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Composite pharmaceutical composition of cefoperazone sodium and tazobactam sodium and preparation process thereof

A technology of cefoperazone sodium and tazobactam sodium, applied in the field of medicine, can solve the problems of irrational drug compatibility, affect the treatment effect, endanger the life of patients, etc., and achieve the effect of overcoming the problem of incompatibility, excellent stability and good uniformity

Active Publication Date: 2014-09-03
福安药业集团庆余堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinically, unreasonable drug compatibility not only affects the therapeutic effect, but also affects the health of patients, and even endangers the lives of patients.

Method used

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  • Composite pharmaceutical composition of cefoperazone sodium and tazobactam sodium and preparation process thereof
  • Composite pharmaceutical composition of cefoperazone sodium and tazobactam sodium and preparation process thereof
  • Composite pharmaceutical composition of cefoperazone sodium and tazobactam sodium and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prescription: 100 bottles

[0037]

[0038] Weigh the prescribed amount of cefoperazone sodium, tazobactam sodium, ambroxol hydrochloride, mannitol, and sodium bisulfite in the aseptic operation room, dissolve them in 360ml of water for injection, wait until they are completely dissolved, and then dissolve them with citric acid-citric acid Adjust the pH value of the mixed solution to 4.8-5.5 with sodium, then add 40ml of water for injection, add activated carbon for needles, stir, let stand for 20min, and decarburize with 0.45μm and 0.22μm filter membranes successively, and distill the sterile solution according to the volume of each bottle. 1ml is divided into 7ml freeze-dried vials, half stoppered, sent to a freeze-drying box, and freeze-dried to obtain the finished product.

[0039] Among them, the freeze-drying process is as follows: rapidly cool the aliquoted sterile solution to -45°C for pre-freezing, so that the sterile solution is completely converted into a ...

Embodiment 2

[0045] Prescription: 1000 bottles

[0046]

[0047]Take cefoperazone sodium, tazobactam sodium, ambroxol hydrochloride, glucose, and sodium bisulfite in the aseptic operating room, stir and dissolve with 3600ml water for injection; adjust the mixed solution with citric acid-sodium citrate When the pH value reaches 4.8-5.5, add 400ml of water for injection. Add activated charcoal for needles, stir, let stand for 20 minutes, decarburize by filtering with 0.45 μm and 0.22 μm filter membranes sequentially, divide the sterile solution into 7ml freeze-drying bottles according to 1ml per bottle, stopper halfway, and send it to the freeze-drying box , freeze-drying (technology is the same as embodiment 1) to get finished product.

Embodiment 3

[0053] Prescription: 1000 bottles

[0054]

[0055] In the aseptic operation room, take cefoperazone sodium, tazobactam sodium, ambroxol hydrochloride, trehalose, sodium bisulfite of prescription quantity, stir and dissolve 3600ml of water for injection; adjust the mixed solution with citric acid-sodium citrate When the pH value reaches 4.8-5.5, add 400ml of water for injection. Add activated charcoal for needles, stir, let stand for 20 minutes, decarburize by filtering with 0.45 μm and 0.22 μm filter membranes sequentially, divide the sterile solution into 7ml freeze-drying bottles according to 1ml per bottle, stopper halfway, and send it to the freeze-drying box , freeze-drying (technology is the same as embodiment 1) to get finished product.

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Abstract

The invention discloses a composite pharmaceutical composition of cefoperazone sodium and tazobactam sodium. The composite pharmaceutical composition is an injection, and is prepared from the following components in parts by weight: 3.5-4.5 parts of cefoperazone sodium, 1 part of tazobactam sodium, 0.5-1 part of ambroxol hydrochloride, 0-6 parts of excipient, 0-10 parts of isotonic agent, 0-1 part of antioxidant, a proper amount of citric acid-sodium citrate and 20 parts of injection water. The composite preparation of the cefoperazone sodium and the tazobactam sodium disclosed by the invention is stable in quality and significant in curative effect, not only can three active ingredients be evenly mixed, but also the composite pharmaceutical composition is excellent in stability, good in solubleness and good in clinical use safety.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a compound pharmaceutical composition containing cefoperazone sodium and tazobactam sodium. Background technique [0002] The compound preparation of cefoperazone sodium and tazobactam sodium for injection was launched in China in 2003. It is used for the treatment of moderate and severe infections caused by β-lactam-producing bacteria resistant to cefoperazone single drug and sensitive to this product. The antibacterial ingredients are cefoperazone and tazobactam. Cefoperazone is a third-generation cephalosporin antibiotic that achieves bactericidal effect by inhibiting the biosynthesis of sensitive bacterial cell walls. Tazobactam has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter, but tazobactam has activity against most important β-lactamases produced by β-lactam antibiotic-resistant strains Irreversible inhibition. [0003] Ambro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61P31/04A61P11/00A61P31/06A61P11/06A61K31/431A61K31/137
Inventor 刘小东张稳稳
Owner 福安药业集团庆余堂制药有限公司
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