Traditional Chinese medicine composition for treating fracture and application thereof
By using a Chinese medicine compound preparation made of compositions containing Chinese medicines such as Rehmannia and Safflower, the problem of difficulty in relieving pain and swelling after fracture is solved, and significant fracture healing effect and safety are achieved.
Patent Information
- Application Number
- CN202411776483.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-05
- Publication Date
- 2025-03-04
AI Technical Summary
Pain, swelling and dysfunction after fracture are difficult to effectively relieve, and existing Western medicine treatments have many complications, affecting fracture healing.
A Chinese medicine composition is adopted, including Rehmannia, safflower, red peony, peach kernel, angelica, cinnamon twig, Glauber's salt, tangerine peel, fried earthworm, turtle grass, turbid, licorice, mountain fragrance round leaves and wood fragrance. The traditional Chinese medicine compound preparation made by decoction or extract is used to promote blood circulation, remove swelling and relieve pain, and promote fracture healing.
It significantly relieves the pain and swelling after the fracture, speeds up the fracture healing rate, and reduces complications. The clinical symptoms scores, swelling degree and healing time of the patients in the trial group have significantly improved without adverse reactions.
Smart Images
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Abstract
Description
Technical Field
[0001] The invention belongs to the field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition having the functions of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and application of the composition in preparing a medicine for promoting fracture healing. Background Art
[0002] Fractures are caused by trauma or bone diseases, and are diseases characterized by the interruption of bone integrity and continuity. Traumatic fractures are caused by direct violence, indirect violence, fatigue fractures, etc. Fractures are manifested by local pain, swelling and functional impairment, and some fracture patients also have systemic manifestations such as shock and fever.
[0003] There are two treatment methods for fractures: general conservative treatment and surgical treatment. The first is general conservative treatment, which is suitable for patients with no obvious fracture displacement, or after manual reduction, the position of the fracture ends can be maintained by plaster, splints or continuous traction until the fracture heals. If the patient has an open fracture, it should be thoroughly debrided in time. The second is surgical treatment, usually open reduction and internal fixation, which is suitable for situations where soft tissues such as muscles or tendons are embedded between the fracture ends, and the intra-articular fracture is poorly aligned after manual reduction, and there are also phenomena such as manual reduction failing to meet the standard of functional reduction, fractures with major vascular and nerve damage that need to be repaired, multiple fractures to facilitate care and treatment to prevent complications, and unstable fractures. In addition, on the basis of general conservative treatment and surgical treatment, patients generally use drugs for treatment under the guidance of doctors, such as analgesics, non-steroidal anti-inflammatory drugs, dehydration and swelling drugs, anti-osteoporosis drugs and calcium agents and other Western medicines, but the use of Western medicine alone has many complications, making fracture healing more difficult.
[0004] In addition to active surgery and Western medicine treatment in modern medical clinical treatment, the auxiliary treatment of traditional Chinese medicine has received more and more attention. Currently, the commonly used traditional Chinese medicines include blood circulation and blood stasis, tendon strengthening and bone strengthening, and qi and blood tonifying. Studies have found that fractures will affect the body's microcirculation, severe ischemia of the fracture ends, aggravated pain after fractures, and muscle reflex spasms will also cause venous return obstruction, significant expansion of vascular walls, increased permeability, and severe edema in tissue spaces. If not treated in time, functional disorders will be aggravated, seriously affecting the prognosis and the patient's physical and mental health. The application of traditional Chinese medicine can improve the patient's blood circulation system, stimulate the patient's growth factor, make it more synthesized and secreted, and effectively regulate the activity of inflammatory factors and bone cells in the patient's blood, which has a very significant effect on fracture healing. Summary of the invention
[0005] The purpose of the present invention is to provide a Chinese medicine composition with the functions of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and its use in preparing a medicine for promoting fracture healing.
[0006] The technical solution adopted by the present invention is:
[0007] A Chinese medicine composition for treating bone fractures, comprising the following raw materials:
[0008] Rehmannia root, safflower, red peony root, stewed peach kernel, angelica root, chuanxiong root, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, lycopodii herb, turmeric, liquorice, round-leaved osmanthus fragrans, costusroot.
[0009] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight:
[0010] 5-45 parts of Rehmannia root, 5-30 parts of Carthamus tinctorius, 5-36 parts of Red Peony Root, 5-30 parts of Simmered Peach Kernel, 5-36 parts of Angelica sinensis, 5-30 parts of Ligusticum chuanxiong, 5-30 parts of Cinnamon Twig, 3-36 parts of Sodium Sulfate, 5-30 parts of Tangerine Peel, 5-30 parts of Stir-fried Eupolyphaga Seu Steleophora, 5-36 parts of Lycopodiella cuneata, 5-30 parts of Curcuma aromatica, 3-30 parts of Licorice, 5-90 parts of Fructus Cynanchum Roundi Leaves, and 3-18 parts of Aucklandia lappa.
