METHOD FOR IMPROVING SLEEP ONSET AND SLEEP MAINTENANCE, METHOD FOR REDUCING STRESS AND IMPROVING RELAXATION, METHOD FOR IMPROVING PERFORMANCE AND CONCENTRATION, AND METHOD FOR IMPROVING RESTING EFFECT AND PROMOTING RECOVERY FROM FATIGUE

Abstract

A method that promotes sleep onset and sleep maintenance, reduces stress, and improves a relaxation effect, performance, concentration, a resting effect and an effect of recovery from fatigue. The method includes administering to a subject Apocynum venetum leaf extract.

Claims

1. A method for improving sleep onset and sleep maintenance comprising a step of: administering to a subject a pharmacologically effective amount of Apocynum venetum leaf extract.

2. The method for improving sleep onset and sleep maintenance according to claim 1, wherein the Apocynum venetum leaf extract contains 4 to 10% hyperoside and isoquercitrin which are flavonoid compounds.

3. The method for improving sleep onset and sleep maintenance according to claim 1, wherein an intake of the Apocynum venetum leaf extract per day is in a range of 40 mg or more and 100 mg or less.

4. The method for improving sleep onset and sleep maintenance according to claim 1, wherein the Apocynum venetum leaf extract is obtained by extracting leaves of Apocynum venetum leaf in a solvent including at least one of water, ethanol, and aqueous ethanol.

5. The method for improving sleep onset and sleep maintenance according to claim 1, wherein the pharmacologically effective amount of Apocynum venetum leaf extract is conveyed by a pharmaceutically acceptable carrier.

Description

EXAMPLES

[0035] Here, the composition according to the above embodiment was actually prepared and effects thereof were checked. Details will be described below.

[0036] (1) Preparation of Apocynum venetum Leaf Extract

[0037] Dried Apocynum venetum leaves were pulverized by a labratory mixer, 60% ethanol (6 L) was added to the pulverized product (1 kg) , and the mixture was heated and circulated for 2 hours, and then filtered to obtain an extract solution. The extraction residue was heated and circulated again in 60% ethanol (6 L) for 2 hours and then filtered to obtain an extract solution. The first extract solution and the second extract solution were combined, condensated under a reduce pressure at 60 degrees, condensated to about 1/5 volume, and then suspended in water in an amount of two times thereof . Then, a pH of the mixture was adjusted to 3 using citric acid, and stirring was performed overnight. Diatomaceous earth was added to form a body feed, the solution was poured onto a filter paper with the diatomaceous earth spread thereon, and insoluble substances were removed by filtration. The obtained filtrate was passed through a synthetic adsorption resin HP20 (1 L) (commercially available from Mitsubishi Chemical Corporation), an active ingredient was adsorbed, and then washing with water (2 L) was performed to remove saccharide and the like. Then, desorption was performed in 70% ethanol (2 L), fractions containing an active ingredient were collected, condensated under a reduced pressure at 50 degrees, and condensated to about 1/10 volume, spray drying was then performed, and thereby a solid substance (95 g) was obtained.

[0038] Here, when measurement of the solid substance obtained above was performed by liquid chromatography, it was confirmed that hyperoside was contained at 2 to 5 weight %, and isoquercitrin was contained at 2 to 5 weight %, with a total amount of 4 to 10 weight %.

(2) Clinical Test

[0039] In a clinical test, healthy Japanese adult males and females participated as subjects, and tablets containing the Apocynum venetum leaf extract (25 mg per tablet) were used. Here, as a placebo, a food additive coloring formulation having the same appearance without the Apocynum venetum leaf extract was used as a test food.

