Preparation of cefoperazone and sulbactam sodium mixed powder

A technology of cefoperazone sodium and sulbactam sodium, applied in the field of medicine, can solve the problems of the density of cefoperazone sodium and sulbactam sodium, the influence of powder fluidity and the uniformity of mixed powder, etc.

Active Publication Date: 2008-11-05
QILU ANTIBIOTICS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Physical mixing requires special mixing equipment, and the density and powder fluidity of cefoperazone sodium and sulbactam sodium will affect the uniformity of the mixing powder

Method used

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  • Preparation of cefoperazone and sulbactam sodium mixed powder
  • Preparation of cefoperazone and sulbactam sodium mixed powder

Examples

Experimental program
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preparation example Construction

[0008] A preparation method of cefoperazone sodium / sulbactam sodium mixed powder is characterized in that cefoperazone acid, sulbactam acid and salt-forming agent are reacted in water to form a salt and then dissolved in water, and a uniform product is obtained by a freeze-drying process, Specific steps are as follows:

[0009] (1) Control the temperature at 0-10°C, make a 20-40%wt aqueous solution with a weight ratio of cefoperazone acid to sulbactam acid (according to pure calculation) of 0.9-2.1:1, and adjust the pH of the feed solution with a salt-forming agent To 6.0-6.5, filter with a 0.22μm filter membrane into a freeze-drying box;

[0010] (2) Cool down to -40~-50°C or lower within 2-3 hours, and keep it for 2-3 hours;

[0011] (3) Turn on the vacuum and reach the pressure of 0.10mbar~0.30mbar for vacuum drying, raise the set temperature to 5~15°C and keep it for at least 2 hours, then raise the set temperature to 30~40°C and keep it for at least 10 hours Guarantee t...

Embodiment 1

[0026] Control the temperature at 0-5°C, add 74g of cefoperazone acid and 35g of sulbactam acid to 200ml of water for injection, add 21.94g of sodium bicarbonate to adjust the pH of the feed solution to 6.37, and filter it through a 0.22μm filter membrane into a freeze-drying box. Cool down to -45°C in 2-3 hours and keep for 2 hours. Turn on the vacuum and reach 0.10-0.30mbar for vacuum drying, raise the set temperature to 10°C and keep it for 3 hours, then raise the set temperature to 40°C and keep it for 12 hours to completely sublimate the water. The temperature was raised to 55°C and dried for 10 hours, and the water content was detected to be 0.76%, and the temperature was lowered to 30°C to obtain 108.5 g of the product.

Embodiment 2

[0028] Control the temperature at 5-10°C, add 42g of cefoperazone acid and 20g of sulbactam acid to 130ml of water for injection, add 8.07g of sodium carbonate to adjust the pH of the feed solution to 6.13, and filter it through a 0.22μm filter membrane into a freeze-drying box. Cool down to -42°C in 2-3 hours and keep for 3 hours. Turn on the vacuum and reach 0.10-0.30mbar for vacuum drying, raise the set temperature to 15°C and keep it for 2 hours, then raise the set temperature to 32°C and keep it for 14 hours to ensure the water sublimation is complete. The temperature was raised to 50°C and dried for 12 hours, and the moisture was detected to be 1.06%, and the temperature was lowered to 30°C to obtain 60.83 g of the product.

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Abstract

The invention relates to a preparation method of cefoperazone sodium/sulbactam sodium mixed powder. Cefoperazone acid and sulbactam acid are prepared into water solution with 20 to 40 percent by weight according to the weight ratio of 0.9 to 2.1: 1, a salt forming agent is used for regulating the pH of material liquid to 6.0 to 6.5, a filter membrane with 0.22Mum is used for filtration, then the material liquid is arranged in a freeze-drying box; and the cefoperazone sodium/sulbactam sodium mixed powder product is obtained after freeze-drying. The product of the mixed powder obtained after freeze-drying has good uniformity, rapid dissolution speed and stable main quality indicators of product content, water content, pH value, clarification of the solution and so on.

Description

technical field [0001] The invention relates to a method for preparing mixed powder of cefoperazone sodium and sulbactam sodium, in particular to a mixed powder product of cefoperazone sodium and sulbactam sodium prepared by a freeze-drying method, and belongs to the technical field of medicine. Background technique [0002] Cefoperazone sodium / sulbactam sodium is a composite preparation with higher antibacterial activity than cefoperazone sodium. It is developed and listed by Pfizer, and its trade name is Sulperazon. Sulbactam is a broad-spectrum enzyme inhibitor and has weak antibacterial activity. It has a strong and irreversible inhibitory effect on the β-lactamase produced by Staphylococcus aureus and most negative bacilli, but it has a strong and irreversible inhibitory effect on the β-lactamase mediated by some negative bacillus chromosomes. β-lactamase is inactive. Cefoperazone is a third-generation cephalosporin with poor stability to β-lactamase. The combination o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K31/43A61K9/14A61P31/04
Inventor 王勇进杜海生徐红梅
Owner QILU ANTIBIOTICS PHARMA
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