[0011] Preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight:
[0012] 10-25 parts of Rehmannia root, 7-15 parts of Carthamus tinctorius, 7-15 parts of Red Peony Root, 8-20 parts of Simmered Peach Kernel, 10-25 parts of Angelica sinensis, 8-15 parts of Ligusticum chuanxiong, 5-12 parts of Cassia Twig, 4-12 parts of Sodium Sulfate, 5-15 parts of Tangerine Peel, 7-15 parts of Stir-fried Earthworm, 7-15 parts of Lycopodiella cuneata, 5-15 parts of Curcuma aromatica, 4-15 parts of Licorice, 7-30 parts of Fructus Cynanchum Roundi Leaves, and 5-20 parts of Aucklandia lappa.
[0013] More preferably, the Chinese medicine composition is composed of the following raw materials in parts by weight:
[0014] 12 parts of Rehmannia glutinosa, 10 parts of Carthamus tinctorius, 10 parts of Red Peony Root, 12 parts of Simmered Peach Kernel, 15 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 6 parts of Cinnamon Twig, 6 parts of Sodium Sulfate, 6 parts of Tangerine Peel, 10 parts of Stir-fried Eupolyphaga Scolopendra Subsoil, 10 parts of Lycopodiella Cervi Paniculata, 6 parts of Curcuma aromatica, 6 parts of Liquorice, 10 parts of Fructus Cynanchum Roundi, and 10 parts of Aucklandia lappa.
[0015] In the present application, the stewed peach kernels are the dried mature seeds of the Rosaceae plant peach or wild peach, which are put into boiling water and stewed until the seed coat changes from shrinking to stretching and can be easily rubbed off, then taken out, put into cold water, the seed coat is removed, dried in the sun, and crushed when used.
[0016] In the present application, the stir-fried earthworm is the dried female body of the Chinese earthworm or Chinese earthworm of the family Blattidae. After being caught, it is put into boiling water and scalded to death, and then sun-dried or oven-dried. Take the earthworm, put it into a stir-frying container, heat it with a slow fire, stir-fry until the fishy smell escapes and the surface is slightly shiny, then take it out and spread it to cool.
[0017] The present invention also provides a Chinese medicine compound preparation for treating fractures prepared from the Chinese medicine composition for treating fractures.
[0018] The dosage form of the Chinese medicine compound preparation includes tablets, capsules, granules, dripping pills, micropills, decoctions or mixtures. The Chinese medicine compound preparation can be prepared according to conventional pharmacy processes and pharmaceutical excipients acceptable to humans.
[0019] In the present invention, preferably, the Chinese medicine compound preparation can be a decoction or a mixture.
[0020] Furthermore, when the Chinese medicinal compound preparation for treating fracture is a decoction or a mixture, it is prepared by the following method:
[0021] Accurately weigh Rehmannia root, safflower, red peony root, stewed peach kernel, angelica root, Chuanxiong root, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, smilax glabra, curcuma, liquorice, safflower leaf, and costus root according to the ratio, soak them in 5-10 times the weight of cold water, boil over high heat, then simmer for 30-40 minutes over low heat, pour out the juice; add 3-7 times the weight of hot water, simmer for 20 minutes over low heat; combine the juices obtained twice, concentrate to a relative density of 1.10±0.05 at 60°C, add ethylparaben while hot, stir well, let stand, take the supernatant, and prepare it into a decoction or mixture.
[0022] When preparing a mixture, it is generally necessary to add ethylparaben as a pharmaceutical preservative.
[0023] The amount of ethylparaben added is generally 0.01 to 0.2% of the weight of all drugs.
[0024] When the Chinese medicinal compound preparation for treating fracture is in the form of tablets, capsules, granules, dripping pills or pellets, it is prepared by the following method:
[0025] According to the formula, take Rehmannia root, safflower, red peony root, stewed peach kernel, angelica, Chuanxiong, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, lycopodii herb, curcuma, liquorice, safflower leaf and costus root, mix them in proportion and grind them into powder, add 60% ethanol by volume, the mass of ethanol being 20 to 25 times the weight of all the drugs, heat and reflux for extraction 3 times, each time for 1 to 2 hours, combine the obtained extracts, evaporate and recover the ethanol, and make the obtained extracts and pharmaceutical excipients acceptable to the human body into tablets, capsules, granules, micropills or dripping pills.
[0026] The present invention also provides application of the traditional Chinese medicine composition for treating fracture or the traditional Chinese medicine compound preparation for treating fracture in preparing medicine for treating fracture.
[0027] The present invention also provides the use of the traditional Chinese medicine composition for treating fracture or the traditional Chinese medicine compound preparation for treating fracture in preparing medicines for promoting blood circulation, removing blood stasis, reducing swelling and relieving pain.
[0028] The formula of the Chinese medicine composition of the present invention follows the basic principle of TCM syndrome differentiation and treatment, and the raw material composition and dosage ratio are selected so that the components can coordinate and promote each other to play a synergistic effect.
