枸橼酸咖啡因注射液灭菌工艺的研究与验证

Research and Verification of the Sterilization Process of Caffeine Citrate Injection

枸橼酸咖啡因注射液的无菌水平是用药过程中的基本保障之一,而灭菌工艺的研究是保证产品质量和用药安全的关键步骤,应充分了解药品活性成分的性质,选择合理的灭菌方式及工艺参数,并且应当经过验证,以保证产品无菌水平,同时对比灭菌前后产品质量,确保产品质量在灭菌过程中的稳定性。

The aseptic level of caffeine citrate injection is one of the basic guarantees in the medication process,and the research of sterilization process is a key step to ensure product quality and medication safety.It is necessary to fully understand the nature of the active ingredients of the drug and select reasonable sterilization methods and process parameters,and they should be verified to ensure the sterility level of the product.At the same time,to ensure the stability of the product quality during the sterilization process,we should compare the product quality before and after sterilization.