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Title:  Herbal supplement for cognitive related impairment due to estrogen loss

United States Patent:  6,426,097

Inventors:  Grose; Tricia (Napa, CA)

Assignee:  Herbaceuticals Inc. (Napa, CA)

Appl. No.:  771034

Filed:  January 26, 2001

Abstract

Estrogen-deficiency related cognitive dysfunction may be improved by administering a composition comprising an herbal composition to a woman. In a preferred embodiment the herbal composition comprises whole plant extract of Leucojum aestivum.

DETAILED DESCRIPTION OF THE INVENTION

The present invention concerns novel herbal compositions, a method for their preparation, and a method of using the compositions for improving cognitive dysfunction in women having estrogen-deficiency. At least one of the active ingredients in the composition is most notably a cholinesterase inhibitor.

While the dietary supplement of the present invention may be used by women who wish to supplement their normal dietary regimen to improve their cognitive abilities, the herbal supplement of the invention is particularly beneficial for use by women who are estrogen-deficient and suffer from memory loss or other symptoms of neurodegeneration. The novel herbal supplement of the invention is suitable for use by women who may be undergoing hormone replacement therapy, however is also ideal for estrogen-deficient women for whom hormone replacement therapy is not recommended or not desirable.

The inventor has found that the combination of the whole plant extract of Leucojum aestivum, and one or more additional components, including the coenzyme Co--Q10, Vitamin B and other herbal extracts, works synergistically to promote improved cognitive performance. It is believed that at least one of the active ingredients in the whole plant extract, galanthamine, in its capacity as an acetylcholinesterase inhibitor, improves neural function by inhibiting acetylcholine hydrolyzation and maintains effective levels of acetylcholine in the neural synapse for longer periods of time.

The combination of active ingredients in the herbal composition of the invention secures stronger impulses in the nerves, which are typically found to be decreased or inhibited in estrogen-deficient conditions. Each of the constituents of the combined herbal preparation of the invention has an individual tendancy to enhance physical well being. However, the combination of Leucojum aestivum, coenzyme Co--Q10 plus vitamin Bs (including vitamin B12 and vitamin B complex) and other herbal extracts, especially ayurvedic and Spagyric herbal extracts, when administered in proper concentration, stimulate memory function.

Regular exercise, good nutrition and appropriate dietary supplementation can lead to an increase in the energy levels, improving muscle cell function, as well as leading to an extended growth and branching out of the capillary network, and optimization of the function of numerous enzyme systems. Applicant has found that dietary supplementation with the herbal composition of the invention can improve these systems, enhancing the ability to overcome muscle fatigue and ability to maintain activity for longer periods of time, particular repetitive motion. The combination of active ingredients in the herbal composition of the invention secures stronger impulses in the nerves, which are typically found to be decreased or inhibited in estrogen-deficient conditions, and when transmitted to the muscles, generate stronger muscle contractions. The ingredients may further stimulate the release of acetylcholine in the neuron endings and increase the sensitivity of the post-synapse membranes and allow for more sustained and effective physical movement, and significantly improve muscle coordination.

Although one of the active ingredients, galanthamine, found in the whole plant extract of Leucojum aestivum can be synthesized by known methods, Applicant has found that using the whole plant extract provides beneficial results. It is believed that the additional components contained within the plant cell wall, as well as the beneficial ingredients contained in the composition as described herein, provide an unexpected synergistic effect on improving memory function performance. An added advantage is that herbal-based compositions provide many other beneficial results to woman's health, including improved cardiac and vascular function. The benefits of the herbal composition of the invention are particularly advantageous for those individuals reluctant to use pharmaceuticals containing synthetic chemicals because of potential siee effects of long term use, or where no nonprescription remedy is available.

For purposes of the invention, a process for preparing the whole plant extract Leucojum aestivum is described as follows: the mucilage is removed from intact plants, the remaining plant material is pulverized or finely chopped in a blender, the pulverized plant material is steam distilled, incinerated and the ash is triple washed with water. The treated plant material is then combined with the washings and the mucilage to form the whole plant extract. The whole plant extract may be used unfiltered, or may be filtered through a Whatman filter. Alternatively the resulting whole plant extract may be dried to a powder by air drying at room temperature or accelerated drying at 37oC. The whole plant extract is preferably stored in a dark container at room temperature in a moisture-free environment until used.

Additional organic ingredients may be added to provide incidental benefits. The supplement may contain ingredients that improve oxygen metabolism, antioxidants, factors which directly or indirectly are related to radical scavengers and that improve cardiac function. These include flavonoids, which are widely distributed in the plant kingdom, and are present in plants such as Gingko biloba, Passiflora incarnata, Matricaria chamomilla and Tea sinensis. Flavonoids are used as anti-inflammatory agents, antihistamines and vasodilators and most importantly are used for their antioxidant activity. Preferred in the present invention is Gingko biloba extract enriched in flavone glycosides, which increase peripheral circulation and provide additional antioxidant properties to protect cell membranes from radical attack.

