External use traditional Chinese medicine composition for promoting fracture healing and preparation method thereof

Abstract

The application discloses a kind of external use of traditional Chinese medicine composition for promoting fracture healing and preparation method thereof, the external use of traditional Chinese medicine composition includes main material and auxiliary material, the raw material of the main material is small braced bone, four blocks of tiles, thousand jin pull, soybean ginger, big drill, through bone, salt skin, eagle not the servant, big braced bone, tianqi, small leaf fig and three money three;The raw material of the auxiliary material is beeswax, sesame oil and vaseline.The method of the application obtains external use of traditional Chinese medicine composition with the advantage of promoting fracture healing, the I phase pain inhibition rate of guinea pig model of local joint swelling and pain after 10-20min of administration is 24.48%, the II phase pain inhibition rate after 20-40min of administration is 38.41%;Guinea pig tibia fracture animal model is formed after 1 month of administration, and some new bone initial formation and obvious formation are obviously formed, and bone mineral density reaches 0.14mg / cm 2 .

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation, specifically to a topical Zhuang medicine composition for promoting fracture healing and its preparation method. Background Technology

[0002] A fracture is the loss of skeletal integrity, usually caused by trauma, accidents, or other diseases. The healing speed of a fracture is often affected by factors such as age, fracture location, fracture type, and fracture severity. Clinically, fracture healing is divided into three stages: hematoma organization, primary callus formation, and callus remodeling. The entire process takes at least three months, which is quite long. Furthermore, the pain at the fracture site can be mentally taxing and affect a patient's recovery. Anti-inflammatory and analgesic medications may also interfere with fracture healing.

[0003] Meanwhile, the local blood stasis at the fracture site and the use of hormones and non-steroidal anti-inflammatory drugs (NSAIDs) hinder the infiltration of inflammatory cells, preventing the formation of granulation tissue and resulting in a long healing period for the fracture site. This causes long-term inconvenience for patients and seriously affects their ability to carry out normal life.

[0004] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide a topical herbal composition that promotes fracture healing, aiming to overcome the shortcomings of local blood stasis at the fracture site hindering fracture healing, and the use of hormones and non-steroidal anti-inflammatory drugs when patients are in pain, which hinder the infiltration of inflammatory cells and result in a long fracture healing period.

[0006] The present invention also aims to provide a method for preparing a topical herbal composition that promotes fracture healing, in order to overcome the long fracture healing period and the significant swelling and pain at the fracture site for a long period of time in fracture patients.

[0007] To achieve the above objectives, the present invention provides a topical Zhuang medicine composition for promoting fracture healing. The topical Zhuang medicine composition includes main ingredients and excipients. The main ingredients are: small bone fragments, four tiles, thousand-pound broom, fermented soybean ginger, big drill, bone-penetrating herb, sumac, eagle-not-pounce, large bone fragments, tianqi, small-leaved banyan, and three-qian-three.

[0008] Preferably, in the above technical solution, the raw materials of the auxiliary materials are beeswax, sesame oil and petrolatum.

[0009] Preferably, in the above technical solution, the raw materials of the auxiliary materials are, by weight fraction, 250-700 parts beeswax, 35-80 parts sesame oil and 200-500 parts petroleum jelly.

[0010] Preferably, in the above technical solution, the main ingredients, by weight, are: 30-70 parts of small bone, 30-70 parts of four-piece tile, 25-60 parts of thousand-pound broom, 25-60 parts of fermented black bean ginger, 20-50 parts of large drill, 20-50 parts of bone-penetrating herb, 20-50 parts of sumac, 20-50 parts of eagle-not-pounce, 15-40 parts of large bone, 15-40 parts of ginseng, 10-30 parts of small-leaved banyan, and 10-30 parts of three-qian-three.

[0011] Preferably, in the above technical solution, the main ingredients, by weight, are: 50 parts of small bone, 50 parts of four-piece tile, 40 parts of thousand-pound broom, 40 parts of fermented black bean ginger, 30 parts of large drill, 30 parts of bone-penetrating herb, 30 parts of sumac, 30 parts of eagle-not-pounce, 25 parts of large bone, 25 parts of ginseng, 20 parts of small-leaved banyan, and 20 parts of three-qian-three.

