A mongolian medicine composition for treating osteoporosis and its preparation and application

Abstract

This invention belongs to the technical field of Mongolian medicine composition, and discloses a Mongolian medicine composition for treating osteoporosis, its preparation and application. The composition, by weight, consists of 5-15 parts of ginseng, 10-20 parts of dragon bone, 8-18 parts of gypsum, 6-16 parts of pomegranate, 3-9 parts of cardamom, 4-12 parts of safflower, 2-8 parts of cinnamon, and 2-8 parts of long pepper. This Mongolian medicine composition integrates characteristic Mongolian medicines such as ginseng and gypsum, following the Mongolian medicine theory of "harmonizing cold and heat, and combining tonification and purgation." It can simultaneously act on three key pathological links: "inhibiting osteoclast activity," "promoting osteogenic differentiation," and "regulating the inflammatory microenvironment of bone tissue," achieving multi-target synergistic treatment. It not only effectively improves low bone mass but also significantly relieves bone pain, fundamentally intervening in bone metabolic imbalance and achieving a comprehensive therapeutic effect that addresses both the symptoms and the root cause.

Description

Technical Field

[0001] This invention relates to the field of Mongolian medicine composition technology, specifically to a Mongolian medicine composition for treating osteoporosis and its preparation and application. Background Technology

[0002] Osteoporosis (OP) is a systemic bone metabolic disease characterized by low bone mass, bone microarchitectural deterioration, and increased bone fragility. Clinically, it primarily manifests as bone pain, spinal deformities, and fragility fractures. Its core pathological mechanism lies in the disruption of the dynamic balance between bone formation and bone resorption, specifically manifested as excessive activation of osteoclasts and inhibited differentiation of osteoblasts. The accompanying chronic inflammatory response further exacerbates the bone metabolic disorder. This disease not only increases the risk of pain, disability, and death but can also lead to decreased cardiopulmonary function, bedridden complications, and psychological disorders, severely impairing patients' quality of life.

[0003] Currently, the main goals of clinical treatment for osteoporosis are to slow bone loss, increase bone density, and relieve pain. However, these treatments have significant limitations in terms of comprehensiveness of efficacy, safety, and practicality. Specifically: Western medicine treatment: Commonly used Western medicines such as bisphosphonates and denosumab mainly focus on inhibiting bone resorption, making it difficult to achieve bidirectional regulation of bone metabolism. Long-term use of these drugs is often accompanied by side effects such as gastrointestinal damage, increased burden on the liver and kidneys, and an increased risk of atypical fractures.

[0004] Traditional Chinese Medicine (TCM) Treatment: TCM theory often categorizes osteoporosis (OP) under the terms "bone atrophy" or "bone obstruction," with basic treatment methods including tonifying the kidneys and strengthening bones, and promoting blood circulation and unblocking the meridians. While some existing TCM compound formulas (such as Danqi granules and compound deer antler bone-strengthening capsules) emphasize the simultaneous regulation of the liver, spleen, and kidneys, most fail to systematically integrate the three core therapeutic targets: "inhibiting bone resorption, promoting bone formation, and regulating the inflammatory microenvironment." Furthermore, some formulas rely on expensive medicinal materials, posing challenges to the economic efficiency and safety of long-term medication.

[0005] Mongolian medicine (traditional Mongolian medicine) treatment: Mongolian medicine emphasizes holistic conditioning and the balance of medicinal properties. In recent years, research on Mongolian medicine in the field of bone metabolic diseases has gradually deepened. For example, Chinese patent application CN109045237A discloses a Mongolian medicine for treating osteoporosis and rheumatism, composed of multiple medicinal materials such as sappanwood, areca nut, galangal, cardamom, costus root, white cardamom, asparagus root, ginseng, polygonatum, nutmeg, clove, and agarwood, focusing on tonifying the liver and kidneys, dispelling dampness and relieving pain. Chinese patent application CN105726979A discloses a new use of the Mongolian medicine compound preparation Shenzhu Jing (composed of palm ginseng, polygonatum, polygonatum, prepared he shou wu, and jujube) in the treatment of osteoporosis. The above studies confirm the potential of Mongolian medicine in regulating bone metabolism.

[0006] However, existing Mongolian medicine compound formulas still have the following shortcomings: Firstly, the formulation logic often focuses on tonifying or eliminating pathogens in a single direction. For example, although CN109045237A contains multiple medicinal materials, its combination is centered on tonifying the liver and kidneys and eliminating dampness and relieving pain. It fails to systematically integrate the three major therapeutic targets of "inhibiting bone resorption, promoting bone formation, and regulating the inflammatory microenvironment," and lacks targeted intervention for the core pathological mechanism of osteoporosis, "imbalance between bone resorption and bone formation."

