低温间歇灭菌法在外障眼水中应用研究  

Application Research of Low-temperature Fractional Sterilization Method in Waizhang Eye Drop

作　　者：章伟胜[1] 陈燕芬[1] 王磊[1] 黄江虹[1] 余楚钦[2] 

机构地区：[1]广东省中医院,广东广州510120 [2]广东药学院药物研究所,广东广州510006

出　　处：《临床医学工程》2011年第7期1102-1103,共2页Clinical Medicine & Engineering

摘　　要：目的通过观察低温间歇灭菌前后外障眼水各检测指标的变化,考察低温间歇灭菌法的可行性。方法用四批外障滴眼剂为研究对象,采用90℃灭菌2h,共三次,观察外障滴眼水灭菌前后的pH值、澄明度、相对密度,做无菌检测,并用高效液相色谱法测定灭菌前后盐酸小檗碱的变化。结果灭菌前后pH值略有降低,相对密度、澄明度符合规定;灭菌后无菌检测合格,盐酸小檗碱的含量无变化。结论低温间歇灭菌法对于外障眼水进行灭菌是可靠的、稳定的、可行的。Objective By observing the different changes of detected indicators in Waizhang eye drop before and after low-tempera-ture fractional sterilization,to observe the feasibility of low-temperature fractional sterilization method.Methods To research the changes of four groups of Waizhang eye drop,the sterilization was applied for three times in two hours.The pH values before and after sterilization,clarity,relative density were observed,the terility testing was done,and the changes of berberine hydrochloride before and after sterilization were checked by HPLC.Results The pH values before and after sterilization were slightly lower,the records of the clarity and relative densi-ty were accorded with the standardization of setting;after sterilization the sterility testing was qualified,the contents of berberine hydrochlo-ride had no changes.Conclusion The method of low-temperature fractional sterilization in Waizhang eye drop is reliable,stable,feasible.

关 键 词：低温间歇灭菌 外障眼水 高效液相 盐酸小檗碱 

分 类 号：R187[医药卫生—流行病学]