Traditional Chinese medicine composition for early stage and middle stage of bone fracture as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for early and middle stages of bone fracture, a preparation method and application. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 25 to 75 parts of radix salviae miltiorrhizae, 12 to 38 parts of flos carthami, 8 to 25 parts of dragon's blood, 10 to 30 parts of radix paeoniae rubra, 25 to 75 parts of radix angelicae pubescentis, 15 to 45 parts of rhizoma corydalis, 12 to 38 parts of rhizoma seu radix notopterygii, 12 to 38 parts of radix angelicae, 10 to 30 parts of rhizoma arisaematis, 25 to 75 parts of rhizoma sparganii, 12 to 38 parts of rhizoma curcumae, 10 to 30 parts of pericarpium citri reticulatae viride, 10 to 30 parts of pericarpium citri reticulatae, 10 to 30 parts of radix aucklandiae, 25 to 75 parts of polyporus umbellatus, 15 to 45 parts of fructus liquidambaris, 12 to 38 parts of cortex phellodendri, 12 to 38 parts of rhizoma atractylodis, the traditional Chinese medicine is prepared from 12-38 parts of radix trichosanthis, 25-75 parts of fructus kochiae, 15-45 parts of fructus cnidii, 12-38 parts of radix dipsaci, 12-38 parts of rhizoma drynariae and 5-20 parts of radix glycyrrhizae. The traditional Chinese medicine composition can promote blood circulation, stop bleeding, relieve swelling and pain, remove blood stasis, promote the circulation of qi, clear away heat, remove dampness and reunion fractures and tendons in the new injury period, and meanwhile is resistant to allergy and high in safety.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for early and middle stages of bone injuries, a preparation method and application thereof. Background Art

[0002] Fractures, dislocations and tendon injuries are common diseases in orthopedics. Traditional Chinese medicine divides bone injuries into three stages (early, middle and late stages), emphasizing the dynamic adjustment of "stage-based treatment", namely, early blood circulation and blood stasis removal, middle-stage bone and tendon connection, and late-stage liver and kidney nourishment.

[0003] In the early stage of bone injury (immediately to 2 weeks after injury, corresponding to the acute stage in modern medicine), its pathological characteristics are qi stagnation and blood stasis, with local manifestations of redness, swelling, heat, pain, and functional disorders. The treatment is mainly to promote qi and blood circulation, reduce swelling and relieve pain; in the middle stage of bone injury (about 2 to 4 weeks after injury, corresponding to the subacute stage in modern medicine), its pathological characteristics are that blood stasis gradually dissipates, qi and blood begin to recover, swelling is reduced but there is still stiffness and adhesion. The treatment principle is mainly to relax muscles and tendons, activate collaterals, and connect tendons and bones; in the late stage of bone injury (more than 4 weeks after injury, corresponding to the chronic stage in modern medicine), its pathological characteristics are that blood stasis has been removed, but the tendons and bones are not strong, or accompanied by qi and blood deficiency, liver and kidney deficiency, and the treatment principle is mainly to nourish the liver and kidney, and strengthen the tendons and bones.

[0004] The existing Chinese herbal compound prescriptions are mostly designed for a single stage. In the fresh stage of bone injury, they mainly emphasize the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain. It is often overlooked that the fresh stage is also a window period for solving the problems of "stagnation of qi and dampness, and internal accumulation of damp heat". In addition, in the fresh stage of bone injury, it is more necessary to consider the anti-allergic compatibility of external medicines. At present, the allergy rate of traditional external bone injury powders that have not undergone anti-allergic compatibility can reach more than 20%, and there will be side effects of varying degrees, which have a great impact on the recovery of bone injuries in the early and middle stages. Summary of the Invention

[0005] To address the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition, preparation method, and application for early and mid-stage bone injuries. In addition to promoting blood circulation and stopping bleeding, reducing swelling and relieving pain in the fresh injury stage, the traditional Chinese medicine composition can also dissipate blood stasis, promote qi circulation, clear away heat and dampness, and strengthen bones and tendons. It is also anti-allergic and highly safe.

[0006] To achieve the above object, the present invention adopts the following technical solutions: In a first aspect, the present invention provides a traditional Chinese medicine composition for early and middle stages of bone injuries, wherein the components of the traditional Chinese medicine composition are calculated by weight as follows: 25-75 parts of salvia miltiorrhiza, 12-38 parts of safflower, 8-25 parts of blood clotting agent, 10-30 parts of red peony root, 25-75 parts of angelica dahurica, 15-45 parts of corydalis yanhusuo, 12-38 parts of notopterygium wilfordii, 12-38 parts of angelica dahurica, 10-30 parts of raw arisaema, 25-75 parts of trillium, 12-38 parts of zedoaria, 10-30 parts of green peel, and 10-30 parts of dried tangerine peel. 10-30 parts of costus root, 25-75 parts of umbellatus, 15-45 parts of liquidambar formosana, 12-38 parts of phellodendron, 12-38 parts of atractylodes, 10-30 parts of californica, 25-75 parts of dandelions, 12-38 parts of scutellaria, 15-45 parts of honeysuckle, 15-45 parts of viola yedoensis, 12-38 parts of raw rhubarb, 12-38 parts of root of trichosanthes, 25-75 parts of kochia scoparia, 15-45 parts of cnidium monnieri, 12-38 parts of dipsera, 12-38 parts of drynaria rhizome, and 5-20 parts of liquorice.

[0007] Preferably, the components of the traditional Chinese medicine composition are calculated by weight as follows: 50 parts of salvia miltiorrhiza, 25 parts of safflower, 15 parts of blood clovers, 20 parts of red peony root, 50 parts of angelica dahurica, 30 parts of corydalis yanhusuo, 25 parts of notopterygium wilfordii, 25 parts of angelica dahurica, 20 parts of raw arisaema, 50 parts of trillium, 25 parts of zedoaria, 20 parts of green peel, 20 parts of dried tangerine peel, 20 parts of costus root, 50 parts of umbellata, 30 parts of rhubarb, 25 parts of phellodendron, 25 parts of atractylodes, 20 parts of chuanmutong, 50 parts of dandelion, 35 parts of scutellaria, 30 parts of honeysuckle, 30 parts of viola yedoensis, 25 parts of raw rhubarb, 25 parts of trichosanthes root, 50 parts of kochia scoparia, 30 parts of cnidium monnieri, 25 parts of dipsaccharum officinale, 25 parts of drynaria rhizome, and 10 parts of liquorice.

[0008] In a second aspect, the present invention provides a traditional Chinese medicine preparation for early and middle stages of bone injuries, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0009] Preferably, the dosage form of the Chinese medicine preparation is any one of powder or plaster.

[0010] In a third aspect, the present invention provides a method for preparing a Chinese medicine composition for early and middle stages of bone injuries, comprising any one of the following four methods: (1) The above components are crushed separately and then mixed; (2) The above components are mixed and then crushed; (3) Weigh salvia miltiorrhiza, safflower, red peony root, atractylodes, scutellaria, radix dipsaci, drynaria, zedoaria, cnidium monnieri, phellodendron, violet yedoensis, trillium, chuanketong, honeysuckle, angelica dahurica, rhubarb, fennel, dandelion, kochia fruit, umbellate, corydalis, radix trichosanthis, raw arisaema, and liquorice, mix and grind to obtain mixture 1; weigh notopterygium root, angelica dahurica, costus root, tangerine peel, and green peel, mix and grind to obtain mixture 2; weigh dragon's blood and grind to obtain grinded blood brown; mix mixture 1, mixture 2, and the grinded blood brown to obtain; (4) Obtain pharmaceutical powder according to preparation method (3), heat medical hot melt adhesive, resin, and mineral oil until melted, add the pharmaceutical powder and penetration enhancer after cooling, stir, apply on release paper, and cover with non-woven fabric backing to obtain the product.

