冻干粉针剂、治疗用生物制品(注射用重组人白介素-2)的生产;保健食品的生产;食品、日用化学品的销售;二类6840体外诊断试剂的生产;药品技术的开发、转让、咨询;自营和代理各类商品及技术的进出口业务(国家限定企业经营或禁止进出口的商品和技术除外)。(依法须经批准的项目,经相关部门批准后方可开展经营活动)
Objective To establish a sterility test method for thymopentin for injection (TP-5).Methods The membrane filtration method was adopted according to the provision of sterility test method in Chinese Pharmacopoeia(Edition 2010,Vol Ⅱ) ,doing methodology validation with different flushing dose,to make sure the optimal flushing dose for eliminate bacteriostasis components.Results The optimal flushing dose for eliminate bacteriostasis component was 600 ml through the verification test of 60 bottles*1 mg TP-5 for injection.Conclusion The TP-5 sterility test of using membrane filtration method is feasible and effective.
Objective To establish a method for the determination of bacterial endotoxin of lansoprazole for injection through interference test of lansoprazole for injection. Methods According to method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia (Edition 2010,Vol Ⅱ) . Results The interference on the determination of bacterial endotoxin can be excluded when Lansoprazole for injection was diluted the concentration of 50μg/ml. Conclusion It is feasible to detect the bacteria endotoxin of lansoprazole for injection by the method of determination of tachypleus amebocyte lysate.