“网脱Ⅰ号”口服液长期稳定性研究  

Research on long-term stability of "No.Ⅰ detachment of retina" oral liquid

作　　者：彭燕[1] 李冬[1] 王本富[1] 胡辉[1] 

机构地区：[1]解放军474医院药剂科,新疆乌鲁木齐830013

出　　处：《中国药物应用与监测》2011年第6期346-349,共4页Chinese Journal of Drug Application and Monitoring

基　　金：中国人民解放军兰州军区科研项目(LXH-2008018)

摘　　要：目的:对"网脱Ⅰ号"口服液的长期稳定性进行考察。方法:根据长期稳定性实验方法,检测"网脱Ⅰ号"口服液的性状、相对密度、pH值。采用HPLC法测定芍药苷和阿魏酸含量,色谱柱:Diamonsil C18柱(4.6 mm×150 mm,5μm),流动相为乙腈-0.1%磷酸(20∶80),双波长检测230 nm/320 nm,流速为1.0 mL.min-1。结果:"网脱Ⅰ号"口服液的性状、相对密度、pH值在18个月内无明显变化;芍药苷和阿魏酸分别在10～200μg.mL-(1r=0.999 6)、10～30μg.mL-(1r=0.999 3)浓度范围内线性关系良好;加样回收率分别为(100.22±1.05)%和(100.68±1.09)%。结论:"网脱Ⅰ号"口服液在18个月内质量较稳定。Objective： To investigate the long-term stability of＂ No.Ⅰdetachment of retina＂ oral liquids.Methods： According to the guidance of China Pharmacopoeia for long-term stability test,the characteristics,relative density and pH value of＂ No.Ⅰdetachment of retina＂ oral liquid were detected.An HPLC method was used to determine paeoni？ orin and ferulic acid with the Diamonsil C18 columm（4.6 mm×150 mm,5 μm）,the mobile phase was a mixture of acetonitrile-0.1% phosphoric acid（20∶80）.The detection wavelengths were 230 nm/320 nm,the ？ ow rate was 1.0 mL.min-1.Results： There were no signif icant changes of the characteristics,relative density and pH value in＂ No.Ⅰdetachment of retina＂ oral liquid in 18 months.The good linear ranges of paeoni？ orin and ferulic acid were 10 – 200 μg.mL-1（r = 0.999 6） and 10 – 30 μg.mL-1（r = 0.999 3）,and the recoveries were（100.22±1.05）% and（100.68±1.09）%,respectively.Conclusion： The quality of＂ NoⅠdetachment of retina＂ oral liquid is stable in 18 months.

关 键 词：“网脱Ⅰ号”口服液 长期稳定性 

分 类 号：R286.0[医药卫生—中药学]