AU2020100565A4 - A composition to boost and enhance immune system and application thereof - Google Patents

Abstract

The invention relates to a composition adapted for use in promoting the immune system of a person, and wherein the composition comprises amounts of extracts isolated from Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinfera, wherein the amounts of Terminaliaferdinandiana is between 10 mg to 40 mg by weight, the Undariapinnatifida is between 150 mg to 600 mg by weight, the Curcuma longa is between 38 mg to 150 mg by weight, and Vitis vinfera is between 26 mg to 105 mg by weight. -1/1 Ingredient Terminalia Ascorbic Undaria Glutamine Curcuma Zinc amino Vitis vinifera ferdinandiana acid 30 pinnatifida 100 mg longa 76.92 acid chelate 52.63 mg 20 mng mg 300 mg mng 20 mg Plant part Fruit flesh N/A Whole plant N/A rhizome N/A Grape Vine Plant powder N/A Extract dry N/A Extract dry N/A Seed Extract preparation concentrate concentrate dry concentrate standardised standardised standardised Ratio (12:1) (20: 1) (120:1) Equivalent Dry 20 mg Dry 30 Dry 3.6 g Dry 100 Dry 1.5384 g Dry 4 mg Vitis vinifera preparation mg mg 6315.6 mg Plant 0 0 1 0 1 0 2 preparation steps Solvents for N/A N/A Purified N/A Purified N/A 1. Ethanol 70% extraction water 100% water 4% Water 30%; Ethanol 96% 2. Ethyl acetate 100% Equivalents Terminalia Ascorbic Fucoidan Glutamine Curcumin Zinc 4 mg Procyanidins ferdinandiana acid 30 (of Undaria 100 mg standardised (of Vitis 20 mg mg pinnatifida) 50 mg vinifera) standardised 49.9985 mg 150 mg

Description

TECHNICAL FIELD [0001] The present invention relates to a composition adapted for use in promoting the immune system of a person. The present invention may include an application derived from the composition.

BACKGROUND [0002] Humans have long been facing influenza threats, from the Spanish, Asian and Hongkong influenza Pandemic in twenty century, the extremely pathogenic avian influenza (H5N1) associated with high death cases in Hong Kong in 1997, the influenza pandemic in June 2009, until most recently COVID-19 worldwide Pandemic in 2019. The emergence of new influenza viruses and human epidemics has been recognized as a serious global health problem.

[0003] The reported statistic data shows that influenza associated deaths increased rapidly in the elderly population. Although as a preventive measure, vaccination effectively lessened symptoms and reduces the death rate from influenza, antibody production is known to be lower in the elderly than in young people and lower in the people who has pre-existing illness. A reduction in immune response to infections has been demonstrated by older people's response to vaccines. For example, studies of influenza vaccines have shown that for people over age 65, the vaccine is less effective compared to healthy children that over 2-year-old.

[0004] The results of many studies have shown that compared with younger people, the elderly is more likely to contract infectious diseases and, even more importantly, more likely to die from them. Respiratory infections, influenza, the COVID-19 virus and particularly pneumonia are a leading cause of death in people over 65 worldwide.

[0005] A strategy to enhance immunity is needed for influenza prevention in the people whose immune response capability becomes reduced. There appears to be a connection between nutrition and immunity in the human body. A form of malnutrition that is surprisingly common even in affluent countries is known as micronutrient malnutrition. Micronutrient malnutrition, in which a person is deficient in some essential vitamins and trace minerals that are obtained from or supplemented by diet, can happen in some people, especially in the elderly. Older people tend to eat less and often have less variety in their diets. Therefore, many compositions

2020100565 15 Apr 2020

-3relating to enhancing immune capability have been developed. However, these compositions may have several major disadvantages.

[0006] One of the major disadvantages of the previous compositions may be insufficient effects of the ingredients on immune response capability. This invention may provide for a dietary supplement for oral consumption which may help people with micronutrient malnutrition maintain a healthier immune system, when taken.

SUMMARY [0007] PROBLEMS TO BE SOLVED [0008] It may be advantageous to provide a composition that is for use to enhance immune systems.

[0009] It may be an advantage to provide efficient antiviral, anti-inflammatory, anti-angiogenic, anticoagulant and antitumor effects on immune system.

[0010] It may be an advantage to provide a variation in the composition of the individual ingredients for varying the dosage of the desirable therapeutic properties to a person suitable to maintain a healthy immune system.

[0011] It may be an advantage to provide a composition with variable properties for use on persons with different or varying degrees of immune strength or capability.

