A traditional Chinese medicine composition for treating bone fracture, preparation method and application

Abstract

This invention discloses a traditional Chinese medicine composition, preparation method, and application for treating fractures, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition is made from the following components in parts by weight: 30-60 parts of Paris polyphylla, 30-55 parts of Pterocarya stenoptera, 20-40 parts of Corydalis yanhusuo, 15-25 parts of Epimedium, 35-65 parts of Sanqia sanguisorba, 30-50 parts of Boswellia carterii, 30-50 parts of Commiphora myrrha, 20-35 parts of Huaxue Dan, 30-65 parts of Salvia miltiorrhiza, 20-40 parts of Angelica pubescens, 20-35 parts of Clematis chinensis, 15-30 parts of Angelica pubescens, 15-35 parts of Lycopodium clavatum, 15-35 parts of Phyllanthus urinaria, 20-35 parts of Rheum palmatum, 20-35 parts of Rheum palmatum, 15-35 parts of Platinum chinense, and 20-35 parts of Dajie Dan. The advantages of this invention are: it can quickly reduce swelling and relieve pain, and it can continuously promote callus formation and improve the healing rate of the fracture site.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating fractures, its preparation method, and its application. Background Technology

[0002] Fractures are common traumatic bone injuries caused by direct violence, indirect violence, or cumulative strain. The pathological process is centered on cortical bone fracture, local qi and blood stagnation, meridian obstruction, muscle contracture, and liver and kidney deficiency. The main clinical manifestations are severe pain, swelling and ecchymosis at the injury site, and functional impairment. If not treated properly, sequelae such as delayed healing, nonunion, joint stiffness, muscle atrophy, and chronic pain may occur, seriously affecting the patient's limb function recovery and quality of life.

[0003] Currently, clinical treatment for fractures primarily focuses on reduction and fixation, supplemented by symptomatic medication. Western medicine mainly employs nonsteroidal anti-inflammatory drugs (NSAIDs) for pain relief, calcium supplements, and vitamin D to promote bone metabolism. While these methods can alleviate pain and supplement calcium to some extent, they suffer from significant analgesic side effects, fail to effectively improve local blood stasis and qi stagnation, and have poor effects on soft tissue repair and joint function recovery. Furthermore, they cannot fundamentally address the core issues of post-fracture blood stasis, malnutrition of tendons and bones, and blocked meridians. They also lack targeted interventions for sequelae such as joint adhesions and limited flexion and extension during the fracture recovery period.

[0004] Traditional Chinese medicine (TCM) has a long history of treating fractures, following the principles of "promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, promoting bone and tendon healing, strengthening tendons and bones, and relaxing muscles and tendons." It boasts the advantages of holistic regulation and addressing both the root cause and symptoms. Current research reports that adding oral TCM at different postoperative stages to intramedullary nailing can effectively improve pain and swelling symptoms 7 days post-surgery and shorten the average bone healing time from 19.2 weeks to 15.7 weeks (P<0.05). However, currently used TCM formulas or preparations for bone healing still have drawbacks such as slow onset of action, weak analgesic efficacy, and a relatively long fracture healing period. Furthermore, the specific relationship between the components of TCM and key pathways of fracture healing remains unclear, and the standardization and reproducibility of medication regimens need improvement. Therefore, developing a TCM compound preparation with definite efficacy, rapid onset of action, and clearly defined components is of significant clinical importance for further optimizing postoperative rehabilitation and shortening the healing period after fracture surgery. Summary of the Invention

[0005] To address the above-mentioned problems, the purpose of this invention is to provide a traditional Chinese medicine composition that is effective in treating fractures.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine composition for treating fractures, the composition comprising the following components in parts by weight: 30-60 parts of Paris polyphylla, 30-55 parts of Pterocarya stenoptera, 20-40 parts of Corydalis yanhusuo, 15-25 parts of Epimedium, 35-65 parts of Sanfensan, 30-50 parts of Boswellia carterii, 30-50 parts of Commiphora myrrha, 20-35 parts of Huaxuedan, 30-65 parts of Salvia miltiorrhiza, 20-40 parts of Angelica pubescens, 20-35 parts of Clematis chinensis, 15-30 parts of Angelica pubescens, 15-35 parts of Lycopodium clavatum, 15-35 parts of Phyllanthus urinaria, 20-35 parts of Rheum palmatum, 20-35 parts of Rheum palmatum, 15-35 parts of Platinum sibiricum, and 20-35 parts of Dajiedan.

[0008] Preferably, the traditional Chinese medicine composition is made from the following components in parts by weight: 40-50 parts of Paris polyphylla, 40-50 parts of Pterocarya stenoptera, 25-35 parts of Corydalis yanhusuo, 18-22 parts of Epimedium, 45-55 parts of Sanfensan, 35-45 parts of Boswellia carterii, 35-45 parts of Commiphora myrrha, 25-30 parts of Huaxuedan, 40-55 parts of Salvia miltiorrhiza, 25-35 parts of Angelica pubescens, 25-30 parts of Clematis chinensis, 20-25 parts of Angelica pubescens, 20-30 parts of Lycopodium clavatum, 20-30 parts of Phyllanthus urinaria, 25-30 parts of Rheum palmatum, 25-30 parts of Rheum palmatum, 20-30 parts of Platinum sibiricum, and 25-30 parts of Dajiedan.

