稀苯扎溴铵溶液微生物限度检查方法的建立及方法学验证

目的建立稀苯扎溴铵溶液微生物限度检查方法并进行方法学验证,确保方法的有效性。方法按《中国药典》2010年版二部附录XI J方法验证试验的要求,对稀苯扎溴铵溶液进行微生物限度检查法的方法学验证。结果对本溶液的微生物限度检查可采用薄膜过滤法进行细菌、霉菌和酵母菌计数;可采用薄膜过滤法进行控制菌的检查。结论通过对溶液进行微生物限度方法学验证而建立的检查方法时,需先考虑消除其抑菌性后,再依法检查。

Methodology establishment and validation of microbial limit examination of diluted benzalkonium bromide solution

Objective To establish a microbial limit examination method and a verified methodology for diluted benzalkonium bromide solution, and ensure the effectiveness of the method.Methods Microbial limit test of diluted benzalkonium bromide solution was used as the validation methodology according to the validation test requirements of appendix XI J of the second version of the "Chinese Pharmacopoeia" published in 2010.Results Membrane filtration method could be used for counting bacteria, mold and yeast count in the microbial limit examination of the diluted benzalkonium bromide solution; membrane filtration method could be adopted to control the bacteria.Conclusion Antibacterial activity of diluted benzalkonium bromide solution should be fully considered before examination when building its examination method through microbial limit methodology validation.