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Recombinant bovine basic fibroblast growth factor freeze-dried formulation for external application

A fibroblast and growth factor technology, which is applied in freeze-dried delivery, medical preparations containing active ingredients, drug combinations, etc., can solve the problem of the formulation and preparation of recombinant bovine basic fibroblast growth factor external-use freeze-dried preparations that have not yet been disclosed Process and other issues, to achieve the effect of good stability, simple preparation process, and enhanced compliance

Inactive Publication Date: 2012-12-19
ZHUHAI ESSEX BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The formula and preparation process of recombinant bovine basic fibroblast growth factor external use freeze-dried preparation have not been disclosed in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Pre-lyophilized solution prescription:

[0017] Recombinant bovine basic fibroblast growth factor 350000IU;

[0018] Human serum albumin 75mg;

[0019] Glucose 1000mg;

[0020] Appropriate amount of water for injection

[0021] A total of 1000 pieces

[0022] The specific preparation method is as follows: after dissolving the recombinant bovine basic fibroblast growth factor, human serum albumin and glucose with water for injection, aseptically filtered with a 0.22 μm filter membrane, packaged in vials, and then sent to the plate In the freeze dryer, first pre-freeze the sample at -20°C for 2 hours, then turn on the condenser, turn on the vacuum system, start heating and sublimation, and then dry at 15°C for 4 hours.

Embodiment 2

[0024] Pre-lyophilized solution prescription:

[0025] Recombinant bovine basic fibroblast growth factor 250000IU;

[0026] Polyethylene glycol 50mg;

[0027] Mannitol 800mg;

[0028] Appropriate amount of water for injection

[0029] A total of 1000 pieces

[0030] The specific preparation method is as follows: after dissolving the recombinant bovine basic fibroblast growth factor, polyethylene glycol and mannitol in water for injection, aseptically filtered with a 0.22 μm filter membrane, packaged in vials, and then sent to the plate In the freeze dryer, first pre-freeze the sample at -40°C for 5 hours, then turn on the condenser, turn on the vacuum system, start heating and sublimation, and then dry at 40°C for 8 hours.

Embodiment 3

[0032] Pre-lyophilized solution prescription:

[0033] Recombinant bovine basic fibroblast growth factor 450000IU;

[0034] Human serum albumin 75mg;

[0035] Lactitol 500mg;

[0036] Appropriate amount of water for injection

[0037] A total of 1000 pieces

[0038] The specific preparation method is as follows: after dissolving the recombinant bovine basic fibroblast growth factor, human serum albumin and lactitol in water for injection, aseptically filtered with a 0.22 μm filter membrane, packaged in vials, and then sent to a plate Put the sample into the freeze dryer, first pre-freeze the sample at -30°C for 4 hours, then turn on the condenser, turn on the vacuum system, start heating and sublimation, and then dry at 30°C for 6 hours.

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PUM

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Abstract

The invention discloses a recombinant bovine basic fibroblast growth factor freeze-dried formulation for external application. The freeze-dried formulation for external application contains the following ingredients: 20000 to 50000 IU of recombinant bovine basic fibroblast growth factors, 5 to 10 mg of a protein protectant and 50 to 100 mg of a diluent, wherein the protein protectant is selected from human blood albumin, mannitol and polyethylene glycol, preferably human blood albumin; and the diluent is selected from mannitol, lactitol or glucose. The product has the characteristics of having a good stability and not containing insoluble substances after re-dissolution.

Description

technical field [0001] The present invention relates to the field of biological products. In particular, it relates to a freeze-dried preparation of recombinant bovine basic fibroblast growth factor for external use and a preparation method thereof. Background technique [0002] The skin is an important barrier to the body from infection and dehydration, and severe trauma, burns, and skin ulcers caused by certain diseases such as diabetes can have a huge physical and mental impact on patients. Therefore, the repair of skin wounds is an issue of great concern in the field of medicine. [0003] Since the end of the last century, a variety of studies have been carried out on the post-traumatic tissue repair process, mechanism and treatment. The level has been continuously improved. At present, a variety of genes that promote granulation tissue growth, vascularization and re-epithelialization have been constructed, such as epidermal cytokine, basic fibroblast growth factor an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K38/18A61P17/02
Inventor 方海洲郑赞顺朱爱堂蓝瑄黄贤科
Owner ZHUHAI ESSEX BIO PHARMA