摘要
目的 优选虎力散最佳提取工艺,为其制剂二次开发提供依据。方法 建立指标成分8-去乙酰滇乌碱(8-deacetyl yunaconitine,8DY)、滇乌碱、三七皂苷R1(notoginsenoside R1,R1)、人参皂苷Rg1(ginsenoside Rg1,Rg1)、人参皂苷Rb1(ginsenoside Rb1,Rb1)、告达亭和党参炔苷的UPLC测定方法,以指标成分含量、出膏率为关键质量属性(critical quality attributes,CQAs),采用AHP-熵权法结合化学计量学确定各指标的综合权重系数,在单因素实验的基础上,采用Box-Behnken设计-响应面法(Box-Behnken design-response surface method,BBD-RSM)优化虎力散提取工艺。结果 BBD-RSM建立的模型显著,虎力散最佳提取工艺为加10倍量60%乙醇溶液,提取时间2.0 h,提取2次,此条件下预测综合评分为0.659 2,3批工艺验证结果(平均综合评分0.659 5,RSD为0.45%)与模型预测结果相近,且各指标RSD均<3%,表明建立的模型可用于虎力散提取工艺的分析和预测。结论 采用AHP-熵权法结合化学计量学优选虎力散提取工艺,所建立的模型可靠,提取工艺稳定可行,为虎力散制剂二次开发提供依据。
Objective To optimize extraction process of Hulisan(虎力散)and to provide a basis for the secondary development of its preparation.Methods A UPLC method was established for the determination of 8-deacetyl yunaconitine,yunaconitine,notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,caudatin and lobetyolin,with the content of the index components and the rate of paste as the key quality attributes,and the combined weighting coefficients of the indexes were determined by AHP-entropy weight method combined with chemometrics,and the extraction process for Hulisan was optimized by the Box-Behnken response surface method based on the one-way test.Results The model established by Box-Behnken design was significant,and the optimal extraction process of Hulisan was ten-fold volume 60%ethanol solution,extraction time of 2.0 h,and two times of extraction,and the comprehensive score was 0.6592 under this condition,and the results of three batches process validation(the average comprehensive score is 0.6595,with an RSD of 0.45%.)were similar to those predicted by the model with an RSD<3%,indicating that the established model can be used for the analysis and prediction of Hulisan extraction process.Conclusion The AHP-entropy weight method combined with chemometrics was used to preferentially select the Hulisan extraction process,and the established model was reliable and the extraction process was stable and feasible,which provides a basis for the secondary development of Hulisan preparations of ethnomedicines.
作者
梅佳华
查学志
柯瑾
杨蕊萍
杨丽娟
程炳铎
李姓喜
马云淑
MEI Jiahua;ZHA Xuezhi;KE Jin;YANG Ruiping;YANG Lijuan;CHENG Bingduo;LI Xingxi;MA Yunshu(Yunnan University of Chinese Medicine,Kunming 650500,China;Yunnan Key Laboratory of Southern Medicinal Utilization,Kunming 650500,China;Yunnan Key Laboratory of Dai and Yi medicines,Kunming 650500,China;The Key Laboratory of External Drug Delivery System and Preparation Technology in University of Yunnan Province,Kunming 650500,China;Engineering Research Center for Medicine and Food Homologous Beverage of Yunnan Province,Kunming 650500,China)
出处
《中草药》
北大核心
2025年第13期4643-4653,共11页
Chinese Traditional and Herbal Drugs
基金
云南省科技厅社会发展专项-重点研发计划项目(202303AC100025)
云南省科技厅重点研发计划(202103AC100005)
云南省科技厅重大科技专项(202102AA310027)
国家自然科学基金资助项目(82174065)
云南省教育厅科学研究基金项目(2024Y379)
云南省中西医结合慢病防治重点实验室开放基金资助项目(YPKLG2024-016)
云南省傣医药与彝医药重点实验室资助项目(2024SS24074)。
