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畅脉乐胶囊(Ⅰ)质量评价

张宽 欧余航 罗春燕 翁一玲 谢玉和 严锦贤

中成药2024,Vol.46Issue(7):2134-2139,6.
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)

张宽 1欧余航 2罗春燕 3翁一玲 1谢玉和 3严锦贤1

作者信息

  • 1. 福建中医药大学附属第二人民医院,福建 福州 350003||福建省医疗机构中药制剂重点实验室,福建 福州 350003
  • 2. 福建中医药大学附属第三人民医院,福建 福州 350108
  • 3. 福建中医药大学附属第二人民医院,福建 福州 350003
  • 折叠

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)

中成药

OA北大核心CSTPCD

1001-1528

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