Drug composition, preparation method, and application for improving the quality of life of the elderly based on vitamin K2

Abstract

The present invention provides a pharmaceutical composition for improving the quality of life of the elderly based on vitamin K2, the pharmaceutical composition being composed of composition I and composition II, with a mass part ratio of (0.5-7):1. The present invention also provides a method for preparing the pharmaceutical composition and its application. This pharmaceutical combination has the main effects of anti-cancer and anti-Alzheimer's, and at the same time has the effects of bone strength, osteoporosis improvement, anti-aging, antioxidant, memory and cognition improvement, lipid reduction, liver protection, etc., which can effectively improve the quality of life of the elderly and provide healthy support and protection. The pharmaceutical composition of the present invention has stable activity of each component and high bioavailability, which overcomes the technical defects of current products for the elderly, which have a single function, low absorption and utilization effect, strong gastrointestinal irritation, strong side effects, and poor palatability, and does not have any toxic side effects when taken for a long time.

Description

Technical Field

[0001] The present invention belongs to the technical fields of drugs, healthcare products and foods, and particularly relates to a drug composition for improving the quality of life of the elderly based on vitamin K2, a preparation method thereof and an application thereof.

Background Art

[0002] According to the latest research data, the main age group of cancer occurrence is middle-aged and elderly people aged 45 and above. This is because as people age, the overall functions of the elderly gradually decline, the immune function gradually decreases, and the immune surveillance function and the function of eliminating mutant cells in the body weaken, making them more susceptible to external carcinogenic factors. Furthermore, the formation of cancer is often the result of long-term chronic stimulation or long-term exposure to carcinogenic substances, and the general incubation period is 10 - 30 years. Therefore, when young people are affected by certain carcinogenic substances, cells gradually undergo abnormal changes and develop into diseases after reaching old age, forming a peak of cancer incidence in the elderly.

[0003] According to the World Health Organization (WHO), one-third of cancers can be completely prevented, one-third can be eradicated by early detection, and one-third can be used to prolong life, relieve pain and improve the quality of life by existing medical measures. Therefore, it is the most ideal preventive state to detect and intervene at the time when precancerous lesions exist and prevent the precancerous lesions from developing into cancer. Dementia, also known as Alzheimer's disease, often shows symptoms such as a decrease in reaction speed, a decrease in memory, and a reversal of speech. This type of disease belongs to the category of nervous system diseases and is a type of chronic disease, mainly occurring in middle-aged and elderly people, with most patients being over 60 years old. According to clinical investigations, the number of Alzheimer's disease patients in China has reached 10 million and is still increasing.

[0004] Because Alzheimer's disease manifests in its early stages with symptoms such as memory loss and mental ecstasy, some people tend to ignore this type of illness, attributing it to lack of sleep or other bad habits, and thus miss the golden age for treatment. Furthermore, since Alzheimer's disease is irreversible, there are few treatments available after the onset of the disease, and the only option is prevention rather than suffering from the woes of Alzheimer's. Therefore, cancer and dementia directly affect the quality of life for middle-aged and older adults.

[0005] Currently, anticancer drugs are classified into Western medicines and traditional Chinese medicines based on their therapeutic characteristics. Western medicines include chemotherapy and biologically targeted therapies, while traditional Chinese medicines include prescription drugs and unique herbal remedies commonly used in clinical practice. Drugs effective in slowing the progression of Alzheimer's disease include anticholinesterase inhibitors such as donepezil hydrochloride, memantine hydrochloride, and carbazine. In addition, nonspecific drugs such as butylphthalide, olanzapine, vitamin E, and cytarabine sodium can also be used, but their effectiveness has not yet been confirmed and requires further investigation in large-scale clinical trials.

[0006] Furthermore, while Western medicines are well known to have strong toxicity and side effects, and are generally expensive to obtain good results, herbal medicines have longer treatment cycles and show clear individual differences. At the same time, due to the decline in the physiological structure and metabolism of middle-aged and elderly people, long-term use of such medicines irritates the gastrointestinal tract, while the decline in bodily function affects the absorption and utilization of the active ingredients of the medicine.

[0007] Vitamin K2 may actively inhibit the proliferation of cancer cells, suggesting potential approaches to cancer prevention and clinical treatment. Furthermore, vitamin K2, when used in combination with established chemotherapy agents, may lead to better outcomes with fewer side effects. It has also been proven that vitamin K2 plays a crucial role in energy production in defective mitochondria. Therefore, vitamin K2 may offer new ideas for treating Parkinson's disease in patients with mitochondrial defects.

[0008] Currently, products aimed at improving the quality of life for the elderly are relatively single-function products, and the country has not yet viewed anti-cancer and anti-Alzheimer's products from a mechanical standpoint. Vitamin K2 is mainly used as a calcium supplement, but it has not yet been developed in this field. Vitamin K2 is a fat-soluble vitamin with low solubility in water, poor intestinal absorption when taken orally, and low bioavailability. Vitamin K2 is very sensitive to light and heat, and the shelf life of commercially available products is generally unstable, with bioactivity significantly decreasing with long-term storage.

[0009] Therefore, in order to improve the quality of life for the elderly, the research and development of products with stable activity, long shelf life, potent functional targets, safety and stability, and no side effects has become an urgent challenge that engineers in this field must address. [Overview of the Initiative]

[0010] The object of the present invention is to provide a drug composition based on vitamin K2 that improves the quality of life of the elderly, in view of the shortcomings of the current situation, and to solve the technical shortcomings of current products aimed at improving the quality of life of the elderly, which include single function, low absorption and utilization effect, high gastrointestinal irritation, strong side effects, and poor palatability.

