一测多评法测定通滞苏润江胶囊中西红花苷-Ⅰ、西红花苷-Ⅱ的含量  

Determination of crocin-Ⅰand crocin-Ⅱin Tongzhi Surunjiang Capsules by QAMS

作　　者：徐鸿 周洋 孙磊[2] XU Hong;ZHOU Yang;SUN Lei(Xinjiang Uygur Autonomous Region Institute for Drug Control,Urumqi 830054,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]新疆维吾尔自治区药品检验研究院,乌鲁木齐830054 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2020年第5期440-446,共7页Drug Standards of China

摘　　要：目的:建立测定通滞苏润江胶囊中的西红花苷-Ⅰ、西红花苷-Ⅱ含量的一测多评方法。方法:采用HPLC法,用相对较稳定的西红花苷-Ⅰ对照品替代西红花苷-Ⅱ对照品测定其含量。结果:西红花苷-Ⅰ、西红花苷-Ⅱ分别在0.0~108.52μg·L-1、0.0~53.41μg·L-1范围内线性关系良好,平均回收率分别为98.09%、97.60%,RSD分别为0.01%、0.40%。52批样品测定结果表明一测多评法与常规外标法测得含量结果一致。结论:该方法准确、可靠,重复性好,可用于通滞苏润江胶囊的质量控制。Objective:To establish a reference substance substitution method for determination of crocin-Ⅰand crocin-Ⅱin Tongzhi Surunjiang Capsules by quantitative analysis of mullti-components by single marker(QAMS).Method:The content of crocin-Ⅱwas determined with relatively stable crocin-I RS substituting crocin-ⅡRS.Results:The linear ranges of crocin-I and crocin-II fell into 0.0-108.52μg·L-1 and 0.0-53.41μg·L-1 respectively,and the average recoveries of crocin-Ⅰand crocin-Ⅱwere 98.09%and 97.60%with RSD as 0.01%and 0.40%respectively.The results of 52 batches of samples showed that the results of QAMS were consistent with that of the conventional external standard method.Conclusion:The established method is accurate,reliable,and reproducible.It can be used for the quality control of Tongzhi Surunjiang Capsules.

关 键 词：一测多评 通滞苏润江胶囊 西红花苷-Ⅰ 西红花苷-Ⅱ 

分 类 号：R921.2[医药卫生—药学]