Traditional Chinese medicine composition for promoting fracture healing

Abstract

The invention relates to a traditional Chinese medicine composition for promoting fracture healing. The traditional Chinese medicine composition is prepared from, by weight, 30-15 g of panax notoginseng leaves, 40-25 g of cucumber seeds, 20-12 g of eucommia ulmoides, 12-6 g of peach kernels, 15-7 g of smoked plums, 12-5 g of cloves, 11-4 g of cinnamon, 12-6 g of radix polygonati officinalis, 12-7 g of licorice roots and 30-20 g of impatiens balsamina. The medicine composition mostly adopts medicinal and edible non-toxic medicinal materials and non-scarce medicinal materials which are easy to plant and obtain, animal components are not used as medicines, a synergistic scheme is formed by optimizing compatibility and integrating the medicinal materials for activating blood, tonifying liver and kidney and strengthening muscles and bones, callus formation is promoted, pain is relieved and bone repair is accelerated through the synergistic effect, and the curative effect is good. Meanwhile, the medicine activates and awakens the strong recovery capability of a human body recovery system, and diseases are cured. The medicine formula is suitable for adjuvant therapy of various stages of fracture.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition that promotes fracture healing. Background Technology

[0002] Fracture healing is a complex physiological process, and current Western medical treatments suffer from long recovery periods and numerous complications. Traditional Chinese medicine compound formulas can promote healing through multi-target regulation. However, in existing technologies, the efficacy of single medicinal herbs (such as Panax notoginseng) or simple combinations is limited.

[0003] Currently, a common problem in the traditional Chinese medicine (TCM) industry is the scarcity of medicinal materials and the difficulty of cultivation. The resulting cost increases due to this scarcity are a real industry issue. The government is addressing this by standardizing cultivation practices, implementing GAP (Good Agricultural Practices) certification, and promoting the establishment of TCM production quality management standard bases to help increase TCM yields while simultaneously improving soil conditions. Additionally, efforts are being made to alleviate the pressure on pharmaceutical demand by promoting the concept of "medicine and food homology" and extending the industrial chain. By 2025, the list of medicinal and edible homology herbs has been expanded to 106 species (such as Gastrodia elata and Codonopsis pilosula), alleviating the pressure of single-source pharmaceutical demand. At the same time, the government encourages the exploration of new uses and cultivation and processing technologies for all TCM raw materials.

[0004] The inventor of this application has practiced medicine for over 40 years, with particular expertise in the treatment and research of orthopedic diseases. Over the past decade, through meticulous study of classical Chinese medicine and corroboration by numerous modern medical surveys, it has been discovered that the past practice of using animal components in medicine, and even the resulting harm to animals during the manufacturing process, is contrary to the original intent of the ancient Chinese medicine ancestors and sages who established the theories of traditional Chinese medicine.

[0005] Sun Simiao, known as the "King of Medicine," synthesized the best of traditional Chinese medicine and pharmacology before the Tang Dynasty and is revered as the "King of Medicine" or "Sage of Medicine." In his book *Qianjin Fang* (Prescriptions Worth a Thousand Gold Pieces), he explicitly stated the core concept that "killing to save lives only takes one further away from life," arguing that exchanging animal lives for human health violates the benevolent nature of a physician. Through observation, he discovered that herbal medicines, "born from the Qi of Heaven and Earth," have a natural rhythm of spring growth and summer development that is more compatible with the Yin and Yang of the human body. In contrast, animal-based medicines are often warming and have a strong, pungent odor, easily causing internal heat. He found that hunters who regularly consumed animal-based medicines suffered from carbuncles and boils, while mountain dwellers who used herbal medicines were healthier. Modern research also confirms that the incidence of carbuncles and boils among hunters who regularly consumed animal-based medicines was significantly higher than among mountain dwellers who used herbal medicines, thus validating Sun Simiao's assertion that "animal-based medicines are often warming." The King of Medicine also compared pangolin scales with *Vaccaria segetalis* (a type of herb) to demonstrate that vines also possess the effect of clearing the meridians, and there is no need to "cut off their life path." The medicine in a doctor's hands should not be a blood-stained blade.

[0006] Clinical practice in 2025 showed that artificial musk and other alternatives could stably mimic natural components, and their bioavailability, after optimization of formulation processes, was close to that of animal-derived drugs. For example, by controlling the ratio of excipients and dissolution technology, the hemostatic effect of gallnut can replace that of ginseng, and the heat-clearing and detoxifying effects of forsythia are comparable to those of rhinoceros horn. Modern pharmacopoeias have explicitly removed animal species such as pangolins from the list of medicinal uses, and the use of herbal medicines is guided through medical insurance policies, echoing the concept of the "King of Herbs."

