经典名方开心散不同温度高压蒸汽灭菌条件下9种指标成分含量变化研究

目的 建立UHPLC-DAD同时测定开心散中西伯利亚远志糖A5、西伯利亚远志糖A6、远志??酮Ⅲ、3,6'-二芥子酰基蔗糖、细叶远志苷A、人参皂苷Rg1、人参皂苷Re、β-细辛醚、a-细辛醚的含量,并比较不同高压蒸汽灭菌温度对开心散中9种指标性成分的含量影响,为开心散灭菌工艺选择提供参考.方法 高压蒸汽灭菌法(灭菌温度...

Changes of nine index components in classic formula Kaixin Powder under different temperatures of high pressures steam sterilization

Objective To establish a UHPLC-DAD method for the simultaneous determination of sibiricose A5, sibiricose A6, polygalaxanthone Ⅲ, 3,6′-disinapoyl sucrose, tenuifoliside A, ginsenoside Rg1, ginsenoside Re, β-asarone and α-asarone in the extract of Kaixin Powder(开心散), and compare the effect of different steam autoclaving temperatures on the content of nine index components in Kaixin Powder extract, to provide reference for the selection of sterilization process for Kaixin Powder. Methods High pressure steam sterilization method(sterilization temperature 111, 121, 131 ℃;holding time 60 s) was performed for the sterilization process of Kaixin Powder. The chromatographic separation was achieved on a Acquity UPLC? BEH C18 column(100 mm × 2.1 mm, 1.7 μm) with acetonitrile-0.05% phosphoric acid solution as mobile phase at the flow rate of 0.3 mL/min for gradient elution. The column temperature was maintained at 30 ℃. The wavelength was set at 203 nm. Results The results showed that the separation of the nine index components was good, and each component had a wide linear range and a good linear relationship(r²> 0.999), with good precision, stability, repeatability and sample recovery. Through the detection and comparison of the content of the nine index components in Kaixin Powder after different sterilization conditions, the autoclave sterilization sterilization was optimized at 111 ℃ for 60 s. The bacterial test met the requirements of Pharmacopoeia, and the content change of each component had the smallest difference with the sample before sterilization. Conclusion The established UHPLC method can be used to simultaneously determine the contents of nine index ingredients in Kaixin Powder. The method is simple to operate, highly sensitive, accurate, practical, and reliable, which provides theoretical basis for the quality control of Kaixin Powder.