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Lipid-containing medicinal preparation, medicinal transdermal patch and preparation method of medicinal transdermal patch

A technology for pharmaceutical preparations and transdermal patches is applied in the field of medicine to achieve the effects of reducing irritation, reducing adverse reactions and improving bioavailability

Pending Publication Date: 2020-12-11
江苏一全药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing transdermal patches are still difficult to achieve long-lasting (up to 5-7 days) effective release, and new absorption enhancers may bring new risks to the human body

Method used

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  • Lipid-containing medicinal preparation, medicinal transdermal patch and preparation method of medicinal transdermal patch
  • Lipid-containing medicinal preparation, medicinal transdermal patch and preparation method of medicinal transdermal patch

Examples

Experimental program
Comparison scheme
Effect test

Embodiment A1

[0080](1) Prepare packaged drugs

[0081]0.15 g of alprazolam is mixed with 0.3 g of molten glyceryl monostearate as a lipid and 0.12 g of lecithin as an emulsifier, and melted at 80°C. The molten mixture is passed through a high-pressure milk homogenizer to make colostrum. It was homogenized 4 times under a high pressure of 120 MPa, and after cooling, semi-solid lipid nanoparticles of alprazolam were obtained, with an average particle size of 142 nm.

[0082](2) Ingredients

[0083]Encapsulated medicine: prepared in this embodiment;

[0084]Unencapsulated drug: Alprazolam, 0.1g;

[0085]Transdermal absorption enhancer: isopropyl myristate, 0.38g;

[0086]Drug-carrying matrix: 4.69g in total, of which the pressure-sensitive adhesive of brand 2852 (containing carboxyl group) is 3.28g, the pressure-sensitive adhesive of brand 2287 (containing hydroxyl group) is 0.94g, and the pressure-sensitive adhesive of brand 4098 (without functional groups) 0.47g;

[0087]Solvent: propylene glycol, 0.4g.

[0088](3) Prep...

Embodiment A2

[0092](1) Prepare packaged drugs

[0093]0.1g of alprazolam is mixed with 0.17g of molten behenic acid diglyceride as a lipid and 0.07g of sodium taurocholate as an emulsifier, melted at 75℃, and the molten mixture is subjected to a high-pressure homogenization mechanism The colostrum was homogenized 4 times under a high pressure of 110 MPa, and after cooling, semi-solid lipid nanoparticles of alprazolam were obtained with an average particle size of 123 nm.

[0094](2) Ingredients

[0095]Encapsulated medicine: prepared in this embodiment;

[0096]Unencapsulated drug: Alprazolam, 0.1g;

[0097]Transdermal absorption enhancer: isopropyl myristate, 0.24g;

[0098]Drug-carrying base: 3.3g in total, of which 235A pressure sensitive adhesive (containing carboxyl groups) is 2.64g, 2516 pressure sensitive adhesive (containing hydroxyl groups) is 0.33g, and 4098 pressure sensitive adhesive (without functional groups) Is 0.33g;

[0099]Solvent: butanediol, 0.3g.

[0100](3) Preparation of drug transdermal patches

[...

Embodiment A3

[0104](1) Prepare packaged drugs

[0105]Mix 0.2g of alprazolam with 0.51g of molten glyceryl citrate as a lipid and 0.13g of sodium lauryl sulfate as an emulsifier, melt at 85°C, and pass the molten mixture through a high-pressure homogenizer. The colostrum was homogenized 4 times under a high pressure of 130 MPa, and after cooling, solid lipid nanoparticles of alprazolam were obtained, with an average particle size of 167 nm.

[0106](2) Ingredients

[0107]Encapsulated medicine: prepared in this embodiment;

[0108]Unencapsulated drug: Alprazolam, 0.1g;

[0109]Percutaneous absorption enhancer: Span 20, 0.66g;

[0110]Drug-carrying base: 7.52g in total, of which the pressure-sensitive adhesive (containing carboxyl group) of brand 2852 is 4.51g, and the pressure-sensitive adhesive (containing hydroxyl group) of brand 2516 is 3.01g;

[0111]Solvent: n-butanol, 0.5g.

[0112](3) Preparation of drug transdermal patches

[0113]Mix and dissolve the unwrapped drug prepared in this example with a solvent, then fu...

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Abstract

The invention relates to the field of medicines, in particular to a medicinal preparation, a medicinal transdermal patch containing the medicinal preparation and a preparation method of the medicinaltransdermal patch. The medicinal preparation comprises a coated medicine and an uncoated medicine, wherein the coated medicine comprises a medicine A and an inclusion material coating the medicine A;the inclusion material contains lipid; the uncoated medicine is a medicine B; and the medicine A and the medicine B are the same or different. The medicinal preparation and the medicinal transdermal patch provided by the invention have the advantages that an effective dose of medicine can be stably and durably (capable of reaching 7 days) released, and in addition, the controllability is high, sothat the medication requirements of patients of different degrees can be met.

Description

Technical field[0001]The invention relates to the field of medicine, in particular to a pharmaceutical preparation, a drug transdermal patch containing the pharmaceutical preparation and a preparation method thereof.Background technique[0002]External therapy is a commonly used clinical method. The early stage is mostly in the form of Chinese herbal plasters, which are used to apply acupoints or damage the local area to achieve a therapeutic effect. This method of treatment is simple and easy to operate, and is highly accepted by patients.[0003]In addition, for western medicines that traditionally use oral or injection methods, transdermal patches have also appeared in recent years to replace oral or injection. This method can be continuously delivered into the human body, which on the one hand prolongs the action time of the drug. On the other hand, it can increase patient acceptance. However, it is still difficult for the drug to release an effective dose through the stratum corneu...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/343A61K47/69A61P25/14
CPCA61K31/343A61K9/7061A61K9/7046A61K47/6951A61K47/6911A61K47/6939A61P25/14
Inventor 全丹毅
Owner 江苏一全药业有限公司
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