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丹参素冰片酯乳剂中丹参素冰片酯和冰片的含量测定
引用本文:左正龙,惠民权,申旭霁,孙宇宏,杨凌鉴,郑晓晖. 丹参素冰片酯乳剂中丹参素冰片酯和冰片的含量测定[J]. 中国药业, 2012, 21(3): 18-20
作者姓名:左正龙  惠民权  申旭霁  孙宇宏  杨凌鉴  郑晓晖
作者单位:1. 西北大学生命科学学院,陕西西安,710069
2. 西安力邦制药有限公司,陕西西安,710075
基金项目:“重大新药创制”科技重大专项“抗脑缺血1类化学新药DBZ的开发”,项目编号:2009ZX09103-121.
摘    要:目的 建立可行的丹参素冰片酯(DBZ)乳剂中DBZ和冰片的含量测定方法.方法 采用高效液相色谱法测定丹参素冰片酯,色谱柱采用Agilent TC-C18柱(250 mm×4.6 mm,5 μm),以甲醇-0.2%甲酸水(65:35)为流动相,检测波长为280 nm.采用气相色谱法测定冰片.HP-1毛细管柱(30.0 m×0.32 mm×0.25μm).进样口温度为260℃,检测器温度为260℃.结果 丹参素冰片酯与杂质峰分离良好,线性范围为0.01-1.00 g/L(R2=0.999);乳剂样品中丹参素冰片酯的含量为4.75 g/L,冰片与杂质峰分离良好,质量浓度线性范围为0.001-0.050 g/L(R2=0.999),乳剂样品中冰片未检出.结论 所采用方法准确、灵敏、专属性好,可用于丹参素冰片酯乳剂中丹参素冰片酯和冰片含量的测定.

关 键 词:丹参素冰片酯乳剂  丹参素冰片酯  冰片  含量测定

Determinatation of Tanshinol Borneol Ester and D-Borneol in the Emulsion of Tanshinol Borneol Ester
Zuo Zhenglong,Hai Minquan,Shen Xuji,Sun Yuhong,Yang Lingjian,Zheng Xiaohui. Determinatation of Tanshinol Borneol Ester and D-Borneol in the Emulsion of Tanshinol Borneol Ester[J]. China Pharmaceuticals, 2012, 21(3): 18-20
Authors:Zuo Zhenglong  Hai Minquan  Shen Xuji  Sun Yuhong  Yang Lingjian  Zheng Xiaohui
Affiliation:1 (1. School of Life Sciences, Northwest University, Xi' an, Shaanxi, China 710069; 2. Xi' an Libang Pharmaceutical Ltd. , Xi' an, Shaanxi, China 710075)
Abstract:Objective To determine tanshinol borneo1 ester and D- borneol in the Tanshinol Borneol Ester Emulsion. Methods DBZ is determinated by HPLC method. The column is Agilent TC-C18(250 mm×4.6 mm,5μm) and the mobile phase is the mixed solution of methanol and 0.2% formic acid water (65:35). The detection wavelength was 280 nm. Borneol was determined by GC. The column is HP - 1 capillary column (30. 0 m × 0. 32 mm × 0. 25 μm) and both of injection and detection temperature is 260 ℃. Results The main peak of DBZ is divided well with other impurity and there is a good linear range between 0. 01- 1.00g/L(R2 =0. 999). The content of DBZ in the sample of DBZ emulsion is 4. 75 g/L. The main peak of D- borneol is divided well with other impurity and there is a good linear range between 0.001-0.050 g/L(R2=0.999).The content of D-borneol is not arrayed in the sample of DBZ emulsion. Conclusion The method was accurate, sensitive, specific, and can be used for determination of DBZ and D- borneol in the DBZ emulsion.
Keywords:Tanshinol Borneo1 Ester Emulsion  tanshinol borneol ester  D- borneol  content determination
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