焦磷酸枸橼酸铁注射液无菌检查法的建立及验证

Establishment and Validation of the Sterility Test Method for Ferric Pyrophosphate Citrate Injection

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 the membrane-filter procedure for Ferric pyrophosphate citrate injection and to validate the accuracy andreliability of the method, according to the fourth volume of the Chinese pharmacopoeia 2015 Edition 1101 Sterility Test were validatedin the sterility test method, fluid thioglycollate medium was used as anaerobic and aerobic inspection medium, tryptose soya brothmedium was used as fungi and aerobic bacteria checking medium, and membrane filtration method was using Staphylococcus aureus,Escherichia coli, Bacillus subtilis, Clostridium sporogenes, Candida albicans and Aspergillus niger as the test organism for methodvalidation. The membrane-filter procedure was used for the Ferric pyrophosphate citrate injection,0.1% peptone water solution aswashing liquid, washing volume 100 mL/film, Staphylococcus aureus was the positive control bacteria, and the methods wereapplicable in experiment. All the results of sterility tests were qualified. The six types of positive control bacteria grew well. The abovementioned method can be used for the sterility test of ferric pyrophosphate citrate injection, and this method established is accurateand reliable.