[0011] Preferably, the above components are dried before being crushed or mixed.

[0012] Preferably, the drying temperature is 60°C.

[0013] Preferably, the drying time is 5 hours.

[0014] Preferably, the powder needs to be sieved after pulverization.

[0015] In a fourth aspect, the present invention provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of a product for treating bone injuries.

[0016] Preferably, the bone injuries include fractures, joint dislocations, and soft tissue injuries.

[0017] Preferably, the product for treating bone injuries is a product that can dissipate blood stasis, promote qi circulation, clear away heat and dampness, and connect bones and tendons.

[0018] Preferably, the product for treating bone injuries is an anti-allergic product.

[0019] The beneficial effects of the present invention are: The traditional Chinese medicine composition of this invention promotes blood circulation and dispels blood stasis, promoting menstruation and relieving pain, specifically targeting blood stasis. Carthamus tinctorius dissipates blood stasis and relieves pain, aiding the salvia miltiorrhiza in promoting blood circulation and dispersing deep-seated blood stasis. Combined with the blood clotting agent, it stops bleeding and promotes regeneration. The blood clotting agent is combined with red peony root (also known as red peony root) to prevent blood stasis from transforming into heat. These four herbs act as the main ingredients, primarily targeting blood stasis. Salvia miltiorrhiza is the main ingredient, while safflower, blood clotting agent, and red peony root work together to form a closed loop of "blood circulation promotion, hemostasis, and cooling blood," directly addressing the symptoms of hematoma, heat, and pain in fresh wounds.

[0020] Corydalis promotes qi and relieves pain, and is particularly good at unblocking qi, making it the "king of painkillers." Raw Arisaema dries dampness and resolves phlegm, reduces swelling and relieves pain, and is particularly good at removing wind and phlegm from the meridians, with strong analgesic properties. Angelica dahurica dispels wind and relieves pain, opens the orifices and reduces swelling, and can enhance the analgesic and dispersing power of Corydalis. When combined with Notopterygium wilfordii and Angelica dahuricae, they can dispel wind and dampness, relieve spasms and relieve pain, and regulate the ascending and descending of qi. Trillium breaks up blood and eliminates symptoms, while Curcuma zedoaria breaks up qi and eliminates accumulation, attacking both qi and blood. Supplemented with Citrus aurantium, Tangerine peel, and Aucklandia lappa, they break up qi stagnation, eliminate accumulation and disperse knots, enhancing the effects of breaking up blood, promoting qi, and relieving accumulation and pain. The above ten herbs are collectively referred to as ministerial herbs, with Corydalis wilfordii as the main herb for promoting qi and relieving pain, Notopterygium wilfordii and Angelica dahuricae treat the upper and lower parts respectively, Trillium wilfordii and Curcuma zedoaria break up stagnation and eliminate accumulation, Citrus aurantium, Tangerine peel, and Aucklandia lappa regulate qi, and Angelica dahuricae and raw Arisaema enhance analgesia, achieving the effect of "promoting qi and removing stagnation, dispelling wind and relieving pain," helping the monarch herbs to dissipate blood stasis without obstruction.

[0021] Phellodendron chinense clears heat and dampness, while Atractylodes macrocephala strengthens the spleen and dispels dampness, clearing damp-heat without damaging yang. Taraxacum mongolicum, Viola yedoensis, Scutellaria baicalensis, and Lonicera japonica work together to clear heat and toxicity from the blood, preventing stasis and heat, and transforming into decay. Rhubarb purges heat and promotes bowel movements, dispelling stasis and promoting menstruation, clearing the bowels and purging heat, channeling heat downward, and, together with Phellodendron chinense and Atractylodes macrocephala, regulates the triple energizers. Polyporus umbellatus, Rhizoma Smilacis Glabrae, and Rhizoma Chuanxiong promote diuresis and dampness removal, unblocking the meridians and reducing swelling. Polyporus umbellatus promotes diuresis, Rhizoma Smilacis Glabrae unblocks the meridians, and Rhizoma Chuanxiong channels heat, eliminating damp-heat from the triple energizers. Kochia scoparia and Cnidium monnieri clear heat and dampness, dispel wind and relieve itching. Both herbs are used together to treat both cold and warming effects, preventing external application. Radix Trichosanthis clears heat and promotes fluid production, moisturizing and detoxifying, neutralizing the harsh, dry nature of Arisaema consanguineum. These are adjuvants, assisting the monarch and ministerial herbs in dispersing stasis and heat, addressing both the exterior and interior.

[0022] Dipsacus root nourishes the liver and kidneys, and strengthens tendons and bones, while Drynaria root promotes blood circulation and strengthens bones. Dipsacus root is mainly used for "tonifying", while Drynaria root is mainly used for "promoting", and the tonifying and promoting complement each other to promote the growth of bone callus; Licorice harmonizes all the medicines, detoxifies and relieves urgency, and can detoxify Arisaema, alleviate the harshness of Trillium and Curcuma, and guide all the medicines to the meridians, so that the medicinal power can reach the diseased area directly, and it is the guiding medicine.

[0023] This product primarily promotes blood circulation and blood stasis, promotes qi circulation and relieves pain, while supplemented by clearing away heat and dampness, and strengthening bones and tendons. It also boasts high safety through its anti-allergic properties. It is indicated for the early and mid-stage (acute and subacute) treatment of various fractures, dislocations, and tendon injuries, as well as for local swelling, pain, bruising, and fever. DETAILED DESCRIPTION

[0024] In order to enable those skilled in the art to better understand the technical solution of the invention, the present invention is further described in detail below in conjunction with specific implementation methods.

[0025] The "fresh injury stage" in the present invention mainly refers to the initial stage of bone injury and the transition stage from the initial stage to the middle stage, which corresponds to the acute stage in modern medicine and the stage in which swelling has not completely subsided after entering the subacute stage. "Emergency Prescriptions for the Elbow" records: "Any traumatic injury with blood stasis, swelling and pain can be applied with a plaster to promote blood circulation, dissipate blood stasis, reduce swelling and relieve pain." In the initial stage of a fresh injury, blood overflows from the vessels and causes stasis, which then settles and causes swelling. The stasis and swelling then lead to blood stasis and qi stagnation, qi stagnation and dampness stagnation, and internal accumulation of damp heat. The stasis and dampness stagnate and cause fever in the injured area and even throughout the body. Therefore, swelling, pain, and stasis heat are a comprehensive reflection of the fracture, tendon injury, bleeding, blood stasis, qi stagnation, dampness stagnation, and heat accumulation.

