对乙酰氨基酚注射液大生产工艺研究

Study on the Production Process of Acetaminophen Injection

目的:对对乙酰氨基酚注射液的制备工艺和产品常温放置下的稳定性进行研究,制定切实可行的大生产工艺。方法:通过单因素考察确定制剂的搅拌溶解时间,灭菌工艺,最适pH值等,筛选出最优工艺条件,用高效液相色谱法测定其含量,并对在最优工艺条件下生产的成品进行稳定性考察,验证工艺路线的稳定性和可行性。结果:对乙酰氨基酚注射液制备工艺最优条件为搅拌溶解时间为60min,控制产品pH值在5.0与6.0之间,115℃热压灭菌30min,可以成功制得对乙酰氨基酚注射液,产品规格为2ml:0.25g。此产品在常温下密封放置6个月稳定性良好。结论:优化后的对乙酰氨基酚注射液生产工艺稳定可行,成品质量稳定可控,适用于工业化大生产。

Objective:To study the preparation process of acetaminophen injection and the stability of the product at room temperature,and to develop a feasible large-scale production process.Methods:The stirring dissolution time,sterilization process and optimal pH value of the preparation were determined by single factor investigation,and the optimal process conditions were selected.The content was determined by high performance liquid chromatography.The stability of the finished product produced under the optimal process conditions was investigated to verify the stability and feasibility of the process route.Results:The optimal conditions for the preparation of acetaminophen injection were as follows:the stirring dissolution time was 60 min,the pH value of the product was controlled at 5.0~6.0,and the hot pressing sterilization was 30 min at 115℃.The acetaminophen injection was successfully prepared,and the product specification was 2 ml:0.25 g.This product has good stability at room temperature for 6 months.Conclusion:The optimized production process of acetaminophen injection is stable and feasible,and the quality of the finished product is stable and controllable,which is suitable for industrial production.