Traditional Chinese medicine composition for treating osteoporosis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating osteoporosis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by mass: spleen-clearing components: 5-10 parts of fructus aurantii, 5-10 parts of gardenia jasminoides ellis and 9-12 parts of rhizoma dioscoreae septemlobae; a spleen-tonifying component: 10-15 parts of white lotus seeds, 10-15 parts of cinnamomum camphora, 15-25 parts of gordon euryale seeds and 6-12 parts of rhizoma atractylodis macrocephalae fried with soil; kidney-tonifying components: 8-13 parts of dendrobium officinale, 5-10 parts of raspberry, 5-10 parts of common fenugreek seed, 8-13 parts of eclipta prostrata and 10-12 parts of polygonatum cyrtonema; and bone strengthening components: 10-15 parts of homalomena occulta, 5-10 parts of kadsura coccinea, 10-20 parts of rhizoma drynariae, 8-13 parts of herba epimedii, 10-15 parts of eucommia ulmoides and 8-13 parts of semen cuscutae. According to the invention, through a chain of clearing the spleen, tonifying the spleen, tonifying the kidney and strengthening the bone, the common problems of abdominal distension, poor appetite, excessive internal heat and the like after a tonic medicine is taken are effectively avoided, and the sustainability of treatment is ensured. The bone mineral density is improved, and meanwhile, the daily activity ability and life quality of a patient are remarkably improved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, and particularly relates to a traditional Chinese medicine composition for treating osteoporosis and its preparation method. Background Technology

[0002] Osteoporosis (OP) is a metabolic bone disease characterized by decreased bone mass and deterioration of bone microstructure, leading to increased bone fragility and a higher risk of fractures.

[0003] The harm of osteoporosis is not only reflected in the high incidence of fractures, but also in the severe decline in patients' quality of life and the increased socioeconomic burden. Fractures of the hip, spine, and wrist are the most common complications of osteoporosis, especially hip fractures, which often lead to high rates of disability and mortality. Therefore, the prevention and treatment of osteoporosis has become an important health issue that urgently needs to be addressed, and exploring the potential of traditional Chinese medicine in the prevention and treatment of osteoporosis is of great significance. Traditional Chinese medicine is characterized by holistic conditioning and syndrome differentiation and treatment, emphasizing the prevention of disease progression by regulating the body's internal balance.

[0004] Chinese patent CN117243996A discloses a micro-traditional Chinese medicine composition for treating osteoporosis, the raw materials of which, by weight, include: 17 parts Rehmannia glutinosa, 9.5 parts Cuscuta chinensis, 5 parts Drynaria fortunei, 11 parts Psoralea corylifolia, 9 parts Cornus officinalis, 9.5 parts Eucommia ulmoides, 1.5 parts Dipsacus asper, 9 parts Paeonia lactiflora, 9 parts Astragalus membranaceus, 14 parts Poria cocos, 14 parts Angelica sinensis, 2 parts deer antler, 11 parts Achyranthes bidentata, 4 parts Epimedium brevicornu, 8.5 parts Pheretima aspergillum, and 6 parts tortoise shell glue; This micro-Chinese medicine composition for treating osteoporosis combines Rehmannia glutinosa with Cuscuta chinensis, Psoralea corylifolia, and Pheretima aspergillum to provide therapeutic effects such as clearing heat and calming the nerves, unblocking the meridians, nourishing blood and promoting blood circulation, strengthening tendons and bones, relieving asthma, and tonifying the liver and kidneys. Tortoise shell glue, combined with Achyranthes bidentata, deer antler, Poria cocos, Paeonia lactiflora, and Astragalus membranaceus, provides therapeutic effects such as nourishing yin and suppressing yang, promoting urination and relieving strangury, eliminating dampness and promoting blood circulation, and dispersing blood stasis and relieving pain. Angelica sinensis also nourishes blood and alleviates deficiencies in the body. However, this patent has a drawback: an imbalance between kidney tonification and spleen strengthening. While kidney-tonifying components (such as Rehmannia glutinosa, Cuscuta chinensis, and deer antler) dominate the formula, the spleen-strengthening component is only Poria cocos, and in a large quantity (14-16 parts), potentially neglecting the spleen's role as the foundation of acquired constitution and its supportive role in bone nutrition. Furthermore, it lacks spleen-clearing components: it does not include spleen-clearing and dampness-resolving herbs (such as Citrus aurantium and Gardenia jasminoides), and long-term use may lead to indigestion due to its rich and greasy nature. Low proportion of bone-strengthening ingredients: The dosage of bone-strengthening drugs such as Drynaria fortunei, Dipsacus asper, and Epimedium is relatively low, which may affect the direct effect of promoting bone formation. Excessive use of blood-activating drugs: The proportion of blood-activating drugs such as Paeonia lactiflora, Pheretima aspergillum, and Angelica sinensis is high, which may not be suitable for patients with qi and blood deficiency.

[0005] Chinese patent CN120789124A discloses a traditional Chinese medicine composition for treating osteoporosis, comprising Drynaria fortunei, Eucommia ulmoides, Psoralea corylifolia, Ligusticum chuanxiong, Astragalus membranaceus, Codonopsis pilosula, Achyranthes bidentata, and Achyranthes bidentata; Drynaria fortunei, Eucommia ulmoides, and Psoralea corylifolia are the principal herbs. This formula uses Drynaria fortunei, Eucommia ulmoides, and Psoralea corylifolia as the principal herbs to directly tonify the kidneys and strengthen bones; Astragalus membranaceus and Codonopsis pilosula are the assistant herbs to invigorate the spleen and replenish qi to nourish the source of qi and blood; Achyranthes bidentata and Achyranthes bidentata are the adjuvant herbs to tonify the liver and kidneys, strengthen tendons and bones, and promote blood circulation; Ligusticum chuanxiong is the guiding herb to promote blood circulation, regulate qi, and clear the bone meridians, focusing on tonification and meridian unblocking. However, its treatment principle is relatively singular, lacking the "eliminating pathogens and clearing the way" step: the entire formula mainly focuses on tonifying the kidneys and spleen, strengthening tendons and bones, supplemented by promoting blood circulation. For patients with osteoporosis, especially those with complex pathogenesis such as spleen and stomach dampness and poor digestion (manifested as abdominal distension, poor appetite, and greasy tongue coating) or internal heat (such as tidal fever and dry mouth), this formula may directly tonify the spleen and stomach or generate heat, thus posing a risk of "inability to tolerate tonification." The formula lacks clear pairs of herbs for regulating qi and resolving dampness, clearing heat, or other "clearing" or "dredging" functions. Furthermore, its yin-nourishing and dryness-moistening effects are relatively weak. Although it contains a small amount of yin-nourishing herbs such as Achyranthes bidentata, its overall effect on nourishing yin, reducing fire, and moistening tendons and bones may be insufficient for the common postmenopausal osteoporosis pattern of liver and kidney yin deficiency and internal heat disturbance. Long-term use should be cautious of the potential for warming and drying that could damage yin.

[0006] In view of the shortcomings of existing technologies, and taking into full account the pathological mechanisms and clinical manifestations of osteoporosis, it is necessary to make fine adjustments to the composition to ensure that the synergistic effect between the medicinal materials is maximized, in order to improve the therapeutic effect and the quality of life of patients. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition for treating osteoporosis and its preparation method.

[0008] The technical solution of the present invention is as follows: A traditional Chinese medicine composition for treating osteoporosis, comprising the following raw materials in parts by weight: Spleen-clearing ingredients: 5-10 parts of Citrus aurantium, 5-10 parts of Gardenia jasminoides, and 9-12 parts of Dioscorea hypoglauca; Spleen-strengthening ingredients: 10-15 parts white lotus seeds, 10-15 parts camphor red, 15-25 parts fox nuts, and 6-12 parts stir-fried Atractylodes macrocephala. Kidney-tonifying ingredients: Dendrobium officinale 8-13 parts, Rubus idaeus 5-10 parts, Trigonella foenum-graecum 5-10 parts, Eclipta prostrata 8-13 parts, Polygonatum sibiricum 10-12 parts; Bone-strengthening ingredients: 10-15 parts of *Hypericum perforatum*, 5-10 parts of *Hemiberlesia lingua*, 10-20 parts of *Drynaria fortunei*, 8-13 parts of *Epimedium brevicornu*, 10-15 parts of *Eucommia ulmoides*, and 8-13 parts of *Cuscuta chinensis*.