[0009] As a further preferred embodiment, the traditional Chinese medicine composition is made from the following components in parts by weight: 45 parts of Paris polyphylla, 45 parts of Pterocarya stenoptera, 30 parts of Corydalis yanhusuo, 20 parts of Epimedium, 50 parts of Sanfensan, 40 parts of Boswellia carterii, 40 parts of Commiphora myrrha, 25 parts of Huaxuedan, 50 parts of Salvia miltiorrhiza, 30 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 25 parts of Lycopodium clavatum, 25 parts of Phyllanthus urinaria, 25 parts of Phyllanthus urinaria, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 25 parts of Platinum chinense, and 25 parts of Dajiegudan.

[0010] Preferably, the traditional Chinese medicine composition is prepared into a clinically commonly used powder or ointment by adding pharmaceutically acceptable excipients. The pharmaceutically acceptable excipients used in preparing the topical ointment are selected from one or more of the following: oil-based matrix, wax-based matrix, resin-based matrix, transdermal penetration enhancer, moisturizer, thickener, and preservative; the oil-based matrix includes white petrolatum, lanolin, liquid paraffin, and edible vegetable oil; the wax-based matrix includes beeswax and insect wax; the resin-based matrix includes rosin; and the transdermal penetration enhancer includes borneol, menthol, laurocapram, and camphor.

[0011] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating fractures, comprising the following steps: weighing out the following herbs according to their weight: Paris polyphylla, Lysimachia christinae, Corydalis yanhusuo, Epimedium, Sanfen San, Boswellia carterii, Commiphora myrrha, Huaxue Dan, Salvia miltiorrhiza, Angelica pubescens, Clematis chinensis, Dudingzi, Lycopodium clavatum, Phyllanthus emblica, Rheum palmatum, Rheum palmatum, Platycodon grandiflorus, and Dajiedan, mixing them, and pulverizing them to obtain the final product.

[0012] The present invention also provides a method for preparing the traditional Chinese medicine composition for treating fractures, comprising the following steps: weighing out the following ingredients by weight: Paris polyphylla, Pteris vittata, Corydalis yanhusuo, Epimedium, Sanfen San, Boswellia carterii, Commiphora myrrha, Huaxue Dan, Salvia miltiorrhiza, Angelica pubescens, Clematis chinensis, Dudingzi, Lycopodium clavatum, Phyllanthus emblica, Rheum palmatum, Rheum palmatum, Rheum palmatum, Platycodon grandiflorus, and Dajie Dan, and preparing them into an ointment.

[0013] Preferably, the ointment is prepared by decoction, reflux or percolation.

[0014] The present invention also provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating fractures.

[0015] In this formula, Paris polyphylla is bitter and cold, and enters the liver meridian. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain. It is an essential medicine for treating carbuncles, boils, and traumatic injuries. In the treatment of fractures, it can eliminate local heat toxins and swelling and pain, so it is the principal medicine.

[0016] The blood of the dragon's palm is pungent and slightly bitter, and warm in nature. It enters the liver and kidney meridians and can promote blood circulation, remove blood stasis, dispel wind and dampness, reduce swelling and relieve pain. It is pungent, bitter, warm, and toxic. It promotes blood circulation, removes blood stasis, and has anesthesia and pain relief. When combined with frankincense and myrrh, it enhances the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain. As an assistant herb, it assists the principal herb in exerting its main effects.

[0017] Corydalis rhizome is pungent, bitter, and warm, entering the liver and spleen meridians; it invigorates blood, promotes qi circulation, and relieves pain. Salvia miltiorrhiza is bitter and slightly cold, entering the heart and liver meridians; it invigorates blood, removes blood stasis, and relieves pain. Huaxue Dan (a traditional Chinese medicine formula) invigorates blood and removes blood stasis; these three herbs assist the principal and assistant herbs in enhancing their blood-invigorating effects. Angelica pubescens is pungent, bitter, and slightly warm, entering the kidney and bladder meridians; Clematis chinensis is pungent, salty, and warm, entering the bladder meridian; Lycopodium clavatum is bitter and warm, entering the liver meridian. These three herbs dispel wind and dampness, unblock meridians, and relieve pain, alleviating discomfort in the limbs and joints after fractures. Other herbs such as angelica pubescens, euonymus fortunei, rhubarb, basil, platinum bark, and large bone-setting pills, either invigorate blood and remove blood stasis or promote bone healing, serve as adjuvant herbs, working synergistically with the principal and assistant herbs to treat fractures.

[0018] The formula is meticulously formulated, with the core principles of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and promoting bone healing. It targets the pathogenesis of fractures by combining multiple drugs to address both the symptoms and the root cause.

[0019] in:

[0020] *Paris polyphylla*: The dried rhizome of *Paris polyphylla Smith var. yunnanensis* (Franch.) Hand.-Mazz. or *Paris polyphylla Smith var. chinensis* (Franch.) Hara, belonging to the Liliaceae family. It is bitter and slightly cold in nature, and enters the liver meridian. It has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, and is an essential medicine for traumatic injuries in traditional Chinese medicine surgery. *Toddalia asiatica* (L.) Lam.: The dried root or root bark of *Toddalia asiatica* (L.) Lam., belonging to the Rutaceae family. It is pungent and slightly bitter in taste, warm in nature, and enters the liver meridian. It is effective in dispelling wind and relieving pain, dispersing blood stasis and stopping bleeding, detoxifying and reducing swelling, and is a commonly used medicine for treating rheumatic pain, traumatic injuries, and carbuncles and boils.

