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Link:  Pharm/Biotech Resources


Title:  Anti-aging/menopause symptoms relief using ganoderma lucidum spores

United States Patent:  6,908,614

Issued:  June 21, 2005

Inventors:  Chung; Chee-Keung (Room 2018, Argyle Centre, 688 Nathan Road, Mongkok, Kowloon, HK); Tong; Siu Kan (Room 2018, Argyle Centre, 688 Nathan Road, Mongkok, Kowloon, HK)

Appl. No.:  224378

Filed:  August 21, 2002

Abstract

The present invention provides a method for preventing/slowing aging and/or reducing menopause symptoms in humans by orally administering an effective amount of germination-activated Ganoderma lucidum spores (GLSs) to humans. The treatment for menopause is especially effective in male patients. GLSs are effective as an antioxidant to reduce free radical damage, particularly by increasing the amount of the reduced form glutathione (GSH) and the superoxide dismutase (SOD) activity. GLSs can also increase testosterone level in blood and improve depression, particularly geriatric depression, in elderly male patients.

Description of the Invention

FIELD OF THE INVENTION

The present invention relates to a method for preventing/slowing an aging process and/or reducing/relieving menopause symptoms in humans by orally administering an effective amount of germination-activated Ganoderma lucidum spores ("GLSs") to humans. The anti-aging effect of GLSs is primarily derived from its being an antioxidant for free radical protection. GLSs also reduce and/or relieve symptoms associated with menopause, particularly male menopause, which are partially due to aging. Symptoms associated with male menopause include fatigue, anorexia, palpitation, forgetfulness, irritation, depression, and/or impotence.

BACKGROUND OF THE INVENTION

The free radical theory of aging was first proposed by Dr. Denham Harman in 1956. It is now recognized that living cells continuously produce free radicals during their normal functions such as producing energy. Free radicals also come from smoking, radiation, sunlight and other factors in the environment. Endogenous and exogenous free radicals are highly reactive substances, capable of reacting irreversibly with many biological molecules, producing random changes, and causing progressive deterioration of the biological system.

The cells have an antioxidant defense system which prevents most, but not all, of the free radical damages. Constant free radical damages can eventually kill the cells. When free radicals kill or damage enough cells in an organism, the organism ages.

The antioxidant defense system removes free radicals through the use of antioxidants. There is sufficient evidence to support the relationship between free radicals and aging. For example, the longer an animal lives, the more antioxidants it has in its body. Some antioxidants are produced by the body through endogenous enzymes, such as catalase, glutathione peroxidases (GPX) and superoxide dismutases (SOD). Others come from oral ingestion, such as vitamin C, vitamin E, β-carotene, selenium etc. It is believed that taking antioxidants to remove access free radicals in the body can slow down the aging process. Some studies show that antioxidants may help prevent heart disease, some cancers, cataracts, and other health problems that are more common as people get older.

One of the aging problems men face is the occurrence of male menopause. It has been estimated approximately 40% of men in their 40s, 50s, and 60s will experience some degree of male menopause. Also known as andropause, male menopause is of recent recognition with researches first published in 1970s.

Less overwhelming than the female menopause, male menopause is more gradual and some never experience it. Male menopause involves the hormonal, physiological and chemical changes that occur in men generally between the ages of 40 and 55. It is characterized with lethargy, depression, increased irritability, mood swings, decreased libido, erectile dysfunction and alteration in cognition. Although its causes have not been fully researched, factors such as hormone deficiencies, excessive alcohol consumption, smoking, hypertension, medications, poor diet, lack of exercise, poor circulation and psychological problems have been known to contribute to this condition.

It has been found the blood level of the male hormone testosterone decreases significantly even in healthy men by age 55, when comparing to what it is at age 45. In fact, by age 80, most male hormone levels have decreased to pre-puberty levels. Low testosterone has been associated with fatigue, depression, loss of concentration, and decreased muscle strength and endurance.

Depression is another common denominator of male menopause. According to the Epidemiologic Catchment Area Study in the 1991 NIH Consens Statement, depressive symptoms occur in approximately 15 percent of community residents over 65 years of age. Patients may suffer from depressed mood, loss of appetite, sleeplessness, anergia and loss of interest and enjoyment of the normal pursuits of life. Depression is often underdiagnosed and undertreated in the elderly, partially because the health care providers and/or the patients themselves often conclude that depression is a normal consequence of physical illnesses, as well as social and economic problems associated with the elderly. At this time, there is no one best agent that provides comprehensive relief for symptoms associated with male menopause, particularly for the elderly.

