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Purification method of ciprofloxacin hydrochloride, ciprofloxacin hydrochloride freeze-dried powder for injection and preparation method of ciprofloxacin hydrochloride freeze-dried powder

A technology of ciprofloxacin hydrochloride and a purification method, which is applied in the directions of medical preparations without active ingredients, medical preparations containing active ingredients, and freeze-dried transportation, can solve the problem of high impurity content of related substances and pH differences in the gastrointestinal tract. It can reduce the content of impurities, reduce the content of impurities and improve the purification yield.

Pending Publication Date: 2021-07-02
海南卓华制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

"Because ciprofloxacin hydrochloride is easy to precipitate under alkaline conditions, and ciprofloxacin hydrochloride is absorbed in the gastrointestinal tract, so the alkaline small intestine environment will cause some ciprofloxacin hydrochloride to precipitate and crystallize, which cannot be absorbed by the human body. Absorption affects the efficacy of the medicine, and at the same time, it is easy to form urinary stones
In addition, the pH of the gastrointestinal tract varies greatly between different patients. Therefore, for patients with different alkaline gastrointestinal tracts, taking this drug may easily cause differences in absorption in the body, resulting in inconsistent drug effects for patients with the same condition.
[0004] In view of the above-mentioned defects that oral preparations exist, parenteral injections of ciprofloxacin hydrochloride are more widely used, but studies have shown that the existing injections made of ciprofloxacin hydrochloride have high levels of impurities in related substances

Method used

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  • Purification method of ciprofloxacin hydrochloride, ciprofloxacin hydrochloride freeze-dried powder for injection and preparation method of ciprofloxacin hydrochloride freeze-dried powder
  • Purification method of ciprofloxacin hydrochloride, ciprofloxacin hydrochloride freeze-dried powder for injection and preparation method of ciprofloxacin hydrochloride freeze-dried powder

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Embodiment 1

[0034] The present embodiment provides a kind of purification method of ciprofloxacin hydrochloride, specifically comprises the following steps:

[0035] Take 1.5kg of crude ciprofloxacin hydrochloride and place it in a 10L flask, add 6.0L of ethanol solution with a volume fraction of 70%, heat to 60°C and stir to dissolve, then add 7.0g of activated carbon, keep heating at 60°C for 25min, filter while hot, and the filtrate Use 30% hydrochloric acid solution to adjust the pH to 4.5, then cool to room temperature, crystallize, filter under reduced pressure to obtain white crystals, dry the white crystals at 65°C for 4 hours under reduced pressure, and obtain 1.30 kg of white crystalline powder Ciprofloxacin hydrochloride .

Embodiment 2

[0037] The present embodiment provides a kind of purification method of ciprofloxacin hydrochloride, specifically comprises the following steps:

[0038] Take 1.5kg of the crude product of ciprofloxacin hydrochloride and place it in a 10L flask, add 5.5L of ethanol solution with a volume fraction of 68%, heat to 62°C and stir to dissolve, then add 7.5g of activated carbon, keep heating at 58°C for 26min, filter while hot, and the filtrate Use 30% hydrochloric acid solution to adjust the pH to 3.0, then cool to room temperature, crystallize, filter under reduced pressure to obtain white crystals, dry the white crystals at 60°C for 4.5 hours under reduced pressure to obtain white crystalline powder Ciprofloxacin Hydrochloride 1.25 kg.

Embodiment 3

[0040] The present embodiment provides a kind of purification method of ciprofloxacin hydrochloride, specifically comprises the following steps:

[0041]Take 1.5 kg of crude ciprofloxacin hydrochloride and place it in a 10L flask, add 6.4L of ethanol solution with a volume fraction of 72%, heat to 58°C and stir to dissolve, then add 6g of activated carbon, keep heating at 62°C for 24min, filter while hot, and use the filtrate Adjust the pH to 4.0 with 30% hydrochloric acid solution, then cool to room temperature, crystallize, filter under reduced pressure to obtain white crystals, dry the white crystals at 62°C for 4.5 hours under reduced pressure to obtain 1.20 kg of white crystalline powder Ciprofloxacin hydrochloride .

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Abstract

The invention belongs to the technical field of medicine purification, and particularly relates to a purification method of ciprofloxacin hydrochloride, a ciprofloxacin hydrochloride freeze-dried powder for injection and a preparation method of the ciprofloxacin hydrochloride freeze-dried powder. The purification method of the ciprofloxacin hydrochloride comprises the following steps: heating and dissolving a ciprofloxacin hydrochloride crude product in ethanol with a volume fraction of 68-72%, decolorizing with activated carbon, adjusting the pH value to 3.0-4.5, crystallizing, and drying to obtain the purified ciprofloxacin hydrochloride. According to the invention, the specific ethanol with the volume fraction of 68-72% is adopted as a purification solvent, and the steps of decoloration with activated carbon and pH regulation are combined, so that the ciprofloxacin hydrochloride injection prepared from the ciprofloxacin hydrochloride obtained by purification is high in purity and low in impurity content; and the purification method is suitable for any ciprofloxacin hydrochloride crude product prepared by the existing preparation method of ciprofloxacin hydrochloride.

Description

technical field [0001] The invention belongs to the technical field of medicine purification, and in particular relates to a purification method of ciprofloxacin hydrochloride, ciprofloxacin hydrochloride freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Ciprofloxacin hydrochloride is the hydrochloride salt of ciprofloxacin, a third-generation fluoroquinolone antibacterial drug. It is used for genitourinary system infections caused by sensitive bacteria, including simple and complicated urinary tract infections, bacterial prostatitis, gonorrhea Neisseria urethritis or cervicitis (including those caused by enzyme-producing strains). Respiratory tract infection, including acute attack of bronchial infection and lung infection caused by sensitive gram-negative bacilli. Gastrointestinal infection, caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. In addition, it ...

Claims

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Application Information

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IPC IPC(8): C07D215/56A61K9/19A61K31/496A61K47/26A61P31/04
CPCC07D215/56A61K31/496A61K9/19A61K9/0019A61K47/26A61P31/04
Inventor 魏雪纹戴宏旭苏凌彭琪
Owner 海南卓华制药有限公司
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