JPH0436136B2 - - Google Patents

Description

[Detailed description of the invention]

The present invention provides pantethine, ginseng and vitamin E.
This article relates to a nourishing tonic containing three ingredients. The nutritional tonic of the present invention is also effective for improving alcohol metabolism, improving sensitivity to cold, and improving indeterminate complaints. In recent years, with the advancement of an aging society and the increasing complexity of social structures, health management, especially after middle age, has become an important social issue, and various nutritional tonics have been developed for this purpose. Drugs aimed at nourishing and tonic include preparations based on Chinese herbal prescriptions, preparations based on herbal medicines, multivitamins, and preparations containing vitamins, amino acids, herbal medicines, organ extracts, etc., and self-medication. It is taken as part of the medicine to maintain and improve health. However, none of these nutritional and tonic drugs are effective in improving alcohol metabolism. Therefore, the present inventors completed the present invention as a result of intensive studies aimed at developing a nutritious tonic with effects not found in conventional nutritious tonics. That is, the nutritious tonic of the present invention has a nutritious and tonic effect,
It has an excellent effect on improving alcohol metabolism, and is also very effective in improving sensitivity to cold and indeterminate complaints, and it is a very unique tonic that has not been recognized before. It is something. More specifically, each of the three active ingredients of the nutritional tonic of the present invention is a known substance and has been used independently in the past. In other words, pantethine is a well-known drug as a lipid metabolism improver, Panax ginseng has been used for a long time as a nutritional tonic and has various pharmacological effects, and vitamin E has antioxidant effects that prevent arteriosclerosis.
It is used to improve malnutrition, etc. However, if a mixture of these known compounds is prepared in an appropriate manner, it can be expected that the effects will be far superior to those obtained when each is used alone.
Furthermore, we have completed the nutritional tonic of the present invention by discovering that it is effective in improving alcohol metabolism, improving sensitivity to cold, and improving indeterminate complaints, etc., which could not be expected when used alone. To prepare the nutritional tonic of the present invention, the three components of pantethine, ginseng, and vitamin E are mixed in an appropriate ratio, and if necessary, suitable pharmaceutical additives commonly used, such as corn starch,
Carboxylmethylcellulose or the like may be added to form a preferred dosage form, ie, tablets, granules, or capsules. The mixing ratio of the former three is about 1:2~
15: It is preferable to set it as 0.05-0.3, and each main component used in this case is the following. In other words, pantethine is used with a content of 90 to 115% according to the content standard, vitamin E is used with a content of 90 to 110%, and Korean ginseng is used with ginseng and red ginseng, which meet the Japanese standards (10th revision). ) can be used, and those with a stable saponin content of 4 to 6 years are preferably used. The nutrient tonic of the present invention is usually orally administered, and the dosage may be about 450 mg per day when the three components are in the ratio as described above. It was confirmed that the nutritional tonic of the present invention thus prepared is stable under normal distribution and storage environmental conditions at room temperature and
Confirmed by stability test (appearance, confirmation test, content, disintegration test, and increase in moisture absorption) under the conditions of 40°C and 75% R and H. Furthermore, as a result of examining the safety of the nutritional tonic of the present invention, it was confirmed that it is extremely safe.
That is, each group of 10 male and female ddY mice was given 2.5 ml of the drug.
As a result of an acute toxicity test in which 5.0 g/Kg was suspended in 0.5% CMC and orally administered, the LD ₅₀ value was 5 g/Kg or more. That is, in both drug groups, no deaths were observed during the experimental period, and no abnormalities in behavior or appearance were observed throughout the 14-day observation period. In addition, no abnormalities were observed in the macroscopic findings of the post-slaughter autopsy. In addition, regarding the effects on the behavior of normal animals using ddY mice, both single administration and continuous administration for 20 days showed no difference from the control group in terms of trunk tension, grip strength, motor coordination, locomotor activity, and exploratory movements. It wasn't recognized. In addition, no side effects were observed in a clinical pharmacology study in which 1.5 times the daily dose was administered to 12 healthy subjects for 8 consecutive days after exercise stress. Furthermore, in a clinical evaluation test of approximately 200 people described below,
Only mild gastrointestinal symptoms were observed in 2 cases;
It was an extremely safe drug. The excellent effects of the nutrient tonic of the present invention are specifically demonstrated in the following test examples. Test Example 1: Basic Pharmacology Test In addition to alcohol loading, animals are subjected to various types of stress such as forced exercise (rope climbing), suspended above water, and submerged restraint, and the effects of drugs on this stress are investigated using behavioral pharmacological indicators. did. Drugs used and dosage (mg/Kg PO) This combination drug (abbreviated as A): 450, 225 Pantethine (abbreviated as P): 90 Dried red ginseng extract (abbreviated as G): 250 d-α-tolferol acetate (abbreviated as T) ): 50 (1) Pharmacological effects related to "improvement of alcohol metabolism" Motor coordination test in response to alcohol load (rotating rod) 0.1ml/10g of 40% alcohol was administered to mice for the purpose of determining the state of recovery from alcohol load. Body weight (human body equivalent: equivalent to about one whiskey bottle) was orally administered, and the time spent on a rotating bar (row) was measured over time to examine the degree of recovery from exercise.The results are shown in Table 1. The component with superior effects (with a significant difference) was huntetin (P), but a synergistic effect was observed in combination drug (A).