[0021] Corydalis: The dried tuber of Corydalis yanhusuo WTWang, a plant of the genus Corydalis in the Papaveraceae family. It has a pungent and bitter taste, is warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, regulating qi, and relieving pain. It is a commonly used blood-activating and pain-relieving drug in clinical practice.

[0022] Epimedium: The dried leaves of Epimedium brevicornu Maxim., Epimedium sagittatum (Sieb. et Zucc.) Maxim., Epimedium pubescens Maxim., or Epimedium koreanum Nakai, belonging to the Berberidaceae family. It has a pungent and sweet taste, is warm in nature, and enters the liver and kidney meridians. It has the effects of tonifying kidney yang, strengthening tendons and bones, and dispelling wind and dampness.

[0023] Anisodus acutangulus CY Wu et C. Chen, a plant in the Solanaceae family, is the root or leaf of plants in the genus Anisodus or Anisodus spp. It has a bitter and pungent taste, is warm in nature, and enters the spleen, stomach, and kidney meridians. It has the effects of relieving spasms and pain, dispelling wind and dampness.

[0024] Frankincense: It is the dried resin of Boswellia carterii Birdw. and Boswellia bhaw-dajiana Birdw., both belonging to the Burseraceae family. It has a pungent and bitter taste, is warm in nature, and enters the heart, liver, and spleen meridians. It has the effects of promoting blood circulation, relieving pain, reducing swelling, and promoting tissue regeneration.

[0025] Myrrh: It is the dried resin of the Burseraceae plant Commiphora myrrha Engl. or Commiphora molmol Engl. It has a pungent and bitter taste, is neutral in nature, and enters the heart, liver, and spleen meridians. It has the effects of dispersing blood stasis, relieving pain, reducing swelling, and promoting tissue regeneration.

[0026] Huaxuedan, also known as Dula, is the tuberous root of Aconitum episcopale Levl. or Aconitum sp., both belonging to the Ranunculaceae family. It has a pungent and bitter taste, is warm in nature, and enters the liver and spleen meridians. It has the effects of dispelling wind and cold, removing dampness and relieving pain. It is an essential medicine for treating wind-cold-dampness arthralgia and traumatic injuries.

[0027] Danshen: The dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. It tastes bitter and is slightly cold in nature. It enters the heart and liver meridians and has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and eliminating carbuncles. It is an important medicine in traditional Chinese medicine for the clinical treatment of blood stasis syndrome.

[0028] Angelica pubescens: The dried root of Angelica pubescens Maxim. f. biserrataShan et Yuan, a plant of the Apiaceae family. It has a pungent and bitter taste, is slightly warm in nature, and enters the kidney and bladder meridians. It has the effects of dispelling wind and dampness, relieving pain and numbness.

[0029] Clematis chinensis: The dried root and rhizome of Clematis chinensis Osbeck, Clematis hexapetala Pall., or Clematis manshurica Rupr. (Ranunculaceae family). It has a pungent and salty taste, is warm in nature, and enters the bladder meridian. It has the effects of dispelling wind and dampness, clearing the meridians and relieving pain.

[0030] Du Ding Zi: also known as Jin Tie Suo, is the dried root of Psammosilene tunicoides WC Wuet CY Wu, a plant of the Caryophyllaceae family. It tastes bitter and pungent, is warm in nature, and enters the liver meridian. It has the effects of dispelling wind and dampness, dispersing blood stasis and relieving pain, and detoxifying and reducing swelling.

[0031] Shenjincao: It is the dried whole herb of Lycopodium japonicum Thunb., a plant of the Lycopodiaceae family. It has a slightly bitter and pungent taste, is warm in nature, and enters the liver, spleen, and kidney meridians. It has the effects of dispelling wind and dampness, and relaxing muscles and tendons.

[0032] Helwingia himalaica Clarke or Helwingia japonica (Thunb.) Dietr., belonging to the Cornaceae family, is a plant with the whole plant and root. It has a slightly bitter and pungent taste, is warm in nature, and enters the lung, liver, and kidney meridians. It has the effects of promoting blood circulation and removing blood stasis, clearing heat and detoxifying, reducing swelling and relieving pain, and promoting bone and tendon healing. It is often used to treat traumatic injuries and fractures.

[0033] Rhubarb root: The dried root of Rumex patientia L. or Rumex crispus L., plants of the Polygonaceae family. It tastes bitter and pungent, is cool in nature, and enters the heart and lung meridians. It has the effect of cooling blood and stopping bleeding.

[0034] Luodeda: also known as Centella asiatica, is the dried whole herb of Centella asiatica (L.) Urb., a plant of the Apiaceae family. It tastes bitter and pungent, is cold in nature, and enters the liver, spleen, and kidney meridians. Its functions are to clear heat and dampness, detoxify and reduce swelling.

[0035] Platinum Bar: Also known as Acer chinense, it is the root or fibrous root of Alangium chinense (Lour.) Harms or Alangium platanifolium (Sieb. et Zucc.) Harms, a plant of the Alangaceae family. It has a pungent and bitter taste, is warm in nature, and enters the liver, kidney, and heart meridians. It has the effects of dispelling wind and dampness, relaxing muscles and tendons, and relieving pain.

[0036] Big Bone-Setting Pill: Also known as elderberry, it is the stem or root bark of Sambucus williamsii Hance, a plant of the Caprifoliaceae family. It tastes sweet and bitter and is neutral in nature. It enters the liver meridian and has the effects of dispelling wind, promoting diuresis, activating blood circulation, and relieving pain. It is often used to treat rheumatic pain, back pain, edema, urticaria, traumatic injuries, and fractures.