[0009] The preferred formula is: 7 parts of Citrus aurantium, 8 parts of Gardenia jasminoides, 10 parts of Dioscorea hypoglauca, 12 parts of Nelumbo nucifera, 12 parts of Cinnamomum camphora, 20 parts of Euryale ferox, 10 parts of stir-fried Atractylodes macrocephala, 10 parts of Dendrobium officinale, 8 parts of Rubus idaeus, 8 parts of Trigonella foenum-graecum, 10 parts of Eclipta prostrata, 12 parts of Polygonatum sibiricum, 12 parts of Homalomena occulta, 5 parts of Scutellaria baicalensis, 15 parts of Drynaria fortunei, 10 parts of Epimedium brevicornu, 12 parts of Eucommia ulmoides, and 10 parts of Cuscuta chinensis; or... 10g of dried orange peel, 5 parts of gardenia fruit, 10 parts of dioscorea hypoglauca, 10 parts of lotus seed, 15 parts of camphor root, 20 parts of foxnut, 12 parts of stir-fried atractylodes macrocephala, 8 parts of dendrobium officinale, 10 parts of raspberry, 10 parts of fenugreek, 8 parts of eclipta prostrata, 12 parts of polygonatum odoratum, 8 parts of stellaria heterophylla, 8 parts of black tiger vine, 18 parts of drynaria fortunei, 12 parts of epimedium, 15 parts of eucommia ulmoides, and 12 parts of cuscuta chinensis; or 5 parts of dried orange peel, 10 parts of gardenia fruit, 12 parts of dioscorea hypoglauca, 15 parts of white lotus seed, 10 parts of camphor seed, 15 parts of euryale seed, 6 parts of stir-fried atractylodes macrocephala, 13 parts of dendrobium officinale, 5 parts of raspberry, 5 parts of fenugreek, 13 parts of eclipta prostrata, 10 parts of polygonatum odoratum, 10 parts of homalomena occulta, 5 parts of black tiger thorn, 10 parts of drynaria fortunei, 10 parts of epimedium, 10 parts of eucommia bark, and 8 parts of cuscuta chinensis; or 6 parts of Citrus aurantium, 9 parts of Gardenia jasminoides, 10 parts of Dioscorea hypoglauca, 13 parts of Nelumbo nucifera, 13 parts of Scutellaria baicalensis, 18 parts of Euryale ferox, 9 parts of Atractylodes macrocephala (stir-fried), 9 parts of Dendrobium officinale, 8 parts of Rubus idaeus, 5 parts of Trigonella foenum-graecum, 10 parts of Eclipta prostrata, 9 parts of Polygonatum sibiricum, 12 parts of Homalomena occulta, 6 parts of Cortex Alternariae, 16 parts of Drynaria fortunei, 11 parts of Epimedium brevicornu, 12 parts of Eucommia ulmoides, and 8 parts of Cuscuta chinensis.

[0010] The preparation method of the stir-fried Atractylodes macrocephala is as follows: T1. Take calcined oyster shell powder, calcined dragon bone and hearth soil, mix them in a mass ratio of 1:1:2, and use them as composite soil for later use; T2. Place the sliced ​​Atractylodes macrocephala in preheated composite soil at 180℃. Use an intelligent stir-frying machine to maintain the temperature of the pot at 170±5℃ and stir-fry for 5-7 minutes until the surface of Atractylodes macrocephala is evenly coated with soil and turns dark yellow. Remove from the pot, sift out the excess composite soil, and let cool.

[0011] The traditional Chinese medicine composition is a decoction, and its preparation method is as follows: S1. Weigh the various raw materials according to the mass fraction of the Chinese medicine composition, clean and chop or cut them, and soak them for 30 minutes. First, add the following herbs to the decoction container: Homalomena occulta, black tiger, Drynaria fortunei, Eucommia ulmoides, Dendrobium officinale, and Trigonella foenum-graecum. Add 8-10 times the amount of cold water, bring to a boil over high heat, and then simmer over low heat for 1 hour to obtain the decoction. S2. Add white lotus seeds, camphor red, fox nuts, stir-fried Atractylodes macrocephala, Citrus aurantium, Dioscorea hypoglauca, and Gardenia jasminoides to the decoction from step S1, add water to 6-8 times the volume, and continue to simmer over low heat for 40 minutes to obtain the second decoction. S3. Add Epimedium, Rubus idaeus, Eclipta prostrata, Polygonatum sibiricum, and Cuscuta chinensis to the second decoction, continue to simmer over low heat for 10-15 minutes, filter out the dregs, and the decoction is obtained.

[0012] The traditional Chinese medicine composition is in granule form, and its preparation method is as follows: P1. Pretreatment and extraction and collection of volatile oil: Take the jujube peel and camphor red powder and crush them into coarse powder. Take the jojoba root and black tiger and crush them into coarse powder. Add 10 times the amount of water and extract with steam distillation for 5 hours. Collect the volatile oil and seal and refrigerate for later use. Collect the aromatic water for later use. Keep the residue A. P2. Alcohol extraction: Take Homalomena occulta, black tiger, Drynaria fortunei, Eucommia ulmoides, Epimedium, Cuscuta chinensis, Dioscorea hypoglauca, and Gardenia jasminoides, combine them with the residue A obtained in step P1, add 8 times the amount of 70% ethanol by mass, heat and reflux for 1.5 hours, filter out the ethanol extract, and recover the ethanol under reduced pressure until there is no alcohol odor to obtain the concentrated alcohol extract. Retain residue B. P3. Water extraction: Take white lotus seeds, fox nuts, stir-fried Atractylodes macrocephala, Dendrobium officinale, raspberries, fenugreek, Eclipta prostrata, and Polygonatum sibiricum, combine them with the dregs B obtained in step P2, add 10 times the amount of water, heat and decoct for 1.5 hours, filter out the water extract, then add 6 times the amount of water and continue to decoct for 1 hour, and combine the two water extracts. P4. Merging and Concentration: The aromatic water obtained in step P1 and the water extract obtained in step P3 were allowed to stand and the supernatant was collected. This supernatant was combined with the alcohol extract concentrate obtained in step P2 and concentrated under reduced pressure to a thick paste with a relative density of 1.30-1.35. P5. Granulation: The volatile oil collected in step P1 is mixed with β-cyclodextrin to prepare a volatile oil inclusion compound by saturated aqueous solution method. After drying, it is pulverized. The thick paste, volatile oil inclusion compound, appropriate amount of dextrin and flavoring agent are mixed evenly. 85% ethanol is used as wetting agent to prepare a soft material. After granulation and drying, granules are obtained.

[0013] The pretreatment methods for various medicinal materials in this invention are described in the 2020 edition of the Pharmacopoeia of the People's Republic of China. The medicinal materials after standardized treatment can be used as raw materials for the traditional Chinese medicine composition in this case.

[0014] The theoretical basis of this invention is as follows: The *Huangdi Neijing Suwen* (Yellow Emperor's Inner Classic - Basic Questions) states in the chapter "On the Six Sections and Visceral Manifestations": "The kidney is the root of hibernation and storage, the abode of essence; its manifestation is in the hair, its fullness is in the bones." This explains that the strength of bones depends on the nourishment of kidney essence. Furthermore, the *Huangdi Neijing Suwen* also states in the chapter "On the Generation of the Five Viscera": "The kidney is associated with the bones, its manifestation is in the hair, and its function is governed by the spleen." This elucidates the leading role of the spleen in the relationship between the kidney and bones, acting as a link between kidney essence and bone nourishment. The *Huangdi Neijing Suwen* also describes the pulse patterns in the chapter "On the Essential Subtleties of the Pulse": "The stomach pulse is strong and long, its color is red, indicating a fracture of the hip… The kidney pulse is strong and long, its color is yellow and red, indicating a fracture of the waist; if it is scattered, it indicates blood deficiency, eventually leading to irreversible damage." This indicates that in the pathological pulse patterns, the spleen, stomach, and kidney pulses are all related to bone diseases. A diseased stomach pulse easily leads to hip fractures, a diseased spleen pulse causes lower limb swelling, and a diseased kidney pulse causes lower back pain. The *Huangdi Neijing Suwen* (Yellow Emperor's Inner Classic - Basic Questions) states in its chapter "On the Correspondence of Yin and Yang" that "injury to Qi causes pain, and injury to the form causes swelling," indicating that pain and swelling are clinical manifestations of obstructed Qi and blood flow. Furthermore, the *Huangdi Neijing Suwen* also states in its chapter "On Bi Syndrome" that "when wind, cold, and dampness combine, they cause Bi syndrome," indicating that external pathogenic factors are one of the main causes of bone diseases. Continuous overwork also affects the bones. The *Huangdi Neijing Suwen* states in its chapter "On the Circulation of Vital Energy" that "excessive exertion injures the kidney Qi, and high bones decay," further emphasizing the damage that overwork causes to kidney Qi and the potential threat to bone health. The *Huangdi Neijing Suwen* also states in its chapter "On the Manifestation of the Five Qi" that "prolonged sitting injures the flesh, and prolonged standing injures the bones," indicating that prolonged sitting and standing postures damage the musculoskeletal system, leading to bone damage. These classic Chinese medicine texts provide important clues for understanding the physiological and pathological changes of bones and serve as the theoretical basis for exploring the etiology and pathogenesis of bone diseases. Therefore, based on the above classics, and according to clinical experience and changes in modern human constitution, the relationship between the spleen and kidneys, which is considered to be innate and acquired, is further expanded. The occurrence of bone diseases is classified as a state of mutual influence between the spleen, which is the foundation of acquired constitution, and the kidneys, which is the foundation of innate constitution. It is believed that the occurrence of bone diseases is clearly related to the internal and external environment of the human body and is affected by both external pathogens and internal factors. Among these, the relationship between the spleen and kidneys is the closest among the five internal organs.

