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Pharmaceutical composition containing prulifloxacin, and preparation method thereof

A technology of prulifloxacin and composition, which is applied in the field of pharmaceutical compositions containing prulifloxacin and its preparation, can solve the problems of affecting the safety and effectiveness of this product, reducing active pharmaceutical ingredients, increasing related substances and the like

Active Publication Date: 2013-10-30
SUZHOU DAWNRAYS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, due to the special structure of the prodrug of this product, there is a risk of easy degradation in vitro or in vivo
Conditions such as humidity, heat and light will affect its stability. The carboxyl group in the structure of this product is easily oxidized or hydrolyzed to form degradation products. The active ingredients of the drug will decrease and the related substances will increase, which will seriously affect the safety and effectiveness of this product.

Method used

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  • Pharmaceutical composition containing prulifloxacin, and preparation method thereof
  • Pharmaceutical composition containing prulifloxacin, and preparation method thereof
  • Pharmaceutical composition containing prulifloxacin, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Composition per prescription:

[0029]

[0030]

[0031] Preparation method: Add prulifloxacin, calcium hydrogen phosphate, croscarmellose sodium, microcrystalline cellulose 102, and 1 / 2 magnesium stearate into a mixer and mix, and the resulting mixed powder is granulated by dry method grain. Weigh the dry granules and 1 / 2 magnesium stearate and add them into the mixer, mix evenly, press the above mixture into tablets, and coat with Opadry.

Embodiment 2

[0033] Composition per prescription:

[0034]

[0035] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing prulifloxacin, and a preparation method thereof. The pharmaceutical composition is characterized by containing prulifloxacin and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier at least comprises phosphate, and the weight ratio of the prulifloxacin to the phosphate is (1:2)-(2:1). Shown by stability tests, the impurity content of the pharmaceutical composition provided by the invention is obviously lower than that of a common preparation.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition containing prulifloxacin and a preparation method thereof. Background technique [0002] Prulifloxacin, its chemical name is: (±)-6-fluoro-1-methyl-7-[4-(5-methyl-2-oxo-1,3-dioxole- 4-yl)-methyl-1-piperidinyl]-4-oxo-4hydro-[1,3]thiazine[3,2-a]quinoline-3-carboxylic acid. Its structural formula is as follows: [0003] [0004] This product is developed by Meiji Pharmaceutical Company of Japan. It belongs to the fourth generation of quinolone antibiotics. It is the prodrug of NM394. It inhibits the activity of bacterial DNA topoisomerase II and IV, inhibits the synthesis of bacterial DNA, and completes the bactericidal effect. Compared with the traditional bactericidal mode, there is no resistance to other types of antibiotics. The drug has a wide antibacterial spectrum, and has significant curative effect on both Gram-negative bacteria ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K47/02A61P31/04
Inventor 徐璞马成孝陈建东陈志荣刘清王羽张海燕
Owner SUZHOU DAWNRAYS PHARM CO LTD
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