Vitamin K2-based pharmaceutical composition for improving the quality of life of the elderly, its preparation method and application

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 medicine, health care products and food, and particularly relates to a pharmaceutical composition for improving the life quality of the elderly based on vitamin K2, its preparation method and application. [Background technology]

[0002] According to the latest research data, the main age group for cancer occurrence is middle-aged and elderly people over 45 years old. This is because as the elderly gradually decline in their overall function with age, their immune function gradually declines, and the body's immune surveillance function and ability to eliminate mutant cells weaken, making them more susceptible to external carcinogenic factors. In addition, the formation of cancer is often the result of many years of chronic irritation and long-term exposure to carcinogens, with a general latency period of 10 to 30 years. Therefore, if a young person is affected by a certain carcinogen, the cells will gradually undergo abnormal changes, and the disease will develop later in life, forming a peak in the incidence of cancer in the elderly.

[0003] According to the World Health Organization (WHO), one-third of cancers can be completely prevented, one-third can be eradicated through early detection, and one-third can be extended, reduced pain, and improved quality of life through existing medical treatment. Therefore, the most ideal prevention situation is to detect and intervene when precancerous lesions exist and prevent them from developing into cancer. Dementia, also known as Alzheimer's disease, is often accompanied by slow reaction speed, memory loss, and speech reversal. This type of disease belongs to the nervous system and is a kind of chronic disease that mainly affects middle-aged and elderly people, with the majority of people over 60 years old. According to clinical surveys, the number of Alzheimer's disease patients in China has reached 10 million and is still increasing.

[0004] Alzheimer's disease has symptoms such as memory loss and mental ecstasy in the early stages, so some people tend to ignore this kind of disease, thinking that it is caused by lack of sleep and other bad habits, so they will miss the golden age of treatment.Alzheimer's disease is also an irreversible disease, so there is almost no treatment after suffering from Alzheimer's disease, and we can only prevent it in advance without enjoying the suffering of Alzheimer's disease. Therefore, cancer and dementia directly affect the quality of life of middle-aged and older people.

[0005] At present, anticancer drugs are classified into Western medicines and Chinese medicines according to their different therapeutic properties. Western medicines include chemotherapy and biological targeted therapy, while Chinese medicines include prescription drugs and original Chinese medicines that are often used in clinical practice. Drugs that are 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 needs to be further explored in large-scale clinical trials.

[0006] It is also well known that Western medicines are highly toxic and have side effects, and are generally expensive to achieve good results, while Chinese medicines have a long treatment cycle and obvious individual differences. At the same time, due to the weakening of the physiological structure and metabolism of middle-aged and elderly people, the long-term use of such medicines will stimulate the stomach and intestines, while the decline of bodily functions will affect the absorption and utilization of the active ingredients of the medicines.

[0007] It has been suggested that vitamin K2 may actively inhibit the proliferation of cancer cells, which may be a possible approach to cancer prevention and clinical treatment. Furthermore, vitamin K2 may be combined with established chemotherapy agents to produce better results with fewer side effects. It has also been proven that vitamin K2 plays an important role in defective mitochondrial energy production. Therefore, vitamin K2 may provide a new idea for the disease treatment of Parkinson's disease patients who also have defective mitochondria in their bodies.

[0008] At present, products aimed at improving the quality of life of the elderly are relatively single-function, and the country has not yet seen from the mechanical level of anti-cancer and anti-Alzheimer's products. Vitamin K2 is mainly used as a calcium supplement, but has not yet been developed in this field. Vitamin K2 is a fat-soluble vitamin with low solubility in water, difficult to be absorbed orally in the intestine, and low bioavailability. Vitamin K2 is very sensitive to light and heat, and the shelf life of commercially available products is generally unstable, and long-term storage will significantly reduce its biological activity.

[0009] Therefore, in order to improve the life quality of the elderly, the research and development of products with stable activity, long shelf life, strong functional targets, safety and stability, and no side effects has become an urgent problem that engineers in this field need to solve. Summary of the Invention

[0010] In view of the above-mentioned current shortcomings, the object of the present invention is to provide a pharmaceutical composition based on vitamin K2 for improving the quality of life of the elderly, thereby solving the technical shortcomings of current products aimed at improving the quality of life of the elderly, such as single function, low absorption and utilization, high gastrointestinal irritation, strong side effects, and poor palatability.

[0011] In order to achieve the above objectives, the present invention provides the following technical solutions: In the first aspect, the present invention provides a pharmaceutical composition for improving the quality of life of the elderly based on vitamin K2, which is composed of composition I and composition II, in which composition I has anti-cancer and immunoregulatory functions, and composition II has targeted anti-Alzheimer's and neuronal damage repair functions; The mass ratio of the composition I to the composition II is (0.5 to 7):1.

[0012] In some embodiments, Composition I contains a primary active ingredient with or without a secondary active ingredient, the primary active ingredients being Omega-3 fatty acids, astaxanthin, and sulforaphane, and the secondary active ingredients being one or more of grapeseed oil, wheat germ oil, Chinese walnut seed oil, camellia oil, and olive oil.

[0013] In another embodiment, Composition II contains major active ingredients with or without minor active ingredients, the major active ingredients including vitamin K2, rare ginsenoside CK and sialic acid, and the minor active ingredients including one or more of tripterin, pterostilbene, resveratrol, curcumin and piceatannol.