[0029] The Chinese medicine composition for treating fractures and promoting fracture healing of the present invention is a modified Taohong Siwu Decoction. The monarch medicine in the prescription is stewed peach kernel and safflower; the minister medicine is prepared rehmannia root and angelica root; the adjuvant medicine is red peony root, cinnamon twig, stir-fried earthworm, spatholobus, and curcuma; the guiding medicine is costus root, chuanxiong, mirabilite, tangerine peel, liquorice, and safflower leaf. Taohong Siwu Decoction has the functions of promoting blood circulation, removing blood stasis, dredge menstruation and relieving pain. Cinnamon twig tastes pungent and sweet, is warm in nature, can induce sweating and relieve muscles, warm and dredge meridians, assist yang and transform qi, and is used for colds caused by wind and cold, cold pain in the wrist and abdomen, amenorrhea caused by cold blood, pain in joints, phlegm and fluid retention, etc. Glauber's salt tastes salty and bitter, is cold in nature, has laxative effects, moisturizes dryness and softens hard masses, clears away heat and reduces swelling; it is used for stagnation of excess heat, abdominal fullness and pain, dry and hard stools, and intestinal carbuncle swelling and pain; Tangerine peel tastes bitter and pungent, is warm in nature, regulates qi and strengthens the spleen, dries dampness and resolves phlegm, and is used for fullness in the wrist and abdomen, vomiting and diarrhea caused by loss of appetite, and cough with excessive sputum; Eupolyphaga sinensis tastes salty and is cold in nature, can break blood and remove blood stasis, connect tendons and set bones, and is used for injuries caused by falls, fractures caused by tendon injuries, amenorrhea caused by blood stasis, abdominal pain caused by postpartum blood stasis, and lumps and masses caused by abdominal masses; Stretching grass tastes slightly bitter and pungent, is warm in nature, and can dispel wind Dehumidification, relaxation of muscles and tendons, used for joint pain, difficulty in flexion and extension; Curcuma is pungent and bitter in taste, cold in nature, promotes blood circulation and relieves pain, promotes qi and relieves depression, clears the heart and cools blood, promotes bile and relieves jaundice, and is used for chest and flank tingling, chest obstruction and heart pain, amenorrhea and dysmenorrhea, etc.; Licorice is sweet in nature, flat in taste, tonifies the spleen and replenishes qi, clears away heat and relieves depression, removes phlegm and relieves cough, relieves urgency and relieves pain, and harmonizes various medicines, and is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with excessive sputum, acute pain in the abdomen and limbs, carbuncles and sores; Fragrance of the mountain is bitter in taste and cold in nature, clears away heat and detoxifies, relieves sore throat and reduces swelling, promotes blood circulation and relieves pain, and is used for sores, swellings and sores, and injuries from falls; Costus fragrance is pungent and bitter in nature, warm in nature, promotes qi and relieves pain, strengthens the spleen and promotes digestion, and is used for chest and flank, abdominal distension and pain, heaviness after diarrhea, and indigestion.
[0030] Compared with the prior art, the present invention has the following beneficial effects:
[0031] The Chinese medicine composition of the present invention can promote fracture healing. After the patient has fractured a bone, oral administration of the Chinese medicine composition liquid provided by the present invention can promote blood circulation and remove blood stasis, relieve swelling and relieve pain, relieve the degree of swelling, accelerate the degree of fracture healing, and reduce inflammation and coagulation, and reduce the occurrence of fracture complications. During the treatment period, the clinical symptom score, swelling degree, fracture healing time and hospitalization time of the test group of patients taking the Chinese medicine compound preparation of the present invention are positively correlated with the treatment time, and the normal recovery rate of each index is significantly improved compared with the control group (p < 0.05). No adverse reactions and complications were found in the test group, the method is simple, and the efficacy is determined.
[0032] In summary, the Chinese medicine composition and Chinese medicine compound preparation of the present invention have good therapeutic effects on promoting fracture healing, and have great application potential and practical significance in fracture drug treatment. The prescription is developed and prepared into a Chinese medicine decoction or mixture using traditional technology, and further promoted and applied, which has good social benefits and application value. DETAILED DESCRIPTION
[0033] In order to make the purpose, technical solutions and advantages of the present application clearer, the following will be described in detail with reference to the embodiments. It should be noted that the described embodiments are only a part of the present invention, not all embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present application.
[0034] Example 1
[0035] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 12g of Rehmannia root, 10g of safflower, 10g of red peony root, 12g of stewed peach kernel, 15g of angelica, 10g of Chuanxiong, 6g of cinnamon twig, 6g of mirabilite, 6g of dried orange peel, 10g of fried earthworm, 10g of smilax glabra, 6g of curcuma, 6g of liquorice, 10g of scutellaria baicalensis, 10g of costusroot, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add an appropriate amount of hot water and slowly boil for 20 minutes. Combine the two obtained juices, concentrate until the relative density of the concentrate at 60°C is 1.10±0.05, add 0.5 g of ethylparaben while hot, stir well, let stand, take the supernatant, add water to 100 ml, stir well, package, sterilize, and make a mixture.
