發(fā)布時(shí)間：2019-01-17 20:34

【摘要】：目的考察注射用硫酸卷曲霉素與包材的相容性。方法以酸堿度、溶液的澄清度、顏色、不溶性微粒、包材對藥物吸附率、有關(guān)物質(zhì)及抗氧劑2,6-叔丁基-4-甲基-苯酚(BHT)遷移為指標(biāo),通過60℃下加速試驗(yàn)考察不同的膠塞及玻璃瓶與注射用硫酸卷曲霉素的相容性。結(jié)果未覆膜溴化丁基膠塞對該藥的澄清度、不溶性微粒及抗氧劑BHT遷移有影響,覆膜溴化丁基膠塞相對未覆膜膠塞影響較小。低硼硅玻璃瓶對其不溶性微粒有影響。結(jié)論覆膜溴化丁基膠塞相對未覆膜溴化丁基膠塞,中硼硅玻璃瓶相對低硼硅玻璃瓶更能保證注射用硫酸卷曲霉素產(chǎn)品的質(zhì)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，

本文編號(hào)：2410366