[0007] The Compendium of Materia Medica proposes the concept of "harmony between man and nature, and the common origin of medicine and food," believing that the human body and the natural world are an interconnected whole.

[0008] From the analogical reasoning in the *Huangdi Neijing* (Yellow Emperor's Inner Classic) to modern molecular pharmacology, the development of Traditional Chinese Medicine (TCM) should always adhere to the principles of "harmony between man and nature" and "following the laws of nature" emphasized in classical TCM theories, drawing its medicines from nature. When artificial musk production facilities use technology to simulate natural components, we both inherit the compassionate tradition of "a grove of doctors providing shade" and practice the ethical principle of "not harming life." This wisdom, blending ancient and modern approaches, is the most compassionate interpretation of "great physicians with profound medical skills and integrity." Summary of the Invention

[0009] The purpose of this invention is to provide a traditional Chinese medicine composition that promotes fracture healing. This formula primarily uses non-toxic medicinal herbs that are both food and medicine, as well as easily cultivated and readily available non-rare herbs. It resolutely avoids the use of animal ingredients. Through optimized compatibility, it integrates herbs that invigorate blood circulation, tonify the liver and kidneys, and strengthen tendons and bones, forming a synergistic effect. This synergistic action promotes callus formation, relieves pain, and accelerates bone repair. Simultaneously, the medicine activates and awakens the body's powerful self-healing system, thus curing the disease. This formula is suitable for adjunctive treatment at all stages of fracture healing.

[0010] The technical solution of the present invention is: a traditional Chinese medicine composition for promoting fracture healing, wherein the weight of each raw material in the traditional Chinese medicine composition is as follows: 30-15g of Panax notoginseng leaves, 40-25g of cucumber seeds, 20-12g of Eucommia ulmoides, 12-6g of peach kernels, 15-7g of dried plums, 12-5g of cloves, 11-4g of cinnamon, 12-6g of Polygonatum odoratum, 12-7g of licorice root, and 30-20g of Impatiens balsamina.

[0011] The preparation method of the traditional Chinese medicine composition for promoting fracture healing described in this invention is as follows: Mix all the ingredients in this formula according to the specified ratio, then use a professional ultra-fine pulverizer to pulverize them into 60 equal portions, each weighing approximately 6 grams, and package them into bags.

[0012] Alternatively, take 360 ​​grams of the crushed medicine powder as one course of treatment, divide it into 20 portions, each about 18 grams, and mix it with petroleum jelly to make a patch.

[0013] The method for preparing the patch is as follows: 1. Heat the petroleum jelly in a water bath until completely melted (about 60-70℃), and continue heating over low heat for 5 minutes to remove moisture. Avoid direct open flame to prevent charring.

[0014] 2. Slowly pour in the powder (adding it in batches is better), stirring clockwise with a glass rod as you pour to ensure the powder is fully incorporated into the petroleum jelly. Keep the heat low throughout to prevent boiling over.

[0015] 3. Continue stirring for about 30 minutes until the paste turns brownish-black, can be pulled into continuous strands when lifted, and emits a rich medicinal aroma. If the paste is too thin, extend the cooking time; if it is too thick, add a small amount of petroleum jelly.

[0016] The dosage and administration of the above-mentioned traditional Chinese medicine of this invention are as follows: 6 grams three times a day, taken with warm water. One course of treatment consists of 20 consecutive days of treatment.

[0017] Alternatively, a patch can be applied directly to the fracture site once a day for 20 consecutive days as one course of treatment.

[0018] Explanation of this Chinese herbal formula.

[0019] Among them, the principal herb includes: - Panax notoginseng leaves: dispersing blood stasis and stopping bleeding, reducing swelling and relieving pain, and accelerating the absorption of hematomas.

Properties and Flavors

Functions and Indications

[0020] - Cucumber seeds: [Properties and Flavors]: Sweet, cool, and non-toxic. [Meridians Entered]: Spleen, Stomach, and Large Intestine meridians. [Functions and Indications]: A traditional medicine for bone setting, rich in calcium and phosphorus, stimulating osteoblast activity.

[0021] Among them, the second ingredient is: - Eucommia ulmoides: [Properties]: Sweet and slightly pungent, warm. [Meridians Entered]: Liver and Kidney meridians. "Ben Cao Jing Jie" states: "Enters the Lung meridian of Hand Taiyin." [Functions and Indications]: Tonifies the liver and kidneys, strengthens tendons and bones, and improves kidney deficiency and lower back pain after fractures.

