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Slow-release film agent of isegenan

A technology of Estherglam and slow-release film, which is applied in the field of slow-release film preparations to achieve long-acting antibacterial effects, increase bioavailability, and prolong the effect of drug action time

Active Publication Date: 2015-01-28
成都山信药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is no report on the preparation of oral film with Esergnam

Method used

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  • Slow-release film agent of isegenan
  • Slow-release film agent of isegenan
  • Slow-release film agent of isegenan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Embodiment 1 Preparation of slow-release film of the present invention

[0039] Extended-release film prescription

[0040] The protective layer:

[0041] PVA17-88 80% Glycerin 0.8% Xylitol 0.4% Propylene Glycol 3.2% Tween 80 1% Purified Water

[0042] Drug film layer:

[0043] Estherglam 0.03% Gum Arabic 50% CMC-Na10% Glycerin 0.8% Propylene Glycol 3.2% Xylitol 0.4% Tween 80 1% Starch 3.2% Sorbic Acid 0.2% Phosphate buffer (pH6.8) added to the balance

[0044] Preparation method:

[0045] 1. Fabrication of protective layer

[0046] Wash and purify PVA17-88 repeatedly with an appropriate amount of 85% ethanol, soak in sufficient pure water overnight to fully swell, heat at 75°C to dissolve, filter, and slowly add glycerin, propylene glycol, Tween, xylitol and pure water in sequence And fully stir to make the mixture uniform, remove air bubbles, and form a film

[0047] 2. Preparation of drug film layer

[0048] ①Soak and swell CMC-Na with buffer solution at a rat...

Embodiment 2

[0055] Example 2 Screening of sustained-release film formulations

[0056] According to the ratio in Table 1, the sustained-release film formulation was investigated, and the results are shown in Table 2

[0057] Table 1

[0058]

[0059] Table 2

[0060]

[0061] According to the content in the above table, only the film prepared by prescription 7 can meet the requirements, not only the sustained release time reaches 3 hours, but also the best film-forming performance, appearance and taste.

Embodiment 3

[0062] Example 3 Inspection of Weight Difference of Sustained-release Film

[0063] 1. Inspection method: Take 20 pieces of the test product, weigh them accurately, obtain the average weight, and then weigh each piece accurately. Weight per piece compared to average weight

[0064] 2. The test results are as follows

[0065] table 3

[0066]

[0067] Inspection and judgment result: qualified

[0068] 3. Release rate test of sustained-release film

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PUM

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Abstract

The invention provides a slow-release film agent of isegenan consisting of a protective layer and a medicament film layer. The invention also provides a preparation method of the film agent and an application of the film agent. The oral film agent provided by the invention not only can prolong the acting time of medicaments, guarantee the long-effect antibacterial effect of medicaments within three hours, but also can guarantee the medicament comfort for human bodies; and medicaments cannot be wasted even though the film agent is removed before a meal.

Description

technical field [0001] The present invention relates to a slow-release film preparation of Esergnan. Background technique [0002] Amino acid sequence H-Arg-Gly-Gly-Leu-Cys-Tyr-Cys-Arg-Gly-Arg-Phe-Cys-Val-Cys- Val-Gly-Arg-NH2 (5-14,7-12; disulfide bond), the molecular formula is C 78 h 126 N 30 o 18 S 4 , with a molecular weight of 1900.29 Iseganan is an analogue of porcine neutrophil peptide-1 (protegrin-1, PG-1), which can combine with bacterial extracellular components such as lipopolysaccharide or lipid membrane acid to cause bacterial swelling and rupture , kills bacteria by disrupting cell membranes. [0003] Due to its unique mechanism of action, Eserginan has broad-spectrum bactericidal properties against oral microorganisms, does not produce drug resistance, has no toxic and side effects, and has the potential to replace traditional antibiotics. In vitro studies have shown that it has inhibitory effects on Gram-positive and negative bacteria and fungi, yeast / ...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K38/10A61P17/02A61P1/02A61P31/02
Inventor 林山叶玉娇
Owner 成都山信药业有限公司
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