摘要
目的:通过全方位的对比试验,优化氧氟沙星氯化钠注射液(100mL:0.2g+0.9g)的配置生产工艺。方法:通过对注射液配置过程中的注射用水温度、pH值,加料顺序等项目的考察,同时对不同工艺所产成品的相关物质与该批氧氟沙星原料的有关物质进行比较,找出工艺稳定,适宜工业化大生产的制剂工艺。结果:氧氟沙星在酸性环境下溶解迅速,成品有关物质稳定,质量可靠。结论:加酸工艺可以解决氧氟沙星氯化钠注射液(100mL:0.2g+0.9g)成品有关物质偏高,不稳定的现象,工艺简单,能耗降低,适宜于工业化大生产。
Objective： To optimize the preparation process of Ofloxacin and Sodium Chloride injection （100mL ： 0. 2g ＋ 0. 9g） with exhaustive comparison tests. Methods ： Through the research of parameters about the injection water temperature,pH and feeding order in preparation,and at the same time, we contrasted the item of related substances of end products from different processes with this batch of Ofloxacin to find stable process suitable forindustrialized production. Results：Ofloxacin was easier to dissolve in the acidic environment, related substance of finished produces was stable and the quality of the injection was higher. Conclusion ：Adding acid technology is successful to solve the problems：there are more and unstable related substances in Ofloxacin and Sodium Chloride injection. The technology is simple and lower energy consumption, which is fit for industri- alized production.
出处
《黑龙江医药科学》
2008年第5期19-20,共2页
Heilongjiang Medicine and Pharmacy
关键词
氧氟沙星
氧氟沙星氯化钠注射液
盐酸
Ofloxacin
Ofloxacin and Sodium Chloride injection
hydrochloric acid
