Traditional Chinese medicine composition, traditional Chinese medicine preparation, preparation method and application thereof

Abstract

The application relates to the field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition, a traditional Chinese medicine preparation, a preparation method and application thereof. The traditional Chinese medicine composition contains angelica sinensis, safflower, red peony root, salvia miltiorrhiza, radix aconiti kusnezoffii, radix aconiti carmichaeli, cassia twig, drynaria, radix rubi sylvestris, frankincense, myrrh, radix rubi sylvestris, natural copper, elderberry, radix curdlane, crab shell and zhangdan. The preparation method of the traditional Chinese medicine preparation comprises the following steps: mixing angelica sinensis, safflower, red peony root, salvia miltiorrhiza, radix aconiti kusnezoffii, radix aconiti carmichaeli, cassia twig, drynaria, radix rubi sylvestris, radix rubi sylvestris, natural copper, elderberry, radix curdlane and crab shell with vegetable oil to perform frying and boiling, performing solid-liquid separation to obtain medicine oil; mixing the medicine oil after being refined with zhangdan, frankincense and myrrh to obtain an ointment; soaking the ointment in water, taking out, heating and melting, mixing with blood ointment powder, and spreading. The traditional Chinese medicine composition and the traditional Chinese medicine preparation have the effects of setting bone, continuing tendon and relieving swelling and pain.

Description

Traditional Chinese medicine compositions, traditional Chinese medicine preparations, their preparation methods and applications Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition, a traditional Chinese medicine preparation, its preparation method, and its application. Background Technology

[0002] Fractures are a very common type of bone injury in daily life. They are caused by external injuries or pathological conditions that result in the partial or complete breakage of bones. If not treated in time or improperly, they may cause lifelong disability, and in severe cases, even threaten life.

[0003] Currently, fracture treatment generally involves plaster casts or splints for fixation, oral administration of anti-inflammatory, analgesic, and antibacterial drugs, and in some cases, surgery is required. Patients then need to rest in bed. As the saying goes, "It takes a hundred days to recover from a bone injury," and fractures generally require at least three months or longer to heal after medication. The above methods rely on the patient's own healing and regeneration abilities to heal the fracture site. Patients not only miss work and study but also have to endure considerable pain.

[0004] To improve symptoms and promote healing, existing research and techniques have developed many topical plasters for treating traditional Chinese medicine bone and joint injuries (such as closed fractures, sprains, and soft tissue injuries). However, these plasters often have drawbacks such as poor drug absorption, limited relief of symptoms, long treatment cycles, and slow onset of action. Some are even expensive, placing a heavy financial burden on patients and affecting the clinical application of these drugs. Summary of the Invention

[0005] The purpose of this invention is to overcome the problems of poor absorption, limited relief of symptoms, long treatment cycle, and slow onset of action of existing bone injury plasters, and to provide a traditional Chinese medicine composition, traditional Chinese medicine preparation, preparation method and application thereof. The traditional Chinese medicine composition has the effects of promoting bone healing, reducing swelling and relieving pain.

[0006] To achieve the above objectives, the first aspect of the present invention provides a traditional Chinese medicine composition containing Angelica sinensis, safflower, red peony root, Salvia miltiorrhiza, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, cinnamon twig, Drynaria fortunei, Clematis chinensis, frankincense, myrrh, Clematis armandii, natural copper, Sambucus chinensis, Dipsacus asper, raw crab shell, dragon's blood, and cinnabar.

[0007] Preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 2-20 parts by weight, the content of red peony root is 2-20 parts by weight, the content of salvia miltiorrhiza is 2-20 parts by weight, the content of raw aconite root is 2-20 parts by weight, the content of raw aconite tuber is 2-20 parts by weight, the content of cinnamon twig is 2-20 parts by weight, the content of drynaria rhizome is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of frankincense is 2-20 parts by weight, the content of myrrh is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of natural copper is 2-20 parts by weight, the content of elderberry is 2-20 parts by weight, the content of Sichuan teasel root is 2-20 parts by weight, the content of raw crab shell is 2-20 parts by weight, the content of dragon's blood is 5-30 parts by weight, and the content of cinnabar is 100-250 parts by weight.

[0008] Preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

[0009] A second aspect of this invention provides a method for preparing a traditional Chinese medicine preparation, the method comprising the following steps:

[0010] (1) Angelica sinensis, safflower, red peony root, salvia miltiorrhiza, raw aconite, raw aconite root, cinnamon twig, drynaria fortunei, clematis root, clematis root, natural copper, elderberry, Sichuan teasel root, and raw crab shell are mixed with vegetable oil and fried and then separated into solid and liquid to obtain medicinal oil.

