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Temperature-sensitive soluble microneedle and preparation method thereof

A temperature-sensitive, soluble technology, used in pharmaceutical formulations, medical preparations with inactive ingredients, drug delivery, etc., can solve problems such as slow dissolution, increased skin irritation, and unfavorable biological drug delivery.

Active Publication Date: 2018-09-28
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Dissolvable microneedles are generally prepared from some biocompatible polymer materials, but the microneedles prepared from these polymer materials have the problem of slow dissolution in the skin
Soluble microneedles can only release the drug loaded on the needle tip after the needle tip is fully dissolved. If the microneedle tip dissolves slowly, it is necessary to prolong the time for the microneedle to attach to the skin surface, which will greatly increase skin irritation. Not conducive to the administration of biologic drugs

Method used

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  • Temperature-sensitive soluble microneedle and preparation method thereof
  • Temperature-sensitive soluble microneedle and preparation method thereof
  • Temperature-sensitive soluble microneedle and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] This embodiment provides a chitosan-β-sodium glycerophosphate-dextran temperature-sensitive soluble microneedle and a preparation method thereof, the preparation method comprising the following steps:

[0039] 1) Preparation of temperature-sensitive material solution

[0040] Take a certain amount of chitosan (degree of deacetylation greater than 95%), add 0.1mol / L hydrochloric acid solution, stir and dissolve to obtain a chitosan solution whose concentration of chitosan is 0.02g / ml; weigh a certain amount of β - Sodium glycerophosphate is dissolved in deionized water to obtain a β-sodium glycerophosphate solution whose concentration of β-sodium glycerophosphate is 1g / ml; get 1ml β-sodium glycerophosphate and add it dropwise to 5ml chitosan solution and stir for 30min to obtain the temperature Sensitive material solution.

[0041] 2) Preparation of dextran solution

[0042] A certain amount of dextran (molecular weight 40000) was weighed and dissolved in deionized wat...

Embodiment 2

[0050] This embodiment provides a chitosan-β-sodium glycerophosphate-polyvinyl alcohol-dextran temperature-sensitive soluble microneedle and a preparation method thereof, the preparation method comprising the following steps:

[0051] 1) Preparation of temperature-sensitive material solution

[0052] Take a certain amount of chitosan (degree of deacetylation greater than 95%), add 0.1mol / L hydrochloric acid solution, stir and dissolve to obtain a chitosan solution whose concentration of chitosan is 0.02g / ml; weigh a certain amount of β - Sodium glycerophosphate is dissolved in deionized water to obtain a sodium β-glycerophosphate solution with a concentration of 1 g / ml of sodium β-glycerophosphate; a certain amount of polyvinyl alcohol is weighed, dissolved in deionized water, heated and stirred to obtain polyvinyl alcohol The concentration of vinyl alcohol is the polyvinyl alcohol solution of 0.11g / ml; 1ml chitosan solution and 1ml polyvinyl alcohol solution are stirred and m...

Embodiment 3

[0070] The soluble microneedles prepared in Examples 1-2 and Comparative Example 1 were tested for skin solubility. The specific method was as follows: press the soluble microneedles on the skin of the depilated rat for 2 minutes, respectively at 0 min, 2 min, and 5 min. , 10min, 20min, 30min, 60min, 120min to take out the microneedle from the skin, take pictures under the microscope to measure the remaining height of the needle tip, the results are as follows Figure 4 as well as Figure 5 shown.

[0071] The results show that: at 2 minutes, the needle tip remaining heights of Examples 1 and 2 were 69% and 62% of the original height, respectively, while the needle tip remaining height of Comparative Example 1 was 86% of the original height; The remaining needlepoint heights were 44% and 46% of the original height, respectively, while the remaining needlepoint heights of Comparative Example 1 were 58% of the original height; at 60 minutes, the remaining needlepoint heights of...

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Abstract

The invention relates to a temperature-sensitive soluble microneedle and a preparation method thereof.The microneedle comprises a needle tip and a base layer, the needle tip is prepared from a temperature-sensitive material and a macromolecular shaping material, and the base layer is prepared from a macromolecular material; the temperature-sensitive material is composed of a material A and a material B, wherein the material A is selected from one or more of chitosan, polyvinyl alcohol and methylcellulose or hydroxypropyl methyl cellulose, the material B is selected from one or more of beta-sodium glycerophosphate, elastic protein polypeptides, poloxamer 184, poloxamer 188 and poloxamer 407, and the mass ratio of the material A to the material B is 1:(1-20); the mass ratio of the temperature-sensitive material to the macromolecular shaping material is 1:(1-10).The microneedle can be quickly dissolved in the skin, therefore, irritation of the microneedle to the skin is reduced, and medicine can be more safely and effectively released.

Description

technical field [0001] The invention relates to a novel biomedical preparation, in particular to a temperature-sensitive soluble microneedle and a preparation method thereof. Background technique [0002] Protein peptides and nucleic acid biomacromolecular drugs occupy an increasingly important position in the field of medicine and beauty, but due to stability factors, these drugs cannot be administered through the most basic oral route of administration. The most important and reliable route of drug administration is the most important, but injection has its insurmountable disadvantages in terms of safety and compliance. The convenient, reliable and highly compliant route of administration of biopharmaceuticals has become the focus of research in the field of pharmacy. [0003] As the most promising development direction of transdermal drug delivery, microneedle transdermal drug delivery combines the efficacy of injection drug delivery with the safety, convenience and high...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K47/36A61K47/26A61K47/32A61K47/24
CPCA61K9/00A61K47/24A61K47/26A61K47/32A61K47/36
Inventor 李革姚港涛陈航平张敏敏张茜
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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