[0026] The present invention first provides a traditional Chinese medicine composition for the early and middle stages of bone injuries. The components of the traditional Chinese medicine composition are calculated by weight as follows: 25-75 parts of salvia miltiorrhiza, 12-38 parts of safflower, 8-25 parts of blood clovers, 10-30 parts of red peony root, 25-75 parts of angelica root, 15-45 parts of corydalis, 12-38 parts of notopterygium root, 12-38 parts of angelica dahurica, 10-30 parts of raw arisaema, 25-75 parts of trigonosciadium japonicum, 12-38 parts of zedoaria, 10-30 parts of green peel, 10-30 parts of dried tangerine peel, 10-30 parts of wood 10-30 parts of Radix Angelicae Sinensis, 25-75 parts of Polyporus, 15-45 parts of Fructus Liquidaminae, 12-38 parts of Cortex Phellodendri, 12-38 parts of Rhizoma Atractylodis Macrocephalae, 10-30 parts of Caulis Atractylodes, 25-75 parts of Herba Taraxaci, 12-38 parts of Radix Scutellariae, 15-45 parts of Flos Lonicerae, 15-45 parts of Herba Violae Yedoensis, 12-38 parts of Radix Rhizoma Rhei, 12-38 parts of Radix Trichosanthis, 25-75 parts of Fructus Kochiae, 15-45 parts of Fructus Cnidium, 12-38 parts of Radix Dipsaci, 12-38 parts of Rhizoma Drynariae, and 5-20 parts of Radix Glycyrrhizae.

[0027] Danshen (Salvia miltiorrhiza): This herb is the dried root and rhizome of the Lamiaceae plant Salvia miltiorrhiza Bge. It is harvested in spring and autumn, desilted, and dried. Its functions and indications include promoting blood circulation and removing blood stasis, relieving pain during menstruation, clearing the heart and relieving restlessness, and cooling blood and eliminating carbuncles. It is used to treat chest pain, abdominal pain, and flank pain, accumulation of masses, pain due to heat rheumatic arthritis, restlessness and insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling.

[0028] Safflower: This product is the dried flowers of Carthamus tinctorius L., a plant in the Asteraceae family. The flowers are picked in summer when they turn from yellow to red and dried in the shade or sun. Its functions and indications include promoting blood circulation and menstruation, dispersing blood stasis and relieving pain. It is used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to blood stasis, stabbing pain in the chest and flanks, injuries from falls, and sores and swelling.

[0029] Dragon's Blood: This product is made from the resin exuded from the fruit of Daemonorops draco Bl., a plant in the palm family. Its functions and indications include promoting blood circulation and relieving pain, dissolving blood stasis and stopping bleeding, promoting tissue regeneration and healing sores. It is used for traumatic injuries, abdominal pain, bleeding from trauma, and persistent sores. For external use, grind into a powder for sprinkling or incorporate into a plaster.

[0030] Red Peony Root: This herb is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch, both Ranunculaceae plants. It is harvested in spring and autumn, the rhizome, fibrous roots, and mud removed, and then sun-dried. Its functions and indications include clearing heat and cooling blood, dispersing blood stasis, and relieving pain. It is used to treat heat invading the blood, fever-induced rashes, hematemesis, epistaxis, red and swollen eyes, liver depression and flank pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, and carbuncles and ulcers.

[0031] Duhuo (Lotus Flower): This root is the dried root of Angelica pubescens Maxim.f. biserrata Shan et Yuan, a plant of the Umbelliferae family. It is harvested in early spring when the seedlings have just sprouted or in late autumn when the stems and leaves have withered. The roots and mud are removed, and the roots are dried until semi-dry. The roots are piled for 2-3 days, and then dried again after softening. Its functions and indications include dispelling wind and dampness, relieving numbness and alleviating pain. It is used for wind-cold-dampness arthritis, pain in the waist and knees, Shaoyin-induced wind-hidden headaches, and headaches caused by wind-cold and dampness.

[0032] Corydalis yanhusuo (Yihusuo): This product is the dried tuber of Corydalis yanhusuo (WTW Wang), a plant in the Poppy family. It is harvested in early summer when the stems and leaves wither. Remove the fibrous roots, wash, and boil or steam in boiling water until the white core is gone. Remove and sun-dry. Its functions and indications include promoting blood circulation, promoting qi circulation, and relieving pain. It is used for chest, flank, and abdominal pain, angina pectoris, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain from falls.

[0033] Qiang Huo (Notopterygium incisum Ting ex HT Chang) or Notopterygium franchetii H. de Boiss. (Umbelliferae) are dried rhizomes and roots. They are harvested in spring and autumn, their fibrous roots and mud removed, and then sun-dried. Their functions and indications include relieving cold, dispelling wind and dampness, and relieving pain. They are used for colds, headaches, stiff necks, rheumatic pain, and shoulder and back pain.

[0034] Angelica dahurica: This product is the dried root of Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. or Angelica dahurica (Fisch. ex Hoffm.) Benth. et Hook. f. var. formosana (Boiss.) Shan et Yuan, both plants of the Umbelliferae family. It is harvested in summer and autumn when the leaves turn yellow, the fibrous roots and mud removed, and then sun-dried or low-temperature dried. Its functions and indications include relieving exterior symptoms and dispelling cold, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and relieving leukorrhea, and reducing swelling and draining pus. It is used for colds, headaches, brow pain, nasal congestion and runny nose, allergic rhinitis, sinusitis, toothache, leukorrhea, and sores and swelling.

[0035] Arisaema: This herb is the dried tuber of Arisaema erubescens (Wall.) Schott, Arisaema heterophyllum Bl., or Arisaema amurense Maxim., all members of the Araceae family. It is harvested in autumn and winter when the stems and leaves wither, the fibrous roots and outer bark removed, and then dried. Its functions and indications include dispersing stagnation and reducing swelling. It can be used externally to treat carbuncles and snake and insect bites.

[0036] Sparganium: This product is the dried tuber of Sparganium stoloniferum Buch.-Ham. (Sparganium family). It is harvested between winter and spring, washed, peeled, and sun-dried. Its functions and indications include promoting blood circulation and promoting qi circulation, eliminating stagnation and relieving pain. It is used to treat lumps and masses, dysmenorrhea, amenorrhea due to blood stasis, chest pain, and bloating and pain caused by food stagnation.

[0037] Curcuma zedoaria: This product is the dried rhizome of Curcuma phaeocaulis Val., Curcuma wangsiensis SGLee et CFLiang, or Curcuma wenyujin YHChenetC.Ling, all members of the Zingiberaceae family. The latter is commonly known as "Wen Curcuma zedoaria." It is harvested in winter after the stems and leaves wither, cleaned, steamed or boiled until thoroughly cooked, then sun-dried or low-temperature dried, and the fibrous roots and impurities removed. Its functions and indications include promoting qi and dissolving blood stasis, eliminating stagnation, and relieving pain. It is used to treat lumps and masses, amenorrhea due to blood stasis, chest pain, and bloating and pain caused by food stagnation.

[0038] Green peel (qingpi): This product is the dried peel of young or immature fruits of Citrus reticulata Blanco (Rutaceae) and its cultivars. The fallen young fruits are collected in May and June and sun-dried, commonly known as "ge qingpi." The immature fruits are harvested in July and August, split longitudinally along the peel to form four lobes to the base, the pulp removed, and sun-dried, commonly known as "sihua qingpi." Its functions and indications include soothing the liver and dispersing qi, eliminating stagnation, and dissolving stagnation. It is used to treat chest and flank pain, hernia pain, breast lumps, breast abscesses, food stagnation and qi stagnation, and abdominal distension and pain.

