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建立焦磷酸枸橼酸铁注射液薄膜过滤无菌检查法,并验证其准确性和可靠性。按照《中国药典》2015年版四部1101无菌检查法项下要求,以硫乙醇酸盐流体培养基作为厌氧菌和需氧菌检查培养基,以胰酪大豆胨液体培养基作为真菌和需氧菌检查培养基,以金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、生孢梭菌、白色念珠菌和黑曲霉为试验菌进行方法学验证。将供试品按薄膜过滤法,用0.1%蛋白胨水溶液冲洗,冲洗量为100 m L/膜,以金黄色葡萄球菌为阳性对照菌进行无菌检查。样品无菌检查均合格,6株阳性对照菌生长良好。该实验条件下焦磷酸枸橼酸铁注射液无抑菌活性或抑菌活性可以忽略,采用薄膜过滤法进行无菌检查,建立的方法准确、可靠。
To establish a sterile filtration method for the filtration of iron pyrophosphate citrate injection and to verify its accuracy and reliability. According to the “Chinese Pharmacopoeia” 2015 edition of the four 1101 sterility test under the requirements of the thioglycollate fluid medium as anaerobic bacteria and aerobic bacteria test medium, tryptic soy broth as fungi and aerobic Bacteria test medium, to Staphylococcus aureus, Escherichia coli, Bacillus subtilis, Clostridium sporogenes, Candida albicans and Aspergillus niger as test bacteria for validation. The test sample according to the membrane filtration method, rinsing with 0.1% peptone aqueous solution, flushing volume of 100 m L / membrane, Staphylococcus aureus as a positive control bacteria for sterile examination. Sterile samples were tested, 6 positive control bacteria grew well. Under the experimental conditions, iron citrate pyrophosphate injection has no antibacterial activity or antibacterial activity, and the method of membrane filtration is used for sterility test. The established method is accurate and reliable.