注射用盐酸乌拉地尔与丁基胶塞相容性研究

摘要

Objective To study the compatibility between the urapidil hydrochloride for injection and butyl rubber plugs.Methods The migration of 2,6-butylated hydroxytoluene in a room temperature test and an accelerated test (3 months) was evaluated by HPLC method,and the compatibility between butyl rubber plugs and different batches of urapidil hydrochloride for injection was determined.Results There was trace migration in samples in both the room temperature test and the accelerated test,and the amount of migration was below 5 μg/package in almost each case,which was within the safe range.The amount of migration in the room temperature test was larger than in the accelerated test.Conclusion Butyl rubber plugs have good compatibility with urapidil hydrochloride for injection.%目的 考察注射用乌拉地尔与其包装材料中丁基胶塞的相容性.方法 本研究应用HPLC法,以抗氧剂2,6-二叔丁基-4-甲基苯酚(BHT)的迁移为指标,考察常温放置3个月和和加速试验3个月后药物中BHT的迁移量,从而得出不同批次的注射用盐酸乌拉地尔与包装材料中的丁基胶塞的相容性.结果 常温放置样品和加速试验样品中,均有微量BHT迁移,但迁移量每包装均在5 μg以下,处于安全范围内,且常温放置样品中BHT的迁移量高于加速试验样品.结论 注射用乌拉地尔与包装材料中的丁基胶塞基本相容.