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An alepsin slow-releasing gel for promoting paradontal part reborn as well as preparation method and application

A technology of phenytoin sodium and sustained-release gel, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., to achieve the effects of stable performance, strong operability, and labor saving

Inactive Publication Date: 2008-04-09
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] After retrieval, phenytoin sustained-release gel and its application in the field of periodontal regeneration have not been reported

Method used

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  • An alepsin slow-releasing gel for promoting paradontal part reborn as well as preparation method and application
  • An alepsin slow-releasing gel for promoting paradontal part reborn as well as preparation method and application
  • An alepsin slow-releasing gel for promoting paradontal part reborn as well as preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Embodiment 1: the preparation method of phenytoin sustained-release gel:

[0060] Raw material: purified water

[0061] 40mg / ml PLGA in dichloromethane

[0062] 80μg / ml phenytoin aqueous solution

[0063] 4% gelatin solution (dissolved in a water bath at 37°C).

[0064] 1.1 W / O / W emulsified solvent evaporation method to prepare PLGA microspheres:

[0065] Mix 100 μl of purified water or an equivalent 80 μg / ml phenytoin sodium solution (inner aqueous phase W 1 ) is added dropwise to the dichloromethane solution (0) of 2ml 40mg / mlPLGA, mixes 1.5min emulsification with the rotating speed of 15000 rev / mins and makes primary emulsion, then it is added dropwise in 10ml 4% gelatin solution (outer aqueous phase W 2 ), mixed at 15000 rpm for 2 minutes to make double emulsion, after 4 hours of magnetic stirring at 8000 rpm at room temperature, centrifuged at 10000 rpm for 10 minutes, removed the sediment in the lower layer, and washed it repeatedly with deionized water for 5 ...

Embodiment 2

[0068] Embodiment 2: The physicochemical performance investigation result of microsphere:

[0069] 2.1 Microsphere particle size and particle size distribution

[0070] 2.1.1 Morphological observation results of microspheres

[0071] The shape of the microsphere is a spherical solid particle, the appearance is round, the surface is smooth, and there is no adhesion phenomenon. Microscope photos are shown in Figure 1.

[0072] 2.1.2 Examination results of particle size and particle size distribution of microspheres

[0073] Count more than 500, according to the formula d av =∑nd / ∑n Calculate the average particle size of the microspheres as (3.93±0.003) μm; take the particle size of the microspheres as the abscissa, divide the particle size range per 1 μm, and within this range, the microspheres Number divided by the distribution frequency (%) of the microspheres that total number obtains is the ordinate and draws the particle size distribution figure, see Fig. 2; With median...

Embodiment 3

[0097] Example 3: In vivo and local application of phenytoin sodium sustained-release gel to experimental periodontal defects in the molar area of ​​rats and its effect determination:

[0098] Thirty-two adult healthy male Wistar rats (body weight 280-300 g) (provided by the Animal Experiment Center of Shandong University), each animal was randomly divided into two groups with the left mandibular molar area as the experimental site: A, control group (surgically established dental periodontal defect model, implanted with blank microsphere gel); B, experimental group (after surgical establishment of periodontal defect model, implanted with microsphere gel containing phenytoin sodium); 16 animals in each group, of which 8 were randomly selected They were killed 14 days after operation, and the remaining 8 animals were killed 28 days after operation.

[0099] After the rats were anesthetized, they were fixed on the operating table, the skin was prepared in the left mandibular area...

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Abstract

The invention discloses phenytoin sodium sustained-release gel which promotes periodontal regeneration, and the phenytoin sodium sustained-release gel is made of components of phenytoin sodium, PLGA sustained-release microspheres and poloxamer gel, wherein, the content of an active component, the phenytoin sodium is 2 to 5 mg / ml. The preparation method of the phenytoin sodium sustained-release gel which promotes the periodontal regeneration has the steps that firstly, the PLGA microspheres containing the phenytoin sodium is prepared in W / O / W type emulsified solvent volatilization method; secondly, the microspheres are mixed into 25 percent of the poloxamer gel, to produce microsphere gel containing 2 to 5 mg / ml phenytoin sodium. The invention provides a new safe, effective drug with acceptable price and easy promotion and application for local administration of periodontal disease therapy. The preparation method of the phenytoin sodium sustained-release gel provided by the invention is convenient, and has strong operability, the prepared sustained-release drug has stable performance, and the distribution of the microsphere graininess is more uniform.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a phenytoin sustained-release gel for promoting periodontal regeneration, a preparation method thereof and an application in the field of periodontal regeneration. Background technique [0002] Periodontitis is a chronic destructive disease of periodontal supporting tissue initiated by repeated bacterial infection. The treatment of periodontal disease should not only control inflammation, but also restore the lost periodontal tissue, that is, realize the coordinated and physiological regeneration of alveolar bone, cementum and periodontal ligament, so as to achieve the complete structure and function of periodontal tissue. recover. The treatment of periodontal disease includes surgical treatment and non-surgical treatment. In order to enhance the effect of various treatments, especially for patients with severe periodontitis, some auxiliary treatment measures are often used. ...

Claims

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Application Information

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IPC IPC(8): A61K31/4166A61K9/00A61K9/16A61K47/34A61P1/02A61K47/10
Inventor 杨丕山黄桂华熊纪敏毕秀丽张建霞于美娇
Owner SHANDONG UNIV
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