胆乐片质量标准的研究  

Quality standard study for danle tablets

作　　者：孟祥松[1] 陈雷[2] 蒋磊[1] 

机构地区：[1]安徽省亳州市食品药品检验所,安徽毫州236800 [2]安徽省淮南职业技术学院,安徽淮南232001

出　　处：《安徽医药》2009年第5期500-502,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立胆乐片的质量标准。方法采用薄层色谱法（TLC）对方中大黄、柴胡、栀子、人工牛黄进行定性鉴别；采用高效液相色谱法（HPLC）测定栀子中栀子苷的含量：色谱柱为KROMASIL C18柱（4．6mm×250mm，5μm）；流动相为乙腈-水（15：85）；柱温为30℃；检测波长为238nm；流速为1．0ml·min^-1。结果TLC能明显地检测出大黄、柴胡、栀子、人工牛黄；栀子苷进样量在0．51～5．10μg范围内呈良好线性关系（r=0．9999）；平均加样回收率为97．94％，RSD为2．07％。结论所建标准可用于胆乐片的质量控制。Aim To establish the quality criteria for danle tablets. Methods Rhubarb, radix bupleuri,gardenia florida and artificial bezoar in the formula were identified by TLC and the content of Jasminoidin was determined by HPLC on Kromasil C18 column （4.6 mm × 250 mm,5 μm） with mobile phase consisting of acetonitrile - water （ 15：85 ） at a flow rate of 1.0 ml · min^ - 1. The detection wavelength was set at 238nm and the column temperature was set at 30℃. Results Rhubarb,radix bupleuri,gardenia florida and artificial bezoar could be detected by TLC. The linear range of jasminoidin was 0.51 - 5.10 μg （ r = 0.999 9 ）. The average recovery rate was 97.94% （ RSD = 2.07% ）. Conclusion The established criteria are suitable for the quality control of danle tablets.

关 键 词：胆乐片 薄层色谱法 栀子苷 高效液相色谱法 质量标准 

分 类 号：R286[医药卫生—中药学]