[0011] (2) The medicinal oil is boiled down and then mixed with camphor, frankincense and myrrh to obtain an ointment;

[0012] (3) After soaking the ointment in water, take it out, heat and melt it, mix it with blood powder and spread it on the surface.

[0013] Preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 2-20 parts by weight, the content of red peony root is 2-20 parts by weight, the content of salvia miltiorrhiza is 2-20 parts by weight, the content of raw aconite root is 2-20 parts by weight, the content of raw aconite tuber is 2-20 parts by weight, the content of cinnamon twig is 2-20 parts by weight, the content of drynaria rhizome is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of frankincense is 2-20 parts by weight, the content of myrrh is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of natural copper is 2-20 parts by weight, the content of elderberry is 2-20 parts by weight, the content of Sichuan teasel root is 2-20 parts by weight, the content of raw crab shell is 2-20 parts by weight, the content of dragon's blood is 5-30 parts by weight, and the content of cinnabar is 100-250 parts by weight.

[0014] Preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

[0015] Preferably, the total weight ratio of each Chinese herbal raw material to the weight of the vegetable oil in step (1) is 1:2-5; the vegetable oil is selected from at least one of sesame oil, soybean oil and rapeseed oil.

[0016] Preferably, the frying conditions include: a temperature of 180-240℃ and a time of 20-60 minutes.

[0017] Preferably, the conditions for refining the medicinal oil in step (2) include: a temperature of 260-320℃ and a time of 4-10h.

[0018] Preferably, the process of mixing with red lead, frankincense and myrrh includes: adding red lead while stirring the refined medicinal oil, then boiling it at a temperature of 260-320℃ until it drips into beads, and mixing it with frankincense and myrrh.

[0019] Preferably, the soaking conditions in the water in step (3) include: a temperature of 15-40°C and a time of 2-4 hours.

[0020] Preferably, the heating and melting rate is 3-6℃ / min; the substrate to be spread is gauze.

[0021] A third aspect of the present invention provides a traditional Chinese medicine preparation prepared according to the above-described preparation method.

[0022] A fourth aspect of the present invention provides the use of the above-described traditional Chinese medicine composition and / or the above-described traditional Chinese medicine preparation in the preparation of a medicine for treating fractures.

[0023] Through the above technical solution, the beneficial effects of the present invention are as follows: The traditional Chinese medicine composition provided by the present invention is scientifically formulated and of excellent quality. When used together, the various medicines work together to promote bone healing, reduce swelling and relieve pain. It can effectively treat fractures and bone injuries, and is well absorbed and fast-acting, which can effectively shorten the treatment cycle. The raw materials are natural, environmentally friendly, safe and non-toxic, and have good application prospects. Detailed Implementation

[0024] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and these ranges or values ​​should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein.

[0025] The first aspect of the present invention provides a traditional Chinese medicine composition containing Angelica sinensis, safflower, red peony root, Salvia miltiorrhiza, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, cinnamon twig, Drynaria fortunei, Clematis chinensis, frankincense, myrrh, Clematis armandii, natural copper, Sambucus chinensis, Dipsacus asper, raw crab shell, dragon's blood, and cinnabar.

[0026] Pharmacological analysis of the raw materials used in this invention:

[0027] Angelica sinensis (Oliv.) Diels, a plant of the Apiaceae family, is sweet and pungent in taste and warm in nature. It has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation.

[0028] Safflower: The dried flower of Carthamus tinctorius L., a plant in the Asteraceae family. It has a pungent taste and warm properties; it has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain.

[0029] Red peony root: The dried root of Paeonia lactiflora or Paeonia veitchii, a plant in the Ranunculaceae family. It tastes bitter and is slightly cold in nature. It has the effects of clearing heat and cooling blood, dispersing blood stasis and relieving pain.

[0030] Danshen: The dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. It has a bitter taste and is slightly cold in nature. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and eliminating carbuncles.

[0031] Raw Aconitum carmichaelii: It has a slight odor and a pungent taste; it has the effects of dispelling cold and dampness, dispersing wind and evil, warming the meridians and relieving pain, breaking up accumulations and eliminating phlegm.

[0032] Raw aconite: The tuberous root of Aconitum carmichaelii (wild species) or Aconitum kusnezoffii, a perennial herb of the Ranunculaceae family. It has a pungent, bitter, and hot taste; it has the effects of dispelling wind and dampness, warming the meridians and dispersing cold, reducing swelling and relieving pain.

[0033] Cinnamon twig: It has a pungent and hot taste; it has the effects of inducing sweating and relieving muscle tension, warming and unblocking the meridians, assisting yang and transforming qi, and calming and descending qi.

[0034] Drynaria fortunei: It has the effects of tonifying the kidneys and strengthening bones, healing injuries and relieving pain.

