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Moxifloxacin capsule and its preparation method

A technology for moxifloxacin and capsules is applied to a capsule dosage form of moxifloxacin or its salt and/or its hydrate and its preparation field to achieve the effects of stable dissolution performance and high dissolution rate

Active Publication Date: 2006-04-26
JIANGSU TIANYISHI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] So far, there are no reports of changes in in vitro dissolution behavior or decreased dissolution of moxifloxacin or its salts and / or hydrated gelatin capsules during storage and their solutions

Method used

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  • Moxifloxacin capsule and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Ingredient: Moxifloxacin Hydrochloride 218.4mg

[0035] Microcrystalline Cellulose 40.0mg

[0036] Sodium starch glycolate 68.0mg

[0037] Magnesium Stearate 3.6mg

[0038] Total 330.0mg

[0039] Preparation method: Take the raw materials and auxiliary materials in the above components, mix them well, and fill them into hydroxypropyl methylcellulose capsule shells.

[0040] The dissolution rate of the obtained capsules was measured. And after the obtained capsules were placed at room temperature for two years, the dissolution rate was measured by the same method, and the results are shown in Table 2 below.

Embodiment 2

[0042] Ingredient: Moxifloxacin Hydrochloride 436.8mg

[0043] Microcrystalline Cellulose 55.0mg

[0044] Carboxymethyl Starch Sodium 100.0mg

[0045] Magnesium Stearate 8.2mg

[0046] Total 600.0mg

[0047] Preparation method: Take the raw materials and auxiliary materials in the above components, mix them well, make granules by dry method, and fill them into hydroxypropyl methylcellulose capsule shells.

[0048] The dissolution rate of the obtained capsules was measured. And after the obtained capsules were placed at room temperature for two years, the dissolution rate was measured by the same method, and the results are shown in Table 2 below.

Embodiment 3

[0050] Ingredient: Moxifloxacin Hydrochloride 218.4mg

[0051] Microcrystalline Cellulose 30.0mg

[0052] Sodium starch glycolate 68.0mg

[0053] Croscarmellose Sodium 10.0mg

[0054] Magnesium Stearate 3.6mg

[0055] Total 330.0mg

[0056] Preparation method: Take the raw materials and auxiliary materials in the above components, mix them well, and fill them into hydroxypropyl methylcellulose capsule shells.

[0057] The dissolution rate of the obtained capsules was measured. And after the obtained capsules were placed at room temperature for two years, the dissolution rate was measured by the same method, and the results are shown in Table 2 below.

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Abstract

The invention provides a Moxifloxacin capsule, which comprises Moxifloxacin or its salts and / or hydrate, at least a disintegrating agent and at least a lubricating agent, the shell of the capsule contains hydroxy propyl ethyl cellulose. The invention also discloses the process for preparing the capsule.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of moxifloxacin, specifically, the invention relates to a capsule dosage form of moxifloxacin or a salt thereof and / or a hydrate thereof and a preparation method thereof. Background technique [0002] Moxifloxacin (moxifloxacin) is a new generation of fluoroquinolone antimicrobials. Currently, this product has been listed in tablets and injections for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute Treatment of bacterial sinusitis and uncomplicated skin and soft tissue infections. [0003] At present, moxifloxacin oral preparations on the market only have moxifloxacin hydrochloride tablets. The Chinese patent "Moxifloxacin Pharmaceutical Preparations", patent No. 99813124.5, discloses the oral drug tablet and its preparation method, which is to combine the drug with at least one Th...

Claims

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Application Information

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IPC IPC(8): A61K31/4709A61K9/48A61P31/04
Inventor 赵冰奇赵邦爱傅雪琦
Owner JIANGSU TIANYISHI PHARMA
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