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Temperature-sensitive microneedle array patch and preparation method thereof

A microneedle array and patch technology, applied in the field of pharmaceutical preparations, can solve the problems of weak curative effect and difficulty in penetrating the stratum corneum of the skin, and achieve the effects of good biocompatibility, sensitive temperature responsiveness and regular structure

Pending Publication Date: 2021-03-16
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The transdermal drug delivery method can avoid gastrointestinal side effects and enzymatic hydrolysis caused by oral administration, as well as first-pass metabolism in the liver, and has the advantages of interrupting the drug administration at any time, but it is difficult for protein and peptide drugs to penetrate the stratum corneum of the skin. So little effect

Method used

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  • Temperature-sensitive microneedle array patch and preparation method thereof
  • Temperature-sensitive microneedle array patch and preparation method thereof
  • Temperature-sensitive microneedle array patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Preparation of insulin-loaded thermosensitive microneedle NIPAm-NVP

[0038]Step 1, weigh 300mg NIPAm, 6mg photoinitiator 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone in 1.5mL EP tube, add 100mg deionized water, a certain quality N-vinylpyrrolidone NVP (240mg, 300mg, 360mg) and 3mg cross-linking agent ethylene glycol dimethacrylate, mix well to obtain a clear and transparent solution, which is the temperature-sensitive microneedle monomer solution; weigh 5mg of recombinant human insulin powder , dissolved in 1mL 0.1M HCl to make a 5mg / mL insulin solution, take 10μL and add it to 100μL of the former solution, transfer it to a 11×11 microneedle array mold after mixing, and place it in a refrigerated centrifuge (4 ℃) at a speed of 5000rpm for 30min to make it fully fill in the pores of the microneedle array mold, then remove the excess liquid, place it in an ice bath and irradiate with 365nm ultraviolet light (power 7W) for 30min to obtain microneedle arrays. need...

Embodiment 2

[0042] Preparation of insulin-loaded thermosensitive microneedle NIPAm-AAc

[0043] Step 1, weigh 300mg NIPAm, 12mg photoinitiator 2-hydroxy-4'-(2-hydroxyethoxy)-2-methyl propiophenone in 1.5mL EP tube, add 300mg deionized water, a certain quality Acrylic acid AAc (240mg, 300mg, 360mg) and 6mg cross-linking agent ethylene glycol dimethacrylate, mix well to get a clear and transparent solution, which is the temperature-sensitive microneedle monomer solution; weigh 5mg recombinant human insulin powder, dissolve in 1mL Prepare 5mg / mL insulin solution in 0.1M HCl, add 10μL to 100μL of the former solution, mix well and transfer it to a 11×11 microneedle array mold, place in a refrigerated centrifuge (4°C) at 5000rpm Centrifuge at a high speed for 30 minutes to fully fill the pores of the microneedle array mold, then remove excess liquid, place in an ice bath and irradiate with 365nm ultraviolet light (power 7W) for 30 minutes to prepare a microneedle array.

[0044] Step 2, weigh ...

Embodiment 3

[0047] Preparation of Thermosensitive Microneedles NIPAm-NVP Loaded with Glucagon

[0048] Step 1, weigh 300mg NIPAm, 6mg photoinitiator 2-hydroxy-4'-(2-hydroxyethoxy)-2-methylpropiophenone in 1.5mL EP tube, add 100mg deionized water, a certain quality N-vinylpyrrolidone NVP (240mg, 300mg, 360mg) and 3mg cross-linking agent ethylene glycol dimethacrylate, mix well to obtain a clear and transparent solution, which is the temperature-sensitive microneedle monomer solution; weigh 5mg glucagon Powder, dissolved in 1mL 0.01M HCl to make a 5mg / mL glucagon solution, take 10μL and add it to 100μL of the former solution, mix well, transfer it to a 11×11 microneedle array mold, and place it in the freezer Centrifuge (4°C) at a speed of 5000rpm for 30min to make it fully fill the pores of the microneedle array mold, then remove excess liquid, place in an ice bath and irradiate with 365nm ultraviolet light (power 7W) for 30min , to produce a microneedle array.

[0049] Step 2, weigh 6mg...

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Abstract

The invention discloses a temperature-sensitive microneedle array patch and a preparation method thereof, and belongs to the field of pharmaceutical preparations. The temperature-sensitive microneedletakes N-isopropylacrylamide (NIPAm) as a temperature-sensitive material, the temperature-sensitive material is copolymerized with a hydrophilic monomer by adopting ultraviolet irradiation, and the low critical solution temperature of the NIPAm is increased by introducing the hydrophilic monomer, so that the temperature-sensitive microneedle is more suitable for application. The preparation methodof the microneedle is simple and easy to repeat, the array structure is regular, the mechanical strength is good, and the microneedle can effectively penetrate through the skin cuticle, so that the medicine is delivered into the body through the rich capillaries of the dermis layer to play a role in the medicine effect; and the microneedle has sensitive temperature responsiveness, the temperaturecan be adjusted according to the severity of the disease so as to adjust the release dosage of the medicine, and weak medicine effect or adverse reaction caused by insufficient or excessive medicinerelease is effectively avoided.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a temperature-sensitive microneedle array patch for delivery of protein and polypeptide drugs and a preparation method thereof. Background technique [0002] Diabetes is a chronic metabolic disorder characterized by elevated blood sugar. It is caused by insufficient insulin produced by the pancreas or the inability of the body to effectively use insulin. It has become a serious non-communicable disease worldwide. According to statistics, diabetes is affecting more than 425 million people around the world, and it is estimated that by 2045, the number of diabetic patients will reach 700 million. In my country, there are over 97 million diabetic patients and about 150 million pre-diabetic people, ranking first in the world. [0003] Insulin is a 51-amino acid peptide secreted by pancreatic beta cells that regulates blood sugar levels by stimulating li...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/28A61K38/26A61K9/70A61K47/32A61P3/10
CPCA61K38/28A61K38/26A61K9/7023A61K9/0021A61K47/32A61P3/10
Inventor 孙敏捷吴慧周占威邓越洋
Owner CHINA PHARM UNIV
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