111 results about "Rabeprazole Sodium" patented technology

The invention belongs to the field of pharmaceutical preparations, and particularly relates to novel rabeprazole sodium enterosoluble micro-particles with high stability in an acid medium, and a preparation method thereof. Each rabeprazole sodium enterosoluble micro-particle comprises a blank pill core (1), a medicine-carrying layer (2), an isolation coating layer (3) and an enteric coating layer (4) in sequence from inside to outside. A pH value regulator is used in the medicine-carrying layer, the isolation coating layer is added between the medicine-carrying layer and the enteric coating layer, and particularly, a retarding agent is added into an enteric coating layer combination, so that the acid tolerance of a medicament active ingredient namely rabeprazole sodium which is extremely unstable in acid is well improved. The rabeprazole sodium enterosoluble micro-particles and a preparation thereof can be used for treating diseases such as active duodenal ulcer, benign active gastric ulcer, rodent or ulcerative gastroesophageal reflux accompanied by clinical symptoms and the like.

The invention belongs to the field of medicines and in particular relates to an enteric-coated preparation of rabeprazole sodium, a proton pump inhibitor and a preparation method thereof. The properties of rabeprazole sodium are very unstable and rabeprazole sodium can be quickly degraded and discolored if rabeprazole sodium is prepared or stored improperly, thus directly affecting the curative effects and medication safety of the medicine. In order to solve the problems, the enteric-coated preparation is prepared by using rabeprazole sodium as the main medicine and adopting three layers of coatings, wherein the three coating layers are respectively an alkaline protective layer, an isolation layer and an enteric-coated layer from inside to outside; the alkaline protective layer comprises film forming agents, lubricating agents, light-screening agents, alkaline stabilizing agents and solvents and the pH value of the coating solution is 8.0-13.0; the isolation layer comprises film forming agents, lubricating agents, plasticizers, light-screening agents and solvents and the pH value of the coating solution is 7.0-8.0; the enteric-coated layer comprises film forming agents, plasticizers, lubricating agents, light-screening agents, stabilizing agents and solvents and the pH value of the coating solution is 5.0-6.0. The enteric-coated preparation has the characteristics of short product production cycle and less influence caused by environments, temperatures, humidity and dust pollution.

The invention relates to a rabeprazole sodium crystal compound and a preparing method thereof. The crystal compound is determined by a powder X-ray diffraction determining method, and an X-ray powder diffraction spectrum represented by 2 theta + / - 0.2 degree diffraction angles shows characteristic diffraction peaks at the positions of 5.8 degrees, 7.5 degrees, 12.1 degrees, 12.8 degrees, 13.3 degrees, 15.6 degrees, 16.7 degrees, 18.3 degrees, 20.4 degrees, 25.7 degrees, 26.8 degrees and 31.5 degrees. The preparing method comprises the following steps of: 1) adding rabeprazole sodium serving as a crude drug in water, stirring and dissolving to obtain a rabeprazole sodium water solution; 2) adding a mixed solution of tetrahydrofuran and methanol into the rabeprazole sodium water solution, conducting heat-insulation decoloration at the temperature of 25-35 DEG C by active carbon and filtering to obtain filtrate; and 3) dropping the filtrate into acetonitrile, cooling, crystallizing, filtering and drying in vacuum, thus obtaining the rabeprazole sodium crystal compound. The crystal compound has good stability and strong inhibitory action on Helicobacter pylori.

A rabeprazole sodium enteric-coated pellet is composed of a pellet core, an insulation layer and an enteric-coated layer from the inside to the outside, wherein by the total weight of the enteric-coated pellet, the content of the pellet core is 50 to 70 wt%, the content of the insulation layer is 10 to 20 wt%, and the content of the enteric-coated layer is 20 to 40 wt%; the pellet core comprises rabeprazole, a filling agent, an adhesive, a disintegrating agent, and an alkalizer, by the total weight of the pellet core, the content of the rabeprazole is 7 to 9 wt%, the content of the filling agent is 60 to 75 wt%, the content of the adhesive is 5 to 10 wt%, the disintegrating agent is 4 to 8 wt%, and the content of the alkalizer is 5 to 12 wt%. The rabeprazole sodium enteric-coated pellet has the advantages of low cost, stable quality, and good safety.

The invention belongs to the technical field of medicines and particularly relates to a rabeprazole sodium compound and a preparation method thereof. Rabeprazole sodium provided by the invention contains less water and has the advantages of chemical purity up to 99.9%, maximum impurity content less than 0.1%, optical purity up to 99.96%ee and good stability. The compound provided by the inventionhas low production cost and stable quality, and is suitable for industrial production.

The invention relates to a lyophilized powder injection of a rabeprazole sodium medicinal composition and a preparation method of the lyophilized powder injection. The medicinal composition is composed of rabeprazole sodium and pharmaceutically acceptable auxiliary materials, wherein the rabeprazole sodium is a rabeprazole sodium crystal compound. By utilizing a powder X-ray diffraction determination method to determine, characteristic diffraction peaks are displayed at parts of 5.8 degrees, 7.5 degrees, 12.1 degrees, 12.8 degrees, 13.3 degrees, 15.6 degrees, 16.7 degrees, 18.3 degrees, 20.4 degrees, 25.7 degrees, 26.8 degrees and 31.5 degrees by an X-ray powder diffraction pattern which is represented by a 2 theta+ / -0.2 degree diffraction angle; and the pharmaceutically acceptable auxiliary materials comprise mannitol and disodium ethylene diamine tetraacetate and further comprise meglumine and sodium sulfite. The prepared rabeprazole sodium powder injection is full in appearance andgood in redissolving property and has fewer insoluble particles; and a test shows that the lyophilized powder injection has a stronger acid-inhibiting capability.

A process for preparation of rabeprazole sodium comprising oxidation of wet or dry rabeprazole sulphide with sodium hypohalite in water or a mixture of water and water miscible solvent using alkali metal hydroxide and catalyst is disclosed herein. The present invention also discloses process for preparation of rabeprazole sulphide.

Rabeprazole sodium in the monohydrate crystalline form, pharmaceutical compositions thereof, the use thereof in therapy, a process for its preparation, and the use thereof for the purification of rabeprazole sodium.