[0007] Secondly, it does not adequately reflect the Mongolian medical theory of "harmony between cold and heat." In Mongolian medicine, osteoporosis often manifests as an imbalance of the three roots and a disorder of clear and turbid substances, exhibiting both a "cold" aspect (such as kidney essence deficiency and malnutrition of bones) and a "heat" aspect (such as inflammatory reactions and blood stasis). Existing compound prescriptions tend to focus on warming and tonifying, rarely considering the dual regulation of cold and heat, thus failing to achieve the essence of Mongolian medical treatment of "combining tonification and purgation."

[0008] Third, some compound prescriptions rely on expensive medicinal materials or have complex compositions, posing challenges to the economy and safety of long-term use, making it difficult to meet the clinical needs of osteoporosis as a chronic disease requiring long-term and safe medication.

[0009] Local bone defect repair materials, such as bone grafts and biological scaffolds, can promote local bone healing to some extent, but their regulatory effect on systemic bone metabolic disorders is limited. Furthermore, these materials suffer from drawbacks such as complex manufacturing processes, high costs, and narrow applicability, making them difficult to promote as routine systemic treatment methods.

[0010] Therefore, this invention provides a Mongolian medicine composition based on natural medicinal materials, scientific formulation, capable of multi-target intervention in bone metabolism, and taking into account both systemic conditioning and medication safety, to fill the gaps in existing treatment options for osteoporosis. Summary of the Invention

[0011] The present invention aims to provide a Mongolian medicine composition for treating osteoporosis, its preparation and application, in order to solve the problems in the prior art.

[0012] To achieve the above objectives, the present invention provides the following technical solution: A Mongolian medicine composition for treating osteoporosis, comprising, by weight, 5-15 parts of ginseng, 10-20 parts of dragon bone, 8-18 parts of gypsum, 6-16 parts of pomegranate, 3-9 parts of cardamom, 4-12 parts of safflower, 2-8 parts of cinnamon, and 2-8 parts of long pepper.

[0013] A Mongolian medicine composition for treating osteoporosis, comprising, by weight, 5-15 parts of ginseng, 15-25 parts of oyster shell, 8-18 parts of gypsum, 6-16 parts of pomegranate, 3-9 parts of cardamom, 4-12 parts of safflower, 2-8 parts of cinnamon, and 2-8 parts of galangal.

[0014] Furthermore, Polygonatum sibiricum was used to replace Codonopsis pilosula, while the remaining composition and weight components remained unchanged.

[0015] The preparation method of the Mongolian medicine composition for treating osteoporosis described above includes the following steps: S1. Raw material pretreatment: Remove impurities, mud and sand and non-medicinal parts from the raw medicinal materials required for the Mongolian medicine composition. After cleaning, dry them in a constant temperature drying oven, then crush and sieve them to obtain fine powder of each single medicinal material for later use. S2. Mixing: Weigh the fine powder of each single herb prepared in step S1 according to the weight ratio, place them in a mixer and mix until uniform to obtain mixed powder; S3. Extraction: Using a water extraction process, purified water is added to the mixed medicinal powder prepared in step S2, and after soaking, it is placed in an extraction tank. The extraction temperature is controlled, and the mixture is decocted multiple times. The decoctions are combined, filtered with a filter cloth to remove the dregs, and a clear decoction is obtained. S4. Concentration: Using a vacuum concentration process, the clarified decoction obtained in step S3 is placed in a vacuum concentration tank and concentrated into a clear paste. S5. Formulation: Based on clinical needs, the ointment prepared in step S4 is formulated into the required dosage form using conventional formulation processes.

[0016] Further, in step S1, after the raw medicinal materials are cleaned, they are placed in a constant temperature drying oven at 60~70℃ and dried until the moisture content is ≤8%; after being pulverized, they are passed through an 80~100 mesh standard sieve.

[0017] Furthermore, in step S2, the mixing time of each individual herbal powder in the mixer is 15-20 minutes.

[0018] Further, in step S3, the mass ratio of the mixed medicinal powder to purified water is 1:3~5, and the mixture is soaked for 30~60 minutes; the extraction temperature is controlled at 90~95℃, and the mixture is decocted 2~3 times, each time for 1.5~2 hours, and then filtered with a 100-mesh filter cloth.

[0019] Furthermore, in step S4, the vacuum degree of the reduced pressure concentration is 0.06~0.08MPa, the concentration temperature is 60~65℃, and the relative density of the concentrated extract is 1.10~1.20.