[0014] In some specific embodiments of the above embodiments, the ratio of EPA to DHA in the Omega-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 pharmaceutical composition comprises the following components, by weight: 10-85 parts Omega-3 fatty acid, 3-20 parts Vitamin K2, 0.1-4 parts Astaxanthin, 3-30 parts Sulforaphane, 1-15 parts rare Ginsenoside CK, and 1-30 parts Sialic Acid.

[0016] Preferably, the pharmaceutical composition further comprises an auxiliary material, the auxiliary material being an excipient, a binder, a flow aid and / or an antioxidant, The excipient is ethanol or pure water, and the ethanol concentration is 40% to 95%; the binder is one or more of modified starch, pregelatinized starch, hydroxypropyl cellulose, sodium carboxymethylcellulose, glycerol, gelatin, methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, mannitol, lactose, microcrystalline cellulose; The flow aid is one or more of talc, silicon dioxide, magnesium stearate, rice flour, and titanium dioxide; The antioxidant may be one or more of rosemary extract, clove extract, cinnamon extract, Angelica dahurica extract, tea polyphenols, butylated hydroxyanisole, dibutylated hydroxytoluene, propyl gallate, tert-butylhydroquinone, and vitamin E.

[0017] According to the first aspect, the dosage form of the pharmaceutical composition is one or more of tablet, powder, hard capsule, soft capsule, and suspension.

[0018] In the second aspect, the above-mentioned pharmaceutical composition based on vitamin K2 for improving the life quality of the elderly is provided for application in dietary supplements and health care products. In a third aspect, the present invention also provides a soft capsule, which contains the above-mentioned pharmaceutical composition for improving the life quality of the elderly based on vitamin K2.

[0019] In a preferred embodiment of the third aspect, the pharmaceutical composition comprises the following components by weight: 10-85 parts Omega-3 fatty acid, 3-20 parts Vitamin K2, 0.1-4 parts Astaxanthin, 3-30 parts Sulforaphane, 1-15 parts Rare Ginsenosides, 1-30 parts Sialic Acid, 50-400 parts Soft Capsule Shell and 20-200 parts Supplementary Materials.

[0020] In a fourth aspect, the present invention provides a method for preparing the above-mentioned soft capsule containing the above-mentioned pharmaceutical composition for improving the life quality of the elderly based on vitamin K2, the preparation method comprising two parts: a first part for preparing sustained-release micropills from composition II; and a second part for preparing soft capsules by encapsulating the sustained-release micropills with composition I, the preparation method comprising the following steps: 1) Mixing: Composition II containing vitamin K2, rare ginsenoside CK and sialic acid is placed in a V-type mixer, dry mixed for 10 to 30 minutes, passed through a 60 mesh sieve, and the mixture is obtained by collecting the material that passed through the sieve; 2) Granulation: The mixture obtained in step 1) is mixed with auxiliary materials, and then dry granulation is adopted to control the particle size to 50-300 mesh to obtain granulated granules; 3) Micropill: The granules obtained in step 2) are mixed with excipients, binders and flow aids in the auxiliary materials, and then placed in the base tray of the granulator together with the core pellets, followed by preparing micropills by powder layering; 4) Capsule liquid: Composition I containing Ω-3 fatty acid, astaxanthin, sulforaphane and antioxidant and the auxiliary antioxidant are weighed by weight, and the antioxidant, astaxanthin and sulforaphane are dissolved in Ω-3 fatty acid oil at 20 to 60°C, respectively, to obtain an oil mixture, which is left for 4 to 12 hours to degas, to obtain a capsule liquid; 5) Capsule shell: Manufacture soft capsule shells using the general recipes and preparation methods in the industry. 6) Soft capsule: The capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed to obtain a soft capsule containing the micropills.

[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 provides anti-cancer and immunomodulatory effects from the macro-organism level, and functional composition II provides anti-Alzheimer's disease and nerve damage repair effects from the micro-cellular level. These two levels act synergistically, exerting a synergistic effect to exert the preventive and therapeutic effects of anti-cancer and anti-Alzheimer's disease, improving the life of the elderly. At the same time, the composition also has other beneficial effects, such as strengthening bones, improving osteoporosis, anti-aging, anti-oxidation, improving memory and cognition, lowering blood lipids, and protecting the liver.

[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, especially the first-pass effect of the active ingredients in functional composition II in the oral cavity and stomach, avoid premature decomposition, improve bioavailability, and ensure longer stable function, and long-term use of the composition without toxic side effects. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Hereinafter, the technical solutions in the embodiments of the present invention will be described clearly and completely in conjunction with the specific embodiments of the present invention, but it is clear that the described embodiments are only some of the embodiments of the present invention, and are not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative efforts fall within 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. In addition to the main effects of anti-cancer and anti-Alzheimer's disease, the pharmaceutical composition also has the effects of strengthening bones, improving osteoporosis, anti-aging, anti-oxidation, improving memory and cognition, lowering blood lipids, protecting the liver and so on, which can effectively improve the quality of life of the elderly and provide health support and protection.

