摘要
目的建立新加香薷饮标准汤剂(简称汤剂)的HPLC指纹图谱,为新加香薷颗粒(简称颗粒)的质量控制提供鉴定方法。方法采用高效液相色谱法,色谱柱为Phenomenex Luna C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%H3PO4溶液为流动相进行梯度洗脱,检测波长为280 nm,检测时间为130 min。采用2012版《中药色谱指纹图谱相似度评价系统》软件,以绿原酸峰为参照峰,建立汤剂对照指纹图谱,并将其与5批颗粒的指纹图谱进行相似度评价。结果 5批颗粒的指纹图谱与新加香薷饮标准汤剂对照指纹图谱的相似度均>0.90。结论该方法简单、稳定、重复性好,可用于辅助控制颗粒的质量。
Objective To establish HPLC fingerprint of Xinjiaxiangruyin standard decoction soasto provide an analytical method for the quality control of Xinjiaxiangruyin granules. Methods HPLC was conducted on a phenonmenex Luna C18 column us?ing acetonitrile-0.1%H3PO4 in gradient elution modes as mobile phase,where detection wavelength was 280 nm and detection time was 130 min. With chlorogenic acid as reference peak,the Edition 2012 of"chromatographic fingerprint similarity evaluation system"software was used to establish the standard decoction reference fingerprint,which was then compared with the fingerprint of 5 batchs of the granules for similarity evaluation. Results The similarity of the fingerprints between the 5 batches of granules and the standard decoction was higher than 0.90. Conclusion The method is simple,stable and reproducible,which could be used for the quality control of the granules as an adjuvant method.
出处
《国际药学研究杂志》
CAS
CSCD
北大核心
2017年第3期288-291,共4页
Journal of International Pharmaceutical Research
基金
国家重大新药创制"经典名方标准颗粒的研究"(2013zx09508-105)