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Epristeride slow release preparation

A slow-release preparation, the technology of Epilite, is applied in the directions of pill delivery, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., which can solve the problems of short time to maintain effective blood drug concentration and so on.

Active Publication Date: 2007-01-24
JIANGSU LIANHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The common preparations currently used have a relatively short time to maintain the effective blood concentration, and none of them can exceed 12 hours.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Sustained-release preparations of Aipriide contain the following ingredients in weight percentage:

[0014] Epulet 18.3%

[0015] Hypromellose 56.4%

[0016] Microcrystalline cellulose 21.8%

[0017] 10% polyvinylpyrrolidone ethanol solution 3%

[0018] Magnesium stearate 0.5%

[0019] It is made into tablets or capsules by conventional methods in the pharmaceutical industry. Hypromellose is a hydrophilic polymer. In this preparation, it is a skeleton material. It swells with water or digestive juice to form a gel-like barrier to control Eplast Special diffusion, so as to achieve the purpose of slow release.

[0020] Determination of the cumulative release of epristeride sustained-release preparations:

[0021] Take this product, according to the dissolution test method (Chinese Pharmacopoeia 2005 edition two appendix XC first method), with 0.001mol / L sodium hydroxide solution 800ml as the solvent, the rotation speed is 80 revolutions per minute, operate according to law, r...

Embodiment 2

[0026] Sustained release tablets (or capsules) are made by methods known in the pharmaceutical industry and contain the following ingredients in weight percentage:

[0027] Epulet 25%

[0028] Ethyl cellulose 55.2%

[0029] Lactose 16.3%

[0030] 3% HPMC ethanol solution 3%

[0031] Magnesium stearate 0.5%

[0032] Ethyl cellulose is an insoluble matrix material in which the drug is dispersed. The rate of drug release depends on the diffusion rate, and is slowly released from the insoluble matrix material to achieve the purpose of sustained release. Ethyl cellulose is excreted from the body after the drug is completely released.

Embodiment 3

[0034] Sustained release tablets (or capsules) are made by methods known in the pharmaceutical industry and contain the following ingredients in weight percentage:

[0035] Epulet 30%

[0036] Ethyl cellulose 30%

[0037] Stearic acid 23%

[0038] Lactose 11.5%

[0039] Ethyl cellulose anhydrous ethanol solution 4.5%

[0040] Magnesium stearate 1%

[0041] As a bioerodible material, stearic acid gradually releases the main drug in the body and plays a slow-release effect. Ethyl cellulose is an inerodible skeleton material, and is discharged from the body after the drug is completely released.

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PUM

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Abstract

The present invention provides a kind of slow released epristeride preparation as 5alpha-reductase inhibiter for treating benign hyperplasia of prostate. The slow released epristeride preparation consists of epristeride 10-30 wt%, slow releasing supplementary material 30-60 wt%, and other supplementary material for the rest. The slow releasing supplementary material is hydropropyl methyl cellulose, ethyl cellulose, polyacrylate resin and / or polyhydroxy ethylene. The other supplementary material includes pore creating agent, filler, adhesive, lubricant, wetting agent, solvent and / or filming agent. The slow released epristeride preparation can maintain the blood medicine level for 24 hr and high curative effect.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition, in particular to a pharmaceutical composition for treating benign prostatic hyperplasia. Background technique: [0002] Epristide, chemical name 17β-(N-tert-butyl-amino-formyl)androsta-3,5-diene-3-carboxylic acid, is a selective and non-competitive Steroid II type 5α-reductase inhibitors reduce the content of dihydrotestosterone in the prostate by inhibiting the conversion of testosterone into dihydrotestosterone, leading to atrophy of the prostatic body, and treating benign prostatic hyperplasia. [0003] Aipriide tablets were developed and marketed by Jiangsu Lianhuan Pharmaceutical Co., Ltd. in 1999. They are ordinary tablets and are administered orally. Eprister elimination half-life (T 1 / 2 β) is 7.5 hours. Therefore, one tablet (5mg) is required for each Epride tablet, once in the morning and once a day, in order to maintain the effective blood concentration in the body and achieve the therapeutic...

Claims

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Application Information

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IPC IPC(8): A61K31/56A61K47/38A61K9/20A61K9/48A61K9/28A61P13/08
Inventor 姚兴田张德伟
Owner JIANGSU LIANHUAN PHARMA
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