Traditional Chinese medicine composition for promoting reunion of fractured tendons and bones and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for promoting reunion of fractured tendons and bones and a preparation method thereof. The traditional Chinese medicine composition for promoting reunion of fractured tendons and bones is prepared from fructus gardeniae, folium ginkgo, flos carthami, pollen typhae, radix dipsaci, leeches, earthworms, radix achyranthis bidentatae, rhizoma curcumae and frankincense, has the effects of promoting qi circulation and dredging collaterals, promoting blood circulation and removing blood stasis and promoting reunion of the tendons and bones, has the effects of removing blood stasis, diminishing swelling, relieving pain, promoting reunion of the tendons and setting the bones, and can be used for treating swelling and pain of acute trauma, joint sprain, tendon fissure and fracture.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a tendon-repairing and bone-setting traditional Chinese medicine composition and a preparation method thereof. Background Art

[0002] In daily life, tendon and bone injuries are common and frequently occurring diseases, including fractures, bone cracks, femoral head necrosis, traumatic injuries, sprains, flash injuries, tendon ruptures, muscle strains, crush injuries, soft tissue injuries, etc., which seriously affect people's physical health and quality of life. Among them, fractures are the most common injury cases in orthopedics. Especially in today's society, due to the flow of people and traffic, and the widespread sports and competitive events, the number of fracture cases has shown a clear upward trend.

[0003] At present, Chinese herbal medicines for bone and tendon setting are mainly used in patients with limb fractures, ligament tears or ligament ruptures. Turmeric is a commonly used medicine for treating injuries and pain, and has the effect of promoting blood circulation, promoting qi and relieving pain. Frankincense is also one of the commonly used medicines, mainly for treating injuries and fractures, tendon injuries, and has a strong effect of promoting blood circulation and removing blood stasis.

[0004] The existing preparation method of tendon-reinforcement and bone-setting medicine is simple, the concentration of active drug ingredients is low, the curative effect is not high, and the treatment cycle is long. For example, the invention patent with publication number CN117838791A discloses a formula and process of eliminating stasis and reinforcing tendons and bone-setting powder, which is specifically related to a process of eliminating stasis and reinforcing tendons and bone-setting powder, comprising the following steps: S1, frankincense and myrrh are placed in a pot and fried with slow fire until the surface is slightly melted, and when there is a melting point, pure grain rice vinegar or aged vinegar is sprayed and stir-fried evenly; S2, natural copper is placed in a forge and calcined to red, and directly put into the rice vinegar solution; S3, the raw materials are dried in a drying oven and then cooled, and cloves, catechu, frankincense, and myrrh are added and crushed; S4, dragon's blood is ground into extremely fine powder, and then ground and mixed with part of the above-mentioned powder in a mortar; this technology stir-fries, crushes, and grinds Chinese medicine, and the concentration of active drug ingredients in the obtained formula is low, and the types of active ingredients are not abundant, and the curative effect is not high.

[0005] Therefore, providing a Chinese medicinal composition for tendon and bone repair with high efficacy and short treatment cycle is a technical problem that needs to be solved at present. Summary of the invention

[0006] The present invention aims at the above technical problems and proposes a technical solution of the present invention, which includes a tendon-repairing and bone-setting Chinese medicinal composition and a preparation method thereof.

[0007] The invention provides a Chinese medicinal composition for tendon and bone setting, wherein the raw materials for preparing the composition include gardenia, ginkgo leaf, safflower, pollen cattail, dipsacus root, leech, earthworm, achyranthes bidentata, zedoaria and frankincense.

[0008] Furthermore, the composition, measured by mass, includes raw materials including 0.5-2 parts of gardenia, 0.5-2 parts of ginkgo leaves, 0.5-2 parts of safflower, 0.4-2.6 parts of pollen, 0.6-2.8 parts of dipspermum, 0.3-2 parts of leech, 0.2-2.2 parts of earthworm, 0.3-2.4 parts of Achyranthes bidentata, 0.4-2.2 parts of Curcuma and 0.2-2 parts of frankincense.

