基于响应面法优化2020年版《中国药典》酸枣仁中斯皮诺素含量测定方法  

Optimization of the content determination method of spinosin in Ziziphi Spinosae Semen in 2020 edition of Chinese Pharmacopoeia by response surface method

作　　者：杨月娥 贺文文 赵伊君 王小平[2] 李军茂 白吉庆 YANG Yue’e;HE Wenwen;ZHAO Yijun;WANG Xiaoping;LI Junmao;BAI Jiqing(Jiangxi University of Chinese Medicine,Nanchang 330000,China;Shaanxi University of Chinese Medicine,Xianyang 712046,China;Shaanxi Provincial Quality Monitoring and Technical Service Center for Chinese Medicinal Materials,Xianyang 712046,China)

机构地区：[1]江西中医药大学,江西南昌330000 [2]陕西中医药大学,陕西咸阳712046 [3]陕西省中药原料质量监测技术服务中心,陕西咸阳712046

出　　处：《广东药科大学学报》2025年第2期69-75,共7页Journal of Guangdong Pharmaceutical University

基　　金：陕西省中医药管理局“秦药”优良种苗选育项目(2013-ZY049);榆林道地秦药研究院开放课题(YLDQ-2024-06);2019年医疗服务与保障能力提升补助资金项目(财社[2019]39号)。

摘　　要：目的优化2020年版《中国药典》(以下简称药典)酸枣仁中斯皮诺素含量测定方法。方法采用单因素试验和Box-Behnken响应面法,以斯皮诺素含量为评价指标,优选斯皮诺素测定样品的处理方法,对优化后的最佳方法进行预测值验证,方法学考察及大量样品的测定,并将优化结果与药典测定结果进行统计学分析、对比验证优化方法的可行性。结果酸枣仁斯皮诺素的最佳提取条件:超声时间60 min、乙醇体积分数70%、液料比20∶1(mL∶g),该条件下测得的斯皮诺素实际质量分数为1212.7μg/g,与预测值接近。方法学考察结果良好,和药典方法的测定结果相比,具有统计学意义。结论优化后方法稳定可行、操作简单、节约成本,有效提高了斯皮诺素的提取率,可为药典方法改进提供参考。Objective To optimize the content determination method of spinosin in Ziziphi Spinosae Semen in 2020 edition of Chinese Pharmacopoeia.Methods Treatment of samples for the determination of spinosin was optimized using one-way test and Box-Behnken response surface method with spinosin content as evaluation index.In order to determine the feasibility of the optimized method,the optimized optimal method was verified by predictive value,methodological investigation,and determination of a large number of samples.The optimized results were statistically analyzed and compared with the Pharmacopoeia determination results.Results The optimal conditions for the extraction of spinosin from Z.Spinosae Semen were as follows:ultrasonic extraction 60 min with 70%ethanol,and 20∶1 liquid-material ratio(mL∶g).The actual content of spinosin measured under these conditions was 1212.7μg/g,which was close to the predicted value.The results of the methodological investigation were good and statistically significant when compared with the results of the pharmacopoeial method of determination.Conclusion The optimized method is stable and feasible,easy to operate,cost-saving,and effective in improving the extraction rate of spinosin,which can provide a reference for the method improvement of the Chinese Pharmacopoeia.

关 键 词：酸枣仁 斯皮诺素 超声提取 高效液相色谱法 响应面法 

分 类 号：R927.12[医药卫生—药学]