[0036] Example 2
[0037] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 8g of Rehmannia root, 10g of safflower, 8g of red peony root, 10g of stewed peach kernel, 20g of angelica, 30g of Chuanxiong, 20g of cassia twig, 5g of mirabilite, 8g of dried orange peel, 12g of stir-fried earthworm, 15g of striata herba, 15g of turmeric, 25g of liquorice, 15g of round leaf of safflower, 15g of costusroot, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add appropriate amount of hot water, and slowly boil for 20 minutes over low heat. Combine the juices obtained twice and concentrate until the relative density of the concentrate at 60°C is 1.10±0.05. Add 0.52 g of ethylparaben while it is hot, stir well, let stand, take the supernatant, add water to 90 ml, stir well, divide and sterilize to make a mixture.
[0038] Example 3
[0039] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 25g of Rehmannia root, 25g of safflower, 30g of red peony root, 15g of stewed peach kernel, 10g of angelica, 10g of Chuanxiong, 12g of cinnamon twig, 10g of mirabilite, 20g of dried orange peel, 20g of fried earthworm, 20g of smilax glabra, 25g of curcuma, 15g of liquorice, 15g of round leaf of safflower, 10g of costus root, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add an appropriate amount of hot water and slowly boil for 20 minutes over low heat. Combine the two obtained juices, concentrate until the relative density of the concentrate at 60°C is 1.10±0.05, add 0.53 g of ethyl hydroxybenzoate while it is hot, stir well, let stand, take the supernatant, add water to 100 ml, stir well, package, sterilize, and make a mixture.
[0040] Example 4
[0041] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 12g of Rehmannia root, 10g of safflower, 10g of red peony root, 10g of stewed peach kernel, 15g of angelica, 12g of Chuanxiong, 10g of cinnamon twig, 8g of sodium sulfate, 12g of dried orange peel, 10g of fried earthworm, 8g of smilax glabra, 12g of curcuma, 10g of liquorice, 10g of round leaf of safflower, 15g of costus root, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add an appropriate amount of hot water and slowly boil for 20 minutes. Combine the juices obtained twice and concentrate until the relative density of the concentrate at 60°C is 1.10±0.05. Add 0.50 g of ethylparaben while it is hot, stir well, let stand, take the supernatant, add water to 80 ml, stir well, divide and sterilize to make a mixture.
[0042] Example 5
[0043] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 40g of Rehmannia root, 10g of safflower, 30g of red peony root, 25g of stewed peach kernel, 5g of angelica, 5g of Chuanxiong, 30g of cinnamon twig, 4g of mirabilite, 5g of dried orange peel, 5g of fried earthworm, 35g of striata herb, 30g of turmeric, 30g of liquorice, 45g of round leaf of safflower, 5g of costus root, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add appropriate amount of hot water, and slowly boil for 20 minutes over low heat. Combine the juices obtained twice and concentrate until the relative density of the concentrate at 60°C is 1.10±0.05. Add 0.50 g of ethylparaben while it is hot, stir well, let stand, take the supernatant, add water to 80 ml, stir well, divide and sterilize to make a mixture.
[0044] Example 6
[0045] A Chinese medicine composition for promoting fracture healing, taking the following raw materials: 30g of Rehmannia root, 20g of safflower, 30g of red peony root, 15g of stewed peach kernel, 5g of angelica, 25g of Chuanxiong, 10g of cinnamon twig, 10g of mirabilite, 30g of dried orange peel, 10g of fried earthworm, 15g of smilax glabra, 20g of turmeric, 10g of liquorice, 40g of safflower leaf, 5g of costus root, put them into a special Chinese medicine decoction pot, add cold water, preferably soak the medicine surface by 2.5 cm, soak for 30 minutes, add cold water in the middle, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, then turn to low heat and slowly boil for 30 minutes, pour out the medicine juice. Add an appropriate amount of hot water and slowly boil for 20 minutes. Combine the juices obtained twice and concentrate until the relative density of the concentrate at 60°C is 1.10±0.05. Add 0.50 g of ethylparaben while it is hot, stir well, let stand, take the supernatant, add water to 80 ml, stir well, divide and sterilize to make a mixture.