[0009] Among them, Gardenia: clears away heat and relieves restlessness, clears away heat and dampness, cools blood and detoxifies; external application can reduce swelling and relieve pain.

[0010] Ginkgo biloba: It has the effects of promoting blood circulation and removing blood stasis, dredge meridians and relieve pain, astringe the lungs and relieve asthma, remove turbidity and reduce fat. It is used for blood stasis blocking the meridians, chest pain and heart pain, hemiplegia caused by stroke, cough and asthma caused by lung deficiency, and hyperlipidemia; it can be used externally to promote blood circulation and remove blood stasis, dredge meridians and relieve pain.

[0011] Safflower: It has the effects of promoting blood circulation, dredge menstruation, dissipate blood stasis and relieve pain. It is often used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to stasis, stabbing pain in the chest and ribs, injuries from falls, and swelling and pain in sores; external use can promote blood circulation, dredge menstruation, dissipate blood stasis and relieve pain.

[0012] Puhuang: It can stop bleeding, dissipate blood stasis, and relieve stranguria. It is often used for hematemesis, epistaxis, hemoptysis, metrorrhagia, traumatic bleeding, amenorrhea, dysmenorrhea, chest and abdominal pain, swelling and pain from falls, and hematuria. External use can stop capillary bleeding.

[0013] Dipsacus: nourishes the liver and kidneys, strengthens tendons and bones, regulates blood vessels, and stops metrorrhagia. It is mainly used to treat back pain, paralysis of limbs, trauma from falls, damaged tendons and broken bones, bleeding during fetal movement, metrorrhagia, spermatorrhea, leucorrhea, carbuncle, and swelling; external application can help mend tendons and bones.

[0014] Leeches: They have the effects of breaking blood and promoting menstruation, removing blood stasis and eliminating symptoms. They are often used for blood stasis, amenorrhea, lumps, hemiplegia caused by stroke, and injuries caused by falls. External use can regulate blood circulation and relax soft tissues.

[0015] Earthworm: It has the effects of clearing away heat and calming the nerves, unblocking meridians, relieving asthma and diuresis. It is often used for high fever and coma, epilepsy and convulsions, joint pain, limb numbness, hemiplegia, lung heat and cough, edema and oliguria; external use can regulate blood circulation and relax soft tissues.

[0016] Achyranthes bidentata: It has the effects of removing blood stasis, tonifying liver and kidney, strengthening tendons and bones, promoting diuresis and relieving stranguria, and guiding blood downward. It is often used for amenorrhea, dysmenorrhea, sore waist and knees, weak tendons and bones, stranguria, edema, headache, dizziness, toothache, mouth sores, hematemesis, and epistaxis; external use has the effects of removing blood stasis, dredge menstruation, strengthening tendons and bones, and strengthening the body.

[0017] Curcuma: It has the effects of promoting qi and removing blood, eliminating stagnation and relieving pain. It is often used for lumps and masses, blood stasis and amenorrhea, chest pain, heart pain, and food stagnation and pain; external use can remove blood stasis, reduce swelling and relieve pain.

[0018] Frankincense: It has the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. It is often used for chest pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to lumps, rheumatic pain, tendon spasm, traumatic injury, carbuncle, sore and ulcer. It can reduce swelling and promote tissue regeneration when used externally.

[0019] The present invention also provides the use of the composition in preparing a pharmaceutical preparation.

[0020] Furthermore, the pharmaceutical preparation is an external-use pharmaceutical preparation.

[0021] The invention also provides a pharmaceutical preparation, comprising the tendon-repairing and bone-setting Chinese medicinal composition and white wine.

[0022] Furthermore, the mass proportion of liquor in the medicine is 85-99%.

[0023] Furthermore, the alcohol content of white wine is 60-72 degrees.

[0024] The present invention also provides a method for preparing the tendon-repairing and bone-setting medicine, comprising the steps of mixing and placing the tendon-repairing and bone-setting Chinese medicine composition with white wine.

[0025] Further, the placement time is 10-60 days.

[0026] The present invention also provides a method for using the drug, comprising applying the drug to an affected area through a wet compress.