TABLE-US-00001 TABLE 1 name of raw materials name shape (per tablet) blending amount a Apocynum tablet Apocynum venetum leaf 25.00 mg venetum leaf extract extract tablet starch decomposition product 84.00 mg crystalline cellulose 59.50 mg lactose 22.70 mg edible fat and oil 6.30 mg glycyrrhiza uralensis 2.50 mg extract gum guaiac a very small mount shellac a very small mount glyceryl fatty acid ester a very small mount carnauba wax a very small mount placebo tablet starch decomposition product 84.00 mg tablet crystalline cellulose 59.50 mg caramel pigment 25.00 mg lactose 22.70 mg edible fat and oil 6.30 mg glycyrrhiza uralensis 2.50 mg extract gum guaiac a very small mount shellac a very small mount glyceryl fatty acid ester a very small mount carnauba wax a very small mount

[0040] A randomized, placebo-controlled, double blind, crossover comparative study was performed with 17 subjects. Until days 1 to 7, an intervention group ingested the Apocynum venetum leaf extract (50 mg/day) 30 minutes to 1 hour before going to bed, and a placebo group ingested the same number of the placebo tablets. On the 8.sup.th day, they ingested the tablets 15 minutes to 30 minutes before the questionnaire started before an Uchida-Kraepelin psychodiagnostic test.

[0041] Immediately after ingestion for 7 days, a feeling of sleep improvement was evaluated using an OSA sleep questionnaire MA version. For scores of question items, scale values for the items were referred to. The score was obtained by an average value of the question items. A higher score indicates a favorable sleep state.

[0042] Here, on the 8.sup.th day, the Uchida-Kraepelin psychodiagnostic test was performed, and calculation was performed within a determined time. An amount of calculation, a calculation accuracy rate, and a perturbation rate were measured to evaluate improvement in performance and concentration. In addition, the questionnaire was performed before and after the Uchida-Kraepelin psychodiagnostic test, and improvement in stress and a relaxation effect were evaluated. Here, the Uchida-Kraepelinpsychodiagnostic test was performed for 15 minutes each in the first half and the second half in a divided manner, with a 5-minute rest therebetween, work efficiencies in the first half and the second half were compared, and efficiency of rest and recovery of fatigue were evaluated.

Results of Clinical Test

(3) Results of OSA Sleep Questionnaire

[0043] It was confirmed that the intervention group had a significantly higher factor II for evaluating sleep onset and sleep maintenance compared to the placebo group (placebo group: 1.9±3.6; intervention group 7.5±7.8, p=0.042)

(4) Uchida-Kraepelin Psychodiagnostic Test Questionnaire

[0044] In evaluation items “nervous,” “restless,” and “irritated” related to improvement in stress and a relaxing effect, the intervention group had significantly lower scores than the placebo group.

TABLE-US-00002 TABLE 2 variation (after ingesting the tablet-before ingesting the tablet) item intervention group placebo group p value nervous −0.5 ± 0.7 0.2 ± 0.9 0.015 restless −0.5 ± 0.9 0.3 ± 1.2 0.038 irritated −0.6 ± 1.1 0.1 ± 0.7 0.038

(5) Uchida-Kraepelin Psychodiagnostic Test

[0045] The item “perturbation rate” related to performance and concentration was for evaluating the variation in work. A lower score indicates a smaller variation in work, higher concentration, and improved performance. As shown in the following table, the intervention group had a significantly lower perturbation rate than the placebo group.

TABLE-US-00003 TABLE 3 variation (after ingesting the tablet-before ingesting the tablet) item intervention group placebo group p value perturbation rate −0.19 ± 0.23 0.09 ± 0.46 0.043

(6) Uchida-Kraepelin Psychodiagnostic Test

[0046] In the evaluation item related to a resting effect and recovery from fatigue, it is significantly improved more in the intervention group than in the placebo group

TABLE-US-00004 TABLE 4 variation (after ingesting the tablet-before ingesting the tablet) item intervention group placebo group p value rest effect rate 0.03 ± 0.09 −0.05 ± 0.08 0.029 rest elongation rate 0.03 ± 0.09 −0.05 ± 0.08 0.029

[0047] As shown above, in the above human test, it was confirmed that the composition promoted sleep onset and sleep maintenance, reduced stress, and improved a relaxation effect, performance, concentration, a resting effect, and an effect of recovery from fatigue.