消核片质量控制研究  

Study on quality control of Xiaohe Tablets

作　　者：孟淑智[1] 田金苗[1] 侯峰[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《药物分析杂志》2011年第3期592-595,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究消核片的质量控制。方法:采用显微鉴别法对浙贝母和金果榄进行鉴别;采用薄层色谱法对制剂中的夏枯草、半枝莲进行定性鉴别;用高效液相色谱法对浙贝母中贝母素甲和贝母素乙进行了含量测定。色谱柱为Diamonsil C18(200mm×4.6 mm,5μm)柱,流动相为乙腈-水-二乙胺(70∶30∶0.03),流速1.0 mL·min-1,蒸发光散射检测器。结果:显微鉴别可以快速鉴别浙贝母和金果榄;薄层色谱能明显检出夏枯草、半枝莲。贝母素甲在1.7664～5.5200μg范围内线性关系良好(r=0.9995,n=5),平均回收率98.22%(n=6)。贝母素乙在1.2800～4.0000μg范围内线性关系良好(r=0.9998 n=5),平均回收率93.45%(n=6)。结论:新建立的质量控制方法能有效地控制消核片的质量,可作为本品质量标准。Objective： To study on Quality Control of Xiaohe Tablets.Method：Bulbus Fritillariae Thunbergii and radix tinosporae were identified by microscopical identification;Common Selfheal and Sculellaria barbata were determined by TLC;The content of peimine and peiminine were determined by HPLC.Column is Diamonsil C18（200 mm×4.6 mm,5 μm）column and a mixture of methanol-water-diethylaminer（70∶30∶0.03） as the mobile phase at the flow rate of 1.0 mL·min-1,ELSD.Result：Bulbus Fritillariae Thunbergii and radix tinosporae were quickly identified by microscopical identification;Prunella vulgaris and Sculellaria barbata were determined by TLC.A linear relationship of Peimine was good from 1.7664-5.5200 μg（r= 0.9995,n=5）.The average recovery was 98.22%（n=6）.A linear relationship of Peiminine was good from 1.2800–4.0000 μg（r=0.9998,n=5）,The average recovery was 93.45%（n=6）.Conclusion：The method can be used for the quality control of Xiaohe tablets.

关 键 词：消核片 质量控制 显微鉴别 薄层色谱法 高效液相色谱法 贝母素甲 贝母素乙 含量测定 

分 类 号：R917[医药卫生—药物分析学]