[0025] The present invention meets the purpose of preventing and treating cancer and Alzheimer's disease, which seriously affect the life of the elderly, at both 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 ingredients. At the micro level, the present invention achieves anti-Alzheimer's disease and repair of neuronal damage by selecting target cell and mitochondrial metabolism regulating and inducing active ingredients. The two levels exert synergistic effects, together fulfilling the prevention and treatment purposes of anti-cancer and anti-Alzheimer's disease, and improving the life quality of the elderly. At the same time, the composition also has other beneficial effects such as strengthening bones, improving osteoporosis, anti-aging, anti-oxidation, improving memory and cognition, lowering blood lipids, and protecting the liver.

[0026] On the one hand, the present invention provides a pharmaceutical composition for improving the quality of life of the elderly based on vitamin K2 (MK-7), which comprises functional composition I and functional composition II, and the mass ratio of composition I and composition II is (0.5-7):1.

[0027] Omega-3 is a long-chain polyunsaturated fatty acid, and current research data shows that Omega-3 has the effect of promoting heart health and preventing coronary artery disease. It is mainly effective in preventing and treating cardiovascular and cerebrovascular diseases by protecting the cells of the inner walls of blood vessels, restoring vascular elasticity, relaxing blood vessels, inhibiting platelet aggregation, lowering blood pressure, inhibiting the formation of blood clots, while reducing blood lipids.

[0028] In addition, Omega-3 also plays a role in preventing arrhythmia and sudden cardiac death. A clinical study that followed more than 11,000 patients with coronary artery disease revealed that taking 1 to 2 grams of Omega-3 unsaturated fatty acids per day significantly reduced the mortality rate of cardiovascular disease patients, and in particular reduced the incidence of sudden cardiac death by 45%.

[0029] There are three types of omega-3 fatty acids: alpha-linolenic acid, eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). EPA has the effect of preventing the onset of stroke and myocardial infarction, lowering blood cholesterol, and preventing arteriosclerosis. DHA activates brain cells, promotes the adjustment of neural circuits, and maintains 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 properties, it is preferable in the present invention to use omega-3 fatty acids in the pharmaceutical composition of the present invention as part of the lifestyle contribution, which can reduce the risk of sudden cardiac death in the elderly.

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

[0032] More preferably, the content of EPA in Omega-3 fatty acids is ≧40%, and the content of EPA is ≧45%.

[0033] Astaxanthin is a ketone carotenoid that is widely present in living organisms. As a non-vitamin A carotenoid, astaxanthin cannot be converted to vitamin A in the animal body, but it has the same antioxidant properties as carotenoids.

[0034] Meanwhile, excessive oxygen radicals are known to be the main culprit in 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 diseases, cardiovascular diseases, blood diseases and respiratory diseases. Due to its special molecular structure, astaxanthin can pass through the outer walls of human cells and directly remove oxygen radicals within the cells, protecting the health of cells from the inside out and maintaining the vitality of the human body.

[0035] On the other hand, it is known that the oxidation of low-density lipoprotein (LDL) in the blood is an important cause of arteriosclerosis and high blood pressure, and the large amount of cholesterol consumed in modern daily diets increases this risk. Astaxanthin can prevent the oxidation of LDL, increase high-density lipoprotein, restore the elasticity of blood vessels, and reduce the probability of high blood pressure, stroke, and heart attack.

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

[0037] Sulforaphane is an isothiocyanate obtained by hydrolysis of thioglucoside by black mustard enzymes in the plant body. It is abundant in cruciferous plants such as broccoli, mustard greens, and northern red radish, and is a common antioxidant and is the most potent plant active substance in vegetables with anti-cancer effects.

[0038] Scientific studies have shown that sulforaphane has a broad-spectrum anti-tumor effect and is effective against cancers such as liver cancer, lung cancer, prostate cancer, breast cancer, rectal cancer, colon cancer, gastric cancer, pancreatic cancer, skin cancer, leukemia, brain glioma cancer, and nasopharyngeal cancer.

[0039] Its main mechanism of action is: 1) Sulforaphane protects DNA by controlling the action of carcinogen-metabolizing enzymes, including an inhibitory effect on phase I enzymes and a strong inductive effect on phase II enzymes. 2) Sulforaphane can induce autophagy and apoptosis, block the cell cycle, and suppress cell proliferation. 3) Sulforaphane inhibits basement membrane microtubule formation and endothelial cell proliferation, thereby inhibiting the generation of blood vessels in tumor bodies, inhibiting tumor metastasis, and preventing cancer progression. In addition, sulforaphane itself is active and can react with some carcinogens to inactivate them.

[0040] Therefore, it is preferred in the present invention 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] For the above reasons, it is macroscopically preferable to configure Composition I with Ω-3 fatty acid, astaxanthin, and sulforaphane as the main active ingredients.

[0043] In consideration of the same action or effect, said composition I may or may not contain secondary active ingredients, and the secondary active ingredients may be one or more of grape seed oil, wheat germ oil, Chinese walnut seed oil, camellia oil, and olive oil.

[0044] Vitamin K2 is a fat-soluble vitamin that is mainly used to treat and prevent osteoporosis. Depending on the length of the tail chain, K2 is divided into subclasses such as MK-4, MK-7, MK-8, and MK-10. All vitamin K2 are structurally similar, but the length of the side chain differs. The longer the side chain, the better it is absorbed, the more bioactive it is, and the longer it remains in the blood. Therefore, the long-chain MK-7 is the best quality, has the highest bioavailability, and has been proven to have a long half-life after oral intake, allowing it to exert its benefits for a long period of time. On the other hand, MK-7 is obtained from plant fermentation and has a healthier source.