[0012] It may be an advantage to provide a composition with active ingredients targeting at least one from the following issues: oxidative stress-related damage, reduced antibody production, free radical damage, inflammation-related disturbances, susceptibility of lowdensity lipoprotein (LDL) to lipid Peroxidation, cell proliferation and platelet aggregation.

[0013] It may be an advantage to provide a composition provided in an enteric coated tablet, dragee, or capsule so as to protect the stomach, provide a targeted release of the supplement, and/or provide a controlled rate of supplement release, when the supplement is ingested.

[0014] It is an object of the present invention to overcome or ameliorate at least one of the disadvantages of the prior art, or to provide a useful alternative.

[0015] MEANS FOR SOLVING THE PROBLEM

-42020100565 15 Apr 2020 [0016] The present invention provides a natural food supplement for boosting and enhancing the immune system. The food supplement having plant compositions for its ingredient, the composition comprising amounts of extracts isolated from Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera. wherein the amounts of Terminalia ferdinandiana is between 10 mg to 40 mg by weight, the Undaria pinnatifida is between 150 mg to 600 mg by weight, the Curcuma longa is between 38 mg to 150 mg by weight, and Vitis vinifera is between 26 mg to 105 mg by weight.

[0017] Preferably, the amount of Terminalia ferdinandiana is 20 mg by weight.

[0018] Preferably, the amount of Undaria pinnatifida is 300 mg by weight.

[0019] Preferably, the amount of Curcuma longa is 76.92 mg by weight.

[0020] Preferably, the amount of Vitis vinifera is 52.63 mg by weight.

[0021] Preferably, the equivalent dry amount of Terminalia ferdinandiana is 20 mg by dry weight.

[0022] Preferably, the equivalent dry amount of Undariapinnatifida is 3.6 g by dry weight.

[0023] Preferably, the equivalent dry amount of Curcuma longa is 1.5384 g by dry weight.

[0024] Preferably, the composition is provided in an enteric coated tablet, dragee, or capsule.

[0025] Preferably, the composition is provided in powdered supplement.

[0026] In the context of the present invention, the words comprise, comprising and the like are to be construed in their inclusive, as opposed to their exclusive, sense, that is in the sense of including, but not limited to.

[0027] The invention is to be interpreted with reference to the at least one of the technical problems described or affiliated with the background art. The present aims to solve or ameliorate at least one of the technical problems and this may result in one or more advantageous effects as defined by this specification and described in detail with reference to the preferred embodiments of the present invention.

DRAWINGS

-52020100565 15 Apr 2020 [0028] The embodiments of the present invention will be explained in more detail with reference to accompanying figures:

FIG. 1 is the illustration of the composition in accordance with a preferred embodiment of the present invention.

DESCRIPTION OF THE INVENTION [0029] Preferred embodiments of the invention will now be described with reference to the non-limiting examples.

[0030] The invention relates to a composition comprising herbal ingredients which is used for boosting and enhancing immune system. It shall be apparent however to one skilled in the art that the exemplifications are provided to better elucidate the invention and therefore should not be construed as limiting the scope of protection. Please refer to FIG. 1 for illustration of the composition in accordance with a preferred embodiment of the present invention.

[0031] The combination of the ingredients may consist of Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera.

[0032] The ingredients used may have a synergistic effect in combination, wherein the combination of the ingredients is greater than the effect of each individual ingredient in isolation.

[0033] The causes of low immune response capability may be from a combination of at least one of the following issues: oxidative stress-related damage, reduced antibody production, free radical damage, inflammation-related disturbances, susceptibility of low-density lipoprotein (LDL) to lipid Peroxidation, cell proliferation and platelet aggregation.

[0034] The ingredients in the composition that may target oxidative stress-related damage, reduced antibody production and inflammation-related disturbances are Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera. The ingredients in Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera may act as a natural agent in the composition, and each of the extracts may provide antioxidant and anti-62020100565 15 Apr 2020 inflammation effects and increase antibody production. The process of oxidation in the human body damages cell membranes and other structures.

[0035] Terminalia ferdinandiana, also called the gubinge, billygoat plum, Kakadu plum, green plum, salty plum, murunga or mador, is a flowering plant in the family Combretaceae, native to Australia, widespread throughout the tropical woodlands from northwestern Australia to eastern Arnhem Land. It has a high concentration of vitamin C in its fruit. Terminalia ferdinandiana is an extremely good source of antioxidants, which has been reported to have ascorbic acid levels per gram of fruit more than 900 times higher than blueberries, which also has high levels of a variety of other antioxidants, including phenolic compounds and anthocyanins. Antioxidants have been associated with the prevention of cancer, cardiovascular diseases, and neurological degenerative disorders. They are also linked with antidiabetic bioactivities and have been associated with the reduction of obesity. Antioxidants can directly scavenge free radicals, protecting cells against oxidative stress-related damage to proteins, lipids, and nucleic acids.

