脉络通颗粒的质量标准研究  

Quality Standard for Mailuotong Granules

作　　者：赵沈娟[1] 张集盘 石晶萍[1] 翟艳[1] 

机构地区：[1]扬子江药业集团质量管理部,泰州225321 [2]湖北浩信药业有限公司,鄂州436070

出　　处：《中国药品标准》2009年第5期352-356,共5页Drug Standards of China

摘　　要：目的:研究脉络通颗粒(槐米,丹参,葛根,树脂残留物等)的质量标准。方法:采用薄层色谱法对槐米、丹参进行定性鉴别;采用顶空气相色谱法对大孔吸附树脂残留物进行残留量检查,色谱柱为HP-INNOWax固定相的弹性石英毛细管柱,载气为高纯氮气,检测器为FID;采用HPLC法对葛根素进行定量分析,色谱柱为AgilentXDBC18柱(4.6mm×150mm,5μm),流动相为甲醇-水(25∶75),检测波长为250nm,流速1.0mL·min-1。结果:薄层斑点清晰,阴性对照无干扰;顶空气相色谱法精密度的RSD小于2%;葛根素在0.08656～0.51936μg范围内有良好的线性关系(r=0.9996),平均回收率为101.76%,RSD=1.89%(n=6)。结论:方法简便可行,结果准确可靠,可作为本产品的质量控制方法。Objective ： To establish the quality standard of Mailuotong Granules （ Flos Sophorae Immaturus, Radix et Rhizoma Salviae Mihiorrhizae, Radix Puerariae Lobatae, residual macroporous resin, etc. ）. Method： Flos Sophorae hnmaturus, Radix et Rhizoma Salviae Miltion＇hizae were identified by TLC. The contents of macroporous resin residual substances were determined by headspace GC on HP-INNOWax column, with FID detector, high purity nitrogen as the carry gases. The content of Puerarin was determined by HPLC. Agilent XDB C18 column（4. 6 mm × 150 mm,5 μm） as chromatographic column, methanol -water（25： 75） as mobile phase, detection wavelength at 250 nm , flow rate kept at 1.0 mL · min^-1. Result： The TLC sports developed were fairly clear, and the blank test showed no interference. The RSD of precision by headspace GC was less than 2%. The linearity of Puerarin was good in the range of 0. 086 56 - 0. 519 36 μg（r = 0. 999 6）. The average recovery of Puerarin was 101.76%, RSD = 1.89% （ n = 6 ）. Conclusion： The method is simple, reliable, accurate and can be applied as the quantity control method of Mailuotong Granules.

关 键 词：脉络通颗粒 质量标准 TLC 顶空气相色谱法 树脂残留物 HPLC 葛根素 

分 类 号：R259.436[医药卫生—中西医结合] R286.0[医药卫生—中医内科学]