[0039] Tangerine peel (Chenpi): This product is the dried, mature peel of the Rutaceae plant, Citrus reticulata Blanco, and its cultivated varieties. It is divided into "Chenpi" and "Guangchenpi." Harvest the ripe fruit, peel it, and then sun-dry or low-temperature dry it. Its functions and indications include regulating qi and strengthening the spleen, drying dampness and resolving phlegm. It is used to treat abdominal distension, loss of appetite, vomiting, diarrhea, and cough with excessive phlegm.

[0040] Costus root: This root is the dried root of Aucklandia lappa Decne. (Asteraceae). It is harvested in autumn and winter, cleaned of mud and fibrous roots, and cut into sections. Larger roots are then split longitudinally into petals. After drying, the rough bark is removed. Its functions and indications include promoting qi circulation, relieving pain, and strengthening the spleen and aiding digestion. It is used for chest, flank, and abdominal distension and pain, heaviness after diarrhea, indigestion, and loss of appetite. Simmered costus root astringes the intestines and stops diarrhea. It is used for abdominal pain caused by diarrhea.

[0041] Poria: This product is the dried sclerotia of the Polyporus umbellatus (Pers.) Fries fungus of the Polyporaceae family. It is harvested in spring and autumn, desilted, and dried. Its functions and indications include promoting diuresis and dispelling dampness. It is used for dysuria, edema, diarrhea, stranguria, and leucorrhea.

[0042] Liquidambar formosana: This product is the dried mature infructescence of Liquidambar formosana Hance, a plant in the Hamamelidaceae family. The fruits are harvested in winter when ripe, removed of impurities, and dried. Its functions and indications include dispelling wind and activating collaterals, promoting diuresis, and stimulating menstruation. It is used for joint pain, numbness, cramps, edema, insufficient milk production, and amenorrhea.

[0043] Huangbai (Phellodendron chinense Schneid): This product is the dried bark of the Rutaceae tree, commonly known as "Sichuan Huangbai." After peeling the bark, remove the rough bark and sun-dry. Its functions and indications include clearing heat and dampness, purging fire and eliminating steam, and detoxifying and treating sores. It is used for damp-heat diarrhea, jaundice, dark urine, vaginal discharge, itching due to heat, painful stranguria, beriberi, paralysis, bone steaming, fever, night sweats, spermatorrhea, sores, swelling, and eczema. Salted Huangbai nourishes yin and reduces fire. It is used for yin deficiency and excessive fire, night sweats and bone steaming. Apply externally in appropriate amounts.

[0044] Atractylodes: This product is the dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz., both of the Asteraceae family. It is harvested in spring and autumn, desilted, sun-dried, and the fibrous roots removed. Its functions and indications include: drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It is used to treat dampness in the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic pain, colds, night blindness, and blurred vision.

[0045] Sichuan Akebia: This herb is the dried stem of Clematis armandii Franch. or Clematis montana Buch.-Ham. (Ranunculaceae). Harvested in spring and autumn, the rough bark removed, and sun-dried, or cut into thick slices while still fresh and sun-dried. Its functions and indications include diuresis, relieving stranguria, clearing the heart and relieving restlessness, and promoting menstruation and lactation. It is used for stranguria, edema, restlessness, dark urine, mouth and tongue sores, amenorrhea, insufficient milk production, and pain due to damp-heat.

[0046] Dandelion: This herb is the dried whole herb of Taraxacum mongolicum Hand.-Mazz., Taraxacum borealisinense Kitam., or several species of the same genus, all from the Asteraceae family. It is harvested from spring to autumn when the flowers first bloom, cleaned of impurities, washed, and sun-dried. Its functions and indications include clearing heat and detoxifying, reducing swelling and dispersing stagnation, and promoting diuresis and relieving stranguria. It is used for carbuncles, breast abscesses, scrofula, red eyes, sore throat, lung abscesses, intestinal abscesses, damp-heat jaundice, and painful stranguria caused by heat.

[0047] Scutellaria baicalensis: This root is the dried root of Scutellaria baicalensis Georgi, a plant of the Lamiaceae family. It is harvested in spring and autumn, the fibrous roots and mud removed, sun-dried, and then pounded to remove the rough bark. Its functions and indications include clearing heat and dampness, purging fire and detoxifying, stopping bleeding, and stabilizing pregnancy. It is used for damp-heat syndrome, summer heat dampness, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, vomiting and epistaxis due to blood heat, carbuncles, sores, and fetal restlessness.

[0048] Honeysuckle: This product is the dried buds or early blooming flowers of Lonicera japonica Thunb., a plant of the Caprifoliaceae family. It is harvested and dried in early summer before the flowers open. Its functions and indications include clearing heat and detoxifying, and dispersing wind-heat. It is used for carbuncles, furuncles, sore throat, erysipelas, dysentery caused by heat toxins, wind-heat colds, and fever caused by febrile diseases.

[0049] Viola yedoensis: This herb is the dried whole herb of Viola yedoensis Makino, a plant of the Violaceae family. Harvested in spring and autumn, impurities removed, and sun-dried. Its functions and indications include clearing heat and detoxifying, cooling blood and reducing swelling. It is used for boils, carbuncles, back ulcers, erysipelas, and snake bites.

[0050] Rhubarb: This product is the dried root and rhizome of Rheum palmatum L., Rheumtanguticum Maxim. ex Balf., or Rheum officinale Baill. (all Polygonaceae). It is harvested in late autumn when the stems and leaves wither or in the following spring before budding. The rootlets are removed, the outer bark scraped off, and the petals or segments are cut and strung into strings for drying or dried directly. Its functions and indications include: purgation, clearing away heat and purging fire, cooling the blood and detoxifying, removing blood stasis and promoting menstruation, and promoting dampness and jaundice. It is used for constipation caused by excess heat, vomiting and bleeding due to blood heat, red eyes and swollen throat, carbuncles and furuncles, abdominal pain due to intestinal carbuncle, amenorrhea due to blood stasis, postpartum blood stasis, traumatic injuries, damp-heat dysentery, jaundice and dark urine, stranguria, and edema; it can also be used externally for burns and scalds.

[0051] Radix Trichosanthis: This herb is the dried root of Trichosanthes kirilowii Maxim. or Trichosanthes rosthornii Harms, both of the Cucurbitaceae family. It is harvested in autumn and winter, cleaned, peeled, cut into sections or split longitudinally into petals, and dried. Its functions and indications include clearing heat and purging fire, promoting fluid production and quenching thirst, and reducing swelling and draining pus. It is used for fever-related thirst, dry cough due to lung heat, internal heat-induced polydipsia, and sores and swelling.

[0052] Kochia scoparia fruit: This product is the dried mature fruit of Kochia scoparia (L.) Schrad., a plant of the Chenopodiaceae family. The fruit is harvested in autumn when ripe, sun-dried, and then broken and freed of impurities. Its functions and indications include clearing heat and dampness, dispelling wind, and relieving itching. It is used for painful and difficult urination, vaginal itching, leucorrhea, urticaria, eczema, and itchy skin.

