Traditional Chinese medicine composition for relieving or treating qi stagnation and blood stasis type bone diseases as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for relieving or treating qi stagnation and blood stasis type bone diseases including osteoarthritis, fracture delayed healing and osteoporosis and a preparation method and application of the traditional Chinese medicine composition, and the traditional Chinese medicine composition comprises, by weight, 6-12 parts of radix paeoniae rubra, 10-20 parts of angelica sinensis, 10-20 parts of ligusticum wallichii, 10-15 parts of carthamus tinctorius and 15-25 parts of vinegar frankincense. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-25 parts of vinegar myrrh, 3-8 parts of borax, 6-12 parts of wine-treated rhubarb, 3-8 parts of dragon's blood, 10-20 parts of pseudo-ginseng, 3-7 parts of fried semen persicae, 3-7 parts of radix aucklandiae, 3-8 parts of vinegar-treated rhizoma cyperi, 20-30 parts of scalded rhizoma drynariae, 8-15 parts of radix achyranthis bidentatae, 6-10 parts of cortex lycii radicis, 6-10 parts of cortex acanthopanacis, 20-30 parts of crabs and 5-10 parts of radix dipsaci slices. The traditional Chinese medicine composition can promote qi to activate blood, relieve swelling and pain, reunion bones and reunion and promote healing, and has no toxic or side effect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for relieving or treating bone diseases of the qi stagnation and blood stasis type, its preparation method and application, including osteoarthritis, delayed fracture healing, and osteoporosis. Background Technology

[0002] Fractures and joint injuries are common clinical conditions. Traditional Chinese medicine classifies fractures into three stages: the initial stage mainly manifests as tendon and bone damage, stagnation of qi and blood, and obstruction of tendons and meridians; the middle stage manifests as the dissipation of blood stasis and the disappearance of swelling, but the tendons and bones have not yet reconnected; and the late stage manifests as deficiency of qi and blood, and insufficiency of liver and kidney. Due to the different stages of the patient's condition, the treatment principles are also different. The initial stage mainly focuses on promoting blood circulation, removing blood stasis, reducing swelling and relieving pain; the middle stage mainly focuses on reconnecting tendons and bones; and the late stage mainly focuses on replenishing qi and blood and strengthening tendons and bones.

[0003] Traumatic fractures are one of the main types of fracture diseases, mostly caused by external violence. Treatment can be divided into three stages: initial, intermediate, and late. Initial stage: After a fracture, due to bone breakage and tendon injury, blood vessels are obstructed, stagnant blood remains internally, qi and blood stagnate, and meridians are blocked, causing pain due to obstruction. Damage to the bone marrow, periosteum, and surrounding soft tissues leads to ruptured blood vessels and bleeding, with extravasated blood flowing through the skin, causing inflammation and swelling between tissues—a condition described as "pain due to qi injury, swelling due to physical injury." Four to five hours after injury, the bleeding begins to clot. Because blood circulation at the fracture site is blocked, tendons and blood vessels are damaged, blood leaves the vessels and accumulates, leading to qi and blood stagnation, meridian obstruction, and partial bone cell necrosis. The *Bai Bing Bian Hui Lu* states, "If blood does not circulate, stasis cannot be removed; if stasis is not removed, bones cannot heal." Blood is the mother of qi; blood carries qi, and qi governs blood. Qi is consumed with blood. Angelica sinensis has the effect of dispersing and clearing qi and blood stagnation. For severe open fractures with significant blood loss, Angelica sinensis and Astragalus membranaceus are often used in large doses to replenish blood, invigorate qi, promote yang, promote tissue regeneration, and reduce inflammation. Patients with multiple pelvic fractures often experience significant blood loss and constipation; Angelica sinensis is used first to replenish and invigorate blood, lubricate the intestines, and relieve constipation. Therefore, the initial treatment principle should be to invigorate blood, remove blood stasis, reduce swelling and pain, and lubricate the intestines to relieve constipation. Thus, Angelica sinensis tails stir-fried with wine are used in large doses to achieve the purpose of treating the injury, supporting the body's resistance, and dispersing blood stasis. It can be used in large doses for injuries to any part of the body. Mid-stage: After the initial treatment, pain is reduced, swelling subsides, and blood stasis is largely dissipated. The tendons and bones rely on qi and blood, as well as the essence of the liver and kidneys, for nourishment. After the blood stasis is resolved, it is necessary to nourish the blood, replenish the liver and kidneys, and promote the regeneration of the fracture ends. Although the swelling has subsided, the remaining blood stasis may not have completely resolved. Sudden administration of tonifying herbs could lead to further blood stasis, while continued treatment to clear the stasis might harm the body's vital energy. Angelica sinensis, however, can warm and nourish the fractured bones and tendons with blood and qi, promoting callus formation. With the remaining blood stasis cleared, timely repair is possible. Stir-fried whole Angelica sinensis is the preferred choice, as it invigorates blood circulation, replenishes blood, clears the meridians, removes blood stasis, promotes new blood production, relaxes muscles and tendons, and helps the bones and tendons reconnect. It also promotes the increase of cells in the inner layer of the periosteum, producing osteoid tissue and forming new bone. This new bone adheres tightly to the cortical bone surface, and fibrous callus quickly surrounds the fracture ends. Peripheral osteoblasts or chondrocytes rapidly enter the fracture site, occupying the original hematoma area. If treatment is delayed, poor blood supply to the fracture ends will slow callus growth, affecting subsequent functional exercises. Summary of the Invention

[0004] Purpose of the invention The purpose of this invention is to provide a traditional Chinese medicine composition for relieving or treating osteoarthritis of the qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis, as well as its preparation method and application. The traditional Chinese medicine composition of this invention can promote qi and blood circulation, reduce swelling and relieve pain, promote bone and tendon healing, and is particularly effective for slow bone healing, significantly reducing side effects.

