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Method for preparing ampicillin sodium salt

A technology of ampicillin sodium salt and ampicillin, applied in the field of compound preparation, can solve the problems of unfavorable market competition, high manufacturing cost, large recovery and the like, and achieve the effects of overcoming unstable product quality, low cost and low hygroscopicity

Active Publication Date: 2010-06-09
华北制药集团先泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, a large amount of solvent needs to be consumed and recovered in the production process, so its manufacturing cost is high, which is not conducive to market competition

Method used

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  • Method for preparing ampicillin sodium salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Add water for injection into the salt-forming tank, pre-cool to 3-5°C, put 50kg of ampicillin into the salt-forming tank under stirring, add 5.44kg of 10% sodium hydroxide solution until the solution is clear, and the final pH is 9.0-10.5. After the ampicillin is completely dissolved, add activated carbon and stir, go through preliminary filtration, prefiltration, and final sterile filtration, and then enter the aseptic room freeze dryer for freeze-vacuum drying. After freeze-drying and vacuum-drying, ampicillin sodium is ground into powder and loaded into the double cone, the manhole of the drier is installed, the vacuum is turned on, the temperature is raised, the temperature is controlled at 40-50°C, the holding time is 40 minutes, and the vacuum gauge pressure is ≤-0.085MPa. Mix the powder, pack and test to obtain the ampicillin sodium product.

Embodiment 2

[0033] Add water for injection into the salt-forming tank, pre-cool to 0-3°C, put 50kg of ampicillin into the salt-forming tank under stirring, add 5.44kg of 9.5% sodium hydroxide solution until the solution is clear, and the final pH is 9.0-10.5. After the ampicillin is completely dissolved, add activated carbon and stir, go through preliminary filtration, prefiltration, and final sterile filtration, and then enter the aseptic room freeze dryer for freeze-vacuum drying. After lyophilized and vacuum-dried, ampicillin sodium is ground into powder and loaded into a double cone, equipped with a manhole in the drier, turned on vacuum, heated up, controlled temperature 70-95°C, holding time 60 minutes, vacuum gauge pressure ≤ -0.075MPa. Mix the powder, pack and test to obtain the ampicillin sodium product.

Embodiment 3

[0035] Add water for injection into the salt-forming tank, pre-cool to 2-4°C, put 50kg of ampicillin into the salt-forming tank under stirring, add 5.44kg of 9.0% sodium hydroxide solution until the solution is clear, and the final pH is 9.0-10.5. After the ampicillin is completely dissolved, add activated carbon and stir, go through preliminary filtration, prefiltration, and final sterile filtration, and then enter the aseptic room freeze dryer for freeze-vacuum drying. After lyophilization and vacuum drying, the ampicillin sodium is ground into powder and loaded into the double cone, the manhole of the drier is installed, the vacuum is turned on, the temperature is raised, the temperature is controlled at 60°C, the holding time is 180 minutes, and the vacuum gauge pressure is ≤ -0.065MPa. Mix the powder, pack and test to obtain the ampicillin sodium product.

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Abstract

The invention discloses a method for preparing an ampicillin sodium salt. In the method, the general refrigerating and drying process has an additional post-treatment step of milling ampicillin sodium which is refrigerated and dried under vacuum into powder, filling the powder into a bipyramid, vacuumizing the bipyramid, heating the powder, keeping the temperature of the powder between 45 and 95 and the heat preservation time between 40 and 180 minutes and mixing the powder and separately packing the mixed powder. The method of the invention overcomes the drawback of instable quality of the products prepared by the traditional refrigerating and drying method and prepares high-purity, low-hygroscopicity and stable-quality ampicillin sodium raw material and preparation. The method is simple in process, avoids consuming a large amount of organic solvent like a solvent crystallization method and recovering the organic solvent and therefore has low cost.

Description

technical field [0001] The present invention relates to the preparation method of compound, specifically a kind of preparation method of ampicillin sodium salt. Background technique [0002] Ampicillin sodium belongs to the broad-spectrum penicillin of β-lactam antibiotics. It is mainly used for infections such as penicillin-sensitive Gram-positive cocci, Escherichia coli, Proteus, aerogenes and influenza bacillus. , treatment of intestinal infections. Because of its low toxicity, strong effect, fast drug absorption in vivo, uniform distribution, not easy to produce drug resistance, good physical and chemical properties, long validity period, etc., it has been widely used in clinical practice. Ampicillin sodium salt is formed by the acid-base neutralization reaction of ampicillin and sodium hydroxide. At present, there are two main methods for the industrial production of ampicillin sodium salt: freeze-drying and solvent crystallization. The freeze-drying method is to sus...

Claims

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Application Information

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IPC IPC(8): C07D499/70A61P31/04
Inventor 高任龙周捷张丽蓉安国红吕竹韩庆雪李晓红
Owner 华北制药集团先泰药业有限公司
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