不同灭菌方法对浓盐酸普鲁卡因注射液质量的影响  

Effect of Different Sterilization Methods on Quality of Concentration Procaine Hydrochloride

作　　者：陈瑶[1] 孙旭[1] 高媛[1] 张世晓 张炜 刘忠良[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,山东济南250022 [2]解放军159医院,河南驻马店463000 [3]解放军107医院,山东烟台264000

出　　处：《解放军药学学报》2016年第2期163-165,共3页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：总后勤部卫生部2013年度军队医疗机构制剂标准提高科研专项课题计划;No.13ZJZ21-2

摘　　要：目的规范浓盐酸普鲁卡因注射液的灭菌方法,确保浓盐酸普鲁卡因注射液的安全有效。方法采用不同灭菌方法对浓盐酸普鲁卡因注射液进行灭菌,运用滴定法和HPLC法分别测定浓盐酸普鲁卡因注射液中盐酸普鲁卡因的含量,无菌试验检查灭菌后浓盐酸普鲁卡因注射剂的无菌性。结果浓盐酸普鲁卡因注射液宜采用流通蒸汽灭菌法30 min进行灭菌。结论流通蒸汽灭菌30 min既可保证浓盐酸普鲁卡因注射液的无菌性,又可确保其含量的稳定性,是较为理想的灭菌方法。Objective To validate the sterilization methods of concentration procaine hydrochloride injection and ensure its safety and effect. Methods Different methods were used to sterilize the concentration procaine hydrochloride injection before the content of procaine hydrochloride was determined by titration method and HPLC. The sterility of procaine hydrochloride injection was tested. Results Flow-steam sterilization for 30 mins is suitable for concentration procaine hydrochloride injection. Conclusion Flow-steam sterilization for 30 mins can not only ensure the sterility of concentration procaine hydrochloride injection,but also keep its content stable.

关 键 词：浓盐酸普鲁卡因注射液 灭菌方法 

分 类 号：R917[医药卫生—药物分析学]