注射用硫酸卷曲霉素与包材的相容性考察  

Study on the compatibility between capreomycin sulfate for injection and packing materials

作　　者：李茜[1] 刘英[1] 杨淑先[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国抗生素杂志》2015年第8期603-606,616,共5页Chinese Journal of Antibiotics

摘　　要：目的考察注射用硫酸卷曲霉素与包材的相容性。方法以酸碱度、溶液的澄清度、颜色、不溶性微粒、包材对药物吸附率、有关物质及抗氧剂2,6-叔丁基-4-甲基-苯酚(BHT)迁移为指标,通过60℃下加速试验考察不同的胶塞及玻璃瓶与注射用硫酸卷曲霉素的相容性。结果未覆膜溴化丁基胶塞对该药的澄清度、不溶性微粒及抗氧剂BHT迁移有影响,覆膜溴化丁基胶塞相对未覆膜胶塞影响较小。低硼硅玻璃瓶对其不溶性微粒有影响。结论覆膜溴化丁基胶塞相对未覆膜溴化丁基胶塞,中硼硅玻璃瓶相对低硼硅玻璃瓶更能保证注射用硫酸卷曲霉素产品的质量。Objective To study the compatibility between capreomycin sulfate for injection and packingmaterials. Methods With the pH, clarification of the solution, color, insoluble particles, packaging materialsadsorption rate, related substances and butylated hydroxytoluene （BHT） as parameters, study on the compatibilitybetween different stoppers/bottles and capreomycin sulfate for injection by accelerated tests at 60℃. ResultsUncoated brominated butyl rubber stopper could affect the clarity of the drug, insoluble particles and BHT migration.Coated brominated butyl rubber stopper has relatively less effect than uncoated rubber stopper. The low borosilicateglass could affect the insoluble particles. Conclusion Coated brominated butyl rubber stopper and in borosilicateglass are better to ensure the quality control of capreomycin sulfate for inject.

关 键 词：硫酸卷曲霉素 相容性 包材 胶塞 硼硅玻璃 

分 类 号：R978.16[医药卫生—药品]