[0011] To achieve the above objectives, the present invention provides the following technical solutions: In the first aspect, the present invention provides a drug composition based on vitamin K2 for improving the quality of life of the elderly, the composition comprising composition I and composition II, wherein composition I has anti-cancer and immunomodulatory functions, and composition II has targeted anti-Alzheimer's and nerve damage repair functions. The mass parts ratio of composition I to composition II is (0.5-7):1.

[0012] In some embodiments, composition I contains a main active ingredient while containing or not containing a secondary active ingredient, wherein the main active ingredient consists of Ω-3 fatty acid, astaxanthin, and sulforaphane, and the secondary active ingredient includes one or more of grapeseed oil, wheat germ oil, Chinese walnut seed oil, camellia oil, and olive oil.

[0013] In other embodiments, composition II contains a main active ingredient while containing or not containing secondary active ingredients, wherein the main active ingredient comprises vitamin K2, the rare ginsenoside CK, and sialic acid, and the secondary active ingredient comprises one or more of the following: trypterin, pterostilbene, resveratrol, curcumin, and piceatannol.

[0014] In some specific embodiments of the above embodiment, the ratio of EPA to DHA in the Ω-3 fatty acids is (0.1-4):1, and the vitamin K2 is in the MK-7 form having an all-trans structure.

[0015] In some preferred embodiments of the above embodiments, the drug composition comprises, in parts by mass, the following components: 10 to 85 parts Ω-3 fatty acids, 3 to 20 parts vitamin K2, 0.1 to 4 parts astaxanthin, 3 to 30 parts sulforaphane, 1 to 15 parts rare ginsenoside CK, and 1 to 30 parts sialic acid.

[0016] Preferably, the drug composition further comprises an auxiliary material, the auxiliary material being an excipient, binder, flow aid and / or antioxidant, where The excipient is ethanol or pure water, and the ethanol concentration is 40% to 95%. The binder is one or more of the following: modified starch, pregelatinized starch, hydroxypropylcellulose, sodium carboxymethylcellulose, glycerol, gelatin, methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, mannitol, lactose, and microcrystalline cellulose. The aforementioned fluidizing agent is one or more of talc, silicon dioxide, magnesium stearate, rice flour, and titanium dioxide. The aforementioned antioxidant is one or more of the following: rosemary extract, clove extract, cinnamon extract, Angelica daflica extract, tea polyphenols, butylhydroxyanisole, dibutylhydroxytoluene, propyl gallate, tert-butylhydroquinone, and vitamin E.

[0017] According to the first aspect, the dosage form of the drug composition is one or more of tablets, powders, hard capsules, soft capsules, and suspensions.

[0018] In the second aspect, drug compositions based on vitamin K2 as described above, which improve the quality of life of the elderly, are provided for application in dietary supplements and healthcare products. In a third aspect, the present invention also provides a soft capsule comprising a drug composition for improving the quality of life of elderly persons based on vitamin K2 as described above.

[0019] In a preferred embodiment of the third aspect, the drug composition comprises, by parts by mass, the following components: 10 to 85 parts Ω-3 fatty acids, 3 to 20 parts vitamin K2, 0.1 to 4 parts astaxanthin, 3 to 30 parts sulforaphane, 1 to 15 parts rare ginsenosides, 1 to 30 parts sialic acid, 50 to 400 parts soft capsule shells, and 20 to 200 parts auxiliary materials.

[0020] In a fourth aspect, the present invention provides a method for preparing the above-described soft capsules comprising a drug composition for improving the quality of life of elderly persons based on vitamin K2, wherein the preparation method comprises two parts: a first part for preparing composition II into a sustained-release micropill and a second part for preparing a soft capsule by enclosing the sustained-release micropill with composition I, and the preparation method consists of the following steps. 1) Mixing: Put Composition II containing vitamin K2, rare ginsenoside CK, and sialic acid into a V-type mixer, dry mix for 10 - 30 minutes, pass through a 60-mesh sieve, take the material passing through the sieve to obtain a mixture. 2) Granulation: Mix the mixture obtained in Step 1) with auxiliary materials, adopt dry granulation, control the particle size to 50 - 300 mesh to obtain granulated particles. 3) Micro - pill: Mix the granules obtained in Step 2) with excipients, binders, and flow - aid agents in the auxiliary materials, put them into the base tray of a granulator together with core pellets, and then prepare micro - pills by the powder layering method. 4) Capsule liquid: Weigh Composition I containing Ω - 3 fatty acids, astaxanthin, sulforaphane, and an antioxidant and the antioxidant in the auxiliary materials by weight. Dissolve the antioxidant, astaxanthin, and sulforaphane in the Ω - 3 fatty acid oil at 20 - 60 °C respectively to obtain an oil mixture, let it stand for 4 - 12 hours to defoam and obtain capsule liquid. 5) Capsule shell: Adopt the general formulation and preparation method in the industry to produce soft capsule shells. 6) Soft capsule: Inject the capsule liquid in Step 4) between the two - layer capsule shells containing the micro - pills in Step 3), and press to obtain soft capsules containing micro - pills.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows. In the composition described in the present invention, Functional Composition I brings anti - cancer and immune - regulating effects at the macro - biological level, and Functional Composition II brings anti - Alzheimer's disease and nerve - injury repair effects at the micro - cell level. These two levels act synergistically to exert a synergistic effect, thereby exerting anti - cancer and anti - Alzheimer's disease prevention and treatment effects and improving the life of the elderly. At the same time, the said composition also has other beneficial effects such as bone strengthening, improvement of osteoporosis, anti - aging, anti - oxidation, improvement of memory and cognitive ability, reduction of blood lipids, and liver protection.

