外障眼水长期稳定性的考察  

An observation on long-term stability of Waishang eyedrops

作　　者：郭朝光[1] 陈燕芬[1] 王磊[1] 黄江虹[1] 

机构地区：[1]广东省中医院药学部,广州510120

出　　处：《国际医药卫生导报》2011年第15期1874-1877,共4页International Medicine and Health Guidance News

摘　　要：目的建立外障眼水中盐酸小檗碱的含量标准，通过各指标的变化考察其稳定性。方法对6个不同批号的外障眼水一年半内不同时间点进行规定项目考察，用高效液相色谱法检测盐酸小檗碱含量，色谱条件：WaterC18柱（4．6mm×250mm，5gm）；流动相：A为乙腈，B为0．2％三乙胺水溶液，洗脱梯度：0～12min（10％A，90％B），12～20min（10％～25％A，90％～75％B），20～35min（25％～35％A，75％-65％B），35～45min（35％-50％A，65％～50％B），45—50min（50％～10％A，50％～90％B），用PHS-3C酸度计测量pH值，用比重瓶测密度，用无菌考察法考察无菌结果。结果外障眼水的盐酸小檗碱含量在70～115μg．ml^-1范围内；pH值、澄明度、相对密度、无菌试验结果各项指标均符合相关标准：pH值为3．5～5．5，相对密度〉1．001g．ml^-1，该制剂为无菌。结论该高效液相色谱法可测定外障眼水中盐酸小檗碱的含量，各检测指标的结果说明该制剂质量稳定、可靠。Objective To establish the content standard of berberine hydrochloride in Waizhang eyedrops, and to observe the stability of the eyedrops using changes in different indexes. Methods Waizhang eyedrops of six different batch number were detected at different time points within 18 months. Berberine hydrochlo-ride content was determined by high-performance liquid chromatography （ HPLC ）. Water C18column （ 4.6 mm×250 mm, 5 pm ）and ternary gradient mobile phase （ A： methyl cyanides and B： 0.2% triethylamine ） were used.The elution gradients were （ IO%A and 90%B ） at 0 - 12 min, （ 10% - 25%A and 90% - 75%B ） at 12-20 min, （25%-35%Aand75%-65%B） at 20-35min, （35%-50%Aand65%-50%B） at 35-45min, and （ 50% - 10%A and 50% - 90%B ） at 45 - 50 min. pH value, relative density, and aseptic level were detected. Results The contents of berberine hydrochloride were limited at the range of 70-115μg.ml^-1. The pH value, clarity, relative density and sterility test results all met the standards： pH 3.5 - 5.5, relative density 〉 1.001 g. ml^-1, and aseptic status. Conclusions HPLC can detect the content of berberine hydrochloride in Waizhang eyedrops. Various test results show Waizhang eyedrops is stable and reliable.

关 键 词：外障眼水 盐酸小檗碱 高效液相色谱法 

分 类 号：S858.24[农业科学—临床兽医学]