JPH05262660A - Tricomponent formulation - Google Patents

Abstract

PURPOSE:To provide a formulation having the effects of improving alcohol metabolism and feeling of cold as well as nutrients supply and analeptic effect. CONSTITUTION:When conventionally known pantethine, ginseng and vitamin E are suitably formulated, the resultant preparation develops synergistic effects, namely improvement in alcohol metabolism, feeling of cold and indefinite complaints in addition to nutrients supply and analeptic effects. Accordingly, the resultant formulation is effective not only for analeptic effect and nutrient enrichment but also for improvements in alcohol metabolism, feeling of cold and the indefinite complaints.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a mixture containing pantethine, ginseng and vitamin E.

[0002]

2. Description of the Related Art In recent years, with the progress of an aging society or the complexity of the social structure, in particular, health management after middle age is
It has become an important social problem, and various nutritional tonics have been developed for that purpose.

[0003] Drugs for nutritional tonic include preparations based on Kampo prescription, preparations based on crude drugs, multivitamin preparations, preparations in which amino acids, crude drugs and organ extracts are mixed with vitamins.・ As part of meditation, it is taken to maintain and improve health. However, none of these drugs for nutritional tonic are effective in improving alcohol metabolism.

[0004]

Therefore, the present inventors have found that, in addition to the effect of nourishing and tonicity, which is not observed in the conventional nourishing and tonicative agents, the improvement of alcohol metabolism, the improvement of cold sensitivity and the improvement of indefinite complaints are achieved. Also provides a highly effective mixture.

[0005]

The three components which are the active ingredients of the mixture of the present invention are known substances and have been conventionally used independently. That is, pantethine is a prominent drug as a lipid metabolism improving agent, ginseng has long been used as a nourishing and tonic agent with various pharmacological effects, and vitamin E is used to prevent arteriosclerosis due to its antioxidative effect. It is used to improve nutritional disorders.

[0006] Therefore, as a result of intensive studies, the present inventors have expected that when a mixture containing these three known compounds is prepared, the effects are far superior to those obtained by using them alone. The present invention has been completed by discovering the effects that were not expected when used alone or alone, that is, effective in improving alcohol metabolism, improving cold sensation, and improving indefinite complaints.

To produce the mixture of the present invention, pantethine,
Ginseng and vitamin E are mixed in an appropriate amount ratio, and if necessary, an appropriate formulation additive such as corn starch, carboxymethyl cellulose, etc., which is usually used, is added to obtain a preferable dosage form, that is, tablets, granules. It may be used as an agent or a capsule.

The mixing ratio of the former three is about 1: 2.
It is preferable to set it to 15: 0.05 to 0.3, and the following main components are used as each main component used in this case.

That is, pantethine has a content standard of 90-
115% is the same as vitamin E 90-110%
Used ginseng, Japanese ginseng standard (10th revision)
Suitable carrots (carrots) and ginseng (red ginseng) can be used, and those having a stable saponin content for 4 to 6 years are preferably used.

The thus prepared mixture of the present invention is stable under ordinary conditions of distribution and storage at room temperature and 40%.
C, 75% R.C. It was confirmed by a stability test under H conditions (appearance, confirmation test, content, disintegration test and moisture absorption increase).

As a result of examining the safety of the mixture of the present invention, it was confirmed that it is extremely safe. That is, each group of 10 males and females of the ddY mouse has 2.5 g of the drug.
/ Kg, 5.0 g / kg were suspended in 0.5% CMC and orally administered. As a result of acute toxicity test, LD ₅₀ value was 5 g / kg.
That was all. That is, in both drug groups, no deaths were observed during the experimental period, and no abnormalities in behavior and appearance were observed during the observation period of 14 days. In addition, no abnormality was observed in the gross findings by autopsy after slaughter. Also, dd
With regard to the effects on the behavior of normal animals using Y mice, there was no difference between the single administration and the administration for 20 consecutive days, such as trunk tone, grip strength, motor coordination, spontaneous motor activity and exploratory movement, etc. There wasn't.

Further, in a clinical pharmacological test in which 12 healthy subjects were continuously administered 1.5 times the daily dose for 8 days after exercise, no side effects were observed.

Further, in a clinical evaluation test of about 200 people described later, only 2 cases of mild gastrointestinal symptoms were observed,
It was an extremely safe drug.

[0014]

INDUSTRIAL APPLICABILITY The combination of the present invention relates to a nourishing tonic agent which is particularly effective in improving alcohol metabolism, improving cold sensation and improving indefinite complaints.

[0015]

TEST EXAMPLE The excellent effect of the mixture of the present invention is specifically shown in the following test example.

Test Example 1: Basic Pharmacological Test In addition to alcohol load on animals, forced exercise (rope climbing),
Apply various stress such as hanging on the water, restraining submersion in water,
The effect of the drug on this was examined using behavioral pharmacological indexes and the like.