[0022] At the same time, the preparation method provided by the present invention can ensure the long-term stability of each active ingredient in the composition. In particular, it can ensure the first-pass effect of the active ingredient in the functional composition II in the oral cavity and stomach, avoid early decomposition, improve bioavailability, and ensure a longer and more stable function, as well as the long-term use of a composition without toxic side effects.

Embodiments for Carrying Out the Invention

[0023] Hereinafter, the technical solutions in the embodiments of the present invention will be clearly and completely described in connection with the specific embodiments of the present invention. It is clear that the described embodiments are only a part of the embodiments of the present invention and not all of them. Based on the embodiments in the present invention, all other embodiments obtained by those skilled in the art without creative labor belong to the protection scope of the present invention.

[0024] The present invention provides a pharmaceutical composition for improving the quality of life of the elderly based on vitamin K2 and a preparation method thereof. The pharmaceutical composition has effects such as anti-cancer and anti-Alzheimer's disease as the main effects, as well as bone strengthening, improvement of osteoporosis, anti-aging, anti-oxidation, improvement of memory and cognition, reduction of blood lipids, and protection of the liver, etc., and can effectively improve the quality of life of the elderly and provide health support and protection.

[0025] The present invention responds to the purpose of preventing and treating cancer and Alzheimer's disease that have a profound impact on the lives of the elderly at both the macro and micro levels. At the macro level, the present invention achieves anti-cancer and immunomodulatory effects by the preferred selection of mild, non-irritating, highly active, and universal components. At the micro level, the present invention achieves the repair of anti-Alzheimer's disease and nerve damage by selecting target cells and mitochondrial metabolism-regulating and inducing active ingredients. These two levels exert a synergistic effect, jointly achieving the purposes of preventing and treating cancer and Alzheimer's disease and improving the quality of life of the elderly. At the same time, the composition also has other beneficial effects such as bone strengthening, improvement of osteoporosis, anti-aging, anti-oxidation, improvement of memory and cognition, reduction of blood lipids, and protection of the liver.

[0026] On the one hand, the present invention provides a drug composition for improving the quality of life of elderly people based on vitamin K2 (MK-7), comprising functional composition I and functional composition II, wherein the ratio of parts by mass of composition I and composition II is (0.5 to 7):1.

[0027] Omega-3 is a long-chain polyunsaturated fatty acid, and current research data suggests that omega-3 promotes heart health and helps prevent coronary artery disease. It is effective in preventing and treating cardiovascular and cerebrovascular diseases primarily by protecting the cells of the vascular wall, restoring vascular elasticity, relaxing blood vessels, inhibiting platelet aggregation, lowering blood pressure, inhibiting thrombus formation, and reducing blood lipids.

[0028] Furthermore, omega-3s play a role in preventing arrhythmias and sudden cardiac death. A clinical study that tracked more than 11,000 patients with coronary artery disease revealed that consuming 1-2 grams of omega-3 unsaturated fatty acids per day significantly reduced mortality in patients with cardiovascular disease, particularly by 45% in the incidence of sudden cardiac death.

[0029] There are three types of omega-3 fatty acids: alpha-linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). EPA helps prevent strokes and myocardial infarctions, lowers blood cholesterol, and prevents arteriosclerosis. DHA activates brain cells, promotes the regulation of neural circuits, and helps maintain the normal function of brain cells. Supplementing with DHA can improve concentration, learning disabilities, memory loss, and Alzheimer's disease.

[0030] On the other hand, since omega-3 also has effects such as resistance to nervous system diseases, prevention and resistance to cancer, and anti-inflammatory effects, it is preferable in the present invention to use omega-3 fatty acids in the pharmaceutical composition of the present invention as part of lifestyle involvement, and it is possible to reduce the risk of sudden cardiac death in the elderly.

[0031] Preferably, the ratio of EPA:DHA in the Ω-3 fatty acids in the present invention is (0.1~4):1.

[0032] More preferably, the EPA content in the Ω-3 fatty acid is ≥40%, and the EPA content is ≥45%.

[0033] Astaxanthin is a ketone-type carotenoid that is widely present in the biological world. As a carotenoid that is not a source of vitamin A, astaxanthin cannot be converted to vitamin A in the body of animals, but it has the same antioxidant properties as other carotenoids.

[0034] On the other hand, excessive oxygen radicals are known to be the main culprits of aging and disease in the human body, causing more than 100 types of diseases, including cancer, ischemic stroke, inflammation, eye diseases, diabetes, central nervous system disorders, cardiovascular diseases, blood disorders, and respiratory diseases. Due to its unique molecular structure, astaxanthin can pass through the outer wall of human cells and directly remove oxygen radicals from within cells, protecting cellular health from the inside out and maintaining the vitality of the human body.

[0035] On the other hand, it is known that oxidation of low-density lipoprotein (LDL) in the blood is a major cause of arteriosclerosis and hypertension, and the intake of large amounts of cholesterol in modern daily diets increases this risk. Astaxanthin can prevent the oxidation of LDL, increase high-density lipoprotein levels, restore the elasticity of blood vessels, and lower the probability of hypertension, stroke, and heart attack.

[0036] Preferably, in the present invention, the ratio of all-trans-astaxanthin content to total astaxanthin content is 70% or more.