[0022] - Peach kernel: [Properties and Flavors] Bitter and sweet, neutral [Meridians Entered] Heart, Liver, Large Intestine meridians. *Tangye Bencao* states: "Enters the Hand and Foot Jueyin meridians." *Lei Gong Paozhi Yaoxing Jie* states: "Enters the Liver and Large Intestine meridians." [Functions and Indications] Breaks up blood stasis, moistens dryness and lubricates the intestines. Treats amenorrhea, epilepsy, blood stasis due to febrile diseases, wind-dampness, malaria, traumatic injuries, swelling and pain due to blood stasis, and constipation due to blood dryness.

[0023] Among them, 3. The adjuvant medicines include: - Cinnamon: [Properties] Pungent and sweet, hot. [Meridians Entered] Kidney, Spleen, Bladder. [Functions and Indications] Tonifies the original Yang, warms the spleen and stomach, removes accumulated cold, and unblocks blood vessels. Treats deficiency of the fire of the gate of life, cold limbs and weak pulse, collapse of Yang, abdominal pain and diarrhea, cold hernia and abdominal distension, cold pain in the waist and knees, amenorrhea and itching, yin carbuncles, phlegm, and floating of deficient Yang with upper heat and lower cold.

[0024] - Clove: [Meridian Tropism] Enters the Stomach, Spleen, and Kidney meridians. *Tangye Bencao* states: Enters the Hand Taiyin, Foot Yangming, and Shaoyin meridians. *Lei Gong Paozhi Yaoxing Jie* states: Enters the Lung, Spleen, Stomach, and Kidney meridians. [Functions and Indications] Warms the middle jiao, warms the kidneys, and relieves nausea and vomiting. Treats hiccups, vomiting, acid reflux, diarrhea, cold pain in the heart and abdomen, abdominal masses, hernia, and tinea.

[0025] - Dried plum: [Properties and Flavors] Sour, warm. [Meridians Entered] Liver, Spleen, Lung, Large Intestine. [Functions and Indications] Astringent and promotes fluid production, expels roundworms. Treats chronic cough, feverish thirst, chronic malaria, chronic diarrhea, dysentery, hematochezia, hematuria, metrorrhagia, abdominal pain and vomiting due to roundworm infection, hookworm disease, psoriasis, and pterygium.

[0026] - Polygonatum odoratum: [Properties] Sweet, neutral. [Meridians Entered] Lung and Stomach meridians. [Functions and Indications] Nourishes Yin, moistens dryness, relieves irritability, and quenches thirst. Treats Yin deficiency due to febrile diseases, cough with thirst, consumptive fever, excessive hunger, and frequent urination.

[0027] 4. The following are medicinal ingredients: - Impatiens flower: [Taste and nature] Sweet and slightly bitter, warm. [Functions and indications] Dispels wind, invigorates blood, reduces swelling, relieves pain, softens callus, and assists in repositioning. Treats rheumatism, lumbar and rib pain, amenorrhea and abdominal pain in women, postpartum blood stasis, traumatic injuries, carbuncles, boils, tinea pedis, and onychomycosis.

[0028] - Licorice:

Properties and Flavors

Meridians Entered

Functions and Indications

[0029] The beneficial effects of this invention are as follows: This invention is composed of 10 medicinal materials, including dried plum, licorice, cinnamon, Panax notoginseng leaves, Eucommia ulmoides, peach kernel, Polygonatum odoratum, clove, cucumber seeds, and Impatiens balsamina, in a specific ratio. This composition promotes callus formation, relieves pain, and accelerates bone repair through synergistic effects. Simultaneously, it activates the body's powerful recovery system through drug activation, thus curing diseases. Clinical trials have demonstrated significant efficacy in treating closed fractures and bone fissures. It possesses the effects of promoting blood circulation, removing blood stasis, promoting bone healing, reducing swelling and relieving pain, and is suitable for adjunctive treatment at all stages of fractures.

