首页|基于指纹图谱及多成分测定评价运脾消食颗粒制备工艺对其整体质量的影响

基于指纹图谱及多成分测定评价运脾消食颗粒制备工艺对其整体质量的影响

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目的 建立运脾消食方的HPLC指纹图谱并进行多成分含量测定,考察提取、浓缩、离心、制粒不同工艺阶段对运脾消食颗粒的影响.方法 以运脾消食颗粒的提取液、浓缩液、离心液、颗粒为供试品,采用高效液相色谱法建立不同工艺阶段的指纹图谱,同时进行相似度分析与色谱峰指认,测定方中绿原酸、阿魏酸、花旗松素、异牡荆素、芸香柚皮苷、橙皮苷、木犀草素、川陈皮素的含量.结果 10批运脾消食颗粒制备过程中不同工艺阶段与对照图谱相比,相似度均大于0.990,表明制剂工艺稳定可行,提取液中标定了 19个共有峰,浓缩、离心后共有峰增至21个,颗粒中共有峰为20个;含量测定结果显示运脾消食颗粒制备过程中不同工艺阶段对其整体质量有不同程度的影响.结论 浓缩期间稳定性较差的成分绿原酸损失较多,橙皮苷分子量相对较大在离心后转移率偏低,制粒后异牡荆素转移率略大于1.基于不同工艺阶段对运脾消食颗粒质量的影响进行探讨分析,可为中药制剂制备过程中整体质量评价的共性技术提供参考.
Influence of different process stages on the overall quality of Yunpi Xiaoshi granules based on HPLC fingerprint and multi-component content determination
Objective To establish an HPLC fingerprint of Yunpi Xiaoshi prescription and determine the content of multi-components,to determine the effect of extraction,concentration,centrifugation and granulation process on Yunpi Xiaoshi granules.Methods The extract,concentrate,centrifuge and granule of Yunpi Xiaoshi granules were taken as the test products,the fingerprints of different process stages were established by HPLC,the similarity was analyzed and chromatographic peaks were identified at the same time to determine the content of chlorogenic acid,ferulic acid,taxifolin,isovitexin,narirutin,hesperidin,luteolin and nobiletin.Results Compared with the control chromatogram,the similarity of different process stages in 10 batches of Yunpi Xiaoshi granules was greater than 0.990,indicating that the preparation process was stable.Totally 19 common peaks were identified in the extract,which increased to 21 after the concentration and centrifugation,and a total of 20 common peaks were found in the granules.The content determination showed that different process stages in the preparation of Yunpi Xiaoshi granules had different influence on the overall quality.Conclusion During the concentration period,more loss of chlorogenic acid is found in components with poor stability.With molecular weight relatively large transfer rate of hesperidin after the centrifugation is reduced,and the transfer rate of isovitexin after the granulation is slightly greater than 1.This paper provides reference for the overall quality evaluation in the preparation of traditional Chinese preparations.

Yunpi Xiaoshi prescriptionprocess stagegranulationfingerprintcontent determination

林欣荣、高紫薇、赵霞、吴磊

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南京中医药大学附属医院,南京 210029

南京中医药大学,南京 210029

运脾消食方 工艺阶段 制粒 指纹图谱 含量测定

江苏省中医药局面上项目江苏省中医院高峰人才项目江苏省中药骨干人才高级研修项目

YB2020014Y2021rc21苏中医科教[2022]11号

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(5)
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