运脾消食方提取工艺放大影响因素研究  

Influencing factors in scale-up of extraction process for Yunpi XiaoshiPrescription

作　　者：林欣荣 高紫薇 束雅春[1] 赵霞[1,2] 吴磊[1] LIN Xin-rong;GAO Zi-wei;SHU Ya-chun;ZHAO Xia;WU Lei(The Hospital Affiliated to Nanjing University of Chinese Medicine,Nanjing 210029,China;Nanjing University of Chinese Medicine,Nanjing 210029,China)

机构地区：[1]南京中医药大学附属医院,江苏南京210029 [2]南京中医药大学,江苏南京210029

出　　处：《中成药》2024年第2期391-396,共6页Chinese Traditional Patent Medicine

基　　金：江苏省中药骨干人才高级研修项目(苏中医科教[2022]11号);江苏省中医药管理局面上项目(YB2020014);江苏省中医院高峰人才项目(Y2021rc21)。

摘　　要：目的考察运脾消食方提取工艺放大影响因素。方法HPLC法测定儿茶素、阿魏酸、花旗松素、异牡荆素、芸香柚皮苷、白术内酯Ⅱ、柚皮苷、桑色素、橙皮苷、木犀草素、常春藤皂苷元、白术内酯I、柚皮素、橙皮素的含量,建立指纹图谱,评价容器体积、火候、投料量对各成分含量的影响。结果15批样品指纹图谱相似度均大于0.995。14种成分在各自范围内线性关系良好(r>0.9990),平均加样回收率96.4%~103.3%,RSD 0.5%~2.7%。火候的影响程度大于提取容器体积、投料量。结论多成分含量测定结合指纹图谱可为运脾消食方提取工艺放大后一致性评价的共性技术提供数据基础和理论参考。AIM To investigate the influencing factors in scale-up of extraction process for Yunpi Xiaoshi Prescription.METHODS HPLC was adopted in the content determination of catechin,ferulic acid,taxifolin,isovitexin,narirutin,atractylenolideⅡ,naringin,morin,hesperidin,luteolin,hederagenin,atractylenolideⅠ,naringenin and hesperetin,the fingerprints were established,after which the effects of container volume,optimal fire and feeding quantity on the contents of various constituents were evaluated.RESULTS Fifteen batches of samples demonstrated the similarities of more than 0.995.Fourteen constituents showed good linear relationships within their own ranges(r>0.9990),whose average recoveries were 96.4%-103.3%with the RSDs of 0.5%-2.7%.The influencing degree of optimal fire was greater than that of container volume and feeding quantity.CONCLUSION The combination of multi-component content determination and fingerprints can provide data basis and theoretical reference for the technology of consistency evaluation in scale-up of extraction process for Yunpi Xiaoshi Prescription.

关 键 词：运脾消食方 提取工艺放大 影响因素 含量测定 指纹图谱 HPLC 

分 类 号：R284.2[医药卫生—中药学]