Injection of piperacillin-sulbactum sodium medicine composition and preparation method thereof

Abstract

The invention discloses an injection of a piperacillin-sulbactum sodium medicine composition and a preparation method thereof. The injection disclosed herein comprises 10-15 weight parts of piperacillin, 2.5 weight parts of sulbactam sodium, 2-5 weight parts of lactose, 1 weight part of sodium chloride, and 0.1-0.5 weight parts of sodium citrate. The preparation method comprises the following steps: weighing piperacillin, sulbactam sodium, lactose, and sodium chloride based on the weight parts, using water for injection to dissolve, preparing sodium citrate into a 0.1mol/L solution by using water for injection, adding the 0.1mol/L solution dropwisely to the solution obtained by dissolving and stopping adding dropwisely when the pH value is 6.8, and then dilute with water for injection to make 5000mL to obtain a colorless and transparent medicine solution; filtering the medicine solution by a filtering membrane, drying, conducting sterile crushing, and filling to obtain the injection. According to the invention, the injection has the advantages of good stability, fast dissolving speed, etc.; and the preparation method has simple operation, reduces production cost, and is suitable for large-scale production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation composition, in particular to an injection preparation formulation and a preparation method thereof. Background technique [0002] Piperacillin, also known as oxygen piperazine penicillin, its English name is PiPRAcil, PiPRL, Tazocin, Piperacillin. Chemical name (2S,5R,6R)-3.3-Dimethyl-6-[(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)phenylacetamido]-7-oxo Dai-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, molecular formula: C 23 h 27 N 5 o 7 S·H 2 O. Piperacillin is a semi-synthetic penicillin antibiotic with broad-spectrum antibacterial activity. Piperacillin is effective against Enterobacteriaceae such as Escherichia coli, Proteus, Serratia, Klebsiella, Enterobacter, Citrobacter, Salmonella and Shigella, as well as Pseudomonas aeruginosa Other Gram-negative bacteria, such as Monas, Acinetobacter, Haemophilus influenzae, and Neisseria, all have good antibacterial effects. Piperacillin ...

AI Technical Summary

Problems solved by technology

[0003] Sulbactam sodium is an irreversible competitive β-lactamase inhibitor. Piperacillin belongs to penicillin drugs and is easily hydrolyzed by β-lactamase. In order to enhance the activity of piperacillin, piperacillin and β-lactamase have been clinically developed. -Lactamase inhibitors are used in combination to achieve a synergistic effect, but the dissolution rate is unsatisfactory

During the production process, the two raw powders of piperacillin and sulbactam sodium are physically mixed, which makes the pH value fluctuate easily and has instability, and the dissolution rate is not ideal at the same time

[0004] In addition, the existing literature records that the piperacillin-sulbactam sodium compound preparation has poor stability and cannot meet the quality requirements of the expiration date; piperacillin and sulbactam sodium preparation solutions are unstable at room temperature and other defects

Patent document CN101632671B adopts freeze-drying method to dry during the preparation process, which leads to higher production cost

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