定量用三七总皂苷对照提取物的协作定值  

The Collaborative Calibration of Quantitative Reference Extract of Notoginseng Total Saponins

作　　者：鲁静[1] 付凌燕[1,2] 戴忠[1] 张雯洁 祝明[4] 曹红[5] 顾立红[6] 季申[7] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]吉林省吉林市药品检验所,吉林132000 [3]云南省食品药品检验所,昆明650011 [4]浙江省食品药品检验所,杭州310004 [5]总后卫生部药品仪器检验所,北京100071 [6]广州市药品检验所,广州500160 [7]上海市食品药品检验所,上海20120

出　　处：《中国药品标准》2012年第3期199-202,共4页Drug Standards of China

摘　　要：目的:建立定量用三七总皂苷对照提取物国家药品标准物质。方法:照《中国药典》2010年版一部三七总皂苷项下方法,以三七皂苷Rd、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd为指标,评价提取物备选原料的均匀性;5个实验室进行协作标定。结果:备选原料均匀性良好;对协作标定的测定结果进行统计分析确定了5种成分的标示值。结论:通过协作标定赋值,建立了首批定量用三七总皂苷对照提取物国家药品标准物质。Objective： To specify quantitative reference extract of notoginseng total saponins. Method： The uniformity of alternative raw materials was investigated by detecting the contents of notoginsenoside R1, ginsenoside Rg1 , ginsenoside Re, ginsenoside Rb1 and ginsenoside Rd using the method described under Notoginseng Total Saponins collected in Chinese Pharmacopoeia, Edition 2010. Five laboratories participate in the collaborative calibration test. Results： The alternative raw materials have good uniformity; the marked values of five components have been determined through the statistical analysis of the determining data provided by the five collaborative laboratories. Conclusion： The first batch of quantitative reference extract of Notoginseng Total Saponins had been specified based on the results of collaborative calibration.

关 键 词：对照提取物 三七总皂苷 标准物质 协作定值 

分 类 号：R921.2[医药卫生—药学]