Preparation of Rabeprazole Sodium for Injection and Its Animal Test on Safty

OBJECTIVES To chose the best prescription and prepare Rabeprazole Sodium for injection and investigate its safety. METHODS Several kinds of parameter were chosen to prepare lyophilized injection of Rabeprazole Sodium such as pH, solvent, Metal ions, excipient, antioxidant and activated carbon. The degradation pattern of Rabeprazole Sodium and its effects were measured．At the same time，Irritative, anaphylaxis and haemolyticus tests were performed to evaluate the injectable safety of Rabeprazole Sodium for injection. RESULTS The pH of the solution should be adjusted above 11 and append a little antioxidant. The preparation had no hemolysis phenomenon, no significant irritation effect on vessels and no allergic response. CONCLUSIONS The technics of preparing Rabeprazole Sodium for injection is simple. The animal tests on safety is up to grade and the preparetion is stabilize.