[0036] Ingredients present in the composition that may promote antiviral, anti-inflammatory, anti-angiogenic, anticoagulant and antitumor effects are Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera.

[0037] Undaria pinnatifida is a species of edible seaweed, a type of marine algae, and a sea vegetable. Mekabu fucoidan, a Sulphated polysaccharide extracted from seaweed, was previously shown to have an immunomodulatory effect and known as an agent that enhances immune function such as antiviral, anti-inflammatory, anti-angiogenic, anticoagulant and antitumor effects. Oral administration of Mekabu Fucoidan in animal studies have shown increased antibody production in the blood and mucosa and inhibited viral growth. Increasing antibody production is important for preventing infections and serious conditions such as pneumonia for elderly persons as well as immunocompromised persons. Mekabu Fucoidan also enhance immune function by involving natural killer cell activation and increased production. The formulation of Undariapinnatifida are designed to induce high concentrations of antibodies in response to small amounts of antigens, in preparation for when vaccines are needed for a new worldwide influenza pandemic.

2020100565 15 Apr 2020

-7[0038] Ingredient present in the composition that may inhibit cell proliferation, lower cholesterol level, inhibit palate aggregation are Curcuma longa and Vitis vinifera. Curcuma longa, also known as turmeric, of ginger family (Zingiberaceae) belongs to the group of oldest cultivated spice plants in the south-east Asian countries. For many years rhizome of this plant has been used also as a safe and active drug for the treatment of various chronic diseases, especially of diabetes mellitus (DM). The active substance of turmeric - curcumin (diferuloylmethane), possesses multiple therapeutic properties. In recent years, many studies along with clinical trials have revealed its very valuable biological activities related to its antiinflammatory, antioxidant and cancer preventive properties.

[0039] Turmeric is used extensively in foods for both its flavour and colour, as well as having a long tradition of use in the Chinese and Ayurvedic systems of medicine, particularly as an anti-inflammatory and for the treatment of flatulence, jaundice, menstrual difficulties, hematuria, hemorrhage, and colic. The active constituents of turmeric are the flavonoid curcumin (diferuloylmethane) and various volatile oils, including tumerone, atlantone, and zingiberone. The best-researched active constituent is curcumin, which comprises 0.3-5.4 percent of raw turmeric. The water- and fat-soluble extracts of turmeric and its curcumin component exhibit stronger antioxidant activity than vitamins C and E. Turmeric has a hepatoprotective characteristic similar to silymarin. Animal studies have demonstrated turmeric’s hepatoprotective effects from a variety of hepatotoxic insults, including carbon tetrachloride (CCI4), galactosamine, acetaminophen (paracetamol), and Aspergillus aflatoxin. Turmeric’s hepatoprotective effect is mainly a result of its antioxidant properties, and its ability to decrease the formation of pro inflammatory cytokines.

[0040] Curcumin is a potent anti-inflammatory with specific lipoxygenase- and COX-2inhibiting properties. Animal studies demonstrate turmeric’s effectiveness at decreasing both acute and chronic inflammation. The volatile oils and curcumin of Curcuma longa exhibit potent anti-inflammatory effects. Oral administration of curcumin in instances of acute inflammation was found to be as effective as cortisone or phenylbutazone, and one-half as effective in cases of chronic inflammation. Curcumin has ability to inhibit carcinogenesis at three stages: tumour promotion, angiogenesis, and tumour growth. Turmeric and curcumin are also found suppressing the activity of several common mutagens and carcinogens in a variety of cell types in both in vitro and in vivo studies. The anticarcinogenic effects of turmeric and

-82020100565 15 Apr 2020 curcumin are due to direct antioxidant and free-radical scavenging effects, and their ability to indirectly increase glutathione levels, thereby aiding in hepatic detoxification of mutagens and carcinogens, and inhibiting nitrosamine formation.

