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Active separation-type soluble microneedle and preparation method thereof

A soluble and microneedle technology, which is applied in the direction of medical preparations with non-active ingredients, pharmaceutical formulas, non-effective ingredients of polymer compounds, etc., can solve the problem that the time of administration depends on the dissolution rate of the needle tip, intradermal fracture waste, and ineffective administration. Adequate and other issues, to achieve the effect of convenient and effective drug release, expanding the dissolution time difference, and avoiding allergic damage

Active Publication Date: 2016-05-25
GUANGZHOU NEWORLD PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Traditional metal microneedles are likely to cause intradermal breakage and the risk of secondary damage from waste; while traditional soluble microneedles fix the base layer carrying the needle tip on the skin through adhesive plasters and other patches, and the administration time depends on the dissolution rate of the needle tip
In this way, the poor adhesion between the non-flexible base layer and the human skin can cause insufficient drug administration, and the needle tip is prone to irregular breakage during the drug administration, resulting in inaccurate dosage. In addition, the patch can also cause some User's skin allergies

Method used

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  • Active separation-type soluble microneedle and preparation method thereof
  • Active separation-type soluble microneedle and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0035] This embodiment provides a soluble microneedle whose middle layer is carbomer 971 and its preparation method, the preparation method comprising the following steps:

[0036] 1) Preparation of needle tip solution

[0037] Weigh a certain amount of dextran (molecular weight 40,000), dissolve it in deionized water at a mass ratio of 1:2, and stir in a water bath at 45°C to obtain the excipient material dextran solution, namely the needle tip solution.

[0038] 2) Preparation of intermediate layer solution

[0039] A certain amount of Carbomer 971 was weighed, added into deionized water, stirred and dissolved to obtain 0.03 g / ml Carbomer gel-like substance.

[0040] 3) Preparation of base solution

[0041] Weigh a certain mass of polyvinylpyrrolidone K90, add absolute ethanol, stir to dissolve, and swell overnight to obtain a base layer solution with a concentration of polyvinylpyrrolidone K90 of 0.4 g / mL.

[0042] 4) Preparation of soluble microneedles

[0043] Inject ...

Embodiment 2

[0045] This embodiment provides a soluble microneedle whose middle layer is poloxamer 184 and its preparation method, the preparation method comprising the following steps:

[0046] 1) Preparation of needle tip solution

[0047] Weigh a certain amount of dextran (molecular weight 40,000), dissolve it in deionized water at a mass ratio of 1:2, and stir in a water bath at 45°C to obtain the excipient material dextran solution, namely the needle tip solution.

[0048] 2) Preparation of intermediate layer solution

[0049] Weigh a certain amount of chitosan hydrochloride, add it to deionized water, stir and dissolve to obtain a 0.2g / ml chitosan hydrochloride solution, weigh a certain amount of poloxamer and dissolve it in the chitosan hydrochloride solution In, 0.4 g / ml poloxamer colloidal substance was obtained.

[0050] 3) Preparation of base solution

[0051] Weigh a certain mass of polyvinylpyrrolidone K90, add absolute ethanol, stir to dissolve, and swell overnight to obta...

Embodiment 3

[0055] This embodiment provides a soluble microneedle whose middle layer is hydroxypropyl methylcellulose and a preparation method thereof, the preparation method comprising the following steps:

[0056] 1) Preparation of needle tip solution

[0057] Weigh a certain amount of dextran (molecular weight 40,000), dissolve it in deionized water at a mass ratio of 1:2, and stir in a water bath at 45°C to obtain the excipient material dextran solution, namely the needle tip solution.

[0058] 2) Preparation of intermediate layer solution

[0059] Weigh a certain amount of hydroxypropylmethylcellulose, add it into deionized water, stir and dissolve in a water bath at 30°C to obtain a 0.5 g / ml hydroxypropylmethylcellulose solution.

[0060] 3) Preparation of base solution

[0061] Weigh a certain mass of polyvinylpyrrolidone K90, add absolute ethanol, stir to dissolve, and swell overnight to obtain a base layer solution with a concentration of polyvinylpyrrolidone K90 of 0.37 g / mL. ...

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Abstract

The invention relates to an active separation-type soluble microneedle and a preparation method thereof. The soluble microneedle sequentially comprises a needle tip, a middle layer and a base layer, wherein the needle tip is prepared from a macromolecular excipient material; the middle layer is prepared from a hydrophilic macromolecular material; and the base layer is prepared from a high-molecular polymer material. The dissolving speed of the middle layer is accelerated by controlling the variety of the hydrophilic macromolecular material of the middle layer and the macromolecular excipient material of the needle tip and the thickness of the middle layer; the dissolving time difference between the needle tip and the middle layer is expanded; the needle tip can be quickly separated from the base; and the needle tip is reserved in the body. The laminating problem of a non-flexibility base of a traditional soluble microneedle and the skin is solved; and the risks of allergic damage, intradermal fracture, secondary damage of waste and the like caused by a patch-type base microneedle are avoided.

Description

technical field [0001] The invention relates to a novel biomedical preparation, in particular to an active separation type soluble microneedle and a preparation method thereof. Background technique [0002] Nowadays, biomacromolecular drugs occupy an increasingly important position in the field of medicine and cosmetics, but their instability characteristics make it impossible for such drugs to be administered through the most basic oral route, and injection administration needs to overcome the corresponding medical technology and poor compliance. Therefore, convenient, reliable, highly compliant, and highly curative drug delivery routes for biomacromolecular drugs have become the focus of research in the field of pharmacy. [0003] Microneedles can simultaneously cover hundreds of microneedles on a small skin area to pierce the stratum corneum of the skin, allowing drugs to be introduced through this important barrier. One of the most promising delivery methods for biolog...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K47/34A61K47/32A61K47/26A61K47/10A61K47/36A61K47/38A61K47/42
CPCA61K9/00A61K47/26A61K47/32A61K47/34
Inventor 李革张茜陈航平姚港涛张敏敏
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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