地塞米松植入剂细菌内毒素检查方法的建立  

Establishment of bacterial endotoxin test for Dexamethasone Suspension for Intraocular Injection

作　　者：黄有兴 甘丽 HUANG Youxing;GAN Li(Hainan Hailing Chemical Pharmaceutical Co.,Ltd.,Haikou 570311,China;Institute of Drug Testing,Hainan Academy of Inspection and Testing,Haikou 570216,China)

机构地区：[1]海南海灵化学制药有限公司,海南海口570311 [2]海南省检验检测研究院药品检验所,海南海口570216

出　　处：《药学研究》2024年第10期968-971,共4页Journal of Pharmaceutical Research

摘　　要：目的建立地塞米松植入剂细菌内毒素检查方法并进行验证。方法地塞米松植入剂混悬液加入二甲亚砜溶解混匀,再用细菌内毒素检查用水稀释,依照《中国药典》2020年版(四部)通则1143细菌内毒素检查法,采用2个厂家的鲎试剂进行凝胶法干扰试验和内毒素回收验证,并对地塞米松植入剂进行细菌内毒素检查。结果在本试验验证条件下,先用二甲亚砜溶解再用细菌内毒素检查用水稀释地塞米松植入剂至40倍浓度时,不干扰鲎试剂与内毒素的酶联反应。结论地塞米松植入剂可用细菌内毒素检查法进行质量控制。Objective To establish and validate the bacterial endotoxin test method for Dexamethasone Suspension for Intraocular Injection.Methods According to Bacterial Endotoxin Test in Chinese Pharmacopoeia(2020 edition,Volume IV,1143),Dexamethasone Suspension for Intraocular Injection was dissolved by dimethylsulfoxide and diluted with bacterial endotoxin test water.Interference test and endotoxin recovery test were carried out with two manufacturers′gel tachypleus amebocyte lysate.Bacterial endotoxin test of the sample were performed too.Results There was no interference between bacterial endotoxin and limulus reagent when Dexamethasone Suspension for Intraocular Injection was diluted 40 times.Dimethylsulfoxide can be used for dissolving Dexamethasone Suspension for Intraocular Injection to perform bacterial endotoxin test.Conclusion Bacterial endotoxin test is suitable for the detection of Dexamethasone Suspension for Intraocular Injection.

关 键 词：地塞米松植入剂 细菌内毒素 凝胶法 干扰试验 

分 类 号：R927.1[医药卫生—药学]