[0030] Traditional Chinese medicine believes that fractures caused by blood stasis and obstruction of the meridians are due to external injury, qi stagnation and blood stasis, broken tendons and bones, obstruction of the flow of qi and blood, and disharmony of the internal organs. Modern medicine believes that fractures are caused by external injury, osteoporosis, or bone diseases, essentially resulting in the interruption of the integrity and continuity of the bone. This formula mainly targets qi stagnation and blood stasis, broken tendons and bones caused by external injury. Based on the theory of traditional Chinese medicine and combined with many years of clinical experience, the inventor adopted the principle of syndrome differentiation and treatment, starting with "calming the mind and opening the orifices, clearing the heart and refreshing the brain, and promoting blood circulation and unblocking the meridians." After repeated practice and screening, a pure herbal medicine preparation was developed, which has achieved good results in treating local pain, swelling, or functional impairment, as well as dark purple tongue caused by fractures. In repeated clinical practice, its therapeutic effects during the fracture recovery period and in the treatment of nonunion and osteonecrosis were also discovered. Clinical observation has confirmed its significant efficacy. Safety tests revealed no damage to liver or kidney function in either group, nor any adverse effects on the heart or lungs. Clinically, no toxic effects on the liver, kidneys, or lungs were observed. This invention demonstrates significant therapeutic efficacy and improves symptoms and signs.

[0031] The formulation of this invention can achieve the following: - Early stage (1-2 weeks): Improves blood circulation and reduces swelling, inhibiting soft tissue adhesions. - Mid-stage (3-6 weeks): Promotes the transformation of fibrocartilaginous callus into bony callus. - Late stage (after 8 weeks): Strengthens bone density and prevents osteoporosis.

[0032] Combining the properties of food and medicine and pharmacological research, the five herbs in this Chinese medicine formula, namely Panax notoginseng leaf, Eucommia ulmoides, Glycyrrhiza uralensis, Prunus persica kernel, and Polygonatum odoratum, are all Chinese medicines that have the effect of activating the self-healing system. The three herbs, namely Cucumber seed, Prunus mume, and Polygonatum odoratum, are Chinese medicines that indirectly support self-healing. The above drugs work together to fully activate the body's own immune-endocrine-repair system. The "Huangdi Neijing" says "When the righteous qi is stored inside, evil cannot invade", which corresponds to the immune-neuro-endocrine network regulation in modern medicine. Traditional Chinese medicine promotes healing through the principle of "combining movement and stillness": (1) Rest: In the early stage of fracture, fixation and immobilization are required to avoid secondary injury. (2) Movement: In the later stage, guided body exercises are used to improve local microcirculation. Mental nourishment: Nourish the mind and get rid of all negative emotions such as worries and fears, return to inner peace, and fill the body and mind with positive energy of happiness, positivity and health. The body's internal self-healing ability and rehabilitation ability are activated, and the body naturally recovers its health. According to modern medicine, a positive and sunny mentality can increase the secretion of endorphins and accelerate repair.

[0033] Among them, Panax notoginseng leaves contain saponins, which can bidirectionally regulate immunity, promote hematopoietic stem cell proliferation, and accelerate the regeneration of damaged tissues. Eucommia ulmoides improves microcirculation by tonifying the liver and kidneys and strengthening tendons and bones; its iridoid components can activate T cell function. Licorice has adrenocortical hormone-like effects, regulating water and electrolyte metabolism and immune response; its flavonoid components can enhance macrophage activity and promote tissue repair. Peach kernel has blood-activating and stasis-removing properties that can improve local ischemia, stimulate angiogenesis, and accelerate wound healing. Cinnamon indirectly enhances cell repair capacity by improving microcirculation and antioxidant effects; its volatile oil components can activate mitochondrial function. Ume plum contains organic acids and antioxidants, which enhance immune barrier function by regulating intestinal flora; Polygonatum odoratum has polysaccharide components that can enhance NK cell activity and improve mucosal immunity, especially suitable for the self-healing repair of those with yin deficiency. Cucumber seeds are traditionally used for bone and tendon repair; modern research shows that their calcium and phosphorus metabolism regulation and calcium supplementation effects can assist in bone repair.

[0034] The herbal formula of this invention follows the traditional Chinese medicine concept of "harmony between man and nature, and the shared origin of medicine and food." The selected medicinal ingredients, including dried plum, licorice root, cinnamon, and cloves, are all listed in the directory of shared medicinal and edible ingredients published by the National Health Commission of China. Furthermore, Panax notoginseng leaves and cucumber seeds have long been commonly used in both edible and medicinal practices. Moreover, all the medicinal ingredients in this invention are readily available and purchasable, rather than scarce, making the medicine very affordable, facilitating large-scale production and easy promotion.

