Box-Behnken响应面法优化大籽蒿膏的炮制工艺及其质量控制研究  

Optimization of the processing technology of Artemisiae extract by Box-Behnken response surface method and its quality control

作　　者：王悦 王亚倩 丁银 苟晓玲 黄雪梅 谢雨宸 张静[2] 范刚[2] WANG Yue;WANG Ya-qian;DING Yin;GOU Xiao-ling;HUANG Xue-mei;XIE Yu-chen;ZHANG Jing;FAN Gang(School of Pharmacy,Chengdu University of Traditional Chinese Medicine/State Key Laboratory of Characteristic Southwest Chinese Medicine Resources,Chengdu 611137,China;School of Ethnic Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China)

机构地区：[1]成都中医药大学药学院/西南特色中药资源国家重点实验室,成都611137 [2]成都中医药大学民族医药学院,成都611137

出　　处：《中国新药杂志》2025年第1期94-101,共8页Chinese Journal of New Drugs

基　　金：国家重点研发计划资助项目(2023YFC3504403)。

摘　　要：目的:优化确定大籽蒿膏的最佳炮制工艺,并建立其HPLC指纹图谱。方法:采用HPLC法测定大籽蒿膏中4种成分(绿原酸、芦丁、异绿原酸A、异绿原酸C)的含量;采用单因素实验结合Box-Behnken设计-响应面法考察料液比、煎煮时间、煎煮次数3个因素。运用权重赋值法(criteria importance though intercrieria correlation, CRITIC)计算4种成分的权重系数,获得综合评分。以综合评分为评价指标,优化大籽蒿膏的炮制工艺。采用HPLC法建立大籽蒿膏的化学指纹图谱,应用“中药色谱指纹图谱相似度评价系统(2012版)”进行相似度评价。结果:大籽蒿膏的最佳炮制工艺为加10倍量的水、煎煮3次、每次煎煮1.6 h,滤液合并,浓缩成稠膏,即得。制备3批样品进行验证,平均综合评分为94.69,RSD为0.56%,与预测值相接近,表明该炮制工艺可行。大籽蒿膏中绿原酸、芦丁、异绿原酸A和异绿原酸C的平均含量分别为2.23%,0.41%,0.66%,1.39%。大籽蒿膏共确定10个共有峰,相似度为0.965~0.998,均大于0.95,满足指纹图谱研究要求,也表明不同批次样品的相似度较好。结论:本研究所确定的最佳炮制工艺稳定可行,建立的含量测定和HPLC指纹图谱方法准确可靠,为大籽蒿膏的质量控制提供了参考。Objective:To optimize the processing procedure of Artemisiae extract,and to establish its HPLC fingerprint.Methods:The content of four components(chlorogenic acid,rutin,isochlorogenic acid A,and isochlorogenic acid C)in Artemisiae extract were determined by HPLC.Single factor experiment combined with Box-Behnken design-response surface method was used to investigate the three factors:solid-liquid ratio,decoction time,and decoction times.The CRITIC weight assignment method was used to calculate the weight coefficients of the four components and obtain the comprehensive score,which was used as the evaluation index to optimize the processing technology of Artemisiae extract.Moreover,the chemical fingerprint of Artemisiae extract was established by HPLC,and the similarity evaluation was performed by“Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 Edition)”.Results:The best processing procedure of Artemisiae extract is adding 10 times the amount of water,decocting for 3 times,decocting for 1.6 h each time,and then combining the filtrate and concentrating into a thick extract.Three batches of samples were prepared for verification.The average comprehensive score was 94.69,and the RSD was 0.56%,which was close to the predicted value,indicating that the processing technology was feasible.The average contents of chlorogenic acid,rutin,isochlorogenic acid A and isochlorogenic acid C were 2.23%,0.41%,0.66%and 1.39%,respectively.A total of 10 common peaks were identified with the similarity ranging 0.965 to 0.998.The similarity of all samples was greater than 0.95,meeting the requirements of fingerprint research,which indicated that the similarity of different batches of samples was good.Conclusion:The optimal processing technology determined in this study is stable and feasible.The established methods of content determination and HPLC fingerprint are accurate and reliable,which provides a reference for the quality control of Artemisiae extract.

关 键 词：大籽蒿膏 Box-Behnken设计-响应面法 炮制工艺 HPLC指纹图谱 质量控制 

分 类 号：R917[医药卫生—药物分析学]