[0035] Speranskia tuberculata (Bunge) Baill., a plant belonging to the Euphorbiaceae family, is a pungent and warm plant. It has the effects of dispelling wind and dampness, relaxing muscles and promoting blood circulation, dispersing blood stasis and reducing swelling, and detoxifying and relieving pain.

[0036] Frankincense: The resin exuded from the bark of Boswellia carterii Birdw. and Boswellia bhaurdajiana Birdw., both belonging to the Burseraceae family. It has a pungent, bitter, and warm taste; it is used to promote blood circulation, relieve pain, reduce swelling, and promote tissue regeneration.

[0037] Myrrh: The dried resin of Commiphora myrrha Engl. or Commiphora molmol Engl., plants of the Burseraceae family. It has a pungent and bitter taste and is neutral in nature. It has the effects of dispersing blood stasis, relieving pain, reducing swelling and promoting tissue regeneration.

[0038] Touguxiao: The root or leaves of the sandalwood plant (Rhododendron family), bitter and pungent, warm in nature; it has the effects of dispelling wind and removing dampness.

[0039] Native copper: Pyrite, a sulfide mineral belonging to the pyrite group, mainly containing iron disulfide (FeS2). It is bitter and pungent, and neutral in nature; it has the effects of dispersing blood stasis, relieving pain, and promoting tendon and bone healing.

[0040] Elderberry: The stems and branches of the elderberry plant (Ligustrum lucidum), belonging to the Caprifoliaceae family. It is sweet and bitter, and neutral in nature; it has the effects of dispelling wind, promoting diuresis, activating blood circulation, and relieving pain.

[0041] Sichuan teasel root: bitter and pungent in taste, slightly warm in nature; it has the effects of tonifying the liver and kidneys, strengthening tendons and bones, regulating blood vessels, and stopping metrorrhagia.

[0042] Raw crab shells: salty in taste and cold in nature; they have the effects of dispersing blood stasis, stopping bleeding, detoxifying, and reducing swelling.

[0043] Blood Dragon's Blood: The resin exuded from the fruit of the palm tree *Dracaena cochinchinensis* is processed. It has a sweet and salty taste and is neutral in nature. It has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, promoting tissue regeneration and healing sores.

[0044] Cinnamomum camphora: It has the effects of relieving phlegm and timidity, eliminating food stagnation and killing parasites, treating diarrhea, malaria, fever, and detoxification.

[0045] All the traditional Chinese medicine components used in this invention can be obtained commercially.

[0046] The traditional Chinese medicine composition of this invention has a unique and rational formulation. The combination of the above raw materials allows them to work synergistically to promote bone healing, reduce swelling, and relieve pain. It can effectively treat fractures and bone injuries, and is well absorbed and has a rapid onset of action, effectively shortening the treatment cycle. The raw materials are natural, environmentally friendly, safe, and non-toxic, showing good application prospects. After repeated research and optimization, the traditional Chinese medicine composition provided by this invention has achieved good results in clinical practice.

[0047] According to the present invention, preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 2-20 parts by weight, the content of red peony root is 2-20 parts by weight, the content of salvia miltiorrhiza is 2-20 parts by weight, the content of raw aconite root is 2-20 parts by weight, the content of raw aconite tuber is 2-20 parts by weight, the content of cinnamon twig is 2-20 parts by weight, the content of drynaria rhizome is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of frankincense is 2-20 parts by weight, the content of myrrh is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of natural copper is 2-20 parts by weight, the content of elderberry is 2-20 parts by weight, the content of Sichuan teasel root is 2-20 parts by weight, the content of raw crab shell is 2-20 parts by weight, the content of dragon's blood is 5-30 parts by weight, and the content of cinnabar is 100-250 parts by weight; all the weight parts of the above Chinese medicinal materials are based on dry weight. Depending on the patient's constitution and symptoms, the dosage of each of the above-mentioned Chinese medicinal ingredients can be adjusted within the given range to achieve the best therapeutic effect.

[0048] More preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

[0049] A second aspect of this invention provides a method for preparing a traditional Chinese medicine preparation, the method comprising the following steps:

[0050] (1) Angelica sinensis, safflower, red peony root, salvia miltiorrhiza, raw aconite, raw aconite root, cinnamon twig, drynaria fortunei, clematis root, clematis root, natural copper, elderberry, Sichuan teasel root, and raw crab shell are mixed with vegetable oil and fried and then separated into solid and liquid to obtain medicinal oil.

[0051] (2) The medicinal oil is boiled down and then mixed with camphor, frankincense and myrrh to obtain an ointment;

[0052] (3) After soaking the ointment in water, take it out, heat and melt it, mix it with blood powder and spread it on the surface.

