白龙解郁颗粒的质量标准研究  

Study on the quality standards of Bailongjieyu granules

作　　者：蔺红伟[1] 江春霞[1] 朴淑娟[1] 李静娴[1] 陆文铨[1] LIN HongWei;JIANG ChunXia;PIAO ShuJuan;LI JingXian;LU WenQuan(Department of Pharmacy,Changzheng Hospital,Second Military Medical University,Shanghai 200003,China)

机构地区：[1]第二军医大学长征医院药学部,上海200003

出　　处：《药学服务与研究》2018年第3期195-198,共4页Pharmaceutical Care and Research

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ04-1);上海市临床药学重点专科建设项目(2016-40044-002)

摘　　要：目的:建立白龙解郁颗粒的质量控制新方法,以提高该制剂质量控制标准。方法:采用薄层色谱(TLC)法分别对白龙解郁颗粒中的柴胡、白芍、陈皮和当归进行鉴别。采用HPLC法测定白龙解郁颗粒中芍药苷的含量,色谱柱为Agilent Zorbax SB-C18柱(250mm×4.6mm,5μm),流动相为乙腈(A相)-0.1%磷酸溶液(B相)梯度洗脱(0~49min,88%~70%B相;50~51min,70%~5%B相;52~59min,5%B相;60~61min,5%~88%B相;62~70min,88%B相),流速1ml/min,检测波长230nm,柱温25℃,进样量10μl。结果:柴胡、白芍、陈皮和当归的TLC鉴别方法专属性良好,显色清晰。用HPLC法测得芍药苷的精密度、回收率和稳定性均符合《中华人民共和国药典》2015年版的标准,在12.001~120.01μg/ml浓度范围内线性关系良好(r=0.999 9),加样回收率为(99.45±0.81)%(n=9)。结论:本研究建立的方法可用于白龙解郁颗粒的质量控制。Objective：To establish a new method for the quality control of Bailongjieyu granules,so as to improve its quality standards.Methods：Bupleurum,Paeoniae Radix Alba,Bupleurum chinense DC.and Angelica sinensis were identified by TLC method.Content of peoniflorin in Bailongjieyu granules was determined by HPLC method.Agilent Zorbax SB-C18 column（250 mm×4.6 mm,5μm）was employed with the mobile phase consisting of acetonitrile（phase A）-0.1% phosphoric acid solution（phase B）in gradient elution（0-49 min 88%-70% phase B,50-51 min 70%-5% phase B,52-59 min 5% phase B,60-61 min5%-88% phase B,62-70 min 88% phase B）at a flow rate of 1 ml/min.The detection wavelength was 230 nm,the column temperature was 25 ℃,and the sample size was 10μl.Results：TLC identification of Bupleurum,Paeoniae Radix Alba,Bupleurum chinense DC.and Angelica sinensis was specific,with clear color display.The precision,repeatability and stability of paeoniflorin conformed to the standards of PharmacopoeiaofthePeople＇s Republic of China（2015 ed）.Peoniflorin displayed good linearity within the ranges of 12.001-120.01μg/ml（r=0.999 9）.The recovery rate was（99.45±0.81）%（n=9）.Conclusion：The established TLC and HPLC methods could be used for the quality control of Bailongjieyu granules.

关 键 词：白龙解郁颗粒 芍药苷 质量标准 色谱法 薄层 色谱法 高效液相 含量测定 

分 类 号：R927.2[医药卫生—药学]