Drug – bio-affecting and body treating compositions – Extract or material containing or obtained from a...
Reexamination Certificate
2001-03-13
2002-12-17
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Extract or material containing or obtained from a...
C424S439000, C514S055000, C514S810000
Reexamination Certificate
active
06495142
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to a method for treating, improving or preventing impulse control disorder, by administering a composition comprising a specified low-molecular weight chitosan and/or a derivative thereof to a living subject, particularly to a subject suffering from an impulse control disorder. In addition, a drug, a food product including a health food product, and a drink containing the chitosan is also provided by the present invention.
2. Description of the Background
Depression and Bulimia are common psychiatric diseases in the stressful current society, and many people suffer from these disorders. Until now, drugs such as anti-depression drugs including selective serotonin reuptake inhibitor (SSRI) have been used for treatment of these diseases. However, these drugs cause many side effects and cannot be used safely for children and aged people. Even if adults take the drugs, they must endure many side effects therefrom.
Recently, the frequency of crimes committed by teen-agers has been increasing. Such children evidencing aggressive behavior often commit violence in their schools and/or families, and the collapse of the school and the family as social structures is the serious problem in society. These children are affected by a syndrome of impulse control disorder, including borderline personality disorder, emotionally unstable personality disorder, conduct disorder, defiant personality disorder, explosive personality disorder, intermittent explosive disorder, etc. Tranquilizers used for treatment of these children cause side effect such as sleepiness all day long and lack of motivation for study and every day life.
It has been pointed out that the aggressive behavior of those children was due to the lack of discipline or irregular dietary regimen at home. However, no effective health food for impulse control disorder has been reported to date.
Chitosan is a polysaccharide which has the chemical structure of &bgr;-1,4-poly-D-glucosamine and is produced by deacetylation of chitin, which is contained in the shell of the Crustacea such as crabs and lobsters. It is soluble in diluted acid solution but insoluble in water. It is not digested by digestion enzymes in humans, and, therefore, it is one of the dietary fibers. To date, it has been used for flocculants in waste water treatment, cosmetics, artificial skin, cationic resins, plant activating agents, and food materials. Recently it was discovered that chitosan showed physiological functions in humans, such as improvement of cholesterol levels in blood, inhibition of lipid absorption, anti-hypertension, and improvement of intestinal metabolism. Nevertheless, no mental effects produced by chitosan have been described.
Chitosan is a high-molecular weight polymer in nature, insoluble in water and alcohol, slightly soluble in diluted acid solution, and it is difficult to make highly concentrated solutions of chitosan due to the high viscosity because of its high molecular weight. To overcome this problem, there are many known methods to produce low-molecular weight chitosan of lower viscosity and higher solubility. For example, the low-molecular weight chitosan having various and arbitrary molecular weight can be produced by treating chitosan obtained by deacetylation of natural chitin, with 0.007 to 0.35% hydrogen peroxide solution adjusted at pH 6 to 12, in Japanese Patent Kokoku Publication JP-B-56-33401.
SUMMARY OF THE INVENTION
It is an object to the present invention to provide a method for treating, improving and/or preventing impulse control disorder.
It is also an object of the present invention to provide a method for treating, improving and/or preventing impulse control disorder by administering a highly safe drug which may be in the form of a food, such as a health food product or a drink.
Recognizing the importance of providing novel methods useful in the therapy of impulse control disorders, the present inventor has investigated the effects of many drugs and health foods for the treatment of impulse control disorder.
These efforts led to the discovery that a low-molecular weight chitosan which has a specified molecular weight, shows excellent effect for improving impulse control disorder.
Accordingly, the present invention provides a method for treating, improving and/or preventing impulse control disorder, which comprises administering or giving to a living subject, particularly to a patient suffering from such diseases as impulse control disorders, a composition comprising chitosan as an effective ingredient, having a weight-average molecular weight of approximately 80,000 to 100,000 and/or a number-average molecular weight of approximately 30,000 to 40,000, as measured or determined by Gel Permeation Chromatography (GPC). The chitosan may be in the form of salt. The chitosan can be in the form of a pharmaceutically acceptable salt, an edible salt or a derivative converted to free chitosan in vivo.
The present invention is not limited to the type of impulse control disorder. Impulse control disorders include, but are not limited to, borderline personality disorder, obsessive-compulsive personality disorder, emotionally unstable personality disorder, defiant personality disorder, conduct disorder, explosive personality disorder, intermittent explosive disorder, bulimia, excessive sexual impulse and compulsive buying.
The composition may in the form of drug, food product or drink. In a preferred embodiment, the chitosan used for the composition in the present invention has a weight-average molecular weight of approximately 85,000 to 95,000 when measured by GPC. In a further preferred embodiment, the composition also comprises an edible organic acid and/or an amino acid. Thus, the chitosan is soluble in water and absorbed easily via oral administration.
Although the functional mechanism of the effect is not known, and without being limited by any particular theory, it is speculated that the chitosan may stimulate the parasympathetic nerves or interact with the neurotransmitters in brain by an unknown mechanism. This theory, of course, does not restrict the scope of the present invention.
It is another object of the present invention is to provide methods for imparting an activity of repressing impulse to a food product or a drink by combining with the food product, drink or the materials (precursors) therefor, chitosan having a weight-average molecular weight of approximately 80,000 to 100,000 and a number-average molecular weight of approximately 30,000 to 40,000, as measured or determined by GPC.
Thus, the present invention also provides a method of imparting an ability to repress impulses to a food product or a drink, comprising combining the food product or the drink with chitosan having a weight-average molecular weight of 80,000 to 100,000 and a number-average molecular weight of 30,000 to 40,000 as measured by GPC.
Thus, according to the method of the present invention, the symptom of the impulse control disorder for which the treatment by the conventional drugs as anti-schizophrenia drug, etc., is ineffective, can be improved greatly without any side effects.
Therefore, the effective ingredient in the composition of the present invention, i.e., the chitosan, can be used not only as the drug for impulse control disorder, but also as food products and drinks such as health food products for unsymptomatic subjects.
A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description.
DETAILED DESCRIPTION OF THE INVENTION
The chitosan used in the present invention as an active ingredient has a defined molecular weight, and can be produced by the method, for example, described in Japanese Patent Kokoku Publication JP-B-56-33401, incorporated herein by reference. The molecular weight of chitosan as a macromolecular compound, can be estimated by the correlation between the viscosity of the solution and the mole
Flood Michele C.
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Sakai Kazuo
Tate Christopher R.
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