[0037] Sulforaphane is an isothiocyanate obtained by hydrolysis of thioglucoside by black mustard enzyme in plants. It is abundant in cruciferous plants such as broccoli, Chinese broccoli, and Kitakata Marubeni radish, and is a common antioxidant. Among vegetables, it is the plant-active substance with the highest anti-cancer effect.

[0038] Scientific studies have already shown that sulforaphane has broad-spectrum antitumor effects and is effective against cancers such as liver cancer, lung cancer, prostate cancer, breast cancer, rectal cancer, colon cancer, stomach cancer, pancreatic cancer, skin cancer, leukemia, glioma cancer, and nasopharyngeal cancer.

[0039] Its main mechanisms of action are: 1) Sulforaphane protects DNA by regulating the action of oncogenic substance-metabolizing enzymes, including inhibitory effects on phase I enzymes and strong induction effects on phase II enzymes. 2) Sulforaphane can induce autophagy and apoptosis, interrupt the cell cycle, and suppress cell proliferation. 3) Sulforaphane inhibits basement membrane microtubule formation and endothelial cell proliferation, thereby suppressing the formation of blood vessels within tumors, inhibiting tumor metastasis, and preventing cancer progression. Furthermore, sulforaphane itself is highly reactive and can inactivate several carcinogens by reacting with them.

[0040] Therefore, in the present invention, it is preferable to provide macro-level anti-cancer protection as one of the active ingredients of composition I of the present invention.

[0041] More preferably, the sulforaphane in the present invention is derived from broccoli seed extract and has a content of ≥10%.

[0042] Based on the above, it is macroscopically preferable to construct Composition I with Ω-3 fatty acids, astaxanthin, and sulforaphane as the main active ingredients.

[0043] Considering similar actions or effects, composition I may or may not contain a secondary active ingredient, which may be one or more of the following: grapeseed oil, wheat germ oil, Chinese walnut seed oil, camellia oil, and olive oil.

[0044] Vitamin K2 is a fat-soluble vitamin primarily used in the treatment and prevention of osteoporosis. Based on the length of its tail chain, K2 is classified into subclasses such as MK-4, MK-7, MK-8, and MK-10. While all vitamin K2 subclasses are structurally similar, they differ in side chain length. Longer side chains result in better absorption, higher bioactivity, and longer presence in the bloodstream. Therefore, the long-chain MK-7 is considered the highest quality, most bioavailable, and has been proven to have a long half-life after oral ingestion, allowing it to exert its benefits over a longer period. Furthermore, MK-7 is obtained through plant fermentation, offering a healthier source.

[0045] Vitamin K2 has been shown to have anticancer effects against many tumor cells, inhibiting cancer cell growth and potentially serving as a preventative and clinical cancer treatment. Current research suggests that the anticancer mechanisms of MK-7 are: (1) During the redox reaction of the naphthoquinone nucleus in the MK-7 structure, free radicals are produced, inducing the expression of the nuclear transcription factor NK-κB and suppressing the expression of the anti-apoptotic gene bcl-2, thereby reducing bcl-2 / bax, damaging mitochondrial function, and leading to cancer cell death. (2) MK-7 regulates the anticancer effects of different transcription factors through tyrosine kinases and phosphoesterases. (3) MK-7 enhances PKA activity by activating AP2 "USF" CREB, suppressing the proliferation and invasion of liver cancer cells via the PKA-MAPK signaling pathway. (4) Vitamin K2 can suppress the proliferation and invasion capacity of liver cancer cells and induce apoptosis by lowering Wnt / β-catenin signaling. (5) It inhibits angiogenesis.

[0046] Therefore, in the present invention, vitamin K2, particularly K2 in the form of MK-7, is preferred as one of the active ingredients of composition II.

[0047] More preferably, the MK-7 is obtained by a method of fermenting organic legumes, has a trans structure, and has a purity of ≥99.5%, and the bioavailability of the trans-structured MK-7 is higher.

[0048] Ginsenosides are the main active ingredients in ginseng, and are triterpene compounds. Currently, at least 60 types of ginsenosides have been isolated from ginseng. Studies suggest that ginsenosides can promote longevity, enhance physical strength, treat conditions such as weakened immune function caused by radiation and chemotherapy in cancer patients, and simultaneously increase the vitality of cells on the body's surface, suppressing aging. Many traditional ginsenosides are in their original form, which has low bioactivity and is poorly absorbed and utilized by the human body. After enzymatic catalytic metabolism, the original ginsenosides are converted into rare ginsenosides, which have smaller molecular weights, stronger lipid solubility, and are more easily absorbed by the human body. Rare ginsenosides include Rg3, Rh1, CK, Rh2, Rg5, Rk1, Rh3, Rk2, Rh4, Rk3, aPPT, and aPPD.

[0049] On the other hand, the rare ginsenoside CK is a non-natural ginsenoside, converted from other diol-type ginsenosides, and is the main metabolite and final absorption form of diol-type ginsenosides in the human intestinal tract. Due to the specificity of the nuclear structure of the tetracyclic triterpene ginsenoside, it is determined that CK can only be obtained through mild bioconversion methods.

[0050] Studies show that CK can exert tumor-suppressing effects against various types of tumors through mechanisms such as inducing apoptosis, inhibiting cell proliferation, suppressing angiogenesis, and inhibiting metastasis. Among these, many studies have focused on its effects against hepatocellular carcinoma, and its cancer-suppressing effect is particularly remarkable. Furthermore, because CK has low toxicity, it is more suitable for long-term treatment than other chemotherapy drugs. Therefore, in the present invention, rare ginsenoside CK is preferred as one of the active ingredients of composition II.

[0051] More preferably, in the present invention, the purity of the rare ginsenoside CK is ≥98%.

