Bone setting traditional Chinese medicine composition and preparation method thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a bone setting traditional Chinese medicine composition and a preparation method thereof, and the bone setting traditional Chinese medicine composition comprises the following raw materials by weight: 13-17 parts of Chinese angelica, 7-13 parts of safflower, 7-11 parts of pseudo-ginseng, 8-12 parts of ligusticum wallichii, 8-10 parts of vinegar-processed corydalis tuber, 8-10 parts of red peony root, 8-10 parts of dried orange peel, 4-8 parts of frankincense stir-fried with bran, 4-8 parts of myrrh stir-fried with bran, 4-6 parts of sappan wood, 5-7 parts of ground beeltle, and 2-4 parts of licorice. According to the bone setting traditional Chinese medicine composition and the preparation method thereof, blood stasis can be removed, blood circulation can be promoted, tissue regeneration can be promoted, swelling can be reduced, and bone setting and reunion can be conducted to treat traumatic injuries.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine formulations, and in particular to a bone-setting traditional Chinese medicine composition and its preparation method. Background Technology

[0002] Fracture healing requires the gradual repair of tissues between the fracture surfaces. Traditional Chinese medicine theory holds that... Fracture healing is actually a developmental process of "hemostasis, new bone formation, and bone fusion." Essentially, This refers to the contradiction between damage and resistance to damage; the body mobilizes all beneficial factors to promote the repair of damaged bones and surrounding tissues. Traditional Chinese medicine believes that Qi and blood are the material basis of human activity. The *Suwen* (Plain Questions) states that the most important substances in the human body are blood and Qi. The *Eighty-One Difficulties Classic* states, "Qi is responsible for warming, and blood is responsible for nourishing." This means that the main function of Qi is warming, and the main function of blood is nourishing. The normal function of all organs in the body depends on the nourishment of Qi and blood, including the bones. The *Shengji Zonglu* (General Records of Sacred Relief) by Emperor Huizong of Song states that the entire human body relies on the continuous circulation of Qi and blood to maintain normal function. If one is injured and suffers a fracture, Qi and blood will stagnate, causing pain, making it difficult for the injury to heal and the fracture to heal properly. Blood can circulate in the vessels, nourish the flesh and bones, and circulate throughout the body because healthy muscles and bones and unobstructed meridians allow for normal Qi and blood circulation. If a fracture is caused by injury affecting the meridians, the flow of qi and blood will be obstructed, blood stasis will be difficult to dissipate, and swelling and pain will result. Treatment should focus on removing blood stasis to ensure the smooth flow of qi and blood. Qing Dynasty physician Chen Shiduo's *Bianzheng Lu* states: "If the blood vessels are not flowing smoothly, blood stasis will be difficult to dissipate, thus making it difficult for the fractured bone to heal." This illustrates that whether a fracture can heal depends on the abundance of qi and blood. Ming Dynasty physician Liu Zonghou's *Yuji Weiyi* says, "First, remove blood stasis, unblock the meridians, harmonize blood and relieve pain, then regulate qi and blood and replenish stomach qi." Later generations of physicians largely followed this treatment method for fractures.

[0003] Fractures are more common in the elderly, but also frequently occur in children and young adults after impact. Elderly individuals, especially postmenopausal women, are particularly prone to fractures due to calcium loss and osteoporosis caused by hormonal changes. Except for mild compression fractures, stable fractures with minimal displacement, and patients who cannot tolerate surgery, most fracture patients require surgery. Post-operative recovery takes a long time, as the saying goes, "a hundred days to recover from a bone injury." During this period, besides rehabilitation therapy, there are few other Western medical methods to promote fracture healing. Therefore, increasingly more traditional Chinese medicine preparations are playing an important role in this field.

[0004] The inventors of this invention conducted market research and found that currently available traditional Chinese medicine preparations for treating sprains, bruises, and fractures can be broadly divided into two categories: one mainly focuses on promoting blood circulation and relieving pain, while the other mainly focuses on bone and tendon healing. There is no traditional Chinese medicine preparation on the market that can simultaneously promote blood circulation, regenerate tissue and reduce swelling, and heal bones and tendons to treat sprains and bruises.

