赤芍标准汤剂质量表征参数的探索性研究  

Exploratory Study on Quality Characterization Parameters of Red Peony Standard Decoction

作　　者：雷阳 杨敏[1] 田佩灵 徐杨 曾珊 唐焓嫣 沈芃 郭晓恒[3] LEI Yang;YANG Min;TIAN Peiling;XU Yang;ZENG Shan;TANG Hanyan;SHEN Peng;GUO Xiaoheng(School of Pharmacy,Chengdu University,Chengdu 610106,China;Chengdu Tianxing Zhiyuan Biotechnology Co.,Ltd.,Chengdu 610040,China;School of Preclinical Medicine,Chengdu University,Chengdu 610106,China)

机构地区：[1]成都大学药学院,四川成都610106 [2]成都天兴致远生物科技有限公司,四川成都610040 [3]成都大学基础医学院,四川成都610106

出　　处：《成都大学学报（自然科学版）》2024年第3期225-230,共6页Journal of Chengdu University（Natural Science Edition）

基　　金：四川省科技成果转移转化示范项目(2023ZHCG0071);成都大学2021—2023年研究生人才培养质量和教学改革立项项目(cdjgy2022004)。

摘　　要：针对标准汤剂质量表征参数不完善的情况,对赤芍配方颗粒进行综合性评价研究,以探索标准汤剂质量表征方法.在《中药配方颗粒质量控制与标准制定技术要求》(以下简称《技术要求》)中规定的特征图谱、出膏率及有效成分含量指标的基础上,增加物理与紫外指纹图谱及活化部分凝血活酶时间等指标对赤芍标准汤剂与配方颗粒进行研究比对,采用SPSS软件进行统计分析.结果显示,各批次赤芍配方颗粒出膏率及芍药苷含量均在《技术要求》规定可允许范围内,赤芍标准汤剂与配方颗粒的物理及紫外指纹图谱相似度较高,但配方颗粒的流动性、防潮性、活性成分及活血药效与标准汤剂有显著性差异,配方颗粒优于标准汤剂.表明目前《技术要求》中规定的参数并不能完全表征标准汤剂与配方颗粒的质量属性,有待进一步丰富.In response to the incomplete quality characterization parameters of standard decoction,a comprehensive evaluation study was conducted on red peony formula granules to explore the quality characterization methods of standard decoction.On the basis of the HPLC fingerprint,extract rate and active ingredient content index stipulated in the Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules(hereinafter referred to as Technical Requirements),the physical and ultraviolet fingerprint,APTT(activated partial thromboplastin time)in vitro blood circulation activity simulation and other indicators were added to study and compare the standard decoction and formula granules of red peony,and SPSS software was used for statistical analysis.The result showed that the extraction rate and paeoniflorin content of each batch of red peony formula granules were within the allowable range specified in the Technical Requirements.The physical and UV fingerprint similarity between the red peony standard decoction and the formula granules was high,but there were significant differences in the fluidity,moisture resistance,active ingredients,and blood activating effect between the formula granules and the standard decoction.The formula granules were superior to the standard decoction.It can be concluded that the parameters specified in the current Technical Requirements cannot fully characterize the quality attributes of standard decoction and formula granules,and further enrichment is needed.

关 键 词：赤芍 标准汤剂 配方颗粒 表征参数 

分 类 号：R283.6[医药卫生—中药学]