[0053] Cnidium monnieri (L.) Cuss.: This product is the dried mature fruit of Cnidium monnieri (L.) Cuss., a plant in the Apiaceae family. The fruit is harvested in summer and autumn when ripe, removed of impurities, and sun-dried. Its functions and indications include: drying dampness and dispelling wind, killing insects and relieving itching, and warming the kidneys and strengthening yang. It is used for vaginal itching and leukorrhea, eczema and pruritus, dampness and arthritis, low back pain, kidney deficiency and impotence, and uterine coldness and infertility. Apply externally in appropriate amounts, decoct in water for fumigation and washing, or grind into a powder for application.

[0054] Dipsacus asper: This is the dried root of Dipsacus asper Wall. ex Henry, a plant of the Dipsacus family. It is harvested in autumn, the root heads and fibrous roots removed, and then dried over a low flame until semi-dry. The root is then piled to "sweat" until the interior turns green, then dried again. Its functions and indications include nourishing the liver and kidneys, strengthening tendons and bones, healing fractures, and stopping metrorrhagia. It is used for liver and kidney deficiency, soreness of the waist and knees, rheumatic pain, injuries from falls, fractures of tendons, metrorrhagia, and miscarriage.

[0055] Drynaria fortunei (Kunze) J.Sm.: This product is the dried rhizome of the Polypodiaceae family. It can be harvested year-round, cleaned of sediment, and dried, or the hairs (scales) can be burned off. Its functions and indications include healing wounds and relieving pain, tonifying the kidneys and strengthening bones; and externally used to dispel wind and remove freckles. It is used for falls, sprains, fractures, kidney deficiency, low back pain, weakness of the tendons and bones, tinnitus, deafness, and loose teeth; and externally for alopecia areata and vitiligo.

[0056] Licorice: This product is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all from the Leguminosae family. It is harvested in spring and autumn, the fibrous roots removed, and sun-dried. Its functions and indications include tonifying the spleen and replenishing qi, clearing heat and detoxifying, removing phlegm and relieving cough, relieving pain, and harmonizing various medicinal herbs. It is used to treat spleen and stomach deficiency, fatigue, palpitations, shortness of breath, cough with excessive sputum, acute pain in the abdomen and limbs, carbuncles, sores, and relieving drug toxicity and potency.

[0057] Among the above herbs, Danshen invigorates blood circulation, dispels blood stasis, promotes menstruation, and relieves pain, specifically targeting blood stasis. Safflower dissipates blood stasis and relieves pain, aiding Danshen in activating blood circulation and dispersing deep-seated blood stasis. It also works in conjunction with Sanguisorba officinalis to stop bleeding and promote regeneration. Sanguisorba officinalis is paired with Paeonia lactiflora (which cools blood and disperses blood stasis) to prevent blood stasis from transforming into heat. These four herbs serve as the main ingredients, primarily targeting blood stasis. Danshen is the primary ingredient, while Safflower, Sanguisorba officinalis, and Paeonia lactiflora work together to form a closed loop of "activating blood circulation, stopping bleeding, and cooling blood," directly addressing the symptoms of hematoma, heat, and pain in fresh wounds. Corydalis yanhusuo promotes qi and relieves pain, particularly effective at promoting the flow of qi, earning it the title of "the best pain reliever." Raw Arisaema dries dampness and resolves phlegm, reducing swelling and relieving pain, and is particularly effective at dispelling wind and phlegm from the meridians, offering strong analgesic properties. Angelica dahurica dispels wind and relieves pain, opening the orifices and reducing swelling, enhancing the analgesic and dispersing properties of Corydalis yanhusuo. Combined with Notopterygium incisum and Angelica dahurica, they dispel wind and dampness, relieve spasms, and relieve pain, while regulating the flow of qi. Sanleng dissolves blood and eliminates symptoms, while Curcuma dissolves qi and eliminates accumulation, attacking both qi and blood. Supplemented with Citrus aurantium, Tangerine peel, and Aucklandia lappa, they dissolve qi stagnation, dissipate accumulation, and enhance the efficacy of dispersing blood, promoting qi circulation, and alleviating pain. These ten herbs serve as auxiliary herbs, with Corydalis yanhusuo as the primary agent for promoting qi and alleviating pain, while Qianghuo and Duhuo address the upper and lower parts of the body, respectively. Sanleng and Curcuma dissolve stagnation and eliminate accumulation, while Citrus aurantium, Tangerine peel, and Aucklandia lappa regulate qi flow, and Angelica dahurica and Arisaema enhance pain relief. Together, they achieve the function of "moving qi, dispelling wind, and relieving pain," assisting the main herbs in dissolving blood stasis. Phellodendron chinense clears heat and dampness, while Atractylodes lancea strengthens the spleen and dispels dampness, clearing damp-heat without damaging yang. The combined effects of Taraxacum mongolicum, Viola yedoensis, Scutellaria baicalensis, and Lonicera japonica clear heat and toxins from the blood, preventing stasis and transforming into rottenness. Rhubarb purges heat and promotes bowel movements, dissipates blood stasis and promotes menstruation, clears the bowels and eliminates heat, and channels heat downward, harmonizing the triple energizers with Phellodendron chinense and Atractylodes lancea. Poria, Rhizoma Smilacis Glabrae, and Rhizoma Chuanxiong are diuretic and eliminate dampness, dredge meridians and reduce swelling. Poria is diuretic, Rhizoma Smilacis Glabrae is a meridian dredge, and Rhizoma Chuanxiong is a heat-transmitting agent, which can eliminate dampness and heat in the three burners. Kochia scoparia and Cnidium monnieri are heat-clearing and damp-removing, dispelling wind and relieving itching. The two herbs are used together with cold and warm properties and should not be applied externally. Radix Trichosanthis clears heat and promotes fluid production, moisturizes dryness and detoxifies, and neutralizes the dry and harsh nature of Arisaema. The above are adjuvants, assisting the monarch and ministerial herbs in dispersing blood stasis and heat, taking into account both the exterior and interior. Dipsacus root nourishes the liver and kidneys and strengthens tendons and bones, while Drynaria root invigorates blood circulation and strengthens bones. Dipsacus root is mainly used for "tonifying", while Drynaria root is mainly used for "unblocking", and the tonifying and unblocking complement each other to promote the growth of bone callus. Licorice harmonizes the various herbs, detoxifies and relieves urgency, relieves the toxicity of Arisaema, alleviates the harshness of Trillium and Curcuma, and guides the various herbs to the meridians so that the medicinal power can reach the diseased area directly, thus serving as the guiding herb. The above Chinese medicine groups are used to treat the disease according to syndrome differentiation and reasonable combination to achieve the effects of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, clearing away heat and dampness, and strengthening bones and tendons.

[0058] In the early stage, clearing away heat and removing dampness can block the pathological chain of "stasis → heat → poison", and bone and tendon continuation can activate bone regeneration signals as early as possible to avoid "weak bones and stiff tendons" in the middle stage. Therefore, in addition to promoting blood circulation and stopping bleeding, reducing swelling and relieving pain in the new injury stage, the present invention also considers removing blood stasis and promoting qi circulation to relieve stagnation, clearing away heat and removing dampness to protect the body, and bone and tendon continuation to strengthen the foundation. In addition, in the new injury stage of bone injuries, it is more necessary to consider the anti-allergic compatibility of external medicines. Although the present invention also uses easily allergic medicinal materials such as Sanguisorba officinalis, Arisaema consanguineum, Angelica dahurica, and Safflower, anti-allergic compatibility is fully considered in the combination, such as using Radix Trichosanthis to moisturize and detoxify, and neutralize the dry and strong nature of Arisaema consanguineum. Kochia scoparia and Cnidium monnieri are used together with cold and warm properties to prevent external drug rashes, detoxify and relieve itching.