Ganoderma (Ganoderma lucidum Leyss ex Fr. Karst) is a polyporous fungus. It belongs to the class Basidiomycetes, the family Polypolaceae, and the genus Ganoderma. Since ancient times, ganoderma has been praised as a miracle fungus for its capability of prolonging human life. It is believed that the medicinal effects of ganoderma lie upon the natural or bioactive substances it produces which can stimulate or modulate the neuro-endocrino-immuno system of human body to fight off diseases. Ganoderma is also well known for its antitumor and immune enhancing properties, (Kim et al., Int. J. Mol. Med. (1999), 4(3):273-277), cardiovascular effects (Lee et al., Chem. Pharm. Bull. (1990), 38:1359-1364), as well as free radical scavenging and antihepatotoxic activities (Lin et al., J. Ethnopharmacol., (1995), 47(1):33-41).

Ganoderma is the most rare and valuable herb in Chinese medicine. It is known in China for over 5,000 years as "ling zhi". There are a variety of ganoderma, for instance, G. lucidum (red), G. applanatum (brown), G. tsugae (red), G. sinense (black), and G. oregonense (dark brown). However, due to the fact that wild types of ganoderma only grow naturally and very rarely on aged trees in steep mountains, research which requires a constant supply of high quantity and quality of ganoderma has rarely been conducted.

Although it is believed that the spores of ganoderma represent the essence of ganoderma because they contain all the bioactive substances of ganoderma , most of the ganoderma studies are conducted using the fruit body or mycelium of ganoderma as experimental materials. Ganoderma spores are rarely studied.

Ganoderma spores are tiny and mist-like spores of 58 μm in sizes which have extremely hard and resilient, double-layer epispores, thus making them difficult to break open. The ganoderma spores normally scatter at the pelius of mature ganoderma . When mature, the ganoderma spores are ejected from the pileus. Such ejected ganoderma spores are collectively called "spore powders". In the wild, the "spore powders" are difficult to collect because of the following reasons: (1) the germination rate (i.e., about 3-15%) of the spores is extremely low; (2) the ejection period is relatively short (i.e., approximately 10 days per lifecycle); and (3) some environmental factors, such as wind and rain, may also hinder the collection of the spores. In addition, the substances of the collected spores are difficult to extract due to the resiliency of the epispores.

In recent years, with the improvement of the spore breaking techniques, more research which directed to the studies of the ganoderma spores has been undertaken. However, the improvement of the spore breaking techniques does not overcome the shortcoming of the low germination rate of the spores. In fact, due to the low germination rate, most of the studies on ganoderma spores are conducted using the extraction of bioactive substances from spores representing an array of dormant to various germination stages. Because the spores at different stages of the lifecycle produce different kinds and/or proportions of bioactive substances, each batch of the mixture of the spores thus contains different active ingredients. The results from such studies are apparently meaningless since no proper controls can be provided.

A germination activation method is disclosed in the parent application of the present application, which was issued as U.S. Pat. No. 6,316,002 B1, which is herein incorporated by reference. The method provides successfully activation of the dormant ganoderma spores and increase the germination rate of the ganoderma spores to more than 95%.

In the invention to be presented below, a method for using the germination activated Ganoderma lucidum spores ("GLSs") as free radical scavenger (i.e., antioxidant) and anti-aging agent, particularly for reducing/relieving symptoms associated with male menopause, will be introduced. GLSs possess multiple biological activities and promotes general health. Particularly, its activities in removal of free radicals, promotion of hormonal production and antidepression render GLSs effective for treating conditions associated with old ages (i.e., anti-aging) and male menopause.

SUMMARY OF THE INVENTION

The present invention provides a method for preventing/slowing the aging process and/or reducing/relieving menopause-associated symptoms in humans. The method requires oral uptake of germination activated Ganoderma lucidum spores (GLSs).

One of the factors that affect the aging process is free radical damage. GLS is an antioxidant. GLSs, when orally given to humans in the amount of about 0.5 to 10 g per day, preferably about 1 to 5 g per day, demonstrate antioxidant effect which protects the body from free radical damage. For example, GLSs increase the amount of the reduced form of glutathione (GSH) and the activity of superoxide dismutase (SOD) in the human body.

Symptoms related to male menopause are fatigue, anorexia, palpitation, forgetfulness, irritation, depression, impotence, and any combination thereof. Male menopause is particularly significant in elderly male.

To reduce or relieve the symptoms of male menopause, about 0.5 to 10 g of GLSs, more favorably about 1 to 5 g of. GLSs, are given to the patient per day. GLSs increase the blood level of testosterone and superoxide dismutase (SOD) activity in patients. GLSs also decrease the blood level malondialdehyde (MDA) in patients. In addition, GLSs improve depression of patient, particularly the elderly.

