治带片的质量控制研究  

The Determination on the Quantity Control Method of Zhidai Tablets

作　　者：石延榜[1] 黄海英[1] 侯国茹[1] 李肇进 

机构地区：[1]河南中医学院,河南郑州450008 [2]河南健康伟业药业公司,河南郑州450008

出　　处：《河南中医学院学报》2007年第5期26-27,共2页Journal of Henan University of Chinese Medicine

摘　　要：目的：研究治带片的质量控制方法。方法：采用HPLC法测定治带片苦参碱的含量，测定波长选用220 nm；以甲醇：乙腈：磷酸盐缓冲液（7.6）：三乙胺（15∶25∶65∶0.1）用磷酸调PH=7.8为流动相，流速1.0 ml/min。结果：苦参碱在0.1-0.8μg的范围内与峰面积呈良好的线性关系，R2=1，精密度RSD为0.79%（n=5），稳定性试验结果显示，制备的供试品溶液在8 h内稳定，RSD为0.73%。重现性试验结果显示，所建立方法重现性良好，RSD为0.73%。平均加样回收率为98.20%，RSD=0.67%。结论：本法操作简便，重复性好，结果准确可靠。Objective： To establish a method for quantity control in Zhidai Tablets. Methods： To establish a method for determining matrine in Zhidai Tablets by HPLC. The detection wavelength is 220 nm, Using C18 column as the stationary phase and methanol. acetonitrile： the buffer of phosphoric acid： triethylamine （ 15 ： 25 ： 65 ： 0.1 ） （PH = 7.8 ） as the mobile phase, and the flow rate is 1.0 ml/min. Results： The linear relationship of matrine was in the range of 0.1-0.8μg. the RSD of the precision is 0.79% （n = 5）. based on the results of Stability test, the solution using in the test will stable in 8 hours, and the RSD was 0.73%. the RSD of the reproduction was 0.73 %. The average recovery was 98.2 % and RSD was 0.67 % （n = 5）. Conclusion. The method is convenient, rapid, accurate and suitable for the quality control.

关 键 词：治带片 高效液相色谱法 苦参碱 

分 类 号：R288[医药卫生—中药学]