中成药2024,Vol.46Issue(7):2134-2139,6.DOI:10.3969/j.issn.1001-1528.2024.07.002
畅脉乐胶囊(Ⅰ)质量评价
Quality evaluation of Changmaile Capsules(Ⅰ)
摘要
Abstract
AIM To evaluate the quality of Changmaile Capsules(Ⅰ).METHODS The analysis was performed on a 35℃ thermostatic Thermo Scientific AccucoreTM XL C18 column(4.6 mm×250 mm,4 μm),with the mobile phase comprising of methanol-acetonitrile-0.5% phosphoric acid flowing at 1 mL/min in a gradient elution manner,and the detection wavelengths were set at 230,280 nm.The contents of gastrodin,danshensu,quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside,3′-hydroxypuerarin,puerarin,3′-methoxypuerarin,puerarin apioside,daidzin,rosmarinic acid,lithospermic acid,ononin,daidzein,salvianolic acid B,calycosin,paeoniflorin and isoquercitrin were determined,after which HPLC fingerprints were established,along with the calculation of similarities.RESULTS Sixteen constituents showed good linear relationships within their own ranges(r≥0.999 0),whose average recoveries were 87.4%-103.9% with the RSDs of 0.54%-3.10% .At 230 nm,the fingerprints of ten batches of samples demonstrated similarities of 0.954-0.999,which displayed obvious differences at 280 nm.3′-Hydroxypuerarin,puerarin,3′-methoxypuerarin,puerarin apioside,daidzin and daidzein were main differential constituents,paeoniflorin and isoquercitrin exhibited stable contents in various batches of samples.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Changmaile Capsules(Ⅰ).关键词
畅脉乐胶囊(Ⅰ)/质量评价/含量测定/HPLC指纹图谱Key words
Changmaile Capsules(Ⅰ)/quality evaluation/content determination/HPLC fingerprints分类
医药卫生引用本文复制引用
张宽,欧余航,罗春燕,翁一玲,谢玉和,严锦贤..畅脉乐胶囊(Ⅰ)质量评价[J].中成药,2024,46(7):2134-2139,6.基金项目
国家自然科学基金(青年科学基金)项目(82305351) (青年科学基金)
福建省自然科学基金项目(2021J01871) (2021J01871)