[0027] The present invention also provides a method for preparing a tendon-repairing and bone-setting Chinese medicinal composition, comprising the following steps:

[0028] S1: According to parts by mass, 0.5-2 parts of Gardenia, 0.5-2 parts of Ginkgo biloba leaves, 0.5-2 parts of Carthamus tinctorius, 0.4-2.6 parts of Pollen Typhae, 0.6-2.8 parts of Dipsacus asper, 0.3-2 parts of Leech, 0.2-2.2 parts of Pheretima, 0.3-2.4 parts of Achyranthes bidentata, 0.4-2.2 parts of Curcuma zedoaria and 0.2-2 parts of Frankincense are crushed and mixed to obtain a mixed powder, and water is added for decoction, and the mixture is cooled to obtain a decoction;

[0029] S2: Add sucrose to the decoction, stir evenly, and sterilize to obtain the material; inoculate the material with fermentation bacteria Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713, and the inoculation number of the fermentation bacteria is 3.8×10 9 -6.7×10 9 cfu / g material, then ferment and sterilize to obtain a fermentation product;

[0030] S3: sterilizing the fermentation product, filtering, concentrating the filtrate under reduced pressure to obtain a concentrate, mixing the concentrate with an extract consisting of water and a composite organic solvent, extracting under stirring conditions, and pouring out the water phase to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate in a mass ratio of 1:2-3.5;

[0031] S4: The extract is concentrated under reduced pressure until no complex organic solvent is detected, and the concentration is stopped to obtain the tendon-repairing and bone-setting Chinese medicine composition.

[0032] Furthermore, in S1, water in an amount of 10-24 times the mass of the mixed powder is added.

[0033] Further, in S1, the mixture is boiled at 80-90° C. for 4-8 hours.

[0034] Further, in S1, cooling to room temperature.

[0035] Furthermore, in S2, 1-4.6% of sucrose by mass of the decoction liquid is added to the decoction liquid.

[0036] Furthermore, in S2, fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 are inoculated into the material in a ratio of 0.2-1:1.

[0037] Further, in S2, fermentation is carried out at 34-42°C for 80-105 days.

[0038] Further, in S3, the filtrate is concentrated under reduced pressure to 1-3 times the mass of the mixed powder to obtain a concentrate.

[0039] Further, in S3, the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:12-30.

[0040] Further, in S3, the extraction is carried out under stirring conditions at 30-40° C. for 3-6 hours.

[0041] Further, in S3, the extraction is carried out under stirring conditions at 30-40° C. for 3-6 hours.

[0042] Furthermore, in S3, the composite organic solvent is composed of cyclohexane and ethyl acetate in a mass ratio of 1:2-3.5.

[0043] Furthermore, in S3, the mass ratio of water to the composite organic solvent in the extract is 1:1.5-3.

[0044] Further, in S4, the extract is concentrated under reduced pressure at 35-50° C. until no composite organic solvent is detected, and the concentration is stopped.

[0045] Furthermore, the preparation method of the tendon-repairing and bone-setting Chinese medicine composition comprises the following steps:

[0046] S1: According to weight parts, 0.5-2 parts of Gardenia, 0.5-2 parts of Ginkgo biloba leaves, 0.5-2 parts of Carthamus tinctorius, 0.4-2.6 parts of Pollen Typhae, 0.6-2.8 parts of Dipsacus asper, 0.3-2 parts of Leech, 0.2-2.2 parts of Pheretima, 0.3-2.4 parts of Achyranthes bidentata, 0.4-2.2 parts of Curcuma zedoaria and 0.2-2 parts of Frankincense are crushed and mixed to obtain a mixed powder, and water 10-24 times the weight of the mixed powder is added, and the mixture is decocted at 80-90° C. for 4-8 hours, and cooled to obtain a decoction;

[0047] S2: 1-4.6% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.2-1:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 3.8×10 9 -6.7×10 9 cfu / g material, then ferment at 34-42°C for 80-105 days, sterilize, and obtain a fermentation product;

[0048] S3: sterilize the fermentation product, filter, and concentrate the filtrate under reduced pressure to 1-3 times the mass of the mixed powder to obtain a concentrate, mix the concentrate with an extract consisting of water and a composite organic solvent at a mass ratio of 1:12-30, extract at 30-40° C. under stirring conditions for 3-6 hours, pour out the aqueous phase, and obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:2-3.5, and the mass ratio of water to the composite organic solvent in the extract is 1:1.5-3;

[0049] S4: The extract is concentrated under reduced pressure at 35-50° C. until no complex organic solvent is detected, and the concentration is stopped to obtain the tendon-repairing and bone-setting Chinese medicine composition.