[0045] Vitamin K2 has been demonstrated to have anti-cancer effects on many tumor cells, inhibiting the growth of cancer cells and being a potential preventive and clinical cancer treatment. Current research shows that the anti-cancer mechanism of MK-7 is: (1) It produces free radicals during the redox reaction of the naphthoquinone nucleus in the MK-7 structure, which induces the expression of the nuclear transcription factor NK-kB and reduces bcl-2 / bax by suppressing the expression of the anti-apoptotic gene bcl-2, damaging the function of mitochondria and leading to cancer cell death. (2) MK-7 controls the anti-cancer effects of different transcription factors through tyrosine kinase and phosphoesterase. (3) MK-7 enhances the activity of PKA by activating AP2 "USF" CREB, and inhibits the proliferation and invasion of liver cancer cells through the signaling pathway mediated by PKA and MAPK. (4) Vitamin K2 can inhibit the proliferation and invasion ability of liver cancer cells and induce apoptosis by reducing the Wnt / β-catenin signal. (5) It inhibits angiogenesis.

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

[0047] More preferably, the MK-7 is obtained by fermenting organic legumes, has a purity of ≧99.5% in the trans configuration, and the bioavailability of the trans configuration MK-7 is higher.

[0048] Ginsenosides are the main active ingredients in ginseng and are triterpene compounds. At present, at least 60 kinds of ginsenosides have been isolated from ginseng. Research has shown that ginsenosides can prolong life, increase physical strength, and treat cancer patients' immune function decline caused by radiation therapy and chemotherapy, while also increasing the vitality of cells on the surface of the human body and inhibiting aging. Most traditional ginsenosides are original ginsenosides, which have low biological activity and are difficult to absorb and utilize by the human body. After undergoing enzyme catalytic metabolism, original ginsenosides are converted into rare ginsenosides, which have smaller molecular weights, stronger lipid solubility, and are easier to absorb by the human body. Rare ginsenosides include Rg3, Rh1, CK, Rh2, Rg5, Rk1, Rh3, Rk2, Rh4, Rk3, aPPT, aPPD, etc.

[0049] Meanwhile, the rare ginsenoside CK is a non-natural ginsenoside, which is converted from other diol-type ginsenosides, and is the main metabolic product and final absorption form of diol-type ginsenosides in the human intestinal tract. The specificity of the mother core structure of ginsenoside tetracyclic triterpene determines that CK can only be obtained by mild bioconversion methods.

[0050] Research has shown that CK can exert tumor-suppressing effects on various tumors through mechanisms such as induction of apoptosis, inhibition of cell proliferation, inhibition of angiogenesis, and inhibition of metastasis. Among them, there have been many studies on its effect on hepatocellular carcinoma, and its cancer-suppressing effect is particularly prominent. In addition, CK has low toxicity, making it more suitable for long-term treatment than other chemotherapy drugs. Therefore, the present invention preferably uses rare ginsenoside CK as one of the active ingredients of composition II.

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

[0052] Sialic acid is a naturally occurring carbohydrate that accounts for more than 99% of the total sialic acid family and is therefore also called sialic acid. Its chemical name is N-acetylneuraminic acid.

[0053] Sialic acid is widely distributed in nature, and is now known to be found in animals, plants, and microorganisms. The brain has the highest sialic acid content in the human body, and the content of sialic acid in brain gray matter is 15 times that of other organs such as the liver and lungs.

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

[0055] Sialic acid promotes brain development mainly through its action in SA, which binds to neurotonin, and in neurotransmitters. Human neurotransmission is essentially a weak electrochemical reaction. When an electric current flows, sialic acid receives an electrical signal (because it has a very strong negative charge itself) and converts it into Ca 2+ is released from neurotonin, passes through ion channels into the presynapse, and opens neurovesicles to release neurotransmitters. The neurotransmitters pass through the cell membrane, reach the postsynapse, and finally enter the neuronal synapse. 2+ The process of neurotransmission is essentially the transmission of electric charge, and sialic acid plays an important role as the "signal gun" in this process.

[0056] In the present invention, sialic acid is preferably selected as one of the active ingredients of Composition II, which is used to promote brain development, improve cognition in the elderly, enhance memory, and prevent and ameliorate Alzheimer's disease.

[0057] More preferably, the purity of the associated sialic acid is ≧98%.

[0058] In conclusion, vitamin K2, rare ginsenoside CK and sialic acid are the main active ingredients of Composition II, which can favorably resist Alzheimer's disease and repair cell damage from a microscopic angle.

[0059] Considering the similar effect or the degree thereof, it is preferable that Composition II further contains or does not contain one or more secondary active ingredients including tripterin, pterostilbene, resveratrol, curcumin, and piceatannol.

