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Human granulocyte-macrophage colony stimulating factor spray and its preparation process

A technology of colony-stimulating factor and macrophages, which is applied in aerosol delivery, extracellular fluid diseases, pharmaceutical formulations, etc., can solve the problems of no recombinant human granulocyte-macrophage colony-stimulating factor spray reports, etc., and achieve improvement Bioavailability, reduced systemic side effects, easy to carry effect

Inactive Publication Date: 2008-06-18
深圳市孚沃德生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the treatment of oral ulcers and anti-inflammation, there is no peptide spray drug available, and there is no recombinant human granulocyte macrophage colony-stimulating factor spray report

Method used

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  • Human granulocyte-macrophage colony stimulating factor spray and its preparation process

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Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0020] 1. Formulation:

[0021] GM-CSF 0.02g

[0022] Mannitol 20.0g

[0023] Lactose 10.0g

[0024] Oleic acid 0.1g

[0025] Polysorbate-80 0.1g

[0026] Add phosphate buffer (0.1N, 7.2pH) to 1000ml

[0027] 2. Preparation method:

[0028] (1) Use disodium hydrogen phosphate and sodium dihydrogen phosphate to prepare a pH of 7.2 and a concentration of 0.1N phosphate buffer solution;

[0029] (2) Measure 100ml of prepared phosphate buffer solution with a graduated cylinder, add mannitol and lactose weighed according to the formula, and stir until initially dissolved to make mother liquor I;

[0030] (3) Measure 100ml of prepared phosphate buffer solution with a graduated cylinder, add oleic acid and polysorbate-80 weighed according to the formula, and stir until initially dissolved to make mother liquor II;

[0031] (4) Add 13ml of GM-CSF stock solution (containing 0.02g of GC-CSF protein) to mother liquor I;

[0032] (5) Mix mother liquor I and II, then add phosphate ...

preparation Embodiment 2

[0035] 1. Formulation:

[0036] GM-CSF0.15g

[0037] Human albumin 2.0g

[0038] Trehalose 20.0

[0039] Soy Lecithin 0.1g

[0040] Polysorbate-80 0.1g

[0041] Ethylparaben 1.5g

[0042] Add phosphate buffer (0.1N, 7.2pH) to 1000ml

[0043] 2. Preparation method:

[0044] (1) Use disodium hydrogen phosphate and sodium dihydrogen phosphate to prepare a solution with a pH of 7.2 and a concentration of 0.1N phosphate buffer.

[0045] (2) Measure 100ml of prepared phosphate buffer solution with a graduated cylinder, add human albumin and trehalose weighed according to the formula, and stir until initially dissolved to make mother solution I;

[0046] (3) Measure 100ml of prepared phosphate buffer solution with a graduated cylinder, add soybean lecithin and polysorbate-80 weighed according to the formula, and stir until initially dissolved to make mother liquor II;

[0047] (4) Add 86ml of GM-CSF stock solution (containing 0.15g of GC-CSF protein) to mother liquor I;

[0...

preparation Embodiment 3

[0051] 1. Formulation:

[0052] GM-CSF0.15g

[0053] Human albumin 2.0g

[0054] Mannitol 20.0g

[0055] Hyaluronic Acid 5.0

[0056] Glycerin 5.0

[0057] Soy Lecithin 0.1g

[0058] Polysorbate-80 0.1g

[0059] Ethylparaben 1.3g

[0060] Add phosphate buffer (0.1N, 7.2pH) to 1000ml

[0061] 2. Preparation method:

[0062] (1) Dissolve human serum albumin, mannitol, hyaluronic acid and glycerin as a composite stabilizer with phosphate buffer (0.1N, 7.2pH), and prepare a transparent The mother liquor of 5% hyaluronic acid and 5% glycerol is used as the preparation mother liquor I.

[0063] (2) Soybean lecithin and polysorbate-80 were dissolved in phosphate buffer (0.1N, 7.2pH) as composite absorption promoters, and prepared into mother liquor II containing 0.1% soybean lecithin and 0.1% polysorbate-80.

[0064] (3) Take 100ml of mother solution I, then add 67ml of GM-CSF stock solution (2.24mg / ml), mix well and place at room temperature for 30 minutes.

[0065] (4) A...

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Abstract

The human granulocyte-macrophage colony stimulating factor spray includes human granulocyte-macrophage colony stimulating factor in 0.02-0.5 weight portions, stabilizer in 10.0-100.0 weight portions, and absorption promoter in 0.05-0.5 weight portions. The stabilizer is one or several selected from human blood albumin, lactose, trehalose, cane sugar, mannitol, glycerin, etc; and the absorption promoter is one or several selected from lecithin, sodium cholate, sodium deoxycholate, oleic acid, etc. The human granulocyte-macrophage colony stimulating factor spray has local bioavailability, less systemic side effect, easy use and other features.

Description

technical field [0001] The invention relates to a spray and a preparation method thereof. Specifically, the present invention relates to a natural or recombinant human granulocyte-macrophage colony-stimulating factor spray and a preparation method thereof. Background technique [0002] Granulocyte-macrophage colony-stimulating factor (GM-CSF) is one of the important hematopoietic factors discovered in recent years. It is a cytokine that can regulate the proliferation and differentiation of hematopoietic progenitor cells. It was only in 1977 that people isolated and purified a glycoprotein that could stimulate granulocytes and macrophage colonies to form a single component with a molecular weight of 23KD from the conditioned medium of mouse lung tissue, and was therefore named GM-CSF (Burgess, et al., 1977); in 1978, Nicola et al took the lead in extracting human GM-CSF from human placenta conditioned medium (Nicola et al., 1979). In 1985, the gene of human granulocyte-macr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/19A61K9/12A61P7/06A61P43/00
Inventor 王玉清吴歧
Owner 深圳市孚沃德生物技术有限公司
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