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Preparation method of azilsartan medoxomil sylvite dispersible tablets

A technology for azilsartan medoxomil and dispersible tablets, which is applied in the field of preparation of azilsartan medoxomil potassium salt dispersible tablets, can solve the problems that Edarbi cannot be replaced by effectiveness, safety and tolerance, and achieve good dissolution rate, The effect of simple operation and convenient preparation

Inactive Publication Date: 2016-11-09
佛山市弘泰药物研发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although some of the current emerging antihypertensive drugs have certain potential, their own shortcomings in effectiveness, safety and tolerability, and / or administration methods may prevent them from replacing Edarbi

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: a kind of preparation method of azilsartan medoxomil potassium salt dispersible tablet, it comprises the following steps:

[0015] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 80 parts by weight of azilsartan medoxomil potassium salt, 50 parts by weight of starch, 70 parts by weight of microcrystalline cellulose, sodium carboxymethyl starch 60 parts by weight, 15 parts by weight of lactose, 3.5 parts by weight of L-hydroxypropylcellulose, 4.5 parts by weight of povidone K30, 20 parts by weight of silicon dioxide, 4.2 parts by weight of magnesium stearate, and 45 parts by weight of ethanol.

[0016] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0017] S3. Preparation of wet granules: Azilsartan medoxomil potassium salt, starch, lactose, L-hydroxypropyl cellulose, microcry...

Embodiment 2

[0020] Embodiment 2: a kind of preparation method of azilsartan medoxomil potassium salt dispersible tablet, it comprises the following steps:

[0021] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 40 parts by weight of azilsartan medoxomil potassium salt, 40 parts by weight of starch, 50 parts by weight of microcrystalline cellulose, sodium carboxymethyl starch 40 parts by weight, 10 parts by weight of lactose, 8 parts by weight of L-hydroxypropyl cellulose, 8 parts by weight of povidone K30, 18 parts by weight of silicon dioxide, 8 parts by weight of magnesium stearate, 30 parts by weight of ethanol;

[0022] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0023] S3. Preparation of wet granules: Azilsartan medoxomil potassium salt, starch, lactose, L-hydroxypropyl cellulose, microcrystalline ...

Embodiment 3

[0026] Embodiment 3: a kind of preparation method of azilsartan medoxomil potassium salt dispersible tablet, it comprises the following steps:

[0027] S1. Weighing: Weigh each raw material according to the following formula ratio, and set aside; the formula is: 20 parts by weight of azilsartan medoxomil potassium salt, 15 parts by weight of starch, 35 parts by weight of microcrystalline cellulose, sodium carboxymethyl starch 30 parts by weight, 10 parts by weight of lactose, 3 parts by weight of L-hydroxypropyl cellulose, 3 parts by weight of povidone K30, 8 parts by weight of silicon dioxide, 4 parts by weight of magnesium stearate, 28 parts by weight of ethanol;

[0028] S2. Preparation of adhesive: ethanol is prepared into a solution with a concentration of 30%, and povidone K30 is added to the ethanol solution to obtain an adhesive;

[0029] S3. Preparation of wet granules: Azilsartan medoxomil potassium salt, starch, lactose, L-hydroxypropyl cellulose, microcrystalline c...

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PUM

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Abstract

The invention discloses a preparation method of azilsartan medoxomil sylvite dispersible tablets. The method comprises the following steps of weighing, preparing an adhesive, preparing wet grains, drying, total blending and tabletting. The dispersible tablets uniform in dispersion, good in dissolution rate, smooth, uniform and good in cleanliness are obtained. The method is easy to implement, low in equipment requirement, convenient to prepare and applicable to industrial large-scale production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of azilsartan medoxomil potassium salt dispersible tablets. Background technique [0002] Azilsartan medoxomil was developed by Takeda, Japan. A prodrug of azilsartan that is hydrolyzed to azilsartan during absorption from the gastrointestinal tract. It was approved for marketing by FDA on February 22, 2011. The trade name is Edarbi, and the specifications are 40mg and 80mg. In April 2012, Azilsartan was launched in Japan, trade name: Azilva, specification: 20mg, 40mg. Azilsartan medoxomil is a selective AT1 subtype angiotensin II receptor antagonist. Azilsartan selectively blocks the binding of angiotensin II to the AT1 receptor (the affinity of azilsartan to the AT1 receptor is more than 10,000 times higher than that of the AT2 receptor), thereby blocking the vasoconstriction caused by angiotensin II , Aldosterone secretion and oth...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K31/4245A61P9/12
CPCA61K9/2059A61K9/2095A61K31/4245
Inventor 雷林芳
Owner 佛山市弘泰药物研发有限公司
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