HPLC法测定新藤黄酸囊泡溶液中药物的含量及包封率

摘要

Objective To establish HPLC method to determine the content and envelope rate of neo - gambogic acid in neo -gambogic acid vesicles solution. Methods The ethanol - injection method was carried out to prepare the neo - gambogic acid vesicles. The chromatographic column was Cosmosil C18( 4. 6 mm ×250 mm,5μm );the flow phase was methanol - 0. 1% orthophosphoric acid ( 90:10 );the sample size was 20 μl;the flow rate was 1. 0 ml/min;the detecting wavelength was 360 nm;and the temperature was 30 ℃. Results Under those chromatographic conditions above, adjuvants and reagent had no intervention on the detection of the medicine,and the isolation effect was good. Gambogic acid had a good liner relation at the content range of 0. 02 - 32. 00 μg/ml( r = 0. 9996,n =7 ). The average recovery rate was 99. 27% , and RSD was 1. 03% ( n = 3 ). The envelope rate was( 48. 0 ± 1. 0 )% . Conclusion This HPLC method is accurate, reliable, and repeatable and can be used in the detection of neo - gambogic acid content and envelope rate in neo - gambogic acid vesicles solution.%目的 建立测定新藤黄酸囊泡中新藤黄酸含量和包封率的HPLC法.方法 用乙醇注入法制备新藤黄酸囊泡,HPLC法测定其中药物含量,微柱离心法测定新藤黄酸囊泡的包封率,其中色谱柱为COSMOSIL C18柱(4.6 mm×250 mm,5 μm),流动相为甲醇:0.1%磷酸(90:10),进样量20 μl,流速1.0 ml/min,检测波长360 nm,温度30 ℃.结果 在上述色谱条件下,辅料和试剂对药物的测定无干扰,分离效果良好.新藤黄酸浓度在0.02~32.00 μg/ml范围内线性关系良好(r=0.9996),平均回收率为99.27%,RSD为1.03%(n=3).新藤黄酸囊泡的包封率为(48.0±1.0)%.结论 所建立的HPLC法准确、可靠、重复性好,可用于新藤黄酸囊泡中新藤黄酸含量及包封率的测定.