HPGPC法检测注射用益气复脉(冻干)中的糖苷类大分子物质  

Test of glycoside macromolecule in Yiqi Fumai Injection(freeze-drying) by HPGPC

作　　者：韩晓萍[1,2] 叶正良[3] 王薇丹[3] 李德坤[3] 周大铮[3] 林瑞超[4] 刘丽芳[2] 

机构地区：[1]青海省药品检验所,青海西宁810000 [2]中国药科大学,江苏南京211198 [3]天津天士力之骄药业有限公司,天津300402 [4]中国药品生物制品检定所,北京100150

出　　处：《中成药》2011年第5期814-817,共4页Chinese Traditional Patent Medicine

摘　　要：目的建立注射用益气复脉(冻干)(红参、麦冬、五味子)中的大分子物质的HPGPC检测方法。方法采用高效凝胶色谱法,色谱柱为Ultrahydrogel 250(7.8 mm×300 mm);流动相0.1 mol/L氯化钠溶液;体积流量0.3 mL/min;柱温30℃;示差折光检测器,检测器温度40℃;进样量20μL。结果对5批注射用益气复脉(冻干)测定发现均无大分子物质。结论该方法简便、快捷,能用于注射用益气复脉(冻干)中大分子物质的排除性检查。AIM To establish the test method of macromolecule in Yiqi Fumai Injection（freeze-drying）（Ginseng Radix et Rhizoma Rubra,Ophiopogonis Radix,Schisandrae Chinensis Fructus）.METHODS The HPGPC method was used with chromatography conditions included Ultrahydrogel 250（7.8 mm×300 mm） column,0.1 mol/L sodium chloride solution as mobile phase,flow rate of 0.3 mL/min,column temperature at 30 ℃,RID and the detector temperature of 40 ℃,and 20 μL injection volumn.RESULTS No macromolecule has been found in five batches of injection（freeze-drying）.CONCLUSION This method is simple,speedy,convenient,and can be applied to the systemic exclusion of existence of macromolecule in Yiqi Fumai Injection（freeze-drying）.

关 键 词：HPGPC 注射用益气复脉(冻干) 大分子检测 

分 类 号：R927.2[医药卫生—药学]