[0020] Further, in step S5, the prepared dosage form includes one or more of decoctions, powders, capsules, and granules; wherein, the clear paste is directly packaged to obtain a decoction; the mixed powder from step S2 is directly packaged to obtain a powder; starch is added to the clear paste as a filler, granulated and dried, and then filled into capsule shells to obtain capsules; sucrose powder is added to the clear paste as a flavoring agent, granulated and dried to obtain granules.

[0021] Further, in step S3, the water extraction process is replaced by an alcohol extraction process. The alcohol extraction process is as follows: 3 to 5 times the mass of 50% to 70% ethanol is added to the mixed powder prepared in step S2, soaked for 30 to 60 minutes, and then refluxed twice at 80 to 85°C for 1.5 hours each time. The extracts are combined, filtered, and the ethanol is recovered until there is no alcohol odor. Then, the extract is concentrated to a clear paste with a relative density of 1.10 to 1.20.

[0022] Furthermore, in steps S2 and S3, the mixture and extraction are carried out using a separate decoction and subsequent mixing process. The separate decoction and subsequent mixing process is as follows: first, cold-natured medicinal materials and warm-natured medicinal materials are extracted separately to obtain two portions of clear extract, and then the cold-natured medicinal material clear extract and the warm-natured medicinal material clear extract are mixed at a volume ratio of 1:2. Among them, the cold-natured medicinal materials are gypsum or gypsum, and the warm-natured medicinal materials include cinnamon, cardamom and long pepper.

[0023] Furthermore, in step S4, the spray drying concentration process is replaced by the vacuum concentration process. The spray drying concentration process is as follows: the clarified decoction prepared in step S3 is processed by a spray dryer with an inlet temperature of 180~200℃ and an outlet temperature of 80~90℃ to directly obtain dried medicinal powder without the need for concentration to a clear paste. In step S5, the dried medicinal powder is prepared into the required dosage form using conventional formulation processes.

[0024] The above-mentioned Mongolian medicine composition for treating osteoporosis is used in the preparation of drugs for treating and / or alleviating osteoporosis.

[0025] It should be noted that the pharmacological effects of each medicinal material in this Mongolian medicine composition are as follows: Hand-ginseng (containing hand-ginsenosides): promotes osteoblast proliferation; Keel (containing calcium carbonate and calcium phosphate): provides raw materials for bone formation; Northern Cold Water Stone (containing calcium sulfate): regulates calcium metabolism in the body; Pomegranate (containing gallic acid): antioxidant, inhibits bone resorption, and reduces the level of inflammatory factors; Cardamom: harmonizes various medicines, promotes absorption, and enhances the bioavailability of other medicinal materials; Safflower (containing safflower yellow pigment): promotes blood circulation, removes blood stasis, improves microcirculation, and increases blood supply to bone tissue; Cinnamon (containing cinnamaldehyde): anti-inflammatory and promotes angiogenesis; Piper longum (containing piperine): regulates metabolism, inhibits osteoclasts, and balances bone metabolism.

[0026] Furthermore, in the Mongolian medicine composition of the present invention, ginseng or palm ginseng or polygonatum (which tonifies qi and nourishes yin, benefits the kidneys and replenishes essence, and is often used in Mongolian medicine for kidney deficiency and bone atrophy) is the principal drug, ensuring that the core effects of tonifying the kidneys and replenishing essence and regulating bone metabolism remain unchanged; Dragon bone or oyster shell (containing calcium carbonate and calcium phosphate, which have the effects of calming the nerves, astringing and consolidating in Mongolian medicine, and supplementing bone minerals) are used as assistant medicines; Northern cold water stone or gypsum (clearing heat and purging fire, relieving irritability and quenching thirst, often used in Mongolian medicine to regulate inflammatory response) are used as assistant medicines, which can inhibit inflammatory damage to bone tissue. Cardamom or nutmeg (which warms the middle and dispels dampness, promotes qi circulation and strengthens the spleen; its effects in Mongolian medicine are equivalent to cardamom) are used as adjuvants to harmonize the cold nature of gypsum and calcite, and to avoid damaging the spleen and stomach. Long pepper or galangal (which warms the middle and dispels cold, and relieves pain; often used in Mongolian medicine to guide other medicines directly to the affected area) are used as guiding herbs, working together with cinnamon to enhance the warming and dispelling effects.

