The Application Of Ultrafiltration For Manufacturing Levofloxacin Lactate And Sodium Chloride Injection

In order to ensure the medicine quality, SFDA published the Good Manufacturing Practice(2010 revision) in March 2011, the new revision GMP highlighted that the sterile drugs are high risky products and reclaimed that the sterile drugs not only need to meet the requirements of the quality and the intended use, but also minimize the contamination which caused by microbial, particulate and pyrogen. If necessary, we should monitor the bacterial endotoxin of the pharmaceutical water regularly. Quality standard of all material also should including the limits of microbe, bacterial endotoxin and pyrogen. Therefore, engineers have been researching on convenient, stable and effective methods to reduce or eliminate the risk of the sterile pharmaceutical process which cause by microbial contamination. The methods should ensure the removement of the particles, microorganism in the liquid effectively, and also the process itself will not cause any adverse effects on the quality of drugs to meet the requirement of quality and safety of sterile products.The most popular methods to remove the pyrogen during the process of sterile product manufacturing is activated carbon adsorption. This method is rather complicated in operation and not conducive for clean production. Moreover, the domestic activated carbon are produced by various treatment methods, which bring difficulty for quality control. The impurities in activated carbon may bring risks to the quality of the product. Ultrafiltration membrane separation is an effective technology to separate different size molecules in the solution, based on the size rejection of membrane.Ultrafiltration technology can remove the pyrogen according to the molecular size in solution under pressure. It will not cause side effects on drug due to this physical separation process. The active ingredients in Levofloxacin lactate and sodium chloride injection are small molecules whereas the bacterial endotoxin is biomacromolecular lipopolysaccharide with molecular weight between 50 KD-500 KD in the water. Theoretically, bacterial endotoxin can be completely removed by ultrafiltration technology, while the effective active ingredients retain.This study determines the ultrafiltration process for the manufacturing of levofloxacin lactate and sodium chloride injection, establishes the method of membrane screening, and confirms the feasibility and superiority of the ultrafiltration...