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.
出处
《解放军药学学报》
CAS
CSCD
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
关键词
浓盐酸普鲁卡因注射液
灭菌方法
concentration procaine hydrochloride injection
sterilization methods
作者简介
作者简介：陈瑶，博士。研究方向：药物分析。Tel：（0531）51637725；E—mail：yao—then@live．com
通讯作者：刘忠良，Tel：（0531）51637761；E—mail：lzl-1962@126．com