[0012] Four-piece tile: It has a pungent and bitter taste and is warm in nature. In traditional Chinese medicine, four-piece tile has the effects of dispelling wind and dampness, promoting blood circulation and removing blood stasis. It can clear local blood stasis, promote local blood circulation, and activate blood at the fracture site. When heated at a temperature of 75-85℃, it can promote the release of its effective components such as Paris polyphylla glycoside and flavonoids into the sesame oil. In external Zhuang medicine compositions, it can play the role of dispelling wind and dampness, promoting blood circulation and removing blood stasis.

[0013] Fermented black bean ginger: The root of Litsea cubeba, a plant in the Lauraceae family. When fermented black bean ginger is heated at a temperature of 75-85℃, its active ingredients are fully released into the sesame oil. It has the effects of dispelling wind, cold, and dampness, warming the middle jiao, regulating qi, and relieving pain.

[0014] Large Diamond: Schisandra chinensis, family Schisandraceae Kadsura coccinea The dried root and stem of *Lem.* AC Smith plant. It has a pungent, slightly bitter taste and is warm in nature. It possesses the functions of promoting qi circulation and relieving pain, dispelling wind and activating blood circulation, and dispersing blood stasis and reducing swelling.

[0015] Touguxiao: It has a pungent and slightly bitter taste, and is slightly cold in nature; it enters the liver, kidney, and bladder meridians. It is effective for treating sores, carbuncles, swelling, and injuries from falls and blows.

[0016] Rhus chinensis: a plant belonging to the Anacardiaceae family, Rhus chinensis. Rhus chinensis Mill. The dried root has the effects of clearing heat and detoxifying, dispersing blood stasis and stopping bleeding.

[0017] Eagle Does Not Pounce: The dried root of Aralia elata, a plant in the Araliaceae family, has a bitter and pungent taste and is neutral in nature; it enters the liver and stomach meridians. It is used to treat traumatic injuries and rheumatic pain.

[0018] Ficus microcarpa: The dried root of Ficus microcarpa (family Moraceae), slightly bitter in taste and neutral in nature; it enters the lung and large intestine meridians. It has the effects of clearing heat and detoxifying, dispelling dampness and cold.

[0019] Sanqian San: Dried flowers of Rhododendron molle, a plant in the Ericaceae family. It has the effects of dispelling wind and dampness, promoting blood circulation and removing blood stasis.

[0020] To achieve the above objectives, the present invention also provides a method for preparing the topical medicated composition for promoting fracture healing as described above, the method comprising the following steps:

[0021] Weigh out the following ingredients in the predetermined amounts: small bone, four tiles, thousand-pound broom, fermented black bean ginger, big drill, bone-penetrating herb, sumac, eagle-not-pouncing, large bone, tianqi, small-leaf banyan or three qian three main ingredients; weigh out the following ingredients in the predetermined amounts: beeswax, sesame oil and petroleum jelly.

[0022] The main ingredient is baked and dried, then ground into a fine powder. The auxiliary ingredients are added to the ground main ingredient and heated and stirred in a high-pressure furnace. After natural cooling, a topical medicated composition that promotes fracture healing is obtained.

[0023] Preferably, in the above technical solution, by weight, the main ingredients are 30-70 parts of small bone, 30-70 parts of four-piece tile, 25-60 parts of thousand-pound broom, 25-60 parts of fermented black bean ginger, 20-50 parts of large drill, 20-50 parts of bone-penetrating herb, 20-50 parts of sumac, 20-50 parts of eagle-not-pounce, 15-40 parts of large bone, 15-40 parts of ginseng, 10-30 parts of small-leaved banyan, and 10-30 parts of three-qian-three; the auxiliary ingredients are 250-700 parts of beeswax, 35-80 parts of sesame oil, and 200-500 parts of petroleum jelly.

[0024] Preferably, in the above technical solution, the baking temperature of the main ingredient is set to 50-60℃ and the baking time is 3-5 hours.

[0025] Preferably, in the above technical solution, the particle size of the fine powder is 200-250 mesh.

[0026] Preferably, in the above technical solution, the working temperature of the high-pressure furnace is set to 75-85℃, the stirring speed is set to 250-350 rpm, and the time is set to 5-7 h.