[0046] Example 7
[0047] A Chinese medicine composition for promoting fracture healing comprises the following raw materials: 12g of Radix Rehmanniae Preparata, 10g of Carthamus tinctorius, 10g of Paeonia lactiflora, 12g of Semen Persicae, 15g of Angelica sinensis, 10g of Rhizoma Chuanxiong, 6g of Cinnamon Twig, 6g of Sodium Sulfate, 6g of Tangerine Peel, 10g of Stir-fried Eupolyphaga Seu Steleophora, 10g of Herba Lycopodiellae, 6g of Curcuma aromatica, 6g of Licorice, 10g of Fructus Cynanchum and 10g of Radix Aucklandiae. The above 15 ingredients are mixed in proportion and ground into powder. Ethanol with a volume fraction of 60% is added, and the mass ratio of ethanol is 20 times the weight of all drugs. The mixture is heated and refluxed for extraction for 3 times, each time for 2.0 hours. The obtained extracts are combined, evaporated and ethanol is recovered to obtain 65g of Chinese medicine extract. 60g of the above Chinese medicine extract is taken, 35g of dextrin is added, and the mixture is mixed evenly. A soft material is prepared by using 80% ethanol solution + 3.5% polyvidone which is 35% of the total amount of the mixture as an adhesive. The mixture is dried at 55°C, crushed and passed through a 10-mesh sieve to prepare granules.
[0048] Example 8
[0049] A Chinese medicine composition for promoting fracture healing comprises the following raw materials: 12g of Radix Rehmanniae Preparata, 10g of Carthamus tinctorius, 10g of Paeonia lactiflora, 12g of Semen Persicae, 15g of Angelica sinensis, 10g of Rhizoma Chuanxiong, 6g of Cinnamon Twig, 6g of Sodium Sulfate, 6g of Tangerine Peel, 10g of Rhizoma Eupolyphaga Seu Steleophora, 10g of Herba Lycopodiellae, 6g of Curcuma aromatica, 6g of Licorice, 10g of Fructus Cynanchum and 10g of Radix Aucklandiae. The above 15 ingredients are mixed in proportion and ground into powder. Ethanol with a volume fraction of 60% is added, and the mass ratio of ethanol is 25 times the weight of all drugs. The mixture is heated and refluxed for extraction for 3 times, each time for 2.0 hours. The obtained extracts are combined, evaporated and ethanol is recovered to obtain 71g of Chinese medicine extract. 70g of the above Chinese medicine extract is added, 25g of starch and 1.5g of magnesium stearate are fully mixed, granulated with 90% ethanol solution as a wetting agent, passed through a 16-mesh sieve, tableted, coated with ethyl cellulose, and made into tablets.
[0050] Example 9
[0051] A Chinese medicine composition for promoting fracture healing comprises the following raw materials: 12g of Radix Rehmanniae Preparata, 10g of Carthamus tinctorius, 10g of Paeonia lactiflora, 12g of Semen Persicae, 15g of Angelica sinensis, 10g of Rhizoma Chuanxiong, 6g of Cinnamon Twig, 6g of Sodium Sulfate, 6g of Tangerine Peel, 10g of Stir-fried Eupolyphaga Seu Steleophora, 10g of Herba Lycopodiellae, 6g of Curcuma aromatica, 6g of Licorice, 10g of Fructus Scutellariae Round Leaves and 10g of Radix Aucklandiae. The above 15 ingredients are mixed in proportion and ground into powder. Ethanol with a volume fraction of 60% is added, and the mass ratio of ethanol is 20 times the weight of all drugs. The mixture is heated and refluxed for extraction for 3 times, each time for 2.0 hours. The obtained extracts are combined, evaporated and ethanol is recovered, and concentrated into a thick paste. An appropriate amount of polyethylene glycol 6000 is taken, heated to melt, added into the thick paste, mixed evenly, and dripped into cooled liquid paraffin at a dripping rate of 90 to 100 drops / min to prepare drip pills.
[0052] Example 10
[0053] A Chinese medicine composition for promoting fracture healing comprises the following raw materials: 12g of Radix Rehmanniae Preparata, 10g of Carthamus tinctorius, 10g of Paeonia lactiflora, 12g of Semen Persicae, 15g of Angelica sinensis, 10g of Rhizoma Chuanxiong, 6g of Cinnamon Twig, 6g of Sodium Sulfate, 6g of Tangerine Peel, 10g of Stir-fried Eupolyphaga Seu Steleophora, 10g of Herba Lycopodiellae, 6g of Curcuma aromatica, 6g of Licorice, 10g of Fructus Cynanchum and 10g of Radix Aucklandiae. The above 15 ingredients are mixed in proportion and ground into powder, 60% ethanol by volume is added, the mass ratio of ethanol being 20 times of the weight of all the drugs, and the mixture is heated and refluxed for extraction for 3 times, each time for 2.0 hours, the obtained extracts are combined, evaporated and ethanol is recovered, concentrated and dried under reduced pressure of 0.09Mpa, dried in a vacuum drying oven, crushed into fine powder, sieved, and filled into capsules to obtain capsules.