[0050] Bacillus subtilis CICC 10397 described in this article: strain number CICC 10397, commercially purchased from: China Industrial Microorganism Culture Collection Administration Center. Bacillus licheniformis CICC 23713: strain number CICC 23713, commercially purchased from: China Industrial Microorganism Culture Collection Administration Center.

[0051] Beneficial effects of the present invention:

[0052] The invention adopts gardenia, ginkgo leaf, safflower, pollen cattail, dipsacus, leech, earthworm, achyranthes, zedoaria and frankincense to prepare the medicine composition, which can promote qi and dredge collaterals, activate blood circulation and remove blood stasis, and promote tendon and bone healing. It has the effects of removing blood stasis, reducing swelling, relieving pain, promoting tendon and bone healing, and can be used for swelling and pain caused by acute trauma, joint sprain, tendon rupture and bone fracture.

[0053] The composition of the present invention can effectively promote the formation of callus and also has a good anti-swelling effect; callus refers to the fiber, cartilage and bone structure formed during the fracture repair process; after a fracture, a small number of bone cells at the fracture end will be necrotic, and then under the regulation of hormone levels in the body, the function of osteoclasts at the fracture site will be inhibited, and at the same time, osteoblasts will grow in large quantities, and the growing osteoblasts will gradually form callus, indicating that the fracture has begun to heal. It can be seen that the composition of the present invention has a good tendon-repairing and bone-setting effect.

[0054] The test experiment on mice showed that the composition of the present invention can increase the mass of callus by 15.66 mg compared with the blank group after continuous administration for 30 days, and has a high efficiency of bone and tendon healing.

[0055] The composition of the present invention was tested in mice and the results showed that after continuous administration for 7 days, the swelling rate was as low as 70.38% compared with the blank group, which enabled the bones to heal with low pain.

[0056] The present invention adopts a fermentation process to enhance the bone-setting effect of the composition, so that the type, concentration and activity of the active ingredients of the composition are better, and the composition is endowed with excellent effects; the present invention uses specific fermentation bacteria Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 to produce a mutually promoting and enhancing bone-setting effect.

[0057] The invention adopts a specific composite organic solvent to match the extractant, which is more suitable for the preparation system of the invention than other organic solvents and water, and can further improve the efficacy of the composition of the invention. The extractant obtained by matching ethyl acetate and cyclohexane can produce better effects than one of them, and the two can synergistically increase the efficacy of the composition; when the ratio of the two is 1:2-3.5, the obtained composition has better efficacy. DETAILED DESCRIPTION

[0058] The present invention will be described below in conjunction with specific embodiments, and various effects of the present invention will be more clearly presented. It should be understood by those skilled in the art that these specific embodiments are used to illustrate the present invention, rather than to limit the present invention.

[0059] 1. Preparation of the composition

[0060] Composition 1: The preparation method thereof comprises the following steps:

[0061] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0062] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0063] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, and the extract is carried out under stirring conditions at 38°C for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:3, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0064] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0065] Composition 2: The preparation method thereof comprises the following steps:

[0066] S1: According to weight parts, 1.3 parts of Gardenia, 1.3 parts of Ginkgo biloba, 1 part of Carthamus tinctorius, 1.1 parts of Pollen Typhae, 1.2 parts of Dipsacus asper, 1.1 parts of Leech, 1.4 parts of Pheretima, 1.1 parts of Achyranthes bidentata, 1.5 parts of Curcuma zedoaria and 1.3 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 19 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5.2 hours, and cooled to obtain a decoction;

