蒙药清热八味胶囊质量标准的建立  

Quality Standard for Meng Medicine Qingre Bawei Capsules

作　　者：刘学良 刘海青 韩达斌 祝艳年 Liu Xueliang;Liu Haiqing;Han Dabin;Zhu Yannian(Qinghai Food and Drug Administration Technical Evaluation Center,Xining 810016,China)

机构地区：[1]青海省食品药品监督管理局食品药品审评中心,西宁810016

出　　处：《中国药师》2020年第5期987-990,共4页China Pharmacist

基　　金：青海省科技计划项目(编号:2020-ZJ-747)。

摘　　要：目的:建立蒙药清热八味胶囊的质量标准。方法:TLC法鉴别处方中的人工麝香、苦地丁、胡黄连;超高效液相色谱-蒸发光散射检测器(UPLC-ELSD)法分析采用Sunfire-ODS C18柱(250 mm×4.6 mm,5μm),以甲醇-0.1冰醋酸(80∶20)为流动相,流速:0.4 ml·min-1;柱温:30℃;蒸发光散射检测器参数为漂移管温度85℃,载气(压缩空气)体积流量为2.5 L·min-1。结果:TLC色谱中斑点清晰,且阴性对照无干扰;胆酸进样质量在0.892~8.916μg的范围内线性关系良好(r=0.9994),平均加样回收率为97.5%,RSD为0.9%(n=6)。结论:该方法操作简便,结果准确,重复性好,可用于清热八味胶囊的质量控制。Objective:To establish the quality standard for Qingre Bawei capsules.Methods:Calculus bovis,Corydalis bungeana Turcz and Rhizoma Picrorhizae were identified by TLC.An UPLC-ELSD analysis was carried out on a Sunfire-ODS C18 column(250 mm×4.6 mm,5 μm) with the mobile phase consisting of methanol(A)-0.1% acetic acid aqueous solution in a gradient elution mode.The flow rate was 0.4 ml·min-1.The column temperature was 30℃.The temperature of drift tube was 85℃,and the flow rate of gas was 2.5 L·min 1.Results:The TLC showed clear sports without any interference from the negative control.Cholic acid showed good linear relationships within the range of 0.892~8.916 μg(r=0.999 4).The average recovery was 97.5% with the RSDs of 0.9%(n=6).Conclusion:The methods are of high specificity,promising sensitivity and good reproducibility,which can be applied in the quality control of Qingre Bawei capsules.

关 键 词：清热八味胶囊 人工牛黄 苦地丁 胡黄连 薄层色谱法 胆酸 超高效液相色谱-蒸发光散射检测器法 

分 类 号：TQ460.7[化学工程—制药化工]