[0037] The present invention has the following beneficial effects:

[0038] This invention presents a well-formulated traditional Chinese medicine composition with synergistic effects, suitable for the repair and treatment of closed fractures and mild comminuted fractures. The composition effectively relieves swelling and pain at the affected area, promotes callus formation, and significantly shortens the fracture repair cycle. Clinical efficacy verification shows that after 4 weeks of intervention with this traditional Chinese medicine composition, significant callus growth can be observed at the affected area, and the fracture healing process is significantly accelerated. Simultaneously, it effectively improves common problems in fracture rehabilitation patients such as joint stiffness and limited limb movement, achieving simultaneous progress in bone healing and limb function recovery. The overall repair effect is excellent, demonstrating promising prospects for clinical application. Attached Figure Description

[0039] Figure 1This is a digital X-ray image of Case 1 before treatment;

[0040] Figure 2 This is a digital X-ray image of Case 1 after treatment;

[0041] Figure 3 This is a digital X-ray image of Case 2 before treatment;

[0042] Figure 4 This is a digital X-ray image of Case 2 after treatment;

[0043] Figure 5 This is a digital X-ray image of Case 3 before treatment;

[0044] Figure 6 Digital X-ray image of Case 3 after treatment;

[0045] Figure 7 Digital X-ray image of Case 4 before treatment;

[0046] Figure 8 Digital X-ray image of Case 4 after treatment;

[0047] Figure 9 This is a digital X-ray image of Case 5 before treatment;

[0048] Figure 10 This is a digital X-ray image of Case 5 after treatment;

[0049] Figure 11 Digital X-ray image of Case 6 before treatment;

[0050] Figure 12 This is a digital X-ray image of Case 6 after treatment. Detailed Implementation

[0051] The specific embodiments of the present invention will be further described below. It should be noted that these descriptions are for the purpose of aiding understanding the present invention, but do not constitute a limitation thereof. Furthermore, the technical features involved in the various embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0052] Example 1

[0053] A method for preparing a traditional Chinese medicine composition for treating fractures: Weigh out 45 parts of Paris polyphylla, 45 parts of Pterocarya stenoptera, 30 parts of Corydalis yanhusuo, 20 parts of Epimedium, 50 parts of Sanfensan, 40 parts of Boswellia carterii, 40 parts of Commiphora myrrha, 25 parts of Huaxuedan, 50 parts of Salvia miltiorrhiza, 30 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 25 parts of Lycopodium clavatum, 25 parts of Phyllanthus urinaria, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 25 parts of Platycodon grandiflorus, and 25 parts of Dajiedan; mix and pulverize to obtain an external fracture treatment powder.

[0054] Example 2

[0055] A method for preparing a traditional Chinese medicine composition for treating fractures: 30 parts of Paris polyphylla, 30 parts of Pterocarya stenoptera, 20 parts of Corydalis yanhusuo, 15 parts of Epimedium, 35 parts of Sanfensan, 30 parts of Boswellia carterii, 30 parts of Commiphora myrrha, 20 parts of Huaxuedan, 30 parts of Salvia miltiorrhiza, 20 parts of Angelica pubescens, 20 parts of Clematis chinensis, 15 parts of Angelica pubescens, 15 parts of Lycopodium clavatum, 15 parts of Phyllanthus urinaria, 20 parts of Rheum palmatum, 20 parts of Rheum palmatum, 15 parts of Platycodon grandiflorus, and 20 parts of Dajiedan are weighed according to their weight. The mixture is then pulverized to obtain an external fracture treatment powder.

[0056] Example 3

[0057] A method for preparing a traditional Chinese medicine composition for treating fractures: 60 parts of Paris polyphylla, 55 parts of Pterocarya stenoptera, 40 parts of Corydalis yanhusuo, 25 parts of Epimedium, 65 parts of Sanfensan, 50 parts of Boswellia carterii, 50 parts of Commiphora myrrha, 35 parts of Huaxuedan, 65 parts of Salvia miltiorrhiza, 40 parts of Angelica pubescens, 35 parts of Clematis chinensis, 30 parts of Angelica pubescens, 35 parts of Lycopodium clavatum, 35 parts of Phyllanthus urinaria, 35 parts of Rheum palmatum, 35 parts of Rheum palmatum, 35 parts of Platycodon grandiflorus, and 35 parts of Dajiedan are weighed by weight; mixed and pulverized to obtain an external fracture treatment powder.

[0058] Example 4

[0059] A method for preparing a traditional Chinese medicine composition for treating fractures: 50 parts of Paris polyphylla, 50 parts of Pterocarya stenoptera, 35 parts of Corydalis yanhusuo, 22 parts of Epimedium, 55 parts of Sanfensan, 45 parts of Boswellia carterii, 45 parts of Commiphora myrrha, 30 parts of Huaxuedan, 55 parts of Salvia miltiorrhiza, 35 parts of Angelica pubescens, 30 parts of Clematis chinensis, 25 parts of Angelica pubescens, 30 parts of Lycopodium clavatum, 30 parts of Phyllanthus urinaria, 30 parts of Rheum palmatum, 30 parts of Rheum palmatum, 30 parts of Platycodon grandiflorus, and 30 parts of Dajiedan are weighed by weight; mixed and pulverized to obtain an external fracture treatment powder.