[0067] S2: 4.05% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.2:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.38×10 9 cfu / g material, then fermented at 39°C for 90 days, sterilized, and obtained the fermentation product;

[0068] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.45 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:27.2, and the extract is carried out under stirring conditions at 38°C for 5.5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:2, and the mass ratio of water to the composite organic solvent in the extract is 1:1.5;

[0069] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0070] Composition 3: The preparation method thereof comprises the following steps:

[0071] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0072] S2: sterilize the decoction, filter, and concentrate the filtrate at 60°C and 0.03MPa under reduced pressure to 1.5 times the mass of the mixed powder to obtain a concentrate, mix the concentrate with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, extract at 38°C under stirring conditions for 5 hours, pour out the aqueous phase, and obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:3, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0073] S3: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0074] Composition 4: The preparation method thereof comprises the following steps:

[0075] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0076] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; the material is inoculated with fermentation bacteria Bacillus subtilis CICC 10397, and the inoculation number of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0077] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, and the extract is carried out under stirring conditions at 38°C for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:3, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0078] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0079] Composition 5: The preparation method thereof comprises the following steps:

[0080] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0081] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; the material is inoculated with fermentation bacteria Bacillus licheniformis CICC 23713, and the inoculation number of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0082] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, and the extract is carried out under stirring conditions at 38°C for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:3, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0083] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0084] Composition 6: A preparation method thereof, comprising the following steps:

[0085] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0086] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0087] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and an organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the organic solvent is cyclohexane, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0088] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no organic solvent is detected, and the concentration is stopped to obtain the composition.

[0089] Composition 7: A preparation method thereof, comprising the following steps:

[0090] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0091] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0092] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and an organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the organic solvent is ethyl acetate, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0093] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no organic solvent is detected, and the concentration is stopped to obtain the composition.

[0094] Composition 8: The preparation method thereof comprises the following steps:

[0095] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0096] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0097] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:1, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0098] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0099] Composition 9: A preparation method thereof, comprising the following steps:

[0100] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0101] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0102] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and a composite organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate at a mass ratio of 1:6, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0103] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0104] Composition 10: A preparation method thereof, comprising the following steps:

[0105] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0106] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0107] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and an organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the organic solvent is petroleum ether, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0108] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no complex organic solvent is detected, and the concentration is stopped to obtain the composition.

[0109] Composition 11: A preparation method thereof, comprising the following steps:

[0110] S1: According to weight parts, 1.2 parts of Gardenia, 1.2 parts of Ginkgo biloba leaves, 1.2 parts of Carthamus tinctorius, 1.2 parts of Pollen Typhae, 1 part of Dipsacus asper, 1.2 parts of Leech, 1 part of Pheretima, 1.2 parts of Achyranthes bidentata, 1.2 parts of Curcuma zedoaria and 1.2 parts of Olibanum were crushed and mixed to obtain a mixed powder, and water 18.5 times the weight of the mixed powder was added, and the mixture was decocted at 82° C. for 5 hours, and cooled to obtain a decoction;

[0111] S2: 3.7% sucrose by weight of the decoction is added to the decoction, stirred evenly, and sterilized to obtain a material; fermentation bacteria consisting of Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 in a ratio of 0.5:1 are inoculated into the material, and the inoculation amount of the fermentation bacteria is 5.24×10 9 cfu / g material, then fermented at 40°C for 92 days, sterilized, and obtained the fermentation product;

[0112] S3: The fermentation product is sterilized and filtered, and the filtrate is concentrated under reduced pressure at 60°C and 0.03MPa to 1.5 times the mass of the mixed powder to obtain a concentrate, and the concentrate is mixed with an extract consisting of water and an organic solvent at a mass ratio of 1:28.6, and the extraction is carried out at 38°C under stirring conditions for 5 hours, and the aqueous phase is poured out to obtain an extract; wherein the organic solvent is chloroform, and the mass ratio of water to the composite organic solvent in the extract is 1:2.2;

[0113] S4: The extract is concentrated under reduced pressure at 48° C. and 0.01 MPa until no organic solvent is detected, and the concentration is stopped to obtain the composition.

