L-alpha-glycerophosphoryl choline film-coated tablet and preparation method thereof

Abstract

The invention discloses an L-alpha-glycerophosphoryl choline film-coated tablet, which is applied to the pharmaceutical industry. The L-alpha-glycerophosphoryl choline film-coated tablet comprises an L-alpha-glycerophosphoryl choline tablet core and a coating layer, wherein the L-alpha-glycerophosphoryl choline tablet core comprises the following components in percentage by weight: 45-55wt% of L-alpha-glycerophosphoryl choline, 40-50wt% of filler, 0.5-5wt% of flow aid and 0.5-3wt% of lubricant; the coating layer is divided into an isolated coat layer and a moisture-proof coat layer; the filler is one or several of microcrystalline cellulose, lactose, calcium hydrophosphate, hydroxypropyl cellulose and pregelatinized starch; the flow aid is one or several of silicon dioxide and talc powder; the lubricant is one or several of magnesium stearate, polyethylene glycol and leucine; and the isolated coat layer of the coating layer is one or several of film-forming materials of hydroxypropyl methyl cellulose, ethyl cellulose and polyvinylpyrrolidone or premix comprising the above film-forming materials. According to prescription screening, the L-alpha-glycerophosphoryl choline film-coated tablet core is prepared by a direct tableting technology and is easy to operate and control, the processes of smashing and screening raw materials are omitted, the phenomenon that the raw materials are easy to adsorb moisture after being smashed is avoided, the technology is simplified, the production cost is lowered, and the production technology is improved.

Description

1. Technical field [0001] The invention relates to L-alpha-glycerophosphorylcholine film-coated tablets in the medical and health industry and a preparation method thereof 2. Background technology [0002] L-α-glycerophosphorylcholine was developed by LPB (Novartis / Italfarmaco) as a nootropic drug, which is effective for aging memory loss. It functions as a precursor of acetylcholine in cerebral cortex neurons and phospholipids in neuronal membranes (Company communication, Italfarmaco, Mar 1992). The drug was listed for the first time in Italy (1990) by LPB under the trade name Delecit. In Italy, it is also distributed by Novartis and Italfarmaco under the trade names Brezal and Gliatilin respectively. In Poland, the drug was listed by Italfarmaco (1993), with the trade name Gliatilin; in Argentina, it was listed by Montpellier (1995), with the trade name Gliatilin; in South Korea, it was listed by Dong Wha (1996, the trade name was Gliatilin) The listed company in Russia...

AI Technical Summary

Problems solved by technology

The disadvantage of this process is that the raw material of L-α-glycerophosphorylcholine is highly hygroscopic, and the environmental humidity must be strictly controlled during the crushing and sieving process, usually below 30%.

In addition, because L-α-glycerophosphorylcholine has good solubility in water, ordinary wet granulation can only use alcohol as a solvent for the binder, and when the binder uses water as the solvent, the raw material will appear dissolves, difficult to granulate

This not only increases the cost, but also requires explosion-proof equipment

The boiling granulation process can use water as a solvent binder, but because the raw material of L-α-glycerophosphocholine is light in weight and has severe static electricity after crushing, the resulting granules have low density and are difficult to fill

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