薄膜过滤法在3种抑菌性原辅料微生物限度检测中的应用OA

This article aims to establish a convenient and efficient method for microbial limit detection of antibacterial raw and auxiliary materials using the membrane filtration method,and to provide basic data for the certification release and microbial risk control of raw and auxiliary materials in biological products.The membrane filtration method was used to perform the method suitability test for microbial limit testing on three antibacterial raw and auxiliary materials:potassium thiocyanate,sodium tetraborate(decahydrate)and phenylmethylsulfonyl fluoride.The results showed that the recoveries of all five test bacteria for the above three raw and auxiliary materials were in the range of 50%-200%,which met the requirements of the 2020 edition of China Pharmacopoeia.As a result,the membrane filtration method can be used for the microbial limit detection of the above three antibacterial raw and auxiliary materials,provide basic data for the comprehensive establishment of the microbial limit detection system of raw and auxiliary materials in biological products,and promote the forward movement of microbial risk control.