Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2002-01-17
2003-07-22
Carr, Deborah D. (Department: 1621)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S560000, C554S224000, C426S648000
Reexamination Certificate
active
06596766
ABSTRACT:
This application is a 371 of PCT/P00/01355 filed Mar. 6, 2000.
TECHNICAL FIELD
The present invention relates to the use of material containing 4, 7, 10, 13, 16-docosapentaenoic acid (hereinafter, also referred to as “DPA”) for relieving arachidonic acid deficient conditions and maintaining a good fatty acid balance in vivo and especially relates to the use of material containing 4, 7, 10, 13, 16-docosapentaenoic acid to prevent the decrease of arachidonic acid levels caused by intake of &ohgr;3 unsaturated fatty acids.
BACKGROUND ART
The two representative families of unsaturated fatty acids are the &ohgr;3 type and &ohgr;6 type. Here, (indicates the number of carbon atoms in a fatty acid, counting from the methyl end to the closest double bond. Recently, the ratio of &ohgr;6 unsaturated fatty acids to &ohgr;3 type fatty acids has been recognized as important.
Various fatty acids including &ohgr;6 type fatty acids, such as linoleic acid, dihomo-&ggr;-linolenic acid, and arachidonic acid, and &ohgr;3 type fatty acids, such as &agr;-linolenic acid, eicosapentaenoic acid, and docosahexaenoic acid, are each known to take on different biological functions. At the same time, and importantly, these two types of unsaturated fatty acids strongly influence each other in their biological functions. In humans, these unsaturated fatty acids cannot be biologically synthesized in vivo, and both types do not inter-convert. Thus, the ratio of &ohgr;3 type to &ohgr;6 unsaturated fatty acids in vivo is expected to reflect the ratio in the source of intake (e.g. food).
Meanwhile, based on a nutrition investigation among the Japanese, the recommended intake ratio of &ohgr;6 unsaturated fatty acids to &ohgr;3 unsaturated fatty acids was approximately 4:1, according to the revised 1994 dietary allowance for the Japanese. (Ministry of Health & Welfare, 5th revised edition, Nihonjin no Eiyo no Shoyoryo (Dietary Allowance for the Japanese), 1994, pp. 56-58.)
In addition, the recent eating habits of the Japanese have been influenced by the diet of Western countries, leading to a marked increase in opportunities to have meals centered on meat, and increase in the intake of &ohgr;6 unsaturated fatty acids in comparison to the &ohgr;3 type. Consequently, the mortality rate due to arteriosclerosis diseases, such as myocardial infarction and cerebral thrombosis is rapidly increasing. To improve this condition, addition of highly concentrated &ohgr;3 unsaturated fatty acids, such as 5, 8, 11, 14, 17-eicosapentaenoic acid (hereinafter, also referred to as “EPA”) and 4, 7, 10, 13, 16, 19-docosahexaenoic acid (hereinafter, also referred to as “DHA”) to nutrient-supplementing food has been developed.
Eicosanoids (prostaglandin, leukotriene, thromboxane, etc.), each exhibiting different physiological functions, are biosynthesized from EPA in the case of &ohgr;3 unsaturated fatty acids, and from dihomo-&ggr;-linolenic acid and arachidonic acid in the case of &ohgr;6 unsaturated fatty acids. Furthermore, &ohgr;3 type and &ohgr;6 unsaturated fatty acids themselves suppress the fatty acid biosynthetic pathway of another type. For example, EPA intake inhibits the &Dgr;6-desaturase controlling the conversion of linoleic acid, the starting fatty acid in the biosynthesis of &ohgr;6 type fatty acids, to &ggr;-linolenic acid, the chain elongation enzyme controlling the conversion of &ggr;-linolenic acid to dihomo-&ggr;-linolenic acid, and the &Dgr;5-desaturase controlling conversion of dihomo-&ggr;-linolenic acid to arachidonic acid. Consequently, the amount of the final product, arachidonic acid (hereinafter, also referred to as “ARA”), significantly decreases. Intake of ARA-precursor fatty acids (such as, linoleic acid, and &ggr;-linolenic acid) is only slightly effective for supplementing this ARA decrease, and direct intake of ARA was said to be necessary.