[0060] The present invention has found that there are many raw materials or functional compositions for anti-cancer and anti-Alzheimer's disease in this field, but these components do not simply redistribute and do not produce a synergistic effect, and some of them have antagonistic effects and may have a single action effect. Therefore, the present invention selects the above-mentioned healthy, safe and mild components through a large number of tests from the perspective of comprehensive synergistic prevention and treatment of cancer and Alzheimer's disease from two levels, macro and micro, and uses them for preferred redistribution to achieve multi-effective synergistic action of targets. From macro-level anti-cancer and immune regulation to micro-level target cell and mitochondrial metabolism regulation and induction. The two levels work together to achieve the prevention and treatment purpose of improving the life quality of the elderly through anti-cancer and anti-Alzheimer's.

[0061] In one specific embodiment of the present invention, the pharmaceutical composition includes 10-85 parts omega-3 fatty acid, 3-20 parts vitamin k2 (MK-7), 0.1-4 parts astaxanthin, 3-30 parts sulforaphane, 1-15 parts rare ginsenoside CK, and 1-30 parts amylose.

[0062] The second aspect of the present invention is to provide a method for preparing a pharmaceutical composition for improving the quality of life of the elderly based on the above-mentioned vitamin K2 (MK-7), the first part including functional ingredient II as sustained-release micropills, and the second part including functional ingredient I encapsulating the sustained-release micropills and then forming them into soft capsules.

[0063] In a representative example, the preparation method is as follows. 1) Mixing: Put functional ingredient II, including vitamin K2, rare ginsenosides, and sialic acid, into a V-type mixer and dry mix for 10-30 minutes. Then pass through a 60-mesh sieve and remove the undersieve to obtain the mixture. 2) Granulation: The mixture obtained in step 1 is mixed uniformly with the auxiliary materials, and granulated by dry method, and the particle size is controlled to 50-300 mesh to obtain granules. 3) Micropills: The granular material obtained in step 2) is uniformly mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out by weight, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 20 to 60°C to obtain a mixed oil liquid, which is then left to stand for 4 to 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0064] Among them, the method for preparing the sustained-release micropills is as follows: the main machine rotation speed is 20-200 r / min, the spray pressure is 0.1-1 MPa, the feed rate is 20-100 r / min, and the spray pump speed is 10-90 r / min.

[0065] The above-mentioned dry granulation and soft capsule shell, i.e., filling techniques must be selected for combination, and the specific methods are recognized by those skilled in the art.

[0066] By making composition II into sustained release micropills, it can enhance its stability guarantee activity and increase its bioavailability in the body.By packaging composition I into the form of composition II, it can effectively protect the active ingredient in composition II, effectively block conditions such as oxo acid, extend shelf life and stability, avoid the first-pass effect in the oral cavity and stomach, and enhance the activity effect, while the physical properties differ depending on the raw material.

[0067] The third aspect of the present invention provides the application of said pharmaceutical composition based on vitamin k2 (MK-7) for improving the quality of life of the elderly in dietary supplements and health care products.

[0068] The fourth aspect of the present invention provides a soft capsule comprising the above pharmaceutical composition, preferably the pharmaceutical composition for improving the quality of life of the elderly based on vitamin K2 (MK-7) comprises the following components: 10-85 parts of omega-3 fatty acid, 3-20 parts of vitamin K2 (MK-7), 0.1-4 parts of astaxanthin, 3-30 parts of sulforaphane, 1-15 parts of rare ginsenoside CK, 1-30 parts of sialic acid, 50-400 parts of soft capsule shell and 20-200 parts of auxiliary materials.

[0069] More preferably, the auxiliary material is an excipient, a binder, a flow aid, or an antioxidant.

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

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

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

[0073] In another embodiment, the antioxidant is one or more of rosemary extract, clove extract, cinnamon extract, Angelica dahurica extract, tea polyphenols, butylated hydroxyanisole, dibutylated hydroxytoluene, propyl gallate, tert-butylhydroquinone, and vitamin E.

[0074] In the composition of the present invention, functional composition I provides the effects of anti-cancer and immunoregulation at the macro level, and functional composition II provides the effects of anti-Alzheimer's and nerve damage repair at the micro level. The two levels work together to achieve the prevention and treatment purposes of anti-cancer and anti-Alzheimer's, which improve the quality of life of the elderly. At the same time, this composition has the effects of strengthening bones, improving osteoporosis, preventing senility, antioxidant, 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, makes its function more stable for a long time, and has no toxic side effects when taken for a long time.

[0076] The following examples are intended to illustrate the present invention but are not intended to limit the scope of the invention.

[0077] Example 1 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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: Put a certain mass of vitamin K2, rare ginsenoside, and sialic acid into a V-type mixer, dry mix for 10 minutes, and then pass through a 60 mesh sieve. Take the mixture that passed through the sieve. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 100 mesh to obtain a granular material. 3) Micropill: The granular material obtained in step 2) is mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. Here, the main body rotation speed during production is 40r / min, the spray pressure is 0.2MPa, the feed speed is 30r / min, and the spray pump speed is 20r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out by weight, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 30°C to obtain a mixed oil liquid, which is then left to stand for 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0079] Example 2 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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: Put a certain mass of vitamin K2, rare ginsenoside, and sialic acid into a V-type mixer, dry mix for 15 minutes, and then pass through a 60 mesh sieve. Take the mixture that passed through the sieve. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 150 mesh to obtain a granular material. 3) Micropill: The granular material obtained in step 2) is mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. Here, the main body rotation speed during production is 40r / min, the spray pressure is 0.3MPa, the feed speed is 35r / min, and the spray pump speed is 25r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out by weight, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 35°C to obtain a mixed oil liquid, which is then left to stand for 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0081] Example 3 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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% adhesive, 0.06% flow aids and 0.06% antioxidants.

