美胡旭颋柯治生陈浩王勤美
Owner SCHOOL OF OPHTHALMOLOGY & OPTOMETRY WENZHOU MEDICAL COLLEGE
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