【摘要】 目的测定复方氟尿嘧啶乳剂中氟尿嘧啶的含量,考察其体外释放性质,并对制剂的安全性进行评价。方法高效液相色谱法测定复方氟尿嘧啶乳剂中氟尿嘧啶的含量及其体外释放特性,色谱柱为Kromasil-C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(体积比为1:99),流速为0.5 mL﹒min-1,检测波长为265 nm;采用溶血试验、静脉刺激性试验及过敏试验对制剂的安全性进行考察。结果氟尿嘧啶在2.5～30μg﹒mL-1的质量浓度范围内呈良好的线性关系(r=0.999 7),精密度和回收率符合要求,3批制剂中氟尿嘧啶的标示百分含量分别为97.1%、97.6%、98.4%;复方氟尿嘧啶乳剂无溶血现象、无血管刺激性、无变态反应。结论该HPLC方法可用于复方氟尿嘧啶乳剂中氟尿嘧啶的含量测定;该制剂可以安全用药,为临床用药提供了实验依据。更多还原

【Abstract】 Objectives To study the determination, release characteristic in vitro and the safety of compound fluorouracil emulsion. Methods The determination and the release in vitro of compound fluorouracil emulsion were measured by HPLC with Kromasil C18column,the mobile phase was methanol-water(V:V = 1: 99) with the flow rate of 0.5 mL·min-1 and the UV detective wavelength was set at 265 nm. The safety was evaluated by the hemolysis test, venous irritation test and allergy test. Results There was a good linearity in the range of 2.5 ～ 30 μg·mL-1(r =0.999 7), both the precision and the recoveries of the method were accorded with the criterion. And the drug content of three batches compound fluorouracil emulsion were 97.1 %, 97.6 %, 98.4 % respectively. The preparation had no hemolysis phenomenon, no significant irritation effect on vessels and no allergic response. Conclusions Determination of fluorouracil in compound fluorouracil emulsion can be measured by the HPLC method.The animal tests on safety provide a safety basis for clinical application of compound fluorouracil emulsion.更多还原