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目的:建立正天丸中挥发性成分的气相特征图谱,为该制剂的质量控制提供参考。方法:采用水蒸气蒸馏法提取正天丸中挥发性成分,通过气相色谱法对16批正天丸中挥发性成分进行分析,以相对保留时间为指标,建立正天丸挥发性成分的气相特征图谱,考察14批正天丸中间体和制剂特征图谱的差异性。结果:正天丸挥发性成分气相特征图谱指定了20个共有峰,确定了3个化学成分(阿魏酸、甲基丁香酚和藁本内酯)。精密度、重复性、稳定性试验中共有峰相对保留时间RSD均<0.1%;14批正天丸中间体挥发性成分气相图谱各共有峰相对保留时间RSD均<0.1%,与制剂特征图谱相对保留时间差别不大。结论:建立的正天丸挥发性成分气相特征图谱特征性强、方法准确可靠、重复性好,可用于正天丸挥发性成分的质量控制。正天丸制备工艺成熟、稳定,制剂批间一致性良好。
OBJECTIVE: To establish the gas chromatogram of volatile components in Zhengtian Pills and provide a reference for the quality control of this preparation. Methods: Volatile components of Zhengtian Pill were extracted by steam distillation. The volatile components in Zhengtai Pills of 16 batches were analyzed by gas chromatography. The relative retention time was used as an index to establish the gas phase characteristics Atlas of 14 batches of Zheng Tian Wan intermediates and preparation of the characteristics of the difference map. Results: The gas chromatogram of volatile components of Zhengtian Pill specified 20 common peaks, and identified three chemical components (ferulic acid, methyl eugenol and ligustilide). The relative retention time (RSD) of common peaks in precision, repeatability and stability test were both less than 0.1%. The relative retention times (RSDs) of all the common peaks in the volatile components of 14 batches of Zhengtian Pills were all less than 0.1% Little difference between retention time. Conclusion: The established gas chromatogram of volatile components of Zhengtian Wan is characterized by high accuracy, good reproducibility and reproducibility, which can be used for the quality control of volatile components in Zhengtian Pills. Zhengtian pill preparation process is mature, stable, good consistency between preparations.