[0114] The above compositions 1-11 were stirred and mixed with 65-degree liquor respectively, and left for 45 days to obtain pharmaceutical preparations 1-11 respectively, wherein the concentration of the composition in each pharmaceutical preparation was 95wt%. Then, the pharmaceutical preparations 1-11 were tested for their effects.

[0115] 3. Effect Test

[0116] 1. Fracture efficacy test

[0117] A number of healthy Kunming male mice weighing about 20±2g were selected, adaptively fed for 3 days, and then randomly divided into 10 groups, each group including blank control group, positive drug group, drug preparation 1-11 group, and a total of 13 groups. The specific experimental process is: the mice were anesthetized and the left hind leg tibia and fibula were broken and fixed with splints; each group was administrated in its own corresponding manner (among which, the positive drug group was administrated with drugs (drug name: Gukang Capsules, brand: Aoqining) by gavage, drug preparation 1-11 groups were administrated with drug preparation 1-11 in turn without removing the splint and applied to the fracture site, and the blank control group was not administrated), the gavage dosage of the positive drug group was 8g / kg of mouse body weight, and the external application dosage of drug preparation 1-11 group was 4.5g of drug preparation / kg of mouse body weight. The drugs were administered once a day for 30 consecutive days; each group of mice was adaptively fed and drank water during the experiment. Half an hour after the last administration, the mice were killed, the fractured legs were removed and fixed with 10% formaldehyde, the calluses were weighed, the average value was taken, and the increase ratio of the callus compared with the blank control group was calculated, and then summarized. The results are shown in Table 1.

[0118] Table 1: Fracture efficacy test

[0119]

[0120] 2. Anti-swelling and anti-inflammatory test

[0121] A number of healthy Kunming male mice weighing about 20±2g were selected, adaptively fed for 3 days, and then randomly divided into groups, with 10 mice in each group, including blank control group, positive drug group, and drug preparation 1-11 groups, for a total of 13 groups.

[0122] The positive drug group was gavaged with 1 mL / kg of mouse body weight of 0.5 g / L dexamethasone saline solution; the drug preparation 1-11 group was coated with drug preparation 1-11 on the left ear of the mouse and the dosage was 1.5 g of drug preparation / kg of mouse body weight; the blank control group was not treated. 1 time / day, for 7 consecutive days. Half an hour after the last administration, 0.05 mL of xylene was evenly applied to the left auricle of each mouse in each group to induce inflammation for 15 minutes, and then the mice were killed, and the same part of both ears was cut off with a puncher with d=6.5 mm, weighed, and the difference between the weight of the left and right ear pieces and the ratio of the weight of the right ear piece were marked as the swelling rate. The swelling rate of each group was calculated, and the results are shown in Table 2.

[0123] Table 2: Anti-swelling and anti-inflammatory test

[0124]

[0125]

[0126] The test results in Table 1-2 show that the composition of the present invention can effectively promote the formation of callus and also has a good anti-swelling effect; callus refers to the fiber, cartilage and bone structure formed during the fracture repair process; after a fracture, a small number of osteocytes at the fracture end will be necrotic, and then under the regulation of hormone levels in the body, the function of osteoclasts at the fracture site will be inhibited, and at the same time, osteoblasts will grow in large quantities, and the growing osteoblasts will gradually form callus, indicating that the fracture has begun to heal. It can be seen that the composition of the present invention has a good tendon-joining and bone-setting effect.

[0127] The test experiment on mice showed that the composition of the present invention can increase the mass of callus by 15.66 mg compared with the blank group after continuous administration for 30 days, and has a high efficiency of bone and tendon healing.

[0128] The composition of the present invention was tested in mice and the results showed that after continuous administration for 7 days, the swelling rate was as low as 70.38% compared with the blank group, which enabled the bones to heal with low pain.