[0054] Embodiment 11
[0055] A Chinese medicine composition for promoting fracture healing, taking the following proportion of raw materials (compared with Example 1, the difference is that only one Chinese medicine, stewed peach kernel, is removed): 12g of Rehmannia root, 10g of safflower, 10g of red peony root, 15g of angelica, 10g of Chuanxiong, 6g of cinnamon twig, 6g of mirabilite, 6g of dried orange peel, 10g of fried earthworm, 10g of lycopodii, 10g of striata herba, 6g of curcuma, 6g of liquorice, 10g of safflower leaf, 10g of costus root, put into a special Chinese medicine decoction pot, add cold water, preferably soak 2.5 cm above the medicine surface, soak for 30 minutes, add cold water halfway, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, turn to slow heat and simmer for 30 minutes, pour out the juice. Add an appropriate amount of hot water, and simmer for 20 minutes. Combine the two obtained juices, concentrate until the relative density of the concentrate at 60°C is 1.10±0.05, add 0.5 g of ethylparaben while hot, stir well, let stand, take the supernatant, add water to 100 ml, stir well, package, sterilize, and make a mixture.
[0056] Example 12
[0057] A Chinese medicine composition for promoting fracture healing, taking the following raw materials (compared with Example 1, the difference is that only one Chinese medicine, Radix Rehmanniae Preparata, is removed): 12g of stewed peach kernel, 10g of safflower, 10g of red peony root, 15g of angelica, 10g of chuanxiong, 6g of cassia twig, 6g of mirabilite, 6g of dried orange peel, 10g of stir-fried earthworm, 10g of lycopodii, 10g of turmeric, 6g of licorice, 10g of round leaf of safflower, 10g of costus root, put into a special Chinese medicine decoction pot, add cold water, preferably soak 2.5 cm above the medicine surface, soak for 30 minutes, add cold water halfway, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, turn to slow heat and boil for 30 minutes, pour out the juice. Add an appropriate amount of hot water, and boil over low heat for 20 minutes. Combine the two obtained juices, concentrate until the relative density of the concentrate at 60°C is 1.10±0.05, add 0.5 g of ethylparaben while hot, stir well, let stand, take the supernatant, add water to 100 ml, stir well, package, sterilize, and make a mixture.
[0058] Example 13
[0059] A Chinese medicine composition for promoting fracture healing, taking the following proportion of raw materials (compared with Example 1, the difference is that only safflower is removed), 12g of Radix Rehmanniae Preparata, 12g of Rhizoma Pruni, 10g of Radix Paeoniae Rubra, 15g of Radix Angelicae Sinensis, 10g of Rhizoma Chuanxiong, 6g of Cinnamon Twig, 6g of Sodium Sulfate, 6g of Tangerine Peel, 10g of Stir-fried Eupolyphaga Seu Steleophora, 10g of Herba Lycopodiellae, 6g of Curcuma, 6g of Licorice, 10g of Fructus Cynanchum, 10g of Radix Aucklandiae, put into a special Chinese medicine decoction pot, add cold water, preferably soak 2.5 cm above the medicine surface, soak for 30 minutes, add cold water halfway, keep 2.5 cm away from the medicine surface. After soaking, boil over high heat, turn to slow heat and simmer for 30 minutes, pour out the juice. Add an appropriate amount of hot water, and simmer for 20 minutes. Combine the two obtained juices, concentrate until the relative density of the concentrate at 60°C is 1.10±0.05, add 0.5 g of ethylparaben while hot, stir well, let stand, take the supernatant, add water to 100 ml, stir well, package, sterilize, and make a mixture.
[0060] Embodiment 14
[0061] Based on the clinical use of the preparation from before to after the registration application, that is, from February 2022 to April 2023, our hospital conducted a phased analysis and summary of its efficacy.
[0062] A randomized controlled trial was used to evaluate and summarize the clinical efficacy of the Chinese herbal compound preparation of the present invention in treating fractures.
[0063] A total of 150 patients who met the fracture criteria in the inpatient department of Hangzhou Xixi Hospital affiliated to Zhejiang Chinese Medical University from April 2022 to April 2023 were selected. They met the TCM diagnostic criteria for fracture disease in the "Standards for Diagnosis and Efficacy of TCM Diseases", and the syndromes were diagnosed as blood stasis, internal accumulation of blood stasis, and blood stasis accumulation. According to the different medications, they were divided into three groups: control group I, 30 cases, including 12 males and 18 females; aged 33-68 (46.26±6.58) years old; course of disease (37.87±3.71) h. Control group II, 30 cases, including 16 males and 14 females; aged 31-66 (46.01±6.08) years old; course of disease (36.38±3.25) h. Control group III, 30 cases, including 13 males and 17 females; aged 32-65 (45.22±5.54) years old; course of disease (35.83±2.83) h. There were 30 cases in the control group, including 12 males and 18 females, aged 33-67 (44.43±5.87) years old, and the course of disease was (38.57±4.09) hours. There were 30 cases in the experimental group, including 15 males and 15 females, aged 31-67 (46.04±6.00) years old, and the course of disease was (36.31±3.09) hours. There was no significant difference in age, gender, course of disease and other general data among the five groups (P>0.05), and they were comparable.
