A kind of piperacillin sodium sulbactam sodium sterile powder injection and preparation method thereof

Abstract

The invention provides a piperacillin sodium and sulbactam sodium sterile powder-injection. The piperacillin sodium piperacillin sodium sterile powder-injection is prepared from piperacillin sodium, sulbactam sodium and a stabilizer. The stabilizer is composed of mycose, sodium pyrosulfite and glycine. The piperacillin sodium and sulbactam sodium sterile powder-injection comprises, by weight, 2-4 parts of the piperacillin sodium, 1 part of the sulbactam sodium, 20-40 parts of the mycose, 8-15 parts of the sodium pyrosulfite and 10-20 parts of the glycine. Compared with the prior art, the stabilizer is composed of the mycose, the sodium pyrosulfite and the glycine. Therefore, the stability of the piperacillin sodium and the sulbactam sodium in the preparation and storage process is effectively improved. It is guaranteed that products are qualified within the period of validity. The powder-injection is dissolved fast. No crystallization or turbidity exists. The curative effect and safety of clinical usage are guaranteed. A preparation method is simple. The cost is low. The powder-injection is suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a piperacillin sodium sulbactam sodium sterile powder injection and a preparation method thereof. Background technique [0002] Piperacillin is a penicillin-like broad-spectrum antibiotic, which mainly plays a bactericidal effect by interfering with the synthesis of bacterial cell walls. It is mainly used for infections caused by Pseudomonas aeruginosa and various Gram-negative bacilli but is easily produced by bacteria. Drug resistance due to amidase hydrolysis; sulbactam has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter, but sulbactam is important for most of the bacteria produced by β-lactam antibiotic resistant strains β-lactamases are irreversibly inhibited. Sulbactam can prevent drug-resistant bacteria from destroying penicillins and cephalosporins, and sulbactam has obvious synergistic effects with penicillins and cep...

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

[0004] Prior art in order to overcome the stability defect of piperacillin sodium sulbactam sodium combination preparation, propose multiple solutions, for example patent document CN101269072A discloses a kind of stable content containing sulbactam sodium and piperacillin sodium and pH value The pharmaceutical composition of the regulator and its preparation method, because of the addition of the pH regulator, avoids the phenomenon of insolubility or milky white turbidity caused by the lowering of the pH value caused by clinical compatibility, but it is also unstable in the aqueous solution after dilution, which affects the curative effect; Patent document CN1927201A discloses an antibiotic compound composed of piperacillin sodium, sulbactam sodium and at least one ion chelating agent that can inhibit the generation of particles. The disadvantage is that the use of ion chelating agent, especially EDTA, is easy to cause sodium, Potassium and calcium ions are lost, and the preparation process adopts freeze-drying, piperacillin sodium and sulbactam sodium are in a solution state during the liquid preparation and drying process, and will quickly undergo oxidative hydrolysis, resulting in failure

To a certain extent, the purity of the preparation is improved, but the two components are simply aseptically packaged, and the active ingredients piperacillin sodium and sulbactam sodium are not protected accordingly, which also leads to poor product stability. Seriously affected the clinical efficacy

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