注射用氨苄西林钠舒巴坦钠无菌检查方法学研究

目的：建立注射用氨苄西林钠舒巴坦钠的无菌检查方法。方法：按《中国药典》2005年版二部（附录ⅪH）（以下简称“ChP2005”）^[1,2]所载“无菌检查方法”项下进行试验。通过对阳性对照菌，冲洗量及青霉素酶的加入顺序等条件的选择，建立了无菌检查方法。结果：样品管无菌生长，六珠阳性对照菌生长良好。结论：采用方法验证试验进行注射用氨苄西林钠舒巴坦钠无菌检查，保证无菌检查方法的有效性。

Studies on Sterility Test of Compound Ampicillin Sodium and Sulbactam Sodium for Injection

Objective：A sterility test method for compound Ampicillin Sodium and Sulbactam Sodium for Injection was established. Methods： The test method was carried out according to the method in volume 11, Chinese Pharmacopoeia Edition 2005. By choosing positive control bacteria,defining washing volumes and adding penicillinase sequence in sterility test, the sterility tests were established. Results： The validation tests were engaged, and the method show that all of six strains positive control tubes reveal growth of microorganism and the control gives no evidence of growth. Conclusion： The method could be used for sterility test of this preparation. The validity of sterility test for the Ampicillin Sodium and Sulbactam Sodium for injections is assured.