高效液相色谱直接测定沸水浴处理人血清中冠心Ⅱ号来源的阿魏酸

• 作 者: 黄熙 陈可冀 任平 李军昌 马红艳
• 机 构: 中国中医研究院西苑医院,中国中医研究院西苑医院,第四军医大学西京医院中药临床药理研究室
• 出 处: 中国中西医结合杂志
• 发表日期: 1999年02期
• 关键词: 高效液相色谱 沸水浴 中冠 阿魏酸钠 冠心Ⅱ号 水浴法 血药浓度测定 香豆精 临床药动学 紫外分光光度法

目的：探讨建立健康人口服冠心Ⅱ号后吸收入血清成分的临床药动学（ＰＫ）研究的新方法。方法：用高效液相色谱（ＨＰＬＣ）直接测定５名健康人服冠心Ⅱ号后经沸水浴处理过的血清样品中的阿魏酸（ＦＡ）。分别用二维、三维ＨＰＬＣ和紫外分光光度法定性ＦＡ后，ＦＡ用内标（香豆精）法定量。结果：甲醇∶乙酸∶水（３８∶０３∶６１７）为流动相，Ｃ１８（ＯＤＳ２）柱（１５０ｍｍ×４６ｍｍ，５μｍ）为固定相时，ＦＡ的最低检测限６ｎｇ（Ｎ／Ｓ＝３）；沸水浴１０ｍｉｎ的最低检测血清浓度是２０２μｇ／Ｌ，线性范围３３７～２１５６８μｇ／Ｌ，ｒ＝０９９９３；方法平均回收率（９３５９±２３６）％，日间及日内精密度ＲＳＤ值均＜８４４％。结论：与乙睛法比较，本法灵敏、快速、简便、精确、专一、价廉、无毒和重复性好。

Objective: To explore a new method for clinical pharmacokinetic (PK) study of the serum composition of healthy subjects after oral administration of Guanxin II. METHODS: Ferulic acid (FA) was measured directly in boiling water bath-treated serum samples of 5 healthy volunteers treated with Guanxin II by high performance liquid chromatography (HPLC). The FA was quantified by internal standard (coumarin) method after qualitative FA was determined by two-dimensional, three-dimensional HPLC and ultraviolet spectrophotometry, respectively. Results: When methanol:acetic acid:water (38∶03:617) was the mobile phase, C18 (ODS2) column (150mm×46mm, 5μm) was the stationary phase, and the lowest detection limit of FA was 6ng (N/ S=3); The lowest serum concentration in the boiling water bath for 10 min was 202μg/L, the linear range was 337～21568μg/L, r=09993; the average recovery rate of the method was 9359±236. )%, intra-day and intra-day precision RSD values ​​were <8 to 44%. Conclusion: Compared with the acetonitrile method, this method is sensitive, rapid, simple, accurate, specific, inexpensive, non-toxic, and reproducible.