Moxifloxacin hydrochloride-containing pharmaceutical composition and preparation method thereof

A technology of moxifloxacin hydrochloride and its composition, which is applied in the field of pharmaceutical composition containing moxifloxacin hydrochloride and its preparation, can solve the problem of flying dust, not being able to meet the requirement that the bioavailability of tablets is not limited by dissolution, and unfavorable for laborers Protection and other issues to achieve the effect of improving compliance

Active Publication Date: 2013-09-18
SICHUAN GOWELL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Cannot meet the requirement that the bioavailability is not limited by dissolution
[0007] Chinese patent CN1672680A discloses a method of using film-forming materials to prepare moxifloxacin hydrochloride tablets to prevent discoloration during granulation and tabletting, but it is found through experiments that the friability of tablets prepared by this method can meet the requirements The dissolution rate in 0.1mol/L HCl for 15 minutes is only 60.3%, which cannot meet the requirement that the tablet bioavailability is not limited by dissolution
However, after testing, it was found that the dissolution rate of the tablets prepared by the patented formula that can meet the requirements in 0.1mol/L HCl for 15 minutes is only 71.6%, which cannot meet the requirement that the bioavailability of the tablet is not limited by dissolution.
[0009] Chinese patent CN102204911A discloses a tablet prescription composed of 500 parts by weight of moxifloxacin hydrochloride, 10-50 parts by weight of m...

Method used

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  • Moxifloxacin hydrochloride-containing pharmaceutical composition and preparation method thereof
  • Moxifloxacin hydrochloride-containing pharmaceutical composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0101] Material Weight (mg) Percentage

[0102] Moxifloxacin hydrochloride 436.4 43.64%

[0103] Microcrystalline Cellulose 10.0 1.00%

[0104] Mannitol 403.6 40.36%

[0105] Hypromellose 100.0 10.00%

[0106] Sodium Lauryl Sulfate 50.0 5.00%

[0107] ______________________________________________________________

[0108] Total 1000 100.00%

[0109] Mix moxifloxacin hydrochloride, mannitol, microcrystalline cellulose, and hydroxypropyl cellulose, moisten it with water, granulate it, dry it, granulate it, mix it with sodium lauryl sulfate, and make it with a hardness of 12kg and 18kg respectively. into tablets.

Embodiment 2

[0111] Material Weight (mg) Percentage

[0112] Moxifloxacin hydrochloride 436.4 43.64%

[0113] Microcrystalline cellulose 461.6 46.16%

[0114] Mannitol 90.0 9.00%

[0115] Croscarmellose Sodium 10.0 1.00%

[0116] Magnesium Stearate 2.0 0.20%

[0117] ______________________________________________________________

[0118] Total 1000 100.00%

[0119] Mix moxifloxacin hydrochloride, mannitol, and microcrystalline cellulose, moisten with water, granulate, dry, granulate, then mix with croscarmellose sodium, magnesium stearate, and use hardness 12kg and 18kg Tablets are made separately.

Embodiment 3

[0121] Material Weight (mg) Percentage

[0122] Moxifloxacin hydrochloride 436.4 54.55%

[0123] Microcrystalline cellulose 80.0 10.00%

[0124] Mannitol 179.6 22.45%

[0125] Croscarmellose Sodium 80.0 10.00%

[0126] Magnesium Stearate 24.0 3.00%

[0127] ______________________________________________________________

[0128] Total 800 100.00%

[0129] Mix moxifloxacin hydrochloride, mannitol, microcrystalline cellulose, and croscarmellose sodium, moisten it with water, granulate it, dry it, granulate it, and mix it with magnesium stearate evenly. Tablets are made separately.

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Abstract

The invention relates to a pharmaceutical composition containing 9%-40% of mannitol moxifloxacin hydrochloride and/or other hydrates, at least one diluent, at least one disintegrating agent and at least one lubricant and a preparation method thereof. Moxifloxacin hydrochloride tablets prepared according to a formula have the advantages of bioavailability without dissolution limitation, satisfied fragility, good liquidity and production feasibility.

Description

technical field [0001] The invention relates to pharmaceutical preparations, in particular to a pharmaceutical composition containing moxifloxacin hydrochloride and a preparation method thereof. Background technique [0002] Moxifloxacin hydrochloride is the fourth generation of fluoroquinolone antibiotics, and the original manufacturer is Bayer, Germany. Because of its broad antibacterial spectrum, low drug resistance, strong antibacterial effect, long half-life, and low phototoxicity, it has become a very effective anti-infective agent. The existing moxifloxacin hydrochloride tablets and moxifloxacin hydrochloride sodium chloride injection were approved by the US FDA in 1996 and 2001 respectively. Compared with injections, tablets are more stable in properties; they are better tolerated and safe for oral absorption and utilization; they also have the advantages of accurate dosage, convenient carrying and application, low cost, and a high degree of mechanization in product...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4709A61K47/38A61K47/10A61P31/04
Inventor 汪飞林蓉郭晖
Owner SICHUAN GOWELL PHARMA
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