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Ramelteon sustained release preparation and preparation method thereof

A technology for ramelteon and sustained-release preparations, applied in the field of ramelteon sustained-release preparations and its preparation, can solve the problems of affecting the mental state of patients, short drug effect maintenance time, and reducing sleep quality

Active Publication Date: 2021-08-20
广东科泰鼎润药业科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the traditional ramelteon drug releases rapidly and can make patients fall asleep in a short period of time, but at the same time, the duration of the drug effect is short, and patients are prone to wake up prematurely, and cannot fall asleep again after waking up, reducing the Sleep quality, which seriously affects the patient's mental state

Method used

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  • Ramelteon sustained release preparation and preparation method thereof
  • Ramelteon sustained release preparation and preparation method thereof
  • Ramelteon sustained release preparation and preparation method thereof

Examples

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preparation example Construction

[0067] The present invention also provides a method of preparing the above-mentioned thundermide sustained release formulation, including the following steps:

[0068] The thundermine, the filler is mixed with the sustained release material, then the lubricant is added, mixed.

[0069] In a specific example, the mixing also includes the following steps: a wet method of wet method using ethanol or water.

[0070] In a specific example, it is pressed after mixing.

[0071] In a specific example, filling the capsule after mixing.

[0072] In a specific example, the mixed filling bag is made into granules.

Embodiment 1

[0075] This embodiment provides a thundermine buffer preparation, and the specific prescription is as follows:

[0076]

[0077] The specific preparation method is as follows:

[0078] Mix the thundermine, lactose, microcrystalline pH101, hydroxypropylene Klucel Exf Pharm, silica mixed. A 95% ethanol solution was slowly added to the above mixed materials, while stirring while adding. The soft material made of manufactured is soft and suitable, and the group is touched. The soft material is grainted through 10 mesh screen, and the formed particles are placed at 60 ° C oven drying. After 1 hour of drying, the dry weight of the particles was measured, and the dry weight was stopped at <3%. The dried particles were further mixed with magnesium stearate. The tablets, the slice weight is 250mg, the hardness is 3 to 10 kg.

Embodiment 2

[0080] This embodiment provides a thundermine buffer preparation, and the specific prescription is as follows:

[0081]

[0082] The specific preparation method is as follows:

[0083] Thundermine, lactose, microcrystalline pH 102, hydroxypropylmethylcellulose K4M, and silica are mixed uniform. The addition of magnesium stearate is mixed. The tablets, the slice weight is 250mg, the hardness is 3 to 10 kg.

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Abstract

The invention provides a Ramelteon sustained release preparation. The dosage form of the Ramelteon sustained release preparation is a tablet, a granule or a capsule. The Ramelteon sustained-release preparation comprises the following raw materials in parts by weight: 1 to 30 parts of Ramelteon, 50 to 250 parts of a filling agent, 5 to 50 parts of a sustained-release material and 0.2 to 10 parts of a lubricating agent; the sustained-release material is selected from at least one of hydroxypropyl methylcellulose, polyvinylpyrrolidone, hydroxypropyl cellulose, sodium alginate, calcium alginate, guar gum and xanthan gum; and the filling agent is selected from at least one of lactose, mannitol, sorbitol, cane sugar, microcrystalline cellulose and calcium hydrophosphate. The Ramelteon sustained release preparation can maintain enough drug concentration in a long time, prolongs the drug action time, and is completely dissolved out.

Description

Technical field [0001] The present invention relates to the pharmaceutical field, particularly to a sustained-release preparation Ramelteon its preparation method. Background technique [0002] Ramelteon, the chemical name (S) -N- [2- (1,6,7,8- tetrahydro -2H- indeno - [5,4-b] furan-8-yl) ethyl] propanamide, Ramelteon is the English name, molecular formula of C 16 Hide 21 NO 2 A molecular weight of 259.34, the following chemical structure: [0003] [0004] Ramelteon is Takeda Pharmaceuticals development of a medicament for treating insomnia, the first used in clinical treatment of insomnia melatonin receptor agonist, able to selectively activate melatonin 2 receptor and receptor, but not with the 3 melatonin receptor having a potent and highly selective characteristics. Further, Ramelteon not bind to GABA receptors neurotransmitter receptors, within a certain range does not interfere with the activity of most enzymes, therefore, to avoid medication associated with GABA distrac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K9/16A61K9/52A61K47/38A61K47/36A61K47/32A61K47/26A61K47/02A61K31/343A61P25/20
CPCA61K9/1611A61K9/1623A61K9/1635A61K9/1652A61K9/2009A61K9/2018A61K9/2027A61K9/205A61K9/2054A61K9/485A61K9/4858A61K9/4866A61K31/343A61P25/20
Inventor 郭德解健博李致伟乔飞
Owner 广东科泰鼎润药业科技有限公司
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