Pharmaceutical composition with bone strengthening function and application

Abstract

According to the theory of homology of medicine and food, through cucumber seeds and millet, the pharmaceutical composition has the effects of strengthening bones, protecting spleen and stomach, promoting nutrient absorption, enhancing bone density and promoting calcium absorption, acts on a human body together, effectively relieves osteoporosis symptoms and promotes bone regeneration and repair. The traditional Chinese medicine composition can be used for directly treating the kidney-yang deficiency type osteoporosis and remarkably improving the living quality of patients, and can also be used as a long-term medicine for preventing the kidney-yang deficiency type osteoporosis; the lettuce seeds, the flaxseeds, the soybeans, the black beans, the mulberry leaves and the folium cortex eucommiae jointly achieve the effects of tonifying the kidney and strengthening the bones; meanwhile, the lucid ganoderma is ingeniously fused in the formula as a guide, so that the medicine effects of other medicinal materials can be guided to penetrate into the internal organs, the vigor and vitality of the internal organs are stimulated and nourished, and meanwhile, kidney essence is tonified, so that the bones are strengthened.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a drug composition with bone strengthening function and application thereof. Background Art

[0002] Osteoporosis, also known as osteoporosis, is a systemic metabolic bone disease characterized by low bone mass, damage to bone tissue microstructure, increased bone fragility, and susceptibility to fractures. Osteoporosis is mainly characterized by a decrease in the amount of bone tissue per unit volume, thinning of the bone cortex, a decrease in the number and size of cancellous bones and trabeculae, widening of the bone marrow cavity, and a decrease in the load-bearing capacity of bones. This makes bones fragile and increases the risk of fractures.

[0003] Traditional Chinese medicine believes that the occurrence of osteoporosis is closely related to the dysfunction of multiple organs, especially the abnormal function of organs such as kidney, spleen, and liver. Kidney is the foundation of innateness, responsible for storing essence, essence produces marrow, and marrow nourishes bones. The rise and fall of kidney essence directly affects the whole process of bone growth, development, strength, and weakness. Kidney essence deficiency, marrow is not nourished, leading to empty bone marrow, which is the root cause of osteoporosis. Western medicine mainly uses some anti-osteoporosis drugs such as alendronate sodium to inhibit bone loss in the treatment of osteoporosis, but anti-osteoporosis drugs may irritate the gastrointestinal mucosa, leading to symptoms of nausea and vomiting, and have side effects to a certain extent.

[0004] Therefore, there is a need for a drug composition with bone strengthening function, which can effectively treat and prevent osteoporosis and has no side effects, and solves the side effects of existing drugs when taken through a combination of medicine and food. Summary of the invention

[0005] In order to solve the above technical problems, the present invention discloses a pharmaceutical composition with bone strengthening function. The pharmaceutical composition is based on the principle of medicine and food being of the same origin, and is used for people suffering from calcium deficiency, back pain, leg pain, osteoporosis, and joint discomfort. It can not only effectively treat osteoporosis of kidney yang deficiency type, but also be used as a medicine for preventing and treating osteoporosis of kidney yang deficiency type. In addition, the composition of the present invention has no side effects on the human body after taking it, and can be used as a health care medicine.

