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.
出处
《中国药品标准》
CAS
2009年第5期352-356,共5页
Drug Standards of China