[0035] In recent years, the inventor has been practicing medicine without animal ingredients, hoping to verify that the efficacy of medicine without animal ingredients is no worse or even better. He hopes to correct the long-standing misconception. Detailed Implementation Example 1: A traditional Chinese medicine composition for promoting fracture healing, wherein the weight of each ingredient in the traditional Chinese medicine composition is as follows: 10g of dried plum, 9g of licorice, 6g of cinnamon, 20g of Panax notoginseng leaves, 15g of Eucommia ulmoides, 6g of peach kernel, 9g of Polygonatum odoratum, 6g of clove, 30g of cucumber seeds, and 25g of Impatiens balsamina.

[0036] The preparation method of the traditional Chinese medicine composition for promoting fracture healing is as follows: Mix all the ingredients in this formula according to the specified ratio, then use a professional ultra-fine pulverizer to pulverize them into 60 equal portions, each weighing approximately 6 grams, and package them into bags.

[0037] Alternatively, take 360 ​​grams of the crushed medicine powder as one course of treatment, divide it into 20 portions, each approximately 18 grams, and mix it with petroleum jelly to make a patch. Example 2: A traditional Chinese medicine composition for promoting fracture healing, wherein the weight of each ingredient in the traditional Chinese medicine composition is as follows: 30g of Panax notoginseng leaves, 40g of cucumber seeds, 20g of Eucommia ulmoides, 12g of peach kernels, 15g of dried plum, 12g of cloves, 11g of cinnamon, 12g of Polygonatum odoratum, 12g of licorice root, and 30g of Impatiens balsamina.

[0038] The preparation method of the traditional Chinese medicine composition for promoting fracture healing is as follows: Mix all the ingredients in this formula according to the specified ratio, then use a professional ultra-fine pulverizer to pulverize them into 60 equal portions, each weighing approximately 6 grams, and package them into bags.

[0039] Alternatively, take 360 ​​grams of the crushed medicine powder as one course of treatment, divide it into 20 portions, each about 18 grams, and mix it with petroleum jelly to make a patch. Example 3: A traditional Chinese medicine composition for promoting fracture healing, wherein the weight of each ingredient in the traditional Chinese medicine composition is as follows: 15g of Panax notoginseng leaves, 25g of cucumber seeds, 12g of Eucommia ulmoides, 6g of peach kernel, 7g of dried plum, 5g of clove, 4g of cinnamon, 6g of Polygonatum odoratum, 7g of licorice, and 20g of Impatiens balsamina.

[0040] The preparation method of the traditional Chinese medicine composition for promoting fracture healing described in this invention is as follows: Mix all the ingredients in this formula according to the specified ratio, then use a professional ultra-fine pulverizer to pulverize them into 60 equal portions, each weighing approximately 6 grams, and package them into bags.

[0041] Alternatively, take 360 ​​grams of the crushed medicine powder as one course of treatment, divide it into 20 portions, each about 18 grams, and mix it with petroleum jelly to make a patch. The traditional Chinese medicine composition of this invention is a pure traditional Chinese medicine preparation developed by the inventor. It has a good effect on the treatment of fractures. From February 2024 to the present, 60 cases of fractures have been clinically observed.

[0042] The ingredients are: dried plum, licorice, cinnamon, Panax notoginseng leaves, Eucommia ulmoides, peach kernel, Polygonatum odoratum, clove, cucumber seed, oyster, and balsam flower.

[0043] Functions and indications: Promotes blood circulation, reduces swelling and pain, and helps to heal bones and tendons. It also activates the body's powerful self-healing system. Used for injuries from falls and blows, fractures, nonunion, osteonecrosis, and other conditions caused by blood stasis obstructing the meridians and deficiency of the liver and kidneys.

[0044] I. Research Objectives Clinical trials will further confirm and verify the clinical efficacy and adverse reactions of this product.

[0045] II. Selection of Medical Records Based on the functional indications of this formula—unblocking meridians and collaterals, reducing swelling and relieving pain, promoting bone and tendon healing—it activates the body's powerful recovery system through medication. It is primarily used to treat injuries caused by traumatic blood stasis obstructing the meridians, fractures, or long-term liver and kidney deficiency leading to nonunion and osteonecrosis. Subjects were selected based on Traditional Chinese Medicine (TCM) diagnosis of fractures: blood stasis obstructing the meridians or liver and kidney deficiency. Western medicine diagnoses included fractures, nonunion, and osteonecrosis.

[0046] (I) Diagnostic criteria for TCM syndromes: formulated with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines".

[0047] (II) Western medicine diagnostic criteria: Diagnosis is based on the "Clinical Practice Guidelines - Orthopedics Section".

