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西嗪伪麻缓释片中伪麻黄碱在人体内的立体选择性研究

Research on Stereoselectivity of Pseudoephedrine in Pseudoephedrine Cetirizine Sustained-Release Tablets in Vivo

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【作者】 邵琳智柏骥刘文英

【Author】 SHAO Lin-zhi,BAI Ji,LIU Wen-ying*(Department of Pharmaceutical Analysis,China Pharmaceutical University,Nanjing 210009,China)

【机构】 中国药科大学药物分析教研室中国药科大学药物分析教研室 南京210009南京210009

【摘要】 目的研究西嗪伪麻缓释片中伪麻黄碱在人体内的立体选择性。方法建立高效液相色谱紫外检测法测定人血浆中伪麻黄碱和麻黄碱的浓度。血浆样品加入内标对乙酰氨基酚,采用氨水作为碱化试剂,以乙醚液-液萃取后进行分析。色谱柱:Phenom enex苯基柱(4.6 mm×150 mm,5μm);流动相:甲醇-水(含50 mmol.L-1磷酸二氢钾)(磷酸调pH至4.0)-三乙胺(10∶90∶0.01);流速:1.0 mL.m in-1;检测波长:210 nm。结果伪麻黄碱和麻黄碱达到良好分离,理论塔板数为8 000左右,两者的最低定量限均约为50μg.L-1,线性范围均为50~1 600μg.L-1,绝对回收率大于70%,日内和日间精密度良好。结论该法简便、灵敏、准确,适合于伪麻黄碱和麻黄碱血药浓度的测定,人血浆中伪麻黄碱未发生代谢转化。

【Abstract】 OBJECTIVE To investigate the stereoselectivity of pseudoephedrine in pseudoephedrine and cetirizine sustained-release tablets in vivo.METHODS A HPLC-UV method was established for determining the concentrations of pseudoephedrine and ephedrine in plasma.Paracetanol was used as the internal standard.The analyte and internal standard were extracted from plasma using liquid-liquid extraction.The column(Phenomenex) was packed with phenyl silica(4.6 mm×150 mm,5 μm).The mobile phase was composed of methanol,water(obtaining 50 mmol·L-1 of potassium dihydrogen phosphate,pH 4.0) and triethylamine(10∶90∶0.01). The flow rate was 1.0 mL·min-1.The detection wavelength was 210 nm. RESULTS The pseudoephedrine and ephedrine were well separated,and the theoretical plate number was about 8 000.The LOqs of them were 50 μg·L-1.The linear ranges were 50~1 600 μg·L-1.The absolute recoveries of the compounds were over 70%.The precision was good.CONCLUSION A simple,sensitive and accurate method is established for the determination of the pseudoephedrine and ephedrine concentrations in plasma.The metabolic biotransformation of pseudoephedrine in pseudoephedrine and cetirizine sustained-release tablets is not observed in vivo.

  • 【文献出处】 中国药学杂志 ,Chinese Pharmaceutical Journal , 编辑部邮箱 ,2007年13期
  • 【分类号】R96
  • 【被引频次】1
  • 【下载频次】89
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