[0059] The present invention also provides a traditional Chinese medicine preparation for early and middle stages of bone injuries, wherein the traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0060] The dosage form of the Chinese medicine preparation is powder or plaster.

[0061] The present invention also provides a method for preparing a Chinese medicine composition for early and middle stages of bone injuries, comprising any one of the following four methods: (1) The above components are crushed separately and then mixed; (2) The above components are mixed and then crushed; (3) Weigh salvia miltiorrhiza, safflower, red peony root, atractylodes, scutellaria, radix dipsaci, drynaria, zedoaria, cnidium monnieri, phellodendron, violet yedoensis, trillium, chuanketong, honeysuckle, angelica dahurica, rhubarb, fennel, dandelion, kochia fruit, umbellate, corydalis, radix trichosanthis, raw arisaema, and liquorice, mix and grind to obtain mixture 1; weigh notopterygium root, angelica dahurica, costus root, tangerine peel, and green peel, mix and grind to obtain mixture 2; weigh dragon's blood and grind to obtain grinded blood brown; mix mixture 1, mixture 2, and the grinded blood brown to obtain; (4) Obtain pharmaceutical powder according to preparation method (3), heat medical hot melt adhesive, resin, and mineral oil until melted, add the pharmaceutical powder and penetration enhancer after cooling, stir, apply on release paper, and cover with non-woven fabric backing to obtain the product.

[0062] Preferably, the above components are dried before being crushed or mixed.

[0063] Preferably, the powder needs to be sieved through a 100-mesh sieve after being crushed.

[0064] The present invention also provides application of the traditional Chinese medicine composition in preparing a product for treating bone injuries.

[0065] Preferably, the bone injuries include fractures, joint dislocations, and soft tissue injuries.

[0066] Preferably, the product for treating bone injuries is a product that can dissipate blood stasis, promote qi circulation, clear away heat and dampness, and connect bones and tendons.

[0067] Preferably, the product for treating bone injuries is an anti-allergic drug.

[0068] The above is a detailed description of the present invention, and the following are embodiments of the present invention.

[0069] Example 1 This embodiment provides a traditional Chinese medicine composition, which comprises, by weight, 50 parts of salvia miltiorrhiza, 25 parts of safflower, 15 parts of blood clovers, 20 parts of red peony root, 50 parts of angelica dahurica, 30 parts of corydalis yanhusuo, 25 parts of notopterygium wilfordii, 25 parts of angelica dahurica, 20 parts of raw arisaema, 50 parts of sparganium, 25 parts of zedoaria, 20 parts of green peel, 20 parts of dried tangerine peel, 20 parts of costus root, 50 parts of umbellate, 30 parts of rhubarb, 25 parts of phellodendron, 25 parts of atractylodes, 20 parts of chuanmutong, 50 parts of dandelion, 35 parts of scutellaria baicalensis, 30 parts of honeysuckle, 30 parts of viola yedoensis, 25 parts of raw rhubarb, 25 parts of trichosanthes root, 50 parts of kochia scoparia, 30 parts of cnidium monnieri, 25 parts of dipsaccharum officinale, 25 parts of drynaria rhizome, and 10 parts of liquorice.

[0070] Example 2 This embodiment provides a traditional Chinese medicine composition, which comprises, by weight, 75 parts of salvia miltiorrhiza, 38 parts of safflower, 25 parts of blood clovers, 30 parts of red peony root, 75 parts of angelica dahurica, 45 parts of corydalis yanhusuo, 38 parts of notopterygium wilfordii, 38 parts of angelica dahurica, 30 parts of raw arisaema, 75 parts of sparganium, 38 parts of zedoaria, 30 parts of green peel, 30 parts of dried tangerine peel, 30 parts of costus root, 75 parts of umbellate, 45 parts of rhubarb, 38 parts of phellodendron, 38 parts of atractylodes, 30 parts of chuanmutong, 75 parts of dandelion, 38 parts of scutellaria baicalensis, 45 parts of honeysuckle, 45 parts of viola yedoensis, 38 parts of raw rhubarb, 38 parts of trichosanthes root, 75 parts of kochia scoparia, 45 parts of cnidium monnieri, 38 parts of dipsaccharum officinale, 38 parts of drynaria rhizome, and 20 parts of liquorice.

[0071] Example 3 This embodiment provides a traditional Chinese medicine composition, which comprises, by weight, 25 parts of salvia miltiorrhiza, 12 parts of safflower, 8 parts of blood clovers, 10 parts of red peony root, 25 parts of angelica dahurica, 15 parts of corydalis yanhusuo, 12 parts of notopterygium wilfordii, 12 parts of angelica dahurica, 10 parts of raw arisaema, 25 parts of sparganium, 12 parts of zedoaria, 10 parts of green peel, 10 parts of dried tangerine peel, 10 parts of costus root, 25 parts of umbellate, 15 parts of rhubarb, 12 parts of phellodendron, 12 parts of atractylodes, 10 parts of chuanmutong, 25 parts of dandelion, 12 parts of scutellaria baicalensis, 15 parts of honeysuckle, 15 parts of viola yedoensis, 12 parts of raw rhubarb, 12 parts of trichosanthes root, 25 parts of kochia scoparia, 15 parts of cnidium monnieri, 12 parts of dipsaccharum officinale, 12 parts of drynaria rhizome, and 5 parts of liquorice.

[0072] Example 4 This embodiment provides a method for preparing a Chinese medicine powder, comprising the following steps: (1) After drying each medicinal material of the Chinese medicine composition of Example 1 (the parts are measured in grams) at 60°C for 5 hours, approximately four times the amount was weighed and put into a Chinese medicine grinder for grinding, and the mixture was passed through a No. 6 sieve (100 mesh). The weight was weighed and the powder yield was calculated as shown in Table 1. (2) According to the ratio of Example 1, the crushed and sieved medicinal materials of each flavor were weighed, mixed, put into a mixer, and quickly mixed to obtain the powder yield of 90.08%.

[0073] Table 1

[0074] Example 5 This embodiment provides a method for preparing a Chinese medicine powder, comprising the following steps: After drying the medicinal materials of the Chinese medicine composition of Example 1 (parts are measured in grams) at 60°C for 5 hours, approximately one-quarter of the weight of each medicinal material was weighed and pulverized in a grinder. The powder was passed through a 100-mesh sieve, and the sieved powder was then placed in a mixer and rapidly mixed to obtain the powder. The powder yield is shown in Table 2.