[0027] This Mongolian medicine composition is based on the holistic theory of Mongolian medicine, which emphasizes "treating both cold and heat, and addressing both the symptoms and the root cause." It precisely targets the core pathogenesis of osteoporosis, namely "imbalance of the three roots, disorder of clear and turbid substances, and malnutrition of bones." It uses warm medicinal materials such as pomegranate to regulate the spleen and stomach and harmonize the three roots, thus addressing the root cause of insufficient bone nourishment. It uses dragon bone and ginseng to tonify the kidneys and promote bone growth, directly improving bone condition. It uses safflower to unblock qi and blood and gypsum to harmonize cold and heat, clearing away the accumulation of pathological products, ultimately achieving the core effects of "warming the stomach and promoting digestion, clearing away impurities and restoring essence, and tonifying the kidneys and promoting bone growth."

[0028] The beneficial effects of the technical solution are: (1) Synergistic effect of multiple targets to achieve both symptomatic and root cause treatment: Compared with traditional Chinese medicine compound prescriptions that focus on a single "kidney tonification" or "blood-activating" effect, the composition of the present invention creatively integrates characteristic Mongolian medicines such as ginseng and Beihan water stone, and strictly follows the Mongolian medicine compatibility theory of "harmonizing cold and heat and combining tonification and purgation". The Mongolian medicine composition of the present invention can simultaneously act on three key pathological links: "inhibiting osteoclast activity", "promoting osteogenic differentiation" and "regulating the inflammatory microenvironment of bone tissue", achieving synergistic treatment of multiple targets. It can not only effectively improve low bone mass, but also significantly relieve bone pain, intervene in the imbalance of bone metabolism from the root, and achieve a comprehensive curative effect that addresses both the symptoms and the root cause.

[0029] (2) High safety and suitable for long-term chronic disease management: Compared with Western medicines (such as bisphosphonates) that are prone to causing gastrointestinal damage and increased burden on the liver and kidneys with long-term use, and compared with some traditional Chinese medicine compound formulas containing precious medicinal materials (such as deer antler) or potent blood-activating drugs (such as leeches), the composition of the present invention uses all natural Mongolian medicinal materials, has no obvious damage to liver and kidney function, and has low toxic side effects. At the same time, the medicinal materials are widely available and the cost is moderate, which greatly meets the clinical needs of osteoporosis as a chronic disease that requires long-term and safe management.

[0030] (3) Standardized process ensures stable and controllable quality: The process parameters (such as specific drying and extraction temperature ranges) of key steps in the preparation of the Mongolian medicine composition of the present invention, such as raw material pretreatment, extraction, and concentration, are clearly defined, and clear modern preparation routes such as alcohol extraction and spray drying are provided. This standardized production process ensures the stable extraction of active ingredients and the reliable uniformity of preparation quality, laying a solid foundation for large-scale industrial production and stable reproduction of clinical efficacy.

[0031] (4) Flexible and diverse dosage forms, wide range of applications: This invention overcomes the shortcomings of existing Mongolian medicines, which have limited dosage forms and applicable populations. The Mongolian medicine composition of this invention can be flexibly formulated into various oral dosage forms such as decoctions, capsules, and granules according to different clinical needs and patient characteristics, and can also be extended to external administration methods such as acupoint application. This not only facilitates medication for the elderly, children, and patients with poor gastrointestinal function, but also expands its application scope. It can be used for the treatment of complications such as osteoporotic fractures and osteoarthritis, and can also be used as a preventive health care method for high-risk groups, with broad clinical application prospects. Attached Figure Description

[0032] Figure 1 In the experimental example of this invention, the lumbar spine (L5) Micro CT images of rats in each experimental group were examined; Figure 2 This is a bar chart showing the biochemical indicators of rats in each experimental group in the present invention. Figure 3 The image shows HE staining of the right femur of rats in each experimental group in this invention. Detailed Implementation

[0033] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments: Example 1: Weigh out 5 parts of ginseng, 10 parts of dragon bone, 8 parts of gypsum, 6 parts of pomegranate, 3 parts of cardamom, 4 parts of safflower, 2 parts of cinnamon and 2 parts of long pepper by weight. Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Place the fine powders of each herb in a mixer and mix for 15-20 minutes until uniform to obtain a mixed powder. Add 3-5 times the weight of purified water to the mixed powder, soak for 30-60 minutes, then place it in an extraction tank and control the extraction temperature at 90-95℃. Decoction is performed 3 times, each time for 1.5-2 hours. The 3 decoctions are combined and filtered through a 100-mesh filter cloth to remove the dregs and obtain a clear decoction. The clarified decoction is placed in a vacuum concentration tank, and the vacuum degree is controlled at 0.06~0.08MPa and the concentration temperature at 60~65℃, until a clear extract with a relative density of 1.10~1.20 (measured at 60℃) is obtained.

