摘要
目的以有效期为指标,筛选维生素K_2口服纳米乳的较优抗氧剂。方法采用高效液相色谱法测定加入抗氧剂和/或金属离子螯合剂的纳米乳中维生素K_2的含量,借助经典恒温法预测各处方纳米乳在25℃的有效期。结果未加抗氧剂的维生素K_2纳米乳的有效期为0.10年;使用单一抗氧剂或金属离子螯合剂只能将有效期提高至原来的2~4倍,而抗氧剂与金属离子螯合剂联用可将制剂的有效期提高至原来的20倍以上,其中维生素C棕榈酸酯与Ca Na2EDTA联用,可使纳米乳的有效期提高24倍,可达2.36 a。结论在处方中加入抗氧剂与金属离子螯合剂后可显著提高纳米乳的有效期,其中维生素C棕榈酸酯与Ca Na2EDTA联用的抗氧化效果最佳。
Objective To optimize the antioxidants of vitamin K_2 oral nanoemulsions with shelf life as an index by classic isothermal kinetic method. Methods The content of Vitamin K_2 in nanoemulsions that added antioxidants and/or metal ion chelating agents was determined by HPLC,and the shelf life of nanaoemulsions at 25 ℃ was forecasted by using the classic isothermal kinetic method. Results The results of classic isothermal kinetic method showed that the shelf life of vitamin K_2 oral nanoemulsions formulation without antioxidants and metal ion chelating agents was only 0. 10 years. The shelf life of nanoemulsions that used a single antioxidant was only increased to 2 to 4 times than that of original nanoemulsions,but the shelf life of nanoemulsions that used both the antioxidants and metal ion chelating agents could extend the shelf life more than 20 times. And the optimum formula composed of ascorbyl palmitate and CaNa2 EDTA could prolong the shelf life of nanoemulsions to 2. 36 years. Conclusions Adding antioxidants and metal ion chelating agent in combination can significantly extend the shelf life of nanoemulsions,and the optimum formula composed of ascorbyl palmitate and CaNa2 EDTA had the best antioxidant effect.
出处
《沈阳药科大学学报》
CSCD
北大核心
2017年第11期951-957,967,共8页
Journal of Shenyang Pharmaceutical University
关键词
经典恒温法
维生素K2
纳米乳
抗氧剂
classical isothermal kinetic method
vitamin K2
nanoemulsion
antioxidant
