Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-05-10
2003-06-10
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S535000, C424S776000, C424S725000, C514S419000
Reexamination Certificate
active
06576252
ABSTRACT:
The present invention relates to a composition for obtaining a triple calming, stress hormone regulating and immune stimulation effect.
It is now scientifically established that stress develops through the following three phases:
in a first stage, the body reacts to an external aggression situation with an alarm reaction which is revealed through several physical signs, including mainly an accelerated cardiac rhythm, short and rapid respiration, general increase in muscular tension and dryness of the throat. The purpose of this reaction is to improve oxygenation of the tissues and to distribute the blood differently in the organism, in particular towards its periphery. These mechanisms, set in action by the body, in principle confer on the individual physical dispositions allowing him to fight against external aggression;
in a second stage, resistance can be organised: the organism is in principle provided to adapt to the aggression, as it has available all the nutrients (oxygen, glucose, adenosine triphosphate release) permitting it to resist the experienced situation over a short or medium term period. It does in fact implement what it is convenient to call a “survival strategy”. However, the mechanisms contributed by the body may be adequate or inadequate compared with the optimum response which can be made. During this phase, intellectual performance diminished, and a tendency is observed in the patient to become depressed and even to abuse alcohol or other drugs;
then comes the exhaustion stage: the physical signs are very high muscle tension, with frequent headaches and migraines and intestinal troubles (spasms and pains). In certain cases, the appearance of ulcers is noted and, generally, there is an effect of strengthening of sub-jacent pathologies. At this stage, the depressive syndrome is complete.
In the course of these three phases, the nervous system comes into play with secretion of different hormones. The most well-known are adrenaline (secreted on the initial alarm reaction), cortisol and corticosterone. Other monoamines are also synthesised and released. The increase in these hormones following a stress situation gives the organism the means for its defence by storing energy, mobilising reserves and desensitising it to certain types of aggressions such as pain. In the medium and long term, however, the effects of these hormones are detrimental, even disastrous. They cause tiring of the organism, make it vulnerable to infections (reduction of immune defences) and damage the neurones (memory loss). These effects finally have an impact inter alia on the cardio-vascular system, ageing of the organism and certain conditions of appearance of cancer.
Thus, the elevation of the cortisol level in the plasma can be related to pathologies such as agitation and mood modification and deterioration of the memory mechanisms causing cognitive deficiencies. Recent experiments confirm that high concentrations of cortisol cause cerebral damage at the neuronal level. It is also known that stress is thought to be at the origin of modulation of several aspects or cellular immune response. This is thought to be the result of problems in the transfer of signals between the central nervous system and the immune system which occur partly through the hormone system.
Lastly, anxiety caused by stress has consequences in particular for sleep, lack of which is involved in tiring the organism.
Generally, taking into account the present knowledge of stress mechanisms, any consideration relating to protection of the organism against the damaging effects due to stress can therefore be oriented in the following directions:
protecting the cells and organs against excess cortisol (neural protection);
reinforcing the immune defences (immune stimulation);
taking action on anxiety by means of a calming effect.
This is the main aim of the invention, which recognises the importance of this triple mechanism and to this end proposes a composition having at the same time a calming, stress hormone regulating and immune stimulation effect. The composition is characterised by the fact that it includes:
at least one component including in particular a combination of linoleic and linolenic acids in a ratio permitting reduction of the production of stress hormones;
at least one component taken from the flavonoid group;
at least one component having calming properties.
Recent research has revealed advantageous properties of linoleic and alpha-linolenic acids relating to the regulation of cortisol counts. According to these studies, it does not seem that the quantity of linoleic and/or linolenic acid itself has a beneficial influence, but rather the ratio between these two acids. This beneficial effect would be the result of an improved bio-availability in the brain of the active principles, the said ratio being capable of crossing the haemato-encephalic barrier and the increasing membrane fluidity (essential for the functioning of the nervous system).
Preferably, the linoleic and linolenic acids are combined in a proportion by weight of 58% and 13% respectively.
Preferably again, the component including the combination of linolenic and linoleic acids is nut oil. This natural, easily available product has the advantage of not requiring preparatory work or complex synthesis.
It has long been known, moreover, that certain flavonoids (for example, ginseng including ginsenosides and other saponines) improve physical endurance and mental capacities both in man and animals. For example, the tonic properties of ginseng have been studied with regard to different parameters such as appetite, sleep, absence of mood change, work efficiency, etc. Ginseng also regulates the concentrations of corticosteroids, studies in animals having shown that ginseng decreased the concentrations of cortisol in the blood. Other studies have revealed its immuno-stimulant action. Thus, these flavonoids in themselves have both a calming, stress hormone regulating and immuno-stimulant effect.
Lastly, certain plant extracts, in known manner, have a particularly advantageous calming and sedative effect. Such is true of extracts of hops (Humulus lupulus). Studies have shown that these extracts have an antispasmodic activity on different preparations of isolated smooth muscles and sedative properties leading to an improved aptitude to confront stress and edginess.
The composition of the invention can also contain tryptophane, as component having sedative properties. The use of tryptophane results from the observation of the effects of 5-hydroxytryptophane (synthesised in the organism from tryptophane) which is one of the close precursors of serotonin. This, present at the level of the brain, the blood platelets and the gastro-intestinal apparatus, permits regulation of mood, behaviour and the sleep cycle. Thus tryptophane and its metabolite are theoretically capable of having similar therapeutic effects, without the side effects. It is known in particular that people suffering from chronic insomnia respond well to tryptophane when it is administered in a low dose in repeated manner.
Preferably, the tryptophane used in the invention is contributed by a fraction of milk proteins and represents a percentage by weight of the order of 3% of this fraction.
The different elements participating in the composition of the invention thus lead to the triple result required, the different constituents acting in combination and mutually strengthening their effects.
In accordance with one possibility, the composition of the invention also comprises extract of althaea (marshmallow), containing inter alia a substance having an immuno-stimulant effect (arabinogalactane).
The composition of the invention must of course be administered in a dose and at a frequency calculated for the patient to be able to feel the beneficial effects by obtaining the above-mentioned triple effect. Thus, for daily use, the composition of the invention comprises the following proportions by weight:
600 to 4000 mg of nut oil;
extract of ginseng such that the quantity of ginsenosides is bet
Anton Jean-Christophe
Chantereau Sylvie
Schwartz Robert
Abelman ,Frayne & Schwab
Davis Ruth A.
Laboratoires Robert Schwartz
Lankford , Jr. Leon B.
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