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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 characteristic map of compound musk injection by gas chromatography and to simultaneously determine the contents of 5 main components of menthol, borneol, pemetrexol, musk ketone and α-asarone. Methods: DB-WAX capillary column and FID detector were used to purify samples by solid-phase extraction. Results: There were 6 characteristic peaks in the characteristic map, and the similarity between 10 batches of samples and the control map was above 0.91. Five components of menthol, borneol, pemetrexol, musk ketone and alpha asarone were linear within their respective ranges Good, r were 0.9999, the recovery rate was 95.1% ~ 102.6%, RSD were less than 3.0%. Conclusion: The method is simple, accurate and reproducible. The combination of characteristic map and multi-component content reflects the overall quality of compound musk injection and can be used for the quality control of the preparation.