[0027] According to the above technical solution, the main ingredients are first baked at 50-60℃ for 3-5 hours to destroy the tissue structure and cell structure of the medicinal materials. Then, the cell walls of the main ingredients are broken by stirring and heating for a long time, so that the effective components are released and dissolved in the excipient sesame oil. This increases the solubility of the effective components of each main ingredient in the excipient, and enhances the local penetration of the released effective components to the application point during the use of the external Zhuang medicine composition, thereby exerting the efficacy of the external Zhuang medicine composition.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The external application herbal composition of this invention has the effect of promoting fracture healing. Its principle is as follows: First, during preparation, the tissue structure of the medicinal materials is destroyed through baking, grinding, stirring, and heating to promote the release and even mixing of effective components. Second, it is closely related to the pharmacological effects of the main ingredients, including *Xiao Bo Gu*, *Si Kuai Wa*, *Qian Jin Ba*, *Dou Chi Jiang*, *Da Zuan*, *Tou Gu Xiao*, and *Yan Fu Mu*. Among these, *Qian Jin Ba*, *Si Kuai Wa*, *Da Zuan*, *Tou Gu Xiao*, *Yan Fu Mu*, *Tian Qi*, and *San Qian San* have the effects of promoting blood circulation and removing blood stasis. They can clear local blood stasis caused by blood clots formed at the fracture site, alleviate capillary hyperplasia and dilation caused by blood stasis, and simultaneously activate vascular endothelial cells at the fracture site, promoting inflammatory cell infiltration and clearing damage or... Necrotic cells and tissues are eliminated, accelerating the formation of granulation tissue. Granulation tissue is an important process in the synthesis of fibroblasts. Fiber cells transform into fibrous connective tissue, which wraps around the fracture ends, allowing the bones at the fracture ends to align parallel to each other. Combined with the stimulation of osteoblasts in the periosteum near the fracture ends by stimulating the proliferation and differentiation of osteoblasts, a thickened bone-like structure parallel to the bone shaft is formed and extended, thereby promoting fracture healing. At the same time, the main ingredients, such as Qianjinba, Touguxiao, fermented soybean and ginger, and yingbupu, have sedative and analgesic effects, relieving pain caused by congestion at the fracture ends. This reduces the need for patients to take hormones and non-steroidal anti-inflammatory drugs (NSAIDs), avoiding these anti-inflammatory drugs from hindering the infiltration of inflammatory cells and delaying fracture healing. Detailed Implementation

[0030] The specific embodiments of the present invention will be described in detail below with reference to specific examples, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. Example 1

[0031] A topical herbal composition for promoting fracture healing, comprising main ingredients and excipients, wherein the main ingredients are: 50 parts of *Small Bones*, 50 parts of *Four-Piece Tile*, 40 parts of *Thousand-Jin-Ba*, 40 parts of fermented black soybean and ginger, 30 parts of *Big Drill*, 30 parts of *Penetrating Bone-Clearing*, 30 parts of *Rhus chinensis*, 30 parts of *Eagle-Not-Pounce*, 25 parts of *Large Bones*, 25 parts of *Panax notoginseng*, 20 parts of *Ficus microcarpa*, and 20 parts of *Sanqian San*; the excipients are: 450 parts of beeswax, 55 parts of sesame oil, and 350 parts of petroleum jelly.

[0032] A method for preparing a topical herbal composition for promoting fracture healing, the method comprising the following steps:

[0033] (1) Weigh out 50 parts of small bone, 50 parts of four tiles, 40 parts of thousand-pound broom, 40 parts of fermented black bean ginger, 30 parts of big drill, 30 parts of bone-penetrating agent, 30 parts of sumac, 30 parts of eagle-not-pounce, 25 parts of large bone, 25 parts of ginseng, 20 parts of small-leaf banyan and 20 parts of three-qian-three as main ingredients, and weigh out 450 parts of beeswax, 55 parts of sesame oil and 350 parts of petroleum jelly as auxiliary ingredients.

[0034] (2) The main ingredients are baked at 55°C for 4 hours to dry them, and then ground into a fine powder with a mesh size of 200. The fine powder is added to a high-pressure furnace containing 450 parts beeswax, 55 parts sesame oil and 350 parts petroleum jelly, and heated and stirred for 6 hours. After natural cooling, a topical medicated composition for promoting fracture healing is obtained. The working temperature of the high-pressure furnace is 80°C and the stirring speed is 300 rpm.