[0005] Solution To achieve the objectives of this invention, the technical solution adopted is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis. Its active ingredients include the following raw materials in parts by weight: 6-12 parts of Paeonia lactiflora, 10-20 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 10-15 parts of Carthamus tinctorius, 15-25 parts of vinegar-processed Boswellia carterii, 15-25 parts of vinegar-processed Commiphora myrrha, 3-8 parts of Borax, 6-12 parts of wine-processed Rheum palmatum, 3-8 parts of Dragon's Blood, 10-20 parts of Panax notoginseng, 3-7 parts of stir-fried Prunus persica, 3-7 parts of Aucklandia lappa, 3-8 parts of vinegar-processed Cyperus rotundus, 20-30 parts of stir-fried Drynaria fortunei, 8-15 parts of Achyranthes bidentata, 6-10 parts of Lycium chinense root bark, 6-10 parts of Acanthopanax senticosus root bark, 20-30 parts of Crab, and 5-10 parts of Dipsacus asper.

[0006] Furthermore, its active ingredients include the following raw materials in parts by weight: 8-12 parts of Paeonia lactiflora, 12-18 parts of Angelica sinensis, 10-20 parts of Ligusticum chuanxiong, 10-15 parts of Carthamus tinctorius, 18-25 parts of vinegar-processed Boswellia carterii, 18-25 parts of vinegar-processed Commiphora myrrha, 3-8 parts of Borax, 6-12 parts of wine-processed Rheum palmatum, 3-8 parts of Dragon's Blood, 12-20 parts of Panax notoginseng, 3-7 parts of stir-fried Prunus persica, 3-7 parts of Aucklandia lappa, 3-8 parts of vinegar-processed Cyperus rotundus, 20-30 parts of stir-fried Drynaria fortunei, 8-15 parts of Achyranthes bidentata, 6-10 parts of Lycium chinense root bark, 6-10 parts of Acanthopanax senticosus root bark, 20-30 parts of crab, and 5-10 parts of Dipsacus asper.

[0007] Furthermore, its active ingredients include the following raw materials in parts by weight: 10 parts of Paeonia lactiflora, 15 parts of Angelica sinensis, 15 parts of Ligusticum chuanxiong, 12 parts of Carthamus tinctorius, 20 parts of vinegar-processed frankincense, 20 parts of vinegar-processed myrrh, 5 parts of borax, 10 parts of wine-processed rhubarb, 5 parts of dragon's blood, 15 parts of Panax notoginseng, 4 parts of stir-fried peach kernel, 4 parts of costus root, 5 parts of vinegar-processed Cyperus rotundus, 25 parts of hot-processed Drynaria fortunei, 10 parts of Achyranthes bidentata, 8 parts of Lycium chinense root bark, 8 parts of Acanthopanax senticosus root bark, 25 parts of crab, and 8 parts of Dipsacus asper.

[0008] Furthermore, the traditional Chinese medicine composition is a powder prepared by pulverizing traditional Chinese medicinal materials.

[0009] Furthermore, the dosage form of the traditional Chinese medicine composition is any one of powder, oral liquid, spray, ointment, injection, and capsule.

[0010] Secondly, a method for preparing the traditional Chinese medicine composition described in the first aspect is provided, wherein the medicinal materials are mixed and ground into powder.

[0011] Thirdly, a powder of a traditional Chinese medicine composition is provided, prepared by the method described in the second aspect.

[0012] Fourthly, a medicine is provided for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis, including the traditional Chinese medicine composition described in the first aspect, or the powder prepared by the method described in the second aspect, as well as other Western medicines, optionally including calcium supplements (e.g., Caltrate).

[0013] Fourthly, the use of the traditional Chinese medicine composition described in the first aspect or the powder prepared by the method described in the second aspect in the preparation of products for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis.

[0014] Furthermore, the product is a medicine.

[0015] Furthermore, the osteoarthritis mentioned includes knee osteoarthritis, hip osteoarthritis, and hand osteoarthritis.

[0016] Beneficial effects (1) The combination of the various herbs in this invention can promote qi and blood circulation, reduce swelling and relieve pain, promote bone healing and tendon reconnection, and promote healing. It is effective for osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis, with almost no side effects. The traditional Chinese medicine composition of this invention contains core ingredients such as safflower, angelica, dragon's blood, notoginseng, and chuanxiong. Its "fast" effect lies in its rapid reduction of swelling and pain relief, and its "specific" effect lies in the fact that the formula of Huoxue Jiegu Wan can accelerate callus growth and promote fracture healing by tonifying the liver and kidneys, strengthening tendons and bones.

[0017] (2) In the formula of this invention, safflower, Panax notoginseng, dragon's blood, vinegar-processed frankincense, and vinegar-processed myrrh are the principal herbs for promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain. "When qi flows, blood flows," so Angelica sinensis, Paeonia lactiflora, and Ligusticum chuanxiong are added to nourish yin and regulate qi, thus tonifying the liver. With the assistance of yang, yin is able to generate endless vitality, strengthening tendons and bones, serving as the assistant herbs. Drynaria fortunei, Dipsacus asper, and Acanthopanax senticosus are added to warm yang and tonify the kidneys, strengthening the waist and kidneys, serving as the adjuvant herbs. Aucklandia lappa and Cyperus rotundus are added to enhance the power of promoting blood circulation and removing blood stasis. Rhubarb and borax are added to clear heat, cool blood, detoxify, and prevent decay, serving as the guiding herbs, further aiding in promoting blood circulation and removing blood stasis, thus combining the medicinal properties. Most of the herbs enter the liver and kidney meridians, primarily promoting qi and blood circulation, reducing swelling, and relieving pain. The liver governs tendons, and the kidneys govern bones; tonifying the liver and kidneys, and strengthening tendons and bones are secondary herbs. The herbs are warm but not drying, tonifying blood without causing stagnation, using both warming and cooling herbs, and combining attacking and tonifying methods. Together, they promote qi and blood circulation, reduce swelling and relieve pain, tonify the liver and kidneys, and promote bone and tendon healing. When used together, these herbs promote blood circulation, reduce swelling and pain, promote bone and tendon healing, and accelerate healing. They are suitable for osteoarthritis of the qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis. Symptoms include pain, tenderness, functional impairment, swelling, and ecchymosis. Attached Figure Description

[0018] One or more embodiments are illustrated by way of example with reference to the accompanying drawings, and these illustrative examples are not intended to limit the embodiments. The term "illustrative" as used herein means "serving as an example, embodiment, or illustration." Any embodiment illustrated herein as "illustrative" is not necessarily to be construed as superior to or better than other embodiments.