[0015] The formula for a traditional Chinese medicine composition for treating osteoporosis according to the present invention is as follows: This formula is based on the treatment principle of "clearing and strengthening the spleen, tonifying the kidney and replenishing essence, and strengthening muscles and bones". It targets the core pathogenesis of osteoporosis (which mostly falls under the categories of "bone atrophy" and "bone decay" in traditional Chinese medicine) with spleen deficiency and dampness, insufficient kidney essence, and malnutrition of bones. The formula has a clear combination of ingredients.

[0016] I. Ingredients for clearing the spleen: Citrus aurantium, Gardenia jasminoides, and Dioscorea hypoglauca; Functions: Clears heat and dampness, promotes qi circulation and relieves stagnation.

[0017] Patients with osteoporosis often have spleen deficiency and damp obstruction, and the dampness stagnates and transforms into heat, which restricts the transportation function of the spleen and stomach, further affecting the production of qi and blood and the distribution of essence. Jiangzhiqiao regulates qi and relieves fullness in the middle jiao, and Huangzhizi clears heat and promotes diuresis. The two work together to clear away damp-heat in the middle jiao, creating a good absorption environment for the subsequent spleen-strengthening and kidney-tonifying herbs. Mianbixie promotes diuresis and removes turbidity, dispels wind and relieves arthralgia. This herb is good at differentiating and separating turbidity, treating damp-heat in the lower jiao, and can remove the damp-turbidity staying in the joints and bones, relieving the heavy pain.

[0018] This formula first uses Jiangzhiqiao, Zhizi, and Mianbixie to "open the way", regulating qi, clearing heat, and removing dampness, creating a "clean" and unobstructed spleen and stomach environment for the subsequent supplementation. This is the application of the idea of "first expelling pathogenic factors and then strengthening healthy qi" in the treatment of deficiency syndromes.

[0019] II. Spleen-strengthening ingredients: White lotus seeds, Zhangtouhong, Gorgon fruits, and stir-fried Atractylodes macrocephala with earth; Functions: Strengthen the spleen and boost qi, secure and astringe essence, and strengthen the root to replenish the source.

[0020] White lotus seeds tonify the spleen and stop diarrhea, nourish the kidney and secure essence; Gorgon fruits strengthen the spleen and remove dampness, secure the kidney and astringe essence; the two work together to tonify both the spleen and kidney.

[0021] Zhangtouhong refers to Zhangtouhong tangerine peel. As a genuine variety of tangerine peel, in addition to the basic effect of regulating qi and strengthening the spleen of tangerine peel, it is especially good at promoting blood circulation and dredging collaterals. Due to its stronger dual effects of promoting qi movement and activating blood circulation, Zhangtouhong can not only prevent the greasy and stomach-obstructing effects of lotus seeds, Gorgon fruits, and Atractylodes macrocephala, but also actively promote the transportation of the spleen and stomach, effectively distribute the generated food essence and qi to reach the bones and joints. This can better meet the needs of this formula to "strengthen the spleen to nourish the bones and joints" than ordinary tangerine peel that only focuses on regulating qi and relieving distension.

[0022] Stir-fried Atractylodes macrocephala with earth: Strengthens the spleen and boosts qi, dries dampness and promotes diuresis. After being stir-fried with earth, Atractylodes macrocephala has a stronger effect of strengthening the spleen and stopping diarrhea, and is specifically designed for diarrhea due to spleen deficiency in the middle jiao.

[0023] This group, by strengthening the transportation of the spleen and stomach, on the basis of clearing the spleen, strongly supplements the spleen and stomach, restores its transportation function, ensures that the food essence and qi are transported upward to the lungs and downward to the kidneys, enables the generation of qi and blood to have a source, and the bones and joints to be nourished, providing a material basis for bone growth. This is the key to "strengthening healthy qi" and "strengthening the root". This compatibility elevates the focus of spleen-strengthening from simple "supplementation" to the coordination of "securing" and "transporting". It not only "opens the source" (generating qi and blood), but also "controls the flow" (preventing loss), and maintains the vitality of the channels through qi-regulating herbs, making the spleen and stomach an efficient and stable "transfer station for qi and blood essence".

[0024] III. Kidney-tonifying ingredients: Dendrobium officinale, Rubus idaeus, Trigonella foenum-graecum, Eclipta prostrata, and Polygonatum cyrtonema; Functions: Nourish yin and warm yang, replenish essence and generate marrow.

[0025] Dendrobium officinale and Polygonatum cyrtonema nourish yin and replenish essence, supplement the liver and kidney; Eclipta prostrata nourishes the kidney yin, cools blood and stops bleeding, preventing the deficiency heat and bleeding associated with osteoporosis.

[0026] Raspberry and fenugreek warm and tonify the kidney yang, astringe essence and reduce urination. When combined with yin-nourishing herbs, they achieve "seeking yang in yin" to balance the yin and yang of the kidney.

[0027] The kidney is in charge of bones and produces marrow. This group of herbs directly tonifies the root, promotes the transformation of marrow, and enhances bone density.

[0028] Eclipta prostrata, Dendrobium officinale, and Polygonatum cyrtonema all mainly nourish the yin of the liver and kidney. Traditional Chinese medicine believes that "yin is the foundation of yang". The growth and strength of bones require sufficient kidney yin (essence) as the material basis. This compatibility closely adheres to the essence of osteoporosis of "deficiency of kidney essence". Assisted by mild yang-warming herbs, fenugreek, a warm-natured herb, is used to warm and tonify the kidney yang. Fenugreek is warm but not dry, aiming to "generate qi with a small amount of fire", slightly generate the kidney qi, and promote the transformation of yin essence into bones, rather than using strongly pungent and hot herbs to simply damage the yin fluid. This kidney-tonifying combination embodies the meaning of "seeking yin in yang and containing yang in yin". It takes a powerful team of "nourishing yin and filling essence" as the main body, assisted by mild "igniting" to ensure that the process of tonifying the kidney can smoothly and persistently generate the substances (yin essence) required for bones and be smoothly transformed into functions (strengthening bones), avoiding the dryness and yin damage caused by pure kidney yang tonification or the stagnant supplementation caused by pure kidney yin tonification.

[0029] IV. Bone-strengthening ingredients: Homalomena occulta, Kadsura coccinea, Drynaria fortunei, Epimedium brevicornu, Eucommia ulmoides, Cuscuta chinensis; Functions: Strengthen tendons and bones, activate blood circulation and promote the healing of injuries.

[0030] Homalomena occulta strengthens tendons and bones, Kadsura coccinea promotes qi movement and activates blood circulation to promote bone growth, Drynaria fortunei is an important herb for orthopedics and traumatology, tonifies the kidney and activates blood circulation to promote the formation of bone callus; Eucommia ulmoides tonifies the liver and kidney, strengthens tendons and bones, and modern research has confirmed that it can promote the activity of osteoblasts.

[0031] Epimedium brevicornu and Cuscuta chinensis warm and tonify the kidney yang, and indirectly enhance bone toughness by regulating the endocrine system (such as estrogen level).

[0032] The core symptoms of osteoporosis are pain and fractures. Traditional Chinese medicine believes that "pain is due to obstruction" and "static blood blocking the collaterals". Using the combination of "Homalomena occulta" and "Kadsura coccinea", this combination closely combines "tonifying the liver and kidney to strengthen bones" with "activating blood circulation and dredging collaterals to relieve pain". It can not only enhance bone density in essence but also quickly and effectively relieve the back pain and general body pain caused by osteoporosis, achieving "treating both the symptoms and the root cause" and improving the quality of life of patients.

[0033] In the formula, Epimedium brevicornu, Eucommia ulmoides, fenugreek, etc. are relatively warm and dry in nature, and there is a risk of injuring yin after long-term use. Eclipta prostrata, Polygonatum cyrtonema, and Dendrobium officinale are all good herbs for tonifying both qi and yin or nourishing the yin of the liver and kidney, and can effectively restrict the warm and dry medicinal properties. The whole formula has a balanced yin and yang, warm but not dry. Especially for the common symptoms of yin-deficiency and fire-excess (such as hot flashes, night sweats, dry mouth) in postmenopausal osteoporosis patients, it has a direct targeted therapeutic effect, making this formula have a wider scope of application and be more suitable for long-term use.