[0082] The preparation method is as follows. 1) Mixing: A certain mass of vitamin K2, rare ginsenoside, and sialic acid are each placed in a V-type mixer, dry mixed for 20 minutes, and then passed through a 60 mesh sieve. The mixture is obtained by taking the material that passed through the sieve. 2) Granulation: The mixture obtained in step 1 is mixed uniformly with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 2000 mesh to obtain a granular material. 3) Micropill: The granular material obtained in step 2) is mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. Here, the main body rotation speed during production is 40r / min, the spray pressure is 0.2MPa, the feed speed is 30r / min, and the spray pump speed is 20r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 40°C to obtain a mixed oil liquid, which is then left to stand for 11 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0083] Example 4 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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% adhesive, 0.07% flow aids and 0.06% antioxidants.

[0084] The preparation method is as follows. 1) Mixing: A certain mass of vitamin K2, rare ginsenoside, and sialic acid are each placed in a V-type mixer, dry mixed for 20 minutes, and then passed through a 60 mesh sieve. The mixture is obtained by taking the material that passed through the sieve. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 200 mesh to obtain a granular material. 3) Micropill: The granular material obtained in step 2) is mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. Here, the main body rotation speed during production is 435r / min, the spray pressure is 0.15MPa, the feed speed is 30r / min, and the spray pump speed is 25r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 40°C to obtain a mixed oil liquid, which is then left to stand for 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0085] Example 5 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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% adhesive, 0.07% flow aids and 0.05% antioxidants.

[0086] The preparation method is as follows. 1) Mixing: A certain amount of vitamin K2, rare ginsenoside, and sialic acid are placed in a V-type mixer, and dry mixed for 25 minutes. The mixture is then passed through a 60 mesh sieve and the undersized material is removed to obtain a mixture. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 150 mesh to obtain a granular material. 3) Micropill: After mixing the granular material obtained in step 2 with a certain mass of excipients, binders, and flow aids in the auxiliary materials, the mixture is put into the granulator base tray together with the core pellets, and the micropills are produced by the powder layering method. Here, the main body rotation speed during production is 45r / min, the spray pressure is 0.25MPa, the feed speed is 35r / min, and the spray pump speed is 30r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out by weight, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 35°C to obtain a mixed oil liquid, which is then left to stand for 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0087] Example 6 This embodiment provides a soft capsule containing a pharmaceutical composition for improving the quality of life of the elderly based on vitamin k2 (MK-7), which is characterized by containing the following weight percentages of ingredients: 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% adhesive, 0.08% flow aids and 0.07% antioxidants.

[0088] The preparation method is as follows. 1) Mixing: Put a certain mass of vitamin K2, rare ginsenoside, and sialic acid into a V-type mixer, dry mix for 15 minutes, and then pass through a 60 mesh sieve. Take the mixture that passed through the sieve. 2) Granulation: The mixture obtained in step 1 is uniformly mixed with excipients and flow aids, and granulated by a dry method. The particle size is controlled to 150 mesh to obtain a granular material. 3) Micropill: The granular material obtained in step 2) is mixed with a certain mass of excipients, binders, and flow aids in the auxiliary materials, and then placed in the granulator base tray together with the core pellets to produce micropills by powder layering method. Here, the main body rotation speed during production is 40r / min, the spray pressure is 0.3MPa, the feed speed is 35r / min, and the spray pump speed is 25r / min. 4) Capsule liquid: Functional ingredient I containing Omega-3 fatty acids, astaxanthin, and sulforaphane, and antioxidants in the auxiliary materials are weighed out by weight, and the antioxidants, astaxanthin, and sulforaphane are each dissolved in Omega-3 oil at 35°C to obtain a mixed oil liquid, which is then left to stand for 12 hours and degassed to obtain the capsule liquid. 5) Capsule shells: Soft capsule shells are manufactured using industry-standard recipes and preparation methods. 6) Soft Capsule: Using special equipment, the capsule liquid from step 4) is injected between the two layers of capsule shell containing the micropills from step 3) and pressed through a special mold to obtain a soft capsule containing the micropills inside.

[0089] Validation Testing Validation: Stability test of the composition prepared according to the present invention The soft capsules containing the pharmaceutical compositions prepared in Examples 1 to 6 were designated as Experiments 1 to 6, and commercially available Vitamin K2 (MK-7) soft capsules (MK-7 content 90 μg) were designated as the control group, each of which was placed in a sealed brown vial. The capsules were placed in a constant temperature and humidity box at 40 ± 2 ° C and 75% ± 5% RH to conduct an accelerated experiment. Sampling was performed 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] From the results in Table 1, it can be seen that the content of MK-7 in the soft capsules containing the compositions of Example 1, Example 2, Example 3, Example 4, Example 5, and Example 6 is almost unchanged and stable, while in the control group, the content begins to decline after 3 months of accelerated treatment. It is explained that in the pharmaceutical composition containing MK-7 prepared by the preparation method of the present invention, the MK-7 active ingredient can be kept stable for a relatively long time. Calculating from the normal accelerated conversion time, the pharmaceutical composition soft capsules for improving the life quality of the elderly based on vitamin K2 prepared by the method of the present invention can guarantee a shelf life of at least 3 years at room temperature.