[0035] Example 2

[0036] A topical herbal composition for promoting fracture healing, comprising main ingredients and excipients, wherein the main ingredients are 30 parts of *Small Bones*, 30 parts of *Four-Piece Tile*, 25 parts of *Thousand-Jin-Ba*, 25 parts of fermented black soybean and ginger, 20 parts of *Big Drill*, 20 parts of *Penetrating Bone-Clearing*, 20 parts of *Rhus chinensis*, 20 parts of *Eagle-Not-Pounce*, 15 parts of *Large Bones*, 15 parts of *Panax notoginseng*, 10 parts of *Ficus microcarpa*, and 10 parts of *Sanqian San*; the excipients are 250 parts of beeswax, 35 parts of sesame oil, and 200 parts of petroleum jelly.

[0037] A method for preparing a topical herbal composition for promoting fracture healing, the method comprising the following steps:

[0038] (1) Weigh out 30 parts of small bone, 30 parts of four tiles, 25 parts of thousand-pound bar, 25 parts of fermented black bean ginger, 20 parts of big drill, 20 parts of bone-penetrating agent, 20 parts of sumac, 20 parts of eagle-not-pounce, 15 parts of large bone, 15 parts of ginseng, 10 parts of small leaf banyan and 10 parts of three qian three as main ingredients, and weigh out 250 parts of beeswax, 35 parts of sesame oil and 200 parts of petroleum jelly as auxiliary ingredients.

[0039] (2) The main ingredients are baked at 50°C for 3 hours to dry them, and then ground into a fine powder with a mesh size of 200. The fine powder is added to a high-pressure furnace containing 250 parts beeswax, 35 parts sesame oil and 200 parts petroleum jelly, and heated and stirred for 5 hours. After natural cooling, a topical medicated composition for promoting fracture healing is obtained. The working temperature of the high-pressure furnace is 85°C and the stirring speed is 250 rpm.

[0040] Example 3

[0041] A topical herbal composition for promoting fracture healing, comprising main ingredients and excipients, wherein the main ingredients are 70 parts of *Small Bones*, 70 parts of *Four-Piece Tile*, 60 parts of *Thousand-Jin-Ba*, 60 parts of fermented black soybean and ginger, 50 parts of *Big Drill*, 50 parts of *Penetrating Bone-Clearing*, 50 parts of *Rhus chinensis*, 50 parts of *Eagle-Not-Pounce*, 40 parts of *Large Bones*, 40 parts of *Panax notoginseng*, 30 parts of *Ficus microcarpa*, and 30 parts of *Sanqian San*; the excipients are 700 parts of beeswax, 80 parts of sesame oil, and 500 parts of petroleum jelly.

[0042] A method for preparing a topical herbal composition for promoting fracture healing, the method comprising the following steps:

[0043] (1) Weigh out 70 parts of small bone, 70 parts of four tiles, 60 parts of thousand-pound bar, 60 parts of fermented soybean and ginger, 50 parts of big drill, 50 parts of bone-penetrating agent, 50 parts of sumac, 50 parts of eagle-not-pounce, 40 parts of large bone, 40 parts of ginseng, 30 parts of small-leaf banyan and 30 parts of three qian three as main ingredients, and weigh out 700 parts of beeswax, 80 parts of sesame oil and 500 parts of petroleum jelly as auxiliary ingredients.

[0044] (2) The main ingredients are baked at 55°C for 4 hours to dry them, and then ground into a fine powder with a mesh size of 250. The fine powder is added to a high-pressure furnace containing 700 parts beeswax, 80 parts sesame oil and 500 parts petroleum jelly and heated and stirred for 6 hours. After natural cooling, a topical medicated composition for promoting fracture healing is obtained. The working temperature of the high-pressure furnace is 80°C and the stirring speed is 300 rpm.

[0045] Example 4

[0046] A topical herbal composition for promoting fracture healing, comprising main ingredients and excipients, wherein the main ingredients are: 50 parts of *Small Bones*, 50 parts of *Four-Piece Tile*, 40 parts of *Thousand-Jin-Ba*, 40 parts of fermented black soybean and ginger, 30 parts of *Big Drill*, 30 parts of *Penetrating Bone-Clearing*, 30 parts of *Rhus chinensis*, 30 parts of *Eagle-Not-Pounce*, 25 parts of *Large Bones*, 25 parts of *Panax notoginseng*, 20 parts of *Ficus microcarpa*, and 20 parts of *Sanqian San*; the excipients are: 500 parts of beeswax, 60 parts of sesame oil, and 400 parts of petroleum jelly.