[0034] The beneficial effects of this invention are as follows: Compatibility characteristics: 1. Addressing both symptoms and root causes: Through the chain of "clearing the spleen, strengthening the spleen, tonifying the kidneys, and strengthening bones," it achieves "simultaneous supplementation of acquired and innate constitutions" and "addressing both symptoms and root causes."

[0035] 2. Addressing the issue of "inability to tolerate tonics," resulting in good patient compliance: The pre-treatment "spleen-clearing" design and the "combination of tonification and purging" spleen-strengthening strategy effectively avoid common problems such as abdominal distension, poor appetite, and internal heat after taking tonics, ensuring the sustainability of treatment.

[0036] 3. Relieve pain and improve quality of life: The "Strengthening Bones and Promoting Blood Circulation" combination can target the core symptom of osteoporosis—pain. While improving bone density, it can significantly improve patients' daily activity ability and quality of life.

[0037] 4. Tonifying both Yin and Yang, with a wider range of indications: The formula itself has a good balance of Yin and Yang, which makes it suitable for osteoporosis patients with both Yin and Yang deficiency, as well as those with kidney Yang deficiency, kidney Yin deficiency, or both Yin and Yang deficiency. This reflects the flexibility of "treating different diseases with the same method" and is in line with the theory that "the kidney is the abode of water and fire".

[0038] 5. Combining Movement and Stillness: Tonifying herbs are combined with qi-regulating and blood-activating herbs to prevent stagnation in the spleen. This formula fully embodies the wisdom of "tonifying without stagnation, nourishing without greasiness" in its formulation. It uses "still" herbs such as spleen-strengthening herbs (Atractylodes macrocephala, Euryale ferox) and kidney-tonifying and essence-replenishing herbs (Polygonatum sibiricum, Dendrobium nobile) to solidify the source of qi, blood, yin, and essence. Furthermore, it is supplemented with "moving" herbs such as Citrus aurantium and Cinnamomum camphora to regulate qi, Black Tiger to activate blood, and Dioscorea hypoglauca to dispel dampness and relieve numbness, continuously promoting the circulation of qi and the metabolism of dampness. Thus, with the assistance of "moving" herbs, the tonifying effect is distributed throughout the body, especially reaching the muscles and bones; and with the support of "still" herbs, the "moving" herbs are unblocked without harming the body's vital energy. The two complement each other, working together to maintain the smooth flow of the spleen and stomach's digestive channels and the efficient absorption and delivery of the medicine's effects. This ensures that the whole formula can deeply nourish the root cause without causing any blockage in the stomach during long-term conditioning and tonification, thus ensuring the stability and longevity of the treatment. Detailed Implementation

[0039] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0040] Unless otherwise specified, the medicinal materials and reagents involved in the embodiments of this invention are all commercially available products and can be purchased through commercial channels.

[0041] Based on the principles of "treatment according to syndrome differentiation" and "dosage according to symptoms," this invention proposes a traditional Chinese medicine composition for treating osteoporosis, taking into account factors such as the properties, compatibility, dosage form, and applicable patients of the herbal composition and raw materials. The basic formula consists of the following raw materials in parts by weight: Spleen-clearing ingredients: 5-10 parts of Citrus aurantium, 5-10 parts of Gardenia jasminoides, and 9-12 parts of Dioscorea hypoglauca; Spleen-strengthening ingredients: 10-15 parts white lotus seeds, 10-15 parts camphor red, 15-25 parts fox nuts, and 6-12 parts stir-fried Atractylodes macrocephala. Kidney-tonifying ingredients: Dendrobium officinale 8-13 parts, Rubus idaeus 5-10 parts, Trigonella foenum-graecum 5-10 parts, Eclipta prostrata 8-13 parts, Polygonatum sibiricum 10-12 parts; Bone-strengthening ingredients: 10-15 parts of *Hypericum perforatum*, 5-10 parts of *Hemiberlesia lingua*, 10-20 parts of *Drynaria fortunei*, 8-13 parts of *Epimedium brevicornu*, 10-15 parts of *Eucommia ulmoides*, and 8-13 parts of *Cuscuta chinensis*.

[0042] All raw medicinal materials used in the basic formula meet the requirements of the Pharmacopoeia of the People's Republic of China (2020 Edition).

[0043] Example 1: This embodiment provides a traditional Chinese medicine decoction for treating osteoporosis, using the following raw materials: 7g of Citrus aurantium, 8g of Gardenia jasminoides, 10g of Dioscorea hypoglauca, 12g of Nelumbo nucifera, 12g of Cinnamomum camphora, 20g of Euryale ferox, 10g of Atractylodes macrocephala (stir-fried with soil), 10g of Dendrobium officinale, 8g of Rubus idaeus, 8g of Trigonella foenum-graecum, 10g of Eclipta prostrata, 12g of Polygonatum sibiricum, 12g of Homalomena occulta, 5g of Scutellaria baicalensis, 15g of Drynaria fortunei, 10g of Epimedium brevicornu, 12g of Eucommia ulmoides, and 10g of Cuscuta chinensis.

[0044] Preparation of decoction: S1. Weigh the various raw materials according to the mass fraction of the above Chinese medicine composition. After cleaning and chopping or cutting, soak for 30 minutes. First, add Qiannianjian, Hei Laohu, Gusuibu, Duzhong, Tiepi Shihu, and Huluba to the decoction container, add 8-10 times the amount of cold water, bring to a boil over high heat, and then simmer over low heat for 1 hour to obtain the decoction. S2. Add white lotus seeds, camphor red, fox nuts, stir-fried Atractylodes macrocephala, Citrus aurantium, Dioscorea hypoglauca, and Gardenia jasminoides to the decoction from step S1, add water to 6-8 times the volume, and continue to simmer over low heat for 40 minutes to obtain the second decoction. S3. Add Epimedium, Rubus idaeus, Eclipta prostrata, Polygonatum sibiricum, and Cuscuta chinensis to the second decoction, and continue to simmer over low heat for 10 minutes. Filter to remove the dregs to obtain the decoction. The decoction obtained in this embodiment is one dose.

[0045] Example 2: This embodiment provides a traditional Chinese medicine decoction for treating osteoporosis, using the following raw materials: 10g of Citrus aurantium, 5g of Gardenia jasminoides, 10g of Dioscorea hypoglauca, 10g of Nelumbo nucifera, 15g of Cinnamomum camphora, 20g of Euryale ferox, 12g of Atractylodes macrocephala (stir-fried with soil); 8g of Dendrobium officinale, 10g of Rubus idaeus, 10g of Trigonella foenum-graecum, 8g of Eclipta prostrata, 12g of Polygonatum sibiricum, 8g of Homalomena occulta, 8g of Dioscorea opposita, 18g of Drynaria fortunei, 12g of Epimedium brevicornu, 15g of Eucommia ulmoides, and 12g of Cuscuta chinensis. The preparation method of this decoction is the same as in Embodiment 1, and the decoction obtained in this embodiment constitutes one dose.

[0046] In this embodiment, the stir-fried Atractylodes macrocephala is prepared using the following method: T1. Take calcined oyster shell powder, calcined dragon bone, and hearth soil, all sieved through a 100-mesh sieve, and mix them in a mass ratio of 1:1:2 to prepare a composite soil for later use. Calcined oyster shell is rich in calcium and can synergistically supplement calcium; hearth soil helps the acquired spleen; calcined oyster shell and calcined dragon bone can tonify the kidneys and benefit the innate kidney qi. The spleen and kidneys work together to enhance the spleen-strengthening effect of Atractylodes macrocephala and also tonify the kidneys. Calcined dragon bone is also rich in calcium, which aligns with the principles of this formula to clear the spleen, strengthen the spleen, tonify the kidneys, and strengthen bones. T2. Place the Atractylodes macrocephala slices in preheated composite soil at 180℃. Use an intelligent stir-frying machine to maintain the pot temperature at (170±5)℃ and stir-fry for 5-7 minutes until the surface of the Atractylodes macrocephala is evenly coated with soil, turns dark yellow, and emits a caramel aroma. Quickly remove from the pot, sift out excess composite soil, and let cool.

[0047] Example 3: This embodiment provides a traditional Chinese medicine decoction for treating osteoporosis, using the following raw materials: The formula consists of: 5g of Citrus aurantium peel, 10g of Gardenia jasminoides, 12g of Dioscorea hypoglauca, 15g of Nelumbo nucifera seeds, 10g of Cinnamomum camphora, 15g of Euryale ferox seeds, 6g of stir-fried Atractylodes macrocephala, 13g of Dendrobium officinale, 5g of Rubus idaeus, 5g of Trigonella foenum-graecum, 13g of Eclipta prostrata, 10g of Polygonatum sibiricum, 10g of Homalomena occulta, 5g of Scutellaria baicalensis, 10g of Drynaria fortunei, 10g of Epimedium brevicornu, 10g of Eucommia ulmoides, and 8g of Cuscuta chinensis. The stir-fried Atractylodes macrocephala in this embodiment uses the same method as in Example 2, and the decoction prepared in this embodiment is considered as one dose.