[0048] (III) Inclusion and exclusion criteria for the medical records of the subjects: 1. Criteria for inclusion in medical records: (1) The patient meets the criteria for fracture according to Western medicine. According to traditional Chinese medicine, the diagnosis is blood stasis obstructing the collaterals or deficiency of liver and kidney, with symptoms such as swelling, pain, purple tongue and choppy pulse.

[0049] (2) Age between 10 and 85 years old 2. Exclusion criteria (1) Pathological fractures caused by tumor infection, etc., as confirmed by examination.

[0050] (2) Women aged 85 and above, pregnant or lactating women, and those allergic to this drug.

[0051] (3) Patients with serious primary diseases of the liver, kidneys, hematopoietic system and endocrine system, or mental disorders.

[0052] (4) Any patient who does not meet the inclusion criteria, does not use medication as prescribed, or whose efficacy or safety assessment is incomplete or whose data is insufficient.

[0053] 3. Observation indicators (1) Pain level and swelling reduction before treatment, 4 weeks after treatment, and 8 weeks after treatment were assessed. Each item was scored on a scale of 0, 2, 4, and 6, respectively, based on the four levels of none, mild, moderate, and severe. The Visual Analogue Scale (VAS) was used to evaluate the pain level; the higher the score, the greater the pain. Swelling was measured with a tape measure, and three consecutive measurements were taken. The swelling level was calculated as (circumference of the affected side - circumference of the healthy side) / circumference of the healthy side × 100%.

[0054] (2) Callus score and fracture healing time. The callus is scored from 0 to 3 according to the X-ray callus assessment standard formulated by Shanghai Institute of Orthopaedics and Traumatology. 0 points: The fracture ends are clear and there is no obvious callus growth; 1 point: The fracture ends are blurred and the callus density is light, like flocculent; 2 points: The edge of the fracture ends is almost gone, but can still be seen and the callus density is relatively deep; 3 points: The edge of the fracture ends is small and the callus density is further deepened and basically the same as the bone ends.

[0055] 4. Criteria for Evaluating Therapeutic Effect (1) Significant effect: Symptoms disappear or are significantly relieved, and the symptom score is reduced by more than 2 / 3 (within the course of treatment).

[0056] (2) Effective: Symptoms are reduced or relieved, and the symptom score is reduced by more than 1 / 3 (within the course of treatment).

[0057] (3) Ineffective: No improvement compared with before treatment or the symptom score is reduced by less than 1 / 3 (within the course of treatment).

[0058] III. Observation Content: (I) Safety Observation 1. General physical examination items (including body temperature, blood pressure, respiration, pulse, etc.) 2. Routine blood, urine, and stool tests 3. Electrocardiogram and liver and kidney function tests (II) Observation of therapeutic efficacy All patients underwent CT scans of the fracture site, chest X-rays, and electrocardiograms before observation.

[0059] (III) Clinical Implementation Plan Observation method: This observation was conducted using a random method.

[0060] 1. Observation group: The observation group selected outpatients, all of whom underwent detailed medical history taking, disease study, and CT examination to make a clear diagnosis.

[0061] 2. Treatment course: Two months.

[0062] 3. Observation of toxic side effects: Pay attention to toxic side effects. If any adverse reactions occur, stop taking the medication immediately, take appropriate treatment measures, and report to the relevant hospital departments.

[0063] 4. When necessary, supplement with appropriate clinical treatment measures.

[0064] 6. During the treatment and observation period, patients should not take similar medications.

[0065] IV. General Information A total of 60 cases were included. Among them, 33 were male and 27 were female. The oldest patient was 84 years old and the youngest was 11 years old, with an average age of 59.1 years.

[0066] Symptom distribution: 60 cases of fracture. Comorbidities: 34 cases of hypertension, 6 cases of coronary heart disease, and 5 cases of diabetes.

[0067] V. Observation and Treatment Methods 1. This observation was conducted using a randomization method, and the results were summarized without the inclusion of similar treatment drugs.

[0068] 2. Diagnostic criteria: Follow the clinical observation plan.

[0069] 3. Usage and dosage: Oral administration, three times a day, one packet each time (each packet weighs 6g). 4. Statistical processing of observational research results: Quantitative data are represented by X. 2 test.

[0070] VI. Results of Therapeutic Effect Observation The main symptoms and signs before and after one course of treatment were compared. See the table below: Note: In the above clinical data, "inefficient" means that, according to the rules established in this clinical trial, the patient's symptom score decreased by less than 1 / 3 within a two-month treatment course.