[0041] Turmeric extract and the essential oil of Curcuma longa have been found to inhibit the growth of a variety of bacteria, parasites, and pathogenic fungi. Diets supplemented with 1percent turmeric resulted in a reduction in small intestinal lesion scores and improved weight gain. Constituents of Curcuma longa exert several protective effects on the gastrointestinal tract. Sodium curcuminate inhibited intestinal spasm and p-tolymethylcarbinol, a turmeric component, increased gastrin, secretin, bicarbonate, and pancreatic enzyme secretion. Turmeric has also been shown to inhibit ulcer formation caused by stress, alcohol, indomethacin, pyloric ligation, and reserpine, significantly increasing gastric wall mucus in rats. Turmeric’s protective effects on the cardiovascular system include lowering cholesterol and triglyceride levels, decreasing susceptibility of low-density lipoprotein (LDL) to lipid peroxidation, and inhibiting platelet aggregation. These effects have been noted even with low doses of turmeric. Turmeric extract’s effect on cholesterol levels may be due to decreased cholesterol uptake in the intestines and increased conversion of cholesterol to bile acids in the liver. Inhibition of platelet aggregation is considered to be via potentiation of prostacyclin synthesis and inhibition of thromboxane synthesis.

[0042] Vitis vinifera, the common grape vine, is a species of Vitis. Grape seed extract is produced from the seeds of Vitis vinifera, which is one of the ingredients of herbal medicinal product for treatment of chronic venous insufficiency, characterised by swollen legs, varicose veins, a feeling of heaviness, pain, tiredness, itching, tension and cramps in the calves; traditional herbal medicinal product to relieve symptoms of discomfort and heaviness of legs related to minor venous circulatory disturbances; traditional herbal medicinal product for symptomatic relief of itching and burning associated with haemorrhoids; is traditional herbal medicinal product for symptomatic treatment of cutaneous capillary fragility.

[0043] Oligomeric Proanthocyanidins, found high concentration in grape vine, in nutritional supplements generally extracted from grape seeds, demonstrate anticarcinogenic, antiinflammatory, antimicrobial and vasodilatory properties, also demonstrate potent, concentration-dependent free radical scavenging ability. Oligomeric Proanthocyanidins are proved to have effect of reducing copper and iron’s oxidative effects by binding of copper and

-92020100565 15 Apr 2020 iron liberated from myocardial tissue. Clinical studies showed significantly increased levels of alpha-tocopherol in red cell membranes.

[0044] Grape seed phenolic compounds inhibit enzymatic systems involved in the production of free radicals and associated to inflammatory responses. Furthermore, procyanidins inhibit the activation the hyaluronidase enzyme, which degrades proteoglycans and affects a number of tissues during inflammation. Proanthocyanidins have anti-inflammatory effects on experimental inflammation. Such an anti-inflammatory action was due to their free radical scavenging activity and inhibitory activity on lipid peroxidation and formation of inflammatory cytokines.

[0045] During inflammation-associated activation of leukocytes, intracellular degranulation occurs, due to the secretion of lysosomal proteases and a number of active oxygen species. Abnormally large amounts of proteases and active oxygen species, damage elastic fibers and endothelial cell membranes, respectively. The studies showed that the powerful actions of proanthocyanidins as free radical scavengers and lipid peroxidation inhibitors are the main factors underlying their vasoprotective effects and strengthen their anti-protease properties. Proanthocyanidins have been shown to inhibit proteolytic enzymes such as collagenase, elastase, hyaluronidase and β-glucuronidase, all of them involved in the degradation of collagen, elastin and hyaluronic acid, the main structural components in the extra-vascular matrix. Proanthocyanidins scavenging activity also contributes to preserve the integrity of the vascular endothelium. Proanthocyanidins are especially recommended for blood-circulation insufficiency or related conditions, where endothelial walls are at risk of tearing. The vasoprotective actions of proanthocyanidins are partly due to their activity on the intima layer: They attach to glycosaminoglycans thus stabilizing collagen fibers and consequently reducing capillary permeability. Such a vasoprotective activity was tested and verified in clinical studies using capillary dynamometry with neuropathy patients, as well as in experimental studies involving intra-dermal injections of histamine, bradykinin and collagenase with several experimental models. Oligomeric Proanthocyanidins demonstrate natural antimutagenic properties when exposed to certain strains of bacteria. Oligomeric Proanthocyanidins supplementation resulted in decreased lipid peroxidation, increased plasma antioxidant levels, and improved resistance of LDL to oxidation.

-102020100565 15 Apr 2020 [0046] The induction of vascular endothelial growth factor (VEGF) is a crucial step in the reepithelialisation phase of skin repair. Extracts of grape seed proanthocyanidins appear to stimulate the expression of VEGF in cultured keratinocytes. Oligomeric Proanthocyanidins may have potential in the treatment of insulin resistance. A short-term study in rats revealed grape seed extract decreased circulating insulin levels and systolic blood pressure. Animal studies show that Oligomeric Proanthocyanidins administration is beneficial in preventing hepatic and renal toxicity in instances of acetaminophen and other drug poisonings. This protection may be attribute to the detoxification of cytotoxic free radicals or the facilitation of DNA repair.

