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Tablet composition with solubilizing and slow release effects

A technology of composition and solubilizer, which is applied in the field of medicine, can solve problems such as adverse reactions of blood pressure elevation, and achieve the effects of convenient preparation, convenient control, and simple process flow

Inactive Publication Date: 2015-01-21
北京博泽德润医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, if the mirabegron concentration is too high, there will be adverse reactions such as increased blood pressure

Method used

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  • Tablet composition with solubilizing and slow release effects
  • Tablet composition with solubilizing and slow release effects
  • Tablet composition with solubilizing and slow release effects

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] 1000 mirabegron sustained-release tablets, each containing 25mg mirabegron.

[0072] Mirabegron 25g,

[0073] Hypromellose 250g,

[0074] PEG300 50g,

[0075] Butylated Hydroxyanisole 10g

[0076] Magnesium stearate 2g~20g

[0077] Adhesive 25 ~ 150ml.

[0078] Preparation method: Mix mirabegron with skeleton material hypromellose, corrosion filler: PEG300, butylated hydroxyanisole, etc. according to the above weight parts, and use 2.5% ethyl cellulose for every 500g Su 95% ethanol solution 80ml. The powder mixed evenly above is made into a soft material, granulated through a 20 mesh sieve, ventilated and dried at 55-60°C, and the water content is controlled to be less than 3%. After granulation with a 14 mesh sieve, add the prescription The amount of magnesium stearate 5g, mixing, tabletting.

Embodiment 2

[0080] 1000 mirabegron sustained-release tablets, each containing 25mg mirabegron.

[0081] Mirabegron 25g,

[0082] Hypromellose 300g,

[0083] PEG300-Lactose 120g,

[0084] Butylated Hydroxyanisole 20g

[0085] Magnesium Stearate 20g

[0086] Adhesive 25 ~ 150ml.

[0087] Preparation method: Mix mirabegron with skeleton material hypromellose, erodible filler (1:1 mixture of PEG300 and lactose by weight), butylated hydroxyanisole, etc. by equal volume addition method, and use 60ml95 % ethanol solution to make ethyl cellulose into a 2.5% solution, make the above mixed powder into a soft material, pass through a 26-mesh sieve to granulate, and ventilate and dry at 55-60°C to control the water content <3%. After the 14-mesh sieve is sized, the magnesium stearate of the prescribed amount is added, mixed evenly, compressed into tablets, and the tablet hardness is controlled between 7.5kg.

Embodiment 3

[0089] 1000 mirabegron sustained-release tablets, each containing 25mg mirabegron.

[0090] Mirabegron 25g,

[0091] Hypromellose 500g,

[0092] PEG300-Lactose 10g,

[0093] Butylated Hydroxyanisole 35g

[0094] Magnesium stearate 2g~20g

[0095] Adhesive 25 ~ 150ml.

[0096] Among them, the erodible filler (a mixture of PEG300 and lactose by weight 3:1).

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Abstract

The invention relates to the technical field of medicines, in particular relates to a tablet composition with solubilizing and slow release effects and a preparation method thereof and particularly relates to mirabegron sustained release tablets. The preparation method comprises the following steps: mixing proper medical auxiliary materials comprising a framework material, a solubilizer and a filling agent with mirabegron, and preparing a mirabegron pharmaceutical preparation which is fully and slowly released. The tablet composition is suitable for single dose and has the service characteristic of lasting slow and full release.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a tablet composition with a solubilizing and slow-release effect and a preparation method thereof. A sufficient and slow-release mirabegron is prepared by combining appropriate pharmaceutical excipients with mirabegron preparation. Background technique [0002] Poorly soluble drugs have unstable bioavailability due to poor solubility, and require special excipients for solubilization; the treatment of some diseases sometimes requires continuous action of low doses of drugs, and transient high blood drug concentrations are sometimes harmful to patients. Adverse. The existence of the above two factors, is the need for clinical treatment of the empty drug with sustained release and solubilization. [0003] For example: Overactive Bladder (OAB) is a syndrome characterized by urinary urgency (including a variety of diseases, such as female urethral syndrome, unexplained frequent ur...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K47/34A61K31/426
Inventor 不公告发明人
Owner 北京博泽德润医药科技开发有限公司
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