[0060] Example 5

[0061] A method for preparing a traditional Chinese medicine composition for treating fractures: Weigh out 40 parts of Paris polyphylla, 40 parts of Pterocarya stenoptera, 25 parts of Corydalis yanhusuo, 18 parts of Epimedium, 45 parts of Sanfensan, 35 parts of Boswellia carterii, 35 parts of Commiphora myrrha, 25 parts of Huaxuedan, 40 parts of Salvia miltiorrhiza, 25 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 20 parts of Lycopodium clavatum, 20 parts of Phyllanthus urinaria, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 20 parts of Platycodon grandiflorus, and 25 parts of Dajiedan; mix and pulverize to obtain an external fracture treatment powder.

[0062] Instructions for use of the powder: For external use only. Take an appropriate amount of the powder and mix it with rice wine, vinegar or warm water to form a paste. Apply the paste evenly to the swollen and painful area of ​​the fracture, with a thickness of about 8-10 mm. Cover and bandage with gauze or oil paper.

[0063] Example 6

[0064] A method for preparing a traditional Chinese medicine composition for treating fractures: Weigh out 45 parts of Paris polyphylla, 45 parts of Pterocarya stenoptera, 30 parts of Corydalis yanhusuo, 20 parts of Epimedium, 50 parts of Sanfensan, 40 parts of Boswellia carterii, 40 parts of Commiphora myrrha, 25 parts of Huaxuedan, 50 parts of Salvia miltiorrhiza, 30 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 25 parts of Lycopodium clavatum, 25 parts of Phyllanthus urinaria, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 25 parts of Platycodon grandiflorus, and 25 parts of Dajiedan; decoct twice with water, each time for 2 hours; combine the decoctions, concentrate into an extract, add a measured amount of beeswax, stir thoroughly and mix evenly, cool and solidify to obtain an external fracture treatment ointment.

[0065] Example 7

[0066] A method for preparing a traditional Chinese medicine composition for treating fractures: Weigh out 30 parts of Paris polyphylla, 30 parts of Pterocarya stenoptera, 20 parts of Corydalis yanhusuo, 15 parts of Epimedium, 35 parts of Sanfensan, 30 parts of Boswellia carterii, 30 parts of Commiphora myrrha, 20 parts of Huaxuedan, 30 parts of Salvia miltiorrhiza, 20 parts of Angelica pubescens, 20 parts of Clematis chinensis, 15 parts of Angelica pubescens, 15 parts of Lycopodium clavatum, 15 parts of Phyllanthus urinaria, 20 parts of Rheum palmatum, 20 parts of Rheum palmatum, 15 parts of Platycodon grandiflorus, and 20 parts of Dajiedan; decoct twice with water, each time for 1.5 hours; combine the decoctions, concentrate into an extract, add a measured amount of beeswax, stir thoroughly and mix evenly, cool and solidify to obtain an external fracture treatment ointment.

[0067] Example 8

[0068] A method for preparing a traditional Chinese medicine composition for treating fractures: 60 parts by weight of *Paris polyphylla*, 55 parts of *Pterocarya stenoptera*, 40 parts of *Corydalis yanhusuo*, 25 parts of *Epimedium brevicornu*, 65 parts of *Trichosanthes kirilowii*, 50 parts of frankincense, 50 parts of myrrh, 35 parts of *Hedyotis diffusa*, 65 parts of *Salvia miltiorrhiza*, 40 parts of *Angelica pubescens*, 35 parts of *Clematis chinensis*, 30 parts of *Smilax china*, 35 parts of *Lycopodium clavatum*, 35 parts of *Euonymus alatus*, 35 parts of *Rheum palmatum*, 35 parts of *Lonicera japonica*, 35 parts of *Gynostemma pentaphyllum*, 35 parts of *Gynostemma pentaphyllum*, and 35 parts of *Dalbergia odorifera*; coarsely crush the herbs, extract them by percolation with 75% ethanol as a solvent, extract twice, 24 hours each time, combine the percolates, concentrate into an extract, add a measured amount of white petrolatum, stir thoroughly and mix evenly, cool and solidify to obtain an external fracture treatment ointment.

[0069] Example 9

[0070] A method for preparing a traditional Chinese medicine composition for treating fractures: 50 parts of Paris polyphylla, 50 parts of Pterocarya stenoptera, 35 parts of Corydalis yanhusuo, 22 parts of Epimedium, 55 parts of Sanfensan, 45 parts of Boswellia carterii, 45 parts of Commiphora myrrha, 30 parts of Huaxuedan, 55 parts of Salvia miltiorrhiza, 35 parts of Angelica pubescens, 30 parts of Clematis chinensis, 25 parts of Angelica pubescens, 30 parts of Lycopodium clavatum, 30 parts of Phyllanthus urinaria, 30 parts of Rheum palmatum, 30 parts of Rheum palmatum var. sarcodactylis, 30 parts of Platycodon grandiflorus, and 30 parts of Dajiedan are coarsely crushed, extracted by percolation with 85% ethanol as solvent, three times, 24 hours each time, the percolates are combined, concentrated into an extract, a certain amount of white petrolatum is added, thoroughly stirred and mixed evenly, cooled and solidified to obtain an external fracture treatment ointment.

