三苯氧胺柠檬酸盐(Tamoxifen citrate)有两种异构体。 临床试验表明,Z式盐具有抗癌作用,对治疗晚期乳腺癌、子宫癌等有一定疗效。而E式盐则具有相反的药理活性。在合成Z式盐时很难完全除去E式盐.为保证药品质量,美国药典规定三苯氧胺药物中的E式盐含量必须控制在1.0％以下。 三苯氧胺柠檬酸盐的Z、E异构体.由于化学性质极为相似,因而分离测定有一定难度。美国药典采用反相离子对色谱法分离测定该异构体。国内 Tamoxifen citrate has two isomers. Clinical trials show that, Z salt has anti-cancer effect, for the treatment of advanced breast cancer, uterine cancer have a certain effect. While the E salt has the opposite pharmacological activity. In the synthesis of Z salt is difficult to completely remove the E salt.In order to ensure the quality of drugs, the United States Pharmacopoeia prescribed tamoxifen drug E salt content must be controlled below 1.0%. Tamoxifen citrate Z, E isomers. Due to the very similar chemical nature, so the determination of separation has a certain degree of difficulty. The United States Pharmacopoeia uses reversed-phase ion-pair chromatography to separate this isomer. domestic