中成药2024,Vol.46Issue(2) :391-396.DOI:10.3969/j.issn.1001-1528.2024.02.007

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 Xiaoshi Prescription

林欣荣 高紫薇 束雅春 赵霞 吴磊
中成药2024,Vol.46Issue(2) :391-396.DOI:10.3969/j.issn.1001-1528.2024.02.007

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 Xiaoshi Prescription

林欣荣 1高紫薇 1束雅春 2赵霞 1吴磊2
扫码查看

作者信息

  • 1. 南京中医药大学附属医院, 江苏 南京 210029;南京中医药大学, 江苏 南京 210029
  • 2. 南京中医药大学附属医院, 江苏 南京 210029
  • 折叠

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>0.999 0),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.

Abstract

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>0.999 0),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

Key words

Yunpi Xiaoshi Prescription/scale-up of extraction process/influencing factors/content determination/fingerprints/HPLC

引用本文复制引用

基金项目

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)

出版年

2024
中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCDCSCD北大核心
影响因子:1.217
ISSN:1001-1528
参考文献量12
段落导航相关论文