Recombinant bovine alkaline fibroblast growth factor eye drops

A fibroblast and growth factor technology, applied in the field of recombinant bovine basic fibroblast growth factor eye drops and preparation thereof, to achieve the effects of expanding the scope of application, high patient compliance, and avoiding toxic and side effects

Active Publication Date: 2015-05-13
ZHUHAI ESSEX BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the eye drops do not add antibacterial agents, the stability of the eye drops needs to be further improved

Method used

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  • Recombinant bovine alkaline fibroblast growth factor eye drops
  • Recombinant bovine alkaline fibroblast growth factor eye drops
  • Recombinant bovine alkaline fibroblast growth factor eye drops

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1, rb-bFGF eye drops and preparation thereof

[0036] Recombinant bovine basic fibroblast growth factor 1680000 IU;

[0037] Human albumin 0.08 g;

[0038] Polyvinyl alcohol 4.0 g;

[0039] Sodium chloride 3.2 g;

[0040] Disodium hydrogen phosphate 0.22g;

[0041] Sodium dihydrogen phosphate 0.48g;

[0042] Add water for injection to 400 ml;

[0043] A total of 1000 pieces

[0044] The specific preparation method is:

[0045] (1) Disperse polyvinyl alcohol in an appropriate amount of water for injection at 90°C, autoclave at 121°C, cool to room temperature, and set aside;

[0046] (2) Dissolve recombinant bovine basic fibroblast growth factor, human serum albumin, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate in an appropriate amount of water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0047] (3) Mix the solution obtained in step (1) and the solution obtained in step (2) evenly under asept...

Embodiment 2

[0049] Embodiment 2, rb-bFGF eye drops and preparation thereof

[0050] Recombinant bovine basic fibroblast growth factor 2,500,000 IU;

[0051] Human albumin 0.12 g;

[0052] Polyvinyl alcohol 2.0 g;

[0053] Sodium chloride 4.0 g;

[0054] Disodium hydrogen phosphate 0.20g;

[0055] Sodium dihydrogen phosphate 0.40g;

[0056] Add water for injection to 400 ml;

[0057] A total of 1000 pieces

[0058] The specific preparation method is:

[0059] (1) Disperse polyvinyl alcohol in an appropriate amount of water for injection at 90°C, autoclave at 121°C, cool to room temperature, and set aside;

[0060] (2) Dissolve recombinant bovine basic fibroblast growth factor, human serum albumin, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate in an appropriate amount of water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0061] (3) Mix the solution obtained in step (1) and the solution obtained in step (2) evenly under as...

Embodiment 3

[0063] Embodiment 3, rb-bFGF eye drops and preparation thereof

[0064] Recombinant bovine basic fibroblast growth factor 2,000,000 IU;

[0065] Human serum albumin 0.10 g;

[0066] Polyvinyl alcohol 6.0 g;

[0067] Sodium chloride 6.0 g;

[0068] Disodium hydrogen phosphate 0.30g;

[0069] Sodium dihydrogen phosphate 0.50g;

[0070] Add water for injection to 400 ml;

[0071] A total of 1000 pieces

[0072] The specific preparation method is:

[0073] (1) Disperse polyvinyl alcohol in an appropriate amount of water for injection at 90°C, autoclave at 121°C, cool to room temperature, and set aside;

[0074] (2) Dissolve recombinant bovine basic fibroblast growth factor, human serum albumin, sodium chloride, disodium hydrogen phosphate and sodium dihydrogen phosphate in an appropriate amount of water for injection, and filter aseptically with a 0.22 μm filter membrane;

[0075] (3) Mix the solution obtained in step (1) and the solution obtained in step (2) evenly unde...

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Abstract

The invention discloses recombinant bovine alkaline fibroblast growth factor eye drops and a preparation method thereof. The recombinant bovine alkaline fibroblast growth factor eye drops are prepared from the following components by weight: 1500-2500 IU of recombinant bovine alkaline fibroblast growth factor, 0.04-0.12mg of human albumin, 2.0-6.0mg of polyvinyl alcohol, 4.0-6.0mg of sodium chloride, 0.20-0.30mg of disodium hydrogen phosphate, 0.40-0.50mg of sodium dihydrogen phosphate and 0.4ml of water for injection. According to the recombinant bovine alkaline fibroblast growth factor eye drops disclosed by the invention, the dosage of auxiliary material is reduced in the eye drops, the stability of the eye drops is also ensured, the shelf life of the eye drops is prolonged, and the application range is enlarged; without the addition of a bacteriostatic agent, the potential risk caused by the bacteriostatic agent and the toxic or side effect to eyes are prevented, and the irritation of the eye drops to eyes is reduced, and the eye drops are safe in use and high in compliance of a patient.

Description

technical field [0001] The present invention relates to the field of biological products. In particular, it relates to a recombinant bovine basic fibroblast growth factor eye drop and a preparation method thereof. Background technique [0002] Basic fibroblast growth factor (bFGF), belonging to the FGF family (23 known members), is a heparin-binding growth factor that promotes cell growth in a range of cells including mesenchymal, neuroectoderm, and vascular endothelial cells. proliferation. Basic fibroblast growth factor also has potential pro-angiogenic activity in vivo. bFGF is mainly distributed in tissues and organs derived from mesoderm and neuroderm. It has effects on many tissue cells, can promote cell division, regulate cell metabolism, affect cell morphology, infiltration, differentiation and aging, and affect corneal epithelial cells, stromal cells, and endothelial cells. Both can have an effect on the regeneration of alkali-burned corneal epithelium, and the r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K47/42A61K9/08A61P27/02
Inventor 方海洲曲伟郑赞顺郑美群姜若峰朱爱堂蓝瑄黄贤科谭佳佳
Owner ZHUHAI ESSEX BIO PHARMA
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