摘要
目的 建立HPLC-DAD法对骨筋丸胶囊中血竭掺杂龙血竭进行检查。方法 以龙血素B为指标成分,采用Agilent Eclipse-C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%甲酸溶液为流动相进行梯度洗脱,流速:1.0 m L/min,柱温:30℃,检测波长:277 nm,二极管阵列检测器进行检测,通过与龙血素B对照品色谱峰比对加以确证。结果 龙血素B在3.49~174.70μg/m L浓度范围内线性关系良好,其平均加样回收率为98.88%。12家生产企业47批次样品中,有11批次样品检查出龙血素B成分,提示企业可能存在以掺杂有龙血竭的血竭投料的情况。结论 所建立的方法专属性强、简便、可行,可用于检查骨筋丸胶囊中血竭掺杂龙血竭的情况。
Objective HPLC-DAD method was established to screen resina draconis in gujinwan capsules.Methods The method was performed on a Agilent Eclipse-C18 column(250 mm×4.6 mm,5µm)with acetonitrile-0.1%formic acid solution as the mobile phase.The flow rate was 1.0 mL/min.The column temperature was 30℃.At 277 nm,it was detected by diode array detection and confirmed by comparison with the chromatographic peak of the reference substance of loureirin B.Results The linear range of loureirin B was 3.49-174.70µg/mL,and the average recovery was 98.88%.Among 47 batches of samples from 12 manufacturers,11 batches of samples were found to contain loureirin B,indicating that the enterprises may have used draconis sanguis mixed with resina draconis.Conclusion The established method is specific,simple and feasible,and can be used to check whether there is resina draconis in gujinwan capsules.
作者
谭志伟
汤珺
张静
TAN Zhiwei;TANG Jun;ZHANG Jing(Ji'an Center for Food and Drug Control,Ji'an Jiangxi 343000,China;Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
出处
《药品评价》
CAS
2023年第9期1082-1085,共4页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2022JS17)。
关键词
骨筋丸胶囊
鉴别
龙血竭
血竭
龙血素B
Gujinwan capsules
Identification
Resina draconis
Draconis sanguis
Loureirin B