Summary Coenzyme Q 10 (CoQ 10 ) is a lipid-soluble antioxidant and essential component of the mitochondrial electron transfer system in the body, and is in wide use as a functional food material and cosmetic raw material. However, as CoQ 10 is extremely lipid-soluble, absorption by the body is not easy. In general, people use soft-gel capsules in which CoQ 10 is suspended in oil, and take these capsules with food. PureSorb-Q TM 40 (P40) was developed to improve CoQ 10 processability and absorption when taken without food, and the present study compared the effects of food on absorption between P40 and conventional lipid-soluble CoQ 10 in rats and humans. The results of a rat study showed higher uptake when P40 was administered in the fasting state or with food compared to lipid-soluble CoQ 10 . The results of a human study showed that uptake was favorable when P40 was administered in the fasting state, and even when administered postprandially, a significant difference was noted in uptake rate up to 6 h after intake and uptake volume up to 8 h after intake when compared to lipid-soluble CoQ 10 . These results show that any CoQ 10 product using P40 can be quickly and reliably absorbed by the body regardless of dosage form or intake time.

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Coenzyme Q10 (CoQ10) is known to be highly hydrophobic and, as such, insoluble in water: this leads to serious inconvenience when trying to incorporate it in food products. Its absorption is also known to be very limited. PureSorb-Q40 (P40) (Water-soluble type CoQ10 powder, CoQ10 content 40 w/w % was developed in order to improve its use with food products and to enhance its absorption. In the present study the absorption of this novel formulation was compared to a conventional lipid soluble CoQ10 by administering both products to rats and humans. Acute, single-administration studies in rats showed that P40 has a higher absorption, compared to lipid soluble CoQ10, both in prandial and fasting states. Similarly, single administration in humans revealed a higher absorption level for P40, taken in the fasting state or together with meals. In the rat study, no adverse effects were observed with P40 at doses up to 2,000 mg/kg in both sexes. In a double-blind, placebo controlled, comparative study conducted on 46 healthy volunteers and randomly divided into two groups, in the group receiving 900~mg of CoQ10 per day, for 4 consecutive weeks, the average level at two weeks was 8.79 +/- 3.34 microg/mL, similar to the corresponding level after 4 weeks (8.33 +/- 4.04 microg/mL). After 2 weeks of washout, serum CoQ10 level decreased to 1.30 +/- 0.49 microg/mL. P40 intake did not cause any significant changes in symptoms and clinical laboratory tests as assessed by physical, hematological, blood biochemical or urinalysis. Clinical examinations also did not reveal any abnormalities. The above blood (serum) CoQ10 level at 2 weeks after start of intake was compared with other reported values. The same dose of CoQ10 (900mg/day), when administered by softgel capsules yielded a plasma CoQ10 concentration of 3.6 microg/mL, while P40 levels were 8.79 +/- 3.34 microg/mL. These levels are remarkably high for instance when compared to the corresponding levels obtained, in patients affected by Parkinson's disease, with CoQ10 doses up to 2,400mg/day. A clinical study was conducted using doses of 300 mg/day and 600 mg/day, in patients affected by cardiovascular disease. Also in this case there was linearity in the response with the levels obtained by administering P40 at a dose of 100 and 900 mg/day.

Summary PureSorb-Q TM 40 (water-soluble type CoQ 10 powder, CoQ 10 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 CoQ 10 even taken postprandially, than those of regular CoQ 10 , which is lipid-soluble and generally taken in the form of soft-gel capsules. Thus, it was anticipated that the serum CoQ 10 level might be higher with P40 tablets than with soft-gel capsules, even for the same dose of CoQ 10 . In the present study, in order to confirm the safety and measure the serum CoQ 10 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 2,250 mg/d of P40 (that is, 900 mg/d of CoQ 10 ) for 4 consecutive wk, the serum CoQ 10 level peaked at 2 wk after the start of intake at 8.79 Ϯ 3.34 g/mL, and at 4 wk, it was at the level of 8.33 Ϯ 4.04 g/mL. At 2 wk from withdrawal of intake, the serum CoQ 10 level decreased to 1.30 Ϯ 0.49 g/mL. The serum CoQ 10 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 CoQ 10 .

Physiological and morphological changes of small intestine after hyperosmolar glucose infusions into canine jejunum were studied using in vivo perfusion model. Infusions of 40 ml of 50% and 20% glucose solution into the jejunal loops induced biphasic osmolar degression in the lumen. Osmolarity of jejunal venous blood was rapidly increased and maintained the maximal level (approximately 320 mOM/L). Blood flow to the jejunal loop was significantly increased after 50% glucose infusion compared to 5% glucose infusion. Most characteristic electron microscopic change of jejunal epithelial cell was pseudo-pod like process projected into the jejunal lumen, which was very similar to that of cholera.

Summary 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.

The following describes the quantitative determining method for phosphatidylcholine (PC) using the HPLC-RI system which we have developed. It uses Lichrosorb, Si 60 (10 pro), 4.6 mm X 250 mm as the column and a mobile phase consisting of n-hexane/isopropanol/water ---1:4:1. In this report, we compared data from selected highpurity (60-100 wt%) samples using the HPLC-RI, HPLC-UV and conventional TLC-P methods.Under the conditions we described, the HPLC-UV method was somewhat affected by fatty acid compositions. As a result, there were some inconsistencies in the measured values. However, the HPLC-RI method we propose was applicable to PC from both egg yolk and soybeans. In addition, the HPLC-RI method produced data which correlated well with data from the TLC-P method, and this data was highly accurate and exhibited satisfactory reproducibility.