[0053] In this invention, there are no special limitations on the methods and equipment for frying, solid-liquid separation, and refining. For example, solid-liquid separation can be achieved by scooping, filtering, centrifugation, or other methods. Dragon's blood powder is the powdered form of dragon's blood; it can be obtained by purchasing powdered products directly or by purchasing block-shaped dragon's blood and crushing it.

[0054] According to the present invention, preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 2-20 parts by weight, the content of red peony root is 2-20 parts by weight, the content of salvia miltiorrhiza is 2-20 parts by weight, the content of raw aconite root is 2-20 parts by weight, the content of raw aconite tuber is 2-20 parts by weight, the content of cinnamon twig is 2-20 parts by weight, the content of drynaria rhizome is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of frankincense is 2-20 parts by weight, the content of myrrh is 2-20 parts by weight, the content of clematis root is 2-20 parts by weight, the content of natural copper is 2-20 parts by weight, the content of elderberry is 2-20 parts by weight, the content of Sichuan teasel root is 2-20 parts by weight, the content of raw crab shell is 2-20 parts by weight, the content of dragon's blood is 5-30 parts by weight, and the content of cinnabar is 100-250 parts by weight.

[0055] According to the present invention, preferably, relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

[0056] In step (1) of the present invention, each Chinese herbal medicine component can be directly mixed with vegetable oil for frying, or some or all of the Chinese herbal medicine components can be pulverized and then mixed with vegetable oil for frying.

[0057] According to the present invention, preferably, the total weight ratio of each Chinese herbal raw material to the weight ratio of the plant oil in step (1) is 1:2-5. The inventors have found that, under this preferred embodiment, the extraction efficiency of the effective components in each raw material can be improved.

[0058] According to the present invention, the vegetable oil can be any type of vegetable oil that can be used to prepare ointments, and preferably, the vegetable oil is selected from at least one of sesame oil, soybean oil and rapeseed oil.

[0059] According to the present invention, the frying or boiling process generally involves frying the medicinal materials until the surface is dark brown and the interior is golden brown. Preferably, the frying or boiling conditions include: a temperature of 180-240℃, specifically 180℃, 190℃, 200℃, 210℃, 220℃, 230℃, and 240℃, or any value between any two of the above; and a time of 20-60 minutes, specifically 20 minutes, 30 minutes, 40 minutes, 50 minutes, and 60 minutes, or any value between any two of the above. The inventors have found that, under this preferred embodiment, the extraction efficiency of the effective components in each raw material can be further improved.

[0060] According to the present invention, preferably, the conditions for refining the medicinal oil in step (2) include: a temperature of 260-320℃, specifically 260℃, 270℃, 280℃, 290℃, 300℃, 310℃ and 320℃, or any value between any two of the above values; and a time of 4-10h, specifically 4h, 6h, 8h, 10h, or any value between any two of the above values.

[0061] According to the present invention, preferably, the process of mixing with red lead, frankincense, and myrrh includes: adding red lead while stirring the refined medicinal oil, then heating it at a temperature of 260-320°C until it drips into beads, and then mixing it with frankincense and myrrh. Specifically, the condition for dripping into beads is that when a small amount of medicinal oil is dropped into water, the oil droplets gather into beads and do not disperse. Specifically, prepare a basin of water in advance, use a stirring stick to pick up 1-2 drops of medicinal oil, and drop them into the water basin. When the oil drops into the water, gravity causes the oil droplets to disperse initially, and then the oil droplets gather into beads and do not disperse.

[0062] According to the present invention, preferably, the conditions for soaking in water in step (3) include: a temperature of 15-40°C and a time of 2-4 hours.

[0063] According to the present invention, preferably, the heating and melting rate is 3-6℃ / min; the inventors have found that, under this preferred embodiment, using a low flame for heating and melting can better preserve the effective components of the ointment and enhance its effects of promoting bone healing, reducing swelling and relieving pain.

[0064] In this invention, the spreading process can use any substrate suitable for ointment application. Preferably, the substrate for spreading is gauze.

[0065] A third aspect of the present invention provides a traditional Chinese medicine preparation prepared according to the above-described preparation method.

[0066] The traditional Chinese medicine preparation provided by this invention is a plaster, but other types of preparations can also be prepared using the above-mentioned traditional Chinese medicine composition to facilitate the application and promotion of this traditional Chinese medicine composition.

[0067] A fourth aspect of the present invention provides the use of the above-described traditional Chinese medicine composition and / or the above-described traditional Chinese medicine preparation in the preparation of a medicine for treating fractures.

[0068] In this invention, the treatment for fractures can be the traditional Chinese medicine preparation provided by this invention, or the above-mentioned traditional Chinese medicine preparation can be further supplemented with pharmaceutically conventional excipients; the method of use can also adopt conventional methods in the field of traditional Chinese medicine, for example, the above-mentioned traditional Chinese medicine preparation (plaster) can be applied to the fracture site once a week.