[0091] Verification test: Efficacy animal verification test of the pharmaceutical composition prepared according to the present invention a) Verification of the tumor suppression effect of drug compositions 140 mice (half male and half female) about 3 months old were selected, with a weight range of 15.41-18.47g. Primary tumor cells were subcutaneously inoculated, and blood was collected 24 hours later to detect tumor markers and confirm the success rate of mouse modeling. 126 mice (half male and half female) with cancer were randomly divided into 6 groups, with 21 mice (half male and half female) in each group being experimental group 1, experimental group 2, experimental group 3, experimental group 4, experimental group 5, and experimental group 6, respectively. Among them, experimental group 1 is fed with the drug composition containing Example 4 once a day (10mg / kg) except for normal feeding. Experimental group 2 is fed with the drug composition containing Example 5 once a day (10mg / kg) except for normal feeding. Experimental group 3 is fed with the drug composition containing Example 6 once a day (10mg / kg) except for normal feeding. Experimental group 4 was fed pure MK-7 (10mg / kg) once a day in addition to the normal feeding. Experimental group 5 was fed a known anticancer drug (sildenafil) (10mg / kg) once a day in addition to the normal feeding. Experimental group 6 was fed the same weight of saline once a day in addition to the normal feeding. The drug was stopped 15 days after administration, and after stopping the drug for 24 hours, the vertebrae were cut and processed, and the tumors of the mice were taken to prepare tumor specimens, which were called heavy tumors and recorded. Calculation of tumor inhibition rate: tumor inhibition rate = (average tumor weight of control group - average tumor weight of experimental group) / average tumor weight of control group. The experimental results are shown in Table 2.

[0092] [Table 2] As can be seen from Table 2, experimental groups 1 to 3 have significant tumor-suppressing effect compared with control group 5. Compared with control group 4, the effects of experimental groups 1 to 3 are better, suggesting that the recovery effect of the pharmaceutical composition of the present invention is due to the effect of the pure product alone.

[0093] b Flow cytometer detects the effect of drug composition on apoptosis MCF-7 cancer cells in the logarithmic growth phase were harvested and digested, followed by 5 × 10 cells per well. 5The cells are inoculated into a six-well plate, and the drug is added after 6 hours. The experimental groups (Examples 1 to 6 correspond to experimental groups 1 to 6, respectively) are treated with the drug composition, and the same amount of medium is added to the negative control group. 48 hours after administration, the target cells are digested into single cells with trypsin, centrifuged at 1000 rpm for 5 minutes to collect the cells, added 4°C pre-cooled PBS buffer to wash the cells, blown the cell precipitate into a single cell suspension, and centrifuged at 1000 rpm for 5 minutes to collect the cells. 4°C pre-cooled PBS buffer is added again to wash the cells, blown the cell precipitate into a single cell suspension, count the cells, and centrifuged at 1000 rpm for 5 minutes to collect the cells. An appropriate amount of 1×Binding Buffer is added according to the number of collected cells, and the number of cells is adjusted to 5×106cells / ml. 100uL (5×105 cells) of the above cell suspension is taken, and 7μl FITCAnnexin V and 7μl Pl are added respectively. Mix by inverting and incubate for 15 minutes at room temperature (25°C) away from light. Finally, add 400ul 1x Binding Buffer and detect the apoptotic status with a flow cytometer within 1 hour. The experimental results are shown in Table 3.

[0094] [Table 3] The experimental results showed that the pharmaceutical composition of the present invention has the effect of significantly inducing apoptosis in MCF-7 cancer cells, which is the mechanism of action of its anti-cancer activity.

[0095] c Drug composition effects on cognition Forty healthy 14-18 month old SD male rats were randomly divided into a sham operation control group, a model control group, and experimental groups 1-6 (corresponding to Examples 1-6, respectively), with 10 rats in each group. A rat common carotid artery severe stenosis block method was used to create a rat model of aged MCI (mild cognitive impairment), and a Morris water maze experiment was performed 30 days after modeling to exclude rats that did not meet the MCI criteria. The experimental group was intragastricly administered with the corresponding example drug composition (12 mg / kg) every day, and the sham operation group and model group were all intragastricly administered with 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 filled into the stomach, the rats in each group were subjected to the Morris water maze experiment to test and measure their learning and memory abilities. The observation indicators were: (1) Stereotaxic navigation experiment: The average latency of the rats to explore the platform. (2) Spatial exploration experiment: The number of times the rats crossed the original platform position and the proportion of swimming time in the original platform quadrant were the observation indicators. The experimental results are shown in Table 4 and Table 5.

[0097] [Table 4]

[0098] [Table 5]

[0099] In the Morris water maze orientation navigation experiment and spatial exploration learning and memory test, the avoidance latency and the number of times crossing the platform are closely related to visual-based spatial orientation memory and spatial orientation memory. The results showed that in the orientation navigation experiment, the average latency of the exploration platform in experimental groups 1-6 was lower than that of the model group (P<0.05), and the data in experimental groups 1-6 differed depending on the composition ratio, with the sham operation group being the lowest (P<0.05). In the spatial exploration experiment, the number of times crossing the original platform and the proportion of the time crossing the target quadrant in the total swimming time in experimental groups 1-6 were significantly higher than that of the model group (P<0.05), and the sham operation was the highest (P<0.05).

