西红花苷对照提取物用于双红活血胶囊的质量控制研究  

Quality control of Shuanghong Huoxue capsules with crocins reference extract

作　　者：何风艳[1] 戴忠[1] 马双成[1] HE Feng-yan DAI Zhong MA Shuang-cheng(National Institutes for Food and Drug Control, Beijing 100050, China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2016年第12期2204-2208,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：中国食品药品检定研究院中青年发展研究基金项目(2012A9)

摘　　要：目的:建立采用西红花苷对照提取物测定双红活血胶囊中西红花苷Ⅰ、西红花苷Ⅱ含量的超高效液相色谱方法。方法:采用Cortecs C18色谱柱(2.1 mm×100 mm,1.6μm),以甲醇-水(40︰60)为流动相,流速0.4 m L·min^(-1),检测波长440 nm,柱温30℃。结果:西红花苷Ⅰ、西红花苷Ⅱ分别在3.04~304、1.02~102μg·m L^(-1)范围内线性关系良好;平均回收率(n=6)分别为98.5%、99.3%,RSD分别为2.8%、1.2%。以西红花苷对照提取物为对照,4批样品的测定结果分别为西红花苷Ⅰ0.255、0.206、0.105、0.063 mg·g^(-1),西红花苷Ⅱ0.088、0.069、0.036、0.019 mg·g^(-1),与采用单体对照品所测得结果基本一致。结论:西红花苷对照提取物可用于双红活血胶囊的质量控制。Objective： To establish an UPLC method for determination of crocin Ⅰ and crocin Ⅱ with crocins reference extract.Methods： The UPLC analysis was performed on a Cortecs C18 column （2.1 mm×100 mm, 1.6 μm）with a mixture of methanol and water （40︰60）as the mobile phase at a flow rate of 0.4 mL·min-1.The detection wavelength was set at 440 nm.The column temperature was 30℃.Results： Crocin Ⅰ and crocin Ⅱ showed good linearity in the ranges of 3.04-304 μg·mL-1 and 1.02-102 μg·mL-1 respectively.The average recoveries were 98.5% and 99.3%, the RSDs were 2.8% and 1.2%.The quantitative results of 4 batches of samples with crocins reference extract were 0.255, 0.206, 0.105, 0.063 mg·g-1 for crocin Ⅰ and 0.088, 0.069, 0.036, 0.019 mg·g-1 for crocin Ⅱ, which were basically the same with the conventional chemical references.Conclusion： Crocins reference extract could be used in quality control of shuanghong Huoxue.

关 键 词：双红活血胶囊 西红花苷 对照提取物 西红花 超高效液相色谱 中成药质量控制 中药标准物质 

分 类 号：R917[医药卫生—药物分析学]