[0052] Sialic acid is a naturally occurring carbohydrate that accounts for over 99% of the entire sialic acid family, hence it is also called sialic acid. The chemical name for sialic acid is N-acetylneuraminic acid.

[0053] Sialic acid has a very wide distribution in nature, and it is now known to be found in animals, plants, and microorganisms. In the human body, the brain has the highest sialic acid content. The sialic acid content in brain gray matter is 15 times higher than in organs such as the liver and lungs.

[0054] Sialic acid is typically located at the end of non-reducing oligosaccharides such as glycoproteins and glycolipids in the form of α-glucosides, and is an important component of cell membrane proteins, involved in various physiological functions on the cell surface.

[0055] Sialic acid promotes brain development primarily through its action in neurotransmitters, specifically in SA, which binds to neurotonin. Human neurotransmission is essentially a weak electrochemical reaction. When an electric current flows, sialic acid receives an electrical signal (because it itself has a very strong negative charge) Ca 2+ The neurotonin is released, enters the presynaptic nerve via ion channels, and then opens a neuronal vesicle to release the neurotransmitter. The neurotransmitter crosses the cell membrane, reaches the postsynaptic nerve, and finally Na 2+ It can transmit signals. The entire process of neurotransmission is essentially the transmission of electric charge, and sialic acid plays a crucial role as the "starting gun" of this process.

[0056] In this invention, it is preferable to select sialic acid as one of the active ingredients of composition II, and it is used to promote brain development, improve cognition in the elderly, enhance memory, and prevent and improve Alzheimer's disease.

[0057] More preferably, the purity of the sialic acid to which it belongs is ≥98%.

[0058] Based on the above, it is preferable that vitamin K2, the rare ginsenoside CK, and sialic acid are the main active ingredients of composition II, as they resist Alzheimer's disease from a microscopic perspective and repair cell damage.

[0059] Considering similar effects or their degree, composition II preferably further contains or does not contain one or more secondary active ingredients such as trypterin, pterostilbene, resveratrol, curcumin, and piceatannol.

[0060] This invention has discovered that while there are many raw materials or functional compositions in this field for anti-cancer and anti-Alzheimer's disease, these components do not necessarily produce synergistic effects simply by being combined; some may have antagonistic effects, and the effects may be singular. Therefore, this invention, from the perspective of comprehensive cooperative prevention and treatment of cancer and Alzheimer's disease at both macro and micro levels, selects the above-mentioned healthy, safe, and mild components through extensive testing and uses them in favorable combinations to achieve multi-effective synergistic effects on targets. From macro-level anti-cancer and immunomodulation to micro-level target cell and mitochondrial metabolic regulation and induction, the two levels work together to jointly achieve the objectives of prevention and treatment that improve the quality of life of elderly people with cancer and Alzheimer's disease.

[0061] As one specific example of the present invention, the drug composition comprises 10 to 85 parts Ω-3 fatty acids, 3 to 20 parts vitamin K2 (MK-7), 0.1 to 4 parts astaxanthin, 3 to 30 parts sulforaphane, 1 to 15 parts rare ginsenoside CK, and 1 to 30 parts amylose.

[0062] A second aspect of the present invention is to provide a method for preparing a drug composition that improves the quality of life of elderly people based on the above-mentioned vitamin K2 (MK-7), the first part comprising forming functional component II into a sustained-release micropill, and the second part comprising encapsulating the sustained-release micropill with functional component I and then forming a soft capsule.

[0063] In a typical example, the preparation method is as follows: 1) Mixing: Place functional component II, which contains vitamin K2, rare ginsenosides, and sialic acid, into a V-type mixer, dry-mix for 10-30 minutes, then pass through a 60-mesh sieve. Remove the sieved material to obtain the mixture. 2) Granulation: The mixture obtained in step 1 and the auxiliary material are uniformly mixed and granulated by a dry method, and granules are obtained by controlling the particle size to 50-300 mesh. 3) Micropiles: The granular material obtained in step 2) is uniformly mixed with a certain mass of excipients, binders, and flow aids in the auxiliary material, and then placed together with the core pellets in a granulator base tray to produce micropiles using the powder stacking method. 4) Capsule liquid: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are dissolved in Ω-3 oil at 20-60°C to obtain a mixed oil solution, which is then allowed to stand for 4-12 hours to remove foam and obtain the capsule liquid. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0064] In this method, the preparation method for the sustained-release micropiles is as follows: main engine rotation speed of 20-200 r / min, spray pressure of 0.1-1 MPa, supply speed of 20-100 r / min, and spray pump speed of 10-90 r / min.

[0065] The aforementioned dry granulation method and soft capsule shelling, i.e., filling techniques, must be selected for bonding, and the specific method is one that is well-known to those skilled in the art.

[0066] By forming Composition II into a sustained-release micropill, its stability-assuring activity can be enhanced while increasing its bioavailability in the body. By encapsulating Composition I in the form of Composition II, while the physical properties differ depending on the raw material, the active ingredient in Composition II can be effectively protected, conditions such as oxoacids can be effectively blocked, the shelf life and stability can be extended, and initial overdose in the oral cavity and stomach can be avoided, while the active effect can be enhanced.

[0067] A third aspect of the present invention provides the application of a drug composition based on the above-mentioned vitamin K2 (MK-7) to dietary supplements and healthcare products for improving the quality of life of the elderly.