[0005] However, many patent documents disclose traditional Chinese medicine compositions used for treating bone injuries, knife wounds, fractures, and finger replantation repair. Examples include: CN106389581A - a traditional Chinese medicine formula for healing bone and knife / gun wounds; CN108210691A - a plaster for treating fractures and its preparation method; CN109954068A - a traditional Chinese medicine formula and decoction method with repair effects after finger replantation; CN110548092A - a traditional Chinese medicine composition for promoting blood circulation and relieving pain and its preparation method; CN116966227A - a composition for treating fractures and its preparation method; CN118845923A - a traditional Chinese medicine for bone healing and its preparation method, etc. However, these compositions differ in their specific drug component combinations, ratios, and dosages, thus targeting different symptoms. They do not meet the requirements of this invention for treating injuries by promoting blood circulation, regenerating tissue, reducing swelling, and promoting bone and tendon healing. Summary of the Invention

[0006] The purpose of this invention is to provide a bone-setting traditional Chinese medicine composition and its preparation method, which can promote blood circulation, promote tissue regeneration and reduce swelling, and reconnect bones and tendons to treat traumatic injuries.

[0007] To solve the above-mentioned technical problems, the bone-setting traditional Chinese medicine composition and its preparation method provided by the present invention are achieved as follows: A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 13-17 parts Angelica sinensis, 7-13 parts Carthamus tinctorius, 7-11 parts Panax notoginseng, 8-12 parts Ligusticum chuanxiong, 8-10 parts Corydalis yanhusuo (processed with vinegar), 8-10 parts Paeonia lactiflora, 8-10 parts Citrus reticulata peel, 4-8 parts Boswellia carterii (stir-fried with wheat bran), 4-8 parts Commiphora myrrha (stir-fried with wheat bran), 4-6 parts Sappanwood, 5-7 parts Eupolyphaga sinensis, and 2-4 parts Glycyrrhiza uralensis.

[0008] Optional ingredients include the following parts by weight: Angelica sinensis 14-16 parts, Carthamus tinctorius 8-12 parts, Panax notoginseng 8-10 parts, Ligusticum chuanxiong 9-11 parts, Corydalis yanhusuo (processed with vinegar) 8-10 parts, Paeonia lactiflora 8-10 parts, Citrus reticulata 8-10 parts, Boswellia carterii (stir-fried with wheat bran) 5-7 parts, Commiphora myrrha (stir-fried with wheat bran) 5-7 parts, Sappanwood 4-6 parts, Eupolyphaga sinensis 5-7 parts, and Glycyrrhiza uralensis 2-4 parts.

[0009] Optional ingredients include the following parts by weight: 15 parts Angelica sinensis, 10 parts Carthamus tinctorius, 9 parts Panax notoginseng, 10 parts Ligusticum chuanxiong, 9 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 6 parts Boswellia carterii (stir-fried with wheat bran), 6 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

[0010] The present invention also provides a method for preparing a bone-setting traditional Chinese medicine composition, wherein the raw materials are ground into powder, passed through a 180-mesh sieve, and the powder is taken orally.

[0011] Optionally, the powdered raw material can be mixed with water to form pills for consumption.

[0012] This invention relates to a bone-setting traditional Chinese medicine composition comprising twelve herbs: Panax notoginseng, Carthamus tinctorius, Angelica sinensis, Ligusticum chuanxiong, Paeonia lactiflora, Eupolyphaga sinensis, Sappanwood, stir-fried frankincense, stir-fried myrrh, vinegar-processed Corydalis yanhusuo, Citrus reticulata peel, and Glycyrrhiza uralensis. Panax notoginseng is sweet, warm, and slightly bitter, resolving blood stasis and stopping bleeding, promoting blood circulation and relieving pain, stopping bleeding without leaving blood stasis, and resolving blood stasis without harming the body's vital energy. Carthamus tinctorius is pungent, dispersing, and warming, entering the heart and liver meridians, promoting blood circulation and unblocking the meridians, dispersing blood stasis and eliminating masses and relieving pain; these two herbs are the principal herbs. Angelica sinensis primarily nourishes blood and secondarily promotes blood circulation, unblocking meridians and relieving pain; Ligusticum chuanxiong is bitter, purgative, pungent, and warming, dispelling wind and cold externally, and promoting blood circulation and relieving pain internally; Paeonia lactiflora clears heat and cools blood, promoting blood circulation and resolving blood stasis; Eupolyphaga sinensis breaks up blood stasis and promotes bone healing; these four herbs are the assistant herbs. The formula is supplemented with sappanwood, frankincense, and myrrh to invigorate blood circulation, remove blood stasis, reduce swelling, promote tissue regeneration, and relieve pain; tangerine peel regulates qi and harmonizes the middle jiao, protecting the spleen and stomach; licorice root serves as the guiding herb, its sweet and neutral properties harmonizing and complementing both angelica and red peony root to relieve spasms, promote tissue regeneration, and stop pain, while also harmonizing the effects of the other herbs. The entire formula combines dispersing and tonifying effects, invigorating blood circulation, removing blood stasis, reducing swelling and relieving pain, while also promoting bone healing, tendon regeneration, and stopping bleeding. It can be used for any injury, blood stasis, swelling, and pain, regardless of whether there is a fracture.