[0069] The present invention will be described in detail below through embodiments.

[0070] In the following examples, the raw materials such as Angelica sinensis, safflower, red peony root, Salvia miltiorrhiza, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, cinnamon twig, Drynaria fortunei, Clematis chinensis, frankincense, myrrh, Clematis armandii, natural copper, elderberry, Dipsacus asper, raw crab shell, dragon's blood, and red cinnabar are all commercially available conventional products.

[0071] Example 1

[0072] (1) Mix 30g Angelica sinensis, 30g Carthamus tinctorius, 30g Paeonia lactiflora, 30g Salvia miltiorrhiza, 30g Aconitum carmichaelii, 30g Aconitum kusnezoffii, 30g Cinnamomum cassia, 30g Drynaria fortunei, 30g Clematis chinensis, 30g Clematis chinensis, 30g natural copper, 30g Sambucus chinensis, 30g Dipsacus asper and 30g raw crab shell with 1.5kg sesame oil and fry at 200℃ for 40 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0073] (2) After boiling the medicinal oil at 300℃ for 6 hours, add 500g of camphor while stirring, and boil it at 300℃ until it drips into beads. Then mix it with 30g of frankincense and 30g of myrrh to obtain the ointment.

[0074] (3) After soaking the ointment in water at room temperature (25℃) for 3 hours, take it out and heat it at a heating rate of 4℃ / min to melt it. Then mix it with 50g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0075] Example 2

[0076] (1) Mix 10g Angelica sinensis, 15g Carthamus tinctorius, 15g Paeonia lactiflora, 15g Salvia miltiorrhiza, 15g Aconitum carmichaelii, 15g Aconitum kusnezoffii, 15g Cinnamomum cassia, 15g Drynaria fortunei, 15g Clematis chinensis, 15g Clematis chinensis, 15g Copper sulfate, 15g Sambucus chinensis, 15g Dipsacus asper and 15g raw crab shell with 1025g rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0077] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 200g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 15g of frankincense and 15g of myrrh to obtain the ointment.

[0078] (3) After soaking the ointment in water at 15°C for 4 hours, take it out and heat it at a rate of 3°C / min to melt it. Then mix it with 20g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0079] Example 3

[0080] (1) Mix 10g Angelica sinensis, 5g Carthamus tinctorius, 5g Paeonia lactiflora, 5g Salvia miltiorrhiza, 5g Aconitum carmichaelii, 5g Aconitum kusnezoffii, 5g Cinnamomum cassia, 5g Drynaria fortunei, 5g Clematis chinensis, 5g Clematis armandii, 5g natural copper, 5g Sambucus chinensis, 5g Dipsacus asper and 5g raw crab shell with 150g soybean oil and fry at 240℃ for 20 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0081] (2) After boiling the medicinal oil at 320℃ for 4 hours, add 150g of camphor while stirring, and boil it at 320℃ until it drips into beads. Then mix it with 5g of frankincense and 5g of myrrh to obtain the ointment.

[0082] (3) After soaking the ointment in 40℃ water for 2 hours, take it out and heat it at a heating rate of 6℃ / min to melt it. Then mix it with 10g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0083] Example 4

[0084] (1) Mix 10g Angelica sinensis, 20g Carthamus tinctorius, 20g Paeonia lactiflora, 20g Salvia miltiorrhiza, 20g Aconitum carmichaelii, 20g Aconitum kusnezoffii, 20g Cinnamomum cassia, 20g Drynaria fortunei, 20g Clematis chinensis, 20g Clematis chinensis, 20g natural copper, 20g Sambucus chinensis, 20g Dipsacus asper and 20g raw crab shell with 1kg rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0085] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 250g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 20g of frankincense and 20g of myrrh to obtain the ointment.

[0086] (3) After soaking the ointment in water at 15°C for 4 hours, take it out and heat it at a rate of 3°C / min to melt it. Then mix it with 30g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0087] Example 5

[0088] (1) Mix 10g Angelica sinensis, 2g Carthamus tinctorius, 2g Paeonia lactiflora, 2g Salvia miltiorrhiza, 2g Aconitum carmichaelii, 2g Aconitum kusnezoffii, 2g Cinnamomum cassia, 2g Drynaria fortunei, 2g Clematis chinensis, 2g Clematis chinensis, 2g Copper sulfate, 2g Sambucus chinensis, 2g Dipsacus asper and 2g raw crab shell with 100g rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0089] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 100g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 2g of frankincense and 2g of myrrh to obtain the ointment.