[Table] (2) Pharmacological effects related to "improvement of sensitivity to cold" Antagonism to the drop in body temperature (rectal temperature) due to suspension When a mouse is suspended above water, it causes a drop in body temperature due to fatigue and water, but we investigated the effects of drugs on this. Ta. Regarding the suppression of body temperature drop after the stress of hanging above water, no significant effect was observed for each single ingredient, but a significant effect was observed for combination drug (A).

[Table] (3) Pharmacological effects related to "improvement of indeterminate complaints" Suppressing effect on stress ulcers Rats were subjected to strong stress by being submerged in water, and the effects of this combination drug were investigated using the resulting gastric ulcers as an indicator. Experimental method Rats (group 1): 10 (single dose), 12 (10 consecutive doses) Water restraint time: 7 hours Drug dosage P: 100, 300 mg/Kg G: 300, 1000 mg/Kg T: 100 , 300mg/Kg A: 450mg/Kg (60 times the usual dose) Judgment of effectiveness Immediately after submersion restraint, the abdomen was opened and the ulcer formed on the stomach wall had a red area (inflammation area) and a black depressed area (erosion area).
In particular, it was evaluated using the Ulcer index. The inhibitory effect on ulcers caused by water immersion restraint stress was generally weak among single ingredients, to the extent that it was observed in large amounts of tocopherol (T.100mg). However, combination drug (A) was found to be effective with a significant difference in both single administration and continuous administration.

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[Table] (4) Pharmacological effects related to "Nourishment tonic" Effect on forced exercise load (rope climbing) Mice were subjected to rope climbing exercise for 1 hour every day for 14 consecutive days (climbing distance 4 m/min, 240 m/min)
The drug was administered every day after exercise to examine performance performance (degree of recovery from fatigue). Long term (14 days), continuous forced exercise (rope climbing)
Concerning recovery from , combination drug (A) was significantly more effective. This trend was especially noticeable in the latter half of the year.

[Table] Effects on reproduction of learning after suspension above water (light/dark box method) Mice that have been trained are suspended in the air with their nose touching the water surface for 1 hour a day for 4 consecutive days, and after severe stress and fatigue, a drug is given to them and a light/dark box method is used. The students were asked to reproduce what they had learned using the software, and their memorability was examined.

[Table] In addition, in the memory reproduction test after stress loading by hanging above water, the only single ingredient that was found to be effective was ginseng (G), but the combination drug (A) was also found to be effective with a significant difference. It was hot. Effects on recovery from sexual behavior disorder after suspension over water Mice were suspended over water for 30 minutes to 2 hours a day for 14 consecutive days, giving them severe stress and fatigue. Degree of activity (mounting motion, number of insertions)
It was investigated. Combination drug (A) was significantly effective for recovery from sexual behavior disorder after stress of hanging above water.

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[Table] Test Example 2: Clinical Evaluation Test As a result of the preliminary test, predictions regarding the efficacy and safety of this combination drug were obtained, and the main test was conducted at 8 institutions nationwide. Same protocol, survey form (for doctors), health questionnaire form (for patients)
A total of 196 cases were collected, analyzed and evaluated, and the results are as follows. In the overall evaluation, 82.5% said it was slightly improved and 37.6% said it was improved or better. In terms of effectiveness by symptom, it was found to be effective for loss of appetite, drunkenness, lower back pain, irritability, feeling cold, and constipation. Regarding the degree of improvement by severity before administration, for most symptoms,
The degree of improvement after administration was greater in cases with higher severity. Regarding gender, women experience fatigue, stiff shoulders, etc.
The improvement in heart palpitations was greater in men.

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Claims (1)

[Claims] 1. A nourishing tonic containing three ingredients: pantethine, ginseng, and vitamin E.