[0019] Figure 1 This refers to the level of pain intensity according to the NRS score of this invention.

[0020] Figure 2This is a comparison of the effects of the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention on female patient A before and after treatment. Figure 2 Image A is an X-ray of female patient A undergoing surgery for internal fixation with a steel plate on August 19, 2025, after fracturing her bone. Figure 2 B represents the X-ray result taken on August 24, 2025, by female patient A due to unbearable pain and swelling after surgery; Figure 2 C represents the X-ray results of female patient A after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention for 2 months (December 16, 2025).

[0021] Figure 3 This is a comparison of the effects of the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention on female patient B before and after treatment. Figure 3 Image A is an X-ray of female patient B undergoing internal fixation surgery on July 18, 2025, after a fracture. Figure 3 B is the X-ray result of female patient B after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention for 3 months (December 9, 2025).

[0022] Figure 4 This is a comparative study of the effects of the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention on male patient C before and after treatment. Figure 4 Image A is an X-ray of male patient C undergoing internal fixation surgery on November 19, 2023, after a fracture. Figure 4 B is the result of an X-ray taken 8 months after surgery (on June 20, 2024) for a patient named C whose wound had not healed properly. Figure 4 C is the X-ray result of male patient C after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention for 3 months (November 19, 2024). The two pictures are the results of being taken at the same time from different angles.

[0023] Figure 5 This is a comparison of the effects of traditional Chinese medicine composition (Huoxue Jiegu Wan) on male patient D before and after treatment, wherein... Figure 5 A is an MRI image of male patient D, taken on April 19, 2019, showing a hematoma from a fall two days prior. Figure 5 B is an MRI image taken on May 20, 2019, one month after male patient D took the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention.

[0024] Figure 6 This is a comparison of the effects of the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention on female patient E before and after treatment. Figure 6 Image A is an X-ray of female patient E undergoing internal fixation surgery on April 20, 2017, after a fracture. Figure 6 B is the result of an X-ray taken 18 months after surgery (October 8, 2018) for a patient named E whose wound had not healed properly. Figure 6C is the X-ray result of female patient E after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention for one month (July 21, 2019); Figure 6 D is the X-ray result of female patient E after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of the present invention for 3 months (September 20, 2019).

[0025] Figure 7 This is a comparative effect of female patient F before and after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention. Figure 7 Image A shows an X-ray of female patient F undergoing internal fixation surgery on September 26, 2017, after a fracture. Figure 7 B is the result of an X-ray taken 6 months after surgery (April 19, 2018) for slow healing in female patient F; Figure 7 C represents the X-ray results of female patient F after taking the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention for 3 months (January 10, 2019); Figure 7 D is the X-ray result of a follow-up examination on September 20, 2019, three months after female patient F took the traditional Chinese medicine composition (Huoxue Jiegu Wan) of this invention. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, 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, 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.

[0027] Furthermore, to better illustrate the present invention, numerous specific details are provided in the following detailed embodiments. Those skilled in the art should understand that the present invention can be practiced without certain specific details. In some embodiments, materials, elements, methods, and means well known to those skilled in the art are not described in detail in order to highlight the spirit of the invention.

[0028] All the Chinese medicinal materials used in this invention are commercially available and are included in the 2020 edition of the Chinese Pharmacopoeia.

[0029] This invention relates to an oral preparation for treating orthopedic diseases, developed by clinicians based on clinical practice. It consists of nineteen medicinal herbs, including red peony root, angelica root, vinegar-processed frankincense, vinegar-processed myrrh, and dried bone-setting herb. It has the effects of promoting blood circulation, reducing swelling and relieving pain, promoting bone healing, and accelerating tendon regeneration. It can be used for delayed healing of various types of fractures, osteoarthritis, soft tissue contusions, osteoporosis, and chronic strain pain.

[0030] The formulation of this invention was used from January 2023 to December 2023 to treat patients with osteoarthritis, delayed fracture healing, and osteoporosis belonging to the qi stagnation and blood stasis syndrome. The clinical efficacy was good. Some of the application effects are summarized below: Target population: Patients aged 18 to 70 with chronic osteoarthritis, delayed fracture healing, or osteoporosis.

[0031] Diagnostic criteria 1) Western medical diagnostic criteria for osteoarthritis Referencing the textbook *Integrative Internal Medicine of Traditional Chinese and Western Medicine* (3rd edition) edited by Chen Zhiqiang and Yang Guanlin, and *Clinical Guidelines for New Traditional Chinese Medicine Drugs* (2002 edition). Osteoarthritis (OA), also known as degenerative joint disease, osteoarthritis, or hypertrophic arthritis, is a joint disease characterized by degeneration and destruction of articular cartilage and bone hyperplasia. Diagnosis of OA is primarily based on the patient's symptoms, signs, imaging examinations, and laboratory tests. Currently, the diagnostic criteria revised by the American College of Rheumatology in 1995 are used, which includes clinical and radiological criteria. These criteria include classification standards for osteoarthritis of the hand, knee, and hip.

[0032] Western medical diagnostic criteria for osteoarthritis ① It is more common in middle-aged and elderly people.

[0033] ② It often affects weight-bearing joints, such as the knee, hip, ankle, and spine.

[0034] ③ The affected joints experience dull pain, which worsens after activity or exertion and is relieved by rest. The pain then becomes persistent, accompanied by joint stiffness, which improves after activity. There may be joint effusion, and in the later stages, the joints become swollen and enlarged, limiting movement and causing deformity, but without ankylosis.

[0035] ④ X-ray confirmed it to be degenerative arthritis.

[0036] Radiographic grading criteria for hand osteoarthritis (Kellgren and Lawrence method, 5 grades) Level 0 is normal.

[0037] Grade I joint space is suspected to be narrowed, and osteophytes may be present.

[0038] Grade II has obvious osteophytes and suspected narrowing of the joint space.

[0039] Grade III moderate osteophytes, with noticeable narrowing of the joint space and sclerotic changes.

[0040] Grade IV: Numerous osteophytes, significantly narrowed joint space, severe sclerotic lesions, and obvious deformity.

[0041] Clinical radiological criteria: ① Hand pain, soreness, and stiffness for most of the past month; ② ≥2 bony enlargement joints among the 10 interphalangeal joints; ③ ≤2 metacarpophalangeal joints with swelling; ④ >2 distal interphalangeal joints with bony enlargement; ⑤ ≥1 deformed joint among the 10 interphalangeal joints.

