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Recombinant hirudin microneedle drug delivery system and preparation method thereof

A technology of recombinant hirudin and drug delivery system, which is applied in the field of biomedicine, can solve the problems of long-term medication inconvenience, poor patient compliance, and high difficulty in hemostasis, and achieve good development prospects, simple use, and infection-free effects

Pending Publication Date: 2021-01-19
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In clinical practice, protein / polypeptide anticoagulant and antithrombotic agents are usually administered by intravenous injection, which has poor patient compliance and is inconvenient for long-term medication; this type of drug is also not suitable for oral administration because its activity is easily affected by the acidic environment of the gastrointestinal tract. and the destruction of digestive enzymes; subcutaneous injection is also the usual route of administration for this type of drug, but subcutaneous injection has poor compliance to patients, and has defects such as increased anticoagulation and high difficulty in hemostasis

Method used

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  • Recombinant hirudin microneedle drug delivery system and preparation method thereof
  • Recombinant hirudin microneedle drug delivery system and preparation method thereof
  • Recombinant hirudin microneedle drug delivery system and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Fully dissolve 1g of hyaluronic acid in 10ml of pure water, add 10mg of recombinant hirudin and mix and dissolve to obtain a drug-loaded material solution;

[0038] Fully dissolve 2g of hyaluronic acid in 10ml of pure water to obtain a blank material solution;

[0039] Add 100 μl of the drug-loaded material solution to the microneedle template, let it stand for 20 minutes under a vacuum degree of -0.06 MPa, recover the excess drug-loaded solution, and dry the microneedle template at 45°C for 2 hours to deposit the drug-loaded hyaluronic acid on The top of the microneedle body;

[0040] Add 100 μl of the drug-loaded material solution to the microneedle template, let it stand for 20 minutes under a vacuum degree of -0.06 MPa, recover the excess drug-loaded solution, and dry the microneedle template at 45°C for 2 hours to make the drug-loaded hyaluronic acid fill the microneedles. Needle body;

[0041] Take 200 μl of the blank material solution and add it to the above-me...

Embodiment 2

[0043] Add 0.1 g of polyvinyl alcohol to 1 ml of pure water, place it in a water-bath shaker at 60°C overnight until the polyvinyl alcohol is completely dissolved, add 10 mg of recombinant hirudin to mix and dissolve, and obtain a drug-loaded material solution;

[0044] Add 0.1g of polyvinylpyrrolidone to 1ml of ethanol, stir until completely dissolved, and obtain a blank material solution;

[0045]Add 100 μl of the drug-loaded material solution to the microneedle template, let it stand for 30 seconds under a vacuum degree of -0.1 MPa, recover the excess drug-loaded material solution, and dry the microneedle template at 25°C for 6 hours to deposit the drug-loaded polyvinyl alcohol on the top of the microneedle body;

[0046] Add 100 μl of the drug-loaded material solution to the microneedle template, let it stand for 30 seconds under a vacuum degree of -0.1 MPa, recover the excess drug-loaded material solution, and dry the microneedle template at 25°C for 6 hours to fill the d...

Embodiment 3

[0049] Add 0.04mg of polyvinyl alcohol and 0.16mg of polyvinylpyrrolidone to 1ml of pure water, place in a 60°C water-bath shaker and shake overnight until completely dissolved, add 20mg of recombinant hirudin, mix and dissolve, and obtain a drug-loaded material solution;

[0050] Add 0.2mg of polyvinyl alcohol to 1ml of pure water, place in a water bath shaker at 60°C overnight and shake until completely dissolved to obtain a blank material solution;

[0051] Add 200 μl of the blank material solution to the microneedle template, let it stand for 20 minutes under a vacuum degree of -0.06 MPa, recover the excess drug-loaded material solution, and dry the microneedle template in a 45°C drying oven for 5 hours to obtain the microneedle body;

[0052] 50 μl blank material solution was added to the microneedle template, and the microneedle template was placed in a 45° C. drying oven for 5 hours to obtain recombinant hirudin microneedles.

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Abstract

The invention belongs to the technical field of biological medicines, and relates to a recombinant hirudin microneedle drug delivery system and a preparation method thereof. The recombinant hirudin microneedle drug delivery system comprises a backing patch and a microneedle body located at the bottom of the backing patch, wherein recombinant hirudin is packaged in the microneedle body, and a microneedle matrix is a water-soluble biodegradable high polymer material. Compared with an existing drug delivery mode, the microneedle drug delivery system has the advantages that pain caused by repeatedinjection can be remarkably relieved during use, and the drug is stable in activity and convenient to store and transport.

Description

technical field [0001] The invention belongs to the field of biomedicine, and in particular relates to a recombinant hirudin microneedle drug delivery system and a preparation method thereof. Background technique [0002] According to the WHO survey, cardiovascular disease is the leading cause of death worldwide. At present, the main prevention and treatment measures for cardiovascular diseases are the intervention of anticoagulant drugs. Traditional anticoagulant drug administration methods mainly include oral administration, intravenous injection and subcutaneous injection (such as figure 1 shown), but practice shows that clinical administration is limited due to certain deficiencies. Among them, oral administration can lead to gastrointestinal bleeding, and the use of patients with gastrointestinal diseases is limited. The degradation of the gastrointestinal tract will also reduce the bioavailability of the drug. Reduce; In addition to bringing pain and other discomfort...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/36A61K47/32A61K47/38A61K47/42A61K38/58A61P7/02A61P9/10
CPCA61K9/0021A61K47/36A61K47/32A61K47/38A61K47/42A61K38/58A61P7/02A61P9/10
Inventor 莫炜沈腾芦晓彤吴梦芳夏天杨时佳
Owner FUDAN UNIV
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