[0064] Diagnostic criteria:
[0065] The clinical manifestations include a clear history of trauma, including local swelling at the injured site, subcutaneous ecchymosis, tension blisters, tension blood blisters, and bone friction sounds; physical examination: bone friction sounds can be heard or touched, pain at rest and during movement at the fracture site, circumferential tenderness, and longitudinal percussion pain.
[0066] Inclusion criteria:
[0067] Patients with fracture confirmed by imaging examinations and meeting surgical indications; informed and signed consent forms; conscious and able to cooperate with treatment; and no history of allergy to the drugs used.
[0068] Elimination criteria:
[0069] Patients with missing clinical data; patients with mental illness and communication barriers; patients with poor compliance and unwillingness to accept follow-up; patients with severe cardiovascular and cerebrovascular diseases and chronic diseases; patients who are allergic to this drug; and pregnant or lactating women.
[0070] Interventions:
[0071] 1) Experimental group: In addition to conventional treatment, i.e., administration of 100 mg of Brussels Sprout Extract for injection, intravenous drip, once a day, the experimental group was treated with the composition prepared in Example 1 of the present application, twice a day, one bottle each time (10 ml / bottle).
[0072] 2) Control group 1: In addition to conventional treatment, i.e., 100 mg of Bone Melon Extract for injection was given by intravenous drip once a day, no Chinese medicine preparations were used.
[0073] 3) Control group 2: In addition to conventional treatment, i.e., administering 100 mg of Bone Melon Extract for injection by intravenous drip once a day, the experimental group was treated with the mixture prepared in Example 11 of the present application (compared with Example 1, the difference is that only one Chinese medicinal material, Dried Peach Kernel, is removed), twice a day, one bottle each time (10 ml / bottle).
[0074] 4) Control group three: In addition to conventional treatment, i.e., administering 100 mg of the injection of the guar extract by intravenous drip once a day, the experimental group was treated with the mixture prepared in Example 12 of the present application (compared with Example 1, the difference is that only one Chinese medicinal material, Rehmannia glutinosa, is removed), twice a day, one bottle each time (10 ml / bottle).
[0075] 5) Control group 4: In addition to conventional treatment, i.e., administering 100 mg of the injection of scoparia extract by intravenous drip once a day, the experimental group was treated with the mixture prepared in Example 13 of the present application (compared with Example 1, the difference is that only safflower is removed as a Chinese medicinal material), twice a day, one bottle each time (10 ml / bottle).
[0076] Criteria for judging efficacy:
[0077] 1) Compare the visual analogue scale score (VAS), skin changes, skin temperature and other symptom scores before and after treatment in the five groups of patients. The total score of VAS is 10 points, and the higher the score, the more obvious the pain. Skin changes and skin temperature increase are scored as 0, 1, 2, and 3 points according to none, mild, moderate, and severe, respectively. 2) Compare the swelling degree of the two groups of patients after treatment. 0 degree means no pain and swelling; 1 degree means no obvious swelling, but clear skin texture; 2 degree means strong swelling, no skin texture, and blisters; 3 degree means obvious blisters and swelling. 3) Record the fracture healing time and hospitalization time of the two groups of patients.
[0078] Treatment results:
[0079] Table 1 Comparison of clinical symptom scores of five groups of fracture patients before and after treatment
[0080]
[0081] Compared with the control group after treatment, # P<0.05
[0082] Table 2 Comparison of swelling degree among five groups of fracture patients
[0083]
[0084]
[0085] Compared with the control group after treatment, * P<0.05
[0086] Table 3 Fracture healing time and hospital stay of patients in five groups
[0087]
[0088] Compared with the control group after treatment, * P<0.05
[0089] Summary and discussion
[0090] From the data in Table 1-Table 3, it can be seen that the Chinese medicine compound preparation of the present invention has a good effect on the treatment of promoting fracture healing. During the treatment period, the clinical symptom score, swelling degree, fracture healing time and hospitalization time of the patients in the test group were positively correlated with the treatment time, and the normal recovery rate of each index was significantly improved compared with the control group one (p<0.05). And no adverse reactions and complications were found in the test group, the method was simple, and the efficacy was determined. Control groups two, three and four were prescriptions that removed only one Chinese medicinal material, namely, simmered peach kernel, prepared rehmannia root and safflower. The data in Table 1-Table 3 show that the lack of one medicinal material will lead to a significant reduction in drug efficacy, such as a large clinical symptom score, a slow recovery of swelling degree, and a prolonged healing time and hospitalization time. It can be seen that the prescription of the present invention cannot be simplified, and the synergistic effect achieves the best drug efficacy. In summary, the Chinese medicine compound preparation of this patent has a good therapeutic effect on promoting fracture healing, and has great application and development prospects.
