注射用硫酸卷曲霉素与包材的相容性考察

发布时间：2019-01-17 20:34

【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。
[Abstract]:Objective to investigate the compatibility of capreomycin sulfate and package for injection. Methods according to pH, clarity of solution, color, adsorption rate of insoluble particulates, drug adsorption rate, related substances and antioxidant 2x6, tert-Ding Ji -4methyl-phenol (BHT) migration, the results showed that: 1. The compatibility of different rubber stoppers and glass bottles with crimmycin sulfate for injection was investigated by accelerated test at 60 鈩，

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