Method for preparing ciprofloxacin lactate sodium chloride injection

Abstract

The invention provides a method for preparing ciprofloxacin lactate sodium chloride injection, and belongs to the field of medicinal preparation. The method includes the steps: firstly, dissolving lactic acid and sodium hydroxide into water for injection to prepare lactic acid solution; secondly, sufficiently mixing ciprofloxacin serving as a raw material, edetate disodium, diluted hydrochloric acid and the water for injection to prepare ciprofloxacin solution; and finally, sufficiently mixing the prepared lactic acid solution and the prepared ciprofloxacin solution, adding sodium chloride for injection into the solution, mixing the sodium chloride with the solution, and adjusting the pH (potential of hydrogen) value, adjusting the volume, pre-filtering, degerming, filling and sealing and performing autoclaved sterilization, inspection and the like to prepare the ciprofloxacin lactate sodium chloride injection. The method has the advantages of simple and convenient process, no environmental pollution, low cost and the like, and the ciprofloxacin lactate sodium chloride injection prepared by the method is high in stability and quality.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a method for preparing a drug injection, in particular to a method for preparing a ciprofloxacin lactate sodium chloride injection. Background technique [0002] Ciprofloxacin lactate (ciprofloxacin lactate) is a synthetic high-efficiency antibacterial drug, and its chemical name is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-crop Throat base)-3-quinoline carboxylic acid lactate, as the third generation quinolones broad-spectrum antibacterial drug, its oral preparation has been listed by German Bayer (Bayer) company in 1987, trade name is Ciproxin. Its sodium chloride injection was launched in the United States in 1990 under the name of CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is clinically used to treat genitourinary system infections caused by sensitive bacteria, including simple and complicated urinary tract infections , Bacterial prostatitis, Neiss...

AI Technical Summary

Problems solved by technology

For example, Chinese patent application CN 102274169 A discloses a preparation method of ciprofloxacin lactate and sodium chloride injection. In the background technology part, it is mentioned that the bulk drug of ciprofloxacin lactate is sensitive to light and easy to decompose, and its water solubility is not Very good, thus the stability and the solubility of the ciprofloxacin lactate sodium chloride injection prepared directly by using the ciprofloxacin lactate crude drug are not very good

And domestic ciprofloxacin lactate all needs to obtain ciprofloxacin through a certain synthesis process, which will not only increase the consumption of a large amount of organic solvents, bring adverse effects to product quality and environmental pollution; also increase production costs, not Conducive to the benign development of pharmaceutical enterprises

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