Preparation process of amoxicillin sodium crystal

A technology for the preparation of amoxicillin sodium, which is applied in the field of chemical crystallization, can solve the problems of high cost of sodium isooctanoate, environmental pollution, and unfavorable environmental protection, and achieve the effects of good fluidity, low environmental pollution, and low production cost

Inactive Publication Date: 2012-12-26
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The cost of sodium isooctanoate used in this method is relatively high, and organic solvents such as diisop

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Add distilled water and amoxicillin into the there-necked flask sequentially at a mass ratio of 100:12, heat in a water bath to 35°C, stir, and after the suspension is completely formed, add sodium sulfate at a molar ratio of sodium sulfate to amoxicillin of 1:2, until the solution is clear. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 45°C, stir, add the entrainer methanol to the crystallizer according to 35% of the water volume, and carry out azeotropic distillation under reduced pressure. The temperature is maintained at 0.07MPa, and the entrainer is gradually replenished during the vacuum azeotropic distillation process to maintain the constant liquid level in the crystallizer. After the solution moisture content in the crystallizer is lower than 10%, stop the vacuum azeotropic distillation. Perform temperature-controlled cooling and crystallization, control the final cooling temperature at 5°C,...

Embodiment 2

[0022] Add distilled water and amoxicillin into the three-necked flask sequentially at a mass ratio of 100:16, heat in a water bath to 40°C, stir, and after the suspension is completely formed, slowly add sodium bicarbonate that is equimolar to amoxicillin into the three-necked flask in until the solution is clear. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 35°C, stir, add 50% water volume entrainer n-butanol to carry out azeotropic distillation under reduced pressure, and maintain the vacuum degree in the crystallizer at 0.085 MPa, replenish the entrainer at any time during the distillation process, keep the liquid level in the crystallizer unchanged, adjust the temperature in the crystallizer to 40°C after 3 hours, and continue distillation until the water content of the solution in the crystallizer is lower than 8%. , stop vacuum azeotropic distillation, carry out temperature-controlled cooling and cr...

Embodiment 3

[0024] Add distilled water and amoxicillin into the three-necked flask sequentially at a mass ratio of 100:25, heat in a water bath to 30°C, stir, and after the suspension is completely formed, slowly add sodium carbonate to amoxicillin at a molar ratio of 0.5:1 Add to the three-necked bottle until the solution is clear. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 42°C, stir, and quickly add isopropanol, an entrainer with 30% water volume, into the crystallizer, and carry out azeotropic distillation under reduced pressure. The internal vacuum is maintained at 0.09MPa. When the distillate volume reaches 40% of the water volume, add the same volume of isopropanol. After adding 3 times, adjust the temperature in the crystallizer to 48°C and continue distillation until crystallization After the water content of the solution in the device is lower than 14%, stop the vacuum azeotropic distillation, carry out te...

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PUM

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Abstract

The invention discloses a preparation process of amoxicillin sodium crystal, which specifically comprises the following steps of: adding distilled water and amoxicillin in proportion to 3-neck flask in turn, heating in water bath, stirring, adding sodium salt powder slowly in proportion until the solution is clear after the suspension is formed fully, then extracting to remove the solid impurities, putting the filtrate in a crystallizer, adding entrainer in proportion, conducting vacuum azeotropic distillation, adding entrainer again in proportion after a certain amount of entrainer is distilled, conducting temperature-controlled cooling crystallization after a certain amount of water is distilled, then filtering and drying to obtain an amoxicillin sodium crystal product. The amoxicillin sodium crystal obtained by the preparation process provided by the invention has the advantages of uniform particle size distribution, high purity, good fluidity, good stability, low production cost, easiness of operation and small environmental pollution.

Description

technical field [0001] The invention belongs to the technical field of chemical crystallization, and in particular relates to a preparation process of amoxicillin sodium crystallization. Background technique [0002] Amoxicillin sodium, the English name is Amoxicillin Sodium, the molecular formula is C 16 h 18 N 3 NaO 5 S. The relative molecular mass is 387.40. Amoxicillin sodium is white or off-white powder or crystal; odorless or slightly stinky, slightly bitter taste; hygroscopic. This product is soluble in water or ethanol, insoluble in ether, and the specific rotation is +240° to +290°. [0003] Amoxicillin sodium is a broad-spectrum penicillin antibiotic widely used clinically. It has a strong and rapid killing effect on Gram-negative bacteria and positive bacteria, and it also has a killing effect on Leptospira. Its bactericidal mechanism is unique, it can inhibit the synthesis of cell walls, and make the cells quickly become spherical and rupture and dissolve....

Claims

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Application Information

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IPC IPC(8): C07D499/68C07D499/16C07D499/18
Inventor 孙华刘宝树宋梦燕何岩刘秀培
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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