[0090] (3) After soaking the ointment in water at 15℃ for 4 hours, take it out and heat it at a heating rate of 3℃ / min to melt it. Then mix it with 5g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0091] Example 6

[0092] The plaster was prepared according to the method of Example 2, except that step (1) was replaced with:

[0093] (1) Mix 10g Angelica sinensis, 15g Carthamus tinctorius, 15g Paeonia lactiflora, 15g Salvia miltiorrhiza, 25g Aconitum carmichaelii, 15g Aconitum kusnezoffii, 15g Cinnamomum cassia, 15g Drynaria fortunei, 15g Clematis chinensis, 1g Clematis chinensis, 15g natural copper, 25g Sambucus chinensis, 25g Dipsacus asper, and 15g raw crab shell with 1025g rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs turn yellow, remove the dregs to obtain the medicinal oil.

[0094] Example 7

[0095] The plaster was prepared according to the method of Example 2, except that the 1025g rapeseed oil in step (1) was replaced with 300g rapeseed oil.

[0096] Example 8

[0097] The plaster was prepared according to the method of Example 2, except that steps (2) and (3) were replaced with:

[0098] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 50g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 15g of frankincense and 15g of myrrh to obtain the ointment.

[0099] (3) After soaking the ointment in water at 15°C for 4 hours, take it out and heat it at a heating rate of 3°C / min until it melts. Then mix it with 2g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0100] Comparative Example 1

[0101] (1) Mix 10g Angelica sinensis, 15g Carthamus tinctorius, 15g Paeonia lactiflora, 15g Salvia miltiorrhiza, 15g Aconitum carmichaelii, 15g Cinnamomum cassia, 15g Drynaria fortunei, 15g Clematis chinensis, 15g natural copper, 15g Sambucus chinensis, 15g Dipsacus asper and 15g raw crab shell with 1025g rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0102] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 200g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 15g of frankincense and 15g of myrrh to obtain the ointment.

[0103] (3) After soaking the ointment in water at 15°C for 4 hours, take it out and heat it at a rate of 3°C / min to melt it. Then mix it with 20g of blood powder and spread it evenly on white gauze to obtain the plaster.

[0104] Comparative Example 2

[0105] (1) Mix 10g Angelica sinensis, 15g Carthamus tinctorius, 15g Paeonia lactiflora, 15g Salvia miltiorrhiza, 15g Aconitum carmichaelii, 15g Aconitum kusnezoffii, 15g Cinnamomum cassia, 15g Drynaria fortunei, 15g Clematis chinensis, 15g Clematis chinensis, 15g natural copper, 15g Sambucus chinensis and 15g Dipsacus asper with 1025g rapeseed oil and fry at 180℃ for 60 minutes. After the Chinese herbs are fried until yellow, remove the dregs to obtain the medicinal oil.

[0106] (2) After boiling the medicinal oil at 260℃ for 10 hours, add 200g of camphor while stirring, and boil it at 260℃ until it drips into beads. Then mix it with 15g of frankincense and 15g of myrrh to obtain the ointment.

[0107] (3) Soak the ointment in water at 15°C for 4 hours, then take it out and heat it at a rate of 3°C / min to melt it. Spread it evenly on white gauze to obtain the plaster.

[0108] Comparative Example 3

[0109] The plaster was prepared according to the method of Example 2, except that in step (1), raw aconite was replaced with notopterygium root and elderberry was replaced with valerian root.

[0110] Comparative Example 4

[0111] The plaster was prepared according to the method of Example 2, except that the raw crab shell in step (1) was replaced with abalone shell and the blood powder in step (3) was replaced with Panax notoginseng powder.

[0112] Comparative Example 5

[0113] (1) Prepare the following herbs: Clematis chinensis 40g, Lycopodium clavatum 50g, Areca catechu 40g, Alisma plantago-aquatica 30g, Clematis armandii 40g, Rehmannia glutinosa 40g, Cinnamomum cassia 30g, Ephedra sinica 30g, Paeonia lactiflora 20g, Aconitum carmichaelii 30g, Buthus martensii 30g, Cinnamomum cassia 60g, Bungarus fasciatus 50g, Gastrodia elata 60g, Arisaema heterophyllum 40g, Blisterella vesicatoria 50g, Eupolyphaga sinensis 55g, Panax ginseng 40g, Ambergris 40g, Sea dragon 40g, Achyranthes bidentata 35g, Seahorse 45g, Zanthoxylum bungeanum 35g, Angelica sinensis 40g, Ligusticum chuanxiong 40g, Pueraria lobata 40g, Angelica dahurica 25g, Commiphora myrrha 30g, Pheretima aspergillum 40g, Colla corii asini 45g, Deer antler 50g, Dracaena cochinchinensis 50g, and Pangolin scales 40g. Mix 50g of Asarum, 50g of Frankincense, 30g of Turmeric, 80g of Salvia miltiorrhiza, 30g of Chaenomeles speciosa, 20g of Panax notoginseng, 20g of Borneol, 20g of Lithospermum erythrorhizon, 15g of Scolopendra subspinipes, 20g of Paeonia lactiflora, 40g of Acanthopanax senticosus, 20g of Natural Copper, 20g of Schisandra chinensis, 20g of Crataegus pinnatifida, 80g of Carthamus tinctorius, 15g of Notopterygium incisum, 40g of Angelica pubescens, 20g of Saposhnikovia divaricata, 10g of Aconitum carmichaelii (processed), 20g of Dog Bone, 20g of Leech, 25g of Dragon Bone, 50g of Drynaria fortunei, 30g of Dioscorea nipponica, 40g of Cinnamomum cassia, 45g of Strychnos nux-vomica, 20g of Euryale ferox, and 1g of Musk with 2kg of sesame oil, fry at around 200℃ until golden brown, remove the dregs, and the oil after removing the dregs is the medicinal oil;

