Preparation method of piperacillin sodium and sulbactum sodium composition for injection

The technology of cillin sodium sulbactam sodium and piperacillin sodium is applied in the field of preparation of piperacillin sodium sulbactam sodium composition for injection, which can solve the problems such as quality requirements that cannot meet the validity period, poor formulation stability, etc. Wide range of storage conditions, good stability and excellent stability

Active Publication Date: 2016-05-11
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has a common defect that the preparation is poorly stable and cannot meet the quality requirements of the expiration date

Method used

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  • Preparation method of piperacillin sodium and sulbactum sodium composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 injection powder and its preparation

[0037] formula:

[0038] Piperacillin sodium 400g;

[0039] Sulbactam sodium 100g;

[0040] Polyalkylcyanoacrylate 200g;

[0041] Polyvinylpyrrolidone (PVP) 60g;

[0042] Trehalose 500g;

[0043] Glycine 500g;

[0044] Tween 80 100g.

[0045] Add piperacillin sodium and sulbactam sodium to 2.5L water for injection in turn, stir and dissolve at room temperature, then add alkyl polycyanoacrylate, Tween 80 and PVP, continue stirring for 3 hours, add trehalose and glycine, add 0.5 L water for injection, stir until completely dissolved, adjust the pH to 5-7, filter aseptically with a 0.22 μm filter membrane; divide the filtrate into sterilized vials.

[0046] Put the above materials into the freeze dryer, turn on the refrigeration, and quickly cool down to -40°C within 1 hour, and the material liquid becomes a block structure. The above-mentioned lumpy material is heated to -10°C within 3 hours, and then rapidly coo...

Embodiment 2

[0047] Example 2 particle size detection

[0048] Get the injection of embodiment 1, add water and dissolve into the solution that every 1ml contains 1mg piperacillin sodium, measure with laser scattering particle size analyzer.

[0049] Results: The piperacillin sodium sulbactam sodium injection prepared in Example 1 was in the shape of microspheres, with uniform particle size distribution, and all particle sizes were between 50-120 nm.

Embodiment 3

[0050] Embodiment 3: detection of encapsulation efficiency

[0051] Add water to dissolve the injection of piperacillin sodium sulbactam sodium into a solution containing 1mg of piperacillin sodium per 1ml, centrifuge at a speed of 5000r / min for 25min, take 1ml of the supernatant, dissolve it with methanol, and measure the concentration of piperacillin sodium. content.

[0052] Encapsulation efficiency = the amount of drug in the microsphere / (the amount of drug in the microsphere + the amount of drug in the medium) × 100%

[0053] Results: The encapsulation efficiency of the injection prepared in Example 1 was between 88% and 95%.

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Abstract

The invention relates to a preparation method of a piperacillin sodium and sulbactum sodium composition for injection. The composition comprises piperacillin sodium, ulbactum sodium, poly(alkyl cyanoacrylate), polyvinylpyrrolidone, trehalose, and glycine, and has the characteristics of good re-dissolution property and high stability. The preparation method is simple, and the composition can be obtained through freeze-drying.

Description

technical field [0001] The invention relates to a preparation method of a piperacillin sodium sulbactam sodium composition for injection. Background technique [0002] Piperacillin sodium is a penicillin antibiotic, which plays a bactericidal effect by interfering with the synthesis of bacterial cell walls, and is widely used in the prevention and treatment of various infectious diseases caused by Gram-negative bacteria. Because it contains a β-lactam ring, it is easily hydrolyzed by the β-lactamase produced by bacteria to produce drug resistance. Sulbactam sodium is a β-lactamase inhibitor, which has irreversible competitive inhibition for β-lactamase produced by Staphylococcus aureus and most Gram-negative bacteria, so sulbactam sodium is often combined with penicillins or cephalosporins Combined use of mycocin drugs has a good antibacterial synergistic effect. [0003] Piperacillin sodium and sulbactam sodium compound preparations have a large amount of clinical use, de...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K9/19A61K47/32A61K47/34A61K47/26A61K47/18A61P31/04A61K31/43
CPCA61K9/0019A61K9/19A61K31/43A61K31/496A61K47/183A61K47/26A61K47/32A61K2300/00
Inventor 张健陈学文
Owner SUZHOU ERYE PHARMA CO LTD
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