HPLC同时测定痛宁凝胶中延胡索乙素和原阿片碱的含量  

HPLC Determination of Protopine and Tetrahydropalmatine in Tongning Gel

作　　者：王伟[1,2,3] 尚强[1,2,3] 杨璐[1,2,3] 毕宇安[1,2,3] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001 [3]江苏省企业院士工作站,江苏连云港222001

出　　处：《中国实验方剂学杂志》2011年第12期93-95,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家科技部重大新药创制项目(2009ZX09313-032)

摘　　要：目的:建立痛宁凝胶中延胡索乙素和原阿片碱的含量测定方法。方法:采用高效液相色谱法,色谱柱为KromasilC18柱(4.6 mm×250 mm,5μm),以乙腈-磷酸盐溶液为流动相进行梯度洗脱,检测波长280 nm,柱温30℃,流速1.0 mL·min-1。结果:原阿片碱在0.100 6～5.03μg呈良好的线性关系(r=1.0),平均回收率为99.14%,RSD 1.34%(n=6);延胡索乙素在0.100 8～5.04μg呈良好的线性关系,r=1.0,平均回收率为101.1%,RSD 1.18%(n=6)。结论:方法操作简便、可靠,重现性好,专属性强,能有效控制该制剂的质量。Objective：To establish an HPLC method for determination of protopine and tetrahydropalmatine in Tongning Gel.Method：The liquid chromatography was carried out using Kromasil C18（4.6 mm × 250 mm,5 μm）,with detection wave length at 280 nm,acetonitile-phosphate buffer as mobile phase,gradient elution.The column temperature was at 30 ℃ and the flow rate was 1.0 mL·min-1.Result：The calibration curve of protopine was linear in the range of 0.100 6-5.03 μg（r = 1）,and the recovery was 99.14%（RSD 1.34%）.The calibration curve of tetrahydropalmatine was linear in the range of 0.100 8-5.0 4 μg（r = 1）,and the recovery was 101.1%（RSD 1.18%）.Conclusion：This method is simple,accurate,reliable and reproducible,which can be used for quality control of Tongning Gel.

关 键 词：痛宁凝胶 延胡索乙素 原阿片碱 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]