[0114] (2) Continue to boil the medicinal oil. When the oil temperature rises to about 300℃, switch to medium heat and continue boiling. When the oil droplets gather in the center of the pot, it is the best boiling temperature. After the medicinal oil is boiled, add 1000g of litharge to the iron pot. While adding litharge, stir the litharge and medicinal oil mixture in the same direction. When it is stirred into a thick paste, the plaster is not sticky and can be pulled into threads without breaking. The plaster process is completed. Spread the plaster in the pot that has not yet cooled down on paper to get the plaster.

[0115] Test Example 1

[0116] In 2021 and 2022, the inventor treated 72 cases of fractures (all diagnosed based on clinical manifestations and imaging examinations), including 45 males and 27 females, with the youngest being 10 years old and the oldest 70 years old, and an average age of 50 years. During treatment, after manual reduction, the plasters provided in Examples 1-8 were applied externally according to the patient's physical condition and symptoms. Follow-up visits were conducted, and the treatment effects were recorded and evaluated. The results are shown in Table 1. The evaluation criteria are as follows:

[0117] Healed: The fracture has healed completely, and the fracture line has disappeared;

[0118] Significant effect: Obvious callus formation at the fracture ends, and blurred fracture line;

[0119] Effective: There is obvious callus formation at the fracture ends, the fracture gap is narrowed, and there is no abnormal movement;

[0120] Ineffective: No obvious callus formation at the fracture ends, fracture line visible after cleaning, no change from before treatment.

[0121] Table 1

[0122]

[0123] It should be noted that in Table 1, the "+" in the number of patients treated in Examples 1-3 refers to 5 out of 72 fracture cases who used the plasters prepared in Comparative Examples 1-5 on the first and second days of treatment, but whose swelling and pain were still not effectively reduced by the third day. They then switched back to the plasters from Examples 1-3 for treatment. The corresponding number of days of treatment is calculated from the time the plasters from Examples 1-3 were used. In this invention, the plasters provided in Examples 1-8 caused pain to disappear after one day of application, and the swelling gradually subsided from the third day.

[0124] Test Example 2

[0125] Typical clinical applications of the traditional Chinese medicine composition of this invention:

[0126] Case 1: Mr. Peng, male, 35 years old, was admitted to the hospital on April 23, 2022. X-ray diagnosis showed a fracture of the 4th and 5th metatarsal bones of the left foot. After manual reduction, the plaster provided in Example 1 was applied to the fracture site and changed weekly. After two applications of the medication, the patient's pain stopped and the swelling and pain disappeared. After three applications of the medication, clinical healing was achieved, the external fixation was removed, and two more applications of the medication resulted in a complete cure.

[0127] Case 2: Ms. Zhao, 50 years old, fractured her wrist a year ago. After being treated with a cast at a hospital, the cast was removed. The fracture site would ache slightly on rainy days. She came to our clinic on the recommendation of someone to apply the plaster provided in Example 2. She changed the plaster once a week. After applying the plaster 5 times, the patient no longer had the ache on rainy days. She continued to apply the plaster 5 more times for consolidation treatment.