[0006] In order to achieve the above technical effects, on the one hand, the present invention discloses a drug composition with bone strengthening function, which comprises, by mass: 10-40 parts of cucumber seeds, 10-20 parts of lettuce seeds, 10-30 parts of flax seeds, 10-40 parts of soybeans, 10-40 parts of black beans, 10-40 parts of millet, 10-40 parts of mulberry leaves, 10-40 parts of eucommia leaves, and 10-30 parts of ganoderma lucidum; Further, the Chinese medicine composition comprises: 20-40 parts of cucumber seeds, 10-15 parts of lettuce seeds, 10-20 parts of flax seeds, 10-30 parts of soybeans, 10-30 parts of black beans, 20-40 parts of millet, 20-40 parts of mulberry leaves, 10-30 parts of eucommia leaves, and 10-20 parts of ganoderma lucidum; Further, the Chinese medicine composition comprises: 30-40 parts of cucumber seeds, 10-12 parts of lettuce seeds, 10-15 parts of flax seeds, 15-30 parts of soybeans, 15-30 parts of black beans, 20-35 parts of millet, 20-25 parts of mulberry leaves, 15-30 parts of eucommia leaves, and 10-15 parts of ganoderma lucidum; Furthermore, the Chinese medicine composition includes: 40 parts of cucumber seeds, 10 parts of lettuce seeds, 15 parts of flax seeds, 20 parts of soybeans, 20 parts of black beans, 30 parts of millet, 20 parts of mulberry leaves, 20 parts of eucommia leaves, and 10 parts of ganoderma lucidum.

[0007] Cucumber seeds: sweet, cool, non-toxic, and enter the liver and kidney meridians; they have the functions of calcium supplementation, bone setting, bone strengthening, and body strengthening. They have the function of repairing and treating long-term strain and bone damage. Modern research shows that cucumber seed polysaccharides can enhance the activity of osteoblasts, increase the metabolic rate of osteoclasts, and effectively promote the healing of tibial fractures in rats.

[0008] Lettuce seeds: They are mild in nature and sweet in taste; they enter the spleen, stomach, and large intestine meridians; lettuce seeds contain effective ingredients such as dietary fiber, which have the effects of relaxing muscles and activating blood circulation, and can relieve and heal contusions, muscle injuries, and soft tissue injuries.

[0009] Flaxseed: mild in nature, sweet in taste; meridians entered: lung, liver, and large intestine; flax seed has the effects of moisturizing dryness and relieving constipation, nourishing blood and dispelling wind, and can be used for intestinal constipation, dry skin, itching, and hair loss; modern research has also found that flax seed has the effects of lowering blood lipids, anti-tumor, anti-diabetes, and anti-kidney damage.

[0010] Soybeans: sweet and neutral in nature, and enter the spleen meridian, stomach meridian, and large intestine meridian. Modern research shows that soybeans can also lower cholesterol, prevent cardiovascular diseases, and enhance immunity.

[0011] Black beans: They are mild in nature, sweet in taste, and enter the spleen and kidney meridians. They have the effects of detoxification, diuresis, improving eyesight, nourishing blood and dispelling wind. Modern research shows that the black bean skin extract in black beans is rich in active ingredients such as anthocyanins, which has antioxidant, anti-inflammatory and anti-tumor effects.

[0012] Millet: sweet and salty in taste, cold in nature, and enters the stomach and kidney meridians; it has the effects of benefiting the stomach and intestines, nourishing the kidneys, clearing away dryness and heat, and relieving constipation; modern research shows that millet can lower blood pressure, improve diabetes and peptic diarrhea, and can also promote blood circulation.

[0013] Mulberry leaves: cold in nature, bitter in taste, and enter the lung and liver meridians; have the effects of dispersing wind-heat, clearing the lungs and moistening dryness, clearing the liver and improving eyesight; modern research shows that mulberry leaves contain flavonoids and flavonoid glycosides, amino acids, vitamins and other chemical components, which have anticoagulant, blood pressure lowering, blood lipid lowering, blood sugar lowering, and antibacterial effects.

[0014] Eucommia leaves: spicy, warm in nature, enter the liver and kidney meridians; have the effects of nourishing the liver and kidneys, strengthening the tendons and bones, and calming the fetus; modern research shows that Eucommia leaves contain a variety of chemically active ingredients such as cyclopentane ether terpenes, phenylpropanoids, lignin, etc., which have the effects of lowering blood pressure, anti-oxidation, anti-cancer, lowering blood lipids, anti-inflammatory, anti-viral, anti-aging, and strengthening tendons and bones.

