The Development Of The Industrial Process For Aseptic Cefotaxime Sodium Using Single Organic Solvent

This paper aimed to modify the sterile manufacturing technique of the third-generation semi-synthetic broad-spectrum cephalosporin antibiotic cefotaxime sodium that taking the leading role of antibiotic in China.In Chinese Pharmacopoeia(2010 edition)acid solubility was addsed,so the traditional manufacturing technique was facing enormous challenges.The clinical use of antibiotics management approach carry out at July 1,2011.In 2012,many areas win the bidding at the lowest price.The improvement of the quality and the limitations of antibiotics will reshuffle the domestic production of sterile cefotaxime sodium.How to produce high quality,low-cost cefotaxime sodium is the urgent problem that many manufacturers to solve.In this severe situation,this paper combine domestic's sterile cefotaxime sodium acetone single-crystalline organic solvent on its basic.Combine with the knowledge of sterile and the sterile manufacturing technique's special limitation and strict product situation,though the small test,pilot-plant test,ultimately produce it in the clean room,get the sterile cefotaxime sodium that have high quality,high customer applicability and conform to the Pharmacopoeia 2010 edition.Compared with the domestic traditional manufacturing technique,its quality and stability is not less than the others,producting one kilogram can save 19.68 yuan at least.According to a pharmaceutical factory that output 300 tons per year in Shijiazhuang,it can save 5.904 million yuan every year.It improve the market competitiveness vastly under the tough market conditions.