[0128] The preferred embodiments of the present invention have been described in detail above; however, the present invention is not limited thereto. Within the scope of the inventive concept, various simple modifications can be made to the technical solutions of the present invention, including combinations of various technical features in any other suitable manner. These simple modifications and combinations should also be considered as the content disclosed in the present invention and are all within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating fractures, characterized in that, This traditional Chinese medicine composition comprises Angelica sinensis, Carthamus tinctorius, Paeonia lactiflora, Salvia miltiorrhiza, Aconitum carmichaelii (raw), Aconitum kusnezoffii (raw), Cinnamomum cassia, Drynaria fortunei, Clematis chinensis, Boswellia carterii, Commiphora myrrha, Clematis armandii, natural copper, Sambucus chinensis, Dipsacus asper, raw crab shell, Daemonorops draco, and Litharge. Relative to 10 parts by weight of Angelica sinensis, the content of Carthamus tinctorius is 2-20 parts by weight, the content of Paeonia lactiflora is 2-20 parts by weight, the content of Salvia miltiorrhiza is 2-20 parts by weight, the content of Aconitum carmichaelii (raw), the content of Aconitum kusnezoffii (raw), the content of Cinnamomum cassia is 2-20 parts by weight, and the content of Drynaria fortunei is... The content of the herbal composition is 2-20 parts by weight of the following ingredients: * **Clematis chinensis**, * **Clematis armandii**, * **Boswellia carterii**, * **Myrrh**, * **Clematis chinensis**, * **Natural copper**, * **Eleutherococcus senticosus**, * **Dipsacus asper**, * **raw crab shell**, * **Dracaena cochinchinensis**, and 100-250 parts by weight. The dosage form of the herbal composition is a plaster.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

3. A method for preparing a traditional Chinese medicine preparation for treating fractures, characterized in that, The method includes the following steps: (1) mixing Angelica sinensis, safflower, red peony root, Salvia miltiorrhiza, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, cinnamon twig, Drynaria fortunei, Clematis chinensis, Clematis armandii, natural copper, elderberry, Dipsacus asper, and raw crab shell with vegetable oil, frying and separating the solid and liquid to obtain medicinal oil; (2) refining the medicinal oil and mixing it with camphor, frankincense, and myrrh to obtain an ointment; (3) soaking the ointment in water, taking it out, heating and melting it, mixing it with blood powder, and spreading it; relative to 10 parts by weight of Angelica sinensis, the content of safflower is 2-20 parts by weight, the content of red peony root is 2-20 parts by weight, the content of Salvia miltiorrhiza is 2-20 parts by weight, and the content of raw Aconitum carmichaelii is 2-20 parts by weight. The contents of the following herbs are as follows: Aconitum carmichaelii (2-20 parts by weight), Aconitum kusnezoffii (2-20 parts by weight), Cinnamomum cassia (2-20 parts by weight), Drynaria fortunei (2-20 parts by weight), Clematis chinensis (2-20 parts by weight), Boswellia carterii (2-20 parts by weight), Commiphora myrrha (2-20 parts by weight), Clematis chinensis (2-20 parts by weight), Natural copper (2-20 parts by weight), Sambucus chinensis (2-20 parts by weight), Dipsacus asper (2-20 parts by weight), Raw crab shell (2-20 parts by weight), Dragon's blood (5-30 parts by weight), and Lithium styrax (100-250 parts by weight).

4. The preparation method according to claim 3, characterized in that, Relative to 10 parts by weight of Angelica sinensis, the content of safflower is 5-15 parts by weight, the content of red peony root is 5-15 parts by weight, the content of salvia miltiorrhiza is 5-15 parts by weight, the content of raw aconite root is 5-15 parts by weight, the content of raw aconite tuber is 5-15 parts by weight, the content of cinnamon twig is 5-15 parts by weight, the content of drynaria rhizome is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of frankincense is 5-15 parts by weight, the content of myrrh is 5-15 parts by weight, the content of clematis root is 5-15 parts by weight, the content of natural copper is 5-15 parts by weight, the content of elderberry is 5-15 parts by weight, the content of Sichuan teasel root is 5-15 parts by weight, the content of raw crab shell is 5-15 parts by weight, the content of dragon's blood is 10-20 parts by weight, and the content of cinnabar is 150-200 parts by weight.

5. The preparation method according to claim 3 or 4, characterized in that, In step (1), the total weight of each Chinese herbal raw material is 1:2-5 to the weight of the vegetable oil; the vegetable oil is selected from at least one of sesame oil, soybean oil and rapeseed oil; the frying conditions include a temperature of 180-240℃ and a time of 20-60min.

6. The preparation method according to claim 3 or 4, characterized in that, The conditions for refining the medicinal oil in step (2) include: a temperature of 260-320℃ and a time of 4-10h; the process of mixing with red lead, frankincense and myrrh includes: adding red lead while stirring the refined medicinal oil, then boiling it at a temperature of 260-320℃ until it drips into beads, and mixing it with frankincense and myrrh.

7. The preparation method according to claim 3 or 4, characterized in that, The conditions for soaking in water in step (3) include: a temperature of 15-40℃ and a time of 2-4h; a heating rate of 3-6℃ / min for melting; and the substrate for spreading is gauze.

8. A traditional Chinese medicine preparation prepared by any one of claims 3-7.

9. The use of the traditional Chinese medicine composition according to claim 1 or 2 and / or the traditional Chinese medicine preparation according to claim 8 in the preparation of a drug for treating fractures, characterized in that, The drug is in the form of a plaster.

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