[0015] Lingzhi: sweet in nature, neutral in taste, enters the heart, spleen, liver, and kidney meridians; has the effects of replenishing qi and calming the mind, relieving cough and relieving asthma. Modern research shows that qi-replenishing drugs, which are classified under the category of tonic drugs, have the pharmacological effects of regulating immunity, lowering blood sugar, lowering blood lipids, anti-oxidation, anti-aging, anti-tumor, sedation, anticonvulsant, cardiotonic, anti-arrhythmic, lowering blood pressure, relieving cough and relieving asthma, anticoagulation, and inhibiting platelet aggregation.

[0016] This recipe uses cucumber seeds and millet as the "main ingredients" and they complement each other. Millet balances the cool nature of cucumber seeds, and while strengthening bones it can also protect the spleen and stomach and promote the absorption of nutrients. Lettuce seeds, flax seeds, soybeans and black beans are used as "ministers" to assist cucumber seeds and millet, and together they achieve the effect of benefiting the kidneys and strengthening bones. Mulberry leaves and Eucommia leaves are used as "assistants" to enhance the bone-strengthening power of the "main ingredients". Ganoderma lucidum is added as an assistant to the formula, which can guide the various herbs in the recipe to reach the five internal organs, generate the qi of the five internal organs, replenish the kidney essence, and strengthen bones.

[0017] The beneficial effects of the present invention are: The present invention designs a drug composition with bone strengthening function. According to the theory of "medicine and food are of the same origin", cucumber seeds and millet are used to strengthen bones while protecting the spleen and stomach, promoting the absorption of nutrients, and drugs that can enhance bone density and promote calcium absorption act on the human body together, effectively relieving osteoporosis symptoms and promoting bone regeneration and repair. It can not only directly treat osteoporosis of kidney yang deficiency type and significantly improve the quality of life of patients, but also be used as a long-term osteoporosis prevention drug; lettuce seeds, flax seeds, soybeans and black beans, mulberry leaves and Eucommia leaves are used together to achieve the effect of strengthening the kidney and bones; at the same time, Ganoderma lucidum is cleverly incorporated into the formula as a guide, which can lead the efficacy of other medicinal materials to penetrate into the internal organs, stimulate and nourish the vitality and vigor of the five internal organs, and at the same time replenish the essence of the kidney, thereby strengthening the bones.

[0018] At the same time, this prescription avoids the side effects that may be caused by chemical ingredients by combining food and medicine, making it suitable for long-term use. It can also be used as a long-term drug for preventing and treating osteoporosis of kidney yang deficiency type. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] In order to more clearly illustrate the technical solution of the embodiment of the present invention, the drawings required for describing the embodiment are briefly introduced below.

[0020] Figure 1 : is a graph showing the expression level changes of testosterone T and cortisol CORT in Example 1 of the present invention, wherein a is the expression level change of testosterone T, and b is the expression level change of cortisol CORT; Figure 2 is a comparison diagram of rat pathological tissue sections at different magnifications in Example 2 of the present invention; Figure 3 This is a bone contrast image of the micro-CT in Example 2 of the present invention. DETAILED DESCRIPTION Example 1

[0021] A pharmaceutical composition with bone strengthening function, which is used for people with calcium deficiency, backache, leg pain, osteoporosis and joint discomfort according to the principle of medicine and food being of the same origin, and can effectively treat osteoporosis and be used as a medicine for preventing and treating osteoporosis; specifically, it comprises 40 parts of cucumber seeds, 10 parts of lettuce seeds, 15 parts of flax seeds, 20 parts of soybeans, 20 parts of black beans, 30 parts of millet, 20 parts of mulberry leaves, 20 parts of eucommia leaves and 10 parts of ganoderma lucidum; according to the above specific parts, they are put into respective containers for washing to wash away the dirt on the surface, and then the soybeans and black beans are soaked for 4-6 hours for subsequent grinding; the millet is soaked for half an hour to one hour to soften the grain and improve the grinding efficiency; the flax seeds, cucumber seeds and lettuce seeds are soaked for 10-15 minutes, and the rest do not need to be soaked, and then they are taken out and dried; the dried soybeans, black beans, millet, cucumber seeds, lettuce seeds and flax seeds are respectively put into a grinder and ground into powder; then they are mixed with clean water, honey and crystal sugar to prepare a liquid preparation for standby use; The effect of this scheme is now further verified through animal experiments. The specific process is as follows: Experimental animals: Fifteen SPF-grade 6-week-old male rats with a body weight of (200±20) g were purchased from Liaoning Mousheng Biotechnology Co., Ltd. The animals were allowed to drink water and eat freely and were raised under the conditions of temperature (25±1)℃, humidity 50%, and 12-h light.