[0042] Hand osteoarthritis can be diagnosed if criteria ①②③④ or ①②③⑤ of the clinical radiological criteria are met. Kellgren and Lawrence's method The classification is based on the grading standards.

[0043] Note: The 10 interphalangeal joints refer to the second and third distal and proximal interphalangeal joints on both sides, and the first carpometacarpal joint on both sides.

[0044] Classification criteria for knee osteoarthritis (clinical criteria) ① Knee pain for most of the past month; ② Bone crepitus; ③ Morning stiffness ≤30 minutes; ④ Age ≥38 years; ⑤ Bony enlargement.

[0045] Knee osteoarthritis can be diagnosed if conditions ①②③④, ①②⑤, or ①④⑤ are met.

[0046] Clinical radiological criteria: ① Knee pain for most of the past month; ② X-ray showing osteophyte formation; ③ Joint fluid examination consistent with osteoarthritis; ④ Age ≥ 40 years; ⑤ Morning stiffness ≤ 30 minutes; ⑥ Presence of bone crepitus.

[0047] Knee osteoarthritis can be diagnosed if conditions ① and ②, ①, ③, ⑤, and ⑥, or ①, ④, ⑤, and ⑥ are met.

[0048] Classification criteria for hip osteoarthritis (clinical + radiological + laboratory criteria) ① Hip pain for most of the past month; ② ESR ≤ 20 mm / h; ③ X-ray shows osteophyte formation; ④ X-ray shows narrowing of the hip joint space.

[0049] Hip osteoarthritis can be diagnosed if conditions ①②③, ①②④, or ①③④ are met.

[0050] 2) Diagnostic criteria for delayed fracture healing Referencing Chen Xiaoping, Wang Jianping, and Zhao Jizong, eds., Surgery (9th edition), People's Medical Publishing House, 2018.

[0051] A fracture that, after treatment, has exceeded the usual healing time (generally 4–8 months) and the fracture ends have not yet achieved union, shows minimal callus formation at the fracture ends and mild decalcification of the fracture line, but no signs of osteosclerosis on X-ray.

[0052] (1) Course of disease: The fracture has not been completely healed within the time required for normal healing (which is longer than the time required for normal healing of the fracture in this location).

[0053] (2) Clinical symptoms and signs: tenderness at the fracture ends, pain upon percussion along the longitudinal axis, and abnormal movement at the fracture ends during limb movement.

[0054] (3) X-ray examination: X-ray films show irregular edges of fracture ends, widened gap between fracture ends, less callus growth, and no disappearance of fracture line. X-rays taken over 3 consecutive months show slow changes in the gap between fracture ends and callus growth, and no sclerosis of fracture ends or medullary canal occlusion.

[0055] 3) Diagnostic criteria for osteoporosis According to the "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022)" and the "Guiding Principles for Clinical Practice of New Traditional Chinese Medicines" (2002 edition), the diagnosis of osteoporosis is based on a detailed medical history, physical examination, fracture risk assessment, bone mineral density measurement, and imaging and laboratory tests. The diagnostic criteria for osteoporosis are based on DXA bone mineral density and / or fragility fracture.

[0056] Western medicine diagnostic criteria ① General weakness, with the most obvious pain in the lower back, which gradually worsens; even minor injuries can lead to fractures.

[0057] ②The spine often has kyphosis.

[0058] ③X-ray findings show widespread osteoporosis, most notably in the spine, pelvis, and upper femur. The spinal spine shows the most distinctive changes, with vertebral bodies exhibiting a fishtail-like double concave shape, widened intervertebral spaces, and Schmorl's nodes. The thoracic vertebrae show mold-like deformities, and the affected vertebrae are multiple and scattered.

[0059] ④ Bone density testing, showing positive signs, such as dual-energy X-ray ablation (DEXA), two-photon ablation (DPA), single-photon ablation (SPA), ultrasound, etc.

[0060] Diagnosis based on bone mineral density DXA bone mineral density is currently the universally accepted diagnostic criterion for osteoporosis. For postmenopausal women and men aged 50 and older, it is recommended to refer to the WHO-recommended diagnostic criteria. DXA-measured bone mineral density usually needs to be converted to a T-score for diagnosis. The T-score is calculated as: (Measured bone mineral density - Peak bone mineral density of normal young adults of the same race and sex) / Standard deviation of peak bone mineral density of normal young adults of the same race and sex. It is recommended that a T-score ≤ -2.5 for axial bone mineral density (L1-L4, femoral neck, or the entire hip) or distal radius bone mineral density measured by DXA be used as the diagnostic criterion for osteoporosis, as shown in Table 1.

[0061] Table 1. Classification criteria for bone mineral density measurement based on DXA

[0062] For children, premenopausal women, and men under 50 years old, the bone mineral density level is recommended to be expressed using the Z-value of the same race. The Z-value = (bone mineral density measurement value - mean bone mineral density of peers of the same race, gender, and age) / standard deviation of bone mineral density of peers of the same race and gender. A Z-value ≤ -2.0 is regarded as "below the expected range for the same age group" or low bone mass.

[0063] Based on the diagnosis of fragility fractures For hip or vertebral fragility fractures, osteoporosis can be clinically diagnosed without relying on bone mineral density measurement; for fragility fractures of the proximal humerus, pelvis, or distal forearm, and bone mineral density measurement shows osteopenia (-2.5 < T-value < -1.0), osteoporosis can be diagnosed.

[0064] The diagnostic criteria for osteoporosis are shown in Table 2: Table 2. Diagnostic Criteria for Osteoporosis

[0065] 4) Traditional Chinese Medicine Diagnostic Criteria (Qi Stagnation and Blood Stasis Syndrome) Refer to "Orthopedics of Traditional Chinese Medicine" (4th Edition), edited by Huang Guicheng and Wang Yongjun, published by China Press of Traditional Chinese Medicine in 2016 and "Clinical Guidelines for New Chinese Medicines" (2002 Edition) to formulate the relevant content of Qi Stagnation and Blood Stasis Syndrome as follows: Main symptoms: pain, pain with a fixed location, tenderness, and functional impairment (limitation of movement).

