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Recombinant human granulocyte-macrophage-stimulating factor vaginal expansive suppository, preparation method and detection method thereof

A macrophage stimulation, vaginal expansion suppository technology, applied in the directions of drug combination, suppository delivery, pharmaceutical formulation, etc., can solve the problems of unstable nature, oxidation, affecting drug release effect, etc., to avoid secondary infection and prevent outflow Effect

Active Publication Date: 2018-11-02
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] So far, the research work and relevant literature on rhGM-CSF topical preparations for the treatment of cervicitis and cervical erosion are still relatively rare
In addition, as a protein, rhGM-CSF itself is unstable, and it is prone to deamination, oxidation, hydrolysis, mismatching of disulfide bonds, denaturation, aggregation, precipitation, etc. With a certain spatial structure, it is more likely to be affected by steric hindrance during the release process, which affects its drug release effect
Patent application CN200510085861.5 discloses the new application of granulocyte-macrophage stimulating factor in treating cervicitis and cervical erosion external preparations, but it does not investigate the stability of rhGM-CSF in its suppositories, and does not solve the long-term storage and transportation of suppositories And other issues

Method used

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  • Recombinant human granulocyte-macrophage-stimulating factor vaginal expansive suppository, preparation method and detection method thereof
  • Recombinant human granulocyte-macrophage-stimulating factor vaginal expansive suppository, preparation method and detection method thereof
  • Recombinant human granulocyte-macrophage-stimulating factor vaginal expansive suppository, preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097]

[0098] Preparation:

[0099] 1) Preparation of drug-containing matrix:

[0100] a. Put Massa Estarinum E, glycerinated gelatin and gum arabic in a water bath to heat and melt at 60°C to obtain a melt, and lower it to 38°C for later use;

[0101] b. Slowly mix the rhGM-CSF and the melt of step a to obtain a drug-containing matrix;

[0102] 2) Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 224 conical suppositories, each weighing about 2.5g.

Embodiment 2

[0104]

[0105] Preparation:

[0106] 1) Preparation of drug-containing matrix:

[0107] a. Put polyethylene glycol 400, polyethylene glycol 4000, gelatin and glycerol tripalmitin in a water bath and heat and melt at 70°C to obtain a melt, and lower it to 45°C;

[0108] b. Slowly add rhGM-CSF to the melt obtained in step a, while slowly mixing evenly to prepare a drug-containing matrix;

[0109] 2) Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 110 cylindrical suppositories, each weighing about 3.5g.

Embodiment 3

[0111]

[0112] Preparation method: make 132 rod-shaped suppositories according to the method in Example 2, each weighing about 5g.

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Abstract

The present invention relates to a recombinant human granulocyte-macrophage-stimulating factor (rhGM-CSF) vaginal expansive suppository and a preparation method and a detection method thereof. The expansive suppository comprises a drug-containing matrix and an expansive carrier mainly formed by rhGM-CSF and matrix ; The addition of claritol, hexidine and carrageenan in the drug-containing matrix can reduce the harmful changes of rhGM-CSF and increase the stability of the suppository; Sour rapeseed oil and polacrilin potassium, the synergistic effect of described canola oil and polacrilin potassium can increase the dissolution rate of the main active ingredient rhGM-CSF, and at the same time promote the absorption of the drug by skin and mucous membranes, thereby further Improve the bioavailability of the suppository; and the rhGM-CSF vaginal expansion suppository provided by the present invention adopts six original leading technologies, which has the beneficial effects of preventing drug liquid outflow, high stability, long-lasting curative effect, and preventing secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, and in particular relates to a recombinant human granulocyte-macrophage stimulating factor vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Recombinant human granulocyte-macrophage-stimulating factor (rhGM-CSF) is an acidic protein produced and secreted by activated T cells, B cells, macrophages, mast cells, endothelial cells and fibroblasts. rhGM-CSF has the effect of generating leukocytes, and is a cell growth factor necessary for regulating hematopoietic and leukocyte functions. It can comprehensively improve the pathological characteristics of chronic ulcers, promote wound repair, and enhance the bactericidal ability of granulocytes and macrophages. Widely involved in immune and anti-infection processes. [0003] In recent years, as rhGM-CSF can be produced in large quantities by genetic engineering technology, its researc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K38/19A61K47/14A61P15/00
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司