[0034] Example 2: Weigh out 10 parts of ginseng, 15 parts of dragon bone, 12 parts of gypsum, 10 parts of pomegranate, 6 parts of cardamom, 8 parts of safflower, 5 parts of cinnamon and 5 parts of long pepper by weight. Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Place the fine powders of each herb in a mixer and mix for 15-20 minutes until uniform to obtain a mixed powder. Add 3-5 times its weight of 50%-70% ethanol to the mixed powder, soak for 30-60 minutes, and then reflux extract twice at 80-85℃ for 1.5 hours each time. Combine the extracts, filter, and recover the ethanol until there is no alcohol odor. Then concentrate to a clear extract with a relative density of 1.10-1.20 (measured at 60℃).

[0035] Example 3: Weigh out 15 parts of ginseng, 20 parts of dragon bone, 18 parts of gypsum, 16 parts of pomegranate, 9 parts of cardamom, 12 parts of safflower, 8 parts of cinnamon and 8 parts of long pepper by weight. Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Place the fine powders of each herb in a mixer and mix for 15-20 minutes until uniform to obtain a mixed powder. Add 3-5 times the weight of purified water to the mixed powder, soak for 30-60 minutes, then place it in an extraction tank and control the extraction temperature at 90-95℃. Decoction is performed 3 times, each time for 1.5-2 hours. The 3 decoctions are combined and filtered through a 100-mesh filter cloth to remove the dregs and obtain a clear decoction. The clarified decoction is processed by a spray dryer with an inlet temperature of 180~200℃ and an outlet temperature of 80~90℃ to directly obtain dried medicinal powder without the need for concentration to a clear paste. Finally, the dried medicinal powder is made into the required dosage form using conventional pharmaceutical processes.

[0036] Example 4: Weigh out 5 parts of ginseng, 15 parts of oyster, 8 parts of gypsum, 6 parts of pomegranate, 3 parts of cardamom, 4 parts of safflower, 2 parts of cinnamon, and 2 parts of galangal; Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Place the fine powders of each herb in a mixer and mix for 15-20 minutes until uniform to obtain a mixed powder. Add 3-5 times the weight of purified water to the mixed powder, soak for 30-60 minutes, then place it in an extraction tank and control the extraction temperature at 90-95℃. Decoction is performed 3 times, each time for 1.5-2 hours. The 3 decoctions are combined and filtered through a 100-mesh filter cloth to remove the dregs and obtain a clear decoction. The clarified decoction is placed in a vacuum concentration tank, and the vacuum degree is controlled at 0.06~0.08MPa and the concentration temperature at 60~65℃, until a clear extract with a relative density of 1.10~1.20 (measured at 60℃) is obtained.

[0037] Example 5: Weigh out 10 parts of ginseng, 20 parts of oyster, 12 parts of gypsum, 11 parts of pomegranate, 6 parts of cardamom, 8 parts of safflower, 5 parts of cinnamon, and 5 parts of galangal; Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Each single herb powder is placed in a mixer and mixed for 15-20 minutes until uniform, to obtain a mixed herb powder; then, the cold-natured herb and the warm-natured herb are extracted separately using the method of Example 4, and two clear extracts are obtained. The cold-natured herb extract and the warm-natured herb extract are mixed at a volume ratio of 1:2; wherein, the cold-natured herb is gypsum or gypsum, and the warm-natured herb includes cinnamon, cardamom and long pepper.

[0038] Example 6: Weigh out 15 parts of Polygonatum sibiricum, 25 parts of oyster shell, 18 parts of gypsum, 16 parts of pomegranate, 9 parts of cardamom, 12 parts of safflower, 8 parts of cinnamon, and 8 parts of galangal. Remove impurities, mud, sand and non-medicinal parts from the above eight raw medicinal materials, clean them and dry them in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%, then pulverize them and pass them through an 80~100 mesh standard sieve to obtain fine powder of each individual medicinal material for later use. Place the fine powders of each herb in a mixer and mix for 15-20 minutes until uniform to obtain a mixed powder. Add 3-5 times the weight of purified water to the mixed powder, soak for 30-60 minutes, then place it in an extraction tank and control the extraction temperature at 90-95℃. Decoction is performed 3 times, each time for 1.5-2 hours. The 3 decoctions are combined and filtered through a 100-mesh filter cloth to remove the dregs and obtain a clear decoction. The clarified decoction is placed in a vacuum concentration tank, and the vacuum degree is controlled at 0.06~0.08MPa and the concentration temperature at 60~65℃, until a clear extract with a relative density of 1.10~1.20 (measured at 60℃) is obtained.

[0039] Example 7: The ointments prepared in Examples 1-6 were formulated into different dosage forms.

