紫杉醇在腹腔热灌注条件下体外稳定性考察

目的：考察不同浓度紫杉醇在腹腔热灌注相关条件下的理化稳定性，为临床安全用药提供理论依据。方法：根据临床用药剂量，用0.9%氯化钠溶液或5%葡萄糖溶液将紫杉醇稀释成不同的浓度，于不同温度（25、37、43、50℃）水浴中放置，目测检查外观的变化，pH计测其pH变化并用高效液相色谱法（HPLC）测其含量变化。结果：当紫杉醇在溶媒中浓度为30 μg·mL^-1时，25～50℃保存24 h基本稳定；当紫杉醇在溶媒中浓度为60 μg·mL^-1时，25～50℃可在8 h内稳定；当紫杉醇浓度为120 μg·mL^-1时，25～50℃可稳定8 h。结论：紫杉醇注射液（30～120 μg·mL^-1）的稳定性受温度和浓度的影响，但均可保证在25～50℃条件下稳定保持8 h，满足腹腔热灌注化疗需求，为临床紫杉醇腹腔热灌注化疗提供了理论依据。

Objective: To investigate physical and chemical stability of paclitaxel in hyperthermic intraperitoneal chemotherapy conditions to provide a theoretical basic for the safe use of drug in clinic. Method: According to the clinical dosage,paclitaxel was diluted to different concentrations with 0.9% sodium chloride solution or 5% glucose solution and placed in water bath at different temperature with further analysis monitored pH and solution clarity as indicators of physical stability,and chemical stability of paclitaxel was measured by high performance liquid chromatography(HPLC). Results: When the concentration of paclitaxel in solution was 30 μg·mL^-1,it was stable at 25-50℃ for 24 h. While at the concentration of 60 μg·mL^-1,it was stable for 8 h at 25-50℃;When the concentration of paclitaxel in solution was 120 μg·mL^-1,it was stable at 25-50℃ for 8 h. Conclusion: The stability of paclitaxel infusions(30-120 μg·mL^-1)was influenced by temperature and concentration. All combinations were physically and chemically stable for at least 8 h at 25-50℃. It can meet the requirements of hyperthermic intraperitoneal chemotherapy. And it provides a theoretical basis for intraperitoneal hyperthermic chemotherapy of paclitaxel.

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