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Double layer laminating sustained release tablet of metronidazole and its preparation method

A technology of metronidazole and sustained-release tablets, which is applied in the direction of drug combination, pharmaceutical formula, drug delivery, etc., and can solve problems such as frequent taking and large gastrointestinal reactions

Inactive Publication Date: 2005-03-16
南京亿华药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, metronidazole oral preparations generally have the disadvantages of large gastrointestinal reactions and frequent administration.

Method used

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  • Double layer laminating sustained release tablet of metronidazole and its preparation method
  • Double layer laminating sustained release tablet of metronidazole and its preparation method
  • Double layer laminating sustained release tablet of metronidazole and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0031] Example 1. Preparation of metronidazole double-layer laminated sustained-release tablets

[0032] First, put the original and auxiliary materials under the condition of 60 ℃ and dry for 4 hours, and set aside; then, prepare the materials for the slow-release layer: take 550 g of metronidazole, 100 g of glyceryl behenate, and 50 g of polyvinylpyrrolidone (PVP) K30 in equal amounts Mix evenly by incremental method, pass through a 60-mesh sieve, add 20% dilute ethanol solution to make a soft material, pass through a 20-mesh sieve to make wet granules, dry at 50°C-60°C for 3-4 hours, pass through a 18-mesh sieve for granulation, and weigh. Get the sustained-release layer granules; the quick-release layer is prepared: get metronidazole 200g, microcrystalline cellulose 60g, polyvinylpyrrolidone 20g, polyvinylpyrrolidone (PVP) K30 8g and mix uniformly by the method of equal increments, cross 60 orders Sieve; add 20% dilute ethanol solution to make soft materials, pass through ...

Embodiment 2

[0033] Example 2. Preparation of metronidazole double-layer laminated sustained-release tablets

[0034] First, put the original and auxiliary materials at 60°C and dry them for 4 hours, and set them aside; then, prepare the materials for the slow-release layer: take 550 g of metronidazole, 100 g of hydroxypropyl methylcellulose (HPMC), and 100 g of polyvinylpyrrolidone (PVP) K30 15g is mixed evenly according to the method of equal increase, passed through a 60-mesh sieve, added 20% dilute ethanol solution to make soft materials, passed through a 20-mesh sieve to make wet granules, dried at 50°C-60°C for 3-4 hours, passed through a 18-mesh sieve granules, weighed to obtain the sustained-release layer granules; quick-release layer preparations: get metronidazole 200g, microcrystalline cellulose 60g, crospovidone 20g, polyvinylpyrrolidone (PVP) K30 8g and mix by equal increment method Evenly, pass through a 60-mesh sieve; add 20% dilute ethanol solution to make a soft material, ...

Embodiment 3

[0036] First, dry the raw materials and auxiliary materials at 60°C for 4 hours, and set aside; then, prepare the slow-release layer: take 550 g of metronidazole, 70 g of ethyl cellulose, and 15 g of polyvinylpyrrolidone (PVP) K30 in equal increments Mix evenly by 60-mesh sieve to get mixed powder ①; quick-release layer preparation: take metronidazole 200g, microcrystalline cellulose 60g, crospovidone 20g, ethyl cellulose 12g and mix evenly by equal increment method , through a 60-mesh sieve to obtain mixed powder ②; dry granulate mixed powder ① and mixed powder ② respectively; tabletting: add 1% micropowder silica gel to the granules of the slow-release layer and the quick-release layer respectively, mix well, and granulate the slow-release layer. Release layer and immediate release layer granules are respectively placed in two hoppers of a double-layer tablet press, and pressed into 1000 tablets on the double-layer tablet press, each containing 750 mg of metronidazole.

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Abstract

Disclosed is a metronidazole double layer laminated slow release tablet comprising two layers, the first layer being a slow release layer consisting of metronidazole, slow release frame, binding agent and lubricating agent, the second layer being a quick release layer consisting of metronidazole, bulking agent, crumbling agent, binding agent and lubricating agent, wherein the mass ratio of metronidazole content in the slow release layer and in the quick release layer is 1 : 0.36-2.75. The invention also discloses the process for preparing the tablet.

Description

1. Technical field [0001] The invention relates to a metronidazole slow-release preparation and a preparation method thereof. 2. Background technology: [0002] Metronidazole is a low-molecular-weight 5-nitroimidazole drug, which is an anti-amoeba and anti-trichomonad drug. It is clinically used for various amoebiasis and trichomoniasis, and also for sepsis, endocarditis, lower respiratory tract infection, intra-abdominal infection, gynecology, central nervous system, bone, joint and other diseases caused by various anaerobic bacteria. Soft skin infection etc. In certain contaminated or potentially contaminated operations, such as elective colorectal surgery, it can also be used as a prophylactic drug for postoperative infection. [0003] Metronidazole has a strong antibacterial effect on most anaerobic bacteria, but has no effect on aerobic bacteria and facultative anaerobic bacteria. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Fusobac...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/4164A61P31/10A61P33/02
Inventor 杨鹏辉
Owner 南京亿华药业有限公司
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