目的:完善注射用头孢唑林钠的无菌检验方法。方法:通过确定冲洗量、选择阳性对照菌及加入顺序等,以注射用头孢唑林钠为例,说明无菌检查法建立在验证试验基础上的必要性。结果:注射用头孢唑林钠的验证试验,保证无菌检查方法的科学性和检验结果的准确性,证明方法可行。结论:将中国药典2005年版二部样品项下无菌检验方法进一步完善。 Objective: To improve the sterility test method of cefazolin sodium for injection. Methods: The determination of the amount of flushing, the selection of positive control bacteria and the order of addition to cefazolin sodium injection as an example, indicating the need for sterility test established on the basis of the validation test. Results: The validation test of cefazolin sodium for injection ensured the scientificity of the sterility test method and the accuracy of test results, and proved that the method was feasible. Conclusion: The Chinese Pharmacopoeia 2005 edition of two samples under sterile test method further improved.