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Method for preparing chitosan in situ gel agent

An in-situ gel and chitosan sol technology, which is applied in the field of medicine, can solve the problems of thermally unstable drug preparation, poor film flexibility, and complicated preparation process, and solve the problems of uncontrollable preparation quality, simple production process, Expand the effect of delivery methods

Inactive Publication Date: 2008-12-24
SHANGHAI JIAO TONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

"The chitosan microspheres prepared by secondary cross-linking not only significantly increase the strength, but also controllable the particle size distribution and sustained release effect of the microspheres, but there are still at least three deficiencies in the preparation of the above-mentioned chitosan microspheres: 1. .During the preparation of the microspheres, a dialdehyde cross-linking agent harmful to humans was added, resulting in unsafe preparations. 2. A large amount of organic solvents were used in the preparation of the microspheres, which made it difficult to guarantee the quality of the product3. .The preparation process of this method is relatively complicated, which is not conducive to large-scale production
"Although the drug film prepared by the above method avoids the use of organic solvents, this method still has at least two shortcomings: 1. The film prepared by chitosan alone has poor flexibility, and some plasticizers need to be added, such as polystyrene. Ethylene glycol, etc. 2. It is necessary to heat to remove the solvent during the preparation of the drug film, which is not suitable for the preparation of thermally unstable drugs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 1. Dissolving 50 mg of chitosan with a degree of deacetylation of 60% and a viscosity of 50 cP in 5 ml of dilute hydrochloric acid aqueous solution of pH 4;

[0022] 2. Add antibacterial drugs with a theoretical drug load of 1% to the chitosan solution and stir thoroughly;

[0023] 3.CO 2 Under the atmosphere, under stirring conditions at 4°C, add 10ml of 0.25 M aqueous sodium bicarbonate solution dropwise into the chitosan acid solution, and continue stirring for 2 minutes;

[0024] 4. In CO 2 Under protection, the homogeneously mixed chitosan sol is divided into vials with stoppers and sealed to obtain the chitosan in situ gel administration preparation.

[0025] Implementation effect: The chitosan in situ gel drug preparation prepared by the present invention does not contain any organic solvents and harmful components to the human body. When in use, the chitosan in situ gel is applied to the skin surface to form a tight layer. A film that adheres to the surface o...

Embodiment 2

[0027] 1. Dissolve 150 mg of chitosan with a degree of deacetylation of 80% and a viscosity of 200 cP in 15 ml of dilute nitric acid aqueous solution at pH 2 containing acetone;

[0028] 2. Add conventional antifungal drugs with a theoretical drug loading of 20% to the chitosan solution, and fully stir;

[0029] 3.CO 2 Under the atmosphere, under 10°C and stirring conditions, slowly add 20ml of 0.35 M sodium carbonate aqueous solution into the chitosan acid solution, and continue stirring for 5 minutes;

[0030] 4. In CO 2 Under protection, the homogeneously mixed chitosan sol is divided into polyvinyl chloride plastic vials to obtain the chitosan in situ gel administration preparation.

[0031] Implementation effect: the chitosan in situ gel preparation prepared by the present invention does not contain any organic solvents and harmful components to the human body. When in use, the chitosan in situ gel is dripped into the nasal cavity to form a layer of tight adhesion The ...

Embodiment 3

[0033] 1. Dissolve 600 mg of chitosan with a degree of deacetylation of 95% and a viscosity of 500 cP in an aqueous solution of dilute hydrochloric acid / dilute nitric acid of pH 0.5 in 30 ml;

[0034] 2. Add conventional antineoplastic drugs with a theoretical drug load of 40% to the acid solution of chitosan, and fully stir;

[0035] 3.CO 2 Under the atmosphere, under stirring conditions at 2°C, slowly add 30ml of 0.3M potassium bicarbonate aqueous solution into the chitosan acid solution, and continue stirring for 10 minutes;

[0036] 4. In CO 2 Under protection, the homogeneously mixed chitosan sol is divided into glass vials with stoppers to obtain the chitosan in situ gel administration preparation.

[0037] Implementation effect: the chitosan in situ gel administration preparation prepared by the present invention does not contain any organic solvents and harmful components to the human body. When in use, the chitosan in situ gel is injected into the tumor resection si...

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PUM

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Abstract

The invention discloses a preparation method of chitosan in situ gel preparation, which belongs to the medicine technical field. The invention comprises the steps as follows: first, dissolving chitosan into water solution and / or water solution with cosolvent; second, adding medicine into the chitosan solution and stirring sufficiently; third, adding strong base-weak acid salt into the chitosan solution slowly in CO2 atmosphere and under the stirring condition, and keeping stirring; fourth, distributing the evenly mixed chitosan collosol into sterile bottles with stoppers for sealing or filling chitosan collosol into an atomizing device under the protection by CO2 and then obtaining the chitosan in situ gel preparation. The invention not only avoids using organic solvent in the cause of preparation production but also simplifies the preparation production flow and widens the preparation application ways.

Description

technical field [0001] The invention relates to a preparation method in the technical field of medicine, in particular to a preparation method of chitosan in-situ gel medicament. Background technique [0002] Chitosan (Chitosan) is chitin off C 2 Acetyl products, also known as chitosan, deacetylated chitin, soluble chitin, polyglucosamine, etc. Chitosan contains a large number of free amino groups in its structure, which can bind acid molecules. It is the only basic polysaccharide among natural polysaccharides, and it is also one of the few natural products with positive charges. Because of this unique physical and chemical properties, as well as its low price and good biocompatibility, it can be widely used in the pharmaceutical industry. At present, chitosan-based drug delivery mainly includes chitosan microspheres and chitosan sustained-release drug films. [0003] After searching the prior art documents, it is found that the Chinese patent announcement number is CN101...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/36
Inventor 郭圣荣程亮刘黎唐奚敏
Owner SHANGHAI JIAO TONG UNIV
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