Olmesartan medoxomil tablet and preparation technology thereof

Abstract

The invention relates to an Olmesartan medoxomil tablet and preparation technology thereof. The core of the Olmesartan medoxomil tablet is prepared by directly pressing Olmesartan medoxomil and medicinal assistants, and the particle size of a position accumulating 90% of Olmesartan medoxomil is 1-100[mu]m; and the medicinal assistants comprise a filler, a disintegrating agent and a lubricant, wherein the lubricant is one or more of neutral or inert lubricants. Raw materials of the core of the tablet comprise, by weight, 20 parts of Olmesartan medoxomil, 80-180 parts of the filler, 10-20 parts of the disintegrating agent and 2-10 parts of the lubricant. The Olmesartan medoxomil is crushed in an airflow crushing mode, the particle size is controlled, and the preparation technology adopts a direct powder pressing method, so the introduction of water in a wet granulation process and the degradation of active substances in a wet particle drying process are avoided, and the incidence of a hydrolysis reaction is prevented. The Olmesartan medoxomil tablet has the advantages of stability, good dissolution and simple preparation.

Description

technical field [0001] The invention relates to an olmesartan medoxomil tablet and a preparation process thereof, belonging to the technical field of medicine preparation. Background technique [0002] There are some reports about olmesartan medoxomil preparation technology in the prior art. For example, patent document CN101478966A discloses a pharmaceutical preparation containing olmesartan medoxomil and its preparation method with improved elution properties, wherein in addition to containing olmesartan medoxomil, it also contains suitable excipients and adjuvants thereof, so The excipients and adjuvants are selected from disintegrants, diluents, lubricants, binders, emulsifiers, flavoring agents and suitable active agents. This method adopts a high-pressure compression method, which consumes a lot of energy and has high requirements on the performance of the equipment. Patent document CN102119930A discloses a kind of olmesartan medoxomil tablet and its preparation meth...

AI Technical Summary

Problems solved by technology

Patent document CN102119930A discloses a kind of olmesartan medoxomil tablet and its preparation method. The auxiliary materials include lactose, microcrystalline cellulose, PVPK30, low-substituted hydroxypropyl cellulose, magnesium stearate and an appropriate amount of ethanol-water. In the method, the drug and lactose need to be ground, which makes the process complicated and poor in controllability

Patent document CN103040777A discloses a liposome solid preparation of olmesartan medoxomil and its preparation method. The stability of the drug is improved by combining olmesartan medoxomil with specific adjuvants into liposomes. The preparation method is very complicated. Moreover, the production cycle is long and the production cost is high, which is not conducive to industrialization

Patent document CN102028663A discloses a preparation method of a stable olmesartan medoxomil solid preparation, which reduces the degradation of olmesartan medoxomil by adding a pH regulator and a stabilizer. The preparation method adopts wet granulation, although absolute ethanol is used instead of Water is used to prevent the hydrolysis of active ingredients, but this method uses organic solvents in the granulation process, which brings great safety hazards to the production process, and the residual amount of organic solvents also needs to be strictly controlled, which makes the production cost high and labor-intensive

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