DETAILED DESCRIPTION OF THE INVENTION

The tiny spore of Ganoderma lucidum has an extremely hard and resilient, double-layered epispore. In the wild, the germination of the spores of Ganoderma lucidum is relatively slow and their germination rate is extremely low. In fact, it takes about 24 to 48 hours for the germ tubes of the spores start to sprout under proper conditions, and the capillitia start to form branches after 72 hours, with a germination rate of only 3-15%.

Mature spores of Ganoderma lucidum were selected to undergo processing treatment. There are three distinctive stages for the spores processing treatment so as to effectively preserve the large amount of bioactive substances produced by the germination activated spores. The first stage involves the induction of germination, which is achieved by soaking the spores in a solution for a period of time, followed by cultivating the germination induced spores in a well-ventillated culture box. The second stage involves the production of sporoderm-broken (i.e., by breaking up the cell walls of epispores) spores, which is achieved by enzyme treatment and/or mechanical force. The final stage involves the extraction of bioactive substances from the sporoderm-broken spores, which is achieved by freeze-drying or vacuum drying followed by extraction with solvent or by thin film condensation.

Below are general descriptions of the steps which lead to the production of bioactive substances:

I. Soaking to induce germination: Mature and perfect spores of Ganoderma lucidum were carefully selected to undergo a soaking process to induce germination. Spores were kept in clear or distilled water, biological saline solution, or other nutritional solutions that could enable the spores of red Ganoderma lucidum to germinate rapidly. Examples of nutritional solutions include coconut juice or a 1-5% malt extract solution, 0.5-25% extracts of Ganoderma lucidum sporocarps or Ganoderma lucidum capillitia, 0.1-5% of culture solution containing biotin, 0.1-3% of culture solution containing potassium phosphate (monobasic) and magnesium sulfate. The choice of solution would depend on the soaking time required, the amount of spores to be processed and other such factors as availability of materials. One or more of the above germination solutions could be used, with the amount added being 0.1-5 times the weight of the spores of red Ganoderma lucidum. The soaking time was determined according to the temperature of the water, and usually the soaking was carried out for 30 min to 8 hours with the temperature of the water at 20-43 C. Preferably soaking times were 2-4 hours, and temperature of the water was 25-35 C.

II. Activation culture: The spores of Ganoderma lucidum were removed from the soaking solution and excess solution was eliminated by allowing it to drip. The spores were then placed in a well-ventilated culturing box at a constant temperature and humidity so that spore activation culture could be carried out. The relative humidity of the culture was generally set at 65-98%, the culture temperature at 18-48 C. and the activation time lasted from 30 min to 24 hours. Preferably humidity is 85-97% and temperature is 25-35 C. Using this method, the activation of spores of red Ganoderma lucidum reached a rate of more than 95%. During activation, the cell walls of the spores of red Ganoderma lucidum were clearly softened such that it was easier to penetrate the cell walls of the spores.

III. Treatment of the epispores: After the germination activation process, the spores were treated by enzymolysis. This process was carried out at a low temperature and under conditions such that enzyme activity was maintained, using chitinase, cellulase, or other enzymes, which are commonly used in the industry. The process was complete when the epispores lost their resilience and became brittle. Alternatively, physical treatments were carried out to penetrate the cell walls, for example, micronization, roll pressing, grinding, super high pressure microstream treatment, and other mechanical methods commonly used in the industry could be carried out, with a penetration rate of over 99%.

IV. Drying/Encapsulation: Drying was carried out at low temperature using standard methods including freeze-drying or vacuum-drying etc., which are commonly used in the industry. The obtained product had a moisture content less than 4%. The dried GLSs are in powder form and encapsulated. Each capsule contains 300 mg of dried GLSs.

The preferable dosage for oral GLSs uptake is about 2-4 capsules per time, 1-3 times per day.

Claim 1 of 12 Claims

1. A method for reducing risk of age-related disorders in a human comprising:

orally administering to said human an effective amount of sporoderm-broken germination activated Ganoderma lucidum spores (GLSs);

whereby said sporoderm-broken GLSs are prepared by soaking ganoderma spores in a solution which is selected from the group consisting of water, saline, and a nutritional solution to cause the spores to germinate;

placing said germination-treated ganoderma spores in a culture box at a relative humidity of 65-98% and temperature of 18-48 degree C. to cause the germinated ganoderma spores to activate; and

breaking sporoderm of said germination activated ganoderma spores to produce said sporoderm-broken GLSs.

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