[0048] Example 4: This embodiment provides a traditional Chinese medicine decoction for treating osteoporosis, using the following raw materials: The formula consists of: 6g of Citrus aurantium peel, 9g of Gardenia jasminoides, 10g of Dioscorea hypoglauca, 13g of Nelumbo nucifera seeds, 13g of Cinnamomum camphora, 18g of Euryale ferox seeds, 9g of stir-fried Atractylodes macrocephala, 9g of Dendrobium officinale, 8g of Rubus idaeus, 5g of Trigonella foenum-graecum, 10g of Eclipta prostrata, 9g of Polygonatum sibiricum, 12g of Homalomena occulta, 6g of Scutellaria baicalensis, 16g of Drynaria fortunei, 11g of Epimedium brevicornu, 12g of Eucommia ulmoides, and 8g of Cuscuta chinensis. The stir-fried Atractylodes macrocephala in this embodiment uses the same method as in Example 2, and the decoction prepared in this embodiment constitutes one dose.

[0049] Example 5: This embodiment provides a traditional Chinese medicine granule for treating osteoporosis. For ease of preparation and administration, the granule prepared in this embodiment is for 14 doses. The proportions of the medicinal materials are as described in Embodiment 2, including: 140g of Citrus aurantium, 70g of Gardenia jasminoides, 140g of Dioscorea hypoglauca; 410g of Nelumbo nucifera seeds, 210g of Cyathula officinalis, 280g of Euryale ferox seeds, 168g of Atractylodes macrocephala (stir-fried); 112g of Dendrobium officinale, 140g of Rubus idaeus, 140g of Trigonella foenum-graecum, 112g of Eclipta prostrata, 168g of Polygonatum sibiricum; 112g of Homalomena occulta, 112g of Dioscorea opposita, 252g of Drynaria fortunei, 168g of Epimedium brevicornu, 210g of Eucommia ulmoides, and 168g of Cuscuta chinensis.

[0050] The preparation method is as follows: P1. Pretreatment and extraction and collection of volatile oil: Take the jujube peel and camphor red powder and crush them into coarse powder. Take the jojoba root and black tiger and crush them into coarse powder. Add 10 times the amount of water and extract with steam distillation for 5 hours. Collect the volatile oil and seal and refrigerate for later use. Collect the aromatic water for later use. Keep the residue A. P2. Alcohol extraction: Take Homalomena occulta, black tiger, Drynaria fortunei, Eucommia ulmoides, Epimedium, Cuscuta chinensis, Dioscorea hypoglauca, and Gardenia jasminoides, combine them with the residue A obtained in step P1, add 8 times the amount of 70% ethanol by mass, heat and reflux for 1.5 hours, filter out the ethanol extract, and recover the ethanol under reduced pressure until there is no alcohol odor to obtain the concentrated alcohol extract. Retain residue B. P3. Water extraction: Take white lotus seeds, fox nuts, stir-fried Atractylodes macrocephala, Dendrobium officinale, raspberries, fenugreek, Eclipta prostrata, and Polygonatum sibiricum, combine them with the dregs B obtained in step P2, add 10 times the amount of water, heat and decoct for 1.5 hours, filter out the water extract, then add 6 times the amount of water and continue to decoct for 1 hour, and combine the two water extracts. P4. Merging and Concentration: The aromatic water obtained in step P1 and the water extract obtained in step P3 were allowed to stand and the supernatant was collected. This supernatant was combined with the alcohol extract concentrate obtained in step P2 and concentrated under reduced pressure (60℃, -0.08MPa) to a thick paste with a relative density of 1.30-1.35 (60℃). P5. Granulation: The volatile oil collected in step P1 is combined with β-cyclodextrin to prepare volatile oil inclusions using the saturated aqueous solution method. After drying, the inclusions are pulverized. This step is crucial to ensuring the stability of the efficacy of the granules during storage.

[0051] Mix the thick paste, volatile oil inclusions, appropriate amount of dextrin and flavoring agent (such as sucralose) evenly, use 85% ethanol as wetting agent to prepare a soft material, granulate it through a 14-mesh sieve using a swing granulator, dry it and package it to obtain granules. Dry the granules at 60-65℃ in a fluidized bed dryer or oven until the moisture content is ≤5%. After the dry granules are sized, seal them in aluminum-plastic composite film bags to obtain granules.

[0052] Comparative Example 1: This comparative example is based on Example 1, with the following changes: *Cinnamomum camphora* is replaced with regular dried tangerine peel; *Dioscorea hypoglauca* and *Epimedium brevicornu* are removed; *Atractylodes macrocephala* (stir-fried) is replaced with raw *Atractylodes macrocephala*; *Trigonella foenum-graecum* is replaced with cinnamon; *Eclipta prostrata* is replaced with *Ligustrum lucidum*; and *Ligusticum striatum* is replaced with *Ligusticum chuanxiong*. The formula is as follows: 7g of *Citrus aurantium*, 8g of *Gardenia jasminoides*, 12g of *Nelumbo nucifera* seeds, 12g of dried tangerine peel, 20g of *Euryale ferox*, 10g of *Atractylodes macrocephala*, 10g of *Dendrobium officinale*, 8g of *Rubus idaeus*, 3g of cinnamon, 10g of *Ligustrum lucidum*, 12g of *Polygonatum sibiricum*, 12g of *Homalomena occulta*, 5g of *Ligusticum chuanxiong*, 15g of *Drynaria fortunei*, 12g of *Eucommia ulmoides*, and 10g of *Cuscuta chinensis*. The preparation method of the decoction is as follows: Weigh all the raw materials according to the mass proportions specified in this comparative ratio, clean and chop or cut them, soak for 30 minutes, add 8-10 times the amount of cold water, bring to a boil over high heat, then simmer over low heat for 1 hour to obtain the first decoction; filter the first decoction, add water to make up to 6-8 times the amount, and continue to simmer over low heat for 40 minutes to obtain the second decoction. Combine the first and second decoctions to obtain one dose of the decoction.

[0053] Clinical trial section: I. General Information and Source of Cases 114 patients with osteoporosis admitted to the outpatient and inpatient departments of the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from September 2023 to December 2024 were selected as the study subjects.

[0054] II. Diagnostic criteria: 1. Western Medicine Diagnostic Criteria: Refer to the 2022 edition of the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis": ① Osteoporotic fracture of the hip or vertebral body, which can be clinically diagnosed as OP; ② T-score of bone mineral density of the axial bones (L1~L4, femoral neck or the whole hip) or bone mineral density of the distal 1 / 3 of the radius measured by dual-energy X-ray absorptiometry (DXA) ≤ -2.5, which can be diagnosed as OP.

[0055] 2. Traditional Chinese Medicine Diagnostic Criteria: The diagnostic criteria for OP (syndrome) in the 2020 edition of the "Expert Consensus on the Prevention and Treatment of Primary Osteoporosis with Traditional Chinese Medicine" are as follows: Main symptoms: Stabbing pain in the joints, with the pain located in a fixed position; Secondary symptoms: ① Fatigue and weakness, abdominal distension; ② Soreness and weakness in the lower back and knees, aversion to cold and cold limbs; ③ Heaviness in the body, sallow complexion; Tongue and pulse: ④ Pale and swollen tongue; ⑤ Deep and thready pulse. If you have ① and ②, plus any two of ③, ④ and ⑤, then you meet the diagnostic criteria of traditional Chinese medicine.

[0056] II. Inclusion Criteria: 1. Meets the Western medical diagnostic criteria for osteoporosis; 2. Meets the TCM diagnostic criteria for osteoporosis; 3. Age between 55 and 75 years old, gender not limited; 4. Local residents with good compliance; 5. Able to adhere to long-term use of the experimental drug throughout the entire treatment course and will not interrupt drug treatment without authorization; willing to participate in the study and sign an informed consent form.

[0057] If either item 1 or 2 is met, then items 3, 4, and 5 must also be met.

[0058] III. Exclusion Criteria: 1. Patients who have used glucocorticoids or other medications that affect bone metabolism within the past 3 months; 2. Those with severe osteoporosis or pathological fractures; 3. Individuals with mental illnesses who are unable to cooperate with the trial; 4. Individuals with severe adverse reactions to traditional Chinese medicine or allergic constitutions that may affect this test; 5. Patients with other serious internal medical conditions such as heart, liver, or kidney diseases; 6. Pregnant and lactating women; 7. Patients with other orthopedic diseases (bone tumors, rheumatoid arthritis, and ankylosing spondylitis, etc.) that may affect the data.

[0059] If any of the above conditions are met, the application is excluded.

