微生物限度检查及无菌检查是涉及制剂安全性的重要质量指标。非无菌制剂一般应进行微生物限度检查,目的是检查其受微生物污染程度。中国药典2000版及以前的版本虽然收载了微生物限度检查及无菌检查法,但在如何保证检验方法的科学性及检验结果的准确性方面存在一些问题。2005版药典则明确规定当进行药品微生物限度检查 Microbial limit tests and sterility tests are important quality indicators related to the safety of the formulation. Non-sterile preparations should generally be tested for microbial limits in order to check their extent by microbial contamination. Although the Chinese Pharmacopoeia 2000 edition and previous versions have contained the limit test and the sterility test of microorganisms, there are some problems on how to ensure the scientificity of the test methods and the accuracy of test results. The 2005 edition of the Pharmacopoeia clearly stipulates that when conducting drug microbiological limits check