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Eplerenone pharmaceutical composition

A technology of eplerenone and a composition, applied in the field of antihypertensive pharmaceutical compositions, can solve the problems of not specifically disclosing eplerenone surfactant and its dosage, increasing insoluble drugs, complicated preparation process, etc., Achieve the effect of being suitable for large-scale production, improving bioavailability and simple preparation method

Inactive Publication Date: 2008-04-02
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the micronized pharmaceutical composition has improved its in vitro dissolution and in vivo bioavailability to a certain extent, the preparation process of this method is complicated and the production cost is high
[0006] US2003236236 discloses a method for increasing insoluble drugs by adding surfactants, including polysorbate, polyoxyethylene fatty acid ester, and sorbitan fatty acid, but there is no specific disclosure for eplerenone surfactant and its dosage , also does not disclose the extent to which the dissolution and bioavailability are improved when the active ingredient is eplerenone

Method used

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  • Eplerenone pharmaceutical composition

Examples

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Comparison scheme
Effect test

Embodiment 1

[0018] Eplerenone

[0019] Preparation method: take prescription amount of lactose, microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, magnesium stearate, poloxamer 407, pass through a 60-mesh sieve, mix evenly, take eplerenone, etc. The amount of auxiliary materials is mixed evenly with the method of increasing in equal amounts, and the powder is directly compressed into tablets to obtain eplerenone tablets.

Embodiment 2

[0021] Eplerenone

[0022] Preparation method: first crush the above-mentioned auxiliary materials through a 100-mesh sieve, fully mix eplerenone, lactose, microcrystalline cellulose, poloxamer 188, and pregelatinized starch, and add appropriate amount of water (or ethanol aqueous solution) to prepare Make soft material, dry after 30 mesh sieve granulation, granulate with 24 mesh sieve, add magnesium stearate and mix evenly, control tablet weight, tablet pressing promptly obtains eplerenone tablet.

Embodiment 3

[0024] Eplerenone

[0025] Preparation method: first crush the above-mentioned excipients through a 100-mesh sieve, fully mix eplerenone, mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and poloxamer 338, and add an appropriate amount of polyvinylpyrrolidone The aqueous solution is made into a soft material, granulated with a 20-mesh sieve, dried, granulated with a 20-mesh sieve, mixed with cross-linked polyvinylpyrrolidone and magnesium stearate, the weight of the tablet is controlled, and the tablet is compressed to obtain eplerenone tablets. This example is the combined application of internal and external disintegrants. The internal disintegrants are microcrystalline cellulose and low-substituted hypromellose, and the external disintegrants are cross-linked polyvinylpyrrolidone.

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Abstract

The invention discloses a drug combination containing eplerenone. The combination also contains nonionic surface active agent, has high bioavailability, and is used to treat cardiovascular diseases including hypertension.

Description

technical field [0001] The invention relates to an antihypertensive pharmaceutical composition, in particular to a pharmaceutical composition containing eplerenone. Background technique [0002] Eplerenone is a selective aldosterone inhibitor (SAB) that specifically inhibits the function of the hormone aldosterone. Aldosterone is an important component of the renin-angiotensin-aldosterone system (RAAS), which plays an important role in regulating the function of the human cardiovascular system. Its chemical structure is as follows: [0003] [0004] Eplerenone can effectively control high blood pressure, reduce damage to target organs such as the heart, brain and kidney, and improve microalbuminuria in patients with type 2 diabetes. The incidence of side effects is similar to that of placebo, and it is well tolerated. It is of great significance for the control of hypertension in hypertensive patients, the prevention of cardiovascular diseases related to target organ dam...

Claims

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Application Information

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IPC IPC(8): A61K31/585A61K47/34A61P9/00A61P9/12A61P3/10A61K47/10
Inventor 卞志家
Owner BEIJING D VENTUREPHARM TECH DEV
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