[0040] The prepared ointments from each embodiment were directly packaged to obtain decoctions; the mixed medicinal powders were directly packaged to obtain powders; an appropriate amount of starch was added to the ointment as a filler, granulated and dried, and then filled into capsule shells to obtain capsules, each containing 0.5g of Mongolian medicine composition; an appropriate amount of sucrose powder was added to the ointment as a flavoring agent, granulated and dried to obtain granules, which were packaged into bags of 5g of Mongolian medicine composition; an appropriate amount of microcrystalline cellulose (filler) and magnesium stearate (lubricant) were added to the ointment, granulated and compressed to obtain tablets, each weighing 0.5g; the ointment was taken, an appropriate amount of steviol glycosides (flavoring agent) and sodium benzoate (preservative) were added, purified water was added to dilute to the specified concentration, and the mixture was aseptically packaged to obtain oral liquid, each 10ml; the ointment and petrolatum were mixed at a mass ratio of 1:3 to prepare acupoint patches.

[0041] For specific use, take 10-20g of the decoction, dilute with warm water to 200-300ml, and take in two divided doses; for the powder, take 3-5g each time, twice a day, with warm water; for the capsule, take 3-5 capsules each time, twice a day, with warm water; for the granules, take one packet each time, twice a day, with warm water; for the tablets, take 3-5 tablets each time, twice a day, with warm water, suitable for elderly patients who have difficulty swallowing capsules; for the oral liquid, take 1-2 vials each time, twice a day, suitable for children and patients with weak digestive function; for acupoint patches, apply to acupoints such as Shenshu, Mingmen, and Zusanli, each patch for 24 hours, 3 times a week, suitable for patients who cannot take oral medication (such as patients with severe gastrointestinal diseases), the effective ingredients are absorbed through skin penetration, improving bone metabolism and increasing bone density. A course of treatment is 8 weeks, and the number of courses can be adjusted according to the patient's improvement in bone density, generally 1-2 courses are needed.

[0042] Experimental example: The efficacy test was conducted on the extract prepared in Example 1. Animal selection: The experimental animals were 72 healthy female SPF-grade SD rats aged 8 weeks, which were acclimatized for 1 week (ambient temperature 22-25℃, humidity 50-60%, 12h light-dark cycle, free access to standard feed and water). Seventy-two 8-week-old SPF-grade rats were housed separately in an animal room at 22°C with a relative humidity of 50%-60% and a 12-hour light-dark cycle. After acclimatization for 5 days, they were randomly divided into two groups: a control group (n=16, administered by gavage with the same volume of 1% CMC solution) and a model group (n=56, administered by gavage with RA at 75 mg / kg / day, prepared with 1% CMC solution). Two weeks after RA administration, six rats in the control group and six rats in the model group were tested to confirm the success of the modeling.

[0043] Grouping: After successful modeling, 10 SD rats from the normal group served as the control group. Then, the remaining 50 SD rats from the model group were randomly divided into 5 groups: model group (n=10), alendronate sodium treatment group (n=10), low-dose Mongolian medicine composition group (n=10), medium-dose Mongolian medicine composition group (n=10), and high-dose Mongolian medicine composition group (n=10). The 6 groups of rats were housed separately in an animal room at 22℃ with a relative humidity of 50%-60%, under a 12-hour light-dark cycle. They were fed standard pellet feed at regular intervals and had free access to food and water. The experimental period was 8 weeks.

[0044] Drug intervention: Based on the conversion formula for human and animal body surface area: D 鼠 =D 人 x R 大鼠 / R 人 (D represents the dosage, and R represents the surface area ratio of mammals to humans) To calculate the dosage for animals, the standard weight for adults is 60 kg, while the standard weight for rats after 8 weeks of normal feeding is generally calculated as 300 g; the specific intervention is as follows: (1) Control group and model group: The same volume of physiological saline was administered by gavage daily; (2) Alendronate sodium treatment group: After modeling, the rats were given estrogen-binding tablet solution by gavage. The adult dose of estrogen-binding tablet was 0.625 mg / day, and the rat dose was 0.017 mg / day. The treatment was continued for 8 weeks by gavage.

[0045] (3) Mongolian medicine composition - low dose group, Mongolian medicine composition - medium dose group and Mongolian medicine composition - high dose group: The daily oral dose of Mongolian medicine composition for adults is 10g. The doses of the low, medium and high dose groups of Mongolian medicine composition are calculated in a ratio of 1:2:4, which are 0.53g / Kg / d, 1.05g / Kg / d and 2.1g / Kg / d respectively, and need to be administered by gavage for 8 consecutive weeks. During the gavage administration period, the mice are generally weighed every three days, and the daily dosage per mouse is calculated based on the weight change.