[0066] Sub-symptoms: local swelling and ecchymosis.

[0067] Tongue and pulse: purple and dull tongue or ecchymosis on the tongue, and stringy and unsmooth pulse.

[0068] If there are 3 or more main symptoms and 1 or more sub-symptoms, combined with tongue and pulse manifestations, the diagnosis can be made.

[0069] The quantitative standards for TCM syndrome symptom scoring are shown in Table 3: Table 3. Quantitative Standard for Symptoms of Traditional Chinese Medicine Syndromes

[0070] Pain level NRS score The degree of pain is evaluated by the NRS score. It is a straight line with numerical scales. The left end of the line is 0 points, and the right end is 10 points, with a total of 11 scores (0 - 10). 0 points indicates "no pain", and 10 points indicates "unbearable severe pain". The subject marks their most severe pain experience with an "×" on the corresponding number on the line. The total score is 10 points. The higher the score, the more severe the pain (as Figure 1 shown). 1 point: The pain is extremely mild, almost imperceptible.

[0071] 2 points: The pain is mild and can be easily ignored.

[0072] 3 points: The pain is mild but not negligible, and it does not interfere with normal life for the time being.

[0073] 4 points: The pain cannot be ignored, but it can be tolerated without interfering with normal life.

[0074] 5 points: Significant pain, feeling distressed, but able to perform normal activities with difficulty.

[0075] 6 points: The pain is particularly severe, making it difficult to perform normal activities and relatively heavy work.

[0076] 7 points: The pain is severe and affects daily activities. Painkillers are needed to ensure that the person does not miss work or school.

[0077] 8 points: Severe pain, significantly limited mobility, often accompanied by autonomic nervous system symptoms such as fatigue, nausea, and vomiting.

[0078] 9 points: The pain is intense and has reached the limit of endurance.

[0079] 10 points: Unable to tolerate, requires bed rest, often accompanied by paleness or cold sweats, rapid heartbeat, or even a feeling of shock.

[0080] Clinical application examples Clinical application summary included in case criteria (1) Those who meet the Western medical diagnostic criteria for osteoarthritis, osteoporosis, and delayed fracture healing.

[0081] (2) Those who meet the criteria for Qi stagnation and blood stasis syndrome.

[0082] (3) Age 18 to 70 years old.

[0083] Clinical application summary of exclusion criteria (1) Those with a history of allergies.

[0084] (2) Patients with serious primary diseases of the cardiovascular, liver, kidney and hematopoietic systems, or mental illness.

[0085] (3) Patients who have used other similar treatment drugs in the past two weeks.

[0086] (4) Pregnant women, breastfeeding women, and those with abnormal liver function (ALT / AST≥60 U / L).

[0087] Treatment Experimental medication: Blood-activating and bone-setting powder: Red peony root 10g, Angelica sinensis 15g, Ligusticum chuanxiong 15g, Safflower 12g, Vinegar-processed frankincense 20g, Vinegar-processed myrrh 20g, Borax 5g, Wine-processed rhubarb 10g, Dragon's blood 5g, Panax notoginseng 15g, Fried peach kernel 4g, Costus root 4g, Vinegar-processed Cyperus rotundus 5g, Fermented drynaria fortunei 25g, Achyranthes bidentata 10g, Lycium chinense root bark 8g, Acanthopanax senticosus root bark 8g, Crab 25g, Dipsacus asper 8g. Grind all the above herbs into powder. Take 3g each time, dissolved in warm water, 3 times a day. Treatment course: 3 months.

[0088] Observation indicators Safety observation (1) Vital signs: such as blood pressure, respiration, heart rate, etc. (before and after the test).

[0089] (2) Routine blood, urine and stool tests (before and after the test).

[0090] (3) Electrocardiogram, liver function (ALT, AST), and kidney function (BUN, Cr, TBIL, TP, ALP) (before and after the test).

[0091] (4) Adverse events (record in detail at any time).

[0092] therapeutic observation Background information observation (before the experiment) .

[0093] (1) Demographic data: age, height, weight, etc.

[0094] (2) General clinical data: comorbidities and medications, etc.

[0095] Diagnostic indicators (before the test).

[0096] (1) Specialist examination: tenderness, longitudinal axis percussion pain examination, pain NRS / VAS score, etc.

[0097] (2) X-ray / CT / MRI, bone density and other tests.

[0098] (3) Traditional Chinese Medicine Syndromes 7.2.3 Observation of therapeutic efficacy (1) Clinical efficacy (before and after the trial) (2) Traditional Chinese Medicine Syndromes (Before and After the Experiment) Efficacy evaluation criteria Traditional Chinese Medicine Syndrome Therapy Evaluation Criteria Refer to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition). Clinical control: TCM clinical symptoms and signs disappear or basically disappear, and the syndrome score decreases by ≥95%.

[0099] Significant effect: Clinical symptoms and signs in TCM are significantly improved, and the syndrome score is reduced by ≥70% and <95%. Effective: Clinical symptoms and signs in TCM patients improved, and the syndrome score decreased by 30% to <70%. Ineffective: No significant improvement or even worsening of clinical symptoms and signs in Traditional Chinese Medicine, with a decrease in syndrome score of less than 30%.

[0100] Calculation formula: Nimodipine method.

[0101] Clinical syndrome score reduction rate = (pre-treatment symptom and sign score - post-treatment symptom and sign score) / pre-treatment symptom and sign score × 100%.

[0102] Evaluation criteria for the treatment of osteoarthritis Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition): Clinical control: Symptoms such as pain disappear, joint mobility is normal, the efficacy score is ≥95%, and X-ray shows normal results; Significant effect: Pain and other symptoms disappear, joint movement is unrestricted, the efficacy index is 70%≤N<95%, and X-ray shows significant improvement; Effective: Symptoms such as pain disappear, joint mobility is slightly limited, and the overall therapeutic effect index is 30% ≤ N < 70%; Ineffective: No significant improvement in symptoms such as pain and joint mobility, efficacy index <30%, and no changes on X-ray; Note: The efficacy index N = (total score before treatment - total score after treatment) ÷ total score before treatment × 100%.

[0103] Evaluation criteria for osteoporosis treatment Formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" (2002 edition): Significant effect: Pain completely disappeared, and bone density test showed increased bone density.

