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.
作者
张丽宝
许方燕
陈慧
Zhang Libao;Xu Fangyan;Chen Hui(Shandong Xinhua Pharmaceutical Co.,Ltd.,Zibo 255000,China)
出处
《山东化工》
CAS
2022年第14期163-165,共3页
Shandong Chemical Industry
关键词
吡拉西坦注射液
灭菌工艺
工艺验证
piracetam injection
sterilization process
process validation
