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Recombinant calf alkaline fibroblast growth factor ophthalmic gel

A fibroblast and growth factor technology, applied in the field of recombinant bovine basic fibroblast growth factor ophthalmic gel and its preparation, can solve the problem of affecting the spreadability of ophthalmic gel, unfavorable use of clinical volunteers, and unfavorable Suitable for high-temperature sterilization and other issues, to achieve good biocompatibility, high safety, and long-lasting effects

Active Publication Date: 2015-04-29
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 calf alkaline fibroblast growth factor ophthalmic gel
  • Recombinant calf alkaline fibroblast growth factor ophthalmic gel
  • Recombinant calf alkaline fibroblast growth factor ophthalmic gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0038] prescription:

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

[0040] Human albumin 0.1 g;

[0041] Carbomer 0.8 g;

[0042] An appropriate amount of triethanolamine;

[0043] Add water for injection to 400 ml ；

[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, ster...

Embodiment 2

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

[0053] prescription:

[0054] Recombinant bovine basic fibroblast growth factor 1,500,000 IU;

[0055] Human albumin 0.05 g;

[0056] Carbomer 0.6 g;

[0057] Sodium hydroxide appropriate amount;

[0058] Add water for injection to 400 ml ；

[0059] A total of 1000 pieces

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

Embodiment 3

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

[0062] prescription:

[0063] Recombinant bovine basic fibroblast growth factor 1,800,000 IU;

[0064] Human albumin 0.2g;

[0065] Carbomer 1.0 g

[0066] An appropriate amount of triethanolamine;

[0067] Add water for injection to 400 ml ；

[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 and in particular relates to recombinant calf alkaline fibroblast growth factor ophthalmic gel and a preparation method thereof. The ophthalmic gel comprises the following components: 1500-1800IU of recombinant calf alkaline fibroblast growth factors, 0.05-0.20mg of human serum albumin, 0.6-1.0mg of Carbomer, a proper amount of a pH regulator and water for injection added to 0.4ml. The ophthalmic gel disclosed by the invention is smooth, uniform, comfortable to use, lasting in drug effect, safe to eyes, non-irritating and high in stability. A bacteriostatic agent is not added into the formula, hazards brought by long-term use of the bacteriostatic agent are avoided, and the safety of the product is improved.

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. Fibroblasts and osteocytes are important mitogenic factors, as well as inducers of morphogenesis and differentiation, promote wound healing and tissue repair, and promote tissue and nerve regeneration, especially for the regeneration of burnt corneal epithelium, corneal stroma and endothelial layer Repairs are promoted. [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 applied to various fields such as agriculture, medicine, ...

Claims

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Application Information

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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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