辅酶Q_(10)天然维生素E软胶囊的稳定性研究

The stability study on coenzyme Q_(10) natural vitamin E soft capsules

目的研究以辅酶Q10天然维生素E为主要原料的软胶囊产品的稳定性。方法不同配方的样品,经过加速试验后,用高效液相色谱法和气相色谱方法分别测定辅酶Q10和天然维生素E的含量,并检测辅酶Q10的存在形态。结果辅酶Q10单独使用或者与维生素E(d-α-醋酸生育酚)配伍使用时,辅酶Q10存在形态为氧化型,其含量经加速试验前后无明显差别。辅酶Q10与维生素E(d-α-生育酚)配伍使用时,氧化型和还原型辅酶Q10共同存在,氧化型含量逐渐降低,还原型含量逐渐升高,两者的含量之和在加速试验前后无明显差别,d-α-生育酚的含量略有降低。结论辅酶Q10单独使用或者与维生素E(d-α-醋酸生育酚)配伍使用时,配方稳定。辅酶Q10与维生素E(d-α-生育酚)配伍使用时,辅酶Q10会逐渐转化为还原型辅酶Q10,d-α-生育酚的含量降低。

Objective To investigate the stability of natural vitamin E coenzyme Q10 soft capsules with different formula.Methods The content of coenzyme Q10 and vitamin E of coenzyme Q10 soft capsule samples with different formulas were analyzed quantitatively with high performance liquid chromatogram（ HPLC） and gas chromatogram（ GC） respectively. At the same time,the existing forms of coenzyme Q10 were also determined. Results In the formulas with only coenzyme Q10 or coenzyme Q10 combined with vitamin E（ d-α-tocopherol acetate） as active ingredients,the existing form of coenzyme Q10 was oxidized form（ Co Q10）,both coenzyme Q10 and d-α-tocopherol acetate were stable during the accelerated stability test.In the formula with coenzyme Q10 combined with vitamin E（ d-α-tocopherol） as active ingredients,both oxidized coenzyme Q10（ Co Q10） and reduced coenzyme Q10（ Co Q10H2） existed,Co Q10 content decreased and Co Q10H2 content increased,the total amount showed no significant difference before and after the accelerated stability test,while the d-α-tocopherol amount reduced to a certain degree. Conclusion The formulas with only coenzyme Q10 or coenzyme Q10 combined with vitamin E（ d-α-tocopherol acetate） were stable. In the formula with coenzyme Q10 combined with vitamin E（ d-α-tocopherol）,Co Q10 would be converted into Co Q10H2 and the d-α-tocopherol content decrease.