[0071] Example 10

[0072] A method for preparing a traditional Chinese medicine composition for treating fractures: 40 parts by weight of *Paris polyphylla*, 40 parts of *Pterocarya stenoptera*, 25 parts of *Corydalis yanhusuo*, 18 parts of *Epimedium brevicornu*, 45 parts of *Trichosanthes kirilowii*, 35 parts of frankincense, 35 parts of myrrh, 25 parts of *Hedyotis diffusa*, 40 parts of *Salvia miltiorrhiza*, 25 parts of *Angelica pubescens*, 25 parts of *Clematis chinensis*, 20 parts of *Smilax china*, 20 parts of *Lycopodium clavatum*, 20 parts of *Eupatorium fortunei*, 25 parts of *Rheum palmatum*, 25 parts of *Lonicera japonica*, 20 parts of *Gynostemma pentaphyllum*, and 25 parts of *Dalbergia odorifera*; coarsely crush the herbs, reflux extract with 75% ethanol as solvent, extract three times, each time for 2 hours, combine the filtrates, concentrate into an extract, add a measured amount of rosin, stir thoroughly and mix evenly, cool and solidify to obtain an external fracture treatment ointment.

[0073] Example 11

[0074] A method for preparing a traditional Chinese medicine composition for treating fractures: 45 parts of Paris polyphylla, 45 parts of Pterocarya stenoptera, 30 parts of Corydalis yanhusuo, 20 parts of Epimedium, 50 parts of Sanfensan, 40 parts of Boswellia carterii, 40 parts of Commiphora myrrha, 25 parts of Huaxuedan, 50 parts of Salvia miltiorrhiza, 30 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 25 parts of Lycopodium clavatum, 25 parts of Phyllanthus urinaria, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 25 parts of Platycodon grandiflorus, and 25 parts of Dajiedan are coarsely crushed, extracted twice with 85% ethanol as solvent under reflux for 3 hours each time, the filtrates are combined, concentrated into an extract, a measured amount of rosin is added, the mixture is thoroughly stirred and mixed evenly, cooled and solidified to obtain an external fracture treatment ointment.

[0075] Instructions for use of ointment: For external use only. Apply an appropriate amount of ointment evenly to the swollen and painful area of ​​the fracture and the surrounding soft tissue injury, with a thickness of about 8-10 mm. Cover and bandage with gauze or oil paper.

[0076] Efficacy verification of the traditional Chinese medicine composition of this invention

[0077] 1. Clinical Data

[0078] The patient's bone fracture was manually reduced. The fracture site was observed under X-ray. The fracture alignment and puncture were good. The ointment obtained in Example 6 of this invention (Diannan Baicao Ointment) was applied to the fracture site. The ointment was applied to a thickness of about 1 cm. After the ointment was covered with gauze, splints, plaster casts, or orthopedic external fixation traction were applied as needed. The external dressing was changed after 48 hours. When changing the dressing, the movements were gentle, accurate, and steady to prevent displacement and misalignment of the fracture ends.

[0079] 1.1. Clinical evaluation of treatment efficacy in patients with fractures and bone injuries

[0080] Assess the onset time and duration of pain in patients.

[0081] The pain, swelling, and ecchymosis of the affected area were assessed at 7, 15, and 30 days after treatment.

[0082] Patients underwent X-ray follow-up examinations at 1, 3, 4, and 5 weeks post-treatment to assess fracture healing clinically.

[0083] 1.2. Clinical Case Data

[0084] Thirty fracture patients admitted to our hospital were randomly selected. Most of the fractures were caused by trauma. Among them, there were 16 males and 14 females, aged 5-65 years.

[0085] Diagnostic criteria: Diagnosis can be made based on clinical manifestations and imaging examinations.

[0086] Treatment method: Apply the ointment (Diannan Baicao Ointment) obtained in Example 6 of this invention to the affected area. Fix it with a splint or plaster as needed, and bandage it with gauze. Change the dressing once every 2 days.

[0087] Criteria for evaluating therapeutic efficacy:

[0088] Cure: Based on X-ray images, the fracture line is blurred, continuous callus passes through the fracture line, swelling and pain disappear, and the patient can move normally and freely.

[0089] Improvement: Significant callus formation, enveloping the fracture ends, swelling and pain disappear, and the patient can move around in the affected area.

[0090] Ineffective: No callus formation or only a small amount of callus formation, with significant swelling and pain.

[0091] Table 1. Case Statistics

[0092] 30 cases 28 2 0 93.3%

[0093] 1.3. Treatment Results:

[0094] The results above show that the ointment (Diannan Baicao Ointment) obtained in Example 6 of this invention has a high efficacy rate and a short treatment course for treating fracture patients, and can greatly reduce the pain of patients.

[0095] 1.4. Some Clinical Cases

[0096] Case 1: Ms. Li, 53 years old, twisted her right wrist while moving a sofa. Immediately after the injury, she experienced pain in her right wrist and limited wrist joint movement. DR examination diagnosed: comminuted fracture of the distal radius combined with fracture of the ulnar styloid process; the DR image before treatment is shown in Figure 1, which shows a clear fracture line at the distal radius, good alignment of the fracture ends, and that it is a fresh fracture with no obvious callus formation at the fracture ends.

[0097] The patient was treated with the herbal ointment of this invention applied externally to the affected area: After 7 days of external application, the swelling and pain in the right wrist were relieved compared with before the treatment; after 15 days of external application, the swelling and pain in the wrist basically subsided; after one month of continuous external application, a follow-up DR examination was performed. The follow-up image is shown in Figure 2. It can be seen that the fracture line of the distal radius is significantly blurred compared with before the treatment, and new callus formation appears around the fracture ends, indicating improved fracture stability.

