摘要
目的建立可溶微针贴片中蜂毒肽的含量测定方法。方法采用HPLC法测定可溶微针贴片中蜂毒肽的含量。色谱柱:Unitary C185μm 100A(4.6 mm×250 mm),A相:0.1%TFA水溶液,B相:0.1%TFA乙腈溶液,梯度洗脱,洗脱程序共30 min。波长220 nm,流速1.0 ml/min,温度30℃,进样量20μl。结果使用高效液相色谱法测定微针中蜂毒肽的专属性高,浓度在10-250μg/ml的范围内呈现良好的线性关系(Y=16564x-41732,R^2=0.9996)。日内和日间精密度、稳定性和加样回收率均符合要求。结论HPLC法测定可溶微针贴片中蜂毒肽的含量操作简单、结果准确,可作为可溶微针贴片中蜂毒肽含量测定的质量控制方法,为微针中蛋白质类等大分子药物的含量测定提供理论基础。
Objective To establish a method for the determination of melittin in dissolving microneedles(DMNs).Methods HPLC was used to determine the content of melittin in dissolving microneedles(DMNs)with Unitary C185μm 100A(4.6 mm×250 mm).The 0.1%TFA in water(solvent A)and 0.1%TFA in acetonitrile(solvent B)were used as the mobile phase for gradient elution for 30 min.The flow rate was 1.0 ml/min.The column temperature was 30℃and the detection wavelength was 220 nm.The input volume was 20μl.Results The calibration curve of melittin showed good linearity in the range of 10-250μg/ml(Y=16564x-41732,R^2=0.9996).The specificity of melittin,the intra-day and inter-day precision,the stability and the sample recovery all met the requirements.Conclusion This HPLC method for determining the content of melittin in dissolving microneedles(DMNs)is simple and accurate,and it could be used as a quality control method for the determination of melittin in dissolving microneedles(DMNs)and provide a theoretical basis for the determination of proteins and other biological macromolecular drugs in DMNs.
作者
董智勇
李莹莹
魏芳
陈远政
刘航
徐雨靓
马涛
王清清
DONG Zhiyong;LI Yingying;WEI Fang;CHEN Yuanzheng;LIU Hang;XU Yuliang;MA Tao;WANG Qingqing(Department of Pharma-ceutics,Faculty of Pharmacy,Bengbu Medical College,Bengbu 233000,China)
出处
《山西医科大学学报》
CAS
2020年第5期444-448,共5页
Journal of Shanxi Medical University
基金
安徽高校自然科学研究重点项目(KJ2019A0296)
地方高校国家级大学生创新创业训练计划项目(201810367014,201910367033)。
关键词
蜂毒肽
可溶微针贴片
高效液相色谱法
melittin
dissolving microneedles
high performance liquid chromatography
作者简介
董智勇,男,1995-06生,在读硕士,E-mail:dongzhiyong0629@163.com;通讯作者:王清清,E-mail:mailto:Qingqingwang@bbmc.edu.cn。