[0075] Table 2

[0076] Example 6 This embodiment provides a method for preparing a Chinese medicine powder, comprising the following steps: (1) After drying the medicinal materials in the Chinese medicine composition of Example 1 (the parts are in grams) at 60°C for 5 hours, 24 medicinal materials, including salvia miltiorrhiza, safflower, red peony root, atractylodes, scutellaria, dipsaccharum officinale, drynaria rhizome, zedoaria, cnidium monnieri, phellodendron amurense, violet yedoensis, trillium, chuanmutong, honeysuckle, angelica dahurica, rhubarb, fennel, dandelion, kochia scoparia, umbellate, corydalis yanhusuo, radix trichosanthis, raw arisaema, and liquorice, were weighed according to one-fourth of the weight of the corresponding medicinal materials, put into a grinder, crushed, passed through a 100-mesh sieve, and set aside; (2) Weigh the five herbs containing more volatile oil, namely, Qianghuo, Duhuo, Muxiang, Chenpi, and Qingpi, according to one-fourth of the weight of the corresponding herbs in the composition, put them into a low-temperature grinder, grind them, pass them through a 100-mesh sieve, and set aside; (3) Weigh one-fourth of the weight of the medicinal material in the composition, grind it into powder in a low-temperature grinder, pass it through a 100-mesh sieve, and set aside; (4) Put the powder obtained by (1) (2) (3) into a mixer and stir and mix to obtain the powder with a yield of 92.33%.

[0077] As can be seen from the preparation methods of embodiment 4~6 different Chinese medicine compositions, three methods are adopted to prepare powders: the first is that each medicinal material is pulverized separately, sieved, and then mixed to obtain finished product in prescription ratio, and dosage is accurate, but the operation is more complicated, and some medicinal material losses are larger, and final powder yield is 90.08%, and dosage may have deviations with prescription. The second is that each medicinal material is weighed in prescription ratio and then put into pulverizer pulverization in lump sum, and operation is simple, and powder yield is higher 93.92%, and loss is little, but some agglomerate powder occurs, and analysis and pulverization process are relevant to the adhesion of the medicinal material containing more volatile oil by Draxonis, Radix Angelicae Pubescentis, Radix Aucklandiae, Pericarpium Citri Reticulatae, Pericarpium Citri Reticulatae, etc., which contain more volatile oil, are pulverized separately, and Draxonis pulverizes separately in addition, and then mixed to obtain finished product in prescription ratio, and powder yield is moderate 92.33%, and each medicinal material relative loss is smaller, and adhesion phenomenon does not occur, so the preparation method of preferred embodiment 6.

[0078] Example 7 This embodiment provides a method for preparing a lead-free black plaster, comprising the following steps: The mixture was prepared in a ratio of 40% EVA hot melt adhesive, 20% rosin, 15% liquid paraffin, 3% azone, and 22% drug powder (the powder obtained in Example 6). The EVA hot melt adhesive, rosin, and liquid paraffin were first heated to 120° C. to melt, stirred until a uniform liquid state was obtained, cooled to 60° C., and the powder obtained in Example 6 and azone were added. The mixture was stirred for 15 minutes (to avoid bubbles). The paste was applied to a release paper (thickness 0.5 mm) while hot, covered with a non-woven fabric backing, and cooled at room temperature to obtain the paste.

[0079] Effect Example 1 The anti-allergic effect and safety effect of the Chinese medicine composition of the present invention are illustrated below through animal experiments.

[0080] 1. Skin allergy test (1) Experimental agents: A. Experimental group: Weigh 20 g of the Chinese medicine powder prepared according to the method of Example 6, mix it with 3 times the weight of boiled distilled water to form a dry paste, and use it after cooling to room temperature.

[0081] B. Positive control group: 2, 4-dinitrochlorobenzene.

[0082] C. Blank control group: distilled water.

[0083] (2) Experimental animals: Guinea pigs (white British breed), provided by Tongxiang Yinhai Animal Husbandry Cooperative.

[0084] (3) Experimental method: 40 healthy guinea pigs weighing 250-300g were selected, half male and half female, and randomly divided into three groups according to body weight, namely, a positive control group (administered 2,4-dinitrochlorobenzene), an experimental group (administered Chinese medicine composition), and a blank control group (administered distilled water). The day before the experiment, the skin on the right side of the guinea pig's back was shaved (an area of ​​3 cm 2 On the day of the experiment, 0.2 g of each of the experimental agents was applied to the shaved area on the right side, then covered with a layer of oil paper and two layers of gauze, and fixed with non-irritating adhesive tape. The drug was washed off after 6 hours, and the skin allergic reaction and other conditions were observed 24, 48, and 72 hours thereafter.

[0085] (4) The sensitization rate was calculated with 72 hours as the final judgment time point. The experimental results are shown in Table 3.

[0086] Table 3. Skin allergy test results

[0087] As can be seen from Table 3, the sensitization rate after using the composition of the present invention for 72 hours is 5%, indicating that the Chinese medicine composition of the present invention has anti-allergic properties after reasonable combination.

[0088] 2. Multiple skin irritation tests (1) Experimental agent: Weigh 20 g of the Chinese medicine powder prepared according to the method of Example 6, mix it with 3 times the weight of boiled distilled water to form a dry paste, and use it after cooling to room temperature.

[0089] (2) Experimental animals: Rabbits (New Zealand breed), half male and half female, provided by Tongxiang Yinhai Animal Husbandry Cooperative.

[0090] (3) Experimental method: Four healthy rabbits were selected, and female rabbits were selected that were not pregnant or had not given birth. The experimental animals were housed in single cages and were allowed to adapt to the experimental animal room environment for at least 3 days before the experiment. About 24 hours before the experiment, the hair on both sides of the experimental animals' spines were trimmed, and the hair removal area was 3cm×3cm. The application area was 2.5cm×2.5cm. Before administration, check whether the hairless skin was injured due to hair removal. Injured skin was not suitable for the experiment. 0.5g of the experimental drug was applied to the hairless skin on one side, and the hairless skin on the other side was used as a control. The application was applied once a day for 14 consecutive days. Starting from the second day, the hair was trimmed before each application, and the residual test substance was removed with warm water. After one hour, the back skin was observed for erythema and edema.

[0091] (4) The experimental results are shown in Table 4.

[0092] Table 4. Results of multiple skin irritation tests on rabbits

[0093] As can be seen from Table 4, the Chinese medicinal composition of the present invention is non-irritating to the skin of rabbits after multiple irritations, indicating that the Chinese medicinal composition of the present invention is mild and non-irritating after reasonable combination and has high safety.

[0094] Effect Example 2 The therapeutic effect of the Chinese medicine composition of the present invention is illustrated below through clinical data.

[0095] From July 2024 to January 2025, a total of 1,217 newly injured patients were treated with the Chinese medicine composition of the present invention, with overall positive feedback from the patients. Among them, 987 patients had fractures, 91 patients had soft tissue injuries, and 139 patients had joint dislocations. Overall, the patients responded well.

[0096] The clinical efficacy of 50 patients with fractures, 50 patients with soft tissue injuries and 50 patients with joint dislocations who used the composition of the present invention in the inpatient department and outpatient clinic during the new injury period was observed and statistically analyzed.

[0097] 1. Research Objects and Methods ①Inclusion criteria A. Fracture patients: Closed fractures confirmed by X-ray or CT (≤ 72 hours after injury); aged 18-65 years, without serious underlying diseases (such as diabetes or coagulation disorders); B. Joint dislocation patients: clinically diagnosed (with joint deformity, elastic fixation), successfully reduced by manipulation; treatment started within 24 hours of reduction; patients with concurrent fractures or neurovascular injuries are excluded; C. Patients with soft tissue injuries: Clear history of trauma, local swelling and ecchymosis, MRI or ultrasound to exclude tendon rupture; seek medical attention within 48 hours of injury.