[0098] Case 2: Fan, male, 5 years old, injured his left lower leg while playing. He experienced persistent pain and limited range of motion in his left lower leg after the injury. DR examination diagnosed a fracture of the middle and lower segment of the left tibia; pre-treatment DR imaging showed… Figure 3 The fracture line of the middle and lower segment of the left tibia is clear, and no obvious callus formation is seen at the fracture ends, indicating that it is in the fresh fracture stage.

[0099] The patient was treated with the herbal ointment of this invention applied externally to the affected area: After 7 days of application, the swelling in the left calf subsided; after 15 days of application, the swelling and pain in the left calf had basically subsided; after one month of continued application, a follow-up DR examination was performed, and the imaging showed... Figure 4It can be seen that there is obvious callus growth around the fracture ends of the left tibia, and the fracture healing process is good.

[0100] Case 3: Ms. Yang, 57 years old, fell and injured her left wrist while walking. Immediately after the injury, she experienced pain in her left wrist and limited wrist joint movement. DR examination diagnosed a comminuted fracture of the distal radius of the left arm; pre-treatment DR imaging showed… Figure 5 The fracture line of the distal radius of the left bone is clear, and no obvious callus formation is seen at the fracture ends, indicating that it is in the stage of a fresh fracture.

[0101] The patient was treated with the herbal ointment of this invention applied externally to the affected area: After 7 days of application, the swelling and pain in the left wrist were reduced; after 15 days of application, the swelling and pain in the left wrist had basically subsided; after one month of continued application, a follow-up DR examination was performed, and the imaging showed... Figure 6 It can be seen that a small amount of new callus has appeared around the fracture ends of the distal radius of the left arm, indicating improved stability of the fracture ends.

[0102] Case 4: Chen, male, 10 years old, fell off his bicycle and injured his right foot. Immediately after the injury, he felt pain and swelling on the dorsum of his right foot and limited foot movement. DR examination diagnosed: fracture of the base of the 2nd, 3rd, and 4th metatarsals of the right foot; the DR image before treatment is shown in Figure 7. The fracture lines of the base of the 2nd, 3rd, and 4th metatarsals of the right foot are clear, and no obvious callus formation is seen at the fracture ends, indicating that it is in the fresh fracture stage.

[0103] The patient was treated with the herbal ointment of this invention applied externally to the affected area: After 7 days of application, the swelling on the dorsum of the right foot subsided; after 15 days of application, the pain and swelling on the dorsum of the right foot were significantly relieved; after one month of continued application, a follow-up DR examination was performed, and the imaging showed... Figure 8 It can be seen that obvious callus growth appears around the fracture ends, and the stability of the fracture ends is improved.

[0104] Case 5: Ms. Tao, female, 65 years old, fell and injured her right wrist while walking. Immediately after the injury, she experienced pain in her right wrist and limited wrist joint movement. DR examination diagnosed a comminuted fracture of the distal radius of the right arm; pre-treatment DR imaging showed… Figure 9 The fracture line of the distal radius of the right bone is clear, and no obvious callus formation is seen at the fracture ends, indicating that it is in the stage of a fresh fracture.

[0105] The patient was treated with the herbal ointment of this invention applied externally to the affected area: after 7 days of application, the swelling and pain in the right wrist were slightly relieved; after 15 days of application, the swelling and pain in the right wrist were significantly reduced; after one month of continued application, a follow-up DR examination was performed, and the imaging showed... Figure 10 It can be seen that a small amount of new callus has appeared around the fracture ends of the distal radius of the right arm, indicating improved stability of the fracture ends.

[0106] Case 6: Mr. Yang, male, 52 years old, slipped and fell while walking, injuring his left wrist. Immediately after the injury, he experienced swelling and pain in his left wrist, and limited wrist joint movement. DR examination diagnosed a comminuted fracture of the distal radius of the left arm; pre-treatment DR imaging showed… Figure 11The fracture line of the distal radius of the left bone is clear, and no obvious callus formation is seen at the fracture ends, indicating that it is in the stage of a fresh fracture.

[0107] The patient was treated with the herbal ointment of this invention applied externally to the affected area: After 7 days of application, the swelling and pain in the patient's left wrist were reduced; after 15 days of application, the swelling and pain had basically subsided; after 30 days of continued application, a follow-up DR examination was performed, and the imaging showed... Figure 12 It can be seen that some new callus has appeared around the fracture ends of the distal radius of the left arm, and the stability of the fracture ends has been improved.

[0108] Case 7: Mr. Chen, male, 42 years old, injured his right finger in a bicycle fall. Immediately after the injury, he experienced pain and limited finger movement in his right middle finger. DR examination diagnosed a fracture of the distal phalanx of the third finger of the right hand. Treatment involved applying the herbal ointment of this invention to the affected area. After 7 days of application, the pain in the patient's right middle finger lessened; after 15 days, the swelling and pain largely subsided; a follow-up DR examination after one month of continued application showed significant callus growth around the fracture ends, indicating improved fracture stability.

[0109] Case 8: Mr. Zhou, male, 44 years old, injured his left ankle when struck by an iron object while lifting heavy objects. Immediately after the injury, he experienced swelling and pain in his left ankle, along with discomfort in ankle joint movement. DR examination revealed no definite fracture, but swelling of the soft tissues around the left ankle. Treatment involved applying the herbal ointment of this invention to the left ankle: after 3 days of application, the swelling and subcutaneous bruising subsided; after 7 days, the swelling and pain lessened; after 15 days, the swelling and pain completely disappeared, and ankle joint movement returned to normal.