[0104] Effective: Pain was significantly relieved, and bone density tests showed no decrease in bone density. Ineffective: There is no improvement in any aspect compared to before treatment.

[0105] Evaluation criteria for fracture healing efficacy The assessment is based on the criteria for bony healing of fractures in the "Traditional Chinese Medicine Orthopedics and Traumatology". Clinical healing: Clinical symptoms are relieved, the limbs can move, and there is no local tenderness or longitudinal percussion pain; imaging shows that the fracture line has healed.

[0106] Improvement: Clinical symptoms have lessened, the limbs can move slightly, and local tenderness and longitudinal percussion pain have decreased; imaging shows a small to moderate amount of callus formation, the fracture line is somewhat blurred, and there is no sclerosis at the fracture ends. Ineffective: The above criteria are not met, and there is significant pain at the fracture site; imaging shows no improvement in the fracture line.

[0107] Observation of adverse reaction events definition Adverse events: The term "adverse event" encompasses any symptom, sign, syndrome, or exacerbation of a disease that occurs in a subject during clinical observation and affects the subject's health. This term includes clinically relevant events discovered during laboratory or other diagnostic processes, such as requiring unplanned treatment, leading to withdrawal from the trial, or laboratory tests exceeding 20% ​​of normal values ​​and being classified as abnormal. Adverse events may include: a new illness; exacerbation of treatment-associated symptoms or signs, or exacerbation of a concomitant disease; the effect of a control drug; events unrelated to participation in the trial; or a combination of one or more factors. Therefore, the term "adverse event" does not imply a causal relationship with the investigational drug.

[0108] Serious adverse events: These are adverse events that occur at any dose of the investigational drug or at any time during the observation period, including: death; immediate life-threatening events; requiring hospitalization or prolonged hospitalization; disability; congenital malformations; events of significant medical importance (those that do not immediately endanger life or cause death or require hospitalization, but may harm the patient or require measures to prevent one of the consequences defined above); and events requiring medical treatment to prevent permanent damage or harm.

[0109] Adverse drug reactions: Harmful and unintended reactions that occur during the normal use of a drug at the prescribed dosage and are causally related to the use of the drug. In clinical trials of a new drug or a new use of a drug, where the therapeutic dosage has not yet been determined, all harmful and unintended reactions causally related to the use of the drug should also be considered adverse drug reactions.

[0110] Severity of adverse reactions Mild: The patient can tolerate it, it does not affect treatment, does not require special treatment, and has no impact on the patient's recovery.

[0111] Moderate: Patients find it difficult to tolerate and need to stop taking the medication or undergo special treatment, which has a direct impact on the patient's recovery.

[0112] Severe: Endangers the patient's life, causing death or disability, requiring immediate discontinuation of medication or emergency treatment.

[0113] Determining the causal relationship between adverse reactions and drugs Relevant indicators for causal judgment: ① Is there a reasonable chronological relationship between the start of medication and the suspected adverse reaction? ② Does the suspected adverse reaction conform to the known adverse reaction type of the drug? ③ Can the suspected adverse reaction be explained by the patient's pathology, concomitant medication, combined therapy, and previous therapy? ④ Can the suspected adverse reaction be reduced or disappeared after stopping the drug or reducing the dosage? ⑤ Does the same reaction recur upon re-exposure to the same drug?

[0114] Efficacy and safety analysis 1. Case distribution All cases were selected from 187 outpatients at our hospital from January 2023 to December 2023, including 76 males and 111 females; the youngest patient was 22 years old, the oldest was 70 years old, and the average age was 63.7 years; the shortest disease duration was 1.5 months, the longest was 9 years, and the average duration was 12.6 months. Among them, there were 65 patients with osteoarthritis, including 26 males and 39 females; the youngest patient was 31 years old, the oldest was 69 years old, and the average age was 61.5 years; the shortest disease duration was 1.5 months, the longest was 9 years, and the average duration was 13.8 months. There were 62 patients with osteoporosis, including 16 males and 46 females; the youngest patient was 46 years old, the oldest was 70 years old, and the average age was 66.3 years; the shortest disease duration was 1 year, the longest was 9 years, and the average duration was 1.9 years. Sixty patients with delayed fracture healing were included; 34 were male and 26 were female; the youngest was 22 years old and the oldest was 68 years old, with an average age of 52.3 years; the shortest fracture duration was 3 months and the longest was 7 months, with an average duration of 5.4 months.

[0115] 2. Security Analysis During clinical application, no serious adverse events related to the drug were found. Six cases (3.21%) experienced mild nausea and discomfort. The drug was not discontinued or treated with medication. Instead, it was taken after meals. The symptoms disappeared spontaneously after 2 to 3 days. This may be related to the drug's stimulation of the gastric mucosa. However, the reaction was mild and no treatment was given. The drug was not discontinued and was taken after meals.

[0116] Laboratory safety tests: 14 cases had abnormal ALT levels before treatment, 8 of which returned to normal after treatment, leaving 6 cases with abnormal ALT levels. Analysis showed that these abnormalities were not related to the investigational drug. 2 cases (1.11%) had normal ALT levels before treatment but abnormal ALT levels after treatment (43 U / L and 46 U / L, respectively). Neither case exceeded 15% of the upper limit of normal, and analysis showed that these abnormalities were not related to the investigational drug.

[0117] 3. Therapeutic effect analysis 3.1 Therapeutic Effects of Traditional Chinese Medicine Syndromes The overall efficacy of TCM syndromes in 187 cases was as follows: 49 cases (26.20%) achieved clinical control, 67 cases (35.83%) showed significant improvement, and 54 cases (28.88%) showed improvement, with a total effective rate of 90.91%. Specifically, for 65 cases of osteoarthritis, the efficacy was as follows: 16 cases (24.62%) achieved clinical control, 23 cases (35.38%) showed significant improvement, and 20 cases (30.77%) showed improvement, with a total effective rate of 90.77%. For 62 cases of osteoporosis, the efficacy was as follows: 14 cases (22.58%) achieved clinical control, 21 cases (33.87%) showed significant improvement, and 21 cases (33.87%) showed improvement, with a total effective rate of 90.32%. For 60 cases of delayed fracture healing, the efficacy was as follows: 19 cases (31.67%) achieved clinical control, 23 cases (38.33%) showed significant improvement, and 13 cases (21.67%) showed improvement, with a total effective rate of 91.67%. See Table 4.

