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A kind of chitosan/insulin nano sustained-release transdermal preparation and preparation method thereof

A nano-sustained-release, insulin technology, applied in pharmaceutical formulations, peptide/protein components, medical preparations with non-active ingredients, etc., can solve the problems of physiological pain, high price, and frequent injections of insulin injection, and avoid physiological and psychological problems. Pain, improve solubility, and reduce the number of doses

Active Publication Date: 2022-04-19
FUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the side effects caused by the existing insulin injections, and solve the problems of insulin injections such as physiological pain, instantaneous hypoglycemia, fat pad formation by long-term injection, high price, frequent injections, etc.

Method used

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  • A kind of chitosan/insulin nano sustained-release transdermal preparation and preparation method thereof
  • A kind of chitosan/insulin nano sustained-release transdermal preparation and preparation method thereof
  • A kind of chitosan/insulin nano sustained-release transdermal preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A: Weigh 0.1ml of glycerin, 200mg of hydroxymethylcellulose, 1g of mannitol, 0.4g of propylene glycol, 5mg of carbomer, and 150mg of sodium acrylate. Weigh 5.5538 mg of insulin and dissolve it in 1 ml of methanol to form a drug-containing organic solution. 11.1076 mg chitosan was dissolved in 1 mL 1wt% acetic acid, and 2 mg sodium tripolyphosphate (TPP) was added to chitosan acetic acid solution to make chitosan nano solution.

[0035] B: Dissolve the glycerin, hydroxymethylcellulose, mannitol, propylene glycol, carbomer, and sodium acrylate weighed in step A in 5ml of water, and at the same time take 100 μL insulin methanol solution and 250 μL chitosan nano solution and mix evenly, Add it dropwise to the hydrophilic excipient, stir at room temperature for 1 hour, then add the penetration enhancer, matrix and pressure-sensitive adhesive and mix well to obtain the drug-loaded layer;

[0036] D: Evenly coat the drug-loaded layer on the backing layer, cover with a protect...

Embodiment 2

[0038] After taking 500 μL of insulin methanol solution and 750 μL of chitosan nano-water solution and mixing them evenly, use a Malvern particle size analyzer to measure the particle size of the nano-solution, such as figure 1 shown. At the same time, chitosan with different molecular weights was used to entrap insulin, and its particle size was measured, such as figure 2 As shown, it can be seen that the smaller the molecular weight of chitosan, the smaller the particle size of chitosan / insulin nanoparticles. And take atomic force images of chitosan / insulin nanoparticles with better particle size, such as image 3 shown.

Embodiment 3

[0040] Place 1ml of the drug-loaded layer in a dialysis bag with a molecular weight cut-off of 10,000, and at the same time place the dialysis bag in 30 ml of PBS solution (NaCl, 137 mM; KCl, 2.7 mM, Na 2 HPO 4 ,10 mM; KH 2 PO 4 , 2 mM; pH 7.4), glucose was added to the buffer solution to achieve a higher blood glucose concentration in the human body, and then the PBS buffer solution was placed in a constant temperature shaker at 37°C with a speed of 233min / r. Take a sample of 500 μl, and add 500 μl of PBS with a higher blood glucose concentration at the same time. Adopt ultraviolet spectrophotometry to detect wavelength 276nm, calculate cumulative amount, such as Figure 4 shown.

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Abstract

The invention relates to a chitosan / insulin nano sustained release transdermal preparation and a preparation method thereof. The present invention uses natural polymer carrier-chitosan to encapsulate insulin, and prepares a nanometer hypoglycemic preparation. Insulin is the only hormone that can lower blood sugar in the body. The drug-loaded layer is composed of insulin, chitosan, transfer body, penetration enhancer and plasticizer. The poorly water-soluble insulin is loaded with better water-soluble chitosan A nanosolution is formed to make a formulation. The invention realizes painless, slow-release, and convenient drug administration. The nanoparticle carrier can protect insulin from the destruction of biological enzymes, improve bioavailability, have slow-release effect, reduce side effects at the same time, and have fast percutaneous absorption rate, safety and stability. , sustained-release drug delivery and painless convenience. The preparation process of the chitosan / insulin nano transdermal preparation of the invention is simple, the production cost is low, and the process is easy to scale up.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a chitosan / insulin nano transdermal preparation and a preparation method thereof. Background technique [0002] Diabetes is a common disease that endangers human health, with an incidence rate of about 3% to 5%. The mortality rate caused by it is second only to cardiovascular diseases and tumors. Insulin still accounts for the majority of the drugs used to treat diabetes, and is the last line of defense in the treatment of diabetes. How rational use of insulin can help patients control blood sugar is something that researchers must consider. Since insulin is a protein polypeptide drug, it can be degraded by proteolytic enzymes in the gastrointestinal tract and not absorbed, so it is ineffective when taken orally. Therefore, the dosage form currently used clinically is injection. To keep blood sugar under control, patients need at least one injec...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/28A61K9/70A61K47/36A61P3/10
CPCA61K38/28A61K47/36A61P3/10A61K9/7023
Inventor 邹俊捷邵敬伟林娟芳
Owner FUZHOU UNIV
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