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Raloxifene emplastrum preparation and preparation method thereof

A technology of raloxifene and preparations, which is applied in the field of pharmaceutical preparations, can solve the problems of difficult control of the dosage of microemulsion preparations, failure to meet the requirements of transdermal effect, and long administration time, etc., so as to avoid the peak of blood drug concentration Valley phenomenon, beneficial to environmental protection and labor protection, and the effect of reducing drug side effects

Inactive Publication Date: 2010-05-05
河南省生物工程技术研究中心
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, external preparations need a longer administration time, and the exposure time of the drug site is too short, and the transdermal effect may not meet the requirements, and if it is covered with clothing, it is easy to wipe off the medicine and pollute the clothing; meanwhile, the microemulsion preparation It is also difficult to control the dosage of

Method used

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  • Raloxifene emplastrum preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Raloxifene 1-100g

[0026] Propylene glycol 100-600g

[0027] Polysorbate 10-500g

[0028] Oleic acid 1-200g

[0029] Add pure or distilled water to 1000g

[0030] Using this prescription, raloxifene microemulsion was prepared for use. Heat the acceptable excipients to 140-160°C to melt, lower the temperature to 90-100°C, add the adhesion enhancer and spare raloxifene microemulsion, mix well, and then pour the mixture while it is hot until it is peeled off Film [release paper], covered with a layer of release film, pressurized on both sides to form a film. After the above film is cooled to room temperature, the upper layer of peeling film is peeled off, and the non-woven fabric is covered on the adhesive layer and pressurized.

Embodiment 2

[0032] Raloxifene 1-100g

[0033] Propylene glycol 100-600g

[0034] Polysorbate 10-500g

[0035] Oleic acid 1-200g

[0036] Carbomer 940 10-100g

[0037] Add pure or distilled water to 1000g

[0038] Using this prescription, raloxifene microemulsion was prepared for use. Heat the acceptable excipients to 140-160°C to melt, lower the temperature to 90-100°C, add the adhesion enhancer and spare raloxifene microemulsion, mix well, and then pour the mixture while it is hot until it is peeled off Film [release paper], covered with a layer of release film, pressurized on both sides to form a film. After the above film is cooled to room temperature, the upper layer of peeling film is peeled off, and the non-woven fabric is covered on the adhesive layer and pressurized.

Embodiment 3

[0040] Raloxifene 1-100g

[0041] Propylene glycol 100-600g

[0042] Polysorbate 10-500g

[0043] Oleic acid 1-200g

[0044] Polyvinyl alcohol 10-100g

[0045] Add pure or distilled water to 1000g

[0046]Using this prescription, raloxifene microemulsion was prepared for use. Heat the acceptable excipients to 140-160°C to melt, lower the temperature to 90-100°C, add the adhesion enhancer and spare raloxifene microemulsion, mix well, and then pour the mixture while it is hot until it is peeled off Film [release paper], covered with a layer of release film, pressurized on both sides to form a film. After the above film is cooled to room temperature, the upper layer of peeling film is peeled off, and the non-woven fabric is covered on the adhesive layer and pressurized.

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Abstract

The invention relates to a raloxifene emplastrum and a preparation method thereof. Raloxifene microemulsion is made into a transdermal emplastrum which is divided into an anti-adhesion layer, a viscose layer, a backlining layer and a medicine storage layer. The raloxifene microemulsion taken as a medical ingredient of the raloxifene emplastrum comprises the following ingredients: raloxifene taken as an active ingredient, polysorbate taken as surfactant, propanediol taken as cosurfactant, pure water or distilled water, and the like. Except for the medical ingredient, a plurality of nonpolar polymers, plasticizing agent, caking agent, transdermal enhancing agent and antioxidant are also added in the emplastrum. Compared with the prior dosage forms, such as tablets, the invention has the remarkable advantages of durable medical effect, safety, low toxicity, simple, convenient and sanitary, and accurate medical dosage.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a raloxifene plaster preparation and a preparation method thereof. Background technique [0002] For more than half a century, improving the quality of life of postmenopausal women has attracted more and more attention. Hormone replacement therapy (HRT) has been widely used in perimenopausal and postmenopausal women. Although evidence from observational data has accumulated over the years, the benefits and harms of HRT in healthy postmenopausal women are still being explored. On the one hand, people are in-depth research on more scientific and reasonable HRT programs, and on the other hand, they are looking for more ideal drugs suitable for postmenopausal women. Selective estrogen receptor modulators (SERMS) are a class of synthetic drugs that play estrogen-like effects in some tissues and anti-estrogen-like effects in other tissues, and are expected to be ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/4535A61K47/34A61K47/44A61P5/30A61P19/10A61K47/06A61K47/26
Inventor 王云龙陈小科霍雯陈冬焕韩洁
Owner 河南省生物工程技术研究中心
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