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双丹胶囊质量标准的建立
引用本文:毕琳琳,缪珊,李穆琼,杨倩,李骅,党碧艳,王四旺.双丹胶囊质量标准的建立[J].中国药师,2014(7):1237-1239.
作者姓名:毕琳琳  缪珊  李穆琼  杨倩  李骅  党碧艳  王四旺
作者单位:第四军医大学药学系天然药物学教研室;西安 710032;第四军医大学药学系天然药物学教研室;西安 710032;第四军医大学药学系药物化学教研室;第四军医大学药学系天然药物学教研室;;第四军医大学药学系天然药物学教研室;;第四军医大学药学系天然药物学教研室;;第四军医大学药学系天然药物学教研室;
基金项目:陕西省科技专项项目(编号:2012K19-03-02 )
摘    要:目的:建立双丹胶囊的质量标准.方法:采用TLC法对双丹胶囊中丹酚酸B成分进行鉴别,采用HPLC法测定胶囊中丹皮酚的含量.色谱条件为.Kromasil-C18柱;流动相:甲醇-0.1%磷酸(64∶36);检测波长274 nm.结果:TLC分离度好,阴性对照无干扰;丹皮酚在26.2~131.0μg· ml-1范围内线性良好(r=0.999 8),平均回收率为99.59%,RSD为0.85%(n=6).结论:该方法简便、准确,可以控制该制剂的质量.

关 键 词:双丹胶囊  质量标准  丹皮酚  丹酚酸B
收稿时间:2014/1/21 0:00:00
修稿时间:2014/3/19 0:00:00

Study on Quality Standard for Shuangdan Capsules
Bi Linlin,Miao Shan,Li Muqiong,Yang Qian,Li Hu,Dang Biyan and Wang Siwang.Study on Quality Standard for Shuangdan Capsules[J].China Pharmacist,2014(7):1237-1239.
Authors:Bi Linlin  Miao Shan  Li Muqiong  Yang Qian  Li Hu  Dang Biyan and Wang Siwang
Institution:Bi Linlin,Miao Shan,Li Muqiong,Yang Qian,Li Hua,Dang Biyan,Wang Siwang(Institute of Materia Medica,School of Pharmacy, the Fourth Military Medical University, Xi'an 710032, China;Department of Medicinal Chemistry,School of Pharmacy, the Fourth Military Medical University, Xi'an 710032, China)
Abstract:Objective:To establish a method for the quality control of Shuangdan capsules.Methods:A TLC method was used in the qualitative identification of salvianolic acid B,and an HPLC method was used to determine the content of paeonol in Shuangdan capsules.A Kromasil-C18 column(250 mm ×4.6 mm,5 μm) was used,the mobile phase was methanol-0.1% phosphoric acid(64∶ 36),and the detection wavelength was 274 nm.Results:The linear range of paeonol was 26.2-131.0 μg · ml-1 (r =0.999 8).The average recovery for paeonol was 99.59% (RSD =0.85 %,n =6).Conclusion:The method is simple and accurate,and suitable for the quality control of Shuangdan capsules.
Keywords:Shuangdan capsules  Quality standard  Paeonol    Salvianolic acid B
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