注射用盐酸平阳霉素的质量评价

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。

Quality assessment of bleomycin A5 hydrochloride for injection

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.