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Eplerenone soft capsule preparations and method for preparing the same

A soft capsule preparation, eplerenone technology, applied in the field of eplerenone preparations, can solve the problem of low bioavailability and the like

Inactive Publication Date: 2008-02-06
韩锦霞
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The main disadvantage of tablets and capsules is that the bioavailability is not high. The tablets are ordinary tablets, 25mg per tablet, 50mg a day

Method used

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  • Eplerenone soft capsule preparations and method for preparing the same
  • Eplerenone soft capsule preparations and method for preparing the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Weigh 1 kg of gelatin, 0.4 kg of glycerin, and 1 kg of pure water to heat the sol, add an appropriate amount of preservatives to prepare rubber, accurately weigh 87.5 g of eplerenone, place it in 875 g of polyethylene glycol 400, heat to melt, and mix well. Prepare 3500 soft capsules through a soft capsule machine, wash, dry, and get ready.

Embodiment 2

[0029] Weigh 1kg of gelatin, 0.4kg of glycerin, 1kg of pure water and heat the sol, add appropriate amount of preservative to prepare rubber, accurately weigh 175g of eplerenone, put it in 1000g of soybean oil and 750g of Tween 80, heat to melt, and mix well . Prepare 3500 soft capsules through a soft capsule machine, wash, dry, and get ready.

Embodiment 3

[0031] Weigh 1kg of gelatin, 0.4kg of glycerin, 1kg of pure water to heat the sol, add an appropriate amount of preservatives to prepare rubber, accurately weigh 350g of eplerenone, put it in 3000g of Tween 80 and 500g of isopropanol, heat to melt, and mix well . Prepare 3500 soft capsules through a soft capsule machine, wash, dry, and get ready.

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Abstract

The invention relates to eplerenone soft capsule preparation and the preparation method thereof . The product consists of a liquid medicine part and a capsule shell part, wherein the composition and weight of the liquid medicine material are as follows: 25 mg to 100 mg eplerenone, 250 mg to 1000 mg organic solvent and 0 mg to 200 mg stabilizer; the composition and weight ratio of the capsule shell material are as following: gelatin (or Arabic gum) to glycerol to water to preservative to plasticizer are respectively equal to 1.0 to 0.3, 0.5 to 0.4, 1.2 to 0.001, 0.003 to 0.4 to 1.2. The invention has the beneficial effects that: a soft capsule with eplerenone as essential component and the preparation method are provided; the product belongs to oral dosage form and overcomes the disadvantages of the prior dosage forms; meanwhile, the invention has high bioavailability and accords with the standards of the dosage form in appearance, hardness, disintegration rate and physical and chemical stability etc.

Description

technical field [0001] The invention relates to eplerenone preparations, specifically eplerenone soft capsules and a preparation method for eplerenone soft capsules. Background technique [0002] The drug name of eplerenone described in the present invention is: [0003] Generic name: eplerenone [0004] English name: Eplerenone [0005] Chinese Pinyin: Yipulitong [0006] Chemical name: 9α, 11-epoxy-7α-(methoxyacyl)-3-oxo-17α-pregna-4-ene-21,17-carbonylactone Structural formula: [0007] [0008] Molecular formula: C 24 h 30 o 6 [0009] Molecular weight: 414.49 [0010] In recent years, the incidence of hypertension has increased year by year, and it is about 20% in some countries in Europe and America. Hypertension is the most important pathogenic factor of coronary heart disease, sudden onset, heart failure, and renal failure, and it is closely related to glucose and lipid metabolism disorders. Eplerenone can lower the blood pressure level of hypertensive pe...

Claims

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Application Information

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IPC IPC(8): A61K9/66A61K31/585A61P9/12A61P9/00
Inventor 韩锦霞
Owner 韩锦霞
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