摘要
目的建立中药复方制剂礞石滚痰丸指纹图谱技术的研究方法。方法采用Thermo ODS HYPERSIL色谱柱(4.6 mm×250 mm,5μm),以甲醇-0.1%磷酸溶液为流动相,流速1.0 mL·min^-1,检测波长254 nm,柱温30℃,以黄芩苷为内参照峰,进行方法学验证。建立10批礞石滚痰丸HPLC指纹图谱,运用中药色谱指纹图谱相似度评价软件对10批制剂进行相似度评价,并对特征峰进行指认。结果建立的礞石滚痰丸HPLC指纹图谱的专属性、精密度、重复性,稳定性均良好;10批制剂的礞石滚痰丸的相似度均大于0.9。结论建立的礞石滚痰丸指纹图谱方法简便、准确、专属性强,通过多指标成分控制制剂质量,可为礞石滚痰丸的整体质量评价提供可靠的依据。
Objective:To establish a method for fingerprint analysis of Yishi guntan pills.Methods:A thermo ODShypersil column(4.6 mm×250 mm,5 um)was used with methanol-O.1%e phosphoric acid solution as the mobile phase,theflow rate was 1.0 mL·min^(-1),the detection wavelength was 254 nm,the column temperature was 30℃,and baicalin wasused as the internal reference peak.HPLC fingerprints of 10 batches of Yishi guntan pills were established.Similarityevaluation software of chromatographic fingerprints of Chinese medicine was used to evaluate the similarity of 10 batches ofpreparations,and the characteristic peaks were identified.Results:The specificity,precision,repeatability and stability ofthe HPLC fingerprint of Yishi guntan pills were good,and the similarity of 10 batches of preparations was greater than 0.9.Conclusion:The established method is simple,accurate and specific.The quality of Yishi guntan pills is controlled by multiindex components,which provides a reliable basis for the overall quality evaluation of Yishi guntan pills.
作者
赵新红
范珊
齐永秀
Zhao Xinhong;Fan Shan;Qi Yongxiu(Shandong First Medical University&Shandong Academy of Medical Sciences,Taian271016,China)
出处
《山东第一医科大学（山东省医学科学院）学报》
2021年第7期492-496,共5页
Journal of Shandong First Medical University ＆ Shandong Academy of Medical Sciences
关键词
指纹图谱
礞石滚痰丸
质量控制
fingerprint
Yishi guntan pill
quality control
