泊沙康唑注射液无菌检查方法适用性研究  

The suitability for sterility test method of posaconazole injection

作　　者：王君[1] 谢益晖 王林[1] 何跃芳 WANG Jun;XIE Yihui;WANG Lin;HE Yuefang(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225321,China)

机构地区：[1]扬子江药业集团有限公司,江苏泰州225321

出　　处：《中国药品标准》2021年第3期289-292,共4页Drug Standards of China

摘　　要：目的:建立泊沙康唑注射液无菌检查的方法。方法:按《中国药典》2015年版,采用薄膜过滤法进行方法适用性试验,选择聚山梨酯80作为中和剂,以及消除泊沙康唑抗菌活性的冲洗方式,建立该品种的无菌检查方法。结果:以0.9%无菌氯化钠溶液每250 mL中加入7.5 mL聚山梨酯80,混匀,作为冲洗液,约每管400 mL的冲洗量,最后胰酪大豆胨液体培养基管内加入含3 mL聚山梨酯80的培养基,可消除泊沙康唑的抑菌作用。结论:该方法有效可行,可用于该品种的无菌检查。Objective:To establish the sterility test method for posaconazole injection.Methods:According to the Chinese Pharmacopoeia 2015,the suitability test was performed for membrane filtration method.Polysorbate 80 was used as the neutralizer and the washing method to eliminate the antibacterial activity of posaconazole was used.Results:7.5 mL polysorbate 80 was added into 250 mL of 0.9%sterile sodium chloride solution and mixed well.The obtained solution was used as the flushing solution.400 mL flushing solution was used for each tube.Then 3 mL polysorbate 80 was added into the trypsin soybean peptone liquid medium tube to eliminate the bacteriostatic effect of posaconazole.Conclusion:The established method is effective and feasible and can be used for the sterility test of posaconazole injection.

关 键 词：泊沙康唑注射液 无菌检查 方法适用性试验 

分 类 号：R921.2[医药卫生—药学]