[0022] Animal grouping and administration: After 1 week of adaptive feeding, all rats were randomly divided into 3 groups, 5 rats in each group, namely blank control group (muscular injection of equal amount of normal saline), kidney yang deficiency type osteoporosis group (kidney yang deficiency type osteoporosis modeling, during modeling, rats were injected with hydrocortisone suspension 2.5mg / 100g into the hind limb muscle, once a day, for 22 consecutive days. This modeling method is a prior art and will not be explained in detail here), experimental group; the drug dosage in the experimental group was 1.05g / (kg·d) (converted to human equivalent dose according to body surface area), and the drug decoction was given by gavage from the 8th day of modeling, and the control group was gavaged with sterile enzyme-free water (pure water); once a day, for 15 consecutive days until the 22nd day; after the experiment, the rats were anesthetized and blood was collected from the abdominal aorta; the rats were killed, and ELISA (enzyme-linked immunosorbent assay) was used to observe the changes in the expression levels of testosterone T and cortisol CORT in serum. The specific changes are as follows Figure 1 As shown by Figure 1 The results showed that compared with the blank control group, the serum testosterone T and cortisol CORT levels in the osteoporosis group with kidney yang deficiency were significantly reduced (P < 0.05), and the above indicators in the drug-treated group increased significantly after treatment (P < 0.05). The serum hormone level proved that the drug in the present invention has a significant effect on improving osteoporosis with kidney yang deficiency. Example 2

[0023] The liquid preparation prepared by the preparation method in Example 1 is now further compared with a commonly used osteoporosis drug (Xianling Gubao) on the market through animal experiments to verify the effect of the present invention. The specific process is as follows: Experimental animals: 20 SPF-grade 6-week-old male rats with a body weight of (200±20) g were purchased from Liaoning Mousheng Biotechnology Co., Ltd. The animals were allowed to drink water and eat freely and were raised under the conditions of temperature (25±1)℃, humidity 50% and 12-h light.

[0024] Animal grouping and administration: All rats were randomly divided into 4 groups after adaptive feeding for 1 week, with 5 rats in each group, namely, blank control group, kidney yang deficiency osteoporosis group (osteoporosis modeling, modeling method is the same as Example 1, no repetition here), Xianlinggubao group, experimental group, wherein the drug usage and dosage in the Xianlinggubao group is 250 mg / (kg·d) (converted into human equivalent dose according to body surface area), and the decoction prepared in Example 1 of the present invention was administered by intragastric administration in the experimental group, and the dosage was 1.05 g / (kg·d); starting from the 8th day of modeling, the Xianlinggubao group and the experimental group were given intragastric administration, once a day, for 15 consecutive days until the 22nd day. After the experiment, the rats were anesthetized, killed, and the femoral tissue was taken for micro-CT observation and pathological section observation by hematoxylin-eosin (HE) staining.

[0025] Afterwards, the above mice were subjected to pathological tissue section observation (bone section); Figure 2 As shown, from Figure 2 It can be seen from the slice tissues at different magnifications that the bone marrow structure of the blank control group is normal, the trabeculae are evenly distributed, the number is not reduced, and the bone marrow cavity is rich in bone marrow cells, as shown by the black arrow; the bone tissue structure of the kidney-yang deficiency type osteoporosis group is abnormal, the number of trabeculae is significantly reduced compared with the blank control group, some trabecular structures are thinner, as shown by the black arrow, and the bone marrow cells are loosely distributed, as shown by the red arrow; the bone tissue structure of the Xianling Gubao group is basically normal, the trabecular structure is not reduced, and the bone marrow cavity cells are rich, as shown by the black arrow; the treatment degree of the experimental group is equivalent to that of the Xianling Gubao group, and the trabecular structure is rich, as shown by the black arrow; it can be seen that the composition provided in the present invention has a comparable effect on osteoporosis than the drugs in the prior art, and has significant progress.

