北沙参标准汤剂制备及质量评价方法研究  

Study on Preparation and Quality Evaluation of Standard Decoction of Glehniae Radix

作　　者：陈桂生 汪静 肖国梁 王艳慧 康志英 Chen Guisheng;Wang Jing;Xiao Guoliang;Wang Yanhui;Kang Zhiying(Guangzhou Xiangxue Pharmaceutical Co.,Ltd.,Guangzhou 510663,China;Longde Liupanshan Chinese Medicine Resources Development Co.,Ltd.,Guyuan 756300,China;Guangdong Xiangxue South Medicine Development Co.,Ltd.,Zhaoqing 526600,China)

机构地区：[1]广州市香雪制药股份有限公司,广东广州510663 [2]宁夏隆德县六盘山中药资源开发有限公司,宁夏固原756300 [3]广东香雪南药发展有限公司,广东肇庆526600

出　　处：《亚太传统医药》2024年第7期91-98,共8页Asia-Pacific Traditional Medicine

基　　金：宁夏回族自治区中药配方颗粒(隆德)工程技术研究中心项目(2019GCJS0029)。

摘　　要：目的:制备15批北沙参标准汤剂,并以出膏率、指标成分含量及转移率、特征图谱为指标建立北沙参标准汤剂质量评价方法。方法:采用紫外分光光度法测定北沙参饮片及标准汤剂中的多糖含量,计算转移率、出膏率;采用HPLC对15批北沙参饮片及标准汤剂进行特征图谱检测,并结合质谱对特征峰进行指认。结果:15批北沙参饮片中的多糖含量为35.31%~48.70%,标准汤剂中多糖的含量为52.49%~71.98%,多糖转移率为30.82%~59.98%,出膏率为17.8%~40.0%。将北沙参饮片和标准汤剂特征图谱进行比对,饮片与标准汤剂均呈现10个共有峰,结合质谱分析指认了其中7个成分。结论:15批北沙参饮片与标准汤剂的化学物质基本一致,研究数据可作为北沙参标准汤剂的工艺及质量控制依据,也可为配方颗粒标准的制订及工业化制备提供基本数据支持。Objective:To prepare 15 batches of standard decoction of Glehniae Radix,and to establish the method of quality evaluation by the indexes:extract rate,content and transfer rate of index components,and characteristic chromatogram.Methods:The content of polysaccharide in Glehniae Radix and standard decoction were determined by UV Spectrophotometer,and the transfer rate and extract rate were calculated.HPLC was used to detect characteristic chromatogram of 15 batches of Glehniae Radix decoction pieces and standard decoction,and the characteristic peaks were identified by mass spectrometry.Results:The polysaccharide content of 15 batches of Glehniae Radix was 35.31%-48.70%,the polysaccharide content of standard decoction was 52.49%-71.98%,and the polysaccharide transfer rate was 30.82%-59.98%.The extract rate was 17.8%-40.0%.The characteristic chromatogram of Glehniae Radix decoction pieces and standard decoction were compared,and both of them had 10 common peaks.Seven compounds were identified by mass spectrometry.Conclusion:The chemical composition of 15 batches of Glehniae Radix was basically the same as the standard decoction.The research data can be used as a reference for the technology and quality of the standard decoction of Glehniae Radix,as well as providing basic data support for formulation granules standard and industrial production.

关 键 词：北沙参 标准汤剂 特征图谱 配方颗粒 含量测定 

分 类 号：R283[医药卫生—中药学]