[0068] A fourth aspect of the present invention provides a soft capsule containing the above-mentioned drug composition, preferably a drug composition for improving the quality of life of the elderly based on vitamin K2 (MK-7), comprising 10 to 85 parts Ω-3 fatty acids, 3 to 20 parts vitamin K2 (MK-7), 0.1 to 4 parts astaxanthin, 3 to 30 parts sulforaphane, 1 to 15 parts rare ginsenoside CK, 1 to 30 parts sialic acid, 50 to 400 parts soft capsule shell, and 20 to 200 parts auxiliary materials by mass.

[0069] More preferably, the auxiliary materials are excipients, binders, flow aids, and antioxidants.

[0070] In typical embodiments, the excipient is ethanol or pure water, with ethanol concentrations of 95%, 90%, 85%, 80%, 85%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, and 40%.

[0071] In another embodiment, the adhesive is one or more of the following: modified starch, pregelatinized starch, hydroxypropyl cellulose, sodium carboxymethylcellulose, glycerol, gelatin, methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, polyvinylpyrrolidone, mannitol, lactose, and microcrystalline cellulose.

[0072] In another embodiment, the fluidizing agent is one or more of talc, silicon dioxide, magnesium stearate, rice flour, and titanium dioxide.

[0073] In another embodiment, the antioxidant is one or more of rosemary extract, clove extract, cinnamon extract, Angelica daflica extract, tea polyphenols, butylhydroxyanisole, dibutylhydroxytoluene, propyl gallate, tert-butylhydroquinone, and vitamin E.

[0074] Of the compositions according to the present invention, functional composition I provides anti-cancer and immunomodulatory effects at the macro level, while functional composition II provides anti-Alzheimer's and nerve damage repair effects at the micro level. The two levels work together to achieve the combined objectives of prevention and treatment, improving the quality of life of the elderly through anti-cancer and anti-Alzheimer's effects. At the same time, this composition has effects such as strengthening bones, improving osteoporosis, preventing senility, providing antioxidant effects, improving memory and cognition, lowering lipids, and protecting the liver.

[0075] At the same time, the preparation method of the present invention ensures the long-term stability of each active ingredient in the composition, increases its bioavailability, ensures longer-term stability of function, and eliminates toxic side effects with long-term use.

[0076] The following examples are for illustrative purposes only and do not limit the scope of the present invention.

[0077] Example 1 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 46.98% omega-3 fatty acids, 0.009% vitamin K2 (MK-7), 1.6% astaxanthin, 2% sulforaphane, 8% rare ginsenoside CK, 10% sialic acid, 29.99% soft capsule shell, 0.4% excipients, 1% adhesive, 0.02% flow aids, and 0.02% antioxidants.

[0078] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 10 minutes, then passed through a 60-mesh sieve. The sieved material is then collected to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulation is carried out by a dry method, controlling the particle size to 100 mesh to obtain granular material. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed in the granulator base tray together with the core pellets, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 40 r / min, the spray pressure is 0.2 MPa, the supply speed is 30 r / min, and the spray pump speed is 20 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are each dissolved in Ω-3 oil at 30°C to obtain a mixed oil solution, which is left to stand for 12 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0079] Example 2 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 42.45% omega-3 fatty acids, 0.015% vitamin K2 (MK-7), 1.66% astaxanthin, 2% sulforaphane, 13.32% rare ginsenoside CK, 11.65% sialic acid, 26.64% soft capsule shell, 0.67% excipients, 1.5% adhesive, 0.03% flow aids, and 0.07% antioxidants.

[0080] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 15 minutes, then passed through a 60-mesh sieve. The sieved material is then collected to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulated by a dry method to obtain granular material by controlling the particle size to 150 mesh. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed together with the core pellets in the granulator base tray, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 40 r / min, the spray pressure is 0.3 MPa, the supply speed is 35 r / min, and the spray pump speed is 25 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are dissolved in Ω-3 oil at 35°C to obtain a mixed oil solution, which is left to stand for 12 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0081] Example 3 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 34.24% omega-3 fatty acids, 0.014% vitamin K2 (MK-7), 1.43% astaxanthin, 2% sulforaphane, 28.53% rare ginsenoside CK, 5.71% sialic acid, 25.68% soft capsule shell, 0.86% excipients, 1.43% adhesives, 0.06% flow aids, and 0.06% antioxidants.

[0082] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 20 minutes, then passed through a 60-mesh sieve. The sieved material is then collected to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulated by a dry method, controlling the particle size to 2000 mesh to obtain granular material. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed in the granulator base tray together with the core pellets, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 40 r / min, the spray pressure is 0.2 MPa, the supply speed is 30 r / min, and the spray pump speed is 20 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in auxiliary materials are weighed by weight. The antioxidants, astaxanthin, and sulforaphane are dissolved in Ω-3 oil at 40°C to obtain mixed oil solutions, which are left to stand for 11 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0083] Example 4 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 34.69% omega-3 fatty acids, 0.015% vitamin K2 (MK-7), 1.49% astaxanthin, 2.48% sulforaphane, 23.54% rare ginsenoside CK, 9.91% sialic acid, 24.78% soft capsule shell, 0.99% excipients, 1.98% adhesives, 0.07% flow aids, and 0.06% antioxidants.

[0084] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 20 minutes, then passed through a 60-mesh sieve. The sieved material is then collected to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulation is carried out by a dry method, controlling the particle size to 200 mesh to obtain granular material. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed together with the core pellets in the granulator base tray, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 435 r / min, the spray pressure is 0.15 MPa, the supply speed is 30 r / min, and the spray pump speed is 25 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are dissolved in Ω-3 oil separately at 40°C to obtain a mixed oil solution, which is left to stand for 12 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0085] Example 5 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 43.58% omega-3 fatty acids, 0.02% vitamin K2 (MK-7), 0.5% astaxanthin, 1.99% sulforaphane, 14.94% rare ginsenoside CK, 11.21% sialic acid, 24.9% soft capsule shell, 1% excipients, 1.74% adhesives, 0.07% flow aids, and 0.05% antioxidants.

