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参藿五味颗粒制备工艺及其质量标准研究 被引量:2

Preparation and quality standard for Shenhuo Wuwei Granules
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摘要 目的 制备参藿五味颗粒(醋五味子、红参、炙淫羊藿),并建立其质量标准。方法 以颗粒成型性和溶化性为评价指标,优化制备工艺。TLC法定性鉴别五味子、红参、炙淫羊藿,HPLC法测定五味子醇甲、五味子甲素、五味子乙素含量。结果 辅料为糊精、75%乙醇,最佳制备工艺为主药与糊精比例1∶4。TLC斑点清晰,阴性无干扰。五味子醇甲、五味子甲素、五味子乙素分别在10.02~120.24、4.95~59.40、6.50~78.00μg/mL范围内线性关系良好(r≥0.999 6),平均加样回收率分别为98.03%、100.75%、100.23%,RSD分别为0.86%、1.09%、1.36%。结论 该方法简便可靠,专属性强,重复性好,可用于参藿五味颗粒的质量控制。 AIM To prepare Shenhuo Wuwei Granules(vinegar-processed Schisandrae chinensis Fructus,Ginseng Radix et Rhizoma Rubra,roasted Epimedii Folium)and to establish its quality standard.METHODS Taking the formability and melting property of particles as evaluation indices,the preparation process was optimized.TLC was adopted in the qualitative identification of vinegar-processed Schisandrae chinensis Fructus,Ginseng Radix et Rhizoma Rubra and roasted Epimedii Folium.HPLC was used for the content determination of schisandrin A,schisandrin A and schisandrin B.RESULTS The excipients are dextrin and 75%ethanol.The ratio of medicine to dextrin was 1∶4 as the best preparation process.The TLC spots were clear without negative interference.Schisandrin A,schisandrin A,schisandrin B showed good linear relationships within the ranges of 10.02-120.24,4.95-59.40,6.50-78.00μg/mL(r≥0.9996),whose average recoveries were 97.72%,102.92%,100.30%with the RSDs of 0.86%,1.09%,1.36%,respectively.CONCLUSION This simple,reliable,specific and repeatable method can be used for the quality control of Shenhuo Wuwei Granules.
作者 刘明 张美玉 吴泳锡 王一竹 孙玥琦 刘智 郑飞 越皓 LIU Ming;ZHANG Mei-yu;WU Yong-xi;WANG Yi-zhu;SUN Yue-qi;LIU Zhi;ZHENG Fei;YUE Hao(Jilin Provicial Ginseng Academy,Changchun University of Chinese Medicine,Changchun 130117,China)
机构地区 长春中医药大学
出处 《中成药》 CAS CSCD 北大核心 2022年第7期2107-2114,共8页 Chinese Traditional Patent Medicine
基金 国家重点研发计划(2017YFC1702105) 吉林省科技发展计划(20191102065YY,20200201141JC,20200201619JC)。
关键词 参藿五味颗粒 制备工艺 五味子醇甲 五味子甲素 五味子乙素 TLC HPLC Shenhuo Wuwei Granules preparation process schisandrin A schisandrin B TLC HPLC
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