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Fluconazole tablet composition, tablet and preparation method

A fluconazole tablet and composition technology, applied in the field of pharmaceutical preparations, can solve the problems of unstable fluconazole crystal form, low dissolution rate of ordinary tablets, and crystal form transformation, and achieve fast disintegration speed and dissolution The effect of high speed, good compressibility and low friability

Inactive Publication Date: 2020-12-29
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because fluconazole is hydrophobic and slightly soluble in water, the dissolution rate of ordinary tablets is usually not high
In addition, fluconazole has four crystal forms Ⅰ, Ⅱ, Ⅲ and monohydrate, which are determined by the properties of fluconazole raw materials. The crystalline form of fluconazole in the preparation is unstable and may crystal transformation

Method used

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  • Fluconazole tablet composition, tablet and preparation method
  • Fluconazole tablet composition, tablet and preparation method
  • Fluconazole tablet composition, tablet and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The present embodiment provides a kind of fluconazole tablet, and prescription consumption is as shown in the table below:

[0035]

[0036]

[0037] The preparation method of above-mentioned fluconazole tablet is as follows:

[0038] Step 1, pulverizing the fluconazole raw material through an 80-mesh sieve for subsequent use, and passing other auxiliary materials through a 60-mesh sieve for subsequent use;

[0039] Step 2: Take corn starch, add it to purified water at 40°C, stir and disperse evenly, then add purified water at 90°C to make slurry, cool down, and prepare starch slurry with a mass concentration of 5 wt%.

[0040] Step 3. Weigh each component according to the prescription amount, mix the weighed fluconazole, dry starch, dextrin, and low-substituted hydroxypropyl cellulose evenly, add the prepared starch slurry, and make a soft material. Soft materials are granulated with a 24-mesh sieve, and the wet granules are dried to control the moisture between...

Embodiment 2

[0042] The present embodiment provides a kind of fluconazole tablet, and prescription consumption is as shown in the table below:

[0043] components parts by weight Fluconazole 40 copies dry starch 25 copies dextrin 15 copies Low-substituted hydroxypropyl cellulose 6 servings Magnesium stearate 1.0 copies 7wt% starch slurry 17 copies

[0044] The preparation method of above-mentioned fluconazole tablet is as follows:

[0045] Step 1, pulverizing the fluconazole raw material through a 60-mesh sieve for subsequent use, and passing other auxiliary materials through a 100-mesh sieve for subsequent use;

[0046] Step 2: Take cornstarch, add it to purified water at 50°C, stir and disperse evenly, then add purified water at 100°C to make slurry, cool down, and prepare starch slurry with a mass concentration of 7wt%;

[0047] Step 3. Weigh each component according to the prescription amount, mix the weighed fluconazole, dry s...

Embodiment 3

[0049] The present embodiment provides a kind of fluconazole tablet, and prescription consumption is as shown in the table below:

[0050] components parts by weight Fluconazole 45 copies dry starch 20 copies dextrin 10 copies Low-substituted hydroxypropyl cellulose 8 servings Magnesium stearate 0.8 parts 6wt% starch slurry 18 copies

[0051] The preparation method of above-mentioned fluconazole tablet is as follows:

[0052] Step 1, pulverizing the fluconazole raw material through a 100-mesh sieve for subsequent use, and passing other auxiliary materials through an 80-mesh sieve for subsequent use;

[0053]Step 2: Take cornstarch, add it to purified water at 45°C, stir and disperse evenly, then add purified water at 80°C to make slurry, cool down, and prepare starch slurry with a mass concentration of 6 wt%.

[0054] Step 3. Weigh each component according to the prescription amount, mix the weighed fluconazole, dry st...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses a fluconazole tablet composition, a tablet and a preparation method. The fluconazole tablet composition comprises the following components in parts by weight: 35-45 parts of fluconazole, 30-40 parts of a filling agent, 6-9 parts of a disintegrating agent, 17-22 parts of an adhesive, and 0.5-1.0part of a lubricating agent, wherein the adhesive is starch slurry with the mass concentration of 5-7 wt%. The fluconazole tablet is prepared from the raw materials and auxiliary materials by adoptinga wet granulation method. Through the cooperation of auxiliary material selection, the optimized auxiliary material proportion and the wet granulation process, the prepared fluconazole tablet is highin in-vitro dissolution rate, low in impurity content and good in crystal form stability, the safety of clinical application is improved, the fluconazole tablet can be consistent with an original developed product in four dissolution media, the preparation process is simple, and thereby the fluconazole tablet is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a fluconazole tablet composition, a tablet and a preparation method. Background technique [0002] Fluconazole is a new type of triazole antifungal drug. It is a broad-spectrum antifungal drug and has the advantages of fast absorption, wide distribution in the body, long half-life, good tolerance, and small adverse reactions. Fluconazole has a therapeutic effect on fungal infections in humans and animals, and is mainly used for the treatment of vaginitis, oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and also for bone marrow transplant patients receiving cytotoxic drugs or radiation therapy , to prevent the occurrence of Candida infection. Originally developed by Pfizer, it was first launched in Denmark, France, Ireland and the United Kingdom in 1988, and was approved by the FDA in 1990 in the United States. There are mainly several dosa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K31/4196A61P31/10
CPCA61K9/2059A61K31/4196A61P31/10
Inventor 孙立杰程彦超李彪杨帆赵文鹤曹柳郝丽曼
Owner SHIJIAZHUANG NO 4 PHARMA
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