摘要
目的:建立胰岛素传递体制剂体外HPLC测定方法。方法:采用HPLC,对胰岛素传递体测定方法专属性、线性关系、系统适应性试验、精密度、回收率、包封率及载药量等指标进行考察。色谱柱为Phenomenex Luna C18 column(250 mm×4.6 mm,5μm),流动相A为0.05 mol/L磷酸二氢钠溶液(pH 3.0),流动相B为乙腈,梯度洗脱;流速1.0 mL/min;柱温为30℃;检测波长为214 nm。结果:胰岛素在6.25-400μg/mL的浓度范围内与峰面积呈良好的线性关系(R 2=0.999 6);精密度和回收率等均符合要求。结论:本方法可靠、稳定、重现性好,可用于胰岛素传递体中胰岛素的含量测定。
Objective:To establish a method for in vitro analysis of insulin delivery system preparations by the method of insulin delivery body chromatography.Methods:HPLC combined with centrifugation method were adopted,The method specificity,linear relationship,system adaptability test,system suitability test,precision,recovery rate,encapsulation rate and drug loading were examined.The determination was performed on Phenomenex Luna C18 column(250 mm×4.6 mm,5μm)column with mobile phase consisted of 0.05 mol/L sodium dihydrogen phosphate solution(pH 3.0)-acetonitrile by gradient elution.The detection flow rate was 1.0 mL/min,the wavelength was set at 214 nm and the column temperature was set at 30℃.Results:There was a good linear relationship between the peak area and the line range was 6.25-400μg/mL(R 2=0.999 6).The precision and recovery were both satisfactory.Conclusion:The method is reliable,stable,reproducible,which can be applied for determining the content of insulin in delivery.
作者
龚菊梅
刘修树
范高福
刘龙云
汤洁
范雪梅
王义明
GONG Jumei;LIU Xiushu;FAN Gaofu;LIU Longyun;TANG Jie;FAN Xuemei;WANG Yiming(Hefei Technology College,Hefei 230038,China;Department of Chemistry,Tsinghua University,Beijing 100084,China)
出处
《安徽科技学院学报》
2019年第3期48-52,共5页
Journal of Anhui Science and Technology University
基金
安徽省名师(大师)工作室项目(2016msgzs062)
安徽省省级教学团队项目(2016jxtd103)
合肥职业技术学院校级自然科学研究项目(201714KJA002)
关键词
胰岛素
传递体
体外分析方法
Insulin
Delivery
In vitro analysis method
