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[摘要]
目的 考察氟尿嘧啶在0.9% NaCl注射液中配伍的稳定性,为临床安全、合理用药提供依据。方法 采用高效液相色谱法,考察配伍液中氟尿嘧啶的变化。Scienhome Kromasil C18色谱柱(250 mm×4.6 mm,5 μm);流动相:水(用磷酸二氢钠调节pH 3.5)–甲醇(85∶15);体积流量:1 mL/min;紫外检测波长:266 nm;柱温:室温;进样量:20 μL。将配伍液分别放置在室温、避光和冷藏3个条件下,于0、1、2、4、8、24、48 h观察外观并测定pH值。结果 氟尿嘧啶在5~25 μg/mL线性关系良好(r=0.999 9),平均回收率分别为98.6%、99.00%、99.3%,RSD值分别为0.88%、0.30%、0.45%。配伍液在48 h内无变色、气体、沉淀、浑浊发生,微粒数、pH值无明显变化,氟尿嘧啶的质量分数也无明显变化。结论 氟尿嘧啶与0.9% NaCl注射液配伍后48 h内稳定。
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[Abstract]
Objectives To observe the stability of compatibility of fluorouracil in 0.9% NaCl Injection, and to provide an evidence for drug safety and efficiency in clinic. Methods The content changes of fluorouracil in compatibility solutions were determined by HPLC method. The analysis was performed on Scienhome Kromasil C18 column (250 mm×4.6 mm, 5 μm) with water (using sodium dihydrogen phosphate with pH 3.5) - methanol (85:15) as mobile phase. The UV detection wavelength was 266 nm at room temperature with the injection volume of 20 μL at a flow rate of 1.0 mL/min. The compatibility solutions were placed in three conditions such as at room temperature, avoiding light, and freezing. Appearance observation and pH value determination were carried out in 0, 1, 2, 4, 8, 24, and 48 h. Results The calibration curve was linear over the range of 5—25 μg/mL (r=0.999 9). The average recovery rate was 98.6%, 99.00%, and 99.3% with RSD of 0.88%, 0.30%, and 0.45%, respectively. There were no evident changes in appearance, color, gas, precipitation or turbid generated, particle number, and pH value, and the contents of fluorouracil did not change within 48 h. Conclusion It is stable for fluorouracil in 0.9% NaCl Injection during 48 h.
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