头孢呋辛钠原料药贮存条件和充氮对色级的影响

发布时间：2018-01-24 03:08

本文关键词： 头孢呋辛钠贮存条件充氮色级　出处：《苏州大学》2014年硕士论文　论文类型：学位论文

【摘要】：【目的】头孢呋辛钠溶液颜色不稳定，本研究探讨无菌头孢呋辛钠原料药贮存条件和充氮对色级的影响。【方法】取完全相同生产工艺生产的194批无菌头孢呋辛钠原料药，每批分装出16瓶模拟小包装，每瓶30g，其中8瓶模拟生产过程充入高纯液氮，8瓶不充氮，将4瓶充氮的和4瓶不充氮的放在冷处保存，另外4瓶充氮的和4瓶不充氮的放在阴凉处保存，分别在贮存第3、6、12个月（±3天）各取冷处充氮1瓶、冷处不充氮1瓶、阴凉处充氮1瓶、阴凉处不充氮1瓶，按《中国药典》溶液颜色检查法的第一法观察颜色变化。为了便于统计，将色级YG1规定为0.5，色级=YG1规定为1.0，色级YG2规定为1.5，色级=YG2规定为2.0，，依次类推。比较冷库和阴凉库贮存、充氮与不充氮情况下色级的差异。【结果】（1）在不充氮条件下，阴凉库贮存12个月已有19.1%批次的达到最高色级YG6，而冷库只有7.2%批次的达到最高色级=YG5。（2）在充氮条件下，阴凉库贮存12个月已有8.8%批次的达到最高色级=YG5，而冷库只有2.6%批次的达到最高色级YG5。【结论】（1）无菌头孢呋辛钠原料冷处贮存时色级稳定性明显好于阴凉贮存；（2）无菌头孢呋辛钠原料充氮时色级稳定性明显好于不充氮。
[Abstract]:[purpose] The color of cefuroxime sodium solution was unstable. The effects of storage conditions and nitrogen filling on color grade of aseptic cefuroxime sodium were studied. [methods] 194 batches of aseptic cefuroxime sodium were obtained from the same production process. Each batch was packed with 16 bottles of simulated small packaging, each bottle of 30g, 8 bottles of simulated production process filled with high-purity liquid nitrogen. 8 bottles without nitrogen, 4 bottles of nitrogen filled and 4 bottles of non-nitrogen filled in cold storage, the other 4 bottles of nitrogen-filled and 4 bottles of non-nitrogen-filled storage in the shade, respectively in storage no. 3. For 12 months (卤3 days), 1 bottle of nitrogen was taken from the cold place, 1 bottle was not filled with nitrogen in the cold place, 1 bottle was filled with nitrogen in the shade place, and 1 bottle was not filled with nitrogen in the cool place. The color change was observed according to the first method of the solution color examination method of Chinese Pharmacopoeia. For the sake of statistics, the color grade YG1 was 0.5, the color grade YG1 was 1.0 and the color grade YG2 was 1.5. The color grade YG2 was 2.0, and so on. The difference of color grade between cold storage and cool storage was compared with that without nitrogen filling. [results] 1) under the condition of no nitrogen filling, 19.1% batches have reached the highest color grade YG6 for 12 months, while only 7.2% batches of cold storage have reached the highest color grade YG5. 2) under the condition of nitrogen filling, 8.8% batches of shady storage have reached the highest color grade YG5 for 12 months, while only 2.6% batches of cold storage have reached the highest color grade YG5. [conclusion] 1) the color stability of aseptic cefuroxime sodium in cold storage was better than that in shady storage. 2) the color stability of aseptic cefuroxime sodium was better than that of no nitrogen filling.
【学位授予单位】：苏州大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：TQ460.4;R978.1

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