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Method for preparing amikacin sulfate through amikacin

A technology of amikacin sulfate and amikacin is applied in the field of medicine to achieve the effects of improving stability, reducing degradation and reducing the generation of impurities

Active Publication Date: 2015-02-18
山东安信制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The amikacin sulfate obtained by the literature process has disadvantages such as a yield of only 80%, residual methanol of more than 3000ppm, impurity content of more than 3.0%, and a light transmittance of only 90%.

Method used

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  • Method for preparing amikacin sulfate through amikacin

Examples

Experimental program
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Effect test

Embodiment 1

[0014] Take 200mL of amikacin solution with a concentration of 40%, transfer it into a 1000mL three-neck flask, stir, add sulfuric acid to adjust the pH value of the feed solution to 0.2, first add 100ml of 95% ethanol, heat to reflux, then add 600ml of ethanol, and cool down to 20°C , filtered with suction, put the obtained solid into a vacuum drying oven, control the inner temperature of the vacuum drying oven at 65-70°C, and bake for 4 hours to obtain amikacin sulfate (number: 1211001).

Embodiment 2

[0016] Take 200mL of amikacin solution with a concentration of 40%, transfer it into a 1000mL three-neck flask, stir, add sulfuric acid to adjust the pH value of the feed solution to 0.4, first add 100ml of 95% ethanol, heat to reflux, then add 700ml of ethanol, and cool down to 15°C , filtered with suction, put the obtained solid into a vacuum drying oven, control the inner temperature of the vacuum drying oven at 65-70°C, and bake for 4 hours to obtain amikacin sulfate (number: 1211002).

Embodiment 3

[0018] Take 200mL of 35% amikacin sulfate solution, transfer it into a 1000mL three-neck flask, stir, add sulfuric acid to adjust the pH value of the feed solution to 0.3, first add 100ml of 95% ethanol, heat to reflux, then add 800ml of ethanol, and cool down to 10°C , filtered with suction, the obtained solid was put into a vacuum drying oven, and the inner temperature of the vacuum drying oven was controlled at 65-70°C, and baked for 4 hours to obtain amikacin sulfate (number: 1211003).

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Abstract

The invention discloses a method for preparing amikacin sulfate through amikacin, belonging to the technical field of a medicine. The method comprises the following steps of: preparing 30-50wt% of an amikacin water solution, under protection of nitrogen, regulating pH value to be 0.1-0.5 through sulfuric acid, and adding ethanol to crystallize: adding ethanol which is 0.5 times as much as volume of material liquid, heating and refluxing, then adding ethanol which is 2.0-4.0 times as much as volume of the material liquid, and decreasing temperature to be 10-40 DEG C; crystallizing, filtering and drying to obtain the amikacin sulfate. According to the method, a sulfuric acid is added for reaction under protection of the nitrogen, the stability of the material liquid is enhanced, the degradation of material is reduced, the generation amount of impurities is reduced, the yield is increased from 80% to 90% and the content of impurities is reduced to be lower than 1.0%. Low-toxicity third-class solvent ethanol is adopted, and ethanol residue is lower than 2000ppm which is lower than methanol residue, so that the prepared amikacin sulfate is safe to guarantee the condition that light transmittance of the amikacin sulfate is not lower than 95%.

Description

technical field [0001] The invention relates to a method for preparing amikacin sulfate from amikacin, belonging to the technical field of medicine. Background technique [0002] Amikacin sulfate is a semi-synthetic aminoglycoside antibiotic with a broad antibacterial spectrum and strong antibacterial ability against a variety of bacteria. Since its launch in the 1970s, amikacin sulfate has been widely used due to its definite curative effect, and has become the first-line anti-infective drug commonly used clinically in the world. In my country, Amikacin Sulfate has been included in the National Essential Drug List, and also included in the Class A drug in the "National Basic Medical Insurance and Work Injury Insurance Drug List". [0003] Amikacin sulfate is a broad-spectrum antibacterial antibiotic. With the continuous development of medical technology and the continuous improvement of medical level, the requirements for the quality of amikacin sulfate raw materials are a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/234C07H1/00
Inventor 蔡成伟孙政军宿乾贞周焕然布彬彬高秀磊王仕川樊长莹李保勇
Owner 山东安信制药有限公司
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