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A compound pharmaceutical composition of mezlocillin sodium and sulbactam sodium for injection

A technology of mezlocillin sodium sulbactam sodium and mezlocillin sodium, which is applied in the field of medicine, can solve the problems of high incidence of adverse reactions, large polymers, and low drug quality, and achieve low incidence of adverse reactions, high polymer The effect of small content and safe clinical use

Active Publication Date: 2017-10-17
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Mixing the two raw materials directly will easily lead to uneven mixing. Even if the mixing is uniform, it will easily lead to stratification due to placement, vibration, etc., and the final preparation has poor stability, and the impurities increase significantly during the validity period, making the drug unsafe.
[0008] In addition, there are many mezlocillin sodium sulbactam sodium pharmaceutical composition products, which have problems such as poor solubility, darker color, uneven mixing of main ingredients, high levels of related substances, large polymers, and high incidence of adverse reactions. , leading to lower drug quality

Method used

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  • A compound pharmaceutical composition of mezlocillin sodium and sulbactam sodium for injection
  • A compound pharmaceutical composition of mezlocillin sodium and sulbactam sodium for injection
  • A compound pharmaceutical composition of mezlocillin sodium and sulbactam sodium for injection

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Effect test

Embodiment 1

[0032] Embodiment 1: mezlocillin sodium compound pharmaceutical composition of the present invention

[0033] 1. Components

[0034] 10 parts of mezlocillin sodium (calculated as mezlocillin), 2.5 parts of sulbactam sodium (calculated as sulbactam), 0.20 parts of sodium benzoate.

[0035] 2. Preparation method

[0036] Add 20Kg of water for injection at 6-10°C into the reaction kettle, add 10Kg of mezlocillin, turn on the stirring device and cooling device, add dropwise sodium bicarbonate suspension (1.60Kg of sodium bicarbonate is added to 6-10°C and 15Kg of water for injection Middle), keep the reaction temperature at 6°C, take the clarified medicinal solution to check the pH value, the pH value should be 6.0-7.3, and after the pH value of the medicinal solution is stable (the deviation of the pH value of the medicinal solution for three consecutive times is within ±0.03), add Dissolved sulbactam sodium solution [2.5Kg sulbactam sodium (calculated as sulbactam) dissolved i...

Embodiment 2

[0044] Embodiment 2: mezlocillin sodium compound pharmaceutical composition of the present invention

[0045] 1. Components

[0046] 10 parts of mezlocillin sodium (calculated as mezlocillin), 2.5 parts of sulbactam sodium (calculated as sulbactam), 0.25 parts of sodium benzoate.

[0047] 2. Preparation method

[0048] Add 20Kg of water for injection at 6-10°C to the reaction kettle, add 10Kg of mezlocillin, turn on the stirring device and cooling device, add dropwise sodium bicarbonate suspension (1.80Kg of sodium bicarbonate is added to 6-10°C and 15Kg of water for injection Middle), keep the reaction temperature at 8°C, take the clarified medicinal solution to check the pH value, the pH value should be 6.0-7.3, and after the pH value of the medicinal solution is stable (the deviation of the pH value of the medicinal solution for three consecutive times is within ±0.03), add Dissolved sulbactam sodium solution [2.5Kg sulbactam sodium (calculated as sulbactam) dissolved in ...

Embodiment 3

[0056] Embodiment 3: mezlocillin sodium compound pharmaceutical composition of the present invention

[0057] 1. Components

[0058] 10 parts of mezlocillin sodium (calculated as mezlocillin), 2.5 parts of sulbactam sodium (calculated as sulbactam), 0.30 parts of sodium benzoate.

[0059] 2. Preparation method

[0060] Add 20Kg of water for injection at 6-10°C to the reaction kettle, add 10Kg of mezlocillin, turn on the stirring device and cooling device, add dropwise sodium bicarbonate suspension (2.0Kg of sodium bicarbonate is added to 6-10°C and 15Kg of water for injection Middle), keep the reaction temperature at 10°C, take the clarified medicinal solution to check the pH value, the pH value should be 6.0-7.3, and after the pH value of the medicinal solution is stable (the deviation of the pH value of the medicinal solution for three consecutive times is within ±0.03), add Dissolved sulbactam sodium solution [2.5Kg sulbactam sodium (calculated as sulbactam) dissolved in ...

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Abstract

The invention relates to the technical field of medicines and discloses a mezlocillin sodium and sulbactam sodium compound drug composition for injection. The mezlocillin sodium and sulbactam sodium compound drug composition comprises mezlocillin sodium, sulbactam sodium and sodium benzoate. The mezlocillin sodium and sulbactam sodium compound drug composition realizes higher product performance by less auxiliary materials, has the advantages of being good in solubility, shallow in color, uniform in main drug mixing, low in related substance, low in polymer content, low in incidence rate of adverse reactions and the like and ensures that patients are safer in the clinical use, and the treatment effect is more reliable.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a compound pharmaceutical composition of mezlocillin sodium and sulbactam sodium for injection. Background technique [0002] With the widespread use of antibiotics, the emergence of bacterial resistance has become an important factor that seriously affects the clinical efficacy. There are many mechanisms for bacterial resistance to antibacterial drugs, among which the production of β-lactamases by bacteria is the key factor for the development of β-lactamase. As an important mechanism of resistance to amide antibiotics, the increase of extended-spectrum β-lactamase (ESBLs)-producing strains has attracted more and more attention in recent years. In order to make clinically effective antibiotics continue to play a role, it is an effective method to add β-lactamase inhibitors to β-lactamase antibiotics. [0003] Mezlocillin is a penicillin-like broad-spectrum antibiotic, which ma...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/431A61K47/12A61P31/04A61K31/43
CPCA61K9/0019A61K9/19A61K31/43A61K31/431A61K47/12A61K2300/00
Inventor 朱峰程云峰王玉娟李锦云
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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