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Insulin nano transdermal patch and preparation method thereof

A technology for insulin and recombinant human insulin, applied in pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., can solve the problems of poor water solubility, low absorption and bioavailability of insulin, and achieve improved efficacy and high drug loading. dose, reducing the effect of drug toxicity and side effects

Inactive Publication Date: 2014-04-09
HUBEI UNIVERSITY OF MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to overcome the deficiencies of the prior art, to solve the problems of poor water solubility, low absorption and bioavailability of insulin, and to provide a kind of nano-insulin freeze-dried powder with good dispersion, good absorption and good stability prepared into transdermal formulations, transdermal formulations provide a completely non-invasive method of drug delivery

Method used

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  • Insulin nano transdermal patch and preparation method thereof
  • Insulin nano transdermal patch and preparation method thereof
  • Insulin nano transdermal patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A: Weigh 8mg of insulin and dissolve it in 10ml of DMF to form an organic solution containing medicine, 300mg of soybean lecithin, 50mg of liposome, 50mg of sodium deoxycholate, 0.1ml of glycerin, 200mg of hypromellose, 0.01M glycine buffer 30ml (pH6.2), 1g of mannitol was dissolved by adding water to 200ml;

[0027] B: The insulin solution is slowly poured into the aqueous solution, stirred, and probe-type ultrasonic to obtain the insulin nanosuspension;

[0028] C: Insulin nano-suspension was freeze-dried at -60°C for 48 hours in a vacuum state to obtain insulin nano-lyophilized powder;

[0029] D: Insulin nano freeze-dried powder, chitosan 50mg, carbomer 5mg, polyethylene glycol 10mg, soybean lecithin 200mg, azone 0.8g, glycerin 0.8g, propylene glycol 0.4g, polyacrylate pressure-sensitive adhesive Mix 4g (dissolved in dichloromethane) with 1g of acrylic pressure-sensitive adhesive and dilute to 5ml with glycine buffer. Stir evenly to obtain a drug-loaded layer;

[...

Embodiment 2

[0032] A: Weigh 8mg of insulin and dissolve it in 10ml of DMF to form a drug-containing organic solution, soybean lecithin 300mg, liposome 30mg, sodium oleate 30mg, glycerin 0.1ml, hypromellose 100mg, glycine buffer 30ml (pH6 .2), 800mg of mannitol is dissolved by adding water to 200ml;

[0033] B: The insulin solution is slowly poured into the aqueous solution, stirred, and probe-type ultrasonic to obtain the insulin nanosuspension;

[0034] C: Insulin nano-suspension was freeze-dried at -60°C for 48 hours in a vacuum state to obtain insulin nano-lyophilized powder;

[0035] D: Insulin nano freeze-dried powder, sodium deoxycholate 50mg, chitosan 50mg, polyethylene glycol 20mg, soybean lecithin 100mg, azone 1g, glycerin 0.8g, propylene glycol 0.4g, polyacrylate pressure-sensitive adhesive Mix 4g (dissolved in dichloromethane) with 1g of acrylic pressure-sensitive adhesive and dilute to 5ml with glycine buffer. Stir evenly to obtain a drug-loaded layer;

[0036] E: The drug-l...

Embodiment 3

[0038] A: Weigh 8mg of insulin and dissolve it in 10ml of DMF to form a drug-containing organic solution, soybean lecithin 300mg, liposome 30mg, oleic acid 2mg, sodium oleate 30mg, hypromellose 80mg, glycine buffer 30ml (pH6 .2), 1g of mannitol is dissolved by adding water to 200ml;

[0039] B: The insulin solution is slowly poured into the aqueous solution, stirred, and probe-type ultrasonic to obtain the insulin nanosuspension;

[0040] C: Insulin nano-suspension was freeze-dried at -60°C for 48 hours in a vacuum state to obtain insulin nano-lyophilized powder;

[0041] D: Insulin nano freeze-dried powder, sodium deoxycholate 30mg, chitosan 30mg, polyethylene glycol 20mg soybean lecithin 150mg, azone 1g, glycerin 0.8g, propylene glycol 0.4g, polyacrylate pressure-sensitive adhesive 4g (dichloromethane dissolved) mixed with 1g of acrylic pressure-sensitive adhesive and diluted to 5ml with glycine buffer solution. Stir evenly to obtain a drug-loaded layer;

[0042] E: The dr...

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Abstract

The invention relates to an insulin nano transdermal delivery preparation and a preparation method thereof. The insulin nano transdermal delivery preparation takes recombinant human insulin as an active pharmaceutical ingredient and is a filled closed type transdermal preparation consisting of an anti-sticking layer, a drug-loaded layer and a back lining layer. The drug-loaded layer consists of nano recombinant human insulin, a carrier, a penetration enhancer and a plasticizer. The nano recombinant human insulin is obtained by dissolving insulin in a solvent, adding water-soluble auxiliary agents including liposome, chitosan, HPMC (hydroxy propyl methyl cellulose) and the like and an aqueous solution of a freeze-drying protective additive, performing low-temperature high-speed stirring and then performing freeze-drying. The patch disclosed by the invention realizes transdermal noninvasive administration through nano-scale combination of insulin and the carrier to ensure that the bioavailability of the insulin is greatly improved; the patch has the advantages of high transdermal absorption rate, fast response, good treatment effect and good product stability, does not have anaphylactic and toxic reactions to skins, and has the characteristics of good safety, small side effect and convenience in use. The preparation method of the insulin nano transdermal patch disclosed by the invention is simple, low in production cost, and easy to magnify.

Description

technical field [0001] The invention relates to an insulin nano transdermal drug delivery preparation and a preparation method thereof. Background technique [0002] Insulin is a polypeptide hormone secreted by pancreatic β cells, and it is currently the only hormone in the body that can lower blood sugar. The human insulin molecule relies on two disulfide bonds to bind the A chain (21 amino acids) and the B chain (30 amino acids). If the disulfide bond is opened, it will lose its activity. The molecular weight of insulin is about 6000, the isoelectric point is 5.35-5.45, and it is almost insoluble in water, ethanol, chloroform or ether. Insulin preparations include injections, pulmonary inhalation preparations, implants, oral or oral mucosal absorption preparations, etc., among which intramuscular injection (including needle-free injection) is currently the most widely used. Intramuscular injections are generally white or off-white suspensions that separate into layers af...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K38/28A61P3/10
Inventor 陈绚丽王兵吴晶
Owner HUBEI UNIVERSITY OF MEDICINE
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