[0013] The herbal composition of this invention mainly comprises: 1. Promoting blood circulation and removing blood stasis: Primarily composed of Panax notoginseng, safflower, Ligusticum chuanxiong, Paeonia lactiflora, Sappanwood, and Eupolyphaga sinensis, which promote local blood circulation and dissipate blood stasis. 2. Reducing swelling and relieving pain: Contains Angelica sinensis, vinegar-processed Corydalis yanhusuo, stir-fried frankincense, stir-fried myrrh, and tangerine peel, which unblock the flow of qi and relieve pain. 3. Promoting tendon and bone healing: Contains Angelica sinensis, Eupolyphaga sinensis, stir-fried frankincense, and stir-fried myrrh, which assist in repairing damaged tissues. 4. Harmonizing the properties of the herbs: Contains Glycyrrhiza uralensis to relieve spasms and pain, harmonizing the properties of the main herbs.

[0014] Angelica sinensis: This product is Angelica sinensis, a plant belonging to the Apiaceae family. Angelica sinensis(Oliv.)Diels The dried roots. Harvested in late autumn, the fibrous roots and soil are removed. After the moisture has slightly evaporated, they are bundled into small bunches, placed on a shed, and slowly dried with smoke. The quality standard is included in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 139.

[0015] Safflower: This product is safflower, a plant belonging to the Asteraceae family. Carthamus tinctorius L. Dried flowers. Harvested in summer when the flowers turn from yellow to red, and then dried in the shade or sun. Quality standards are listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 157.

[0016] Panax notoginseng: This product is Panax notoginseng, a plant belonging to the Araliaceae family. Panax notoginseng (Burk.) F. The dried roots and rhizomes of *H. Chen*. Harvested in autumn before flowering, washed, and the taproot, lateral roots, and rhizomes separated, then dried. The lateral roots are commonly referred to as "tendons," and the rhizomes as "cut ends." Quality standards are listed in the 2020 edition of the *Chinese Pharmacopoeia*, Volume I, page 12.

[0017] Chuanxiong: This product is Chuanxiong, a plant of the Apiaceae family. Ligusticum chuanxiong Hort.The dried rhizome. Harvested in summer when the nodes on the stem are prominent and slightly purplish, the soil and sand are removed, and the rhizomes are dried after sun-drying and baking. The fibrous roots are then removed. The quality standard is listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 42.

[0018] Corydalis: This product is Corydalis, a plant of the Papaveraceae family. Corydalis yanhusuo Dried tubers of WTWang. Harvested in early summer when the stems and leaves wither, remove fibrous roots, wash clean, boil or steam in boiling water until just past the white core disappears, then remove and sun-dry. Quality standards are listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 145.

[0019] Red peony: This product is the peony plant of the Ranunculaceae family. Paeonia lactiflora Pall. Or Sichuan red peony Paeonia veitchii Lynch The dried roots. Harvested in spring and autumn, the rhizomes, fibrous roots, and soil are removed, and then dried in the sun. The quality standard is listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 165.

[0020] Dried tangerine peel: This product is made from the citrus fruit, a plant of the Rutaceae family. Citrus reticulata Blanco The dried, mature pericarp of its cultivated varieties. The medicinal material is divided into "Chenpi" and "Guangchenpi". Mature fruits are harvested, the pericarp is peeled off, and then sun-dried or dried at low temperature. The quality standards are listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 199.

[0021] Frankincense: This product is made from the frankincense tree, a plant belonging to the Burseraceae family. Boswellia carterii Birdw. and related plants Boswellia bhaw-dajiana Birdw. The resin exuded from the bark. It is divided into Somali frankincense and Ethiopian frankincense, each of which is further divided into frankincense beads and raw frankincense. The quality standard is included in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 233. The quality standard for stir-fried frankincense is included in the 2022 edition of the "Henan Province Standards for Processing Traditional Chinese Medicine Pieces". Myrrh: This product is derived from the plant Viola yedoensis of the Burseraceae family. Commiphora myrrha Engl. Or Hadid tree Commiphora molmol Engl. Myrrh is a dried resin. It is divided into natural myrrh and gum myrrh. The quality standard is included in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 193. The quality standard for stir-fried myrrh is included in the 2022 edition of the "Henan Province Standards for Processing Traditional Chinese Medicine Pieces".