[0086] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 25 minutes, then passed through a 60-mesh sieve, and the sieved material is removed to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulated by a dry method to obtain granular material by controlling the particle size to 150 mesh. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed together with the core pellets in the granulator base tray, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 45 r / min, the spray pressure is 0.25 MPa, the supply speed is 35 r / min, and the spray pump speed is 30 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are dissolved in Ω-3 oil at 35°C to obtain a mixed oil solution, which is left to stand for 12 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0087] Example 6 This embodiment provides a soft capsule containing a drug composition that improves the quality of life of elderly people based on vitamin K2 (MK-7), characterized in that it contains the following weight percentages of the components. 47.72% omega-3 fatty acids, 0.015% vitamin K2 (MK-7), 1.33% astaxanthin, 1.67% sulforaphane, 21.65% rare ginsenoside CK, 8.33% sialic acid, 21.65% soft capsule shell, 0.83% excipients, 1.67% adhesives, 0.08% flow aids, and 0.07% antioxidants.

[0088] The preparation method is as follows: 1) Mixing: A fixed amount of vitamin K2, rare ginsenosides, and sialic acid are each placed in a V-type mixer, dried and mixed for 15 minutes, then passed through a 60-mesh sieve. The sieved material is then collected to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with the excipient and flow aid, and granulated by a dry method to obtain granular material by controlling the particle size to 150 mesh. 3) Micropiles: After mixing a certain mass of the granular material obtained in step 2) with the excipients, binders, and flow aids in the auxiliary materials, the mixture is placed together with the core pellets in the granulator base tray, and micropiles are manufactured by the powder stacking method. During manufacturing, the machine rotation speed is 40 r / min, the spray pressure is 0.3 MPa, the supply speed is 35 r / min, and the spray pump speed is 25 r / min. 4) Capsule solution: Functional component I, which contains Ω-3 fatty acids, astaxanthin, and sulforaphane, and the antioxidant in the auxiliary material are weighed by weight. The antioxidant, astaxanthin, and sulforaphane are dissolved in Ω-3 oil at 35°C to obtain a mixed oil solution, which is left to stand for 12 hours to remove foam and obtain the capsule solution. 5) Capsule shell: Soft capsule shells are manufactured using industry-standard formulations and preparation methods. 6) Soft capsules: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropill from step 3), and pressed through a special mold to obtain a soft capsule containing the micropill inside.

[0089] Verification Test Verification: Stability test of the composition prepared according to the present invention Soft capsules containing the drug compositions prepared in Examples 1-6 were designated as Experiments 1-6, and commercially available vitamin K2 (MK-7) soft capsules (MK-7 content 90 μg) were used as the control group. Each was placed in a sealed brown vial. Accelerated stability testing was performed in a constant temperature and humidity chamber at 40±2°C and 75±5% RH. Samples were taken at 0, 1, 2, 3, 4, 5, 6, and 9 months, and the MK-7 content was measured. The MK-7 content was measured by high-performance liquid chromatography. The results of the accelerated stability test are shown in the table below.

[0090] [Table 1] The results in Table 1 show that the MK-7 content in the soft capsules containing the compositions of Examples 1, 2, 3, 4, 5, and 6 remained almost unchanged and stable, while in the control group, decay began after 3 months of accelerated conversion. This explains that the MK-7 active ingredient in the drug composition containing MK-7 produced by the preparation method of the present invention remains stable for a relatively long period of time. Based on calculations from normal accelerated conversion times, soft capsules of the vitamin K2-based drug composition for improving the quality of life of the elderly produced by the method of the present invention can be guaranteed a shelf life of at least 3 years at room temperature.

[0091] Verification Test: Animal Verification Test of the Efficacy of the Drug Composition Prepared According to the Present Invention Verification of tumor-suppressing effects of drug compositions a. 140 mice (half male, half female) approximately 3 months old were selected, with a weight range of 15.41-18.47 g. Endogenous tumor cells were inoculated subcutaneously, and blood samples were taken 24 hours later to detect tumor markers and confirm the success rate of mouse modeling. 126 mice (half male, half female) with cancer were randomly divided into 6 groups, each consisting of 21 mice (half male, half female): Experimental Group 1, Experimental Group 2, Experimental Group 3, Experimental Group 4, Experimental Group 5, and Experimental Group 6. Experimental Group 1 received a drug composition containing Example 4 once daily (10 mg / kg), in addition to their normal diet. Experimental Group 2 received a drug composition containing Example 5 once daily (10 mg / kg), in addition to their normal diet. Experimental Group 3 received a drug composition containing Example 6 once daily (10 mg / kg), in addition to their normal diet. Experimental group 4 was fed pure MK-7 once daily (10 mg / kg) in addition to their normal diet. Experimental group 5 was fed a known anticancer drug (sildenafil) once daily (10 mg / kg) in addition to their normal diet. Experimental group 6 was fed the same weight of saline once daily, in addition to their normal diet. Drug administration was stopped 15 days after administration, and after a 24-hour drug-free period, the vertebrae were amputated and processed, the tumors of the mice were removed and tumor specimens were prepared, and the tumors were recorded as being heavy. Tumor suppression rate calculation: Tumor suppression rate = (average tumor weight of the control group - average tumor weight of the experimental group) / average tumor weight of the control group. The experimental results are shown in Table 2.

