利多卡因纳米乳的制备及质量控制  

Determination of the content of lidocaine in lidocaine nanoemulsion by HPLC

作　　者：朱晓亮[1] 陈志良[2] 李国锋[2] 曾抗[1] 刘婵[2] 

机构地区：[1]南方医科大学南方医院皮肤科,广东广州510515 [2]南方医科大学南方医院药材科,广东广州510515

出　　处：《中国医院药学杂志》2008年第1期30-33,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:制备利多卡因纳米乳并建立其质量控制的方法。方法:伪三元相图法结合origin7.0软件分析确定制备5%利多卡因纳米乳的最佳Km值(表面活性剂/助表面活性剂)及各组分的比例;对利多卡因纳米乳的外观及稳定性进行考察;马尔文Zeta粒径分析仪测定利多卡因纳米乳粒径大小及分布范围;透射电镜观察利多卡因纳米乳的形态及体系类型;HPLC法对利多卡因纳米乳进行质量控制考察。结果:Km=3时利多卡因纳米乳形成区域的面积值最大,利多卡因纳米乳的平均粒径为36.4nm,其中98%的粒径范围介于17.1～57.5nm之间,2%介于77.9～261.3nm之间;其分布体系为大小不均的球形多分散体系;利多卡因进药量与色谱峰面积在10～200mg.L-1范围内线性关系良好(r=0.9994),平均回收率为99.45%,RSD为1.08%。结论:伪三元相图法结合origin7.0软件分析并确定利多卡因纳米乳各组分比例的方法简便、准确;马尔文粒径测定结合透射电镜观察测定利多卡因纳米乳的粒径、分布、形态及体系类型的方法较为全面;利多卡因纳米乳样品的处理和HPLC测定方法简便、快速、准确,可作为利多卡因纳米乳的质量控制考察。OBJECTIVE To study the preparation process and method of quality control of lidocaine nanoemulsion. METHODS The optimal Km（surfactant/cosurfactant）value and component proportion were obtained through pseudo-ternary phase diagrams together with origin 7. 0 software;The diameter and its distribution range were detected through Zeta particle size analysis instrument and the appearance with system type of nanoemulsion was observed through transmission electron micrograph;The quality of lidocaine nanoemulsion was controlled by HPLC method. RESULTS The nanoemulsion area of the pseudo-ternary phase diagrams was the maximum as the Km value was three; the average drop size of lidocaine nanoemulsion was 36. 4 nm,ninety-eight percent of the drop size range was between 17. 1 - 57. 5 nm and two percent was between 77. 9 - 261.3 nm; The nanoemulsion drop showed that the appearance was spherical shape and multi-disperses system; There was a good liner relationship within the concentration range of 1（1 - 200 mg.L^-1 of lidocaine （r = 0. 999 4） and the average recovery was 99. 45%（n = 5, RSD=1.08%）. CONCLUSION The component proportion of lidocaine nanoenmlsion can be convenient obtained through pseudo-ternary phase diagrams and origin 7.0 software analysis; The drop size, distribution, shape and system type can be observed through Malvern Zetasizer combining with electron micrograph; Results obtained shows that the methods of nanoemulsion sample treatment and the HPLC is accurate and reliable for the quality control of lidocaine nanoemulsion.

关 键 词：高效液相色谱法 利多卡因 纳米乳 

分 类 号：R944.9[医药卫生—药剂学]