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Azilsartan tablet and preparation method thereof

A technology for azilsartan tablets and tablets, applied in the field of azilsartan tablets and their preparation, can solve the problems of slow dissolution rate, incomplete dissolution, etc. Effect

Inactive Publication Date: 2018-09-21
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention aims to provide an azilsartan tablet with high stability and high dissolution rate and its preparation process, to solve the problems of incomplete dissolution and slow dissolution rate caused by the low solubility of azilsartan, and effectively inhibit the Generation of Azilsartan Impurities to Improve Medication Safety

Method used

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  • Azilsartan tablet and preparation method thereof
  • Azilsartan tablet and preparation method thereof
  • Azilsartan tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-2 and comparative example 1-8

[0030] The preparation of embodiment 1-2 and comparative example 1-8 azilsartan sheet

[0031] The composition of embodiment 1-2 azilsartan tablet is shown in the following table 1:

[0032] The azilsartan tablet composition of table 1 embodiment 1 and embodiment 2 (the tablet weight of described azilsartan tablet is 137mg)

[0033]

Embodiment 1

[0037] The preparation of embodiment 1 azilsartan tablet:

[0038] S1 Micronize azilsartan to control particle size D90 10-24 μm to obtain azilsartan micropowder;

[0039] S2 Weigh an appropriate amount of purified water, put it in a stainless steel bucket, add the binder under the condition of stirring, stir until dissolved, and prepare a solution with a concentration of 6-10%, then add the stabilizer under the condition of stirring and stir until Dissolved to obtain B solution;

[0040] S3 sequentially put diluent (2), diluent (1), azilsartan micropowder obtained in step S1, and diluent (3) into a wet mixing granulator, stir and shear to mix to obtain a mixture;

[0041] S4 Turn on the stirring paddle, spray the mixture obtained in step S3 evenly into the B solution obtained in step S2, stir for 60-150 s, cut for 50-120 s, granulate, granulate, and obtain wet granules;

[0042] S5 Pour the wet granules obtained in step S4 into the fluidized bed spray drying granulator, set: ...

Embodiment 2

[0044] Example 2 The preparation of Azilsartan Tablets refers to that shown in Example 1. Compared

[0045] Examples 1-8 The preparation of azilsartan tablets is shown in Example 1. Test case

[0046] 1. Quality inspection of Azilsartan tablets

[0047] The azilsartan tablets prepared in Examples 1-2 and Comparative Examples 1-8 were tested for angle of repose, hardness, disintegration time limit, and in vitro dissolution rate.

[0048] Tablet inspection items and testing methods:

[0049] ①Measurement of angle of repose Fix the iron ring on the hoop (the height is enough to allow the funnel to hang directly above the watch glass), place the watch glass right below the funnel, adjust the watch glass so that the origin is perpendicular to the funnel, Slowly add the material from the funnel until the edge of the watch glass can no longer contain the material, that is, until a regular cone is formed. Use a ruler to measure the height h of the material, and then measure the...

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Abstract

The invention belongs to the technical field of pharmaceutic preparations, and particularly relates to an azilsartan tablet and a preparation method thereof. The provided azilsartan tablet comprises the following preparation raw materials in percentages by weight: 14-28% of azilsartan, 25-55% of a diluent (I), 8-26% of a diluent (II), 8-12% of a diluent (III), 1-4% of a stabilizer, 4-8% of a disintegrating agent, 0.4-2% of a lubricating agent and 1-3% of a binding agent. The prepared azilsartan tablet is smooth in appearance, good in hardness, small in tablet weight difference and uniform in content, and in-vitro dissolution behaviors of the azilsartan tablet are consistent to those of original drug. Through acceleration tests for six month, single impurity content is 0.14%, the sum of impurity contents is 0.54%, the quality is excellent, the stability is good, the process is simple, and commercialized production is facilitated.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an azilsartan tablet and a preparation method thereof. Background technique [0002] Azilsartan, the chemical name is 1-[[2'-(4,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)biphenyl-4-yl]methanol Base]-2-ethoxy-benzimidazole-7-carboxylic acid is a new generation of selective AT1 subtype angiotensin II receptor antagonists (ARBs) antihypertensive drugs. Compared with angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs, the new angiotensin Ⅱ receptor subtype (AT1) antagonists (ARBs) have the advantages of stably lowering blood pressure and not causing dry cough. Despite the availability of several ARBs, 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 generat...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K31/4245A61P9/12
CPCA61K9/2095A61K9/2031A61K31/4245A61P9/12
Inventor 徐赟杨锐丛海建姜锋高苇
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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