ABSTRACT
As part of a series of non-clinical studies to evaluate the safety of PureSorb-Q(TM)40 (Water-soluble type CoQ(10) powder, CoQ(10) content is 40 w/w%; hereinafter referred to as P40), male and female rats were treated orally by gavage with P40 once a day for 91 d, and its repeated dose toxicity was assessed. Control animals were treated with a 0.5 w/v% solution of methylcellulose, the vehicle for P40. Each test group consisted of 6 animals of each sex. No adverse effects of P40 were noted in general signs, body weight, food consumption, ophthalmological examination, urinalysis, hematological examination, blood chemical analysis, necropsy, organ weights, or histopathological examination in animals of either sex. From these results, the no observed adverse effect level of P40 was estimated at 2,000 mg/kg in both sexes of rats under the conditions of the present study, and P40 was confirmed to be a food material whose safety is high.
Subject(s)
Coenzymes/toxicity , Food Additives/toxicity , Administration, Oral , Animals , Blood Chemical Analysis , Body Weight/drug effects , Eating/drug effects , Female , Hematologic Tests , Histocytochemistry , Male , No-Observed-Adverse-Effect Level , Organ Size/drug effects , Organ Size/physiology , Rats , Rats, Sprague-Dawley , Ubiquinone , UrinalysisABSTRACT
As part of a safety evaluation of Coenzyme Q10, a subchronic toxicology study was conducted. Coenzyme Q10 was repeatedly administered orally to male and female Crl:CD(SD) rats at daily dose levels of 300, 600 and 1200 mg/kg for 13 weeks. Neither death nor any toxicological signs were observed in any group during the administration period. No change related to the test substance administered was observed in any group with regard to body weight, food consumption, ophthalmoscopy, hematology, blood biochemistry, necropsy, organ weights or histopathology. Based on these results, the non-observed-adverse-effect level (NOAEL) of Coenzyme Q10 was considered to be 1200 mg/kg/day for male and female rats under these study conditions.
Subject(s)
Dietary Supplements/toxicity , Toxicity Tests, Chronic , Ubiquinone/analogs & derivatives , Administration, Oral , Animals , Body Weight/drug effects , Coenzymes/administration & dosage , Coenzymes/toxicity , Feeding Behavior/drug effects , Female , Male , No-Observed-Adverse-Effect Level , Organ Size/drug effects , Organ Specificity , Rats , Rats, Sprague-Dawley , Ubiquinone/administration & dosage , Ubiquinone/toxicityABSTRACT
PureSorb-Q40 (water-soluble type CoQ10 powder, CoQ10 content is 40 w/w%; hereinafter referred to as P40) is reported in the single-dose human and rat studies to have a greater absorption rate and absorbed volume of CoQ10 even taken postprandially, than those of regular CoQ10, which is lipid-soluble and generally taken in the form of soft-gel capsules. Thus, it was anticipated that the serum CoQ10 level might be higher with P40 tablets than with soft-gel capsules, even for the same dose of CoQ10. In the present study, in order to confirm the safety and measure the serum CoQ10 level for the case of an excessive dose of P40, a double-blinded Placebo controlled comparative study was conducted on 46 healthy volunteers and they were randomly divided into two groups. The P40 tablets or placebo were repeatedly taken by the volunteers. As the result of the study, for the group of taking 2250 mg/d of P40 (that is, 900 mg/d of CoQ10) for 4 consecutive wk, the serum CoQ10 level peaked at 2 wk after the start of intake at 8.79 +/- 3.34 microg/mL, and at 4 wk, it was at the level of 8.33 +/- 4.04 microg/mL. At 2 wk from withdrawal of intake, the serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. The serum CoQ10 levels at these three points were significantly higher than those of the first day of intake and the Placebo group, which had no significant change throughout the study. Furthermore, P40 intake did not cause any significant changes in symptoms or clinical laboratory results as assessed by physical, hematological, blood biochemical or urinalysis tests. Physician examinations also did not reveal any abnormalities. These results confirm that P40 is an extremely safe material and it can produce better absorption of CoQ10.
Subject(s)
Coenzymes/toxicity , Ubiquinone/analogs & derivatives , Adult , Blood Cell Count , Blood Pressure/drug effects , Coenzymes/blood , Coenzymes/urine , Dose-Response Relationship, Drug , Double-Blind Method , Drug-Related Side Effects and Adverse Reactions , Electrocardiography/drug effects , Female , Heart Rate/drug effects , Hematocrit , Hemoglobins/drug effects , Humans , Male , Physical Examination , Reference Values , Tablets , Ubiquinone/bloodABSTRACT
Potential toxicity of CoQ(10) was studied in rats by oral gavage for 90 days at 500, 1500, and 3000 mg/kg.day. A 15-day recovery period after the administration period was investigated. Body weight and food consumption were measured throughout the study. Meanwhile, clinical observations were recorded. Hematological and blood chemistry parameters were evaluated at both the end of the dosing period and the end of the recovery period. Gross-pathologic and histopathologic examination was performed on select tissues from all animals. No adverse changes in mortality and clinical signs occurred. The body weights of males in the 1500 mg/kg dosage group were slightly reducted; likewise, the food consumption in 3000 mg/kg female rats decreased, but this is not a dose-dependent behavior. Significant change of liver function (TRIGL) and CHOL did not show a dose-dependent effect. Weight of ovary and ovary-to-body weight ratio decreased in the 1500 mg/kg dosage groups. Meanwhile, the uterus -to-body weight ratio increased the in 3000 mg/kg dosage groups. However, there were no significant histopathological changes observed in ovary and uterus: so they were not considered to be adverse. It suggested that CoQ(10) is relatively safe on the test dosage administration. Nevertheless, appetite the body weight, blood lipid and liver function should be observed during long-term clinical administration of this drug with high dosage. Overall, CoQ(10) was well tolerated by male and female rats at dose levels up to 3000 mg/kg.day.
