稀戊二醛溶液的微生物限度检查方法的建立及方法学验证

目的建立稀戊二醛溶液的微生物限度检查方法，确保方法的有效性。方法按中国药典2010年版二部附录ⅪJ对稀戊二醛溶液进行微生物限度检查法的方法学验证。结果稀戊二醛溶液的微生物限度检查可采用薄膜过滤法进行细菌计数，可采用培养基稀释法进行霉菌和酵母菌计数，采用常规法进行控制菌的检查。结论对本品进行微生物限度检查时，应充分考虑采用一定的方法，消除其抑菌性后再依法检查。

Establishment and Methodology Validation of Microbial Limit Examination for Dilute Glutaral Solution

OBJECTIVE To establish a effective method for microbial limit test of dilute glutaraldehyde solution. METHODS The methodology validation experiment for dilute glutaraldehyde solution was conducted according to the microbial limit test in the appendix XIJ of Chinese pharmacopoeia （second part, 2010 Edition）. RESULTS In microbial limit test of dilute glutaraldehyde solution, the culture medium dilution method was used for mould and yeast count, the membrane filtration method was used for bacterial count and the routine method for control the bacteria. CONCLUSION During this article, some certain methods should be fully considered to eliminate this dilute glutaraldehyde solution＇s bacteriostasis before the experiment for microbial limit test of this medicine.