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Preparation method of colistin methane sodium sulfonate

A technology of sodium methanesulfonate and sodium hydroxymethanesulfonate is applied in the field of preparation of pharmaceutical and chemical raw materials, and can solve the problems of residue, increased toxicity, unstable product quality, etc., and achieves easy control, content reduction, and avoidance of formaldehyde residues. Effect

Active Publication Date: 2013-03-27
HEBEI SHENGXUE DACHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage of this method is that there are residual formaldehyde and colistin in the product, and the quality of the product is extremely unstable, which also greatly increases the potential toxicity of the product

Method used

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  • Preparation method of colistin methane sodium sulfonate

Examples

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Embodiment 1

[0020] Weigh 40kg of colistin sulfate, dissolve it in 400L deionized water, stir and add 25% ammonia water to adjust the pH of the solution to 10.0, maintain the reaction for 1 hour, filter with suction, and then wash the filter cake with deionized water until the pH of the effluent is 8.90. Add the above filter cake to 150L deionized water, stir evenly, and prepare colistin suspension;

[0021] Take 28kg of sodium hydroxymethanesulfonate, dissolve it in 220L of deionized water, add the sodium hydroxymethanesulfonate solution to the colistin suspension prepared in advance, heat to 65°C, and maintain it for 1 hour until the solution is clear and transparent. Rapidly cool down to below 20°C. Add the above reaction solution to the regenerated mixed resin composed of 24kg of 001×16 styrene-based strong acidic cation exchange resin and 50kg of 703 model acrylic weakly basic anion-exchange resin, maintain the reaction for 0.5 hours, and filter to obtain a clear and transparent solut...

Embodiment 2

[0023] Weigh 100kg of colistin sulfate, dissolve it in 1000L deionized water, stir and add 25% ammonia water to adjust the pH of the solution to 11, filter with suction, and then wash the filter cake with deionized water until the pH of the effluent is 8.0. Add the above filter cake to 500L deionized water, stir evenly, and prepare colistin suspension;

[0024] Take 56kg of sodium hydroxymethanesulfonate, dissolve it in 560L of deionized water, add the sodium hydroxymethanesulfonate solution to the previously prepared colistin suspension, heat the reaction solution to 55°C, and maintain it for 3 hours until the solution is clear Transparent, quickly cool down to normal temperature. Add the above solution to the regenerated mixed resin composed of 60kg of styrene-based strongly acidic cation exchange resin of model 001x16 and 120kg of weakly basic anion-exchange resin of model 703 acrylic system, keep the reaction for 1 hour, and filter the solution to obtain a clear and transp...

Embodiment 3

[0026] Take by weighing colistin sulfate 150kg, be dissolved in 1500L deionized water, stir and add 20% sodium hydroxide to adjust the pH of the solution to 12.0, maintain the reaction for 2 hours, filter with suction, then clean the filter cake with deionized water to effluent pH9. 0 ends. Add the above filter cake to 750L deionized water, stir evenly, and prepare colistin suspension;

[0027] Take 74.5kg of sodium hydroxymethanesulfonate, dissolve it in 190L deionized water, add the sodium hydroxymethanesulfonate solution to the colistin suspension prepared in advance, heat the reaction solution to 80°C, and maintain it for 2 hours until The solution is clear and transparent; add the above solution at 40°C, concentrate by rotary evaporation 4 times, cool down to below 25°C, add the above solution into the regenerated 94kg of styrene-based strong acid cation exchange resin of model 001x7, and acrylic acid of model D318 A mixed resin composed of 263 kg of weakly basic anion e...

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Abstract

The invention discloses a preparation method of colistin methane sodium sulfonate, comprising the following steps: (a) adjusting the pH of a colistin sulphate aqueous solution by ammonia water or a sodium hydroxide solution to 9-13, stirring, reacting for 1-3 hours, filtering in vacuum, and adding deionized water into an obtained filter cake to prepare a colistin suspension; (b) adding methylolsulfonic acid sodium salt into the suspension, and reacting for 1-24 hours at the temperature of 10-90DEG C; (c) separating and purifying the reaction solution generated in step (b) by mixed resins; and (d) drying the product obtained in step (c). With the method disclosed by the invention, formaldehyde harm is fundamentally eliminated, the content of residual myxomycete in the product is reduced, and the quality of the colistin methane sodium sulfonate is improved.

Description

technical field [0001] The invention relates to a preparation method of pharmaceutical and chemical raw materials, in particular to a preparation method of colistin sodium methanesulfonate. Background technique [0002] Colistin is a group of polypeptide antibiotics produced by bacillus polymyxa. Among them, polymyxin B and E have significant antibacterial activity against Gram-negative bacteria, and are the drugs of choice for the treatment of Pseudomonas aeruginosa infection. The common salt of colistin is sulfate. However, colistin sulfate is highly toxic, so in many countries (such as the United States), it is only applicable to topical or oral treatment of intestinal infections, while other parenteral administration is strictly prohibited. In order to overcome the high toxicity of colistin sulfate, medical researchers chemically modified it to make colistin methanesulfonate sodium, thereby reducing the LD50 of the drug by 50 times. Colistin sodium methanesulfonate ca...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/32C07K1/18
Inventor 谷新华刘聪洁
Owner HEBEI SHENGXUE DACHENG PHARMA
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