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Recombinant human granulocyte macrophage stimulating factor spray and preparation method thereof

A macrophage stimulation and spray technology, used in aerosol delivery, extracellular fluid diseases, drug combinations, etc., can solve problems such as adverse reactions, increase patient pain, and short half-life, and achieve accurate metering results.

Inactive Publication Date: 2016-06-29
SHANGHAI TONGREN HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At the same time, since rhG-CSF is easily hydrolyzed by enzymes and cleared by the kidneys, and has a short half-life in the body, daily administration is required. Repeated injections not only increase the suffering of patients, but also cause some adverse reactions

Method used

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  • Recombinant human granulocyte macrophage stimulating factor spray and preparation method thereof
  • Recombinant human granulocyte macrophage stimulating factor spray and preparation method thereof
  • Recombinant human granulocyte macrophage stimulating factor spray and preparation method thereof

Examples

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Effect test

Embodiment 1

[0034] Embodiment 1: Preparation of recombinant human granulocyte macrophage stimulating factor liposome spray

[0035] Prescription: recombinant human granulocyte macrophage stimulating factor 150mgU—U

[0036]

[0037] Preparation Process:

[0038] 1) Dissolving lecithin and cholesterol in chloroform according to the prescription ratio to form a clear solution;

[0039] 2) Add sorbitol powder to the above solution, sorbitol is insoluble in chloroform, and is very fine particles in chloroform solution:

[0040] 3) Vacuum drying, so that the chloroform is completely volatilized, and the lipid is evenly adsorbed on the carrier particles;

[0041] 4) Dissolving the recombinant recombinant human granulocyte-macrophage stimulating factor in water and adding it to the lipid carrier system to form liposome emulsion with uniform size.

Embodiment 2

[0042] Example 2: Preparation of recombinant human granulocyte-macrophage-stimulating factor nanoemulsion spray

[0043] Prescription: recombinant human granulocyte macrophage stimulating factor 150mgU—U

[0044]

[0045] Preparation Process:

[0046] 1) Heat phospholipids and glycerin to 60°C, fully stir and disperse evenly;

[0047] 2) Heat Pluronic and appropriate amount of water to 80°C to dissolve,

[0048] 3) Add the water phase to the oil phase dropwise while stirring at a constant temperature of 60°C, disperse through a high-pressure homogenizer several times, and filter to obtain a nanoemulsion;

[0049] 4) Then carry out drug-loading treatment.

Embodiment 3

[0050] Embodiment 3: Preparation of recombinant human granulocyte macrophage stimulating factor natural milk spray

[0051] Prescription: recombinant human granulocyte macrophage stimulating factor 150mgU—U

[0052]

[0053] Preparation Process:

[0054] 1) Dissolving lecithin and cholesterol in chloroform according to the prescription ratio to form a clear solution;

[0055] 2) Add sorbitol powder in the above solution, sorbitol is insoluble in chloroform, and is very fine particle in chloroform solution;

[0056] 3) Vacuum drying, so that the chloroform is completely volatilized, and the lipid is evenly adsorbed on the carrier particles;

[0057] 4) Dissolving the recombinant human granulocyte-macrophage stimulating factor in water and adding it to the liposome carrier system to form a liposome nanoemulsion with uniform size.

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Abstract

The invention discloses a recombinant human granulocyte-macrophage-stimulating factor spray, which uses liposomes, emulsions, micelles, synthetic or natural fats and volatile oils as drug carriers, and contains (0.01 ‑5.0) parts by weight of recombinant human granulocyte-macrophage-stimulating factor; at the same time, a preparation method of the spray and its application in nasal cavity, oral cavity and sublingual mucosa for increasing white blood cells are provided. The spray prepared by the special process of the present invention can not only protect the activity of recombinant human granulocyte-macrophage-stimulating factor, but also achieve the effect of slow drug release, and the product of the present invention has high biological potency, quick onset and long-lasting effect. slow, easy to use, and has broad prospects in clinical practice.

Description

technical field [0001] The invention belongs to the field of biopharmaceuticals, and relates to a spray and a preparation method thereof, in particular to a recombinant human granulocyte-macrophage stimulating factor spray and a preparation method thereof. Background technique [0002] Granulocyte colony-stimulating factor (G-CSF) is also known as colony-stimulating factor 3 (CSF-3), granulocyte-macrophage differentiation factor (GM-DF), pluripotent hematopoietin (pluripoietin, pCSF) and colony-stimulating factor β (CSF-β) and so on. There are two variants of G-CSF, one containing 174 amino acids (type b) and the other containing 177 amino acids (type a), both of which are products of alternative splicing. Smaller variants predominate and show greater biological activity than larger variants. [0003] G-CSF is more and more used in patients with malignant tumor chemotherapy due to its ability to rapidly increase the white blood cell count. Increases neutrophil count and p...

Claims

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Application Information

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IPC IPC(8): A61K38/19A61K9/12A61K9/127A61K9/107A61P7/00
CPCA61K38/193A61K9/0043A61K9/0053A61K9/006A61K9/1075A61K9/12A61K9/127A61K47/24A61K47/26
Inventor 孙西洋马俐君张扬
Owner SHANGHAI TONGREN HOSPITAL
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