[0071] 1. Ms. An, female, age 60, date of consultation: October 8, 2024, medical record: The patient suffered a right radius fracture due to trauma 4 weeks ago. She had previously undergone surgery at a hospital with mediocre results. Seeking systematic treatment, she came to our clinic. Presenting with swelling and tenderness on the right upper limb, she had poor appetite, normal sleep, a dark red tongue with a thin white coating, and a wiry, hesitant pulse. Auxiliary examination: X-ray of the right wrist joint (anteroposterior and lateral views) showed a distal radius fracture. Traditional Chinese Medicine diagnosis: Fracture due to qi stagnation and blood stasis, promoting blood circulation and unblocking the meridians to heal tendons and bones. Western medicine diagnosis: Postoperative right radius fracture. Treatment with the above-mentioned traditional Chinese medicine preparation of this invention (oral administration: 6 grams three times a day).

[0072] Second visit: November 8, 2024. After one month of medication, the patient's pain at the affected area has lessened, but mobility remains limited. Auxiliary examination: X-rays of the right wrist joint (anteroposterior and lateral views) show initial healing of the fracture line and the beginning of callus formation. Treatment: Continue taking the herbal preparation of this invention (oral administration: 6 grams three times a day).

[0073] Third visit: December 8, 2024. After two months of medication, the patient's pain at the affected area was greatly reduced, but movement was still slightly limited. Auxiliary examination: X-ray of the right wrist joint (anteroposterior and lateral views) showed significant blurring of the distal radius fracture line, with continuous callus passing through the fracture ends; the fracture ends were well aligned. Continued medication: Treatment with the above-mentioned traditional Chinese medicine preparation of this invention (oral administration: 6 grams three times a day).

[0074] 2. Mr. Yang, male, age 38, date of consultation: December 20, 2024. Medical record: The patient came to our clinic 4 hours prior after accidentally spraining his ankle and experiencing pain, which he did not treat. His right ankle was swollen and tender. He had poor appetite, slept well, had a dark red tongue with a thin white coating, and a wiry, hesitant pulse. Auxiliary examination: X-ray of the right ankle joint (anteroposterior and lateral views) on December 20, 2024: Closed fracture of the distal right fibula. Traditional Chinese Medicine diagnosis: Fracture disease, qi stagnation and blood stasis, promoting blood circulation and unblocking collaterals, and healing tendons and bones. Western medicine diagnosis: Fracture of the distal right fibula. Treatment: Oral administration of the above-mentioned traditional Chinese medicine preparation (6 grams three times a day), with external fixation in a plaster cast.

[0075] Second visit: January 20, 2025. The patient returned for a follow-up visit after one month of medication. Swelling and tenderness in the right ankle joint had decreased, but movement remained limited. Auxiliary examination: Anteroposterior and lateral X-rays of the right foot showed a clear fracture line at the distal fibula, with good alignment of the fracture ends. A small amount of cloudy callus was observed around the fracture. The ankle joint space was normal, and there was no widening of the distal tibiofibular syndesmosis. Treatment: Continue taking the herbal preparation of this invention (oral: 6 grams three times a day).

[0076] Third visit: March 20, 2025. The patient returned for a follow-up visit after two months of medication. Swelling and tenderness in the right ankle joint had disappeared, and movement was normal. Auxiliary examination: X-ray of the right foot (anteroposterior and lateral views) showed a significantly blurred fracture line, with bridging callus formation visible at the fracture ends, and partial restoration of cortical continuity. The fracture alignment was stable, with no displacement. Ankle joint alignment was normal, and the distal tibiofibular syndesmosis was well-matched. Treatment: Continue taking the herbal preparation of this invention (oral: 6 grams three times a day). Doctor's instructions: Perform foot and ankle muscle strengthening exercises. Follow-up visit in 6 months. Continue medication as prescribed.

[0077] 3. Ms. Fan, female, age 75. Date of visit: August 4, 2023. Medical record: Two hours prior, the patient accidentally fell and lay flat on the road, experiencing back pain. She was diagnosed with a "T12 compression fracture" at a local hospital and came to our clinic for further treatment. Current symptoms: lower back pain and discomfort, limited mobility, good appetite, good sleep, normal bowel movements. Dark red tongue with a thin white coating, wiry and hesitant pulse. Auxiliary examinations: Thoracic spine X-ray: showed T12 compression fracture. Traditional Chinese Medicine diagnosis: Fracture disease, qi stagnation and blood stasis, promoting blood circulation and unblocking collaterals, promoting tendon and bone healing. Western medicine diagnosis: T12 compression fracture. Treatment with the above-mentioned traditional Chinese medicine preparation of this invention: oral administration, 6 grams three times a day; calcium and vitamin D chewable tablets (oral administration, 0.5g once a day).

