注射用胸腺五肽的无菌检查方法研究

Research on sterility test of thymopentin for injection

目的建立注射用胸腺五肽的无菌检查方法。方法按《中国药典》2010年版二部收载的无菌检查法的规定,采用薄膜过滤法,分别用不同的冲洗量进行方法学验证,探索、确定消除抑菌成分的最佳冲洗量。结果规格为1mg的注射用胸腺五肽60瓶经验证试验后,确定消除抑菌成分的最佳冲洗量为600ml。结论注射用胸腺五肽采用薄膜过滤法的无菌检查方法可行、有效。

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.