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New method for preparing fosfomycin sodium for injection

A technology for fosfomycin sodium and injection, which is applied in the field of preparation of fosfomycin sodium for injection, which can solve problems such as difficult quality control, large capital occupation in production, and too large production area, so as to improve capital turnover rate and reduce Effects of capital in production, process simplification and operation process

Active Publication Date: 2010-09-29
NORTHEAST PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a new method for preparing fosfomycin sodium for injection, to overcome the high energy consumption of the prior art method, long production cycle, high difficulty in quality control, excessive production area, large occupation of funds in production and production problems. costly defects

Method used

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  • New method for preparing fosfomycin sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] In a three-necked bottle equipped with a stirrer, add 15g of distilled water, start stirring, add 5.89g of sodium hydroxide, control the temperature during the process not to exceed 45°C, then lower the temperature to 10-15°C, add 20g of left salt (for dry After the measurement), the temperature is controlled at 10-15°C during the process, and then the temperature is raised to 36-39°C, and the temperature is kept for 1 hour. Salt solution) was collected in a three-necked bottle equipped with a stirrer, started to stir, added dropwise a saturated aqueous solution of 0.3g citric acid dissolved therein at room temperature, then added 0.8g activated carbon to it, continued to stir for 20 minutes, and then filtered After sterilizing and filtering the filtrate, add it dropwise into a stirring three-neck bottle filled with 384g, 62±2°C, decolorized, sterilized and filtered absolute ethanol. Separate the solid-liquid mixture, wash the filter cake with 48g of decolorized, steril...

Embodiment 2

[0023] In a three-necked bottle equipped with a stirrer, add 15g of distilled water, start stirring, add 5.81g of sodium hydroxide, control the temperature during the process not to exceed 45°C, cool down to 10-15°C after adding, add 20g of left salt After drying), the temperature is controlled at 10-15°C during the process. After the addition, the temperature is raised to 36-39°C, and the temperature is kept for 1 hour. (sodium salt solution) was collected in a three-necked flask equipped with stirring, started stirring, and added dropwise a saturated aqueous solution of 0.3 g of citric acid therein at room temperature, then added 0.8 g of activated carbon thereto, continued to stir for 20 minutes, and then Filtrate, sterilize and filter the filtrate dropwise into a stirred three-neck bottle filled with 384g, 62±2°C decolorized, sterilized and filtered absolute ethanol. After the dropwise addition, keep warm for 45 minutes to precipitate crystals. Separate the solid-liquid mi...

Embodiment 3

[0025] In a three-necked bottle equipped with a stirrer, add 15g of distilled water, start stirring, add 5.85g of sodium hydroxide, control the temperature during the process not to exceed 45°C, cool down to 10-15°C after adding, add 20g of left salt After drying), the temperature is controlled at 10-15°C during the process. After the addition, the temperature is raised to 36-39°C, and the temperature is kept for 1 hour. (sodium salt solution) was collected in a three-necked flask equipped with stirring, started stirring, and added dropwise a saturated aqueous solution of 0.3 g of citric acid therein at room temperature, then added 0.8 g of activated carbon thereto, continued to stir for 20 minutes, and then Filtrate, sterilize and filter the filtrate dropwise into a stirring three-neck bottle filled with 384g, 62±2°C decolorized, sterilized and filtered absolute ethanol. After the dropwise addition, keep warm for 45 minutes to precipitate crystals. Separate the solid-liquid m...

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Abstract

The invention relates to a new method for preparing fosfomycin sodium for injection, which comprises the following steps of: 1) adding sodium hydroxide into distilled water with stirring, continuously stirring the solution, adding levo salt into the solution, and preserving the heat; 2) standing and demixing the solution obtained in the step 1), and collecting sodium salt solution on the lower layer; 3) dripping saturated solution of citric acid into the sodium salt solution, adding active carbon into the solution, continuously stirring the solution, and filtering the solution to remove carbon; 4) sterilizing and filtering the filtrate obtained in the step 3), then dripping the filtrate into a three-necked bottle of decolorized, sterilized and filtered anhydrous ethanol, preserving the heat, separating out crystals, filtering and separating the solid-liquid mixture, and washing filter cakes by using the decolorized, sterilized and filtered anhydrous ethanol to obtain a wet fosfomycin sodium product for injection; and 5) drying the wet fosfomycin sodium product for injection to constant weight to obtain the fosfomycin sodium for injection. The method has the advantages of reducing difficulty in quality control, saving production area, improving the utilization rate of resources, reducing capital in process and reducing production cost, along with simple process, convenient operation and energy conservation.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a new method for preparing fosfomycin sodium for injection. Background technique [0002] Fosfomycin sodium [(-)-cis-1,2-epoxypropyl phosphate sodium] (hereinafter referred to as fosfomycin sodium) is a new broad-spectrum antibiotic with a pH between 9 and 10.5. In clinical use, to stimulate blood vessels and eliminate adverse reactions, a certain proportion of citric acid needs to be added to it to make the pH between 6.5 and 8.5 to form fosfomycin sodium for injection. IR??2S-(-)-cis-1,2-epoxypropyl phosphate-R-(+)-α-phenethylamine salt (hereinafter referred to as left phosphorus right amine salt or left salt) is chemically synthesized by Glamkowski method An important intermediate in the process of fosfomycin sodium. The production process of fosfomycin sodium for injection mainly includes the following three steps: 1) Production of fosfomycin sodium sterile powder: left salt reacts ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07F9/655
Inventor 张庆武
Owner NORTHEAST PHARMA GRP