[0022] Sappanwood: This product is sappanwood, a plant belonging to the legume family. Caesalpinia sappan L. The dried heartwood. Harvested mostly in autumn, the white sapwood is removed, and then dried. The quality standard is listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 171.

[0023] Ground beetle: This product is the ground beetle, an insect belonging to the Blattodea family. Eupolyphaga sinensis Walker Or the ground beetle Steleophaga plancyi (Boleny)The dried body of the female insect. After capture, it is scalded to death in boiling water and then sun-dried or oven-dried. The quality standard is included in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 19.

[0024] Licorice: This product is licorice, a plant belonging to the legume family. Glycyrrhiza uralensis Fisch. licorice root Glycyrrhiza inflata Bat. Or licorice root Glycyrrhiza glabra L. The dried roots and rhizomes of the plant. Harvested in spring and autumn, the fibrous roots are removed, and the plants are sun-dried. The quality standard is listed in the 2020 edition of the Chinese Pharmacopoeia, Volume I, page 88.

[0025] Angelica sinensis contains various amino acids, volatile organic compounds, linoleic acid, water-soluble alkaloids, sucrose, vitamin E, fat, phytosterol, niacin, palmitic acid, stearic acid, vitamin B12, and other components.

[0026] Safflower: The main active ingredients include flavonoids, polyyne derivatives, fatty acids, steroids, volatile oils, safflower polysaccharides, and trace elements. Among these, safflower yellow pigment, a flavonoid, is the most active ingredient, comprising 20%–30%; a small amount of safflower red pigment, comprising 0.3%–0.6%; and other flavonoids, primarily glycosides based on kaempferol and quercetin. Linoleic acid is the most abundant fatty acid, reaching up to 80%.

[0027] Panax notoginseng mainly contains saponins, flavonoids, volatile oils, amino acids, polysaccharides, starch, and proteins.

[0028] Ligusticum chuanxiong contains volatile oil, ferulic acid, 4-hydroxy-3-buty lphthalide, senkyunolide, ligustilide, tetramethylpyrazine, chuanxiongol, sedanic acid, etc.

[0029] Corydalis: The main chemical components are pyridine alkaloids, hyoscyamine alkaloids, isoquinoline alkaloids, indole alkaloids, and organic amine alkaloids.

[0030] Red peony root: Its main chemical components are saponins, and it also contains flavonoids, tannins, and volatile oils. Saponins are the main active ingredients.

[0031] Dried tangerine peel: mainly contains flavonoids, such as hesperidin, nobiletin, and neohesperidin. In addition, dried tangerine peel also contains abundant volatile oils, with a volatile oil content of 1.5-2.0% for dried tangerine peel and 1.2%-3.2% for Guangchenpi. Its components are limonene (about 80%), α-pinene, β-pinene, β-phellandrene, etc.

[0032] Frankincense: Its main components are volatile oil (3%–8%), resin (60%–70%), and gum (27%–35%), with the remainder being impurities and water. The resin mainly consists of pentacyclic and tetracyclic triterpenoids; the volatile oil mainly consists of octyl acetate, n-octanol, borneol acetate, and cis-β-ocimene; and the gum mainly consists of polysaccharides.

[0033] Myrrh: Primarily contains volatile oil (3%–8%), resin (25%–40%), and gum (30%–60%). Its main chemical components include monoterpenes, sesquiterpenes, steroids, and lignans. Sappanwood: mainly contains volatile oil, fatty acids, flavonoids, tannins, benzofuran derivatives, etc.

[0034] Ground beetle: Contains volatile oil and amino acids. The total volatile oil content is approximately 22.19%, mainly naphthalene, and also contains various aliphatic and aromatic aldehydes, accounting for 24.95%.

[0035] Licorice contains four main chemical components: triterpenoids, flavonoids, alkaloids, and polysaccharides. Among them, triterpenoids include glycyrrhizic acid and 24-hydroxyglycyrrhetinic acid. Flavonoids include glycyrrhizin, isoglycyrrhizin, glycyrrhizin, and isoglycyrrhizin. Detailed Implementation

[0036] To make the objectives, technical solutions, and advantages of this invention clearer, the following embodiments provide a more detailed description of the invention. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of the invention.

