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Nifuratel tablet and preparation method thereof

A nifuratel tablet, the technology of nifuratel, which is applied in the field of pharmaceutical preparations, can solve the problems of low dissolution rate, poor stability, slow disintegration rate and the like, and achieves high dissolution rate, good stability and disintegration rate. quick effect

Inactive Publication Date: 2018-01-19
四川摩尔生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Aiming at the above-mentioned deficiencies in the prior art, the invention provides a nifuratel tablet and a preparation method thereof, which can effectively solve the problems of the existing nifuratel oral tablet with slow disintegration speed, low dissolution rate, stable The problem of disadvantages such as sexual difference

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] A nifuratel tablet, comprising the following components in parts by weight: 100 parts of nifuratel, 5 parts of a disintegrant, 3 parts of a lubricant, 30 parts of a filler, 3 parts of a glidant, and 20 parts of a binder and 5 parts of coating material;

[0033] Wherein, lubricant is magnesium stearate; Filler is the mixture that mannitol, microcrystalline cellulose and sucrose mix by weight ratio are 4:8:3; Glidant is talcum powder and micropowder silica gel with weight ratio as 2: 3 mixed mixture; binder is hydroxypropyl cellulose.

[0034] The disintegrant is a mixture of modified starch, low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone in a weight ratio of 10:6:4.

[0035] Modified starch is prepared by the following methods:

[0036] (1) dissolving corn starch in an ethanol solution with a volume fraction of 85% to obtain starch slurry, wherein the mass fraction of corn starch in the starch slurry is 35%;

[0037] (2) Add compound enz...

Embodiment 2

[0046] A nifuratel tablet comprising the following components in parts by weight: 120 parts of nifuratel, 10 parts of a disintegrant, 6 parts of a lubricant, 50 parts of a filler, 5 parts of a glidant, and 30 parts of a binder and 10 parts of coating material;

[0047]Wherein, lubricant is magnesium stearate; Filler is the mixture that mannitol, microcrystalline cellulose and sucrose mix by weight ratio are 8:12:6; Glidant is talcum powder and micropowder silica gel with weight ratio is 7: 5 mixed mixture; binder is hydroxypropyl cellulose.

[0048] The disintegrant is a mixture of modified starch, low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone in a weight ratio of 20:8:6.

[0049] Modified starch is prepared by the following methods:

[0050] (1) dissolving corn starch in an ethanol solution with a volume fraction of 95% to obtain starch slurry, wherein the mass fraction of corn starch in the starch slurry is 45%;

[0051] (2) Add compound en...

Embodiment 3

[0060] A nifuratel tablet comprising the following components by weight: 110 parts of nifuratel, 6 parts of disintegrant, 4 parts of lubricant, 35 parts of filler, 3.5 parts of glidant, 23 parts of binder and 6 parts of coating material;

[0061] Wherein, lubricant is magnesium stearate; Filler is the mixture that mannitol, microcrystalline cellulose and sucrose are mixed by weight ratio of 5:9:4; Glidant is talcum powder and micropowder silica gel with weight ratio as 3: 4 mixed mixture; binder is hydroxypropyl cellulose.

[0062] The disintegrant is a mixture of modified starch, low-substituted hydroxypropyl cellulose and cross-linked polyvinylpyrrolidone in a weight ratio of 13:6.5:4.5.

[0063] Modified starch is prepared by the following methods:

[0064] (1) Dissolving potato starch in an ethanol solution with a volume fraction of 85% to obtain starch slurry, wherein the mass fraction of potato starch in the starch slurry is 37%;

[0065] (2) Add composite enzyme in s...

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Abstract

The invention discloses a nifuratel tablet. The nifuratel tablet comprises the following components in parts by weight: 100-120 parts of nifuratel, 5-10 parts of a disintegrating agent, 3-6 parts of alubricant, 30-50 parts of a filler, 3-5 parts of a flow aid, 20-30 parts of an adhesive and 5-10 parts of a coating material, wherein the coating material comprises the following components in partsby weight: 5-8 parts of sodium chloride, 1-3 parts of maltose, 8-10 parts of cellulose acetate and 2-3 parts of sorbitol. The preparation method comprises the following steps: mixing nifuratel with the adhesive; adding water, and performing stirring to be a paste; adding the disintegrating agent, the lubricant, the filler and the flow aid; performing mixing; performing pressing to produce a tabletcore; coating the tablet core with the coating material to obtain the nifuratel tablet. The nifuratel tablet is reasonable and scientific in compounding, and the nifuratel tablet prepared from the specific components is quick in disintegration, high in dissolution rate and good in stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a nifuratel tablet and a preparation method thereof. Background technique [0002] Nifuratel, the chemical name is 5-[(methylthio)methyl]-3-[[(5-nitro-2-furyl)methylene]amino]-2-oxazolidinone, the molecular formula is C 10 h 11 N 3 o 5 S, the molecular weight is 285.28. Nifuratel was developed and marketed by Poli IndustriaChimica S.p.A in Italy in the 1960s. It is a nitrofuran antibiotic drug that has a significant effect on treating mixed vaginal infections. Its trichomonadicidal activity is equivalent to that of metronidazole and has antibacterial properties. It can also effectively kill Chlamydia trachomatis and Mycoplasma, and it also has certain activity against Candida. [0003] At present, nifuratel has been on the market with oral tablets, capsules, vaginal tablets and capsules, etc., but at present, various dosage forms have problem...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/32A61K47/36A61K47/38A61K47/26A61K47/02A61K31/422A61P31/04A61P33/02A61P31/10A61P15/02
Inventor 彭捷贺正全陈文刚
Owner 四川摩尔生物制药有限公司
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