复方氨基酸注射液(18AA)过热灭菌可行性探析

The feasibility of thermal sterilization about Compound Amino Acid Injection(18AA)

目的探讨复方氨基酸注射液(18AA)采用参数121℃、10min灭菌的可行性.方法采用121℃、10min与105℃、30min两个条件对该产品进行灭菌,考察灭菌后产品的质量.结果复方氨基酸注射液(18AA)在121℃、10min与105℃、30min两个条件下灭菌的产品,其含量、降解物质、颜色、透光度等各质量指标未有明显区别,综合对比结果121℃、10min灭菌能同时达到保证产品内在质量和无菌保证值的要求.结论 121℃、10min可以作为复方氨基酸注射液(18AA)的灭菌条件.

OBJECTIVE Probing the feasibility of Compound Amino Acid Injection（18AA） sterilization using the parameters：121℃,10min.METHODS Using two conditions for the sterilization：121℃,10min and 105℃,30min,studying the quality of the product after sterilization.RESULTS After the two conditions for the product sterilization：121℃,10min and 105℃,30min,the content,degradation products,color,transmittance and other quality indicators have no significant difference,the parameter of 121℃,10min for sterilization can ensure product quality and reach the requirements of sterility assurance value by comprehensive comparison.CONCLUSION The parameter of 121℃,10min can be used for Compound Amino Acid Injection（18AA） sterilization.