《中国药典》收载种子类药材统计分析与监管建议——以青葙子、鸡冠花子为例  

Statistical Analysis of and Supervision Suggestions for Medicinal Seeds in Chinese Pharmacopoeia——A Case Study of Celosiae Argentea Semen and Celosiae Cristatae Semen

作　　者：连超杰[1] 康帅[1] 张南平[1] 郑健[1] 马双成[1] LIAN Chao-jie;KANG Shuai;ZHANG Nan-ping;ZHENG Jian;MA Shuang-cheng(National Institutes for Food and Drug Control)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国食品药品监管》2022年第3期25-33,共9页China Food & Drug Administration Magazine

摘　　要：目的:通过对《中国药典》2020年版收载种子类药材进行统计分析并以青葙子及其混淆品鸡冠花子的鉴别研究为实例,对我国种子类药材的监管提出建议。方法:对《中国药典》2020年版收载种子类药材进行数据采集、拆分、统计和分析;收集青葙子和鸡冠花子的多批样品,分别进行体式显微镜、扫描电子显微镜等设备观察、比较两者特征。结果与结论:从长度、宽度、厚度的数据范围来看,超过50%的《中国药典》2020年版收载种子类药材的大小都集中在1cm以下,部分长度(或直径)数据精度达到0.01cm(0.1mm)。普通解剖镜难以达到要求,建议在监管检验中使用体式显微镜,甚至电镜等仪器进行观察、测量。本文实例青葙子和鸡冠花子在形状、大小和表面构造特征上存在区别;在微形态与微性状特征上具有更为稳定的区别,其中种脐、表面纹理是主要鉴别点。Objective:To put forward suggestions for the supervision of medicinal seeds in China through statistical analysis of medicinal seeds in the Chinese Pharmacopoeia(2020 Edition)and a case study of differentiating between Celosiae Semen and its adulterant cockscomb seeds.Methods:Data on medicinal seeds in the Chinese Pharmacopoeia(2020 Edition)was collected,classified,calculated and analyzed.Several batches of Celosia argentea and Celosia cristata seed samples were collected and stereomicroscope and scanning electron microscope were used to observe and compare their characteristics.Results and conclusion:With respect to data on length,width and thickness,more than 50%of the medicinal seeds in the Chinese Pharmacopoeia were less than 1cm in size,and the accuracy of some length(or diameter)data reached 0.01cm(0.1mm).It is suggested that stereoscope,even electron microscope and other instruments be used for observation and measurement.There are differences in the shape,size and surface structure between the seeds of Celosia argentea and Celosia cristata,among which,hilum and surface texture are the main identification points.

关 键 词：种子类药材 统计分析 青葙子 鸡冠花子 监管建议 

分 类 号：R285[医药卫生—中药学]