[0060] V. Rejection, detachment, and termination criteria: 1. Patients with poor compliance, who do not strictly follow the treatment guidelines, thus affecting the evaluation of treatment efficacy; 2. Those whose statistical or evaluation data is missing, incorrect, or incomplete, affecting the assessment of treatment efficacy; 3. Other illnesses that may affect treatment develop during the trial; 4. Those who experience serious adverse reactions during the trial; 5. Individuals who develop serious complications or whose condition worsens during the trial, potentially leading to dangerous events.

[0061] VI. Test Methods (I) Grouping Method: The 114 participants were randomly divided into three groups using a random number table: an experimental group, a control group, and a control group, with 38 participants in each group. In the experimental group, 2 participants withdrew voluntarily, and 2 had poor compliance, resulting in a total of 4 dropouts, with 34 participants ultimately completing the trial. In the control group, 2 participants were lost to follow-up, and 2 had poor compliance, resulting in a total of 4 dropouts, with 34 participants ultimately completing the trial. In the control group, 1 participant was lost to follow-up, 1 withdrew voluntarily, and 1 had poor compliance, resulting in a total of 3 dropouts, with 35 participants ultimately completing the trial.

[0062] (II) Treatment methods: 1. General treatment: Basic treatment is given to all patients, including disease-related education, low-salt and low-fat diet, smoking cessation and alcohol limitation, appropriate exercise, avoiding wind and cold, maintaining emotional well-being, and careful attention to daily life.

[0063] 2. Drug treatment: 1) Control group: The control group received only basic anti-osteoporosis treatment: oral calcitriol soft capsules (Gai San Chun) (National Drug Approval Number H20030491), 0.25ug, once a day; Caltrate D tablets (Wyeth Pharmaceuticals, National Drug Approval Number H10950030) 600mg, once a day.

[0064] 2) Experimental group: In addition to the control group, the group was given the traditional Chinese medicine decoction of Example 2. Usage: one dose per day, divided into two doses, taken warm in the morning and evening.

[0065] 3) Control group: In addition to the control group, the control group was given the same Chinese herbal decoction as the control group. Usage: one dose per day, divided into two doses, taken warm in the morning and evening.

[0066] The three groups were treated for 7 days per course, for a total of 2 courses.

[0067] (III) Observation Indicators: 1. Safety indicators: (1) General physical examination items: body temperature, heart rate, blood pressure, pulse, etc.; (2) Routine examinations: electrocardiogram; routine blood, urine, and stool tests; liver and kidney function tests, etc. (3) Observe for possible adverse reactions, including local skin reactions and systemic reactions, such as whether general rashes, allergic reactions, and gastrointestinal reactions occur. Pay attention to analyzing the causes of adverse reactions, make accurate judgments in a timely manner, and record the treatment process and results truthfully; (4) Pain assessment: The VAS score was used to assess the patient’s pain level before and after treatment.

[0068] 2. Therapeutic indicators: 1) TCM syndrome scoring criteria: The TCM syndrome quantitative grading scoring table in the "Expert Consensus on the Prevention and Treatment of Primary Osteoporosis with Traditional Chinese Medicine (2020)"

[103] was used for scoring. The scores were recorded once before treatment and once after treatment. Tongue and pulse were recorded truthfully and were not used as scoring items.

[0069] Clinical control: Clinical symptoms and signs disappear or basically disappear, and the TCM syndrome score decreases by ≥95%; Significant effect: Clinical symptoms and signs are significantly improved, and the TCM syndrome score is reduced by ≥70% and <95%; Effective: Clinical symptoms and signs improved, and the TCM syndrome score decreased by ≥30% and <70%; Ineffective: Clinical symptoms and signs show no significant improvement or even worsen, and the TCM syndrome score decreases by less than 30%; Overall effective rate = (number of patients with clinical control + number of patients with significant effect + number of patients with effective results) / total number of patients * 100%.

[0070] 2) Western medicine efficacy evaluation criteria: Bone mineral density measurement: Dual-energy X-ray absorptiometry was used to measure the bone mineral density (BMD) of the vertebral bodies from the first to the fourth lumbar vertebrae of the subjects. The data were recorded once before treatment and once after treatment, and the average T value was used as the observation index.

[0071] Detection of bone turnover markers: Fasting venous blood samples were drawn on the morning of the day before treatment and on the morning of 6 months after treatment to detect the levels of N-MIDOC, β-CTX, and 25-(OH)D in the subjects.

[0072] VII. Statistical Analysis: Data were entered and analyzed using SPSS 26.0 software. For measurement data, the mean ± standard deviation was used. Data should be described as follows: For data that conforms to a normal distribution and homogeneity of variance, paired samples t-tests should be used for within-group comparisons, and one-way ANOVA should be used for between-group comparisons; otherwise, the rank-sum test should be used. For count data, express the data as frequency or percentage (%), and use the chi-square test for between-group comparisons. For ordinal data, use the rank-sum test for between-group comparisons. A p-value < 0.05 is considered statistically significant between the two groups.

[0073] VIII. Research Results: 1. Comparison of gender among the three groups of patients: This study included 103 patients, 19 males and 84 females. The experimental group consisted of 34 patients: 6 males (17.60%) and 28 females (82.40%). The control group consisted of 34 patients: 5 males (14.70%) and 29 females (85.30%). The control group consisted of 35 patients: 8 males (22.90%) and 27 females (77.10%). (X-ray)2 The test yielded X. 2 =0.783, P=0.676>0.05, indicating that there was no statistically significant difference in gender among the three groups of patients, demonstrating that the gender data of the three groups were comparable. See Table 1.

[0074] Table 1: Comparison of genders among the three groups of patients: ; 2. Comparison of ages among the three groups of patients: The ages of the three groups of patients were compared. In the experimental group, the oldest patient was 75 years old, the youngest was 55 years old, and the mean age was 66.03 ± 6.35 years. In the control group, the oldest patient was 75 years old, the youngest was 55 years old, and the mean age was 66.74 ± 6.25 years. In the control group, the oldest patient was 75 years old, the youngest was 55 years old, and the mean age was 65.34 ± 6.89 years. The rank-sum test yielded H... c =0.637, P=0.727>0.05, indicating that there was no statistically significant difference in age among the three groups of patients, and that the age data of the two groups were comparable, as shown in Table 2.

[0075] Table 2: Comparison of ages among the three groups of patients ; 3. Comparison of BMI values ​​among the three groups of patients: The BMI values ​​of the three groups of patients were compared. The mean BMI of the experimental group was 22.82±1.50; the mean BMI of the control group was 23.57±1.53; and the mean BMI of the control group was 23.11±1.48. A nonparametric test was performed, and H was obtained. c =5.150, P=0.076>0.05, indicating that there was no statistically significant difference in BMI values ​​among the three groups of patients, suggesting that the BMI data of the three groups are comparable. See Table 3.

[0076] Table 3: Comparison of BMI values ​​among the three groups of patients ; 4. Comparison of pain visual analog scale (VAS) scores among the three groups of patients: Comparison of data within each group: After treatment, VAS scores decreased in all three groups. A t-test showed that the experimental group had a t=9.303, P<0.001; a rank-sum test showed that the control group had a Z=-4.763, P<0.001, and the control group had a Z=-4.879, P<0.001, indicating statistically significant differences in VAS scores before and after treatment among the three groups, suggesting that all three interventions were effective. Comparison of data between groups: Non-parametric analysis showed no statistically significant difference in VAS scores before treatment among the three groups (Hc=0.157, P=0.925>0.05), indicating that the VAS scores before treatment were comparable. However, there was a statistically significant difference in VAS scores after treatment among the three groups (Hc=10.165, P=0.006<0.05), suggesting that the experimental group had a more significant effect on improving pain levels than the control and control groups (see Table 4).

[0077] Table 4: Comparison of VAS scores (points) among the three groups of patients before and after treatment ; 5. Comparison of TCM syndrome scores among the three groups of patients before and after treatment: Comparison of data within each group: After treatment, the TCM syndrome scores of all three groups decreased. A t-test showed that the difference was statistically significant: t=15.490 (P<0.001) for the experimental group, t=10.126 (P<0.001) for the control group, and t=13.766 (P<0.001) for the comparison group. This indicates that the differences in TCM syndrome scores before and after treatment were statistically significant among the three groups, suggesting that the intervention was effective in all three groups. Comparison of data between groups: One-way ANOVA showed no statistically significant difference in TCM syndrome scores before treatment among the three groups (F=0.418, P=0.659>0.05), indicating that the TCM syndrome scores before treatment were comparable. A rank-sum test showed a statistically significant difference in TCM syndrome scores after treatment among the three groups (H0.05). c =10.763, P<0.001), indicating that the experimental group had a more significant effect on improving TCM symptoms such as lower back pain, weakness, limited lumbar spine mobility, aversion to cold and preference for warmth, and frequent urination compared with the control group and the control group, as shown in Table 5.

