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Oral adhering piece for treating oral exulceratio, and its prepn. method

A technology for oral ulcers and adhesive sheets, which is applied to the oral adhesive sheet for treating oral ulcers and the field of preparation thereof, can solve the problems of short retention time of the gel, failure to achieve treatment, dilution of the gel, etc., so as to reduce systemic side effects. Response, increased duration of action, effect of dose reduction

Inactive Publication Date: 2006-01-11
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

As a body surface drug, such as Chinese Patent No. 02150093.2 and Chinese Patent No. 0310044.X invented recombinant human granulocyte macrophage colony-stimulating factor gel, which mainly treats skin burns, scalds and ulcers on the skin or mucous membranes, but the gel It stays in the affected part of the skin for a short time and is easy to be removed. Especially for oral medicine, the gel is easily diluted by saliva and cannot achieve the good effect of treating oral ulcers.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] 1. Components:

[0034] Main drug: Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is a stock solution prepared by bacterial fermentation and column chromatography according to the "China Biological Products Regulations" (2000 edition).

[0035] Stabilizers: propylene glycol, human serum albumin, and lactose are commercially available products of pharmaceutical grade.

[0036] Transdermal absorption agent: Sodium deoxycholate and oleic acid are commercially available products of pharmaceutical grade.

[0037] Adhesive agent: Carbomer and magnesium stearate are commercially available products of pharmaceutical grade.

[0038] Auxiliary materials for the protective layer: acrylic resin, polyvinyl alcohol 17-88, all of which are commercially available.

[0039] 2. Prepare 1000 tablets of the main drug and auxiliary materials:

[0040] GM-CSF: 0.1g Propylene Glycol: 5.0g

[0041] Human albumin: 5.0g Lactose: 40.0g

[0042] Sodium deox...

Embodiment 2

[0054] 1. Components:

[0055] Main drug: Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is a stock solution prepared by bacterial fermentation and column chromatography according to the "China Biological Products Regulations" (2000 edition).

[0056] Stabilizers: Glycerin, lactose, and hyaluronic acid are commercially available products of pharmaceutical grade.

[0057] Transdermal absorbent: lecithin and oleic acid are commercially available products of pharmaceutical grade.

[0058] Adhesive agent: Carbomer and magnesium stearate are commercially available products of pharmaceutical grade.

[0059] Auxiliary materials for the protective layer: polyvinyl alcohol 17-88, dioctyl phthalate, and yellow pigment are all commercially available products.

[0060] 2. Prepare 1000 tablets of the main drug and auxiliary materials:

[0061] GM-CSF: 0.3g Glycerin: 2.0g

[0062] Hyaluronic Acid: 5.0g Lactose: 30.1g

[0063] Lecithin: 0.1g Oleic aci...

Embodiment 3

[0075] 1. Components:

[0076] Main drug: Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), which is a stock solution prepared by bacterial fermentation and column chromatography according to the "China Biological Products Regulations" (2000 edition).

[0077] Stabilizer: human albumin, vitamin B2, lactose, and sodium alginate are commercially available products of pharmaceutical grade.

[0078] Transdermal absorption agent: lecithin and polysorbate 80 are commercially available products of pharmaceutical grade.

[0079]Adhesives: Carbomer, hydroxypropyl cellulose, and magnesium stearate are all pharmaceutical-grade commercially available products. Auxiliary materials for the protective layer: acrylic resin, polyvinyl alcohol 17-88, glycerin, dioctyl phthalate, and yellow pigment are all commercially available products.

[0080] 2. Prepare 1000 tablets of the main drug and auxiliary materials:

[0081] GM-CSF: 0.05g

[0082] Human Albumin: 2.0g V...

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PUM

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Abstract

An oral sticking sheet of the recombinant human granulocyte-macrophage colony stimulating factor for treating oral ulcer is composed of a water-insoluble protecting layer and an adhesive layer containing said active medicine, adhesive, the stabilizer for stabilizing the activity of protein and percutaneous absorption promoter.

Description

technical field [0001] The invention relates to an anti-oral ulcer drug recombinant human granulocyte macrophage colony-stimulating factor oral patch and a preparation method thereof. Background technique [0002] Oral ulcer is a kind of common disease, frequently-occurring disease. Its incidence rate accounts for about 15% of the total cases in dental clinics. There are many reasons for oral ulcers, such as low autoimmunity; vitamin deficiency; individual wound healing barriers; various viruses invade the oral cavity; low levels of white blood cells in the blood can cause oral ulcers. Though oral ulcer is not serious disease, because the patient has in every age group, and the course of disease is long, is difficult to cure, affects diet and even conversation, so majority of patients hope to have a kind of easy to use, the drug dosage form of good curative effect. [0003] At present, there are several kinds of medicines for the treatment of oral ulcers. Traditional Chine...

Claims

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Application Information

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IPC IPC(8): A61K38/19A61K9/70A61P1/02
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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