A kind of olmesartan medoxomil tablet and preparation technology thereof

Abstract

The invention relates to an olmesartan medoxomil tablet and a preparation process thereof. The olmesartan medoxomil tablet core is made by direct compression of olmesartan medoxomil and pharmaceutical excipients, and the particle size at 90% cumulative volume of olmesartan medoxomil is 1 ‑100 microns; the pharmaceutical excipients include fillers, disintegrants and lubricants, wherein the lubricants are selected from one or more of neutral or inert lubricants. The weight ratio of raw materials in the tablet core is 20 parts of olmesartan medoxomil, 80-180 parts of filler, 10-20 parts of disintegrant, and 2-10 parts of lubricant. Olmesartan medoxomil of the present invention is pulverized by means of airflow pulverization to control the particle size. The preparation process adopts the powder direct tableting method, which avoids the introduction of moisture in the wet granulation process, the degradation of active substances in the wet granule drying process, and prevents hydrolysis. The reaction takes place, the medicine is stable, the dissolution property is good, and the preparation is simple.

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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