Epinastine hydrochloride transdermal patch and preparation method thereof

A technology of epinastine hydrochloride transdermal and epinastine hydrochloride, which is applied in the field of drug preparation, can solve the problems of epinastine hydrochloride bitter taste, poor patient compliance, and restriction of drug use, and achieve good uniformity, Good for absorption and good skin tolerance

Inactive Publication Date: 2017-10-10
重庆瑞泊莱医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In the current prior art, the main route of administration of epinastine hydrochloride is oral administration, but epinastine hydrochloride has a very bitter taste and poor patient compliance. For sensitive patients, other alternative drugs may be selected. The use of epinastine hydrochloride limits the use of the drug to a certain extent, which is not conducive to the expansion of popularization and utilization.

Method used

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  • Epinastine hydrochloride transdermal patch and preparation method thereof
  • Epinastine hydrochloride transdermal patch and preparation method thereof
  • Epinastine hydrochloride transdermal patch and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] The prescription of epinastine hydrochloride patch drug storage layer is as follows table 1:

[0040] The consumption of each component of table 1 (total amount 1000g meter)

[0041]

[0042]Preparation method: Weigh each material according to the prescription amount, add methyl phthalate and azone into ethanol and stir well, then add epinastine hydrochloride, methyl methacrylate, butyl acrylate, methacrylate , Stir in a water bath at 60°C for 4 hours until completely mixed, degas after stirring, dry in an oven, apply to an anti-adhesive material to dry, cover with a liner, cut and measure, test, pack, and seal for storage.

Embodiment 2

[0044] The prescription of epinastine hydrochloride patch drug storage layer is as follows table 2:

[0045] The dosage of each component in table 2 (total amount 1000g meter)

[0046]

[0047] Preparation method: Weigh each material according to the prescription amount, add methyl phthalate, succinic acid, azone, and N-methylpyrrolidone into ethanol and stir well, then add epinastine hydrochloride, methyl methacrylate , butyl acrylate, hydroxyl-containing acrylate, stirred in a water bath at 70°C for 4 hours until completely mixed at a speed of 300rpm, degassed after stirring evenly, dried in an oven at a drying temperature of 150°C, coated on an anti-adhesive material to dry, covered Lining layer, cutting and sub-measurement, testing, packaging, sealing and storage.

Embodiment 3

[0049] The prescription of epinastine hydrochloride patch drug storage layer is as follows table 3:

[0050] The consumption of each component of table 3 (total amount 1000g meter)

[0051]

[0052]

[0053] Preparation method: Weigh each material according to the prescription amount, add methyl phthalate, succinic acid, azone, and N-methylpyrrolidone into ethanol and stir well, then add epinastine hydrochloride, methyl methacrylate , butyl acrylate, methacrylate, stirred in a water bath at 70°C for 4 hours until completely mixed at a rate of 700rpm, degassed after stirring evenly, dried in an oven at a drying temperature of 100°C, coated on an anti-adhesive material to dry, covered Lining layer, cutting and sub-measurement, testing, packaging, sealing and storage.

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PUM

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Abstract

The invention provides an epinastine hydrochloride transdermal patch. The epinastine hydrochloride transdermal patch is composed of a back lining layer, a drug containing layer and a anti-adhesion layer, wherein the drug containing layer is composed of, by weight percentage, 0.5-10% of epinastine hydrochloride, 60-90% of pressure-sensitive adhesives, 5-20% of plasticizer and 4-30% of transdermal enhancer. The preparation method of the epinastine hydrochloride transdermal patch comprises stirring and dissolving the plasticizer and the transdermal enhancer, sequentially add in and uniformly mixing the epinastine hydrochloride and the pressure-sensitive adhesives, performing degassing and drying processes, applying anti-adhesion materials to form the anti-adhesion layer, drying the anti-adhesion layer and covering the back lining layer to obtain the epinastine hydrochloride transdermal patch. The epinastine hydrochloride transdermal patch is prepared by mixing and matching water-soluble polymer materials and main drugs and is low in dosage; the epinastine hydrochloride transdermal patch can be prepared into thin patches, which are stable in properties, safe, free from irritation and good in skin tolerance; compared with traditional oral medicines, the epinastine hydrochloride transdermal patch is good in effects, beneficial to absorption by patients and capable of avoiding first-pass effects of liver of the patients.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to an epinastine hydrochloride transdermal patch and a preparation method thereof. Background technique [0002] Epinastine hydrochloride is an antihistamine H1 receptor antagonist, suitable for allergic rhinitis, urticaria, eczema, dermatitis, itchy skin, prurigo, psoriasis vulgaris with itching and allergic bronchial asthma prevention. Because of its good effect, high safety, wide range of indications, few drug interactions and low cardiotoxicity, it is one of the leading products in oral antiallergic drugs. [0003] In the current prior art, the main route of administration of epinastine hydrochloride is oral administration, but epinastine hydrochloride has a very bitter taste and poor patient compliance. For sensitive patients, other alternative drugs may be selected. Use epinastine hydrochloride, like this, has limited the use of medicine to a certain extent, is unfavorabl...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/55A61K47/32A61K47/14A61K47/12A61K47/10A61K47/22A61P37/08A61P11/02A61P17/00A61P17/04A61P17/06A61P11/06
CPCA61K9/7053A61K31/55A61K47/10A61K47/12A61K47/14A61K47/22
Inventor 陈向鲁定国姚利勇朱学琳
Owner 重庆瑞泊莱医药科技有限公司
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