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Tamoxifen citrate emplastrum and preparation method thereof

A technology of tamoxifen and citric acid, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, tablet delivery, etc., which can solve the difficulty in controlling the dosage of microemulsion preparations and the failure of transdermal effects to meet the requirements , protection of personal privacy and other issues, to reduce the incidence of drug side effects, conducive to environmental protection and labor protection, and reduce the effect of side effects

Inactive Publication Date: 2010-05-26
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

[0003] However, the drug site of the tamoxifen citrate microemulsion external preparation is the breast. As we all know, the external preparation requires a long administration time. If the exposure time of the drug site is too long, it is unfavorable to protect personal privacy. If the exposure time is too short, the transdermal effect may not meet the requirements, and if it is covered by clothing, the drug will be easily wiped off and the clothing will be polluted; at the same time, the dosage of the microemulsion preparation is also difficult to control

Method used

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  • Tamoxifen citrate emplastrum and preparation method thereof
  • Tamoxifen citrate emplastrum and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Tamoxifen Citrate 1-100g

[0022] Propylene glycol 100-600g

[0023] Polysorbate 10-500g

[0024] Oleic acid 1-200g

[0025] Add pure or distilled water to 1000g

[0026] Using this prescription, tamoxifen citrate microemulsion was prepared for use. Heat the acceptable excipients to 140-160°C to melt, then lower the temperature to 90-100°C, add the adhesion enhancer and spare tamoxifen citrate microemulsion, mix well, and pour the mixture while it is still hot Put it on the release film [release paper], cover it with a layer of release film, pressurize 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

[0028] Tamoxifen Citrate 1-100g

[0029] Propylene glycol 100-600g

[0030] Polysorbate 10-500g

[0031] Oleic acid 1-200g

[0032] Carbomer 940 10-100g

[0033] Add pure or distilled water to 1000g

[0034] Using this prescription, tamoxifen citrate microemulsion was prepared for use. Heat the acceptable excipient ingredients to 140-160°C to melt, then lower the temperature to 90-100°C, add the adhesion enhancer and spare tamoxifen citrate microemulsion, mix well, and then put the mixture while it is hot Pour it onto the release film [release paper], cover it with a layer of release film, pressurize 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

[0036] Tamoxifen Citrate 1-100g

[0037] Propylene glycol 100-600g

[0038] Polysorbate 10-500g

[0039] Oleic acid 1-200g

[0040] Polyvinyl alcohol 10-100g

[0041] Add pure or distilled water to 1000g

[0042] Using this prescription, tamoxifen citrate microemulsion was prepared for use. Heat the acceptable excipient ingredients to 140-160°C to melt, then lower the temperature to 90-100°C, add the adhesion enhancer and spare tamoxifen citrate microemulsion, mix well, and then put the mixture while it is hot Pour it onto the release film [release paper], cover it with a layer of release film, pressurize 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 tamoxifen citrate emplastrum and a preparation method thereof. A tamoxifen citrate micro emulsion is prepared into a transdermal emplastrum, and the transdermal emplastrum is divided into four layers: an anti-adhesion layer, a viscose layer, a back lining layer and a medicine storage layer. The tamoxifen citrate micro emulsion is used as a drug effect ingredient and comprises tamoxifen citrate used as an active ingredient, polysorbate 80 used as a surfactant, propylene glycol used as a cosurfactant, pure water or distilled water, and the like. Besides the drug effect ingredient, some non-polar polymers, a plasticizer, a tackifier, transdermal enhancer and an antioxidant are also added to the emplastrum. Compared with the traditional dosage forms such as tablets, solutions, oral cavity disintegrants, dispersants and external micro emulsion preparations, the tamoxifen citrate emplastrum has the prominent advantages of safety, low toxicity, convenient and simple use and accurate drug dosage.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a tamoxifen citrate plaster preparation and a preparation method thereof. Background technique [0002] In the patent "Tamoxifen Citrate Microemulsion External Preparation and Its Preparation Method" (Application No. 200610017526.6), we disclosed a preparation method of Tamoxifen Citrate Microemulsion External Preparation. This microemulsion improves the solubility of tamoxifen citrate, has good transdermal effect, sustained release, and targeting effect. Hydrolysis improves stability, masks bad smell, prolongs storage time, simple preparation process, and does not require special equipment. [0003] However, the drug site of the tamoxifen citrate microemulsion external preparation is the breast. As we all know, the external preparation requires a long administration time. If the exposure time of the drug site is too long, it is unfavorable to protect perso...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K31/205A61P15/14
Inventor 王云龙陈小科霍雯韩洁陈冬焕张怡
Owner 河南省生物工程技术研究中心
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