Preparation method of mezlocillin sodium-sulbactam sodium for injection

A technology of mezlocillin sodium sulbactam sodium and mezlocillin sodium, applied in the field of medicine, can solve the problems of stratification, single product, unable to meet diversified requirements, etc., and achieve the effect of good storage stability

Inactive Publication Date: 2018-06-01
QILU TIANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] At present, the problems existing in the preparation process of mezlocillin sodium sulbactam sodium compound preparations are as follows: 1) most of them are directly mixing mezlocillin sodium and sulbactam sodium aseptic bulk drug powder at present, which easily causes mixing inhomogeneity, even if mixing Evenly, it is also easy to cause stratification due to reasons such as vi...

Method used

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  • Preparation method of mezlocillin sodium-sulbactam sodium for injection
  • Preparation method of mezlocillin sodium-sulbactam sodium for injection
  • Preparation method of mezlocillin sodium-sulbactam sodium for injection

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Embodiment 1

[0022] Example 1: Freeze-dried preparation of mezlocillin sodium and sulbactam sodium for injection (8:1)

[0023] 1) 100ml of bottom water is added in the batching tank, cooled to 8.9°C, 124.7g mezlocillin is transferred into the batching tank, and the 14% sodium bicarbonate solution (19.36g sodium bicarbonate is added with water to be mixed with 14wt% Sodium bicarbonate solution) is added dropwise into the batching tank, and the temperature is controlled at 5-10°C. Pay attention to observe the reaction in the tank. If there are too many foams, slow down the feeding speed to prevent rushing. Observe the online pH value at any time to control the feeding process The pH should not be higher than 7.0.

[0024] Continue to add 14.7g of sulbactam, while the prepared 14wt% sodium bicarbonate solution (4.10g sodium bicarbonate is added with water to be mixed with 14wt% sodium bicarbonate solution) is added dropwise in the batching tank, and the control batching tank is added in the ...

Embodiment 2

[0030] Mezlocillin: moisture 3.4%, content 99.2%, weighing 124.7g;

[0031] Sulbactam: moisture 0.04%, content 99.9%, weighing 14.7g;

[0032] Sodium bicarbonate: 23.46g (19.36g+4.10g, prepared as a solution with a concentration of 14wt%).

[0033] EDTA: 31.06mg.

[0034] 1) Bottom water 110ml, cool down to 7.5°C, add 124.7g of mezlocillin, 14.7g of sulbactam, dropwise add sodium bicarbonate: 23.46g;

[0035] 2) Add the EDTA solution dissolved in advance, after adding the EDTA solution, continue to stir for 20 minutes, and then vacuum again;

[0036] 3) After 1 hour the pH is 6.21, ready for filtration.

[0037] 4) Sterilize, filter, and freeze-dry to obtain the original powder of mezlocillin sodium and sulbactam sodium (8:1).

[0038] All the other are with embodiment 1.

Embodiment 3

[0040] Mezlocillin: moisture 3.4%, content 99.2%, weighing 124.7g;

[0041] Sulbactam: moisture 0.04%, content 99.9%, weighing 14.7g;

[0042] Sodium bicarbonate: 23.46g (19.36g+4.10g, prepared as a solution with a concentration of 15wt%);

[0043] EDTA: 31.06mg.

[0044] 1) Bottom water 115ml, cool down to 6.3°C, add 124.7g of mezlocillin, 14.7g of sulbactam, dropwise add sodium bicarbonate: 23.46g;

[0045] 2) Add the EDTA solution dissolved in advance, after adding the EDTA solution, continue to stir for 20 minutes, and then vacuum again;

[0046] 3) After 1 hour, the pH is 6.20, ready for filtration;

[0047] 4) Sterilize, filter, and freeze-dry to obtain the original powder of mezlocillin sodium and sulbactam sodium (8:1).

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Abstract

The invention discloses a preparation method of mezlocillin sodium-sulbactam sodium for injection. The method comprises the following steps: firstly, adding mezlocillin into a mixing tank, and then dropwise adding a sodium hydrogen carbonate solution; after the addition is finished, adding sulbactam, and dropwise adding the sodium hydrogen carbonate solution again; after material feeding is finished, vacuumizing to remove carbon dioxide gas, and then adjusting the pH value to 6.0-6.5; then, adding an ethylene diamine tetraacetic acid (EDTA) solution, stirring for 15-30min, then vacuumizing again, and maintaining the pH value to be 6.0-6.5; sterilizing and filtering, and freeze-drying to obtain mezlocillin sodium-sulbactam sodium freeze-dried preparation raw powder for injection. Accordingto the method, mezlocillin sodium-sulbactam sodium is generated by using the mezlocillin, the sulbactam and sodium hydrogen carbonate as raw materials for carrying out a reaction, and the acidity stability of the product is improved by adding EDTA into reaction liquid, so that the mezlocillin sodium-sulbactam sodium, which has mezlocillin sodium content and sulbactam content meeting the requirements and is good in storage stability, for injection is finally obtained.

Description

technical field [0001] The invention relates to a preparation method of mezlocillin sodium sulbactam sodium for injection, which belongs to the technical field of medicine. Background technique [0002] Mezlocillin sodium and sulbactam sodium are commonly used compound preparations in clinical practice. Mezlocillin sodium is a penicillin-like broad-spectrum antibiotic, which mainly plays a bactericidal effect by interfering with the synthesis of bacterial cell walls; sulbactam sodium has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter, but sulbactam Sodium has an irreversible inhibitory effect on most important β-lactamases produced by β-lactam antibiotic-resistant strains. Sulbactam sodium can prevent drug-resistant bacteria from destroying penicillins and cephalosporins antibiotics, and sulbactam sodium has obvious synergistic effects with penicillins and cephalosporins antibiotics. In vitro tests show that the combination of mezlo...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/02A61K47/18A61K31/431A61K31/43A61P31/04
CPCA61K9/0019A61K9/19A61K31/43A61K31/431A61K47/02A61K47/18A61K2300/00
Inventor 董潇杜军田芳芳
Owner QILU TIANHE PHARMA
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