畅脉乐胶囊(Ⅰ)质量评价

Quality evaluation of Changmaile Capsules(Ⅰ)

目的对畅脉乐胶囊(Ⅰ)质量进行评价。方法分析采用ThermoScientificAccucoreTMXLC18色谱柱(4.6mm×250mm,4μm);流动相甲醇-乙腈-0.5%磷酸,梯度洗脱;体积流量1mL/min;柱温35℃;检测波长230、280nm,测定天麻素、丹参素、槲皮素-3-O-β-D-葡萄糖-7-O-β-D-龙胆双糖苷、3′-羟基葛根素、葛根素、3′-甲氧基葛根素、葛根素芹菜糖苷、芍药苷、大豆苷、迷迭香酸、紫草酸、异槲皮苷、芒柄花苷、大豆苷元、丹酚酸B、毛蕊异黄酮的含量,建立HPLC指纹图谱,测定相似度。结果16种成分在各自范围内线性关系良好(r≥0.9990),平均加样回收率87.4%~103.9%,RSD0.54%~3.10%。在230nm处,10批样品指纹图谱相似度为0.954~0.999,而在280nm处其差异较明显。3′-羟基葛根素、葛根素、3′-甲氧基葛根素、葛根素芹菜苷、大豆苷、大豆苷元是主要差异成分,芍药苷、异槲皮苷含量在各批样品中稳定。结论该方法简便、准确、可靠,可用于畅脉乐胶囊(Ⅰ)的质量控制。

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,4μm),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≥0.9990),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 ofsamples.CONCLUSION This simple,accurate and reliable method can be used for the quality control of Changmaile Capsules(Ⅰ).