乳酸左氧氟沙星氯化钠注射液生产工艺优化研究  

Study on production technology optimization of Levofloxacin Lactate and Sodium Chloride Injection

作　　者：崔效廷[1] 王红芸 张春仙[3] 

机构地区：[1]山东大学药学院,山东济南250012 [2]山东鲁抗医药股份有限公司,山东济宁272021 [3]济宁学院化学与化工系,山东曲阜273155

出　　处：《齐鲁药事》2012年第9期546-547,553,共3页qilu pharmaceutical affairs

摘　　要：目的提高乳酸左氧氟沙星氯化钠注射液的成品率。方法以成品中可见异物为评价指标,采用正交设计试验,对生产工艺条件进行优化筛选。结果减少可见异物的最佳生产工艺条件为:生产前密闭循环的金属络合剂EDTA-2Na浓度为0.2‰、密闭循环温度为40℃、密闭循环时间为20 min、灌装温度为40℃、NaCl浓配加药用炭量为3%。结论改进后的生产工艺简单易行,大大提高了产品的成品率。Objective To improve the production yield of Levofloxacin Lactate and Sodium Chloride Injection. Methods The preparation technology was optimized by the orthogonal test with visible foreign sunstance as index. Results The optimum production technology was as follows：the closed loop time was 20 minutes at the temperature of 40 ℃ with the EDTA -2Na con- centration of 0.2%o, the burden temperature was 40 ℃ and the quantity of active carbon was 3 %. Conclusion The new prepara- tion technology was more practical and simple,and it can greatly improve the production yield.

关 键 词：乳酸左氧氟沙星氯化钠注射液 含量测定 生产工艺优化 

分 类 号：TQ460.6[化学工程—制药化工]