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Recombinant bovine basic fibroblast growth factor ophthalmic gel

A technology of fibroblasts and ophthalmic gel, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and drug combinations, etc. Volunteer use, not suitable for high temperature sterilization and other problems, to achieve good biocompatibility, high safety, and long-lasting effects

Active Publication Date: 2016-03-23
ZHUHAI ESSEX BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN102389392B discloses a recombinant bovine basic fibroblast growth factor ophthalmic gel, the gel matrix is ​​hydroxypropyl methylcellulose and carbomer, and the pH regulator is sodium hydroxide or hydrochloric acid. The gel agent has the advantages of little irritation, easy coating and long-lasting drug effect, but the hydroxypropyl methylcellulose in the gel matrix of the ophthalmic gel has a slight opalescence after being dissolved in water, and it is not easy to absorb light when heated. The solubility in water is small, and it is easy to separate out. The gel matrix containing hydroxypropyl methylcellulose is not suitable for high-temperature sterilization. The ophthalmic gel has certain safety problems for the eyes, and carbomer is a highly Hydrophilic anionic polymer, compatibility with acidic raw materials will reduce its viscosity, thereby affecting the spreadability of the ophthalmic gel, which is not conducive to the use of clinical volunteers

Method used

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  • Recombinant bovine basic fibroblast growth factor ophthalmic gel
  • Recombinant bovine basic fibroblast growth factor ophthalmic gel
  • Recombinant bovine basic fibroblast growth factor ophthalmic gel

Examples

Experimental program
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Embodiment 1

[0037] Embodiment 1, Preparation of recombinant bovine basic fibroblast growth factor ophthalmic gel of the present invention

[0038] prescription:

[0039] Recombinant bovine basic fibroblast growth factor 1680000IU;

[0040] Human serum albumin 0.1g;

[0041] Carbomer 0.8g;

[0042] Appropriate amount of triethanolamine;

[0043] Add water for injection to 400ml;

[0044] A total of 1000 pieces

[0045] The preparation process is as follows:

[0046] (1) Pour water for injection into a stainless steel bucket, add the prescribed amount of carbomer under stirring, swell overnight, and obtain carbomer solution for later use;

[0047] (2) Add the prescribed amount of triethanolamine to the carbomer solution obtained in step (1), adjust the pH value to 6.5-7.5, stir evenly, and pour into the diluted tank;

[0048] (3) Add an appropriate amount of water for injection to rinse the stainless steel barrel, pour the rinsed injection water into the dilution tank, sterilize a...

Embodiment 2

[0052] Embodiment 2, Preparation of recombinant bovine basic fibroblast growth factor ophthalmic gel of the present invention

[0053] prescription:

[0054] Recombinant bovine basic fibroblast growth factor 1500000IU;

[0055] Human serum albumin 0.05g;

[0056] Carbomer 0.6g;

[0057] Appropriate amount of sodium hydroxide;

[0058] Add water for injection to 400ml;

[0059] A total of 1000 pieces

[0060] The preparation process is as in Example 1.

Embodiment 3

[0061] Embodiment 3, Preparation of recombinant bovine basic fibroblast growth factor ophthalmic gel of the present invention

[0062] prescription:

[0063] Recombinant bovine basic fibroblast growth factor 1800000IU;

[0064] Human serum albumin 0.2g;

[0065] Carbomer 1.0g

[0066] Appropriate amount of triethanolamine;

[0067] Add water for injection to 400ml;

[0068] A total of 1000 pieces

[0069] The preparation process is as in Example 1.

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Abstract

The invention relates to the field of biological products, in particular to a recombinant bovine basic fibroblast growth factor ophthalmic gel and a preparation method thereof. The components and dosage of the ophthalmic gel are: recombinant bovine basic fibroblast growth factor 1500-1800IU, human serum albumin 0.05-0.20mg, carbomer 0.6-1.0mg, appropriate amount of pH regulator, water for injection Add to 0.4ml. The ophthalmic gel of the present invention is fine and uniform, comfortable to use, durable in efficacy, safe to eyes, non-irritating, and high in stability. No antibacterial agent is added in the formula, which prevents the harm caused by long-term use of antibacterial agent and increases the safety of the product.

Description

technical field [0001] The invention relates to the field of biological products, in particular to a recombinant bovine basic fibroblast growth factor ophthalmic gel and a preparation method thereof. Background technique [0002] Basic fibroblast growth factor (Basic fibroblast growth factor, abbreviated as bFGF) is mainly distributed in the pituitary gland, brain and nerve tissues, retina, adrenal gland, placenta, etc., and mainly acts on bone cells, fibroblasts and Osteocytes are important mitogenic factors and inducers of morphogenesis and differentiation. They promote wound healing and tissue repair, and promote tissue and nerve regeneration, especially for the regeneration of burnt corneal epithelium and the repair of corneal stroma and endothelial layers. There is a promotional effect. [0003] Since the birth of recombinant DNA technology in 1972, life science has entered a new period of development. Modern biotechnology with genetic engineering as the core has been ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K38/18A61K47/32A61K47/42A61P27/02
Inventor 方海洲曲伟郑赞顺姜若峰朱爱堂蓝瑄寻新平陈雄来许岩
Owner ZHUHAI ESSEX BIO PHARMA
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