The drug used and the dose (mg / kg
P. O) This compounding agent (abbreviated as A): 450, 250 Pantethine (abbreviated as P): 90 Dried ginseng extract (abbreviated as G): 250 d-α-tocopherol acetate (abbreviated as T): 50

(1) Pharmacological action related to "improvement of alcohol metabolism" Exercise coordination test for alcohol load (rotating rod) For the purpose of knowing the recovery state from alcohol load, 40% alcohol 0.1 ml / 10 g body weight was given to mice. (Human body conversion:
Oral administration of whiskey bottles) was performed, and the staying time on the rotating rod (rotor rod) was measured over time to examine the degree of recovery of motor coordination. The results are shown in the table below.

[0019]

[Table 1]

As is clear from the above results, pantetine (P) was the most effective (significantly different) component in this test, but the compounding agent (A) showed a synergistic effect.

(2) Pharmacological action related to "improvement of cold sensation" Antagonism of decrease in body temperature (rectal temperature) caused by hanging in suspension When a mouse is suspended in water, the body temperature is lowered due to fatigue and water. It was

Regarding the suppression of the decrease in body temperature after the stress of suspension on the water, each plain component had no significant effect, but the combination agent (A) showed a significant effect. The results are shown in the table below.

[0023]

[Table 2]

(3) Pharmacological action related to "improvement of indefinite complaints" Inhibitory action against stress ulcer Strong stress due to restraint in water was applied to rats, and the effect of the present combination agent was examined by using the gastric ulcer caused by the stress as an index.

-Experimental Method- Rats (1 group): 10 (single dose) 12 (consecutive 10 doses) Restraint time in water: 7 hours Drug dose: P: 100, 300 mg / kg G: 300, 1000 mg / Kg T: 100, 300 mg / kg A: 450 mg / kg (60 times the normal dose)

-Determination of Effect- The laparotomy was performed immediately after submersion in water, and the ulcer formed on the stomach wall was divided into a red part (inflamed part) and a black recess (erosed part) and evaluated by the ulcer index.

The ulcer inhibitory action due to the submersion restraint stress is that a large amount of tocopherol (T.
It was generally weak as observed in g).

However, the effectiveness of the combination drug (A) was recognized with a significant difference in both single and continuous administration. The results are shown in the table below.

[0029]

[Table 3]

[0030]

[Table 4]

[0031]

[Table 5]

(4) Pharmacological action related to "nutrition tonic" Effect on forced exercise load (rope climbing) Rope climbing exercise (climbing distance 4 m / min, 240 m / hour) for 1 hour and 14 days continuously using mice ), The drug was given every day after exercise, and its performance (fatigue recovery) was examined.

The combination (A) was effective with a significant difference in recovery from long-term (14 days) continuous forced exercise (rope climbing). Especially, the tendency was remarkable in the latter half. The results are shown below.

[0034]

[Table 6]

Effect on Reproduction of Learning after Suspension on the Water (Light and Dark Box Method) The learned mice were suspended for one hour and four days a day so that the nose surface was in contact with the water surface, and the drug was given after intense stress and fatigue, The learning was reproduced using a light-dark box and the memory was examined. The results are shown in the table below.

[0036]

[Table 7]

In the memory reproduction test after the stress suspended in the water, the simple component which was recognized to be effective was ginseng (G).
However, compounding agent (A) was also effective with significance.

Effect on Recovery from Sexual Behavior Disorders after Suspension on the Water Mice were suspended on the water for 30 minutes to 2 hours a day for 14 consecutive days in the same manner, and after severe stress and fatigue, the drug was given. , Next morning, the degree of sexual behavior (horse riding behavior, number of insertions) was examined.

The combination drug (A) was significantly effective in recovering from sexual behavior disorder after stress suspension on the water. The results are shown in the table below.

[0040]

[Table 8]

[0041]

[Table 9]

Test Example 2: Clinical Evaluation Test As a result of the preliminary test, the efficacy and safety of this drug combination were predicted, so this test was conducted at 8 institutions nationwide. The results obtained by collecting, analyzing and evaluating 196 cases of all cases using the same protocol, survey table (for doctors) and health questionnaire sheet (for patients) are as follows.

In the comprehensive evaluation, 82.5% is a little improvement or more.
Even after the improvement, 37.6% was shown.

By the effect according to the symptom, anorexia, sickness, low back pain,
Effectiveness was seen in irritability, coldness, constipation, etc. In most of the symptoms of pre-dose severity improvement, the higher the severity, the greater the post-dose improvement. By gender,
Females had greater improvement in fatigue and stiff shoulders, while males had greater improvement in heart palpitations. The results are shown in the table below.

[0045]

[Table 10]

[0046]

[Table 11]

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Claims (5)

[Claims] 1. A mixture containing three components of pantethine, ginseng and vitamin E. 2. The mixture according to claim 1, wherein the compounding ratio of the three components of pantethine, ginseng and vitamin E is 1: 2 to 15: 0.05 to 0.3. 3. An alcohol metabolism improving agent containing three components of pantethine, ginseng and vitamin E. 4. An agent for improving chills, which contains three components of pantethine, ginseng and vitamin E. 5. An agent for improving indefinite complaints which contains three components of pantethine, ginseng and vitamin E.