OBJECTIVE: To establish a method of microbial limit test for liquid preparation of Iron sucrose injection before filtration and sterilization. METHODS: According to the microbial limit test in the “1005” and “general rules 1006” of 2015 edition of Chinese Pharmacopoeia (vol.Ⅴ), plate method and membrane filtration method were used to measure total number of aerobic bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans, Aspergillus niger) and total number of molds and yeasts (C. albicans, A. niger). The optimal test method was obtained by comparing the bacterial recoveries. RESULTS: By plate method, the recoveries of P. aeruginosa and B. subtilis were 2% and 5%. The test sample was diluted 10 times with pH 7.0 sodium chloride-peptone buffer solution, and the bacterial recoveries were in the range of 88% to 96%; but he medium was dark in color. By membrane filtration method, without rinse solution, the bacterial recoveries in the range of 88% to 95%. Add rinse solution, the bacterial recoveries were in the range of 91% to 103%. After validated,the recoveries of menbrane filtration method with tlushing tluid ranged 50%-200%,which was in line with the requnements. CONCLUSIONS: The membrane filtration method established in this experiment has higher bacterial recovery rate than the plate method. The bacterial recoveries rate were higher after adding rinse solution, and no dark substance in the surface of filter membrane affect the account. It can be used as the microbial limit test method for preparation liquid of Iron sucrose injection before filtration and sterilization.
关键词
蔗糖铁注射液配制液微生物限度检查薄膜过滤法平皿法
Keywords
Iron sucrose injectionPreparation liquidMicrobial limit testMembrane filtration methodPlate method