[0078] Second visit: September 5, 2023. After one month of medication, the patient's pain at the affected area has lessened, but mobility remains limited. Appetite and sleep are good, and bowel movements are regular. Tongue is dark red with a thin white coating, and pulse is wiry and hesitant. Auxiliary examination: X-ray of the thoracic spine (anteroposterior and lateral views): shows a compression fracture of T12, with partial loss of height at the anterior edge of the vertebral body, blurred fracture line, and surrounding callus formation. Treatment: Continue taking the herbal preparation of this invention (oral: 6 grams three times a day), and calcium and vitamin D chewable tablets (oral: 0.5 grams once daily).

[0079] Third visit: November 2, 2023. After 3 months of medication, the patient experienced no pain or tenderness, had good mobility, appetite, sleep, and bowel movements. The tongue was dark red with a thin white coating, and the pulse was wiry and hesitant. Auxiliary examinations: X-rays of the thoracic vertebrae (anteroposterior and lateral views) showed a compression fracture of the T12 vertebral body, with the fracture line largely disappearing, callus remodeling further, and the vertebral height more stable than before. Treatment: Continue taking the herbal preparation of this invention (oral: 6 grams three times a day), and calcium and vitamin D chewable tablets (oral: 0.5 g once daily). Doctor's orders: Wear a chest brace as prescribed; follow-up examination in 6 months; immediate follow-up if lower limb numbness / pain worsens, and continue medication as prescribed.

[0080] VII. Safety and Adverse Reactions Observation No adverse reactions or allergic reactions occurred in the 60 patients during the treatment. Routine blood, urine, and stool tests, as well as heart, liver, and kidney function tests, showed no changes before and after treatment.

[0081] VIII. Discussion: Traditional Chinese medicine believes that fractures caused by blood stasis and obstruction of the meridians are due to external injury, qi stagnation and blood stasis, broken tendons and bones, obstruction of the flow of qi and blood, and disharmony of the internal organs. Modern medicine believes that fractures are caused by external injury, osteoporosis, or bone diseases, essentially resulting in the interruption of the integrity and continuity of the bone. This formula mainly targets qi stagnation and blood stasis, broken tendons and bones caused by external injury. Based on the theory of traditional Chinese medicine and combined with many years of clinical experience, the inventor adopted the principle of syndrome differentiation and treatment, starting with "calming the mind and opening the orifices, clearing the heart and refreshing the brain, and promoting blood circulation and unblocking the meridians." After repeated practice and screening, this pure Chinese herbal formula was developed, achieving good results in treating local pain, swelling, or functional impairment, as well as a dark purple tongue caused by fractures. In repeated clinical practice, its therapeutic effects during the fracture recovery period and in the treatment of nonunion and osteonecrosis were also discovered. Clinical observation has confirmed its significant efficacy. Safety tests revealed no damage to liver or kidney function in either group, nor any adverse effects on the heart or lungs. Clinically, no toxic effects on the liver, kidneys, or lungs were observed. The treatment demonstrated significant efficacy and improved symptoms and signs.

[0082] IX. Conclusion: The above information demonstrates that this formula possesses the functions of "unblocking meridians and collaterals, reducing swelling and relieving pain, and promoting bone and tendon healing." Its overall effective rate for treating fractures is 94%, with 76.7% of patients showing significant efficacy. In actual treatment, three patients with low efficacy continued treatment beyond the prescribed course (two months), and their subsequent treatment results also reached the standard for significant efficacy. The drug exhibits no obvious toxic side effects in clinical application and is convenient to take, making it highly worthy of clinical promotion and application.

[0083] 10. Note: This formula contains blood-activating and stasis-removing drugs, and is contraindicated for pregnant women.

Claims

1. A traditional Chinese medicine composition for promoting fracture healing, characterized in that: The weight of each raw material in the traditional Chinese medicine composition is: 30-15 grams of Panax notoginseng leaf, 40-25 grams of Cucumis sativus seed, 20-12 grams of Eucommia ulmoides, 12-6 grams of Semen Persicae, 15-7 grams of Prunus mume, 12-5 grams of Syzygium aromaticum, 11-4 grams of Cinnamomum cassia, 12-6 grams of Polygonatum odoratum, 12-7 grams of Glycyrrhiza uralensis, and 30-20 grams of Impatiens balsamina. ​