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Genipin cross-linked soybean protein based theophylline controlled-release gel preparation and preparation method thereof

A gel preparation, soybean protein technology, applied in pharmaceutical formulations, medical preparations with non-active ingredients, respiratory diseases, etc., can solve the problems of cross-linking agent residue, limited application, and high equipment requirements, and achieves elimination of accurate positioning and release. , The effect of stabilizing the blood concentration of the drug and prolonging the absorption time

Inactive Publication Date: 2013-01-02
ZHANJIANG NORMAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, chitosan has poor hydrophilicity, is insoluble in water, and can only be dissolved in acidic solutions, which limits its application in the biological field and the delivery of biomacromolecular drugs.
Although chitosan is also cross-linked in the current prior art, there are also certain defects, that is, the current technology all uses cross-linking agents such as glutaraldehyde, so the finished preparation will produce cross-linking agent residues, which is difficult for human body to use. There are hidden dangers in terms of safety, and it will cause certain pollution to the environment
[0005] Soy protein has high nutritional value, good gelatinity and biodegradability, but there is a common problem in protein gels. Once heated, the protein will be denatured, causing some heat-sensitive drug-loaded molecules to lose their physiological activity.
At the same time, the current hydrogel preparation process is complicated, the requirements for equipment are high, the quality control is difficult, and the production cost is relatively high.

Method used

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  • Genipin cross-linked soybean protein based theophylline controlled-release gel preparation and preparation method thereof
  • Genipin cross-linked soybean protein based theophylline controlled-release gel preparation and preparation method thereof
  • Genipin cross-linked soybean protein based theophylline controlled-release gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Disperse the soy protein in a 0.1mol / L sodium hydroxide solution and heat and stir at 40°C until it is completely dissolved, and then continue to stir at a constant temperature for 20 minutes. The solution and the 2% chitosan acetic acid solution in a volume ratio of 1:2 Mix well; add theophylline to the solution and stir and mix; finally add 40 mmol / L genipin aqueous solution to the solution for cross-linking, and finally gelatinize in a constant temperature water bath at 35°C. The obtained gel formulation is The surface is smooth, opaque dark green, and the inside is a dense fold network structure.

Embodiment 2

[0032] Disperse the soy protein in a 0.15mol / L sodium hydroxide solution and heat and stir at 45°C until it is completely dissolved, then continue to stir at a constant temperature for 25 minutes, and the solution and the 3% chitosan acetic acid solution in a volume ratio of 1:2 Mix well; add theophylline to the solution and stir and mix; finally add 45 mmol / L genipin aqueous solution to the solution for cross-linking, and finally gel in a constant temperature water bath at 37°C. The resulting gel formulation is The surface is smooth, opaque dark green, and the inside is a dense fold network structure.

Embodiment 3

[0034] Disperse soy protein in 0.2mol / L sodium hydroxide solution and heat and stir at 50°C until it is completely dissolved, then continue to stir at constant temperature for 30 minutes, and the solution and 4% chitosan acetic acid solution are in a volume ratio of 1:2 Mix evenly; add a certain amount of theophylline to the solution and stir and mix; finally add 50 mmol / L genipin aqueous solution to the solution for cross-linking, and finally gelatinize in a constant temperature water bath at 40°C to make The gel preparation has a smooth surface, an opaque dark green, and a dense fold network structure inside.

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Abstract

The invention relates to a genipin cross-linked soybean protein based theophylline controlled-release gel preparation and a preparation method thereof. According to the invention, two different high-molecular compounds of soybean protein and chitosan, and a natural cross-linking agent genipin form a framework material of the gel preparation for controlling the releasing of theophylline. The preparation method of the gel preparation comprises steps that: soybean protein is dispersed in a sodium hydroxide solution; the mixture is heated and stirred until completely dissolved; the mixture and anacetic acid solution of chitosan are well mixed according to a certain proportion; theophylline is added to he mixture; a certain amount of an aqueous solution of genipin is added to the mixture for carrying out cross-linking; and a gel is formed through a thermostatic water bath. The surface of the gel preparation is smooth, and the gel is dark green and opaque. The inner part of the gel preparation is in a compact folded network structure. The gel preparation is characterized by no toxicity, stable three-dimensional network structure, good compatibility, and good dispersity. With the gel preparation, the stability of the active component is improved.

Description

Technical field [0001] The invention relates to a controlled-release gel preparation and a preparation method thereof, in particular to a genipin cross-linked soy protein-based theophylline controlled-release gel preparation and a preparation method thereof, and belongs to the technical field of drug slow-release preparations. Background technique [0002] Theophylline can strengthen bronchial muscles, reduce contraction, relax smooth muscles, and is very effective in treating bronchial asthma. However, theophylline treatment has a narrow range of blood concentration (5-20 μg / ml), and the clearance rate and half-life vary from person to person. Ordinary theophylline tablets need to be taken 3 times a day. The medication at night will affect sleep, and blood after frequent administration The drug concentration is prone to "peak and valley" phenomenon, causing headache, nausea, insomnia, cramps and allergies and other side effects. In recent years, some countries have developed ma...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/522A61K47/42A61K47/36C08J3/24C08L89/00C08L5/08A61P11/06
Inventor 金蓓
Owner ZHANJIANG NORMAL UNIV