中国临床药学杂志

目的 考察微量泵持续静脉给药下，米力农在给药后48h内的稳定性。方法 采用ACQUITY UPLC BEH C₁₈(100mm×2.1mm,1.7μm)色谱柱，水-甲醇-硼酸钠缓冲液(725∶250∶25)为流动相，流速0.18mL·min^-1，检测波长269 nm，建立输液中米力农含量测定的HPLC法。将米力农注射液按临床常规剂量加入5%葡萄糖注射液中，在遮光与不遮光的条件下，采用HPLC法测定米力农在输液泵中不同时间点的浓度变化及有关物质，并观察溶液外观性状，测定pH值和渗透压。结果 建立的用于测定输液中米力农浓度的HPLC法具有良好的专属性、线性关系(r=0.999 8)、精密度(RSD=0.23%)和稳定性(RSD=1.04%)。米力农注射液经配制后，在48 h内无论遮光或不遮光，外观性状均澄明，无沉淀及浑浊出现；输液中米力农含量百分比、有关物质、pH值及渗透压均无明显变化，遮光条件下的RSD分别为0.95%、2.17%、0.25%和1.10%，不遮光条件下的RSD分别为0.94%、1.43%、0.32%和0.68%。结论 米力农用5%葡萄糖注射液配制后进行微量泵输注，可将输注时间延长至48 h。

AIM To investigate the stability of milrinone infusion within 48 h of continuous intravenous administration with micro-pump. METHODS A HPLC method for the determination of milrinone content in infusion was established by us ACQUITY UPLC BEH C₁₈(100 mm × 2.1 mm, 1.7 μm) chromatographic column, with water-methanolsodium borate buffer(725∶250∶25) as mobile phase, flow rate of 0.18 mL·min^-1, and wavelength of 269 nm. A clinical routine dose of milrinone injection was added to 5% glucose solution. The intravenous infusion was kept in micro-pump at room temperature for 48 h with or without light. The concentration of milrinone and related substances in the fluids at different time points in infusion pump were determined by HPLC. The outward appearance was observed, pH value and osmotic pressure were checked. RESULTS The HPLC method for determining the concentration of milrinone in infusion had good specificity, linear relationship(r=0.999 8), precision(RSD=0.23%), and stability(RSD=1.04%). After preparation, milrinone infusion had a clear appearance and no precipitation or turbidity within 48 h, with or without light.The content of milrinone, the related substances, pH value and osmotic pressure of infusion shown no significantly changes with or without light, the RSD(with light) was 0.95%, 2.17%, 0.25% and 1.10% respectively, and the RSD(without light)was 0.94%, 1.43%, 0.32% and 0.68% respectively. CONCLUSION The intravenous infusion time of milrinone diluted with 5% glucose injection administrated by micro-pump could be extended to 48 h.