Quality evaluation of Changmaile Capsules(Ⅰ)
10.3969/j.issn.1001-1528.2024.07.002
- VernacularTitle:畅脉乐胶囊(Ⅰ)质量评价
- Author:
Kuan ZHANG
1
,
2
;
Yu-Hang OU
;
Chun-Yan LUO
;
Yi-Ling WENG
;
Yu-He XIE
;
Jin-Xian YAN
Author Information
1. 福建中医药大学附属第二人民医院,福建 福州 350003
2. 福建省医疗机构中药制剂重点实验室,福建 福州 350003
- Keywords:
Changmaile Capsules(Ⅰ);
quality evaluation;
content determination;
HPLC fingerprints
- From:
Chinese Traditional Patent Medicine
2024;46(7):2134-2139
- CountryChina
- Language:Chinese
-
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).
