复方麝香注射液特征图谱及5种主要成分的含量测定

Specific Chromatogram of Fufang Shexiang Injection and Simultaneous Determination of Five Components by GC

目的：利用气相色谱法建立复方麝香注射液的特征图谱,并同时测定薄荷脑、冰片、百秋李醇、麝香酮、α-细辛脑5种主要成分的含量。方法：采用DB-WAX毛细管色谱柱,FID检测器采取固相萃取技术净化样品。结果：特征图谱共有6个特征峰,10批样品与对照图谱相似度在0.91以上;薄荷脑、冰片、百秋李醇、麝香酮、α-细辛脑等5种成分在各自范围内线性关系良好,r均为0.9999,回收率在95.1%~102.6%之间,RSD均小于3.0%。结论：该方法简单、准确、重复性好,特征图谱结合多成分含量测定较好地体现了复方麝香注射液的整体质量状况,可用于该制剂的质量控制。

Objective： To establish the specific chromatogram of Fufang Shexiang injection and simultaneously determine five com- ponents （ menthol, borneol, patchouli alcohol, muscone, α-asarone） in the injection by GC. Methods： The sample solution was extracted by a solid-phase extraction method. The separation was performed on a DB-WAX GC capillary column with an FID detection. Results： The specific chromatogram had six common peaks, and the similarity was above 0.91. The five chemical components（ menthol,borne- ol, patchouli alcohol, muscone, α-asarone） were well separated and with good linear relationship, the recoveries were between 95.1 and 102.6%, and RSD was less than 3.0%. Conclusion： The method is simple, accurate and reproducible. The specific chromatogram combined with multi-component determination can reflect the overall quality of Fufang Shexiang injection, which can be used for the quality control of the preparation.