伊曲康唑注射液无菌检查方法研究

Study on Sterility Test of Intraconacole Injection

目的建立伊曲康唑注射液的无菌检查方法。方法采用薄膜过滤法,每管接种量50mL,用pH=7.0的氯化钠-蛋白胨缓冲液500mL冲洗,对伊曲康唑注射液进行无菌检查。结果用400mL的pH=7.0的氯化钠-蛋白胨缓冲液冲洗,可消除该药对金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、枯草芽孢杆菌和生孢梭菌的抗菌作用,用500mL冲洗可消除其对黑曲霉菌和白色念珠菌的抗菌作用。该药对真菌的抗菌作用比对细菌的抗菌作用更强。结论所建立的方法简便、准确、可靠、重现性好。

Objective To establish a sterility test of Intraconacole Injection. Methods To perform the sterility test by the membrane filtration method. To inoculate 50 mL sample solution into each tube and rinse the filter membrane by 500 mL pH7, 0 sodium chloridepeptone buffer solution. Results It could remove the antibacterial activity to Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Bacillus subtilis and Clostridium sporogenes by rinsing the filter membrane in 400 mL pH7.0 sodium chloride- peptone buffer solution, but it needed 500 mL to Aspergillus niger and Candida albieans. The antibacterial activity of Intraconaeole Injection to fungus was stronger than to bacteria. Conclusion The method established is convenient, accurate and reliable with good reproducibility.