[0047] A method for preparing a topical herbal composition for promoting fracture healing, the method comprising the following steps:

[0048] (1) Weigh out 50 parts of small bone, 50 parts of four tiles, 40 parts of thousand-pound bar, 40 parts of fermented soybean and ginger, 30 parts of large drill, 30 parts of bone-penetrating agent, 30 parts of sumac, 30 parts of eagle-not-pounce, 25 parts of large bone, 25 parts of ginseng, 20 parts of small-leaf banyan and 20 parts of three-qian-three as main ingredients, and weigh out 500 parts of beeswax, 60 parts of sesame oil and 400 parts of petroleum jelly as auxiliary ingredients.

[0049] (2) The main ingredients are baked at 60°C for 5 hours to dry them, and then ground into a fine powder with a mesh size of 200. The fine powder is added to a high-pressure furnace containing 500 parts beeswax, 60 parts sesame oil and 400 parts petroleum jelly, and heated and stirred for 7 hours. After natural cooling, a topical medicated composition for promoting fracture healing is obtained. The working temperature of the high-pressure furnace is 75°C and the stirring speed is 350 rpm.

[0050] Example 5

[0051] An external Zhuang medicine composition for promoting fracture healing, the external Zhuang medicine composition includes main ingredients and auxiliary ingredients. Calculated by weight parts, the raw materials of the main ingredients are 60 parts of Gendarussa vulgaris, 60 parts of Chloranthus serratus, 50 parts of Flemingia philippinensis, 50 parts of Alpinia galanga, 50 parts of Kadsura coccinea, 40 parts of Glechoma longituba, 40 parts of Rhus chinensis, 40 parts of Sparganium stoloniferum, 30 parts of Gendarussa macrostachya, 30 parts of Panax notoginseng, 25 parts of Ficus microcarpa, and 25 parts of Aristolochia fangchi; the raw materials of the auxiliary ingredients are 600 parts of beeswax, 70 parts of sesame oil, and 400 parts of vaseline;

[0052] A preparation method of an external Zhuang medicine composition for promoting fracture healing, the method includes the following steps:

[0053] (1) Weigh 60 parts of Gendarussa vulgaris, 60 parts of Chloranthus serratus, 50 parts of Flemingia philippinensis, 50 parts of Alpinia galanga, 50 parts of Kadsura coccinea, 40 parts of Glechoma longituba, 40 parts of Rhus chinensis, 40 parts of Sparganium stoloniferum, 30 parts of Gendarussa macrostachya, 30 parts of Panax notoginseng, 25 parts of Ficus microcarpa, and 25 parts of Aristolochia fangchi as the main ingredients respectively, and weigh 600 parts of beeswax, 70 parts of sesame oil, and 400 parts of vaseline as the auxiliary ingredients respectively;

[0054] Bake the main ingredients at 60 °C for 3 h to make them dry, grind them into fine powder with a mesh size of 200 meshes, add the fine powder into a high-pressure furnace containing 600 parts of beeswax, 70 parts of sesame oil, and 400 parts of vaseline, heat and stir for 7 h, and then cool naturally to obtain the external Zhuang medicine composition for promoting fracture healing; wherein, the working temperature of the high-pressure furnace is 75 °C, and the stirring speed is 250 revolutions per hour.

[0055] Example 6

[0056] An external Zhuang medicine composition for promoting fracture healing, the external Zhuang medicine composition includes main ingredients and auxiliary ingredients. Calculated by weight parts, the raw materials of the main ingredients are 40 parts of Gendarussa vulgaris, 40 parts of Chloranthus serratus, 35 parts of Flemingia philippinensis, 35 parts of Alpinia galanga, 40 parts of Kadsura coccinea, 40 parts of Glechoma longituba, 40 parts of Rhus chinensis, 40 parts of Sparganium stoloniferum, 20 parts of Gendarussa macrostachya, 20 parts of Panax notoginseng, 15 parts of Ficus microcarpa, and 15 parts of Aristolochia fangchi; the raw materials of the auxiliary ingredients are 300 parts of beeswax, 40 parts of sesame oil, and 300 parts of vaseline;

[0057] A preparation method of an external Zhuang medicine composition for promoting fracture healing, the method includes the following steps:

[0058] (1) Weigh 40 parts of Gendarussa vulgaris, 40 parts of Chloranthus serratus, 35 parts of Flemingia philippinensis, 35 parts of Alpinia galanga, 40 parts of Kadsura coccinea, 40 parts of Glechoma longituba, 40 parts of Rhus chinensis, 40 parts of Sparganium stoloniferum, 20 parts of Gendarussa macrostachya, 20 parts of Panax notoginseng, 15 parts of Ficus microcarpa, and 15 parts of Aristolochia fangchi as the main ingredients respectively, and weigh 300 parts of beeswax, 40 parts of sesame oil, and 300 parts of vaseline as the auxiliary ingredients respectively;

[0059] (2) The main ingredients are baked at 60°C for 5 hours to dry them, and then ground into a fine powder with a mesh size of 200. The fine powder is added to a high-pressure furnace containing 300 parts beeswax, 40 parts sesame oil and 300 parts petroleum jelly, and heated and stirred for 7 hours. After natural cooling, a topical medicated composition for promoting fracture healing is obtained. The working temperature of the high-pressure furnace is 80°C and the stirring speed is 250 rpm.

[0060] Comparative Example 1

[0061] It is basically the same as Example 1, except that the main ingredients are missing four tiles and small-leaf banyan.

[0062] Comparative Example 2

[0063] It is basically the same as Example 1, except that the main ingredients are missing four tiles, bone-penetrating medicine, fermented black beans and ginger.

[0064] Comparative Example 3

[0065] The method is basically the same as in Example 1, except that the main ingredients are missing fermented black beans and ginger, clematis root extract and sumac.

[0066] Comparative Example 4

[0067] It is basically the same as Example 1, except that the main ingredients are missing the ingredients of Touguxiao, Douchi Jiang and Sanqian San.

[0068] Comparative Example 5

[0069] It is basically the same as Example 1, except that the main ingredients are missing Dazuan, Touguxiao and Douchijiang.

[0070] Comparative Example 6

[0071] It is basically the same as Example 1, except that the main ingredients are missing from the ingredients of Touguxiao, Yingbupu and Douchi Jiang.

[0072] Comparative Example 7

[0073] It is basically the same as Example 1, except that the main ingredients are missing from the ingredients list: bone-penetrating agent, four tiles, and large drill.

[0074] Mouse pain experiment

[0075] Experimental subjects: SPF-grade guinea pigs were used, and 50 μL of 4% formalin solution was injected subcutaneously into the right hind leg ankle of the guinea pigs. If swelling was observed at the injection site 2-4 hours after injection, the local joint swelling and pain model was successfully established. 45 guinea pigs with local joint swelling and pain model were obtained.

[0076] Forty-five guinea pigs with local joint swelling and pain were randomly divided into nine groups of five each. One group served as a blank control group with a medicated patch coated with petroleum jelly. The other groups were treated with the medicated patches prepared in Example 1 and Comparative Examples 1-7, respectively, applied to the right hind leg ankle. The pain response of the guinea pigs was observed 10-20 min (phase I) and 20-40 min (phase II) after application. The pain response scores of the guinea pigs were as follows: (1) 3 points: the guinea pig licked or bit the right hind leg and shook its foot; (2) 2 points: the guinea pig lifted its right leg; (3) 1 point: the guinea pig limped when lightly touching the ground but not bearing weight; (4) 0 points: normal weight-bearing and walking freely. Record the number of seconds of each of the above-mentioned levels of reaction in each time period, multiply by the corresponding reaction score, and use the sum of the products as the cumulative pain response score. The formula is: Cumulative pain response score = Limping time × 1 + Foot lifting time × 2 + Licking, biting or shaking time × 3. After 40 minutes of drug administration, the pain inhibition rate is calculated as follows: Pain inhibition rate (%) = (Mean pain response of blank control group − Mean pain response of drug administration group) / Mean pain response of blank control group × 100%.

[0077] Table 1. Cumulative pain response score and pain inhibition rate of mice in each group at 10-20 min and 20-40 min.

