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目的评价与考察小分子抗氧化保护剂抗坏血酸(AA)对含有血红蛋白类载氧体的胶体代血浆(NCPS)在保存期内稳定性的影响。方法在5 m L NCPS液中加入0.025%和0.05%2种浓度水平的AA,以未加入AA的NCPS液为对照,在(4±1)℃保存条件下,每间隔1个月定期取样检测各浓度NCPS样品液中的高铁血红蛋白含量(Met Hb)、p H值、不溶性微粒、晶体渗透压值与光谱学性质等指标的变化。结果在6个月的保存期内,NCPS液中的Met Hb含量得到明显抑制,保持p H>7.0,不溶性微粒数处于合格范围,渗透压值保持在(325.0-350.0)mmol/kg,紫外/可见光谱图未有明显变化。结论加入AA后NCPS溶液的主要性质符合药典对静脉输注液质量标准的要求,初步证明AA对NCPS溶液的抗氧化和保存稳定性具有良好的作用。
Objective To evaluate and investigate the effect of low molecular weight antioxidant protectant ascorbic acid (AA) on the stability of hemoglobin-containing colloidal plasma (NCPS) during storage. Methods AA concentrations of 0.025% and 0.05% were added to 5 m L NCPS solution. NCPS solution without AA was used as a control. Samples were taken periodically at intervals of 1 month under the condition of (4 ± 1) ℃. The changes of methemoglobin (Hb), p H, insoluble particulates, crystal osmotic pressure and spectroscopic properties of NCPS samples at various concentrations were investigated. Results During the 6 months storage period, the content of Met Hb in NCPS solution was significantly inhibited, while p H> 7.0, the number of insoluble particles was within the acceptable range and the osmotic pressure was maintained at (325.0-350.0) mmol / kg, UV / Visible spectrogram no significant change. Conclusion The main properties of NCPS solution after the addition of AA meet the requirements of Pharmacopoeia on the quality standard of intravenous infusion, and preliminary proof AA has a good effect on the anti-oxidation and storage stability of NCPS solution.