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目的:考察聚氯乙烯(PVC)软袋装川芎嗪在腹膜透析液中的稳定性。方法:含川芎嗪0.04mg·ml-1和0.20mg·ml-1的腹膜透析液分别置于4℃,25℃和37℃,定时取样以HPLC测定含量,药物浓度降低≤5%为稳定性指标。结果:由于PVC软袋的吸附作用,各浓度在25℃6h后均有显著性降低,12h后降至95%以下;37℃4h即均有显著性降低,8h后降至95%以下。0.20mg·ml-1(4℃)在24h后浓度明显下降,但10d后浓度下降未超过5%,0.04mg·ml-1(4℃)在观察期间浓度略有升高。结论:PVC软袋可吸附川芎嗪,随温度的升高,吸附作用亦增强。川芎嗪溶于腹膜透析液后室温贮放不宜超过6h,温度升至37℃后尽快使用。
Objective: To investigate the stability of ligustrazine in PVC peritoneal dialysis solution. Methods: Peritoneal dialysate containing ligustrazine 0.04mg · ml-1 and 0.20mg · ml-1 were placed in 4 ℃, 25 ℃ and 37 ℃, respectively. The content of the drug was reduced by 5% Stability indicators. Results: Due to the adsorption of PVC pouch, all the concentrations were significantly decreased after 6 hours at 25 ° C, and dropped below 95% after 12 hours; at 37 ° C for 4 hours, all of them were significantly reduced and dropped below 95% after 8 hours. The concentration of 0.20mg · ml-1 (4 ℃) decreased obviously after 24h, but the concentration did not drop more than 5% after 10d. The concentration of 0.04mg · ml-1 (4 ℃) slightly increased during the observation period. CONCLUSION: Tetramethylpyrazine can be absorbed by PVC soft bag. With the increase of temperature, the adsorption is also enhanced. Tetramethylpyrazine dissolved in peritoneal dialysis fluid should not be stored at room temperature more than 6h, the temperature rose to 37 ℃ as soon as possible after use.