伊贝母标准汤剂制备及质量标准研究  

Study on Preparation and Quality Evaluation of Fritillaria Pallidiflora Schrenk Standard Decoction

作　　者：康汶铉 祝婕 孟文全 尹强 穆丹丹 Kang Wenxuan;Zhu Jie;Meng Wenquan;Yin Qiang;Mu Dandan(School of Pharmacy,Shihezi University,Shihezi 832002,China;Xinjiang Uygur Pharmaceutical Co.,Ltd.,Urumqi 830026,China)

机构地区：[1]石河子大学药学院,新疆石河子832002 [2]新疆维吾尔药业有限责任公司,新疆乌鲁木齐830026

出　　处：《亚太传统医药》2023年第9期66-73,共8页Asia-Pacific Traditional Medicine

基　　金：新疆维吾尔自治区创新环境(人才、基地)建设专项项目(天山创新团队计划)(2020D14030)。

摘　　要：目的:制备15批伊贝母饮片标准汤剂,建立其质量评价方法,为制定伊贝母配方颗粒质量标准提供参考依据。方法:以传统的水煎药工艺为基准制备伊贝母标准汤剂;采用高效液相色谱-蒸发光散射检测器(HPLC-ELSD)测定15批伊贝母标准汤剂中指标成分西贝母碱苷和西贝母碱的含量,计算二者的转移率;计算标准汤剂的出膏率并测定相对密度与pH;以薄层色谱法(TLC)对15批次伊贝母标准汤剂中的西贝母碱薄层检识,并同时建立伊贝母饮片和标准汤剂特征图谱。结果:15批伊贝母标准汤剂中西贝母碱苷成分转移率为20.19%~48.57%,西贝母碱成分转移率为18.89%~47.39%,平均转移率分别为32.02%、34.89%;出膏率范围为6.06%~10.12%,平均出膏率为7.83%;相对密度值为1.014~1.024;pH值为4.70~6.38;15批伊贝母饮片与标准汤剂特征图谱共标定了7个特征峰,并指认了其中的5个色谱峰,分别为峰2贝母辛,峰3西贝母碱苷,峰4伊贝碱苷A,峰6西贝母碱,峰7梭砂贝母碱,特征图谱批次间相似度均超过0.99。结论:该实验建立了定性、定量评价伊贝母标准汤剂的质量评价方法,该方法较为系统、简单易行,且专属性和重复性良好。饮片与标准汤剂特征图谱相似度高。可用于伊贝母标准汤剂质量控制,并为后续配方颗粒及其他研究提供参考。Objective:To carry out the quality standards research of 15 batches of standard decoction of Fritillaria pallidiflora Schrenk,and to provide a reference for the quality evaluation of its formula granules.The standard decoction of Fritillaria pallidiflora Schrenk was prepared according to the preparation principles of the standard decoction of traditional Chinese medicine.Methods:With Sipeimine-3β-D glucoside and imperialine as the detection indexes,the contents and transfer rates of index components were calculated by the high-performance liquid chromatography evaporative light scattering detector(HPLC-ELSD).The paste-out rates,relative densitiesand pH values were measured.The imperialine in 15 batches standard decoction of Fritillaria pallidiflora Schrenk was identified by the thin-layer chromatography(TLC)methodand the characteristic chromatograms of decoction pieces and standard decoction was established.Results:The result revealed that the transfer rates of Sipeimine-3β-D-glucoside and imperialine were from 20.19% to 48.57%and 18.89% to 47.39% respectively,with average transfer rates of 32.02% and 34.89%.The paste-out rate were 6.06%~10.12% and the average paste-out rate was 7.83%.The relative densities were between 1.014~1.024 and the pH values were between 4.70~6.38.There 7 common characteristic peaks were indentified in 15 batches of Fritillaria pallidiflora Schrenk decoction pieces and standard decoction characteristic chromatography,and 5 characteristic peaks were identified,respectively,Peimisine,Sipeimine-3β-D-glucoside,Yibeinosid A,imperialine and Hupehenine.The similarity of characteristic chromatograms among each batch was greater than 0.99.Conclusion:The quality standard of standard decoction of Fritillaria pallidiflora Schrenk established in this research is feasible,which is suitable for the quality evaluation of Fritillaria pallidiflora Schrenk and provides a reference for the quality control of formula granules.

关 键 词：伊贝母标准汤剂 饮片 出膏率 HPLC-ELSD 含量测定 转移率 特征图谱 

分 类 号：R284.1[医药卫生—中药学]