[0100] From the above, it was revealed that supplementation with the pharmaceutical composition of the present invention improved the learning and memory ability of aged MCI rats, and had an auxiliary therapeutic effect on senile dementia.

[0101] All of the techniques described in detail in the present invention are 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 intended to be limiting. Although the present invention has been described in detail with reference to the 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 are included in the claims of the present invention.

Claims

1. Composition I and composition II are included, in which composition I has anti-cancer and immunomodulatory functions, and composition II has targeted anti-Alzheimer's and neuronal damage repair functions; A vitamin K composition, characterized in that the mass part ratio of composition I to composition II is (0.5 to 7):

1. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

2. 2. The vitamin K composition according to claim 1, wherein the composition I contains a main active ingredient and may or may not contain a secondary active ingredient, the main active ingredients being omega-3 fatty acid, astaxanthin, and sulforaphane, and the secondary active ingredients being one or more of grape seed oil, wheat germ oil, Chinese walnut seed oil, camellia oil, and olive oil. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

3. The composition II contains a main active ingredient, and may or may not contain a secondary active ingredient, and the main active ingredient is vitamin K. 2 2. The vitamin K extract according to claim 1, characterized in that it contains rare ginsenoside CK and sialic acid, and the secondary active ingredients include one or more of tripterin, pterostilbene, resveratrol, curcumin and piceatannol. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

4. Vitamin K according to claim 2, characterized in that the ratio of EPA to DHA in the Omega-3 fatty acids is (0.1-4):

1. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

5. Vitamin K 2 4. Vitamin K according to claim 3, characterized in that it is in the MK-7 form having an all-trans structure. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

6. 10-85 parts Omega-3 fatty acids, 3-20 parts Vitamin K 2 2. The vitamin K extract according to claim 1, comprising the following components by mass: 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. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

7. The pharmaceutical composition further comprises an auxiliary material, the auxiliary material being an excipient, a binder, a flow aid and / or an antioxidant; The vehicle is ethanol or pure water, and the ethanol concentration is 40% to 95%; the binder is one or more of modified starch, pregelatinized starch, hydroxypropyl cellulose, sodium carboxymethylcellulose, glycerol, gelatin, methylcellulose, ethylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, mannitol, lactose, microcrystalline cellulose; The flow aid is one or more of talc, silicon dioxide, magnesium stearate, rice flour, and titanium dioxide; 2. Vitamin K according to claim 1, characterized in that the antioxidant is one or more of rosemary extract, clove extract, cinnamon extract, Angelica dahurica extract, tea polyphenols, butylhydroxyanisole, dibutylhydroxytoluene, propyl gallate, tert-butylhydroquinone, and vitamin E. 2 A pharmaceutical composition for improving the quality of life of the elderly based on the above.

8. Vitamin K according to any one of claims 1 to 8 2 The pharmaceutical composition for improving the quality of life of the elderly based on this invention is applied in dietary supplements and health care products.

9. Vitamin K according to any one of claims 1 to 8 2 A soft capsule comprising a pharmaceutical composition for improving the quality of life of the elderly based on the above.

10. The pharmaceutical composition comprises 10 to 85 parts omega-3 fatty acid, 3 to 20 parts vitamin K 2 The soft capsule according to claim 10, characterized in that it contains the following ingredients: 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 shell, and 20 to 200 parts auxiliary materials by mass.

11. The soft capsule contains vitamin K according to any one of claims 1 to 8. 2 The pharmaceutical composition for improving the life quality of the elderly is based on the above-mentioned compound II, and the preparation method includes two parts: a first part is to prepare sustained-release micropills from the composition II; and a second part is to prepare soft capsules by encapsulating the sustained-release micropills with the composition I, and the preparation method includes the following steps: 1) Mixed: Vitamin K 2 The composition II containing rare ginsenoside CK and sialic acid is put into a V-type mixer, dry-mixed for 10 to 30 minutes, and passed through a 60-mesh sieve. The mixture is taken from the sieve. 2) Granulation: The mixture obtained in step 1) is mixed with auxiliary materials, and then dry granulation is adopted to control the particle size to 50-300 mesh to obtain granulated granules. 3) Micropill: The granules obtained in step 2) are mixed with excipients, binders and flow aids in the auxiliary materials, and then placed in the base tray of the granulator together with the core pellets, followed by preparing micropills by powder layering method; 4) Capsule liquid: Composition I containing Omega-3 fatty acid, astaxanthin, sulforaphane and antioxidant and auxiliary antioxidant are weighed by weight, and the antioxidant, astaxanthin and sulforaphane are respectively dissolved in Omega-3 fatty acid oil at 20-60°C to obtain an oil mixture, which is left for 4-12 hours to degas, to obtain a capsule liquid; 5) Capsule shell: The soft capsule shell is manufactured according to the general recipe and preparation method of the industry. 6) Soft capsule: The method for preparing soft capsule described in claim 10 or 11, characterized in that the capsule liquid of step 4) is injected between the two layers of capsule shell containing the micropills of step 3), and pressed to obtain a soft capsule containing the micropills.

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