基于质量常数评价方法研究泽泻饮片的等级  

Exploration of objective quality evaluation parameter of Alismatis Rhizoma decoction pieces

作　　者：刘德文 邓哲[3] 石佳 焦梦姣 仝燕 王锦玉[2] 程锦堂[2] 陈莎[2] 陈畅[2] 章军[2] 沈立[1,2] 于欢 潘争红[4] 龚千锋[1] 刘安[2] LIU De-wen;DENG Zhe;SHI Jia;JIAO Meng-jiao;TONG Yan;WANG Jin-yu;CHENG Jin-tang;CHEN Sha;CHEN Chang;ZHANG Jun;SHEN Li;YU Huan;PAN Zheng-hong;GONG Qian-feng;LIU An(School of Pharmacy,Jiangxi University of Traditional Chinese Medicine,Nanchang 330004,China;Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Institute of Traditional Chinese Medicine,China National Traditional & Herbal Medicine Co.,Ltd.,Beijing 102600,China;Guangxi Key Laboratory of Functional Phytochemicals Research and Utilization,Guangxi Institute of Botany,Guangxi Zhuang Autonomous Region and Chinese Academy of Sciences,Guilin 541006,China)

机构地区：[1]江西中医药大学药学院,江西南昌330004 [2]中国中医科学院中药研究所,北京100700 [3]中国中药有限公司中药研究院,北京102600 [4]广西壮族自治区中国科学院广西植物研究所广西植物功能物质研究与利用重点实验室,广西桂林541006

出　　处：《中国中药杂志》2019年第9期1729-1733,共5页China Journal of Chinese Materia Medica

基　　金：国家中药标准化项目(ZYBZH-Y-JX-27);中国中医科学院"十三五"重点领域研究专项(ZZ10-007);广西植物功能物质研究与利用重点实验室开放基金项目(FPRU2017-1)

摘　　要：目前,对于饮片等级的评价主要从外观性状以及指标成分含量2个角度入手,另外可能会增加2015年版《中国药典》中所设定的检查项,但存在检测项目较多或者设定指标不够科学等问题。基于此,该研究拟建立泽泻饮片的质量常数等级评价体系,为规范该饮片的市场流通、保证其临床用药的安全有效提供参考,同时,为其他饮片的等级评价提供参考和借鉴。从不同药厂收集18批泽泻饮片样品,检测各样品的形态参数,测定泽泻饮片中23-乙酰泽泻醇B的含量,计算质量常数与相对质量常数等参数。结果显示,18批泽泻饮片的质量常数为0. 390～2. 076。若将18批泽泻饮片分为3个等级,以最大质量常数的80%为一等,50%～80%为二等,其余为三等来进行饮片的等级划分,确定一等泽泻饮片质量常数≥1. 66,二等泽泻饮片质量常数≥1. 04且<1. 66,三等泽泻饮片质量常数<1. 04。该文建立的质量常数评价方法客观、可行,且操作非常简便,可用于泽泻饮片的等级划分,为控制该饮片的质量提供了参考方法,并为其他饮片的等级评价提供了借鉴。To establish a quality constant evaluation system of Alismatis Rhizoma decoction pieces,in order to provide reference for regulating the market circulation of this decoction pieces. A total of 18 batches of Alismatis Rhizoma decoction pieces were collected from different pharmaceutical factories,and the morphological parameters of each sample were tested. The content of alisol B 23-acetate in Alismatis Rhizoma decoction pieces was determined by HPLC in the 2015 edition of Chinese Pharmacopoeia,and the parameters such as quality constant and relative quality constant were calculated. The quality constant range of 18 batches of Alismatis Rhizoma decoction pieces was 0. 390-2. 076. If 18 batches of Alismatis Rhizoma decoction pieces were divided into 3 grades,taking 80% of the maximum quality constant as first grade,50% to 80% as second grade,and the rest as third grade,then the quality constant of firstgrade samples was ≥1. 66,the quality constant of second-grade samples was ≥1. 04 and <1. 66,and the quality constant of third-grade samples was <1. 04. The established quality constant evaluation method is objective and feasible,which can be used to classify the grade of Alismatis Rhizoma decoction pieces and provide a reference method to control the quality of this decoction pieces.

关 键 词：泽泻 饮片 质量常数 客观指标 23-乙酰泽泻醇B 形态参数 

分 类 号：R284.1[医药卫生—中药学]