Toxicological Assessment And Health Protective Function Evaluation Of Tea Catechins Preparation

In this dissertation, both toxicological assessment and health protective function of tea catechins preparation (TCP) were systemically studied.Toxicological Assessment of TCPAcute Toxicity TestNo visible symptom was observed and no death occurred both in rats and mice administrated orally with TCP during the acute toxicity experiment. The medium lethal dose of TCP on SD rats and ICR mice was more than 10.00 g / kg body weight, which indicated TCP was actually no toxicity according the standard of toxicity grade classification.. The one-time maximum tolerance dosage experiment also confirmed the high safety of TCP.GenotoxicologyIn Ames test with plate infiltration, TCP showed no mutagenic effects. In mice bone marrow cell micronucleus Polychromatic Erythrocyte assay, no significant difference was observed between TCP treatment groups and negative control group both in the rate of micronucleus in polychromatic erythrocytes (PEC) and the ratio of PEC to mature erythrocyte, which also implied that TCP had no mutagenic effects. Mice sperm assay showed that the abnormal sperm rate in treatment group was not different significantly from control group, indicating TCP is of no genetic toxicity.Thirty days Feeding Study with RatsNeither any case of unconventional syndrome,body characteristic, and animal death occured in rats administrated with TCP of different doses throughout the 30 days feeding experiment, nor any abnormality in body weight increment, food intake, and food utilization efficiency was observed as compared with the control group. The red blood cell count, hemoglobin, leukocyte count and category, and hemogram were found to be at normal level in TCP treatment groups. TCP had no bad effects on the blood sugar, albumin, cholesterol, carbamide, GPT, total proteins, TG, and creatinine in rats. The pathological slice examination did not show any abnormality in liver, kidney, spleen, stomach, intestines, testis, and ovary of rats administrated with TCP.TeratogenicityPregnant mice were found to grow normally and no animal death occurred throughout the TCP feeding experiment. Study on the embryo toxicity showed that no significant difference between TCP treatment mice and control groups in the number of absorbed embryos. No dead fetus was observed and all the fetus developed normally in pregnant mice administrated withTCP. The marrow development as determined by examining breastbone, rib and spine indicated that TCP had no bad effects on the reproduction and embryo development in mice.The effects of TCP on the animal reproductive behavior and embryo development was confirmed in rats administrated daily with TCP for 10 days. It can be concluded that TCP is of teratogenicity in mice and rats.Long-term ToxicityTo observe the long-term toxicity of TCP, rats were fed with TCP at a dose of 2.50 g/kg for 90 days. It was found that the growth, total amount of food intake and food utilization efficiency were not apparently affected as compared with the control group, the hemogram, plasma lipid and the kidney function in rats administrated with TCP were kept at a normal level. TCP also had no bad effects on the breath, blood pressure and cardiogram in healthy rats .All results in the long-term toxicity study indicated that TCP is of no long-term toxicity.Effects of TCP on Healthy HumanThe experiment on oral administration of TCP by healthy human revealed that there was no difference in the four indexes for healthy huamn plasma lipid [total cholesterol (TC), trigalloyl glycerol (TG), HDL, and albumin(a)], blood sugar, fibrinogen, the three indexes in blood conagulation, and the three indexes for blood rheology in persons before and after TCP administration. The results implied TCP at the recommended dose had no side effects.Health Protective Function of Tea Catechins PreparationEffects of TCP on Plasma Lipid Content in Experimental Hyperlipemia RatsThe results obtained in experimental hyperlipemia rats administrated with TCP for 30 days revealed that compared with the control group, the total cholesterol (TC) and TG decreased significantly in a dosage dependent manner, while the HDL-C content increased to some extents in treatment group, which indicated that TCP could modulate plasma lipid.Plasma Lipid Modulation of TCP in Hyperlipemia PeopleTo probe the therapic potential of TCP in hyperlipoidemic people, 50 cases were employed and the curative efficiency of TCP in respect to TC, TG, HDL-C and LDL-C were 80.0%, 73.3%, 83.3% and 87.0% respectively. In these 50 patients, a decrease of 18.1%, 22.7% and 23.9% was observed in TC, TG and LDL-C contents respectively, while an increase of 23.9% was detected in HDL-C content. The modulation of plasma lipid by TCP was found to be characterized by a decrease in TC, TG and LDL-C contents while an increase in HDL-C.Immuno-Enhancement Function of TCPAdministrated orally at doses of 150, 300 and 600 mg/kg BW /d (equivalent to 5,10 and 20 times the recommended dosage for human), TCP had no bad effects on the body weight, the...