Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-03-03
2002-10-22
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S484000, C424S489000, C514S549000, C514S560000, C514S893000
Reexamination Certificate
active
06468556
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a novel liver fat accumulation inhibitory composition, a food additive for liver fat accumulation inhibition, and a method of inhibiting liver fat accumulation.
BACKGROUND ART
It has been considered that fatty liver, which is a disease wherein fat is excessively accumulated in the liver (hepatocytes), is caused by supernutrition, hyperingestion of alcohol, diabetes and side effects due to administration of pharmaceuticals, and can cause severe diseases such as chronic hepatitis and hepatic cirrhosis. It is an important subject to treat and prevent fatty liver; however, there have not been accomplished any other safe and effective method for treatment and prevention thereof than control of nutrition to be fed, and there have scarcely been made any development of drugs (pharmaceuticals) for treatment and prevention.
Fatty liver refers to a state where lipid, particularly neutral fat, is accumulated in hepatocytes to the degree exceeding a physiologically permissible range, but a morphological/biochemical clear definition for a quantitative standard of fat deposition has still to be made. In general, fatty liver refers to a case where a remarkable morphological change in accumulation of neutral fat is recognized in hepatocytes over a range of a third of all lobuli and any other remarkable morphological abnormality can not be recognized. From a biochemical point of view, a standard for judgment of fatty liver is that the weight of neutral fat is about 10% (100 mg/g wet weight) or more of the wet weight of hepatic tissue.
An object of the present invention is to provide a novel composition capable of effectively preventing fatty liver, in its turn diseases such as chronic hepatitis and hepatic cirrhosis, by inhibiting hyperaccumulation of liver fat, and a method of inhibiting accumulation of liver fat.
DISCLOSURE OF THE INVENTION
To attain the above object, the present inventors have intensively studied and found that accumulation of liver fat is successfully inhibited by feeding or administering a conjugated linoleic acid. The present invention has been completed based on this novel knowledge.
That is, the present invention includes:
(1) a liver fat accumulation inhibitory composition characterized by containing an effective amount of a conjugated linoleic together with a support for medicinal preparations or foods.
(2) The liver fat accumulation inhibitory composition according to the item (1), wherein the conjugated linoleic acid is at least one selected from cis-9,trans-11-octadecadienoic acid, trans-10,cis-12-octadecadienoic acid, an isomer thereof, and an avirulent salt and ester thereof;
(3) The liver fat accumulation inhibitory composition according to the item (1) or (2), which is in the form of a food;
(4) The liver fat accumulation inhibitory composition according to the item (1) or (2), which is in the form of a pharmaceutical;
(5) A food additive for liver fat accumulation inhibition characterized by containing a conjugated linoleic acid as an active ingredient.
(6) A method of inhibiting liver fat accumulation, which comprises administering or feeding an effective amount of a conjugated linoleic acid to mammals; and
(7) Use of a conjugated linoleic acid for preparation of a pharmaceutical composition or food additive for inhibiting liver fat accumulation.
According to the present invention, there can be provided a liver fat accumulation inhibitory composition, containing an effective amount of a conjugated linoleic acid (hereinafter referred to as “CLA”) together with a support for medicinal preparations or foods; a food additive for liver fat accumulation inhibition, containing CLA as an active ingredient; and a method of inhibiting liver fat accumulation, using CLA.
More particularly, according to the present invention, there can be provided the above composition and additive, wherein CLA is at least one selected from cis-9,trans-11-octadecadienoic acid, trans-10,cis-12-octadecadienoic acid, an isomer thereof, and an avirulent salt and ester thereof; the above composition and additive, which are in the form of a food; the above composition and additive, which are in the form of a pharmaceutical; and a method of inhibiting liver fat accumulation, which comprises administering or feeding an effective amount of CLA to animals for subject.
Preferred composition of the present invention includes, for example, those containing CLA in the amount within a range from 0.2 to 90% (% by weight, the same rule applies correspondingly to the following) on a dry weight basis.
With the above constitution, accumulation of liver fat can be remarkably inhibited by feeding or administering the composition of the present invention. The reason is not clear at present, but is considered as follows. That is, since the amount of glutathione stored in the liver, which may be related to elimination of a free radical in the living body, shows significantly a high value, the capability of synthesizing glutathione is improved or consumption of glutathione is inhibited by feeding or administering CLA, thereby inhibiting liver fat accumulation. Any way, the present invention provides a novel composition or additive for inhibiting liver fat accumulation, or a novel method of inhibiting liver fat accumulation, which is very effective in the fields of pharmaceuticals and foods.
BEST MODE FOR CARRYING OUT THE INVENTION
It is essential that CLA as an active ingredient is incorporated into the composition of the present invention. CLA may be any of those contained in processed foods derived from ruminants, particularly dairy products such as yoghurt, and purified products and chemically synthesized products thereof. Details with respect to the method of producing CLA are described, for example, in literature of Ha, Y. L., et al., (Carcinogenesis, Vol. 8, 1881-1887 (1987)) and literature of Chin, S. F. et al., (Journal of Food Composition and Analysis, Vol. 5, 185-197 (1992)).
Preferred typical method includes, for example, a method of mixing linoleic acid or a natural supply source containing the same, more specifically corn oil, safflower oil or butter fat, with milk whey protein in almost the same amount and reacting the mixture at room temperature. CLA obtained by the method contains 9,11-octadecadienoic acid and/or 10,12-octadecadienic acid and an active isomer thereof. CLA can be used advantageously in the present invention in a free form (liquid), or in the form of an avirulent salt such as sodium salt or potassium salt, or an ester (e.g. methyl ester, ethyl ester, etc.) with a suitable alcohol such as methanol or ethanol, or in the form of a dry powder. 9,11-CLA and 10,12-CLA each including four geometric isomers such as cis,cis-, cis,trans-, trans,cis- and trans,trans-isomers, and all of these isomers can be used as the active ingredient of the composition of the present invention. CLA prepared from a supply source such as natural product is usually obtained as a mixture of these two or more isomers. In the present invention, CLA is generally used in the form of the mixture without being isolated, but can also be used after isolating according to a conventional procedure, as a matter of course.
The composition of the present invention is prepared in the form suited for feeding or administration by using a suitable support such as excipient or diluent in the same manner as in case of a conventional food composition or pharmaceutical, except that CLA is contained as the active ingredient.
The form of the food composition includes, for example, solid such as powder, granule, tablet, and block; aqueous solution such as beverage and soup; and liquid such as emulsion, dispersion, and suspension; and these forms are prepared by using suitable excipients, diluents and other edible substances according to a conventional procedure.
Nutrient resources such as protein, fat and carbohydrate are included in the support used herein. The protein includes, for example, casein and salts thereof, gelatin and salts thereof, water-soluble gelatin (e.g. enzymatically h
Imada Takuma
Masaki Kyosuke
Noda Tsuneyuki
Shimizu Seiichi
Toba Masamichi
Evans Charesse
Finnegan Henderson Farabow Garrett & Dunner LLP
Otsuka Pharmaceutical Co. Ltd.
Page Thurman K.
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