Method for reducing visible foreign matters in piperacillin sodium and tazobactam sodium for injection

Abstract

A method for reducing visible foreign matters in piperacillin sodium and tazobactam sodium for injection is characterized by comprising the steps as follows: 1), bottle washing equipment is cleaned; 2), piperacillin sodium and tazobactam sodium are taken at a weight ratio of 8:1; and 3), ion exchange resin and water are taken at a weight ratio of 1: 35 and jointly or independently mixed with piperacillin sodium and tazobactam sodium for stirring, filtering and filter pressing, and filter liquor is prepared into an aqueous injection, an infusion solution, a powder injection or a freeze-dried powder injection according to conventional requirements of pharmaceutics. According to the invention, the number of visible foreign matters in each bottle is reduced to be less than 4 from less than 10 and exceeds the specified requirements of the drug standard of Chinese pharmacopoeia, and the safety of drug application is greatly improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for reducing visible foreign matter in piperacillin sodium and tazobactam sodium for injection. Background technique [0002] B-lactam antibiotics such as penicillins and cephalosporins are currently the most clinically used and most important class of antibiotics, accounting for more than 50% of the total sales of antibiotics. The application of B-lactam antibiotics such as penicillins and cephalosporins has made great contributions to human resistance to bacterial infections, but long-term use will cause bacteria to gradually develop drug resistance. Due to the increase in bacterial resistance, infections caused by drug-resistant bacteria are not easy control, leading to an increase in infection mortality. All B-lactam antibiotics have a typical or atypical B-lactam ring, which is the main active site of the antibiotic. Once the ring is hydrolyzed, the antibiotic wil...

AI Technical Summary

Problems solved by technology

Invention patent CN102018713B discloses a piperacillin / tazobactam pharmaceutical composition, in which the weight ratios of piperacillin sodium to tazobactam sodium are 8:1, 4:1 and 2: 1. Use the method of ion exchange resin to exchange HT in piperacillin acid and tazobactam acid with Na+ to obtain the pharmaceutical composition of piperacillin acid sodium and tazobactam acid sodium, and there is no carbon dioxide in the composition Residue, after being prepared into a preparation, the drug piperacillinate sodium and tazobactam sodium composition is obtained, but the carbon dioxide in the drug will always remain in the water, so the stability of the preparation and insoluble particles are always unsolvable Yes, the main factor affecting the product stability of piperacillin sodium and tazobactam sodium for injection is the visible foreign matter in the drug, so research and development is required: first, the cleaning process of the vials for filling the drug should be improved; 2. The second is to transform the bottle washing The flushing method of the equipment, 3. The second is the improvement of the liquid medicine filter device