Piperacillin-sulbactam sodium medicinal composition liposome injection

Abstract

The invention discloses piperacillin-sulbactam sodium medicinal composition liposome injection and a preparation method thereof. The liposome injection comprises the following components in part by weight: 4 parts of piperacillin, 1 part of sulbactam sodium, 2.5 to 7.5 parts of liposome carrier and 0.2 to 1 part of freeze-drying supporting agent, wherein the liposome carrier is the combination of the sitosterol and octadecylamine, preferably the combination of the sitosterol and octadecylamine in a weight ratio of 3:1; and the freeze-drying supporting agent is the combination of mannitol and lactose, preferably the combination of the mannitol and lactose in a weight ratio of 2:1; or the liposome injection comprises the following components in part by weight: 2 parts of piperacillin, 1 part of sulbactam sodium, 1.5 to 4.5 parts of liposome carrier and 0.1 to 0.6 part of freeze-drying supporting agent, wherein the liposome carrier is the combination of sitosterol and phosphatidyl ethanolamine, preferably the combination of the sitosterol and phosphatidyl ethanolamine in a weight ratio of 5:8; and the freeze-drying supporting agent is the combination of nucleo-glycan and sodium alginate, preferably the combination of the nucleo-glycan and sodium alginate in a weight ratio of 3:1.

Description

technical field [0001] The invention relates to a piperacillin sodium sulbactam sodium pharmaceutical composition injection and a preparation method thereof, in particular to a liposome injection preparation prepared by using specific auxiliary materials, and belongs to the technical field of medicine. 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 penici...

AI Technical Summary

Problems solved by technology

Although this application has solved the problem of poor stability of piperacillin sodium and sulbactam sodium to a certain extent, the appearance of the prepared freeze-dried powder injection is not full, and even collapsed, which does not meet the requirements of pharmacy

[0007] More importantly, according to the inventor's long-term comparative study, it is found that the key that affects the combination of piperacillin sodium and sulbactam sodium is the combination of piperacillin sodium and sulbactam sodium in a content ratio of 4:1 or 2:1. Pharmaceutical compositions are widely used in clinical practice as active ingredients. However, after scale-up production using the preparation process of the prior art, the solution after reconstitution of the lyophilized powder is still turbid, and is even completely unsuitable for injection.

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