[0046] Collection: After the second administration at the end of week 8 of the experiment and a 24-hour fast, mice in each group were anesthetized by intraperitoneal injection of 3% sodium pentobarbital (45 mg / kg). Blood was collected from the heart using a disposable syringe. Whole blood samples were incubated overnight at 4°C and then centrifuged at 1000×g for 15 min at 4°C. The supernatant was aliquoted into sterile, enzyme-free centrifuge tubes. Store at 80℃ for later use, avoiding repeated freeze-thaw cycles. After successful blood collection, collect the left femur and the fifth lumbar vertebra, remove the surrounding muscles and fascia, rinse with ice-cold saline, fix with 4% paraformaldehyde for 72 hours, and then transfer to 75% ethanol for storage.

[0047] MicroCT scan: used to examine the lumbar spine (L5), such as Figure 1As shown, the trabecular bone structure of the lumbar vertebrae in the normal group rats was intact, tightly arranged, and well-connected; the trabecular bone in the model group was significantly sparse and fractured, with severe damage to the bone microstructure, exhibiting typical osteoporotic changes; the number of trabecular bone in the positive group increased, and the structure was partially restored; all dosage groups of the Mongolian medicine composition improved the microstructure of the trabecular bone to varying degrees. Among them, the number of trabecular bone in the medium and high dosage groups increased significantly, the thickness increased, and the connectivity was enhanced, approaching the level of the normal group, indicating that the Mongolian medicine composition of the present invention can effectively improve the bone microstructure of osteoporotic rats.

[0048] Liver and kidney function tests: Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), urea (UREA), creatinine (CREA), and uric acid (UA) were measured using a fully automated biochemical analyzer. As shown in Table 1, statistical analysis results indicated that there were no statistically significant differences in any of the measured indicators among the normal group, model group, positive control group, and the three treatment groups with different doses of the Mongolian medicine composition (P>0.05). This result shows that under the experimental conditions, the Mongolian medicine composition treatment did not significantly affect the liver and kidney function of rats.

[0049] Table 1. Comparison of serum bone metabolism indicators in rats of different groups Note: n=6, comparisons between groups. P >0.05.

[0050] Serum bone metabolism markers were detected using an ELISA kit: Type I procollagen N-terminal propeptide (PINP), a marker of bone formation, and bone resorption markers (bone alkaline phosphatase (BALP) and tartrate-resistant acid phosphatase 5b (TRACP-5b)). Figure 2 As shown, regarding bone turnover dynamics, BALP and PINP levels were significantly lower in the model group than in the normal group (P<0.01), indicating that bone formation activity was inhibited. After drug intervention, the levels of BALP and PINP in each treatment group were significantly higher than in the model group (P<0.01), demonstrating that the Mongolian medicine composition can effectively promote osteogenic activity. Meanwhile, TRACP-5b, a key marker of bone resorption, was significantly elevated in the model group (P<0.01), indicating active osteoclast function and significantly accelerated bone resorption. Compared with the model group, the levels of TRACP-5b in each treatment group were significantly lower (P<0.01), proving that the drug has a clear inhibitory effect on excessive bone resorption.

[0051] Histopathological observation of bone tissue: The left femur and fifth lumbar vertebra were decalcified, paraffin-embedded, sectioned (5μm), stained with hematoxylin and eosin (HE), and the morphology of the trabecular bone was observed under a light microscope. Figure 3As shown in the HE staining results, compared with the control group, the number of trabeculae in the rat femur was significantly reduced, their structural density decreased and their distribution tended to be disordered, and the gaps between the trabeculae were significantly widened. These findings are consistent with the typical pathological features of osteoporosis. Compared with the model group, the number of trabeculae in rats treated with each dose of the Mongolian medicine composition increased, their structural density increased, and their pathological histological morphology was close to that of the normal control group, indicating that the Mongolian medicine composition has an ameliorative effect on osteoporosis.

[0052] The above descriptions are merely embodiments of the present invention, and common knowledge regarding specific technical solutions or characteristics is not elaborated upon here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A Mongolian medicine composition for treating osteoporosis, characterized in that, The Mongolian medicine composition, by weight, consists of 5-15 parts of ginseng, 10-20 parts of dragon bone, 8-18 parts of gypsum, 6-16 parts of pomegranate, 3-9 parts of cardamom, 4-12 parts of safflower, 2-8 parts of cinnamon, and 2-8 parts of long pepper.

