加味藿香正气丸特征图谱建立及3种成分测定  

Establishment of characteristic chromatogram and determination of three constituents for modified Huoxiang Zhengqi pills

作　　者：张一唱 范晓磊 宋德芳 ZHANG Yichang;FAN Xiaolei;SONG Defang(Wuhan Institute for Drug and Medical Device Control,Wuhan 430075,China)

机构地区：[1]武汉药品医疗器械检验所,武汉430075

出　　处：《中国药师》2024年第7期1115-1124,共10页China Pharmacist

基　　金：2021年国家药品抽验项目。

摘　　要：目的基于HPLC法建立加味藿香正气丸特征图谱,并测定3种成分含量。方法样品甲醇提取液采用Agilent TC-C_(18)色谱柱(250 mm×4.6 mm,5μm)分析,以乙腈-0.1%磷酸溶液为流动相,梯度洗脱;流速为1.0 mL/min;检测波长为254 nm和284 nm;柱温为30℃。结果橙皮苷、厚朴酚、和厚朴酚分别在2.715~434.400μg/mL、2.760~176.600μg/mL、2.623~167.900μg/mL范围内呈现良好的线性(r=1.0000),平均加样回收率分别为99.2%,96.3%,95.9%,RSD分别为1.5%,1.3%,1.8%(n=9)。建立的特征图谱对制剂中7味主要药材进行了控制,为整体上评价不同企业的原药材、投料、工艺以及制剂的质量情况提供了依据。结论该方法准确可靠、重复性好,可用于加味藿香正气丸的质量控制。Objective To establish the characteristic chromatogram for modified Huoxiang Zhengqi pills and determine the content of three components based on HPLC.Methods The analysis of methanol extract of this preparation was performed on a Agilent TC-C_(18) column(250 mm×4.6 mm,5μm)at 30℃,with mobile phase comprising of acetonitrile-0.1%phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 254 nm and 284 nm.Results Three components(hesperidin,magnolol and honokiol)showed good linearity within the range of 2.715-434.400μg/mL,2.760-176.600μg/mL and 2.623-167.900μg/mL(r=1.0000),whose average recoveries were 99.2%,96.3%and 95.9%,with the RSD of 1.5%,1.3%and 1.8%(n=9),respectively.The established characteristic chromatogram controlled the 7 main Chinese medicinal herbs in the formulation,which provided a basis for evaluating the quality of raw materials,feedings,processes and preparations of different enterprises as a whole.Conclusion This method is accurate,reliable and has good repeatability,and can be used for the quality control of modified Huoxiang Zhengqi pills.

关 键 词：加味藿香正气丸 HPLC特征图谱 橙皮苷 和厚朴酚 厚朴酚 含量测定 

分 类 号：R286.0[医药卫生—中药学]