[0078]

[0079] As shown in Table 1, the topical herbal composition prepared using Example 1 of the present invention exhibits a higher pain inhibition rate compared to Comparative Example 1. This indicates that the *Symplocos cuspidata* and *Ficus microcarpa* in the formula alleviate or improve pain caused by capillary dilation or rupture by clearing local blood stasis caused by formalin. Compared to Comparative Example 2, the *Symplocos cuspidata*, *Touguxiao*, and fermented soybean ginger in the formula have the effects of promoting blood circulation, calming the nerves, and relieving pain. The *Symplocos cuspidata* and *Touguxiao* promote blood circulation to clear blood stasis and resolve the swelling and poor blood flow caused by formalin, which stimulates pain receptors. Combined with *Touguxiao* and fermented soybean ginger, they reduce the sensitivity of pain receptors, thereby achieving the effect of inhibiting pain. Compared to Comparative Example 3, the *Fermented soybean ginger*, *Touguxiao*, and *Rhus chinensis* in the formula have the effects of promoting blood circulation and calming the nerves. *Touguxiao* and *Rhus chinensis* work together to activate vascular endothelial cells around the formalin injection site and promote the infiltration of inflammatory cells into *Fermented soybean ginger* and *Touguxiao*. The pain response was reduced, achieving analgesia. Compared with Comparative Example 4, it was shown that the blood-activating and stasis-removing effects of Touguxiao, Douchijiang, and Sanqiansan could also alleviate formalin-induced pain. Compared with Comparative Example 5, the addition of Dazuan, Touguxiao, and Douchijiang, through the combination of blood-activating and stasis-removing effects and sedation and analgesia, had a better analgesic effect on the local joint swelling and pain guinea pig model. Compared with Comparative Example 6, the addition of Touguxiao, Yingbupu, and Douchijiang in Example 1 had a better analgesic effect on the local joint swelling and pain guinea pig model in phases I and II. Compared with Comparative Example 7, the addition of Touguxiao, Sikuawa, and Dazuan had a better analgesic effect. However, compared with Comparative Example 5, Comparative Example 7 had a lower pain inhibition rate in phase I relative to Comparative Example 5, but a lower pain inhibition rate in phase II relative to Comparative Example 7. This may be because Dazuan, Touguxiao, and Douchijiang have a better inhibitory effect on acute pain, but a poorer effect on inhibiting the activation of dorsal horn neurons.

[0080] II. Mouse Fracture Experiment

[0081] Tibial fracture animal model: SPF-grade guinea pigs were fixed in a supine position on the operating table. The guinea pigs were anesthetized by intraperitoneal injection of 0.8% sodium pentobarbital or azithromycin. The right tibia was prepared, and the surgical site was disinfected with alcohol. A longitudinal incision of about 1 cm was made along the medial side of the right knee joint, reaching the periosteum and then dissecting the periosteum. The guinea pig tibia was sawn off, and the surgical incision was rinsed with a large amount of physiological saline. The muscles and skin were sutured layer by layer with 2-0 silk sutures. The wound was treated locally with cefazolin sodium pentahydrate powder to prevent infection and bandaged with sterile dressings. The guinea pig tibial fracture animal model was considered successfully established when the wound healed without bleeding and infection. 27 guinea pig tibial fracture animal models were obtained and randomly divided into 9 groups, with 3 guinea pigs in each group. In the blank control group, a medicated patch made solely of petroleum jelly was applied to the fracture ends of the guinea pig tibial fracture animal model. In the other groups, the traditional Chinese medicine compositions prepared according to the methods of Example 1 and Comparative Examples 1-7 were applied to the fracture ends of the guinea pig tibial fracture animal models for 2 weeks. X-ray films were taken 2 weeks after the application to detect the bone healing at the fracture ends of the guinea pigs and to detect bone mineral density (BMD) by dual-energy X-ray absorptiometry. The evaluation rules for bone healing were as follows: (1) 0 points: no bridging; (2) 1 point: no callus formation; (3) 2 points: a small amount of callus formation; (4) 3 points: initial and obvious formation of new bone. The method for detecting bone mineral density by dual-energy X-ray absorptiometry was to scan the right hind limb tibia using a dual-energy X-ray bone mineral density detector, with the distance from the midpoint of the tibia set to 0.8 cm. 2 ×1.0cm 2 A rectangular area was scanned with accuracy, scanning speed, resolution, and scanning width parameters of 0.01%, 60 mm / s, 1.0 mm × 1.0 mm, and 5 cm, respectively. The scans were performed three times consecutively, and the average value was taken.