[0110] Case 9: Ms. Yang, female, 62 years old, injured her right knee while walking. Immediately after the injury, she experienced pain in her right knee and limited knee joint movement. DR examination showed no definite fracture or dislocation of the right knee joint, but significant soft tissue swelling. Treatment involved applying the herbal ointment of this invention to the affected area: after 3 days of application, the swelling and pain in her right knee were slightly relieved; after 7 days, the swelling and pain were significantly reduced; after 15 days, the swelling and pain completely disappeared, and knee joint movement was unimpeded.

[0111] Case 10: Ms. Jia, 49 years old, injured her left lower leg in a bicycle accident. Immediately after the injury, she experienced pain, swelling, and limited movement in her left lower leg. DR examination revealed no definite fracture of the left tibia and fibula, but soft tissue contusion and swelling around the left tibia and fibula. Treatment involved applying the herbal ointment of this invention to the left lower leg: after 3 days of application, the pain lessened; after 7 days, the swelling and pain subsided; after 15 days, the swelling and pain in the left lower leg completely disappeared, and limb movement returned to normal.

[0112] Clinical applications show that when the herbal ointment of this invention is used to intervene in various closed fractures and mild comminuted fractures, most patients experience significant relief of local swelling and pain within 3 to 7 days, and noticeable callus growth can be seen in about 4 weeks. The improvement in joint stiffness and limited mobility during the rehabilitation period is outstanding, and the overall healing efficiency and limb function recovery are significant.

[0113] The embodiments of the present invention have been described in detail above, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and these variations still fall within the protection scope of the present invention.

[0114] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the described embodiments. For those skilled in the art, various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and these variations still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating fractures, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 30-60 parts of Paris polyphylla, 30-55 parts of Pterocarya stenoptera, 20-40 parts of Corydalis yanhusuo, 15-25 parts of Epimedium, 35-65 parts of Sanfensan, 30-50 parts of Boswellia carterii, 30-50 parts of Commiphora myrrha, 20-35 parts of Huaxuedan, 30-65 parts of Salvia miltiorrhiza, 20-40 parts of Angelica pubescens, 20-35 parts of Clematis chinensis, 15-30 parts of Angelica pubescens, 15-35 parts of Lycopodium clavatum, 15-35 parts of Phyllanthus urinaria, 20-35 parts of Rheum palmatum, 20-35 parts of Rheum palmatum, 15-35 parts of Platinum chinense, and 20-35 parts of Dajiedan.

2. The traditional Chinese medicine composition for treating fractures according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 40-50 parts of Paris polyphylla, 40-50 parts of Pterocarya stenoptera, 25-35 parts of Corydalis yanhusuo, 18-22 parts of Epimedium, 45-55 parts of Sanfensan, 35-45 parts of Boswellia carterii, 35-45 parts of Commiphora myrrha, 25-30 parts of Huaxuedan, 40-55 parts of Salvia miltiorrhiza, 25-35 parts of Angelica pubescens, 25-30 parts of Clematis chinensis, 20-25 parts of Angelica pubescens, 20-30 parts of Lycopodium clavatum, 20-30 parts of Phyllanthus urinaria, 25-30 parts of Rheum palmatum, 25-30 parts of Rheum palmatum, 20-30 parts of Platinum sibiricum, and 25-30 parts of Dajiedan.

3. The traditional Chinese medicine composition for treating fractures according to claim 2, characterized in that, The traditional Chinese medicine composition is made from the following components in parts by weight: 45 parts of Paris polyphylla, 45 parts of Pterocarya stenoptera, 30 parts of Corydalis yanhusuo, 20 parts of Epimedium, 50 parts of Sanfensan, 40 parts of Boswellia carterii, 40 parts of Commiphora myrrha, 25 parts of Huaxuedan, 50 parts of Salvia miltiorrhiza, 30 parts of Angelica pubescens, 25 parts of Clematis chinensis, 20 parts of Angelica pubescens, 25 parts of Lycopodium clavatum, 25 parts of Phyllanthus emblica, 25 parts of Rheum palmatum, 25 parts of Rheum palmatum, 25 parts of Platinum chinense, and 25 parts of Dajiedan.

4. A traditional Chinese medicine composition for treating fractures according to any one of claims 1 to 3, characterized in that, The traditional Chinese medicine composition is prepared into a powder or ointment commonly used in clinical practice by adding pharmaceutically permissible excipients.

5. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: Weigh out the following ingredients by weight: Paris polyphylla, Pterocarya stenoptera, Corydalis yanhusuo, Epimedium, Sanfen San, Frankincense, Myrrh, Huaxue Dan, Salvia miltiorrhiza, Angelica pubescens, Clematis chinensis, Du Ding Zi, Lycopodium clavatum, Ye Shang Hua, Rheum palmatum, Luo De Da, Bai Jin Tiao, and Da Jie Gu Dan. Mix them together, pulverize them, and you will get the final product.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: Weigh out the following ingredients by weight: Paris polyphylla, Pterocarya stenoptera, Corydalis yanhusuo, Epimedium, Sanfen San, Frankincense, Myrrh, Huaxue Dan, Salvia miltiorrhiza, Angelica pubescens, Clematis chinensis, Angelica dahurica, Lycopodium clavatum, Phyllanthus emblica, Rheum palmatum, Rheum palmatum, Platycodon grandiflorus, and Da Jiegu Dan, and prepare them into an ointment.

7. The method for preparing the traditional Chinese medicine composition according to claim 6, characterized in that, The ointment is prepared by decoction, reflux or percolation.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating fractures.

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