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Powder mixing technology for compound antibiotic

An antibiotic and powder mixing technology, applied in the field of medicine, can solve the problems of lack of universal applicability and difficulty in ensuring the uniformity of powder mixing, and achieve the effects of good uniformity, low cost and fast dissolution speed.

Active Publication Date: 2013-04-17
山东二叶制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing powder mixing technology, whether it is the traditional physical mixing method, spray drying method or crystallization method, is not universally applicable, and can only be applied to the production of one or two compound antibiotics, and the uniformity of the powder mixing is difficult. be guaranteed

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation of Mezlocillin Sodium / Sulbactam Sodium Mixed Powder

[0029] At room temperature, the powders of mezlocillin sodium (56.1 g, 0.1 mol) and sulbactam sodium (25.5 g, 0.1 mol) were mixed evenly. Control the temperature at 0-5°C, add the above-mentioned mixed mezlocillin sodium / sulbactam sodium powder to 220mL water for injection, add 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 middle. 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, maintain for 2 hours, then increase the set temperature to 10°C, maintain for 3 hours, increase the set temperature to 40°C, and maintain for 12 hours to completely sublimate the water. The temperature was raised to 55° C. and dried for 10 hours, and the detected moisture was 0.76%. Naturally cool down to room temperature to obtain the product. After testing, the homogen...

Embodiment 2

[0031] Preparation of Amoxicillin Sodium / Sulbactam Sodium Mixed Powder

[0032] At room temperature, the powders of amoxicillin sodium (38.7 g, 0.1 mol) and sulbactam sodium (25.5 g, 0.1 mol) were mixed evenly. Control the temperature at 0-5°C, add the above mixed amoxicillin sodium / sulbactam sodium powder to 180mL water for injection, add sodium bicarbonate to adjust the pH of the feed solution to 6.32, and filter it through a 0.22μm filter membrane into a freeze-drying box middle. 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, maintain for 2 hours, then increase the set temperature to 10°C, maintain for 3 hours, increase the set temperature to 40°C, and maintain for 12 hours to completely sublimate the water. The temperature was raised to 55° C. and dried for 10 hours, and the detected moisture was 0.73%. Naturally cool down to room temperature to obtain the product. After testing, the uniformity, stabi...

Embodiment 3

[0034] Preparation of Cefoperazone Sodium / Sulbactam Sodium Mixed Powder

[0035] At room temperature, the powders of cefoperazone sodium (66.7 g, 0.1 mol) and sulbactam sodium (25.5 g, 0.1 mol) were uniformly mixed. Control the temperature at 0-5°C, add the above-mentioned mixed cefoperazone sodium / sulbactam sodium powder to 260mL water for injection, add sodium bicarbonate to adjust the pH of the feed solution to 6.42, and filter it through a 0.22 μm 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, maintain for 2 hours, then increase the set temperature to 10°C, maintain for 3 hours, increase the set temperature to 40°C, and maintain for 12 hours to completely sublimate the water. The temperature was raised to 55° C. and dried for 10 hours, and the detected moisture was 0.71%. Naturally cool down to room temperature to obtain the product. After testing, the homogene...

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PUM

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Abstract

The invention relates to a powder mixing technology for a compound antibiotic. The compound antibiotic is obtained by cold drying after uniform mixing of antibiotic A and antibiotic B in advance, wherein the antibiotic A is mezlocillin sodium, amoxicillin sodium, cefoperazone sodium, and piperacillin sodium, and the antibiotic B is sulbactam sodium. According to the powder mixing technology, organic solvent is omitted, the environment is less polluted, the freeze-drying technology has stable yield, and the cost is low; the freeze-drying mixed powder has good uniformity, fast dissolution rate, and stable chemical quality, so that the powder mixing technology is applicable to preparation of various of compound antibiotics, and is suitable for mass production.

Description

technical field [0001] The invention relates to a powder mixing technology of compound antibiotics, which belongs to the technical field of medicine. [0002] Background technique [0003] Today, with the continuous high incidence of infectious diseases, the demand for antibiotics continues to increase, but the continuous emergence of drug-resistant bacteria caused by the abuse of antibiotics has become a worldwide problem. At the same time, it is becoming more and more difficult to develop new antibiotic varieties, and the research and development cycle and funding have repeatedly hit new highs. People urgently need to find a fast, effective and low-cost method to combat drug-resistant strains, among which the development of antibiotic compound is a feasible way. Effective shortcut. [0004] Mezlocillin sodium / sulbactam sodium, amoxicillin sodium / sulbactam sodium, cefoperazone sodium / sulbactam sodium and piperacillin sodium / sulbactam sodium are relatively representative c...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K45/06A61K31/43A61K31/431A61K31/546A61K31/496A61P31/00
Inventor 陈学文华军杰陆建忠房婷
Owner 山东二叶制药有限公司
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