The composition may further include a combination of other naturally occurring substances to promote overall wellness and maintain balanced health. Such substances include enzymes such as coenzyme Q10 (CoQ10) chemically known as 2,3-dimethoxy-5-methyl-6-decaprenyl-1,4-benzoquinone, a fat soluble quinone, which is an essential component of the mitochondrial respiratory chain and may be important in producing energy for all the body's activities. Also included are hormones; growth factors; amino acids; trace elements, vitamins and minerals, including zinc, in amounts 100-500% or RDA; extracts of Chinese plants and herbs, Spagyric and ayurvedic herbs; and other nonessential nutrients. The composition can further include acetyl L-carnitine, a metabolic cofactor, which promotes neurological recovery from trauma. While any of these constituents taken alone would be insufficient to produce the desired result, in combination with the active ingredients found in the whole plant extract of Leucojum aestivum, such as galanthamine, they work synergistically to produce significant enhancement of cognitive abilities and motor function in estrogen deficient women. The constituents are not toxic in the amounts provided and have no known side-effects.

For the herbal preparation, the composition of the invention comprises the ingredients provided in Table 1

 

    TABLE 1
    Ingredient         Broad range (wt %) Preferred range (wt %)
    Leucojum aestivum      0.10-0.6            0.25-0.40
    Spagyric .RTM. Gota Kola      2.0-5.5             3.5-5.0
    Zinc                    0.5-3.5             1.0-2.5
    Vitamin B12       0.001-0.1          0.003-0.06
    Vitamin B complex      0.001-0.3           0.005-0.2
    Bacopa monniera        15.0-25.0           18.0-21.0
    Convolulus pluricaulis     15.0-25.0           18.0-21.0
    L-carnitine              20-60             35.0-45.0
    Co-Q10                  2.0-5.5             3.5-5.0
    Gingko biloba           8.0-12.0            9.5-11.5



The desired effect is best achieved with a dose comprising the following preferred concentrations:

2.5 mg (0.33 wt %) of the whole plant extract of Leucojum aestivum

30 mg (3.96 w %) Spagyric.RTM. Gota Kola

15 mg (1.98 wt %) Zinc

0.2 mg (0.026 wt %) Vitamin B12

0.1 mg (0.013 wt %) Vitamin B complex

150 mg (19.8 wt %) Bacopa monniera (ayurvedic)

150 mg (19.8 wt %) Convolulus pluricaulis (ayurvedic)

80 mg (10.56 wt %) Gingko biloba Extract (24% flavone glycosides/6% terpene lactones)

300 mg (39.6 wt %) Acetyl-L-carnitine

30 mg (3.96 wt %) Co--Q10.

The herbal extract of the invention may be administered orally. The optimal daily dose of active ingredient, i.e., Leuojum aestivum extract, is from about 2 to 5 mg.

The herbal extract of the invention may be administered for the purposes of the present invention in the form of capsules or caplets, although other conventional oral dosage forms such as tablets may also be used. In preparing capsules or tablets, standard tablet or capsule making techniques may be employed. In the case of the herbal composition of the invention, the preferred dosage from is a capsule. In this manner the free flowing powders of the herbal extracts and other components in the composition of the invention are readily absorbed into the body.

The invention can be better understood by reference to the following Example, which is provided by way of illustration and not by way of limitation.

The utilization of the herbal composition of the present invention is shown to be effective through testing for a year or more by administering the composition of the present invention to menopausal women exhibiting symptoms common to an estrogen deficiency condition.

    Women                Age Range 40-60 years
    Dosage               2.5-5.0 mg of Leucojum aestivum extract
    Length of Treatment  30 days to 18 months
    Estrogen deficiency  menopause, ovariectomy
    Menopausal Symptoms  memory, attention loss
    Effects              increase in memory
    Side Effects         none detrimental
                         increased energy and improved 
                           motor function.

The present invention is not to be limited in scope by the specific embodiments described herein. Indeed, various modifications of the invention in addition those described herein will become apparent to those skilled in the art from the foregoing description. Such modifications are intended to fall within the scope of the appended claims. Various patents, patent applications, and publications are cited herein, the disclosures of which are incorporated by reference in their entireties.

Claim 1 of 3 Claims

What is claimed is:

1. A daily dietary supplement for improving estrogen deficiency related neurodengenration and cognitive dysfunction in a woman, said supplement comprising an

effective amount of steam distilled Leucojum aestivum plant extract;

an effective amount of Co--Q10;

an effective amount of B vitamins;

an effective amount of non-essential amino acids;

an effective amount of antioxidants; Bacopa monniera; and, Convolulus pluricaulis.
 



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If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.

 

 

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