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Recombinant bovine basic fibroblast growth factor solution for external use

A technology for fibroblasts and growth factors, which is applied in the field of external use solution of recombinant bovine basic fibroblast growth factor and its preparation, can solve the problems of further improvement of stability and safety, inconvenient use and high production cost, Achieve the effect of promoting wound healing, improving stability and prolonging shelf life

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

The current active protein substances are generally stored in a solid state after freeze-drying at low temperature, which has high production costs and is inconvenient to use.
[0009] For this reason, some rb-bFGF topical solution dosage forms suitable for storage at low temperature are also disclosed in the prior art. Chinese patent application 201110342458.1 discloses a recombinant bovine basic fibroblast growth factor topical solution, but its stability and Security needs to be further improved

Method used

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  • Recombinant bovine basic fibroblast growth factor solution for external use
  • Recombinant bovine basic fibroblast growth factor solution for external use
  • Recombinant bovine basic fibroblast growth factor solution for external use

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1: rb-bFGF topical solution and its preparation

[0042] prescription:

[0043] Recombinant bovine basic fibroblast growth factor 63 million IU;

[0044] Human serum albumin 3g;

[0045] Mannitol 300g;

[0046] Dextran - 7022.5g;

[0047] Disodium hydrogen phosphate 80g;

[0048] Sodium dihydrogen phosphate 45g;

[0049] Add water for injection to 15000ml;

[0050] A total of 1000 pieces

[0051] The specific preparation method is as follows:

[0052] (1) Disperse the prescribed amount of mannitol in water for injection, sterilize by autoclaving at 121°C, and cool down for later use;

[0053] (2) Dissolve the prescribed amount of recombinant bovine basic fibroblast growth factor stock solution, human serum albumin, dextran-70, disodium hydrogen phosphate, and sodium dihydrogen phosphate in water for injection, and then mix with the obtained Mix the solutions to ensure that each 15 ml solution contains recombinant bovine basic fibroblast growth facto...

Embodiment 2

[0057] Embodiment 2: rb-bFGF topical solution and its preparation

[0058] prescription:

[0059] Recombinant bovine basic fibroblast growth factor 50000000IU;

[0060] Human serum albumin 2g;

[0061] Mannitol 250g;

[0062] Dextran - 7020g;

[0063] Disodium hydrogen phosphate 90g;

[0064] Sodium dihydrogen phosphate 50g;

[0065] Add water for injection to 15000ml;

[0066] A total of 1000 pieces

[0067] The specific preparation method is:

[0068] (1) Disperse the prescribed amount of mannitol in water for injection, sterilize by autoclaving at 121°C, and cool down for later use;

[0069] (2) Dissolve the prescribed amount of recombinant bovine basic fibroblast growth factor stock solution, human serum albumin, dextran-70, disodium hydrogen phosphate, and sodium dihydrogen phosphate in water for injection, and then mix with the obtained Mix the solutions to ensure that each 15 ml solution contains recombinant bovine basic fibroblast growth factor 63000IU; in...

Embodiment 3

[0073] Embodiment 3: rb-bFGF topical solution and its preparation

[0074] prescription:

[0075] Recombinant bovine basic fibroblast growth factor 70000000IU;

[0076] Human serum albumin 4g;

[0077] Mannitol 350g;

[0078] Dextran - 7025g;

[0079] Disodium hydrogen phosphate 100g;

[0080] Sodium dihydrogen phosphate 55g;

[0081] Add water for injection to 15000ml;

[0082] A total of 1000 pieces

[0083] The specific preparation method is:

[0084] (1) Disperse the prescribed amount of mannitol in water for injection, sterilize by autoclaving at 121°C, and cool down for later use;

[0085] (2) Dissolve the prescribed amount of recombinant bovine basic fibroblast growth factor stock solution, human serum albumin, dextran-70, disodium hydrogen phosphate, and sodium dihydrogen phosphate in water for injection, and then mix with the obtained Mix the solutions to ensure that each 15 ml solution contains recombinant bovine basic fibroblast growth factor 63000IU; i...

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Abstract

The invention discloses an external application solution of recombinant bovine basic fibroblast growth factor and a preparation method thereof. In the scheme of the present invention, the components and dosages contained in each 15 ml of the external application solution are recombinant bovine basic fibroblast growth factor 40000-80000 IU, human serum albumin 1-5 mg, mannitol? 250~350mg, dextran 20~25mg, disodium hydrogen phosphate 80~100mg, sodium dihydrogen phosphate 45~55mg, add water for injection to 15mL, the pH value of the external solution is 7.0. The rb-bFGF solution for external use of the present invention has optimized raw material compatibility, good stability, can quickly, permanently and effectively promote wound healing, increase healing rate, reduce scar rate, shorten healing time, and has good curative effect.

Description

technical field [0001] The present invention relates to the field of biological products. In particular, it relates to an external application solution of recombinant bovine basic fibroblast growth factor and a preparation method thereof. Background technique [0002] The skin covers the whole body, and it protects various tissues and organs in the body from physical, mechanical, chemical and pathogenic microorganisms. The skin has two barrier functions: on the one hand, it prevents the loss of water, electrolytes and other substances in the body; on the other hand, it prevents the invasion of harmful substances from the outside. Maintaining the stability of the internal environment of the human body plays an important protective function physiologically, and the skin also participates in the metabolic process of the human body. [0003] However, severe trauma to the skin, burns, and skin ulcers caused by certain diseases such as diabetes can have a huge physical and menta...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K47/42A61K47/26A61K9/08A61P17/02
Inventor 郑赞顺龙伟蒋丹丽王新志
Owner ZHUHAI ESSEX BIO PHARMA