Azilsartan pharmaceutical composition and preparation method thereof

A composition and medicine technology, applied in the field of pharmaceutical compositions containing azilsartan and its preparation, can solve problems such as poor stability and unsatisfactory drug dissolution, achieve simple production process, reduce equipment and plant investment, save money The effect of production costs

Inactive Publication Date: 2015-01-21
JIANGXI SHIMEI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to overcome the problems in the above-mentioned prior art, the first object of the present invention is to provide a new pharmaceutical composition of azilsartan, which solves the problem of unsatisfactory drug dissolution and stable drug composit

Method used

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  • Azilsartan pharmaceutical composition and preparation method thereof
  • Azilsartan pharmaceutical composition and preparation method thereof
  • Azilsartan pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] 1. Prescription

[0049]

[0050] 2. Preparation process

[0051] 1) Azilsartan is micronized, the particle size is controlled to be no more than 15 microns, weighed according to the prescription amount, and set aside;

[0052] 2) Dry lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate in an oven at 80°C for 2 hours, sieve through 80 mesh, and set aside;

[0053] 3) Weigh the above-mentioned standby azilsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, mix them evenly, and press into tablets.

Embodiment 2

[0055] 1. Prescription

[0056]

[0057] 2. Preparation process

[0058] 1) Azilsartan is micronized, the particle size is controlled to be no more than 20 microns, weighed according to the prescription amount, and set aside;

[0059] 2) Dry lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide, and sodium stearyl fumarate in an oven at 60°C for 3 hours, sieve through a 60-mesh sieve, and set aside;

[0060] 3) Weigh the above-mentioned standby azilsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, mix them evenly, and press into tablets.

Embodiment 3

[0062] 1. Prescription

[0063]

[0064] 2. Preparation process

[0065] 1) Azilsartan is micronized, the particle size is controlled to be no more than 30 microns, weighed according to the prescription amount, and set aside;

[0066] 2) Dry lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate in an oven at 70°C for 2 hours, sieve through 80 mesh, and set aside;

[0067] 3) Weigh the above-mentioned standby azilsartan, lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, silicon dioxide and sodium stearyl fumarate according to the prescription amount, mix them evenly, and press into tablets.

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Abstract

The invention relates to an azilsartan pharmaceutical composition and a preparation method of the pharmaceutical composition. The pharmaceutical composition consists of the raw materials in parts by weight: 20 parts of azilsartan, 60-150 parts of lactose, 30-120 parts of microcrystalline cellulose, 4-10 parts of low substituted hydroxypropyl cellulose, 0.3-2 parts of silicon dioxide and 0.5-5 parts of sodium stearyl fumarate. The pharmaceutical composition is prepared by adopting a direct powder tabletting process. The dissolution rate of over 90 percent can be achieved by adopting a small amount of disintegrating agent, and the pharmaceutical composition has the advantages of high stability and fast disintegration. The preparation method disclosed by the invention is simple in production process, the corresponding equipment plant investment is reduced, and the production cost is saved. The tablets produced by adopting the direct powder tabletting process are fast in disintegration, and dissolution of the medicine is improved. The detection proves that the dissolution rate of the tablets prepared by the method disclosed by the invention is over 90 percent in 30min.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition containing azilsartan and a preparation method thereof. Background technique [0002] Azilsartan is a new generation of selective AT1 subtype angiotensin II receptor antagonists (AR Bs) antihypertensive drugs. Compared with angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs, it has the advantages of stably lowering blood pressure and not causing dry cough. Despite the presence of several ARBs on the market, for many patients, inhibition of the renin-aldosterone system (RAS) activity alone is not sufficient to control blood pressure and reduce the risk of cardiovascular disease and diabetes. Studies have shown that azilsartan, as a new generation of dual-function ARBs, not only antagonizes the type 1 receptor of angiotensin II (AT1 receptor), but also may reduce the risk of cardiovascular disease and diabetes through multipl...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4245A61K47/38A61P9/12
Inventor 江鸿杨大龙
Owner JIANGXI SHIMEI PHARM CO LTD
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