[0082] Table 2

[0083] Bone healing evaluation <![CDATA[Dual-energy X-ray absorptiometry for detecting bone mineral density (mg / cm 2 ).]]> Blank control group 0.33±0.09 0.09±0.01 Example 1 2.67±0.16 0.14±0.01 Comparative Example 1 2.00±0.13 0.12±0.02 Comparative Example 2 2.00±0.16 0.12±0.02 Comparative Example 3 1.33±0.14 0.11±0.02 Comparative Example 4 2.00±0.15 0.12±0.01 Comparative Example 5 1.67±0.12 0.11±0.01 Comparative Example 6 2.33±0.09 0.14±0.02 Comparative Example 7 1.33±0.16 0.11±0.01

[0084] As shown in Table 2, the topical herbal composition obtained in Example 1 using the method of the present invention showed higher bone healing and bone mineral density compared to Comparative Example 1. This indicates that the combination of *Symplocos sipatica* and *Ficus microcarpa* in the formula can alleviate or improve capillary proliferation and dilation at the fracture site of tibial fractures in guinea pigs, activate vascular endothelial cells at the fracture site, and improve the bone healing speed. Compared to Comparative Examples 2-4, it shows that the combination of *Touguxiao*, *Douchi Jiang*, and *Sanqian San*, *Symplocos sipatica*, or *Dazuan* in the formula all have the effect of improving bone mineral density, promoting bone health, and accelerating bone healing, with similar effects. Compared to Comparative Example 3, it shows that *Douchi Jiang*, *Touguxiao*, and *Rhus chinensis* in the formula have a significant promoting effect on callus and new bone at the fracture site. Compared to Comparative Example 6, it shows that *Touguxiao*, *Yingbupu*, and *Douchi Jiang* have a lower effect on promoting bone healing and bone mineral density. Compared to Comparative Example 7, the addition of *Touguxiao*, *Symplocos sipatica*, and *Dazuan* has a better effect on promoting bone healing.

[0085] The foregoing description of specific exemplary embodiments of the invention is for illustrative and explanatory purposes. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made in accordance with the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A topical herbal composition for promoting fracture healing, characterized in that, The external application of the herbal medicine composition includes main ingredients and excipients. The main ingredients are 30-70 parts of small bone fragments, 30-70 parts of four-piece tile, 25-60 parts of thousand-pound broom, 25-60 parts of fermented black soybean and ginger, 20-50 parts of large drill, 20-50 parts of bone-penetrating herb, 20-50 parts of sumac, 20-50 parts of eagle-not-pounce, 15-40 parts of large bone fragments, 15-40 parts of ginseng, 10-30 parts of small-leaved banyan, and 10-30 parts of three-qian-three. The excipients are 250-700 parts of beeswax, 35-80 parts of sesame oil, and 200-500 parts of petroleum jelly.

2. The topical medicated composition for promoting fracture healing according to claim 1, characterized in that, The main ingredients, by weight, are: 50 parts of small bone fragments, 50 parts of four-piece tile, 40 parts of thousand-pound broom, 40 parts of fermented black soybean and ginger, 30 parts of large drill, 30 parts of bone-penetrating herb, 30 parts of sumac, 30 parts of eagle-not-pounce, 25 parts of large bone fragments, 25 parts of ginseng, 20 parts of small-leaved banyan, and 20 parts of three-qian-three.

3. A method for preparing a topical herbal composition for promoting fracture healing as described in any one of claims 1-2, characterized in that, The method includes the following steps: (1) Weigh out the following ingredients respectively: small bone, four tiles, thousand-pound bar, fermented black ginger, big drill, bone-penetrating medicine, sumac, eagle-not-pounce, big bone, tianqi, small-leaf banyan and three qian three main ingredients; weigh out the following ingredients respectively: beeswax, sesame oil and petroleum jelly. (2) The main ingredients are baked and dried, ground into fine powder, and the excipients are added to the fine powder. The mixture is heated and stirred in a high-pressure furnace and then cooled naturally to obtain a topical medicated composition that promotes fracture healing.

4. The method for preparing the topical herbal composition for promoting fracture healing according to claim 3, characterized in that, The baking and drying of the main ingredients is set at a baking temperature of 50-60℃ and a baking time of 3-5 hours.

5. The method for preparing the topical herbal composition for promoting fracture healing according to claim 3, characterized in that, The fine powder has a particle size of 200-250 mesh.

6. The method for preparing the topical herbal composition for promoting fracture healing according to claim 3, characterized in that, The operating temperature of the high-pressure furnace is set to 75-85℃, the stirring speed is set to 250-350 rpm, and the time is set to 5-7 h.

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