Preparation method of ampicillin sodium for injection

A technology of ampicillin sodium and ampicillin, applied in the field of pharmaceuticals, can solve the problems of time-consuming, increase of product impurities, long cooling and freezing time, etc., and achieve the effect of increasing the sublimation rate, improving stability, and promoting the volatilization of bound water

Active Publication Date: 2022-07-29
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Therefore, rapid low-temperature freezing is required, and a longer storage time or freezing time will cause a sharp increase in impurities in the product
The temperature of the eutectic point of ampicillin sodium aqueous solution in the traditional process is -30~-32°C, so the freezer temperature of the ampicillin sodium aqueous solution freezer should be at least -35°C~-40°C to completely freeze the ampicillin sodium aqueous solution. 30-60 minutes; At the same time, the ampicillin sodium aqueous solution also needs to be put into the freeze-drying equipment after the preparation is completed, such as activated carbon impurity removal, filtration and sterilization. Formation of impurities

Method used

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  • Preparation method of ampicillin sodium for injection
  • Preparation method of ampicillin sodium for injection
  • Preparation method of ampicillin sodium for injection

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Embodiment 1

[0031] A preparation method of ampicillin sodium for injection provided in the embodiment of the present invention comprises the following steps:

[0032] 1) Weigh the raw materials: 70 g of ampicillin, 10% sodium hydroxide solution (density 1.1 g / cm 3 ) 63.5ml, water for injection 100ml, dry ice 10g, mannitol 15g;

[0033] 2) Alkali-soluble: add water for injection and mannitol to the reaction vessel, stir evenly, then add ampicillin and stir to obtain a suspension, then add 10% sodium hydroxide solution, control the pH value of the solution to be 7.8, and adjust the pH after the reaction is completed Add dry ice and mesoporous silica to coat Fe immediately after the value reaches 7.1 3 O 4 The magnetic material of the particles removes impurities;

[0034] 3) Freezing: The ampicillin sodium solution generated by alkali dissolution is separated from the magnetic adsorbent by magnetic field, and after precision filtration, it is poured into the freeze-drying equipment, firs...

Embodiment 2

[0042] A preparation method of ampicillin sodium for injection provided in the embodiment of the present invention comprises the following steps:

[0043] 1) Weigh the raw materials: Ampicillin 60g, 10% sodium hydroxide solution (density 1.1g / cm 3 ) 54.5ml, water for injection 95ml, dry ice 10g, mannitol 14g;

[0044] 2) Alkali-soluble: add water for injection and mannitol to the reaction vessel, stir evenly, then add ampicillin and stir to obtain a suspension, then add 10% sodium hydroxide solution, control the pH value of the solution to be 7.7, and adjust the pH after the reaction is completed Add dry ice and mesoporous silica to coat Fe immediately after the value reaches 7.1 3 O 4 The magnetic material of the particles removes impurities;

[0045] 3) Freezing: The ampicillin sodium solution generated by alkali dissolution is separated from the magnetic adsorbent by magnetic field, and after precision filtration, it is poured into the freeze-drying equipment, firstly co...

Embodiment 3

[0053] A preparation method of ampicillin sodium for injection provided in the embodiment of the present invention comprises the following steps:

[0054] 1) Weigh the raw materials: 80 g of ampicillin, 10% sodium hydroxide solution (density 1.1 g / cm 3 ) 63.5ml, water for injection 105ml, dry ice 10g, mannitol 15g;

[0055] 2) Alkali-soluble: add water for injection and mannitol to the reaction vessel, stir evenly, then add ampicillin and stir to obtain a suspension, then add 10% sodium hydroxide solution, control the pH value of the solution to be 7.8, and adjust the pH after the reaction is completed Add dry ice and mesoporous silica to coat Fe immediately after the value reaches 7.1 3 O 4 The magnetic material of the particles removes impurities;

[0056] 3) Freezing: The ampicillin sodium solution generated by alkali dissolution is separated from the magnetic adsorbent by magnetic field, and after precision filtration, it is poured into the freeze-drying equipment, firs...

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Abstract

The preparation method comprises the following steps: S1, dissolving an ampicillin sodium crude product in deionized water, and adding a proper amount of alkali liquor to adjust the pH value of the solution to 6.7-6.9; s2, adding a magnetic nanotube into the alkalized solution, and stirring and adsorbing in a vacuum environment; s3, separating the magnetic nanotubes by using a magnetic field, and dispersing the magnetic nanotubes into deionized water for oscillation desorption; wherein the magnetic nanotube comprises a multi-layer structure, and the multi-layer structure sequentially comprises a compact silicon dioxide nanotube layer, a Fe3O4 layer and a mesoporous silicon dioxide layer from inside to outside; and S4, merging and crystallizing the ampicillin sodium solution obtained by oscillation desorption to obtain refined ampicillin sodium. The ampicillin sodium molecules are reversibly adsorbed by adopting the special structure of the magnetic nanotube in a weak acid environment, and the inner layer of the silicon dioxide nanotube and the outer layer of the mesoporous silicon dioxide layer can be subjected to physical adsorption reaction with the ampicillin sodium molecules through hydrogen bonds, surface atomic coordination and the like.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a preparation method of ampicillin sodium for injection. Background technique [0002] Ampicillin sodium is a β-lactam antibiotic broad-spectrum penicillin, mainly used for penicillin-sensitive Gram-positive cocci, Escherichia coli, Proteus, Aerogenes and influenza bacillus infections, for urinary system, respiratory system, biliary tract , intestinal infection treatment. Because of its low toxicity, strong effect, fast absorption of drugs in vivo, uniform distribution, resistance to drug resistance, good physical and chemical properties, and long validity period, it has been widely used in clinical practice. Ampicillin sodium salt is formed by acid-base neutralization of ampicillin and sodium hydroxide. [0003] At present, there are two main methods for industrial production of ampicillin sodium salt: freeze-drying method and solvent crystallization method. Wherein, ampicil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/43A61K47/02A61K47/26A61P31/04A61J3/02
CPCA61K31/43A61K9/19A61K47/26A61K47/02A61P31/04A61J3/02Y02A50/30
Inventor 葛言周燕伟黄智龙
Owner SICHUAN PHARMA
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