目的 考察氟尿嘧啶在0.9% NaCl注射液中配伍的穩(wěn)定性，為臨床安全、合理用藥提供依據(jù)。方法 采用高效液相色譜法，考察配伍液中氟尿嘧啶的變化。Scienhome Kromasil C18色譜柱（250 mm×4.6 mm，5 μm）；流動相：水（用磷酸二氫鈉調(diào)節(jié)pH 3.5）–甲醇（85∶15）；體積流量：1 mL/min；紫外檢測波長：266 nm；柱溫：室溫；進樣量：20 μL。將配伍液分別放置在室溫、避光和冷藏3個條件下，于0、1、2、4、8、24、48 h觀察外觀并測定pH值。結(jié)果 氟尿嘧啶在5～25 μg/mL線性關系良好（r=0.999 9），平均回收率分別為98.6%、99.00%、99.3%，RSD值分別為0.88%、0.30%、0.45%。配伍液在48 h內(nèi)無變色、氣體、沉淀、渾濁發(fā)生，微粒數(shù)、pH值無明顯變化，氟尿嘧啶的質(zhì)量分數(shù)也無明顯變化。結(jié)論 氟尿嘧啶與0.9% NaCl注射液配伍后48 h內(nèi)穩(wěn)定。

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.