[0078] Table 5: Comparison of TCM syndrome scores before and after treatment in the three groups (points) ; 6. Comparison of lumbar spine (L1-L4) bone mineral density T-scores (BMD) among the three groups of patients: Comparison of data within each group: After treatment, the bone mineral density (BMD) scores of the lumbar spine (L1-L4) increased in all three groups. The rank-sum test showed that the experimental group had Z=-5.151 (P<0.001), the control group had Z=-4.472 (P=0.001<0.05), and the control group had Z=-5.090 (P<0.001), indicating a statistically significant difference in BMD scores before and after treatment among the three groups, suggesting that the intervention was effective in all three groups. Comparison of data between groups: One-way ANOVA showed no statistically significant difference in BMD scores before treatment among the three groups (F=0.327, P=0.722>0.05), indicating that the BMD scores before treatment were comparable. Nonparametric tests showed a statistically significant difference in BMD scores after treatment among the three groups (H0.05). c =9.751, P=0.008<0.05), indicating that the experimental group had a more significant effect on improving bone mineral density (BMD) than the control group and the control group, as shown in Table 6.

[0079] Table 6: Comparison of bone mineral density (BMD) scores (g / cm²) of the three groups of patients before and after treatment. ; 7. Comparison of N-MID OC levels in the mid-shaft bone before and after treatment in the three groups of patients: Comparison of data within each group: After treatment, N-MID OC levels decreased in all three groups. A t-test showed that the experimental group (t=7.224, P<0.001), the control group (t=4.155, P<0.001), and the control group (t=3.069, P=0.004<0.05) had statistically significant differences in N-MID OC levels before and after treatment, indicating that the interventions were effective in all three groups. Comparison of data between groups: Non-parametric tests showed no statistically significant difference in N-MID OC levels before treatment among the three groups (H0.05). c =0.026, P=0.987>0.05), indicating that the N-MID OC levels before treatment in the three groups were comparable; the differences in N-MID OC levels after treatment among the three groups were statistically significant (H0.05). c =16.268, P<0.001), indicating that the experimental group had a more significant effect on improving the N-MID OC level in patients than the control group and the control group, as shown in Table 7.

[0080] Table 7: Comparison of N-MID OC levels (ng / mL) in the three groups of patients before and after treatment ; 8. Comparison of β-collagen cross-linked carboxyl-terminal peptide (β-CTX) levels before and after treatment in the three groups of patients: Comparison of data within each group: After treatment, β-CTX levels decreased in all three groups. The rank-sum test showed Z=-5.091 for the experimental group (P<0.001), and the t-test showed t=4.661 for the control group (P<0.001) and t=4.788 for the control group (P<0.001), indicating statistically significant differences in β-CTX levels before and after treatment among the three groups, suggesting that all three interventions were effective. Comparison of data between groups: Non-parametric tests showed no statistically significant difference in β-CTX levels before treatment among the three groups (H0.001). c =0.029, P=0.986>0.05), indicating that the β-CTX levels before treatment in the three groups were comparable; the differences in β-CTX levels after treatment among the three groups were statistically significant (H0.05). c =36.400, P<0.001), indicating that the experimental group had a more significant effect on improving patients' β-CTX levels than the control group and the control group, as shown in Table 8.

[0081] Table 8: Comparison of β-CTX levels before and after treatment in the three groups of patients (ng / mL) ; 9. Comparison of 25-(OH)D levels before and after treatment in the three groups of patients: Comparison of data within each group: After treatment, the 25-(OH)D levels of patients in all three groups increased. A t-test showed that the experimental group had t=-9.378 (P<0.001), the control group had t=-3.612 (P=0.001<0.05), and the control group had t=-2.158 (P=0.038<0.05), indicating a statistically significant difference in 25-(OH)D levels before and after treatment among the three groups, suggesting that the interventions in all three groups were effective. Comparison of data between groups: Non-parametric test analysis showed no statistically significant difference in 25-(OH)D levels before treatment among the three groups (H0). c =3.227, P=0.199>0.05), indicating that the 25-(OH)D level data before treatment in the three groups were comparable; the differences in 25-(OH)D levels after treatment among the three groups were statistically significant (H c =21.324, P<0.001), indicating that the experimental group had a more significant effect on improving patients' 25-(OH)D levels than the control group and the control group. See Table 9.

[0082] Table 9: Comparison of 25-(OH)D levels before and after treatment in the three groups of patients (ng / mL) ; 10. Comparison of treatment effects among the three groups of patients: After the completion of all treatment courses in this study, the experimental group consisted of 34 patients, of whom 6 achieved clinical control, 17 showed significant improvement, 8 showed improvement, and 3 showed no improvement, with a total effective rate of 91.18%. The control group also consisted of 34 patients, of whom 4 achieved clinical control, 8 showed significant improvement, 17 showed improvement, and 5 showed no improvement, with a total effective rate of 85.29%. The control group consisted of 35 patients, of whom 1 achieved clinical control, 3 showed significant improvement, 20 showed improvement, and 11 showed no improvement, with a total effective rate of 68.57%. The rank-sum test was used to analyze the total effective rate of the three groups. The rank-sum test yielded H0. c =20.411, P<0.001, indicating a statistically significant difference in the total effective rate among the three groups, suggesting that the total effective rate of the experimental group was higher than that of the control group and the control group. See Table 10.

[0083] Table 10: Comparison of treatment efficacy among the three groups of patients (cases) ; Note: Overall effective rate (%) = (clinical control + significant effect + effective) / number of patients × 100%.

[0084] 11. Security Assessment: (1) Drug safety assessment Patients in each group underwent routine examinations of vital signs, blood, urine, and stool, as well as liver and kidney function tests and electrocardiograms before, during, and after treatment to evaluate the safety of the drug. No results were found that were normal before treatment but abnormal after treatment, indicating that the drug is safe.

[0085] (2) Comparison of adverse reactions among the three groups of patients Regarding adverse reactions, 2 patients in the experimental group, 3 patients in the control group, and 2 patients in the control group experienced discomfort such as itching and gastrointestinal reactions during treatment. These symptoms disappeared after timely symptomatic treatment, and treatment was not interrupted during the study period. (Using X) 2 The incidence of adverse reactions in the three groups of patients was analyzed using the test, and X was obtained. 2 =0.330, P=0.848>0.05, indicating that there was no statistically significant difference in the incidence of adverse reactions among the three groups of patients. See Table 11.

[0086] Table 11: Comparison of adverse reaction rates among the three groups of patients (cases) .

[0087] Typical treatment case: Case 1: Female, 70 years old.

[0088] I. Consultation time (first consultation): 9:00 AM on January 14, 2022.

[0089] II. Patient's chief complaint: Pain in both knees with limited mobility for 3 months, worsening in the last 3 days.

[0090] III. Present Illness: The patient reported that three months ago, he experienced pain and limited mobility in both knees after exertion. He rested at home and applied Yunnan Baiyao externally, which provided slight relief. Three days ago, the patient suddenly experienced severe pain and limited mobility when bending his knees. He was accompanied by his family to the orthopedic clinic. Upon arrival, the patient was conscious, with a sallow complexion, poor spirits, fatigue, pain in both knees that was slightly relieved by warmth, cold extremities, abdominal distension, poor appetite, frequent urination of clear urine, loose stools, and poor sleep. His tongue was pale and dark with a white coating, and his pulse was deep and hesitant.

[0091] IV. Past medical history, personal history, family history, etc.: History of hypertension for 10 years, treated with amlodipine besylate tablets, blood pressure is well controlled; no history of acute or chronic infectious diseases; no history of trauma; no history of food or drug allergies; no history of blood transfusions; no history of diabetes or heart disease; denies family history of hereditary diseases.

[0092] V. Auxiliary Examinations: DR of both knee joints showed degenerative changes. Dual-energy X-ray absorptiometry (DXA) bone mineral density measurement showed: L1-L4 0.557 g / cm³. 2 T-score -4.5; right hip joint 0.247 g / cm² 2 T-score -4.2; left hip joint 0.240 g / cm² 2 T-score -4.2. Physical examination by the outpatient doctor revealed: mild limitation of movement in both knee joints, local tenderness, positive percussion pain, normal sensation and muscle strength in both lower extremities, and no other obvious abnormalities.

[0093] VI. Traditional Chinese Medicine Diagnosis: Bone atrophy, deficiency of both spleen and kidney (osteoporosis).

[0094] Diagnosis and treatment basis: The patient is an elderly woman with insufficient fire, blood vessels lack warmth or kidney essence deficiency, insufficient production of essence and blood, weak circulation of qi and blood, spleen deficiency and dampness stagnation, and malnourishment of bones; spleen qi and kidney qi deficiency, insufficient primordial qi, resulting in bone atrophy and malnourishment, muscle and bone weakness, and bone atrophy and disuse, which is called bone atrophy.

