加味六君子合剂在不同工艺放大过程中6种活性成分含量比较  

Comparison of six active constituent contents in modified Liujunzi Decoction during different process amplifications

作　　者：朱亚苹 刘玉鑫 邵孟其 汪有锦[1,2] 吴磊 ZHU Ya-ping;LIU Yu-xin;SHAO Meng-qi;WANG You-jin;WU Lei(The Hospital Affiliated to Nanjing University of Chinese Medicine,Nanjing 210029,China;The First Clinical Medicial College,Nanjing University of Chinese Medicine,Nanjing 210029,China;Laboratory for Traditional Chinese Medicine Preparations,The Hospital Affiliated to 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]南京中医药大学第一临床医学院,江苏南京210029 [3]南京中医药大学附属医院中药制剂实验室,江苏南京210029

出　　处：《中成药》2025年第2期395-400,共6页Chinese Traditional Patent Medicine

基　　金：国家中医药管理局2023年中药创新能力提升项目(k2023BZ04);江苏省中医药管理局项目(YB2020014);江苏省中药骨干人才高级研修项目(苏中医科教[2022]11号)。

摘　　要：目的比较加味六君子合剂在小试、中试(500、1500 L)、大生产过程中咖啡酸、阿魏酸、芸香柚皮苷、毛蕊异黄酮、甘草酸、白术内酯Ⅲ的含量。方法分别在浸泡60 min,一煎煮沸0、5、10、15、20、25、30 min,二煎煮沸5、10、15、20 min时取样,建立HPLC指纹图谱,测定活性成分含量。结果小试、中试HPLC指纹图谱中有6个共有峰,而大生产HPLC指纹图谱中有5个,相似度均大于0.980。在不同时间点中试过程中,各活性成分含量变化趋势一致,其总含量高于小试、大生产过程中。结论工艺放大对加味六君子合剂中活性成分含量影响较小,并非随着容器扩大和投料量增加呈升高趋势。AIM To compare the contents of caffeic acid,ferulic acid,narirutin,calycosin,glycyrrhizic acid and atractylenolideⅢof modified Liujunzi Decoction(MLJZD)during small test,pilot test(500,1500 L)and large production.METHODS The samples were taken after soaking for 60 min,boiling for 0,5,10,15,20,30 min in the first decoction,and boiling for 5,10,15,20 min in the second decoction,respectively,after which the HPLC fingerprints were established,the contents of active constituents were determined.RESULTS There were 6 common peaks in the HPLC fingerprints for small test and pilot test,while 5 common peaks were observable in the HPLC fingerprints for large production,along with the similarities of more than 0.980.During pilot tests at different time points,various active constituents demonstrated consistent content changing trends,whose total content was higher than those during small test and large production.CONCLUSION Process amplification exhibits a little influence on active constituent contents in MLJZD,which don’t show increasing trends with the expansion of container and enhancement of dosage.

关 键 词：加味六君子合剂 活性成分 小试 中试 大生产 HPLC指纹图谱 含量测定 

分 类 号：R943[医药卫生—药剂学]