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Production process for ampicillin sodium crystal

A technology of ampicillin sodium and production process, applied in the direction of organic chemistry, can solve the problems of long sublimation drying time, long freezing time, low freezing temperature, etc., and achieve the effect of shortening the sublimation drying time, facilitating sublimation, and increasing the sublimation rate

Active Publication Date: 2017-05-31
河北联合制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The present invention provides a method for ampicillin sodium crystals to solve the problems of low freezing temperature, long freezing time, long sublimation drying time, poor product quality and instability when using the freeze-drying method to prepare ampicillin sodium crystals in the prior art. The production process, by changing the raw materials in the alkali dissolution process, adding tert-butanol, vitamin C and EDTA-disodium, increases the freezing temperature, shortens the freezing time to reach the eutectic point, and increases the sublimation rate. At the same time, the obtained ampicillin Good sodium stability and high quality

Method used

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  • Production process for ampicillin sodium crystal
  • Production process for ampicillin sodium crystal
  • Production process for ampicillin sodium crystal

Examples

Experimental program
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Embodiment 1

[0026] Prepare the following raw materials: Ampicillin 60g, 10% NaOH solution (density 1.1g / cm 3 ) 54ml, water for injection 55ml, tert-butanol (density 0.81g / ml) 13ml, vitamin C 2g, EDTA-disodium 0.2g.

[0027]Specific process operation steps: add 55ml of water for injection at 0-5°C and 13ml of tert-butanol into the reactor, start stirring, add 60g of ampicillin and 0.2g of EDTA-disodium in turn and stir to form a suspension solution, slowly add 10ml of water below 4°C % sodium hydroxide solution 54ml until the solution is translucent, the pH value at the end of the solution is controlled at 9.3 After the reaction is completed, add vitamin C2g and activated carbon with a total solution volume of 1-3‰ in the reactor and stir evenly. After decarburization and 0.2um precision filtration, the solution that has completed the reaction is evenly poured into the tray of the freeze-drying equipment, the freeze-drying process is started, the temperature of the solution is lowered to -...

Embodiment 2

[0029] Prepare the following raw materials: Ampicillin 40g, 10% NaOH solution (density 1.1g / cm 3 ) 38ml, water for injection 35ml, tert-butanol (density 0.81g / ml) 12ml, vitamin C1g, EDTA-disodium 0.1g.

[0030] Specific process operation steps: add 35ml of water for injection at 1-4°C and 12ml of tert-butanol into the reactor, start stirring, add 40g of ampicillin and 0.4g of EDTA-disodium in turn and stir to form a suspension solution, slowly add 10ml of water below 3°C % sodium hydroxide solution 38ml until the solution is translucent, the pH value of the solution end point is controlled at 9.7 After the reaction is completed, add vitamin C1g and activated carbon with a total solution volume of 1-3‰ in the reactor and stir evenly. After decarburization and 0.2um precision filtration, the solution that has completed the reaction is evenly poured into the tray of the freeze-drying equipment, the freeze-drying process is started, the temperature of the solution is lowered to -3...

Embodiment 3

[0032] Prepare the following raw materials: Ampicillin 45g, 10% NaOH solution (density 1.1g / cm 3 ) 40ml, water for injection 40ml, tert-butanol (density 0.81g / ml) 14ml, vitamin C 1.3g, EDTA-disodium 0.13g.

[0033] Specific process steps: Add 40ml of water for injection at 2-3°C and 14ml of tert-butanol into the reactor, start stirring, add 45g of ampicillin and 0.13g of EDTA-disodium in turn and stir to form a suspension solution, slowly add 10 ml of water below 4°C 40ml of sodium hydroxide solution until the solution is translucent, and the pH value at the end of the solution is controlled at 9.6. After the reaction is completed, add 1.3g of vitamin C and activated carbon with a total volume of 1-3‰ of the solution in the reactor and stir evenly. After decarburization and 0.2um precision filtration, the solution that has completed the reaction is evenly poured into the tray of the freeze-drying equipment, the freeze-drying process is started, the temperature of the solution ...

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Abstract

The invention discloses a production process for an ampicillin sodium crystal, and belongs to the technical field of antibiotics. The production process comprises the following steps: by adopting a freeze-drying method for preparation, performing alkali dissolution on ampicillin into a sodium hydroxide solution, freezing the obtained ampicillin sodium solution into a solid, and sublimating moisture in the solid, thereby obtaining ampicillin sodium, wherein in the alkali dissolution process, the following raw materials in parts by weight: 40-60 parts of ampicillin, 40-60 parts of 10% sodium hydroxide solution, 35-55 parts of injection water, 9-13 parts of tertiary butanol, 1-2 parts of vitamin C and 0.1-0.2 part of EDTA (Ethylene Diamine Tetraacetic Acid)-disodium are included. According to the production process disclosed by the invention, the raw materials in the alkali dissolution process are changed, tertiary butanol, and the vitamin C and EDTA-disodium are added, so that the freezing temperature is increased, the freezing time for reaching an eutectic point is shortened, the sublimation velocity is increased, and moreover the obtained ampicillin sodium is high in stability and high in quality.

Description

technical field [0001] The invention belongs to the technical field of antibiotics, and relates to the production of β-lactam antibiotics, in particular to a production process of ampicillin sodium crystals. The ampicillin sodium crystal of the present invention has a good crystal form, is white or off-white crystal, has better specific volume and fluidity after being pulverized, more than 90% of the total mass has a particle size of less than 100 mesh, high product quality, and less impurity quality. Stable performance. Background technique [0002] Ampicillin sodium (Ampicillin sodium) chemical name D-a-aminobenicillin, is the world's first broad-spectrum semi-synthetic penicillin used clinically. Ampicillin sodium belongs to β-lactam antibiotics, which can inhibit and interfere with the synthesis of sensitive bacterial cell walls to achieve antibacterial effect, and has strong antibacterial ability against Gram-positive bacteria and some Gram-negative bacteria. Ampicill...

Claims

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Application Information

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IPC IPC(8): C07D499/68C07D499/16
CPCC07D499/16C07D499/68
Inventor 李东升袁国强张卷王霄飞张丽云赵学军
Owner 河北联合制药有限公司
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