[0095] VII. Treatment Principles: Clear and strengthen the spleen, tonify the kidneys and replenish essence, strengthen muscles and bones. VIII. Intervention: Administer the decoction as described in Example 2. A total of 60 doses, one dose daily. Instruct the patient to increase outdoor activities and sun exposure appropriately, avoid falls, and consume foods rich in calcium, iron, and protein.

[0096] IX. Changes and Outcome of the Illness: Second visit (January 29, 2023): The patient reported that the pain in both knees had lessened, range of motion had improved, posture was normal, gait was easy, urination was normal, stool was soft, appetite and sleep were good, tongue was dark red with a thin white coating, and pulse was deep and thready. Dual-energy X-ray absorptiometry (DXA) bone mineral density measurement showed: L1-L4 0.596 g / cm³.2 T-score -4.2; right hip joint 0.258 g / cm² 2 T-score -4.1; left hip joint 0.306 g / cm 2 The T value was -3.7. Continue administering the decoction from Example 2 for a total of 60 doses, one dose daily. Instruct the patient to increase outdoor activities and sun exposure appropriately, avoid falls, and eat foods rich in calcium, iron, and protein.

[0097] Third visit (January 25, 2024): The patient's knee pain has significantly improved, complexion is rosy, spirits are good, voice is strong, movement is free, bowel movements are normal, tongue is pale red with a thin white coating, and pulse is deep and forceful. Dual-energy X-ray absorptiometry (DXA) bone mineral density measurement showed: L1-L4 0.608 g / cm³. 2 T-score -4.0; right hip joint 0.262 g / cm² 2 T-score -4.0; left hip joint 0.253 g / cm 2 The T-value was -4.1. The above treatment was continued for a total of 60 doses, one dose daily, taken with warm water. The patient was advised to eat more foods that strengthen the spleen and promote diuresis, such as yam, coix seed, kidney beans, and hawthorn, which are rich in calcium and vitamin D. A follow-up visit later revealed that the patient's symptoms had disappeared and there was no recurrence.

[0098] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating osteoporosis, characterized in that, consists of the following raw medicinal materials by mass fraction: Spleen clearing ingredients: Jiang Zhikou 5-10 parts, Huangqianzi 5-10 parts, Mianbixie 9-12 parts; Spleen strengthening ingredients: Bailianzi 10-15 parts, Zhangtouhong 10-15 parts, Qianshili 15-25 parts, Tuocha Baishu 6-12 parts; Kidney tonifying ingredients: Tieshishu 8-13 parts, Mopensi 5-10 parts, Huluba 5-10 parts, Hanmolian 8-13 parts, Duofu Huangjing 10-12 parts; Bone strengthening ingredients: Qianianjian 10-15 parts, Heilao 5-10 parts, Gushu 10-20 parts, Yinyanghe 8-13 parts, Duzhong 10-15 parts, Tuisi 8-13 parts.

2. The traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, consists of the following raw medicinal materials by mass fraction: Jiang Zhikou 7 parts, Huangqianzi 8 parts, Mianbixie 10 parts, Bailianzi 12 parts, Zhangtouhong 12 parts, Qianshili 20 parts, Tuocha Baishu 10 parts, Tieshishu 10 parts, Mopensi 8 parts, Huluba 8 parts, Hanmolian 10 parts, Duofu Huangjing 12 parts, Qianianjian 12 parts, Heilao 5 parts, Gushu 15 parts, Yinyanghe 10 parts, Duzhong 12 parts, Tuisi 10 parts; or, Jiang Zhikou 10 parts, Huangqianzi 5 parts, Mianbixie 10 parts, Bailianzi 10 parts, Zhangtouhong 15 parts, Qianshili 20 parts, Tuocha Baishu 12 parts, Tieshishu 8 parts, Mopensi 10 parts, Huluba 10 parts, Hanmolian 8 parts, Duofu Huangjing 12 parts, Qianianjian 8 parts, Heilao 8 parts, Gushu 18 parts, Yinyanghe 12 parts, Duzhong 15 parts, Tuisi 12 parts; or, Jiang Zhikou 5 parts, Huangqianzi 10 parts, Mianbixie 12 parts, Spleen strengthening ingredients: Bailianzi 15 parts, Zhangtouhong 10 parts, Qianshili 15 parts, Tuocha Baishu 6 parts, Tieshishu 13 parts, Mopensi 5 parts, Huluba 5 parts, Hanmolian 13 parts, Duofu Huangjing 10 parts, Qianianjian 10 parts, Heilao 5 parts, Gushu 10 parts, Yinyanghe 10 parts, Duzhong 10 parts, Tuisi 8 parts; or, Jiang Zhikou 6 parts, Huangqianzi 9 parts, Mianbixie 10 parts, Bailianzi 13 parts, Zhangtouhong 13 parts, Qianshili 18 parts, Tuocha Baishu 9 parts, Tieshishu 9 parts, Mopensi 8 parts, Huluba 5 parts, Hanmolian 10 parts, Duofu Huangjing 9 parts, Qianianjian 12 parts, Heilao 6 parts, Gushu 16 parts, Yinyanghe 11 parts, Duzhong 12 parts, Tuisi 8 parts.

3. The traditional Chinese medicine composition for treating osteoporosis according to claim 1, characterized in that, The preparation method of the Tuocha Baishu is: T1. Take calcined oyster shell powder, calcined dragon bone, and zaoxin soil, mix them according to a mass ratio of 1:1:2, and use as a composite soil for standby; T2. Put the clean Baishu tablets into the composite soil preheated to 180°C, use an intelligent medicine roasting machine, keep the pot temperature at 170±5°C, and stir-fry for 5-7 minutes until the Baishu surface is evenly coated with soil and turns dark yellow. Take out the pot, sieve out the excess composite soil, and cool down.

4. The traditional Chinese medicine composition for treating osteoporosis according to any one of claims 1 to 3, characterized in that, The Chinese medicine composition is a decoction, and its preparation method is: S1. Weigh various raw medicinal materials according to the mass fraction of the Chinese medicine composition, soak them for 30 minutes after cleaning and cutting or cutting, and then add Qianianjian, Heilao, Gushu, Duzhong, Tieshishu, Huluba, and Huluba into the decoction container, add 8-10 times the amount of cold water, boil it with a strong fire, and then simmer it with a weak fire for 1 hour to obtain the first decoction; S2. Add Bai Lian Zi, Zhang Tou Hong, Qian Shi, Tu Chao Bai Zhu, Jiang Zhi Ke, Mian Bi Qie, Huang Zhi Zi into the decoction from step S1, add water to 6-8 times the volume of the decoction, continue to boil for 40 minutes, get the second decoction; S3. Add Yin Yang Huo, Mu Teng Zi, Han Mo Lian, Duo Hua Huang Jin, Tu Si Zi into the second decoction, continue to boil for 10-15 minutes, filter out the residue, get the decoction.

5. The traditional Chinese medicine composition for treating osteoporosis according to any one of claims 1 to 3, characterized in that, The Chinese medicine composition is granules, and the preparation method is as follows: P1. Pre-treatment, extraction and collection of volatile oil: Jiang Zhi Ke and Zhang Tou Hong are crushed into coarse powder, Qian Nian Jian and Hei Laohu are crushed into coarse powder, 10 times the volume of water is added, and the water vapor distillation method is used for extraction for 5 hours, the volatile oil is collected and sealed for cold storage, the aromatic water is collected for standby, and the residue A is reserved; P2. Alcohol extraction: Qian Nian Jian, Hei Laohu, Gu Sui Bu, Du Zhong, Yin Yang Huo, Tu Si Zi, Mian Bi Qie and Huang Zhi Zi are combined with the residue A obtained in step P1, 8 times the volume of 70% ethanol is added, heating reflux extraction is carried out for 1.5 hours, the ethanol extract is filtered out, and the ethanol is recovered under reduced pressure until there is no alcohol smell, the alcohol extraction concentrate is obtained, and the residue B is reserved; P3. Water extraction: Bai Lian Zi, Qian Shi, Tu Chao Bai Zhu, Tiepi Shizhu, Mu Teng Zi, Hu Luoba, Han Mo Lian and Duo Hua Huang Jin are combined with the residue B obtained in step P2, 10 times the volume of water is added, heating decoction is carried out for 1.5 hours, the water extract is filtered out, and 6 times the volume of water is continuously added for decoction for 1 hour, and the water extracts obtained twice are combined; P4. Combine and concentrate: The supernatant of the aromatic water obtained in step P1 and the water extract obtained in step P3 is placed, and the supernatant is combined with the alcohol extraction concentrate obtained in step P2, and concentrated under reduced pressure to a thick paste with a relative density of 1.30-1.35; P5. Granulation: The volatile oil collected in step P1 is mixed with β-cyclodextrin to prepare a volatile oil inclusion, dried and crushed, the thick paste, the volatile oil inclusion, dextrin and flavoring agent are uniformly mixed, 85% ethanol is used as a wetting agent to prepare a soft material, and granulation, drying, and granulation are carried out to obtain granules.