Silk-fibroin multilayer composite micro-needle and preparation method thereof

A silk fibroin, multi-layer composite technology, used in microneedles, needles, other medical devices, etc., to achieve good biocompatibility, no irritation, allergic reactions, and excellent mechanical properties.

Inactive Publication Date: 2018-08-14
PHARSUN MEDICAL BIOTECHNICS (SHANGHAI) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims at the shortcomings of the existing single microneedles, and provides a method that can simultaneously load different types of drugs in the same needle body, or different loading amounts of the same drug, so as to obtain different drug release rates and drug release effects. Silk fibroin multi-layer composite microneedle with multi-drug characteristics and preparation method thereof

Method used

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  • Silk-fibroin multilayer composite micro-needle and preparation method thereof
  • Silk-fibroin multilayer composite micro-needle and preparation method thereof
  • Silk-fibroin multilayer composite micro-needle and preparation method thereof

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Embodiment 1

[0025] See attached figure 1 , which is a schematic diagram of a structural decomposition model of a multi-layer composite needle wall microneedle provided in this embodiment; from the inside to the outside, there are microneedle base layer 1, microneedle slow-release intermediate layer 2 and microneedle quick-release shell 3 , the specific steps of its preparation are as follows:

[0026] 1. Preparation of silk fibroin solution: place silkworm silk in a sodium carbonate-sodium bicarbonate buffer solution, treat it at 98-100°C for 30 minutes, then wash it with deionized water, repeat the above operation three times, and perform degumming treatment. The silk fibroin obtained after degumming and drying was dissolved in a 9.3M lithium bromide solution at a bath ratio of 1:10 at 60°C, and dialyzed for three days to obtain a silk fibroin solution.

[0027] 2. Preparation of microneedle base layer: Mix silk fibroin solution and doxorubicin hydrochloride solution at a mass ratio of ...

Embodiment 2

[0033] 1. Preparation of silk fibroin solution: place silkworm silk in sodium carbonate-sodium bicarbonate buffer solution, treat it at 98-100°C for 30 minutes, then wash it with deionized water, repeat the above operation three times for degumming, degumming and drying The dried silk fibroin was dissolved in a 9.3M lithium bromide solution at a bath ratio of 1:10 at 60°C, and dialyzed for three days to obtain a silk fibroin protein solution;

[0034] 2. Preparation of microneedle base layer: Prepare insulin solution, blend silk fibroin solution and insulin solution in step 1 at a mass ratio of 100:1, and apply 3 mg silk fibroin dry weight per 15*15 array on PDMS (polydimethylsiloxane mould) on the mold, after vacuum defoaming under the condition of vacuum degree less than 90 kPa, dry at constant temperature and humidity, temperature 26°C, relative humidity: 59, dry for 21 hours. The dried microneedle sheet was clamped with the tip facing down, immersed in 75 v / v% ethanol for ...

Embodiment 3

[0039] 1. Preparation of silk fibroin solution: place silkworm silk in sodium carbonate-sodium bicarbonate buffer solution, treat it at 98-100°C for 30 minutes, then wash it with deionized water, repeat the above operation three times for degumming, degumming and drying The dried silk fibroin was dissolved in a 9.3M lithium bromide solution at a bath ratio of 1:10 at 60°C, and dialyzed for three days to obtain a silk fibroin protein solution;

[0040] 2. Preparation of the microneedle base layer: Prepare an epidermal growth factor (EGF) solution, blend the silk fibroin solution in step 1 with the EGF solution at a mass ratio of 500:1, and mix 3.1 mg silk fibroin dry weight per 15* 15 arrays were applied on the PDMS (polydimethylsiloxane mold) mold, and after vacuum degassing under the vacuum condition of less than 90 kPa, they were dried at constant temperature and humidity at 24°C, relative humidity: 56%, and dried for 15 hours. The dried microneedle sheet was clamped with th...

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Abstract

The invention discloses a silk-fibroin multilayer composite micro-needle and a preparation method thereof and belongs to the field of micro-needle transdermal drug release. The preparation method includes: preparing an inner-layer micro-needle array, using a layer-by-layer composite solidification method to soak the micro-needle into a silk fibroin solution and then dry and solidify the micro-needle, and repeating the soaking and solidification step to obtain the multilayer composite micro-needle. The silk-fibroin multilayer composite micro-needle has the advantages that the multilayer composite micro-needle is formed by silk fibroin layers loaded with identical or different drugs, and multilayer superposition in a certain needle length range can be achieved; the superposition of differentlayers is achieved in the single needle body, and the varieties of loadable drugs are increased; meanwhile, by regulating the structure of each silk fibroin layer, the crystalline structure of the silk fibroin is changed, different release speed of different layers can be achieved, and the micro-needle is applicable to the treatment of diseases which need composite drug use; the micro-needle andrelease the drugs in a layered manner during puncture, the outer layer dissolves to fast release the drug, the inner layer swells to slowly release the drug, and balanced drug delivery in a long timecan be achieved.

Description

technical field [0001] The invention relates to a medical microneedle drug delivery system, in particular to a silk fibroin multilayer composite microneedle drug delivery system and a preparation method thereof. technical background [0002] The microneedle transdermal drug delivery system refers to a form of drug release in which the drug is smeared or pasted and gathered on the surface of the skin, and then penetrates the skin at a certain rate and enters the human body's circulation, where it is absorbed by capillaries into the body's blood circulation. The stratum corneum of the skin is the biggest obstacle for transdermal administration of drugs into the human body. Microneedles can penetrate the stratum corneum of the skin without causing pain or damage. The needles passing through the stratum corneum can dissolve or swell to release drugs in body fluids. The current microneedle transdermal drug delivery system has some shortcomings, such as poor biocompatibility of ne...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M37/00
CPCA61M37/0015A61M2037/003A61M2037/0046A61M2037/0053
Inventor 卢神州王诗怡殷祝平匡大江邢铁玲潘涛
Owner PHARSUN MEDICAL BIOTECHNICS (SHANGHAI) CO LTD
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