Pharmaceutical composition containing prulifloxacin, and preparation method thereof

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 ...

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.

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