[0118] Table 4. Therapeutic Effects of Traditional Chinese Medicine Syndromes

[0119] Note: Overall effective rate = (number of cases with clinical control + significant effect + effective) / total number of cases × 100%.

[0120] 3.2 Treatment efficacy for osteoarthritis The efficacy of treatment in 65 cases of osteoarthritis was as follows: 13 cases (20.00%) achieved clinical control, 26 cases (40.00%) showed significant improvement, and 17 cases (26.15%) showed improvement, with a total effective rate of 86.15%. Specifically, in 31 cases of knee osteoarthritis, the efficacy was as follows: 7 cases (22.58%) achieved clinical control, 12 cases (38.71%) showed significant improvement, and 8 cases (25.81%) showed improvement, with a total effective rate of 87.10%. In 21 cases of hip osteoarthritis, the efficacy was as follows: 4 cases (19.05%) achieved clinical control, 8 cases (38.10%) showed significant improvement, and 6 cases (28.57%) showed improvement, with a total effective rate of 85.71%. In 13 cases of hand osteoarthritis, the efficacy was as follows: 2 cases (15.38%) achieved clinical control, 6 cases (46.15%) showed significant improvement, and 3 cases (23.08%) showed improvement, with a total effective rate of 84.62%. See Table 5.

[0121] Table 5. Therapeutic effects of osteoarthritis

[0122] Note: Overall effective rate = (number of cases with clinical control + significant effect + effective) / total number of cases × 100%.

[0123] 3.3 Treatment efficacy for osteoporosis The efficacy of treatment in 62 cases of osteoporosis was as follows: 41 cases (66.13%) showed significant improvement, 14 cases (22.58%) showed improvement, and the total effective rate was 88.71%; see Table 6.

[0124] Table 6. Treatment efficacy for osteoporosis

[0125] Note: Overall effectiveness rate = (number of cases with significant effect + number of cases with effective effect) / total number of cases × 100%.

[0126] 3.4 Efficacy of delayed fracture healing A total of 60 cases of delayed fracture healing were studied: 39 cases (65.00%) achieved clinical healing, 16 cases (26.67%) showed improvement, and the total effective rate was 91.67%; see Table 7. Table 7. Efficacy of delayed fracture healing

[0127] Note: Overall effectiveness rate = (number of cases that healed + number of cases that improved) / total number of cases × 100%.

[0128] The composition of this invention has strong effects in promoting blood circulation, removing blood stasis, reducing swelling and pain, strengthening bones, and reducing inflammation. It can dilate capillaries to effectively improve microcirculation, achieving local swelling and pain relief. It also nourishes the liver and kidneys, increasing mineral deposition in bone through improved blood circulation, mineral replenishment, and changes in trace elements, thereby accelerating callus growth and promoting fracture healing. Furthermore, it has no obvious toxic side effects on the human body. It is worthy of clinical promotion and application.

[0129] The composition of the present invention can enhance the metabolic activity of osteocytes and plays an important role in bone formation.

[0130] The composition of this invention can also be prepared into pills according to the traditional Chinese medicine pill preparation method, named Huoxue Jiegu Wan (Blood-Activating and Bone-Setting Pill). Compared with similar products, it shortens the bone healing cycle by more than 20%. The specific comparison between this invention and other competing products is as follows:

[0131] Clinical case examples: 1. Patient A, 62 years old, residing in Chengcheng County, suffered a left shoulder injury in a car accident on August 14, 2025. X-ray examination showed a fracture and displacement of the left clavicle. She underwent internal fixation with a plate on the 18th (screenshot of the X-ray is shown). Figure 2 As shown in A), the pain became unbearable and swelling increased (an X-ray was taken on August 24th, as shown in A). Figure 2 (As shown in B), after being introduced by someone, I took the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan) orally on September 25th, three times a day, one packet each time. After taking it for half a month, the pain was greatly reduced. I continued to take it for two months. After two months, a follow-up X-ray showed that the fracture line was blurred and disappeared, and the recovery was good (as shown in B). Figure 2 C).

[0132] 2. Patient B, female, 83 years old, residing in Chengcheng County, has a 30-year history of diabetes and over 10 years of osteoporosis. On July 1, 2025, she suffered a fall resulting in an intertrochanteric fracture of the right femur. She underwent internal fixation surgery on July 18, 2025 (X-ray results are as follows). Figure 3A) The surgical alignment was good. The patient experienced local swelling, tenderness, and inability to walk or stand. On August 1st, the patient took the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan) orally, one packet at a time, three times a day, for three consecutive months. Seven days after taking Huoxue Jiegu Wan, the swelling and pain disappeared. After two months, the patient was able to walk. After three months, the patient could walk freely and go up and down stairs. Imaging examination showed good callus growth and blurred fracture line (X-ray results as shown). Figure 3 B).

[0133] 3. Patient C, male, 75 years old, residing in Qingdao, Shandong Province, suffered multiple comminuted fractures of the tibia and fibula due to trauma in November 2023 (e.g. Figure 4 A) After undergoing traction and external fixation surgery at a local hospital, the fracture did not heal 8 months later (e.g.) Figure 4 B), local swelling and pain, later introduced by a friend to the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan) for oral administration, one packet at a time, three times a day, for three consecutive months. The pain and swelling disappeared after 10 days of medication, and imaging examinations were performed three months later (such as...). Figure 4 C) The bone callus has formed well, and the patient can walk normally.

[0134] 4. Male patient D, 54 years old, was admitted on April 19, 2019, due to "falling down stairs and discovering a large hematoma on his left calf for 2 days." Physical examination upon admission revealed subcutaneous hematoma on the left calf, measuring 15x12 cm. A hard nodule measuring 10x5x5 cm was also found on the left calf. Figure 5 A). After taking the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan) for 30 days, the hematoma was significantly absorbed (e.g. Figure 5 (B) Continue taking the medication until June 5th, when the hematoma was completely absorbed. Clinically, large hematomas are often treated with surgical incision and drainage. This patient received conservative treatment, taking the composition of this invention, avoiding trauma, reducing costs, and achieving ideal therapeutic effects, demonstrating the significant advantages of traditional Chinese medicine in promoting blood circulation and removing blood stasis. It has certain unique characteristics in improving local blood supply, eliminating edema, dissipating aseptic inflammation, and absorbing effusion.

