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Moxifloxacin-containing pharmaceutical composition

A technology of moxifloxacin hydrochloride and composition, which is applied in the field of medicine, can solve the problems of metal ion loss, product quality reduction, discoloration, etc., and achieve the effects of increasing stability, reducing red impurities, good dissolution properties and hardness

Active Publication Date: 2013-02-06
TIANJIN CHASE SUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention finds that improper storage of moxifloxacin hydrochloride tablets will cause discoloration. After research, it is the 3 and 4 carboxyl groups and ketone carbonyl groups in the compound structure, which can form chelates with metal ions such as calcium, magnesium, iron, zinc, etc. compound, resulting in discoloration, which affects the antibacterial activity of the drug and reduces the quality of the product. At the same time, the chelating properties of moxifloxacin hydrochloride also cause the loss of metal ions in the body, causing deficiency to women, the elderly and children who take the product for a long time. Calcium, iron deficiency, zinc deficiency and other side effects

Method used

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  • Moxifloxacin-containing pharmaceutical composition
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  • Moxifloxacin-containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062]

[0063] 1) Take moxifloxacin hydrochloride, microcrystalline cellulose, mannitol, calcium sodium edetate, pulverize, pass through an 80-mesh sieve, and set aside.

[0064] 2) Take the pulverized moxifloxacin hydrochloride, microcrystalline cellulose, and mannitol and mix them evenly.

[0065] 3) Take the mixed material obtained in step 2), add 10% povidone solution, sequentially make soft material, make wet granules, and dry to obtain drug-loaded granules.

[0066] 4) Take the drug-loaded granules obtained above, add calcium sodium edetate, croscarmellose sodium, and magnesium stearate and mix well.

[0067] 5) Take the above-mentioned mixed material, press it into tablets with a suitable die, and obtain moxifloxacin tablets, which are light yellow in color.

[0068] 6) Take the plain tablets obtained above and coat them with Opadry to obtain coated moxifloxacin tablets.

[0069] 7) Put the coated tablet obtained above into a solid pharmaceutical high-density poly...

Embodiment 2

[0072]

[0073] 1) Take moxifloxacin hydrochloride, microcrystalline cellulose, and mannitol, pulverize them, pass through an 80-mesh sieve, and set aside.

[0074] 2) Take the pulverized moxifloxacin hydrochloride, microcrystalline cellulose, and mannitol and mix them evenly.

[0075] 3) Take the mixed material obtained in step 2), add 10% povidone solution, sequentially make soft material, make wet granules, and dry to obtain drug-loaded granules.

[0076] 4) Take the drug-loaded granules obtained above, add calcium sodium edetate, croscarmellose sodium, and magnesium stearate and mix well.

[0077] 5) Take the above-mentioned mixed material, press it into tablets with a suitable die, and obtain moxifloxacin tablets, which are light yellow in color.

[0078] 6) Take the plain tablets obtained above and coat them with Opadry to obtain coated moxifloxacin tablets.

[0079] 7) Put the coated tablet obtained above into a solid pharmaceutical high-density polyethylene bottle...

Embodiment 3

[0082]

[0083] 1) Take moxifloxacin hydrochloride, microcrystalline cellulose, mannitol, edetate calcium sodium and pulverize, pass through a 80-mesh sieve, and set aside.

[0084] 2) Take the pulverized moxifloxacin hydrochloride, microcrystalline cellulose, and mannitol and mix them evenly.

[0085] 3) Take the mixed material obtained in step 2), add 10% povidone solution, sequentially make soft material, make wet granules, and dry to obtain drug-loaded granules.

[0086] 4) Take the drug-loaded granules obtained above, add calcium sodium edetate, croscarmellose sodium, and magnesium stearate and mix well.

[0087] 5) Take the above-mentioned mixed material, press it into tablets with a suitable die, and obtain moxifloxacin tablets, which are light yellow in color.

[0088] 6) Take the plain tablets obtained above and coat them with Opadry to obtain coated moxifloxacin tablets.

[0089] 7) Put the coated tablet obtained above into a solid pharmaceutical high-density po...

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Abstract

The invention relates to a moxifloxacin-containing pharmaceutical composition which is a solid pharmaceutical composition prepared from moxifloxacin and minor ingredients acceptable pharmaceutically. The composition can be prepared into orally-taken solid preparations according to the technical scheme, and metal ion chelating agents added into a formula avoid generation of red moxifloxacin metal ion chelates during production of the solid preparations, so that stability of moxifloxacin tablets is improved. Besides, the solid preparations have the dissolution behavior and hardness similar to those of imported tablets in the market. The preparation formula and process quality are stable and controllable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of moxifloxacin and a preparation method thereof. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone antibacterial drugs. At present, moxifloxacin hydrochloride has been approved for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, and acute bacterial sinusitis. and uncomplicated skin and soft tissue infections. [0003] Moxifloxacin hydrochloride tablets were first registered in Mexico in February 1999, and listed in Germany in September 1999. The infusion solution was first listed in the United States and Germany in December 2001. At present, the product has been sold in Germany, Spain, Italy, Listed in Sweden, Switzerland, the United States, Canada, Australia, Argentina, Brazil, South Korea, Ma...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/4709A61K47/18A61P31/04
Inventor 李宝齐董凯何晓娟王瑞卿
Owner TIANJIN CHASE SUN PHARM CO LTD
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