Nifuratel solid preparation and preparation method thereof

A technology of nifuratel solid and nifuratel, which is applied in the field of nifuratel solid dispersion and nifuratel tablets and its preparation, can solve the problem of low dissolution rate and low bioavailability of nifuratel preparations and other issues, to achieve the effect of improving bioavailability, high bioavailability, and ensuring drug efficacy

Active Publication Date: 2016-05-11
南京卓康医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The object of the present invention is to provide a solid dispersion of nifuratel, which mai...

Method used

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  • Nifuratel solid preparation and preparation method thereof
  • Nifuratel solid preparation and preparation method thereof
  • Nifuratel solid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] (1) Preparation of solid dispersion: Weigh the nifuratel raw material drug and mannitol in the prescription amount shown in Table 1, and use a ball mill to perform ball milling and mixing for 45 minutes to obtain a nifuratel solid dispersion.

[0023] (2) Preparation of soft material: mix the solid dispersion obtained in step (1) with the starch in the prescription amount shown in Table 1, and add 35-40g of water to prepare soft material.

[0024] (3) Granulation and drying: pass the soft material obtained in step (2) through a 24-mesh sieve to granulate, and then dry in an oven at 60°C for 1 hour.

[0025] (4) Grain sizing: pass the dry granules obtained in step (3) through a 20-mesh sieve for sizing.

[0026] (5) Mixing and tableting: Mix the granules obtained in step (4) with the prescription amounts shown in Table 1, talcum powder and magnesium stearate evenly, and press into tablets.

[0027] (6) Coating: prepare a coating liquid, coat plain tablets, and get ready...

Embodiment 2

[0031] (1) Preparation of solid dispersion: Weigh the nifuratel raw material drug and PEG-6000 in the prescription amount shown in Table 2, and use a ball mill to perform ball milling and mixing for 60 minutes to obtain a nifuratel solid dispersion.

[0032] (2) Preparation of soft material: mix the solid dispersion obtained in step (1) with the starch in the prescription amount shown in Table 2, and add 30-35g of water to prepare soft material.

[0033] (3) Granulation and drying: Pass the soft material obtained in step (2) through a 20-mesh sieve to granulate, and then dry it in an oven at 60°C for 1 hour.

[0034] (4) Grain sizing: pass the dry granules obtained in step (3) through a 20-mesh sieve for sizing.

[0035] (5) Mixing and tableting: Mix the granules obtained in step (4) with talcum powder and magnesium stearate in the prescription amounts shown in Table 2, and then press them into tablets.

[0036] (6) Coating: prepare a coating liquid, coat plain tablets, and g...

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Abstract

The invention provides a nifuratel solid preparation and a preparation method thereof. A nifuratel solid dispersion is contained. The solid dispersion comprises a nifuratel crude drug and an auxiliary material A. The auxiliary material A is selected from one or more of lactose, polyethylene glycol and mannitol. A preparation method of the nifuratel solid dispersion includes the steps that the nifuratel crude drug and the auxiliary material A are taken and mixed in a ball-milling mode in proportion, wherein the ball-milling mixing time ranges from 10 min to 360 min every kg of the nifuratel crude drug. The nifuratel solid dispersion and a nifuratel tablet containing the nifuratel solid dispersion have the high dissolution rate and bioavailability.

Description

technical field [0001] The invention relates to the technical field of drug research and development, and provides a nifuratel solid preparation and a preparation method thereof, in particular to a nifuratel solid dispersion, nifuratel tablets and a preparation method thereof. Background technique [0002] Nifuratel (Nifuratel), its chemical name is: 5-[(methylthio)methyl]-3-[(5-nitrofuryl methylene)amino]-2-oxazolidinone, molecular formula: C 10 h 11 N 3 o 5 S, molecular weight: 285.28. The structural formula is as follows: [0003] [0004] Nifuratel is a nitrofuran derivative and is a broad-spectrum antibiotic, especially for common pathogens of gynecological infections such as Gram-positive and negative bacteria, trichomonas, mold, chlamydia and mycoplasma. Among them, Nifuratel showed antibacterial activity against Gram-positive aerobic bacteria (β-hemolytic streptococcus, Staphylococcus aureus, Staphylococcus epidermidis). In vitro experiments showed that nif...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K9/28A61K47/26A61K47/10A61K31/422A61P31/04A61P31/10A61P33/02
CPCA61K9/145A61K9/146A61K9/2018A61K9/2031A61K9/2866A61K31/422
Inventor 张夕瑶刘伟李强
Owner 南京卓康医药科技有限公司
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