Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2000-12-01
2002-05-21
Lankford, Jr., Leon B. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S746000, C424S725000
Reexamination Certificate
active
06391344
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of promoting the synthesis of nerve growth factor, more particularly, a method capable of efficiently promoting the synthesis of nerve growth factor in the treatment of nerve-denaturing diseases such as Alzheimer-type dementia and brain ischemia pathologies.
DESCRIPTION OF THE PRIOR ART
Senile dementia has a tendency to increase with the shift to an aging society. This tendency has become an extremely large social problem. A number of diseases are known which are responsible for senile dementia. These are roughly divided into dementia attributable to an organic disorder of the brain, dementia incidental to a disease of other organs than the brain, and dementia attributable to a physical disease due to stress. In particular, the dementia attributable to an organic disorder of the brain, which constitutes the greater part of the causes of dementia, is divided into cerebrovascular dementia and Alzheimer-type dementia due to the differences of the causes.
Currently, it has been known that a drug such as a cerebrovascular dilator exhibits a certain effect on the cerebrovascular dementia. However, the causes of development of Alzheimer-type dementia are not known yet, and a pharmacotherapy and other treatingmethods suitable for preventing the development and progression of the dementia are not known yet. Accordingly, it is greatly desired to develop a drug useful for the treatment of dementia due to an organic disorder of the brain, in particular, Alzheimer-type dementia.
Recently, it has been found that a neurotrophic factor such as nerve growth factor (NGF) secreted from nerve cells has an excellent effect on nerve-denaturing diseases and special attention has been paid to the factor. NGF is a factor necessary and important to the growth and functional maintenance of the nervous tissue. NGF is essential for maturation, differentiation and survival of sensory and sympathetic nerves in the peripheral nervous system as well as for those of large cell cholinergic neurons in the central nervous system. Also, NGF exhibits an effect of preventing denaturing of nerve cells when undergoing a brain lesion. Accordingly, it is believed that an elevation of the NGF level in the living body is effective for treating a disorder of central functions (including Alzheimer-type dementia and cerebrovascular dementia), a lesion of peripheral nerves, a diabetic neuropathy and a disorder of peripheral functions (including amyotrophic lateral sclerosis).
However, NGF is a protein having a high molecular weight of about 13,000 in its monomer form and about 26,000 in its dimer form, and can not pass through the blood-brain barrier. Accordingly, it is necessary to administer NGF intraventricularly, for example, when the treatment of a disorder of central functions is aimed. In addition, it is difficult to prepare NGF in a large amount. Thus, it is very problematic to use NGF per se. Consequently, it is very difficult to use NGF per se clinically.
A method of administering a substance for promoting the synthesis of NGF in the living body, instead of NGF, is also known in the art. For example, Y. Furukawa et al. (FEBS Lett., Vol.208 (1986), p.258 et seq.) discloses that catecholamines (epinephrine, norepinephrine and dopamine) are used as the substance for promoting the synthesis of NGF.
However, they are hormone substances, and therefore, the administration of them causes a problem of losing a quantitative balance of hormones in the living body.
The present invention is addressed to the solution of the above problems. Thus, the object of the present invention is to provide a substance for promoting the synthesis of NGF which allows an effective synthesis of NGF in the living body without being accompanied by a side effect such as a loss of a quantitative balance of hormones in the living body. Another object of the present invention is to provide a method of promoting the synthesis of NGF in the living body.
SUMMARY OF THE INVENTION
The present inventors have intensively searched for a substance having a potent effect of promoting the synthesis of NGF. As a result, they found that rosemary and sage extracts have such an effect. Furthermore, they found that carnosic acid of the formula (I) below and carnosol of the formula (II) below, which are contained in the rosemary and sage extracts, also have the above effect.
Thus, the present invention provides a method of promoting the synthesis of nerve growth factor comprising administering an effective amount of at least one plant extract having an effect of promoting the synthesis of nerve growth factor selected from the group consisting of rosemary and sage extracts as an effective ingredient to a subject requiring such promotion.
In a preferred embodiment, the above rosemary and/or sage extracts are those obtained by extracting rosemary and/or sage with ethanol or a mixture of water and ethanol.
Also, the present invention provides a method of producing a plant extract having an effect of promoting the synthesis of nerve growth factor comprising the steps of:
soaking rosemary or sage in ethanol or an aqueous ethanol solution having an ethanol concentration of 80% (v/v) to 100% (v/v) to obtain a first extract;
adding water to the first extract so as to give an ethanol concentration of not greater than 40% (v/v), to deposit a precipitate having an effect of promoting the synthesis of nerve growth factor; and
separating the precipitate to obtain the desired plant extract.
Furthermore, the present invention provides a method of promoting the synthesis of nerve growth factor comprising administering an effective amount of at least one ingredient selected from the group consisting of carnosic acid of the above formula (I) and carnosol of the above formula (II) as an effective ingredient to a subject requiring such promotion.
DETAILED DESCRIPTION OF THE INVENTION
In the present invention, the rosemary and/or sage extracts as well as carnosic acid and/or carnosol are generally administered in the form of a preparation for promoting the synthesis of nerve growth factor.
The first preparation according to the present invention contains a rosemary extract or a sage extract. The rosemary and sage extracts used in the present invention are obtained from rosemary (Rosmarinus officinalis L.) and sage (Salvia officinalis L.). Rosemary and sage are plants having a high safety and are widely used for a long time in the West as a herb for medicinal, fragrant and cooking purposes. In the present invention, the rosemary and sage extracts may be used in admixture with each other.
The content of the rosemary and sage extracts contained in the first preparation as an effective ingredient is preferably about 0.0001% to 100% by weight, more preferably about 0.1% to 100% by weight, per 100% by weight of the first preparation. If the content of the extracts is less than 0.0001% by weight, the preparation can not produce an sufficient amount of NGF.
The rosemary or sage extract may be obtained in the following manner, for example. Firstly, the whole plant, leaves and/or petals of rosemary or sage are soaked in an extraction solvent, or refluxed with the extraction solvent. There is no limitation in the type of the extraction solvent used. Examples of the extraction solvent which may be used are organic solvents such as methanol, ethanol, propanol, butanol, propylene glycol, 1,3-butylene glycol, glycerin, acetone, methyl ethyl ketone, ethyl acetate, ethers, chloroform and dichloromethane as well as water. These solvents may be used alone or in combination with one another. In the present invention, it is preferable to use methanol, ethanol, ethyl acetate or a mixture of these solvents with water. More preferably, ethanol or a mixture of water and ethanol is used, in the light of the safety (low toxicity) in the living body.
Preferably, the rosemary and sage extracts are obtained in the following manner, respectively. Firstly, rosemary or sage are soaked in ethanol or an aqueous ethanol solution having an ethanol concentratio
Ito Hisatomi
Kosaka Kunio
Miyazaki Toshitsugu
Davis Ruth
Jacobson & Holman PLLC
Lankford , Jr. Leon B.
Nagase & Company, Ltd.
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