注射用盐酸平阳霉素的质量评价  

Quality assessment of bleomycin A5 hydrochloride for injection

作　　者：韩彬 高燕霞 庞文哲 徐艳梅 田兰 Han Bin;Gao Yan-xia;Pang Wen-zhe;Xu Yan-mei;Tian Lan(Hebei Institute for Drag and Medical Device Control,Shi Jia-zhuang 050000;Hebei Drug evaluation Center,Shi Jia-zhuang 050000)

机构地区：[1]河北省药品医疗器械检验研究院,石家庄050000 [2]河北省药品审评中心,石家庄050000

出　　处：《中国抗生素杂志》2021年第3期239-243,共5页Chinese Journal of Antibiotics

摘　　要：目的评价国产注射用盐酸平阳霉素的质量现状并分析存在的问题。方法根据2019年国家药品质量评价抽验方案的总体要求,法定标准检验与探索性研究相结合,对国产注射用盐酸平阳霉素的质量现状进行评价。结果按法定标准检验,合格率100%;但现行标准存在限度宽松、方法设置不合理、色谱信息不完善等问题。探索性研究配伍稳定性结果显示,盐酸平阳霉素在5%葡萄糖注射液中迅速降解为具有较强毒性的平阳霉素A6。结论国内现有制剂整体质量好;建议对现行质量标准进行增修订;对说明书中溶剂配伍用法进行修订。Objective To evaluate the quality status of the domestic bleomycin A5 hydrochloride for injection.Methods According to the general requirements of national assessment programs in 2019,the standard methods combined with exploratory researches were used to test the quality of bleomycin A5 hydrochloride for injection.Results The sample was tested according to the legal standard,and the qualified rate was 100%.The standard inspection results showed that the existing standard had some problems,such as loose limit,and method settings were not reasonable or imperfect.Exploratory studies showed that bleomycin A5 hydrochloride was rapidly degraded to bleomycin A6 with stronger toxicity in 5%glucose injection.Conclusion At present,the quality of bleomycin A5 hydrochloride for injection is good,but the quality standards need to be improved and the package insert should be modified.

关 键 词：盐酸平阳霉素 配伍稳定性 评价性抽验 质量分析 

分 类 号：R978.1[医药卫生—药品]