[0098] The above information was obtained and the informed consent was voluntarily signed.

[0099] ② Elimination criteria A. Combined with severe liver and kidney dysfunction or malignant tumor; B. History of allergy to any ingredient in the formula; C. Failure to complete treatment according to the plan or incomplete information; D. Open injuries or those requiring emergency surgery.

[0100] ③Research methods A. Grouping and treatment: a. The included patients were divided into three groups according to injury type (fracture, joint dislocation, and soft tissue injury), with 50 patients in each group; b. Apply the composition of the present invention according to the dosage and usage (once a day, treatment course: 4 weeks for fractures, 2 weeks for dislocations and soft tissue injuries); c. Combined with conventional treatment (plaster fixation, bandage immobilization).

[0101] B. Observation indicators: pain score (VAS, 0-10 points); Swelling reduction rate (measured by the difference in circumference of the affected limb); Functional recovery (joint range of motion, muscle strength assessment); Adverse reactions (itching, erythema, etc.).

[0102] 2. Clinical efficacy statistics (1) Fracture patients (n=50)

[0103] (2) Patients with joint dislocation (n=50)

[0104] (3) Patients with soft tissue injury (n=50)

[0105] (4) Overall efficacy and safety

[0106] Adverse reactions: 2 cases (1.30%) experienced mild skin itching, which resolved spontaneously within 24 hours after drug discontinuation and did not affect the treatment process.

[0107] In the early stages of a fresh injury, blood overflows from the vessels, causing stasis. This stasis then accumulates, leading to swelling. This stasis and swelling then lead to blood stasis and qi stagnation, qi stagnation and dampness stagnation, and internal accumulation of damp heat. The accumulation of stasis and dampness causes fever in the injured area and even throughout the body. Therefore, swelling, pain, and stasis and heat are a comprehensive reflection of the fracture, tendon injury, bleeding, blood stasis, qi stagnation, dampness stagnation, and heat accumulation. Clinical statistics show a significant efficacy of 90.00% and an overall efficacy of 96.00% for treating fractures; an 88.00% significant efficacy and an overall efficacy of 96.00% for treating joint dislocations; and a 94.00% significant efficacy and an overall efficacy of 98.00% for treating soft tissue injuries. The traditional Chinese medicine composition of this invention has significant efficacy (overall efficacy >96%) for patients in the fresh stage of bone injuries and a good safety profile.

[0108] The above are merely preferred embodiments of the present invention. It should be noted that the above preferred embodiments should not be construed as limiting the present invention, and the scope of protection of the present invention should be determined by the scope defined in the claims. Persons skilled in the art will appreciate that improvements and modifications may be made without departing from the spirit and scope of the present invention, and such improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for the early and middle stages of bone injuries, characterized in that: The components of the traditional Chinese medicine composition are as follows: 25-75 parts of salvia miltiorrhiza, 12-38 parts of safflower, 8-25 parts of blood clovers, 10-30 parts of red peony root, 25-75 parts of angelica root, 15-45 parts of corydalis, 12-38 parts of notopterygium root, 12-38 parts of angelica dahurica, 10-30 parts of raw arisaema, 25-75 parts of trigonosciadium japonicum, 12-38 parts of zedoaria, 10-30 parts of green peel, 10-30 parts of dried tangerine peel, 10-30 parts of costus root, 25-30 parts of umbellate polypore. 75 parts, 15-45 parts of Fructus Liquidamina, 12-38 parts of Cortex Phellodendri, 12-38 parts of Atractylodes, 12-38 parts of Caulis Atractylodes, 10-30 parts of Caulis Atractylodes, 25-75 parts of Herba Taraxaci, 12-38 parts of Radix Scutellariae, 15-45 parts of Flos Lonicerae, 15-45 parts of Viola yedoensis, 12-38 parts of Rheum officinale, 12-38 parts of Radix Trichosanthis, 25-75 parts of Fructus Kochiae, 15-45 parts of Fructus Cnidium, 12-38 parts of Radix Dipsaci, 12-38 parts of Rhizoma Drynariae, and 5-20 parts of Radix Glycyrrhizae.

2. The Chinese medicine composition for early and middle stage bone injuries according to claim 1, characterized in that The components of the traditional Chinese medicine composition are as follows by weight: 50 parts of salvia miltiorrhiza, 25 parts of safflower, 15 parts of blood clovers, 20 parts of red peony root, 50 parts of angelica dahurica, 30 parts of corydalis yanhusuo, 25 parts of notopterygium wilfordii, 25 parts of angelica dahurica, 20 parts of raw arisaema, 50 parts of sparganium, 25 parts of zedoaria, 20 parts of green peel, 20 parts of dried tangerine peel, 20 parts of costus root, 50 parts of umbellate, 30 parts of rhubarb, 25 parts of phellodendron, 25 parts of atractylodes, 20 parts of chuanmutong, 50 parts of dandelion, 35 parts of scutellaria, 30 parts of honeysuckle, 30 parts of viola yedoensis, 25 parts of raw rhubarb, 25 parts of trichosanthes root, 50 parts of kochia scoparia, 30 parts of cnidium monnieri, 25 parts of dipsaccharum officinale, 25 parts of drynaria rhizome, and 10 parts of liquorice.

3. A Chinese medicine preparation for early and middle stage bone injuries, characterized in that: The traditional Chinese medicine preparation is prepared from the traditional Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable excipients.

4. The Chinese medicine preparation according to claim 3, characterized in that The dosage form of the Chinese medicine preparation is powder or plaster.

5. A method for preparing a Chinese medicine composition for early and middle stages of bone injury, characterized in that: Any of the following four methods: (1) The components described in claim 1 or 2 are crushed separately and then mixed; (2) The components described in claim 1 or 2 are mixed and then crushed; (3) Weigh salvia miltiorrhiza, safflower, red peony root, atractylodes, scutellaria, radix dipsaci, drynaria, zedoaria, cnidium monnieri, phellodendron, violet yedoensis, trillium, chuanketong, honeysuckle, angelica dahurica, rhubarb, fennel, dandelion, kochia fruit, umbellate, corydalis, radix trichosanthis, raw arisaema, and liquorice, mix and grind to obtain mixture 1; weigh notopterygium root, angelica dahurica, costus root, tangerine peel, and green peel, mix and grind to obtain mixture 2; weigh dragon's blood and grind to obtain grinded blood brown; mix mixture 1, mixture 2, and the grinded blood brown to obtain; (4) Obtain pharmaceutical powder according to preparation method (3), heat medical hot melt adhesive, resin, and mineral oil until melted, add the pharmaceutical powder and penetration enhancer after cooling, stir, apply on release paper, and cover with non-woven fabric backing to obtain the product.

6. The method for preparing the Chinese medicine composition according to claim 5, wherein: Before the components are crushed or mixed, they are first dried.

7. The method for preparing the Chinese medicine composition according to claim 5, wherein: The powder needs to be sieved after pulverization.

8. Use of the traditional Chinese medicine composition according to claim 1 or 2 in preparing a product for treating bone injuries.

9. The use according to claim 8, characterized in that The bone injuries include fractures, joint dislocations, and soft tissue injuries.

10. The use according to claim 8, characterized in that The bone injury treatment product is a product that can dissipate blood stasis, promote qi circulation, clear away heat and dampness, and connect bones and tendons.

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