[0026] In addition, in this embodiment, the specific conditions of the bones of the experimental mice were further observed by micro-CT. Figure 3 As shown by Figure 3 It can be seen that the femoral heads of rats in the blank control group showed smooth edges of the articular surface, while the femoral heads of rats in the kidney yang deficiency type osteoporosis group showed blurred edges of the articular surface, sparse trabeculae, discontinuous fractures, and damaged bone microstructure. The bone microstructure of the Xianling Gubao group and the experimental group was significantly improved compared with the kidney yang deficiency type osteoporosis group; it can also be reflected from the side that the pharmaceutical composition of the present invention has made significant progress and can well improve kidney yang deficiency type osteoporosis, and through the combination of food and medicine as medicine, it also avoids the side effects that may be caused by chemical components, and is suitable for long-term use. At the same time, it can also be used as a drug for the prevention and treatment of kidney yang deficiency type osteoporosis for a long time.

[0027] The preferred embodiments of the present invention disclosed above are only used to help explain the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the invention to only the specific implementation methods described.

Claims

1. A pharmaceutical composition having bone strengthening function, characterized in that: According to mass, the ingredients include: 10-40 parts of cucumber seeds, 10-20 parts of lettuce seeds, 10-30 parts of flax seeds, 10-40 parts of soybeans, 10-40 parts of black beans, 10-40 parts of millet, 10-40 parts of mulberry leaves, 10-40 parts of eucommia leaves, and 10-30 parts of ganoderma lucidum.

2. A pharmaceutical composition having bone strengthening function according to claim 1, characterized in that: The traditional Chinese medicine composition comprises: 20-40 parts of cucumber seeds, 10-15 parts of lettuce seeds, 10-20 parts of flax seeds, 10-30 parts of soybeans, 10-30 parts of black beans, 20-40 parts of millet, 20-40 parts of mulberry leaves, 10-30 parts of eucommia leaves and 10-20 parts of ganoderma lucidum.

3. A pharmaceutical composition having bone strengthening function according to claim 1, characterized in that: The traditional Chinese medicine composition comprises: 30-40 parts of cucumber seeds, 10-12 parts of lettuce seeds, 10-15 parts of flax seeds, 15-30 parts of soybeans, 15-30 parts of black beans, 20-35 parts of millet, 20-25 parts of mulberry leaves, 15-30 parts of eucommia leaves and 10-15 parts of ganoderma lucidum.

4. A pharmaceutical composition having bone strengthening function according to claim 1, characterized in that: The traditional Chinese medicine composition comprises: 40 parts of cucumber seeds, 10 parts of lettuce seeds, 15 parts of flax seeds, 20 parts of soybeans, 20 parts of black beans, 30 parts of millet, 20 parts of mulberry leaves, 20 parts of eucommia leaves and 10 parts of ganoderma lucidum.

5. A pharmaceutical preparation prepared from a pharmaceutical composition having bone strengthening function as claimed in claims 1 to 4, characterized in that: The pharmaceutical preparations include capsules, pills, powders, tablets, granules and oral liquids.

6. Use of the pharmaceutical preparation according to claim 5 as a drug for treating and preventing osteoporosis.

7. The use of the pharmaceutical preparation according to claim 6, characterized in that: One or more pharmaceutically acceptable excipients or additives may be added to the pharmaceutical preparation to improve drug absorption or facilitate administration; the excipients or additives include fillers, diluents, binders, absorption enhancers, stabilizers, flavoring agents, and sweeteners.

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