Ramelteon sustained release preparation and preparation method thereof

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...

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