[0092] [Table 2] As is clear from Table 2, experimental groups 1-3 showed a significant tumor-suppressing effect compared to control group 5. Compared to control group 4, the effects of experimental groups 1-3 were better, suggesting that the compounding effect of the drug composition of the present invention is due to the effect of the pure product alone.

[0093] b flow cytometry detects the effect of drug compositions on apoptosis. MCF-7 cancer cells were collected during the logarithmic growth phase, digested, and then 5 × 10⁶ cells were collected per well. 5Individual cells are inoculated into a six-well plate, and the drug is added after 6 hours. The drug composition is added to each experimental group (Examples 1-6 correspond to experimental groups 1-6), and the same amount of culture medium is added to the negative control group. 48 hours after administration, the target cells are digested into single cells with trypsin, the cells are collected by centrifugation at 1000 rpm for 5 minutes, the cells are washed with 4°C pre-cooled PBS buffer, the cell precipitate is blown into a single-cell suspension, and the cells are collected by centrifugation at 1000 rpm for 5 minutes. The cells are washed again with 4°C pre-cooled PBS buffer, the cell precipitate is blown into a single-cell suspension, the cells are counted, and the cells are collected by centrifugation at 1000 rpm for 5 minutes. An appropriate amount of 1×Binding Buffer is added according to the number of collected cells to adjust the cell count to 5×10⁶ cells / ml. 100 μL (5×10⁵ cells) of the above cell suspension is taken, and 7 μl FITCAnnexin V and 7 μl Pl are added to each. Mix the mixture upside down and incubate for 15 minutes in a light-free environment (RT) at 25°C. Finally, add 400µl 1x Binding Buffer and detect the apoptotic state using a flow cytometer within 1 hour. The experimental results are shown in Table 3.

[0094] [Table 3] Experimental results showed that the drug composition of the present invention significantly induces apoptosis in MCF-7 cancer cells, and this is the mechanism of action of its anticancer activity.

[0095] c. Effects of drug compositions on cognition Forty healthy 14-18 month old male SD rats were randomly divided into a sham surgery control group, a model control group, and experimental groups 1-6 (corresponding to examples 1-6, respectively), with 10 rats in each group. A senile MCI (mild cognitive impairment) rat model was created using the rat common carotid artery severe stenosis occlusion method. Thirty days after modeling, the Morris water maze experiment was performed, and rats that did not meet the MCI criteria were excluded. Daily, the experimental groups received intragastric administration of the corresponding drug composition (12 mg / kg), while the sham surgery group and model group all received intragastric administration of the same dose of saline. After 30 days of intragastric administration, the Morris water maze experiment was performed again to measure the learning and memory abilities of the rats.

[0096] Thirty days after the drug composition was placed in the stomachs of the rats, the Morris water maze experiment was performed on each group of rats to test and measure their learning and memory abilities. The observational indicators were: (1) Orientation experiment: the average latency period of the rat's search platform. (2) Spatial search experiment: the number of times the rat crossed the original platform position and the percentage of time spent swimming in the original platform quadrant were observed indicators. The experimental results are shown in Tables 4 and 5.

[0097] [Table 4]

[0098] [Table 5]

[0099] In Morris water maze navigation experiments and spatial search learning and memory tests, latency avoidance and the number of platform crossings are closely related to visually-based spatially oriented memory and spatially oriented memory. The test results showed that in the navigation experiment, the mean latency of the search platform was lower in all experimental groups 1-6 than in the model group (P<0.05), and there were differences in data among experimental groups 1-6 depending on the proportion of composition, with the sham surgery group having the lowest (P<0.05). In the spatial search experiment, the number of times the original platform was crossed and the proportion of time spent crossing the target quadrant as a percentage of total swimming time were significantly higher in experimental groups 1-6 than in the model group (P<0.05), with the sham surgery group having the highest (P<0.05).

[0100] From the above, it has become clear that supplementing with the drug composition of the present invention improves the learning and memory abilities of aged MCI rats and has an adjunctive therapeutic effect against senile dementia.

[0101] The details described in this invention are all well known to those skilled in the art.

[0102] Finally, the above specific embodiments are for illustrating the technical idea of ​​the present invention and are not limiting. Although the present invention has been described in detail with reference to examples, those skilled in the art will understand that the technical idea of ​​the present invention can be modified and replaced with equivalents without departing from the technical idea and scope of the present invention, and that these modifications are included within the scope of the claims of the present invention.

Claims

1. It contains 34.24-47.72% omega-3 fatty acids, 0.009-0.02% menaquinone-7 with an all-trans structure, 0.5-1.66% astaxanthin, 1.67-2.48% sulforaphane, 8.00-28.53% ginsenoside CK, 5.71-11.65% N-acetylneuraminic acid, and 21.65-29.99% soft capsule shell. A soft capsule for tumor suppression and cognitive function improvement in the elderly, characterized in that a sustained-release micropill containing the menaquinone-7 and the N-acetylneuraminic acid is dispersed in a composition containing the omega-3 fatty acid, the astaxanthin, and the sulforaphane.

2. The soft capsule according to claim 1, wherein the ratio of eicosapentaenoic acid to docosahexaenoic acid in the Ω-3 fatty acid is (0.1 to 4):

1.

3. A soft capsule according to claim 1, comprising 0.4 to 1.00% excipient, 1 to 1.98% adhesive, 0.02 to 0.08% flow aid, and 0.02 to 0.07% antioxidant.

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