Furthermore, in recent years, elucidation of the biologically active functions of DHA and its practical use have progressed due to discovery of fish material that contains high concentrations of DHA, such as the orbital fat of tuna, and technological advancement in producing highly purified fatty acids. It has become apparent that the effect of lowering cholesterol levels, anticoagulant effect, and carcinostatic effect are biologically active functions of DHA. In relation to the metabolic system of the brain, it has also become apparent that DHA is effective in improving memory and learning, preventing senile dementia, and treating Alzheimer's disease. In addition, it has been proven that DHA is an essential fatty acid for the growth of fry. From the above-mentioned reasons, DHA is used in various foods, feedstuffs, and baits. DHA also inhibits the biosynthetic pathway involving &ohgr;6 unsaturated fatty acids, leading to ARA, and this inhibition is known to be stronger than that by EPA. Thus, decline in ARA levels as a secondary effect due to administration of DHA alone is considered a problem.
Administration of DHA alone is hardly a problem if &ohgr;3 unsaturated fatty acids are administered only for a limited period to a particular patient as a medicament, or if administration of DHA supplements lowered levels or complete deficiency of &ohgr;3 unsaturated fatty acids. However, the balance between &ohgr;6 and &ohgr;3 type fatty acids must be considered when &ohgr;3 unsaturated fatty acids are taken to prevent diseases. In the past, direct intake of ARA was necessary to repress the decrease of ARA levels due to intake of &ohgr;3 unsaturated fatty acids. However, controlling the amount of ARA intake is difficult because ARA is the direct precursor of eicosanoids, such as 2-series prostaglandin and 4-series leukotriene.
ARA deficient conditions are not limited to those caused by &ohgr;3 unsaturated fatty acid intake. For example, among infants, the aged, patients with adult diseases, and those at risk of adult diseases such as hepatic diseases, the biosynthetic pathway to produce ARA from linoleic acid is weak, and plainly, ARA In vivo tends to be deficient. Under diseased conditions, prostaglandin and its precursor, ARA, are in high demand for central defense and repair mechanisms in vivo. Therefore, ill patients suffer from deficiency of ARA that may contribute to recovery and survival. Regardless of age, inadequate nutrition leads to ARA deficient conditions. Furthermore, ARA is often deficient in individuals whose fat intake is restricted (for example, due to hyperlipidemia, diabetes, obesity, and so on).
Consequently, techniques to improve ARA deficient conditions and to maintain a good fatty acid balance in vivo, and especially techniques that provide safer alternatives to direct intake of ARA in efforts to prevent decrease of ARA levels caused by intake of &ohgr;3 unsaturated fatty acids were in high demand.
DISCLOSURE OF THE INVENTION
The present invention intends to solve the problems mentioned above and provides a novel technique to improve arachidonic acid deficient conditions and to maintain a good fatty acid balance in vivo, and especially, a novel technique to prevent decrease of arachidonic acid levels caused by intake of &ohgr;3 unsaturated fatty acids.
Upon intensive research to accomplish the objectives described above, the present inventors found that &ohgr;6 type docosapentaenoic acid (4, 7, 10, 13, 16-docosapentaenoic acid, hereinafter, also referred to as “DPA”) is converted to arachidonic acid (ARA) in vivo under ARA deficient conditions, and especially under ARA deficient conditions caused by intake of &ohgr;3 unsaturated fatty acids. The inventors also found that the resulting increase in ARA levels can affect the fatty acid balance in vivo leading to maintenance of a good fatty acid balance. The present invention was completed based on these findings.
In one embodiment, the present invention provides a use of a DPA containing material for relieving ARA deficient conditions and maintaining a good fatty acid balance in vivo. In another embodiment, the present invention provides a composition for relieving ARA deficient conditions and maint
Akimoto Kengo
Igarashi Osamu
Kiso Yoshinobu
Yaguchi Toshiaki
Carr Deborah D.
Fay Sharpe Fagan Minnich & McKee LLP
Suntory Limited
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