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External solution for recombinant bovine basic fibroblast growth factor

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

Active Publication Date: 2015-06-03
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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  • External solution for recombinant bovine basic fibroblast growth factor
  • External solution for recombinant bovine basic fibroblast growth factor
  • External solution for recombinant bovine basic fibroblast growth factor

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 albumin 3g;

[0045] Mannitol 300g;

[0046] Dextran-70 22.5g;

[0047] Disodium hydrogen phosphate 80g;

[0048] Sodium dihydrogen phosphate 45g;

[0049] Add water for injection to 15000 ml;

[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 The solutions were mixed to ensure that every 15 milliliters of the solution contained recombinant bovine basic fibr...

Embodiment 2

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

[0058] prescription:

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

[0060] Human albumin 2g;

[0061] Mannitol 250g;

[0062] Dextran-70 20g;

[0063] Disodium hydrogen phosphate 90g;

[0064] Sodium dihydrogen phosphate 50g;

[0065] Add water for injection to 15000 ml;

[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 The solutions were mixed to ensure that every 15 milliliters of the solution contained recombinant bovine basic fibroblast growth...

Embodiment 3

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

[0074] prescription:

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

[0076] Human albumin 4g;

[0077] Mannitol 350g;

[0078] Dextran-70 25g;

[0079] Disodium hydrogen phosphate 100g;

[0080] Sodium dihydrogen phosphate 55g;

[0081] Add water for injection to 15000 ml;

[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 The solutions were mixed to ensure that every 15 milliliters of the solution contained recombinant bovine basic fibroblast growt...

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PUM

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Abstract

The invention discloses an external solution for a recombinant bovine basic fibroblast growth factor, and a preparation method of the external solution. According to the scheme disclosed by the invention, each 15ml of external solution comprises the following components: 40,000-80,000IU of recombinant bovine basic fibroblast growth factor, 1-5mg of human albumin, 250-350mg of mannitol, 20-25mg of dextran, 80-100mg of disodium hydrogen phosphate, 45-55mg of sodium dihydrogen phosphate and water injected to 15mL; and the pH value of the external solution is 7.0. The rb-bFGF external solution is optimal in compatibility of raw materials, good in stability and good in curative effect, and is capable of rapidly, lastingly and effectively promoting wound healing, improving the healing rate, lowering the scar rate and shortening the healing time.

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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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
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