| Objectives:To explore antioxidation effects of the content in Grape seed soft capsule and predict its safety on human health for the purposing of providing theoretical evidents for exploitation and utilization of health food.Methods:we studied the content in Grape seed soft capsule, whose main material was grape seed extract. We detected the concentration of Grape seed proanthocyanidin extract (GSPE), tea polyphenol (TP) by colorimetric determination and the concentration of Vitamin E (VE) by HPLC. Then, we put the Grape seed soft capsule in chamber which kept constantly temperature 38±1℃and relative humidity 75% for three months. During this progress, we analized the concentration of GSPE, TP and VE in the content every month, in order to observe the stability of three components. The antioxidant effects of the content in Grape seed soft capsule was assessed by measuring the malondialdehyde (MDA) concentration, serum superoxide dismutase (SOD) and glutathione peroxidase (GSH-Px) activities. The chronically edible safety of the content in Grape seed soft capsule was comprehensively evaluated by acute toxicity test, Ames test, mouse bone marrow cell micronucleus test, sperm malformation test in mice, and 30-day feeding study in rats.Results:The concentration of GSPE, TP and VE in Grape seed soft capsule were 2.85,4.13 and 2.33g/100g. The content in Grape seed soft capsule was stable in constant temperature and humidity chamber for three months. The concentration of MDA decreased and SOD activity increased at the high dose group of Grape seed soft capsule significantly compared with those in control group. But, no significant change of GSH-Px activity was found in all groups. The content in Grape seed soft capsule was nontoxic according to acute toxicity classification standard. The genotoxicity of the content in Grape seed soft capsule was not observed in Ames test, bone marrow cell micronucleus test and sperm malformation test. The result of 30-day feeding test showed that there were no treatment-related adverse effects on mice treated with the content in Grape seed soft capsule.Conclusions:the content in Grape seed soft capsule is a mixture composition that includes GSPE, TP and VE. Under this experiment conditions, these efficacy contents are stable. The results show that the content in Grape seed soft capsule has antioxidant effects and it is safe for humam health. |