Olmesartan medoxomil amlodipine compound tablet and preparation method thereof

Abstract

The invention discloses a compound tablet of olmesartan medoxomil and amlodipine besylate and a preparation method of the compound tablet. The compound tablet is prepared from the following raw materials in parts by mass: 20 to 40 parts of olmesartan medoxomil, 5 to 10 parts of amlodipine besylate, 15 to 25 parts of pregelatinized starch, 50 to 60 parts of silicified microcrystalline cellulose, 5 to 10 parts of croscarmellose sodium, 1 to 2 parts of magnesium stearate and 2 to 5 parts of film coating premix. The preparation method comprises the following steps: 1) controlling the particle size D90 of olmesartan medoxomil to be less than or equal to 40 microns, and controlling the particle size D90 of amlodipine besylate to be less than or equal to 70 microns; (2) mixing olmesartan medoxomil, amlodipine besylate, pregelatinized starch, silicified microcrystalline cellulose and croscarmellose sodium in a mixing machine, then sieving with a 1.5 mm sieve, and continuously mixing; (3) preparing particles from the premixed materials by adopting a dry granulation method; 4) adding magnesium stearate and mixing; (5) tabletting; and (6) coating.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound tablet of olmesartan medoxomil and amlodipine and a preparation method thereof. Background technique [0002] According to statistics, 1 / 4 of the world's population suffers from high blood pressure, but the control rate of blood pressure is not ideal, and patients often cannot reach the target recommended by the guidelines. WHO multi-country monitoring of cardiovascular disease incidence trends and determinants (MONICA study) confirmed that only 13% to 38% of males and 17% to 54% of female patients with hypertension between the ages of 35 and 64 received antihypertensive treatment However, many patients who received treatment did not reach the target, and the treatment target ratios of male and female patients were only 13%-67% and 12%-63%, respectively. Many patients require multiple antihypertensive drug regimens to achieve goals. [0003] The 2007 "Eu...

AI Technical Summary

Problems solved by technology

This preparation process does not consider that the raw material of olmesartan medoxomil is an insoluble drug, and the particle size is not controlled. At the same time, the powder is mixed and directly compressed, and the fluidity of the material is too poor, which is not suitable for large-scale industrial production.

[0008] Chinese patent CN103006651B discloses a compound preparation of amlodipine dispersible tablets and olmesartan medoxomil, which solves the problem of inconsistent release curves of the two drugs in the body and reduces the side effects of the drug, but the preparation process requires separate preparation Dispersion, the preparation process is complicated, the production cost is too high, and it is not suitable for industrialized large-scale production

[0009] Chinese patent CN103565807B discloses a dry granulation process, using microcrystalline cellulose and croscarmellose sodium as auxiliary materials. The preparation method is simple, and the dry granulation process also improves the fluidity of the material. However, this preparation process does not consider that the raw material of olmesartan medoxomil is an insoluble drug, and the particle size is not controlled, so the consistency of product quality between different batches after commercial production cannot be guaranteed.

This preparation process does not consider that the raw material of olmesartan medoxomil is an insoluble drug, and the particle size is not controlled. At the same time, the powder is mixed and directly compressed, and the fluidity of the material is too poor, which is not suitable for large-scale industrial production.

[0011] Chinese patent CN104644589 discloses a powder direct compression process, which mixes olmesartan medoxomil, amlodipine besylate, calcium hydrogen phosphate, mannitol, and an appropriate amount of fillers, disintegrants, and lubricants and then directly compresses the tablet. Tablets and coating, this preparation process does not consider that the raw material of olmesartan medoxomil is an insoluble drug, and the particle size is not controlled. At the same time, the powder is mixed and directly compressed into tablets. The fluidity of the material is too poor, which is not suitable for large-scale industrial production.

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