论文部分内容阅读
目的 建立参芪降糖颗粒石油醚部位的气相色谱-质谱联用(GC-MS)指纹图谱方法,评价产品质量.方法 利用GC-MS技术建立参芪降糖颗粒石油醚部位的GC-MS指纹图谱,用NIST2014对指纹峰对应的化学成分做结构定性分析;采用中药指纹图谱相似度评价和主成分分析(PCA)技术,基于石油醚部位化学成分对参芪降糖颗粒的批次一致性做出全面评价;同时采用Hotelling's T2和DModX两种统计量,为不同批次产品的质量设定控制范围.结果 从参芪降糖颗粒石油醚部位中鉴定出22种成分,占已分离总组分的60.94％.24批次参芪降糖颗粒石油醚部位指纹图谱的相似度均大于0.95.24批次样品PCA均在Hotelling's T2和DModX的控制之下,表明不同批次参芪降糖颗粒石油醚部位的一致性良好.结论 所开发的GC-MS指纹图谱方法,可用于参芪降糖颗粒质量评价.“,”Objective To establish gas chromatography-mass spectrometry (GC-MS) fingerprint method for the petroleum ether fraction of Shenqi Jiangtang Granules (SQJTG) and evaluate the product quality. Methods The GC-MS fingerprint of petroleum ether fraction of SQJTG was established by GC-MS, and the chemical components corresponding to the fingerprint peaks were structurally identified on NIST2014. The batch consistency of SQJTG products was evaluated based on the chemical composition of petroleum ether parts by using fingerprint similarity evaluation and Principal components analysis (PCA) technology. At the same time, Hotelling's T2 and DMODX statistics are used to set the control range for the quality of different batches of products. Results Twenty-two components were identified from the petroleum ether part of SQJTG, accounting for 60.94％ of the total components separated. The similarity of fingerprints of petroleum ether parts of 24 batches of SQJTG was greater than 0.95. The PCA of 24 batches of samples were all under the control limits of Hotellin's T2 and DMODX statistics, indicating that the petroleum ether parts of different batches of SQJTG were consistent. Conclusion The developed GC-MS fingerprint method can be used to evaluate the quality of SQJTG.