独活寄生丸HPLC指纹图谱的建立及灭菌方法的选择  

Establishment of HPLC fingerprints and selection of sterilization methods for Duhuo Jisheng

作　　者：卢晓林 张欣渊 周小雪 王文涛 曲婷丽[1] Wan LU Xiaolin;ZHANG Xinyuan;ZHOU Xiaoxue;WANG Wentao;QU Tingli(School of Pharmacy,Shanxi Medical University,Tai-yuan 030001,China)

机构地区：[1]山西医科大学药学院,太原030001

出　　处：《山西医科大学学报》2025年第1期76-82,共7页Journal of Shanxi Medical University

基　　金：太原市科技局“双百攻关行动”首批关键核心技术攻关“揭榜挂帅”项目(2024TYJB0150);山西省中医药管理局科研课题(2022ZYYC110,2023ZYYA036,2023ZYYB062);山西省基础研究计划项目(20210302124586)。

摘　　要：目的 建立独活寄生丸的高效液相色谱(HPLC)指纹图谱,并分别评价高温蒸汽灭菌、^(60)Co辐照灭菌对独活寄生丸指纹图谱的影响。方法 采用Venusil MP-C18色谱柱,以0.1%磷酸水溶液-甲醇为流动相进行梯度洗脱,流速1.0 mL/min,柱温30℃,检测波长(254 nm和325 nm),并对建立的色谱条件进行方法学考察,通过分析12份样品建立独活寄生丸的指纹图谱。采用指纹图谱相似度评价分析、多元统计分析方法,分别分析高温蒸汽灭菌、^(60)Co辐照灭菌对独活寄生丸化学成分的影响。结果 方法学考察显示,建立指纹图谱的色谱方法符合要求。通过12份样品的测定,建立了独活寄生丸HPLC指纹图谱,相似度为0.994~1.000,共确认了19个共有峰。高温蒸汽灭菌会影响独活寄生丸中14个化学成分,而^(60)Co辐照灭菌不影响独活寄生丸中的化学成分。结论 建立的HPLC指纹图谱方法准确可靠、具有良好的重复性。高温蒸汽灭菌会影响独活寄生丸的指纹图谱,而^(60)Co辐照灭菌对独活寄生丸的指纹图谱没有影响。Objective To establish HPLC fingerprints of Duhuo Jisheng Wan,and explore the effects of high temperature steam steri-lization and ^(60)Co irradiation sterilization on these fingerprints.Methods A Venusil MP-C18 column was employed for gradient elution using a mobile phase of 0.1%aqueous phosphoric acid-methanol at a flow rate of 1.0 mL/min.The column temperature was maintained at 30℃,and the detection wavelength was set at 254 nm and 325 nm.The chromatographic conditions were methodologically investi-gated,and the fingerprints of Duhuo Jisheng Wan were established by analyzing 12 samples.Fingerprint similarity evaluation and mul-tivariate statistical analysis were conducted to assess the effects of high temperature steam sterilization and ^(60)Co irradiation sterilization on the chemical compositions of Duhuo Jisheng Wan.Results The chromatography method met the required standards for establish-ing fingerprints.The HPLC fingerprints of Duhuo Jisheng Wan were established through the analysis of 12 samples,and the similarity ranged from 0.994 to 1.000.A total of 19 common peaks were identified in the fingerprints.High temperature steam sterilization had ef-fects on 14 chemical constituents in Duhuo Jisheng Wan,while ^(60)Co irradiation sterilization did not affect the chemical constituents of Duhuo Jisheng Wan.Conclusion The established HPLC fingerprinting method is found to be accurate,reliable,and reproducible.High temperature steam sterilization has effects on the fingerprints of Duhuo Jisheng Wan,whereas ^(60)Co irradiation sterilization has no discernible effect on these fingerprints.

关 键 词：独活寄生丸 高效液相色谱法 指纹图谱 高温蒸汽灭菌 60Co辐照灭菌 多元统计分析 

分 类 号：R9[医药卫生—药学]