[0047] The grape seed extract significantly induced the transcription of interferon-gamma (INF-γ) mRNA. INF-γ is a cytokine produced by Thl leukocytes, which also produce IL-2 and stimulate cell-mediated immunity (unspecific immune system). Grape seed extract had no effect on IL- 6, a cytokine derived from Th2 leukocytes, which also regulate the activity of the Specific Immune System. The functions of cytokines are to eliminate rests of dead cells or other substances foreign to the organism, so that cell regeneration factors can exert their functions; and to activate cell regeneration factors. Such an immunostimulatory effects, makes grape seed extract recommendable for acne-treatments, as it stimulates the elimination of dead cells and microorganisms and its cell-regeneration effects are beneficial for acne as well as for sensitive/irritated skin. Furthermore, grape seed extract is beneficial for aged skin as age is known to slow-down immune activation, which results in slower cell regeneration.

[0048] The ingredient Curcuma longa may function as an antibacterial and/or an antimycotic agent in the composition. Curcuma longa may assist in preserving the composition from bacteria, fungi and yeast. The presence of Curcuma longa after the composition has been applied, may protect body from harmful bacteria or fungi. By inhibiting a broad spectrum of harmful bacteria and fungi in the body, Curcuma longa may assist in promoting general health.

[0049] The composition provided is in an enteric coated tablet, dragee, or capsule so as to protect the stomach, provide a targeted release of the supplement, and/or provide a controlled rate of supplement release, when the supplement is ingested. The composition may be provided in powdered supplement with an enteric coating, which may be polymer barrier applied on oral medication that may prevent its dissolution or disintegration in the gastric environment. This coating may assist in protecting the composition and/or the active ingredients from the acidity

-112020100565 15 Apr 2020 of the stomach, as well as protecting the stomach from the detrimental effects of large localised doses of the drug in the area. It may be appreciated that some of the active compounds may be unstable at the pH of gastric acid, and may be needed to be protected from degradation. By preventing the drug from dissolving into the stomach, enteric coatings may protect the gastric mucosa from the irritating effects of the medication itself. When the composition reaches the neutral or alkaline environment of the intestine, its active ingredients can then dissolve and become available for absorption into the bloodstream. Materials used for enteric coatings may include at least one from the group selected from: fatty acids, waxes, shellac, plastics, and plant fibers. The composition of the enteric coating may comprise of methyl acrylate-methacrylic acid copolymers, cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methyl cellulose phthalate, hydroxypropyl methyl cellulose acetate succinate, polyvinyl acetate phthalate, methyl methacrylate-methacrylic acid copolymers, shellac, cellulose acetate trimellitate, sodium alginate, zein, ethylcellulose, triglycerides, oleic acid, sodium alginate, stearic acid.

[0050] The first preferred embodiment of the present invention may be also applied to the use of the composition for the preparation of a medicament for the treatment of dry skin.

[0051] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms, in keeping with the broad principles and the spirit of the invention described herein.

[0052] The present invention and the described preferred embodiments specifically include at least one feature that is industrial applicable.

Claims (5)

1. THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:

   1. A composition adapted for use in promoting the immune system of a person, and wherein the composition comprises amounts of extracts isolated from Terminalia ferdinandiana, Undaria pinnatifida, Curcuma longa and Vitis vinifera, wherein the amounts of Terminalia ferdinandiana is between 10 mg to 40 mg by weight, the Undaria pinnatifida is between 150 mg to 600 mg by weight, the Curcuma longa is between 38 mg to 150 mg by weight, and Vitis vinifera is between 26 mg to 105 mg by weight.
2. 2. The composition as claimed in claim 1, wherein the amount of Terminalia ferdinandiana is 20 mg by weight, the Undaria pinnatifida is 300 mg by weight, the Curcuma longa is 76.92 mg by weight, and Vitis vinifera is 52.63 mg by weight.
3. 3. The composition as claimed in claim 1, wherein the composition includes an equivalent dry amount of Terminalia ferdinandiana is 20 mg by dry weight, the Undaria pinnatifida is 3.6 g by dry weight, and the Curcuma longa is 1.5384 g by dry weight.
4. 4. The composition as claimed in any one of Claims 1 to 3, wherein the composition is provided in an enteric coated tablet, dragee, or capsule.
5. 5. The composition as claimed in any one of claims 1 to 4, wherein the composition is provided in powdered supplement.