西黄丸中指标成分含量测定及挥发性成分指纹图谱的建立

目的:建立西黄丸中指标成分麝香酮的含量测定方法及挥发性成分的气相色谱指纹图谱,为提高西黄丸质控标准提供依据。方法:采用气相色谱法,使用Agilent DB-17MS毛细管柱(30 m×0.25 mm×0.25μm),初始柱温120℃,以4℃·min^-1升至220℃,保持20 min;进样口温度220℃,检测器温度250℃。结果:所建立的方法进行了系统的方法学考察。20批样品中麝香酮含量在0.16~0.51 mg·g^-1之间,指纹图谱相似度计算结果在0.99~0.30之间。结论:本文建立的西黄丸麝香酮含量测定方法及挥发性成分气相色谱指纹图谱,为有效控制西黄丸质量,完善其质量标准提供了科学依据。

Objective:To establish a GC method for the component determination of muscone and establish the fingerprint chromatography of volatile components in Xihuang pills.Methods:The gas chromatography method was developed with an Agilent DB-17MS column(30 m×0.25 mm×0.25μm).The initial temperature was 120℃, raised to 220℃ at the rate of 4℃·min^-1 and maintained for 20 min.The inlets temperature was 220℃, and the FID detector temperature was 250℃.Results:The established method was validated.For 20 batches of samples, the contents of muscone ranged from 0.16 to 0.51 mg·g^-1, and the similarities of chromatographic fingerprint ranged from 0.99 to 0.30.Conclusion:The developed method provided scientific basis for effective quantity control and drug standard improvement of Xihuang pills.

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