Claims
1. A Chinese medicine composition for treating fractures, characterized in that The Chinese medicine composition comprises the following raw materials: Rehmannia root, safflower, red peony root, stewed peach kernel, angelica root, chuanxiong root, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, lycopodii herb, turmeric, liquorice, round-leaved osmanthus fragrans, costusroot.
2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 5-45 parts of Rehmannia root, 5-30 parts of Carthamus tinctorius, 5-36 parts of Red Peony Root, 5-30 parts of Simmered Peach Kernel, 5-36 parts of Angelica sinensis, 5-30 parts of Ligusticum chuanxiong, 5-30 parts of Cinnamon Twig, 3-36 parts of Sodium Sulfate, 5-30 parts of Tangerine Peel, 5-30 parts of Stir-fried Eupolyphaga Seu Steleophora, 5-36 parts of Lycopodiella cuneata, 5-30 parts of Curcuma aromatica, 3-30 parts of Licorice, 5-90 parts of Fructus Cynanchum Roundi Leaves, and 3-18 parts of Aucklandia lappa.
3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 10-25 parts of Rehmannia root, 7-15 parts of Carthamus tinctorius, 7-15 parts of Red Peony Root, 8-20 parts of Simmered Peach Kernel, 10-25 parts of Angelica sinensis, 8-15 parts of Ligusticum chuanxiong, 5-12 parts of Cassia Twig, 4-12 parts of Sodium Sulfate, 5-15 parts of Tangerine Peel, 7-15 parts of Stir-fried Earthworm, 7-15 parts of Lycopodiella cuneata, 5-15 parts of Curcuma aromatica, 4-15 parts of Licorice, 7-30 parts of Fructus Cynanchum Roundi Leaves, and 5-20 parts of Aucklandia lappa.
4. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following raw materials in parts by weight: 12 parts of Rehmannia glutinosa, 10 parts of Carthamus tinctorius, 10 parts of Red Peony Root, 12 parts of Simmered Peach Kernel, 15 parts of Angelica sinensis, 10 parts of Ligusticum chuanxiong, 6 parts of Cinnamon Twig, 6 parts of Sodium Sulfate, 6 parts of Tangerine Peel, 10 parts of Stir-fried Eupolyphaga Scolopendra Subsoil, 10 parts of Lycopodiella Cervi Paniculata, 6 parts of Curcuma aromatica, 6 parts of Liquorice, 10 parts of Fructus Cynanchum Roundi, and 10 parts of Aucklandia lappa.
5. A Chinese medicine compound preparation for treating fractures prepared from the Chinese medicine composition for treating fractures as claimed in any one of claims 1 to 4.
6. The Chinese medicinal compound preparation for treating fractures according to claim 5, characterized in that The dosage forms of the Chinese medicine compound preparation include tablets, capsules, granules, dripping pills, micropills, decoctions or mixtures.
7. The Chinese medicinal compound preparation for treating fractures according to claim 6, characterized in that When the Chinese medicinal compound preparation for treating fracture is a decoction or a mixture, it is prepared by the following method: Accurately weigh Rehmannia root, safflower, red peony root, stewed peach kernel, angelica root, Chuanxiong root, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, smilax glabra, curcuma, liquorice, safflower leaf, and costus root according to the ratio, soak them in 5-10 times the weight of cold water, boil over high heat, then simmer for 30-40 minutes over low heat, pour out the juice; add 3-7 times the weight of hot water, simmer for 20 minutes over low heat; combine the juices obtained twice, concentrate to a relative density of 1.10±0.05 at 60°C, add ethylparaben while hot, stir well, let stand, take the supernatant, and prepare it into a decoction or mixture.
8. The Chinese medicinal compound preparation for treating bone fractures as claimed in claim 6, characterized in that When the Chinese medicinal compound preparation for treating fracture is in the form of tablets, capsules, granules, dripping pills or micropills, it is prepared by the following method: According to the formula, take Rehmannia root, safflower, red peony root, stewed peach kernel, angelica, Chuanxiong, cinnamon twig, sodium sulfate, tangerine peel, stir-fried earthworm, lycopodii herb, curcuma, liquorice, safflower leaf and costus root, mix them in proportion and grind them into powder, add 60% ethanol by volume, the mass of ethanol being 20 to 25 times the weight of all the drugs, heat and reflux for extraction 3 times, each time for 1 to 2 hours, combine the obtained extracts, evaporate and recover the ethanol, and make the obtained extracts and pharmaceutical excipients acceptable to the human body into tablets, capsules, granules, micropills or dripping pills.
9. Use of the traditional Chinese medicine composition for treating fractures according to any one of claims 1 to 4 or the traditional Chinese medicine compound preparation for treating fractures according to claim 5 or 6 in the preparation of a medicine for treating fractures.
10. Use of the Chinese medicinal composition for treating fractures according to any one of claims 1 to 4 or the Chinese medicinal compound preparation for treating fractures according to claim 5 or 6 in the preparation of drugs for promoting blood circulation, removing blood stasis, reducing swelling and relieving pain.