包顺茹 李妍 林燕 韩塔娜

【摘 要】 目的：建立冠心七味片中对甲氧基肉桂酸乙酯的含量测定方法及挥发性成分的特征图谱。方法：采用气相色谱法建立冠心七味片的含量及特征图谱测定方法。采用DB-FFAP毛细管柱（30m×0.32mm，0.25μm），初始温度150℃，以每分钟5 ℃的速率升温至220℃，保持10min;进样温度230℃，检测器温度250℃。结果：含量测定中对甲氧基肉桂酸乙酯在29.447～588.940ng范围内呈良好的线性关系（r=0.9993），平均加样回收率为97.31%，RSD为1.01%（n=6）;建立以对甲氧基肉桂酸乙酯为参照峰的特征图谱，共11个特征峰。结论：建立的含量测定及特征图谱方法可以从定量、定性两方面对冠心七味片的挥发性成分进行控制，该方法准确可靠，可用于冠心七味片的质量控制。

【关键词】 冠心七味片;气相色谱;含量测定;特征图谱;对甲氧基肉桂酸乙酯

【中图分类号】R284 【文献标志码】 A【文章编号】1007-8517（2021）1-0020-06

Study on Quantitative Analysis and Characteristics Spectrum of Volatile Components from Guanxinqiwei Tablets

BAO Shunru LI Yan LIN Yan HAN Tana*

Inner Mongolian Institute for Drug Control，Hohhot010010，China

Abstract：Objective To establish the quantitative analysis of Ethyl 4-methoxycinnamate and the determination method of characteristics spectrum of vo1atile components from Guanxinqiwei tablets. Method The quantitative analysis and characteristics spectrum of Guanxinqiwei tablets was performed by gas chromatography. DB-FFAPcapillary column （30m×0.32mm，0.25μm）;the initial column temperature was 150℃，then 5℃·min-1up to 220℃ maintained for 10min;injection port temperatures was 230℃，detector temperatures was 250℃. Results The content of ethyl 4-methoxycinnamate was in the range of 29.447ng to 588.940ng， and the linear relationship was good， r=0.9993. Moreover， the average recovery rate was 97.31%， and RSD was 1.01%（n=6）; The specific chromatogram which comprised eleven common peaks of Guanxinqiwei tablets was established with ethyl 4-methoxycinnamate as the reference peak. Conclusion The established determination method and the GC characteristic chromatogram can be used to control the volatile components in Guanxinqiwei tablets qualitatively and quantificationally.This accurate and reliable method can be used for the quality control of Guanxinqiwei Tablets.

Keywords：Guanxinqiwei Tablets;Gas Chromatography;Content Determination; Characteristics Spectrum;Ethyl 4-methoxycinnamate

冠心七味片由丹參、檀香、降香、山柰、肉豆蔻、广枣、沙棘七味药材制备而成，具有活血化瘀、强心止痛的作用，用于冠心病、心烦心悸、心绞痛等症。现行标准为《卫生部药品标准》蒙药分册1998年版，中文名为“冠心七味片”，蒙文名为“乌兰·温都顺-7”，收载项目为【处方】【制法】【性状】【检查】项[1]。近年来仿制该品种生产企业增多，各企业注册标准均有不同程度提高，但均无对山柰的质量控制，故对其进行含量测定以期对其进行质量控制。基于处方中有檀香、降香、山柰、肉豆蔻四味药材含挥发性成分，单一的对其建立标准项目耗时耗力耗材，而中药特征图谱是一种多指标的质量控制模式 ，能够全面、综合地反映和控制中药的质量[2]。……