2. A Mongolian medicine composition for treating osteoporosis, characterized in that, The Mongolian medicine composition, by weight, consists of 5-15 parts of ginseng, 15-25 parts of oyster shell, 8-18 parts of gypsum, 6-16 parts of pomegranate, 3-9 parts of cardamom, 4-12 parts of safflower, 2-8 parts of cinnamon, and 2-8 parts of galangal.

3. The Mongolian medicine composition for treating osteoporosis according to claim 2, characterized in that, The palm ginseng was replaced with Polygonatum sibiricum, while the rest of the composition and weight components remained unchanged.

4. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 1 or 2, characterized in that, Includes the following steps: S1. Raw material pretreatment: Remove impurities, mud and sand and non-medicinal parts from the raw medicinal materials required for the Mongolian medicine composition. After cleaning, dry them in a constant temperature drying oven, then crush and sieve them to obtain fine powder of each single medicinal material for later use. S2. Mixing: Weigh the fine powders of each single herb prepared in step S1 according to the weight ratio, place them in a mixer and mix until uniform to obtain mixed powder; S3. Extraction: Using a water extraction process, purified water is added to the mixed medicinal powder prepared in step S2, and after soaking, it is placed in an extraction tank. The extraction temperature is controlled, and the mixture is decocted multiple times. The decoctions are combined, filtered with a filter cloth to remove the dregs, and a clear decoction is obtained. S4. Concentration: Using a vacuum concentration process, the clarified decoction obtained in step S3 is placed in a vacuum concentration tank and concentrated into a clear paste. S5. Formulation: Based on clinical needs, the ointment prepared in step S4 is formulated into the required dosage form using conventional formulation processes.

5. The method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 4, characterized in that, In step S1, after cleaning, the raw medicinal materials are dried in a constant temperature drying oven at 60~70℃ until the moisture content is ≤8%; after pulverizing, they are passed through an 80~100 mesh standard sieve.

6. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 5, characterized in that, In step S2, the mixing time of each individual herbal powder in the mixer is 15-20 minutes.

7. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 6, characterized in that, In step S3, the mass ratio of the mixed medicinal powder to purified water is 1:3~5, and the mixture is soaked for 30~60 minutes; the extraction temperature is controlled at 90~95℃, and the mixture is decocted 2~3 times, each time for 1.5~2 hours, and then filtered through a 100-mesh filter cloth.

8. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 7, characterized in that, In step S4, the vacuum degree of the reduced pressure concentration is 0.06~0.08MPa, the concentration temperature is 60~65℃, and the relative density of the concentrated extract is 1.10~1.

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9. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 8, characterized in that, In step S5, the prepared dosage form includes one or more of decoctions, powders, capsules, and granules; wherein, the clear paste is directly packaged to obtain a decoction; the mixed powder from step S2 is directly packaged to obtain a powder; starch is added to the clear paste as a filler, granulated and dried, and then filled into capsule shells to obtain capsules; sucrose powder is added to the clear paste as a flavoring agent, granulated and dried to obtain granules.

10. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 4, characterized in that, In step S3, the water extraction process is replaced by an alcohol extraction process. The alcohol extraction process is as follows: 3 to 5 times the mass of 50% to 70% ethanol is added to the mixed powder prepared in step S2, and after soaking for 30 to 60 minutes, the mixture is refluxed twice at 80 to 85°C for 1.5 hours each time. The extracts are combined, filtered, and the ethanol is recovered until there is no alcohol odor. The mixture is then concentrated to a clear extract with a relative density of 1.10 to 1.

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11. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 4, characterized in that, In steps S2 and S3, the mixture and extraction are carried out using a decoction-and-mixing process. The decoction-and-mixing process is as follows: first, cold-natured medicinal materials and warm-natured medicinal materials are extracted separately to obtain two clear extracts. Then, they are mixed at a volume ratio of 1:2 between the cold-natured medicinal material extract and the warm-natured medicinal material extract. The cold-natured medicinal materials are gypsum or calcite, and the warm-natured medicinal materials include cinnamon, cardamom, and long pepper.

12. A method for preparing a Mongolian medicine composition for treating osteoporosis according to claim 4, characterized in that, In step S4, the spray drying concentration process is used to replace the vacuum concentration process. The spray drying concentration process is as follows: the clear decoction prepared in step S3 is processed by a spray dryer with an inlet temperature of 180~200℃ and an outlet temperature of 80~90℃ to directly obtain dried medicinal powder without the need for concentration to clear paste. In step S5, the dried drug powder is prepared into the desired dosage form using conventional pharmaceutical processes.

13. The use of a Mongolian medicine composition for treating osteoporosis according to claim 1 or 2 in the preparation of a medicament for treating and / or alleviating osteoporosis.

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