保心宁片HPLC特征图谱研究及8个指标性成分的含量测定  

Study on HPLC specific chromatogram of Baoxinning tablets and simultaneous determination of its eight index components

作　　者：翟宏宇[1] 王海洋[1] 杨献玲[1] 单柏宇 

机构地区：[1]吉林省药品检验所,长春130033 [2]白城市食品药品检验所,白城137000

出　　处：《药物分析杂志》2017年第9期1633-1639,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立保心宁片的特征图谱,并同时测定柚皮苷、新橙皮苷、迷迭香酸、丹酚酸B、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A 8个指标性成分的含量。方法:采用高效液相色谱法,使用Capcell C_(18)色谱柱(4.6 mm×250 mm,5μm),以乙腈-0.05%磷酸水作为流动相进行梯度洗脱,流速0.8 mL·min^(-1),柱温30℃,检测波长270 nm;分别对8批保心宁片的特征图谱进行研究及含量测定。结果:初步建立了保心宁片的HPLC特征图谱,标定了10个共有特征峰。待测的8个成分在各自范围内(柚皮苷0.16~4.14μg,新橙皮苷0.20~5.08μg,迷迭香酸0.08~2.09μg,丹酚酸B 0.11~2.67μg,二氢丹参酮Ⅰ0.03~0.75μg,隐丹参酮0.02~0.52μg,丹参酮Ⅰ0.04~1.08μg,丹参酮Ⅱ_A 0.01~0.23μg)线性关系良好,回收率在96.8%~99.9%之间,RSD均小于3.0%;8批样品中柚皮苷、新橙皮苷、迷迭香酸、丹酚酸B、二氢丹参酮Ⅰ、隐丹参酮、丹参酮Ⅰ、丹参酮Ⅱ_A含量分别为0.046~5.263、0.064~4.623、0.066~0.311、0.120~1.991、0.012~0.067、0.010~0.165、0.023~0.292、0.004~0.109 mg·片^(-1)。结论:该方法可用于保心宁片的质量控制。Objective： To establish the HPLC specific chromatogram of Baoxinning tablets, and to simultaneously determine eight index components-naringin, neohesperindin, rosmarinic acid, salvianolic acid B, dihydrotanshione I , crytotanshinone, tanshinone I , tanshinone 11 A. Methods： The components were separated by HPLC with Capcell C18 （ 4.6 mm × 250 mm, 5 μm ） column in a gradient elution of acetonitrile and water with 0.05% H3PO4 as the mobile phase at the flow rate of 0.8 mL· min-1, temperature of 30 ℃ and detection wavelength of 270 nm. The specific chromatograms of 8 batches of Baoxinning tablets were studied and eight index components were determined respectively. Results： the specific chromatogram of Baoxinning tablets was established and 10 common peaks were indicated. The eight chemical components were well separated and with good liner relationship over the range of 0.16-4.14 μg for naringin, 0.20-5.08 μg for neohesperindin, 0.08-2.09 μg for rosmarinic acid, 0.11-2.67 μg for salvianolic acid B. 0.03-0.75 μg for dihydrotanshione I. 0.02-0.52 μg for crytotanshinone, 0.04-1.08 txg for tanshinone 1, 0.01-0.23 μg for tanshinone Ⅱ A·The recoveries were between 96.8% and 99.9%, and the RSD was less than 3.0%. The contents of naringm, neohesperindin, rosmarinic acid, salvianolic acid B, dihydrotanshione I, crytotanshinone, tanshinone I, tanshinone Ⅱ A in 8 samples were 0.046- 5.263 mg per tablet, 0.064-4.623 mg per tablet, 0.066-0.311 nag per tablet, 0.120-1.991 mg per tablet, 0.012- 0.067 mg per tablet, 0.010-0.165 mg per tablet, 0.023-0.292 mg per tablet, 0.004-0.109 mg per tablet, respectively. Conclusion： The method can be used for quality control of Baoxinning tablets.

关 键 词：保心宁片 特征图谱 丹参 枳壳 含量测定 质量控制 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学]