清肺化痰口服液的质量标准研究  

Quality Standard Study of Qingfei Huatan Koufu Ye

作　　者：陆萍 倪东杰 郭良君 谭兴起[2] 

机构地区：[1]解放军九八医院,浙江湖州3130002 [2]中国人民解放军第一○二医院,江苏常州213002

出　　处：《世界中西医结合杂志》2013年第6期573-575,共3页World Journal of Integrated Traditional and Western Medicine

摘　　要：目的制定清肺化痰口服液的质量标准。方法采用薄层色谱法鉴别清肺化痰口服液中重楼、浙贝母;高效液相色谱法测定绿原酸的含量,采用Diamonsil C18色谱柱(4.6 mm×150 mm,5μm),以甲醇-水-醋酸(20∶80∶1.5)为流动相;流速1.0 mL.min-1;检测波长为327 nm。结果重楼及浙贝母鉴别斑点清晰,分离良好。绿原酸对照品在8.0～80.0μg.mL-1范围内与峰面积值具有良好的线性关系。r=0.999 8(n=5),平均加样回收率为98.88%,RSD=1.01%。结论试验方法简便、准确、重现性好,能很好地控制清肺化痰口服液的质量。Objective To establish the quality standard of qingfei huatan koufu ye. Methods TLC was adopted to identify paris polyphylla and thunberg fritillary bulb in qingfei huatan koufu ye. HPLC was ap- plied to determine the content of ehlorogenic acid. Chromatographic column： Diamonsil C18 column （4.6 mm × 150 mm, 5 μm ） ; mobile phase ： methanol - water - acetic acid （ 20： 80： 1.5 ） ; flow rate ： 1.0 mL · min - l ; detection wavelength ：327 nm Results The identification spots were clear for paris polyphylla and thunberg fritillary bulb, presenting good separation. The reference substance of chlorogenic acid presented the good lin- ear relationship with peak area value in the range of 8.0 - 80.0 μg · mL - 1, r = 0. 999 8 （ n = 5 ）. Average re- covery rate ：98.88% ,RSD = 1.01%. Conclusion This method is simple, accurate and good in reproduc- ibility. It can well control the quality of qingfei huatan koufu ye.

关 键 词：清肺化痰口服液 重楼 浙贝母 绿原酸 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]