吡拉西坦注射液的生产工艺研究  

Production Technology of Piracetam Injection

作　　者：张丽宝[1] 许方燕 陈慧 Zhang Libao;Xu Fangyan;Chen Hui(Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255000,China)

机构地区：[1]山东新华制药股份有限公司,山东淄博255000

出　　处：《山东化工》2022年第14期163-165,共3页Shandong Chemical Industry

摘　　要：目的:研究吡拉西坦注射液的生产工艺。方法:对吡拉西坦注射液进行灭菌工艺研究,筛选并确定最佳工艺条件,并根据确定的工艺条件进行工艺验证。结果:吡拉西坦注射液采用湿热灭菌工艺,灭菌条件选择121℃灭菌12 min,F_(0)值≥12,制备的产品质量符合要求。结论:合理的制备工艺和条件,可以保证吡拉西坦注射液的质量。Objective:To study the production technology of Piracetam injection.Methods:The sterilization process of Piracetam injection was studied to determine the best process.It was verified according to the determined process conditions.Results:Piracetam injection adopts the thermal sterilization process.The sterilization condition is 121℃for 12 min and F_(0)≥12,The prepared product quality meets the requirements.Conclusion:Reasonable preparation process and conditions can ensure the quality of Piracetam injection.

关 键 词：吡拉西坦注射液 灭菌工艺 工艺验证 

分 类 号：TQ460[化学工程—制药化工]