Irbesartan-containing pharmaceutical composition and preparing process thereof

A composition and lactose technology, applied in the field of preparation of irbesartan, can solve the problems of increasing tableting difficulty, tableting difficulty, low solubility, etc. Effect

Active Publication Date: 2015-06-17
HARBIN ZHENBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] However, in actual operation, it was found that irbesartan has static electricity and can adhere to the punch surface of the tablet press and the surface of the die, causing difficulty in...

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Embodiment 1: Preparation of Irbesartan Hydrochlorothiazide Tablets

[0060] 1. Ingredients: irbesartan 150.0g, hydrochlorothiazide 12.5g, lactose 46.0g, microcrystalline cellulose 18.0g, croscarmellose sodium 15.0g, hydroxypropyl methylcellulose 4.0g, silicon dioxide 2.5 g and magnesium stearate 2.0g and coating 7.5g.

[0061] 2. Preparation method:

[0062] (1) Treatment of raw and auxiliary materials: Weigh each component according to the proportion, and then perform pretreatment, wherein: irbesartan is pulverized through a 100-mesh sieve for subsequent use; hydrochlorothiazide and lactose are crushed together, and passed through a 120-mesh sieve for subsequent use; The element, croscarmellose sodium, silicon dioxide and magnesium stearate are respectively passed through an 80-mesh sieve for subsequent use.

[0063] (2) Preparation of adhesive liquid: hydroxypropyl methylcellulose was dissolved in 100.0 g of purified water to make a solution, which was used as adhe...

Embodiment 2

[0067] Embodiment 2: Preparation of Irbesartan Hydrochlorothiazide Tablets

[0068] 1. Ingredients: irbesartan 157.5g, hydrochlorothiazide 13.2g, lactose 46.0g, microcrystalline cellulose 18.0g, croscarmellose sodium 15.0g, hydroxypropyl methylcellulose 4.0g, silicon dioxide 2.5g, magnesium stearate 2.0g and coating 7.7g.

[0069] 2. Preparation method:

[0070] (1) Processing of raw and auxiliary materials: irbesartan is pulverized through a 100-mesh sieve for subsequent use; hydrochlorothiazide and lactose are pulverized together and passed through a 120-mesh sieve for subsequent use; microcrystalline cellulose, croscarmellose sodium, silicon dioxide, Magnesium stearate is passed through 80 mesh sieves respectively, and is set aside.

[0071] (2) Preparation of adhesive liquid: hydroxypropyl methylcellulose was dissolved in 100.0 g of purified water to make a solution, which was used as adhesive liquid for later use.

[0072] (3) Dry blending and granulation: put the irbe...

Embodiment 3

[0075] Embodiment 3: Preparation of Irbesartan Hydrochlorothiazide Tablets

[0076] 1. Ingredients: irbesartan 142.5g, hydrochlorothiazide 11.9g, lactose 48.3g, microcrystalline cellulose 18.9g, croscarmellose sodium 15.7g, hydroxypropyl methylcellulose 4.2g, silicon dioxide 2.7g, magnesium stearate 2.1g and coating 7.2g.

[0077] 2. Preparation method:

[0078] (1) Processing of raw and auxiliary materials: irbesartan is pulverized through a 100-mesh sieve for subsequent use; hydrochlorothiazide and lactose are pulverized together and passed through a 120-mesh sieve for subsequent use; auxiliary materials: microcrystalline cellulose 18.9g, croscarmellose sodium, Silicon dioxide and magnesium stearate are respectively passed through an 80-mesh sieve for subsequent use.

[0079] (2) Preparation of adhesive liquid: hydroxypropyl methylcellulose was dissolved in 100.0 g of purified water to make a solution, which was used as adhesive liquid for later use.

[0080] (3) Dry mixi...

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PUM

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Abstract

The invention relates to an irbesartan-containing pharmaceutical composition and a preparing process thereof; the pharmaceutical composition comprises the following components: irbesartan, hydrochlorothiazide, lactose, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl methyl cellulose, silicon dioxide, magnesium stearate and a coating. Because a solid dispersoid technology is applied in the production manufacturing process, the materials are only subjected to conventional crushing treatment, and great change of the material physical properties are not caused; therefore, selection of a flow aid has no special requirements, and a high-quality and competitive-price precipitated silicon dioxide is selected in the premise of meeting the requirements of the production process.

Description

technical field [0001] The invention relates to a preparation of irbesartan, in particular to a pharmaceutical composition containing irbesartan and a preparation process thereof. Background technique [0002] Hypertension is the most common cardiovascular disease and a major public health problem worldwide. According to the 2004 survey on nutrition and health status of Chinese residents, the prevalence rate of hypertension among residents aged 18 and over in my country is 18.8%, and it is estimated that the number of patients nationwide exceeds 160 million. Compared with 1991, the prevalence rate increased by 31%, and the number of patients increased by about 70 million people. [0003] In 1998, cerebrovascular disease was the second leading cause of death among urban residents in my country and the first in rural areas. There are more than 1 million deaths every year in the country, and about 5 to 6 million surviving patients, of which more than 75% have disabilities of ...

Claims

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Application Information

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IPC IPC(8): A61K31/549A61K9/36A61K47/38A61K47/26A61K47/04A61P9/12A61K31/4184
Inventor 方同华马丽梅高丽王天晔周广红范玉奇
Owner HARBIN ZHENBAO PHARMA
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