Prepn process of hydrogel prepn of recombined platelet derived growth factor

A growth factor, hydrogel technology, applied in the direction of drug combination, pharmaceutical formula, medical preparation containing active ingredients, etc., can solve the problems of difficult to cure diabetic foot, tissue regeneration, etc., achieve obvious repairing effect, long time, The effect of good contact performance

Inactive Publication Date: 2004-06-23
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Diabetic foot is difficult to cure. At present, there are three main clinical treatment methods: maintenance, infec

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of rhPDGF-BB liquid medicine

[0037] The rhPDGF-BB medicinal solution involved in the present invention is to construct a recombinant human PDGF-BB strain by using general genetic engineering technology, and to obtain a protein purity greater than 97% and a protein content of 1 mg / ml of rhPDGF-BB drug solution sample.

Embodiment 2

[0038] Example 2 Preparation of the hydrogel formulation of rhPDGF-BB

[0039] The entire process described below is performed under sterile conditions.

[0040] 1) Preparation of blank matrix

[0041] Take 4.0 grams of Carbopol940, add about 900 ml of water to make it fully soaked and swell completely. Under the condition of mechanical stirring, add an appropriate amount of 10% NaOH solution dropwise to make the pH value of the glue between 5.0-9.0, then add 30 grams of mannitol, 0.3 grams of EDTA-Na, and 0.8 grams of paraben Stir the ester until it dissolves, put it in a suitable container, sterilize it with high-pressure steam for 30 minutes (121°C, 115Pa), fully cool it at room temperature, store it in the refrigerator, and store it for later use.

[0042] 2), configuration of lysine solution

[0043] Take 5.0 grams of lysine, add an appropriate amount of water for injection, and after dissolving, put it in the refrigerator (2-8°C) and store it for later use.

[0044] ...

Embodiment 3

[0046] Example 3 Preparation of the hydrogel formulation of rhPDGF-BB

[0047] The entire process described below is performed under sterile conditions.

[0048] 1) Preparation of blank matrix

[0049] Take 10 grams of Carbopol981, add about 900 ml of water to make it fully soaked and swell completely. Under the condition of mechanical stirring, add an appropriate amount of 10% NaOH solution dropwise to make the pH value of the glue between 5.0-9.0, then add 30 grams of mannitol, 0.3 grams of EDTA-Na, and 0.8 grams of paraben Stir the ester until it dissolves, put it in a suitable container, sterilize it with high-pressure steam for 30 minutes (121°C, 115Pa), fully cool it at room temperature, store it in the refrigerator, and store it for later use.

[0050] 2), configuration of lysine solution

[0051] Take 5.0 grams of lysine, add an appropriate amount of water for injection, and after dissolving, put it in the refrigerator (2-8°C) and store it for later use.

[0052] 3...

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PUM

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Abstract

The present invention relates to preparation process of hydrogel preparation of medicine, and is especially preparation process of hydrogel preparation of recombined platelet derived growth factor, (rhPDGF-BB).

Description

technical field [0001] The invention relates to a method for preparing a hydrogel preparation of medicine, in particular, the invention relates to a method for preparing a hydrogel preparation of recombinant platelet-derived growth factor (rhPDGF-BB). Background technique [0002] Diabetes is one of the most common diseases worldwide. Statistics in 1998 showed that there were approximately 143 million people with diabetes worldwide. There are currently about 16 million people in the United States suffering from diabetes, and the number of diabetics in China is as high as more than 40 million, and it is increasing at a rate of 1‰ every year. According to estimates by WHO experts, by 2025 there will be 300 million diabetic patients worldwide, and 75% of them are in developing countries such as India and China. [0003] A special problem of diabetics is the occurrence of ulcers on the feet and lower extremities, referred to as diabetic foot (dry gangrene)....

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K38/18A61P3/10
Inventor 卓冰
Owner TIANJIN TASLY PHARMA CO LTD
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