[0129] The test results of drug preparations 1 and 3 show that the present invention uses a fermentation process to enhance the bone setting effect of the composition, so that the type, concentration and activity of the active ingredients of the composition are better, giving the composition excellent effects. The test results of drug preparations 1, 4-5 show that the use of specific fermentation bacteria Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713 can produce a mutually reinforcing bone setting effect, and the reason may be that the active ingredients of the fermented products of the two bacteria complement each other and produce a relationship that promotes the efficacy of the medicine.

[0130] The test results of pharmaceutical preparations 1, 10-11 show that the specific composite organic solvent used in the present invention is more suitable for the preparation system of the present invention than other organic solvents and water-based extractants, and can further enhance the efficacy of the composition of the present invention. The test results of preparations 1, 6-9 show that the extractant obtained by combining ethyl acetate and cyclohexane can produce better effects than one of them, and the two can synergistically increase the efficacy of the composition; and the composition obtained by a ratio of 1:2-3.5 has better efficacy.

[0131] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Chinese medicinal composition for tendon repair and bone setting, characterized in that: The preparation raw materials include gardenia, ginkgo leaf, safflower, pollen, dipsacus, leech, earthworm, Achyranthes bidentata, zedoaria and frankincense.

2. The composition according to claim 1, characterized in that Measured by mass, the raw materials include 0.5-2 parts of gardenia, 0.5-2 parts of ginkgo leaves, 0.5-2 parts of safflower, 0.4-2.6 parts of pollen, 0.6-2.8 parts of dipsaci, 0.3-2 parts of leech, 0.2-2.2 parts of earthworm, 0.3-2.4 parts of Achyranthes bidentata, 0.4-2.2 parts of Curcuma zedoaria and 0.2-2 parts of frankincense.

3. Use of the composition according to claim 1 or 2 in preparing a pharmaceutical preparation.

4. The use according to claim 3, characterized in that: The pharmaceutical preparation is an external-use pharmaceutical preparation.

5. A pharmaceutical preparation, characterized in that The invention comprises the tendon-repairing and bone-setting Chinese medicinal composition according to claim 1 or 2 and white wine.

6. The pharmaceutical preparation according to claim 5, characterized in that The mass proportion of liquor in the medicine is 85-99%.

7. The pharmaceutical preparation according to claim 5, characterized in that The alcohol content of white wine is 60-72 degrees.

8. A method for preparing the tendon-repairing and bone-setting medicine according to any one of claims 5 to 7, characterized in that: The method comprises the steps of mixing and placing the tendon-repairing and bone-setting Chinese medicinal composition with white wine.

9. The preparation method according to claim 8, characterized in that: The storage time is 10-60 days.

10. A method for preparing a tendon-repairing and bone-setting Chinese medicine composition, characterized in that: The steps include: S1: According to parts by mass, 0.5-2 parts of Gardenia, 0.5-2 parts of Ginkgo biloba leaves, 0.5-2 parts of Carthamus tinctorius, 0.4-2.6 parts of Pollen Typhae, 0.6-2.8 parts of Dipsacus asper, 0.3-2 parts of Leech, 0.2-2.2 parts of Pheretima, 0.3-2.4 parts of Achyranthes bidentata, 0.4-2.2 parts of Curcuma zedoaria and 0.2-2 parts of Frankincense are crushed and mixed to obtain a mixed powder, and water is added for decoction, and the mixture is cooled to obtain a decoction; S2: Add sucrose to the decoction, stir evenly, and sterilize to obtain the material; inoculate the material with fermentation bacteria Bacillus subtilis CICC 10397 and Bacillus licheniformis CICC 23713, and the inoculation number of the fermentation bacteria is 3.8×10 9 -6.7×10 9 cfu / g material, then ferment and sterilize to obtain a fermentation product; S3: sterilizing the fermentation product, filtering, concentrating the filtrate under reduced pressure to obtain a concentrate, mixing the concentrate with an extract consisting of water and a composite organic solvent, extracting under stirring conditions, and pouring out the water phase to obtain an extract; wherein the composite organic solvent is composed of cyclohexane and ethyl acetate in a mass ratio of 1:2-3.5; S4: The extract is concentrated under reduced pressure until no complex organic solvent is detected, and the concentration is stopped to obtain the tendon-repairing and bone-setting Chinese medicine composition.

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