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Irbesartan medicinal composition, as well preparation method and application thereof

A technology of irbesartan and its composition, which is applied in the field of irbesartan pharmaceutical composition and its preparation, and can solve the problems of unpredictability, many influencing factors, and the inability to make oral preparations, etc.

Inactive Publication Date: 2014-08-20
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Irbesartan is an insoluble drug with low bioavailability and cannot be directly made into qualified oral preparations from raw materials
The oral absorption of drugs is a complex physiological process with many influencing factors. Compared with other routes of administration, oral administration is more unpredictable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Weigh 200g of PEG4000 and 400g of PEG6000 and mix evenly, add 300g of irbesartan raw material, mix evenly, add it to a hot-melt extrusion granulator for hot-melt granulation to obtain a solid dispersion of irbesartan, and pulverize it over 100 Mesh sieve; lactose, precrossed starch, sodium carboxymethyl starch, sodium lauryl sulfate, silicon dioxide, and magnesium stearate were respectively pulverized through a 100 mesh sieve, and 8g of povidone was weighed and dissolved in an appropriate amount of 40% In ethanol: Weigh 450g of irbesartan solid dispersion, 100g of lactose, 80g of pre-crossed starch, 15g of sodium carboxymethyl starch, and 6g of sodium lauryl sulfate, mix well, and mix with 2% povidone + 40% Soft powder made from ethanol, granulated with a 20-mesh sieve, wet granules at 60°C, granulated with a 24-mesh sieve; add 5g of silicon dioxide and 1.5g of magnesium stearate, mix well, and press into tablets. The cumulative dissolution rate of this batch of irbesar...

Embodiment 2

[0028] Weigh 200g of PEG4000 and 400g of PEG6000 and mix evenly, add 300g of irbesartan raw material, mix evenly, add it to a hot-melt extrusion granulator for hot-melt granulation to obtain a solid dispersion of irbesartan, and pulverize it over 100 Mesh sieve; microcrystalline cellulose, precrossed starch, sodium carboxymethyl starch, sodium lauryl sulfate, polysorbate 80, silicon dioxide, magnesium stearate were respectively pulverized through a 100 mesh sieve, and 6g was weighed Dissolve hypromellose in an appropriate amount of 40% ethanol; weigh 450 g of irbesartan solid dispersion, 70 g of microcrystalline cellulose, 80 g of precrossed starch, 15 g of sodium carboxymethyl starch, and sodium lauryl sulfate Mix 6g evenly, make softener with 2% HPMC+40% ethanol, granulate with a 20-mesh sieve, dry the wet granules at 60°C, granulate with a 20-mesh sieve: add 4g silicon dioxide, 1.5g magnesium stearate, mix well, Tablet. The cumulative dissolution rate of this batch of irbe...

Embodiment 3

[0030] Weigh 200g of PEG4000 and 400g of PEG6000 and mix evenly, add 300g of irbesartan raw material, mix evenly, add it into a spray-type solid dispersion preparation machine for hot-melt granulation to obtain irbesartan solid dispersion, and pulverize it over 100 Mesh sieve; lactose, precrossed starch, sodium carboxymethyl starch, sodium lauryl sulfate, silicon dioxide, and magnesium stearate were respectively pulverized through a 100 mesh sieve, and 8g of povidone was weighed and dissolved in an appropriate amount of 40% In ethanol: Weigh 450g of irbesartan solid dispersion, 100g of lactose, 80g of pre-crossed starch, 15g of sodium carboxymethyl starch, and 6g of sodium lauryl sulfate, mix well, and mix with 2% povidone + 40% Made from ethanol, granulate with a 20-mesh sieve, dry the wet granules at 60°C, and granulate with a 24-mesh sieve; add 5g of silicon dioxide and 1.5g of magnesium stearate, mix well, and press into tablets. The dissolution rate of this batch of irbes...

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PUM

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Abstract

The invention relates to an irbesartan medicinal composition, as well as a preparation method and application thereof. The preparation method comprises the following steps: preparing irbesartan solid dispersion which is prepared from irbesartan and a carrier material by adopting hot-melt granulation of a hot-melt extrusion granulator or a spray type solid dispersing agent preparation machine; mixing the irbesartan solid dispersion with a proper amount of diluting agent, disintegrating agent, surfactant, adhesive, flow aid and lubriant into tablets. According to the preparation method, irbessartan is prepared into a solid dispersing agent body and further prepared into a tablet, so that the dissolution rate is improved, and good absorption and biological utilization are achieved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition of irbesartan, a preparation method and application thereof. Background technique [0002] Cardiovascular disease is a kind of disease that seriously endangers human health. With the progress of society and the improvement of human living standards, the incidence of this type of disease has gradually increased, becoming the number one killer of human health. Hypertension is cardiovascular disease. The most common disease in the disease, its incidence rate is getting higher and higher, and there is a trend of younger people, so the demand for antihypertensive drugs is very huge, and the development of high-efficiency, long-acting, high cardiovascular selectivity, and multi-organ protection 1. Antihypertensive drugs that can correct various metabolic disorders complicated by hypertension and have few side effects are the ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4184A61P9/12
Inventor 王艳皎闫立颖王海盛何艳
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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