[0135] 5. Patient E, female, 47 years old, with a history of mild anemia, fracture of the right radius and ulna, surgery date: April 20, 2017 (e.g., Figure 6 A), 18 months post-surgery (e.g.) Figure 6 B), poor bone healing. As of June 2019, healing remained poor, and the patient began taking the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan), one packet at a time, three times a day, for three consecutive months. On July 21, 2019, one month after starting the medication, healing began (e.g., Figure 6 C), after 3 months of medication (September 20, 2019), the healing was good (e.g.) Figure 6 D).

[0136] 7. Female patient F, 28 years old, right tibia and fibula fracture, surgery date: September 26, 2017 (e.g.) Figure 7 A), 6 months post-surgery (e.g.) Figure 7 B), slow bone healing. As of September 2018, healing was still slow, and the patient began taking the traditional Chinese medicine composition of this invention (Huoxue Jiegu Wan), one packet at a time, three times a day, for six consecutive months. On January 10, 2019, after three months of medication, initial bone healing was observed (e.g., Figure 7 C), continued medication for 3 months, and a follow-up examination on October 21, 2019, showed good healing (e.g. Figure 7 D).

[0137] Clinically, Western medicine offers few conservative treatments for poor bone healing. The herbal composition of this invention achieves ideal results with definite efficacy. Clinically validated, the herbal composition of this invention is particularly effective in promoting blood circulation and reducing bone calcium deposition.

[0138] The herbal composition of this invention has no effect on the coagulation mechanism, is safe to use, and is suitable for the treatment of aseptic inflammation and pain, hematoma absorption, improvement of tissue blood circulation, and promotion of self-repair. The calcium deposition effect of the composition of this invention has a significant therapeutic effect on poor bone healing or even nonunion, and can be used as a trial treatment before secondary surgery.

[0139] The combination of the present invention has not shown any adverse reactions after many years of use, and patients have a high degree of acceptance.

[0140] The formulation of this invention was evaluated in 407 patients in a hospital, and the conclusion was that it had no toxic side effects and significant clinical efficacy.

[0141] The formulation of this invention can replace most blood-activating intravenous medications (statistics available). It significantly reduces the proportion of drug costs, thus decreasing patient expenses. It can also be used in combination with Western medicines such as Caltrate to enhance therapeutic effects.

[0142] In summary, the Blood-Activating and Bone-Setting Powder (prescription agreed upon) of this invention has good efficacy and safety in treating osteoarthritis, osteoporosis, and delayed fracture healing of patients with qi stagnation and blood stasis syndrome, manifested as pain, tenderness, swelling, ecchymosis, and functional impairment.

[0143] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis, characterized in that, Its active ingredients include the following raw materials in parts by weight: 6-12 parts of red peony root, 10-20 parts of angelica root, 10-20 parts of chuanxiong rhizome, 10-15 parts of safflower, 15-25 parts of vinegar-processed frankincense, 15-25 parts of vinegar-processed myrrh, 3-8 parts of borax, 6-12 parts of wine-processed rhubarb, 3-8 parts of dragon's blood, 10-20 parts of notoginseng, 3-7 parts of stir-fried peach kernel, 3-7 parts of costus root, 3-8 parts of vinegar-processed cyperus rhizome, 20-30 parts of scalded drynaria rhizome, 8-15 parts of achyranthes root, 6-10 parts of lycium root bark, 6-10 parts of eleutherococcus root bark, 20-30 parts of crab, and 5-10 parts of calcined teasel root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Its active ingredients include the following raw materials in parts by weight: 8-12 parts of red peony root, 12-18 parts of angelica root, 10-20 parts of chuanxiong rhizome, 10-15 parts of safflower, 18-25 parts of vinegar-processed frankincense, 18-25 parts of vinegar-processed myrrh, 3-8 parts of borax, 6-12 parts of wine-processed rhubarb, 3-8 parts of dragon's blood, 12-20 parts of notoginseng, 3-7 parts of stir-fried peach kernel, 3-7 parts of costus root, 3-8 parts of vinegar-processed cyperus rhizome, 20-30 parts of scalded drynaria rhizome, 8-15 parts of achyranthes root, 6-10 parts of lycium root bark, 6-10 parts of eleutherococcus root bark, 20-30 parts of crab, and 5-10 parts of calcined teasel root.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, Its active ingredients include the following raw materials in parts by weight: 10 parts red peony root, 15 parts angelica root, 15 parts chuanxiong rhizome, 12 parts safflower, 20 parts vinegar-processed frankincense, 20 parts vinegar-processed myrrh, 5 parts borax, 10 parts wine-processed rhubarb, 5 parts dragon's blood, 15 parts notoginseng, 4 parts stir-fried peach kernel, 4 parts costus root, 5 parts vinegar-processed cyperus rhizome, 25 parts hot-processed drynaria rhizome, 10 parts achyranthes root, 8 parts lycium root bark, 8 parts eleutherococcus root bark, 25 parts crab, and 8 parts teasel root.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is a powder made by pulverizing Chinese medicinal materials.

5. The traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, The dosage form of the traditional Chinese medicine composition is any one of powder, oral liquid, spray, ointment, injection, and capsule.

6. A method for preparing a traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, Mix all the medicinal materials and grind them into powder.

7. A powder of a traditional Chinese medicine composition, characterized in that, It is prepared by the method described in claim 6.

8. A drug for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis, characterized in that, It includes the traditional Chinese medicine composition according to any one of claims 1 to 5, or the powder prepared by the method according to claim 6, as well as other Western medicines, optionally including calcium supplements.

9. The use of a traditional Chinese medicine composition according to any one of claims 1 to 5, or a powder prepared by the method according to claim 6, in the preparation of products for relieving or treating osteoarthritis of qi stagnation and blood stasis type, delayed fracture healing, and osteoporosis.

10. The application according to claim 9, characterized in that, The product is a medicine; And / or, the osteoarthritis includes knee osteoarthritis, hip osteoarthritis, and hand osteoarthritis.

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