藿香正气滴丸质量标准提高研究  

Study of Improving Quality on Huoxiang Zhengqi Dripping Pill

作　　者：阚红玉[1] 赵卫春[2] 孙玉侠[1] 吕曙华[2] 王杰[2] 曹凤兰[1] 

机构地区：[1]天津天士力制药股份有限公司,天津300410 [2]天津市药品检验所,天津300070

出　　处：《中国实验方剂学杂志》2012年第1期72-76,共5页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:完善藿香正气滴丸的质量控制方法。方法:采用薄层色谱法鉴别处方中的广藿香油、白芷、厚朴、苍术、陈皮、甘草、紫苏叶油及半夏;采用高效液相色谱法测定处方中厚朴及陈皮的含量。色谱条件:以十八烷基硅烷键合硅胶为填充剂,以乙腈-冰醋酸水溶液为流动相,梯度洗脱,检测波长294 nm。结果:在选定的薄层色谱条件下,色谱斑点清楚,分离效果较好;HPLC方法学考查表明处方中橙皮苷在0.199 1～3.982 0μg(r=0.999 9)、和厚朴酚在0.135 4～2.707 0μg(r=0.999 9)、厚朴酚在0.107 2～2.144 0μg(r=0.999 9)峰面积与其进样量线性关系良好,橙皮苷平均回收率为98.36%,RSD为0.86%;和厚朴酚平均回收率为100.60%,RSD 1.04%;厚朴酚平均回收率为98.11%,RSD 0.70%。结论:该方法快捷、准确,能够更加确切地反应制剂质量的真实情况。Objective：To improve the quality standard of Huoxiang Zhengqi Dripping pill.Method：On the original basis,the TLC identification of atractylodes lancea,tangerine peel,perilla leaf,liquoric root,pineuia ternata and determination the content of honokiol and hesperidin by HPLC were also revised.The HPLC separation was performed on Agilent ZORBAX SB-C18 column（4.6 mm×250 mm,5 μm）,the mixture of acetonitrile-0.1% acetic acid water was used as mobile phase in gradient elution.The detection wavelength was 294 nm.Result：The spot in the TLC was clear,and with no interference from negative control.In the HPLC experiments of precision,reproducibility and stability,the samples could be separated entirely.For hesperidin,honokiol and magnolol,the linear range was 0.199 1-3.982 0 μg（r=0.999 9）,0.135 4-2.707 0 μg（r=0.999 9）,0.107 2-2.144 0 μg（r=0.999 9） respectively,the average recoveries were 98.36% with RSD 0.86%;100.6% with RSD 1.04%;98.11% with RSD 0.70% respectively.Conclusion：The method was sensitive simple,accurate and reproducible,can be used to control the quality of Huoxiang Zhengqi Dripping Pill better.

关 键 词：藿香正气滴丸 薄层鉴别 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]