Sitafloxacin hydrate tablet composition and preparation method thereof

The technology of sitafloxacin and composition is applied in the field of sitafloxacin tablet composition and preparation thereof, which can solve the problems of lack of self-developed drugs and high price of sitafloxacin tablets, and achieve low drug cost and low cost. Effect

Inactive Publication Date: 2013-06-19
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] At present, there is a lack of self-developed drugs for sitafloxacin tablets in China, and the price is relatively high

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The present embodiment provides a kind of sitafloxacin tablet composition, and active ingredient of medicine comprises the component of following weight ratio:

[0036] Tablet core: sitafloxacin 53.3g (equivalent to 50g C 19 h 18 CIF 2 N 3 o 3 50g), mannitol 61.15g, starch 32.13g, hydroxypropyl cellulose 11.27g, hydroxypropyl methylcellulose 2.25g, magnesium stearate 1.53g.

[0037] Coating: Opadry (OPADRY XY WHITE) 4.13 g, pure water 30.29 g.

[0038] The preparation method of the present embodiment sitafloxacin tablet composition comprises the following steps:

[0039] Crush and sieve: crush the sitafloxacin and pass through an 80-mesh sieve, and all other tablet core auxiliary materials pass through an 80-mesh sieve.

[0040]Granulation: put sitafloxacin, mannitol, starch, and 1.61 g of hydroxypropyl cellulose in a high-speed wet mixing granulator, mix well, and prepare hydroxypropyl methylcellulose into 5% hydroxypropyl cellulose Aqueous methyl cellulose sol...

Embodiment 2

[0048] The present embodiment provides a kind of sitafloxacin tablet composition, and active ingredient of medicine comprises the component of following weight ratio:

[0049] Tablet core: sitafloxacin 53.2g (equivalent to 50g C 19 h 18 CIF 2 N 3 o 3 50g), mannitol 59.74g, starch 33.93g, hydroxypropyl cellulose 10.8g, hydroxypropyl methylcellulose 2.1g, magnesium stearate 1.64g.

[0050] Coating: Opadry (OPADRY XY WHITE) 4.54 g, pure water 30.39 g.

[0051] The preparation method of the present embodiment sitafloxacin tablet composition comprises the following steps:

[0052] Crush and sieve: crush the sitafloxacin and pass through an 80-mesh sieve, and all other tablet core auxiliary materials pass through an 80-mesh sieve.

[0053] Granulation: put sitafloxacin, mannitol, starch, and 1.49 g of hydroxypropyl cellulose in a high-speed wet mixing granulator, mix well, and prepare hydroxypropyl methylcellulose into 5% hydroxypropyl cellulose Aqueous methyl cellulose solu...

Embodiment 3

[0061] The present embodiment provides a kind of sitafloxacin tablet composition, and active ingredient of medicine comprises the component of following weight ratio:

[0062] Tablet core: sitafloxacin 54.9g (equivalent to 50g C 19 h 18 CIF 2 N 3 o 3 50g), mannitol 60.8g, starch 32.3g, hydroxypropyl cellulose 9.69g, hydroxypropyl methylcellulose 2.27g, magnesium stearate 1.46g.

[0063] Coating: Opadry (OPADRY XY WHITE) 5.72 g, pure water 30.29 g.

[0064] The preparation method of the present embodiment sitafloxacin tablet composition comprises the following steps:

[0065] Crush and sieve: crush the sitafloxacin and pass through an 80-mesh sieve, and all other tablet core auxiliary materials pass through an 80-mesh sieve.

[0066] Granulation: put sitafloxacin, mannitol, starch, and 1.65 g of hydroxypropyl cellulose in a high-speed wet mixing granulator, mix well, and prepare hydroxypropyl methylcellulose into 5% hydroxypropyl cellulose Aqueous methyl cellulose solut...

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PUM

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Abstract

The invention relates to the field of preparation of medicaments and specifically relates to a sitafloxacin hydrate tablet composition and a preparation method thereof. The medicament comprises the following active ingredients in percentage by weight: 33-34% of sitafloxacin, 37-39% of mannitol, 20-21% of starch, 6-7% of hydroxypropyl cellulose, 1.3-1.4% of hydroxypropyl methyl cellulose and 0.9-1% of magnesium stearate; and the method for making the sitafloxacin hydrate tablets comprises the steps of crushing, screening, pelletizing, drying, stabilizing size, totally mixing, pressing tablets and the like. The sitafloxacin hydrate tablet composition disclosed by the embodiment of the invention selects a small quantity of excipients with low cost to prepare the tablets having the same efficacy with the existing sitafloxacin hydrate tablets, the medicament cost is low, and the side effects can be avoided basically.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a sitafloxacin tablet composition and a preparation method thereof. Background technique [0002] The main method of treating bacterial infections is antibiotic therapy. Antibacterial drugs include synthetic antibacterial drugs (such as quinolones) and antibiotics. The mechanism of action of antibacterial drugs is generally to specifically interfere with or block certain key links unique to bacteria, thereby exerting selectivity between host cells and bacteria Antibacterial effect. The mechanism of action of common antibacterial drugs is as follows: [0003] Inhibition of bacterial cell wall synthesis For example, β-lactam drugs can bind to penicillin-binding proteins (PBPs) on the bacterial cytoplasmic membrane to inactivate transpeptidase and prevent the formation of peptidoglycan, thereby inhibiting the synthesis of bacterial cell walls, and the cells lose penetration The barrier e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4709A61K47/38A61P31/04
Inventor 刘振腾朱绪辉赵树楷韩后良
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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