[0037] Unless otherwise specified, the experimental methods used in the following examples are conventional methods, performed according to the techniques or conditions described in the literature in this field or according to the product instructions. Unless otherwise specified, the materials and reagents used in the following examples are commercially available.

[0038] Example 1 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 15 parts Angelica sinensis, 10 parts Carthamus tinctorius, 9 parts Panax notoginseng, 10 parts Ligusticum chuanxiong, 9 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 6 parts Boswellia carterii (stir-fried with wheat bran), 6 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

[0039] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0040] Example 2 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 13 parts Angelica sinensis, 7 parts Carthamus tinctorius, 11 parts Panax notoginseng, 12 parts Ligusticum chuanxiong, 10 parts Corydalis yanhusuo (processed with vinegar), 8 parts Paeonia lactiflora, 8 parts Citrus reticulata peel, 4 parts Boswellia carterii (stir-fried with wheat bran), 8 parts Commiphora myrrha (stir-fried with wheat bran), 4 parts Sappanwood, 7 parts Eupolyphaga sinensis, and 4 parts Glycyrrhiza uralensis.

[0041] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0042] Example 3 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 17 parts Angelica sinensis, 13 parts Carthamus tinctorius, 7 parts Panax notoginseng, 8 parts Ligusticum chuanxiong, 8 parts Corydalis yanhusuo (processed with vinegar), 10 parts Paeonia lactiflora, 10 parts Citrus reticulata peel, 8 parts Boswellia carterii (stir-fried with wheat bran), 4 parts Commiphora myrrha (stir-fried with wheat bran), 6 parts Caesalpinia sappan, 5 parts Eupolyphaga sinensis, and 2 parts Glycyrrhiza uralensis.

[0043] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0044] Example 4 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12 parts Angelica sinensis, 8 parts Carthamus tinctorius, 10 parts Panax notoginseng, 10 parts Ligusticum chuanxiong, 11 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 5 parts Boswellia carterii (stir-fried with wheat bran), 7 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

[0045] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0046] Example 5 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 16 parts Angelica sinensis, 12 parts Carthamus tinctorius, 8 parts Panax notoginseng, 9 parts Ligusticum chuanxiong, 9 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 5 parts Boswellia carterii (stir-fried with wheat bran), 7 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

[0047] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0048] Example 6 A bone-setting traditional Chinese medicine composition comprises the following raw materials in parts by weight: 14 parts Angelica sinensis, 9 parts Carthamus tinctorius, 9 parts Panax notoginseng, 10 parts Ligusticum chuanxiong, 9 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 5 parts Boswellia carterii (stir-fried with wheat bran), 7 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

[0049] Take all the above-mentioned raw materials, grind them into powder, pass them through a 180-mesh sieve, and take them directly; or grind them into powder, mix them with water, make them into pills, and take them.

[0050] Example 7 further elaborates on the dialectical treatment and usage of the traditional Chinese medicine composition of the present invention.

[0051] 1. The bone-setting traditional Chinese medicine composition of this invention is based on syndrome differentiation and treatment: It is mainly used for limb swelling and pain caused by falls and sprains. Physical examination: pale purple / dark purple tongue, wiry / hesitant pulse; Diagnosis: Fracture, sprain or bruise; Syndrome: Bone fracture and tendon injury, qi stagnation and blood stasis; Treatment: Promote blood circulation and remove blood stasis, regulate qi and relieve pain, and promote bone and tendon healing.

[0052] 2. Prescription Issuance: Depending on the patient's specific condition, one to two courses of treatment are generally required. Combination therapy may be necessary for some patients depending on their specific condition.

[0053] 3. Instructions for use: Medication should be started after fracture reduction and fixation. It is administered orally as a powder, 9g twice daily (morning and evening). The dosage should be reduced for children. It is recommended to take it after meals to reduce gastrointestinal irritation.

[0054] 4. Analysis of the principal, assistant, adjuvant, and guiding herbs in the traditional Chinese medicine composition of this invention 4.1. Principal herbs: Panax notoginseng: sweet, warm and slightly bitter, it can resolve blood stasis and stop bleeding, promote blood circulation and relieve pain, stop bleeding without leaving blood stasis, and resolve blood stasis without harming the body's vital energy; Carthamus tinctorius: pungent, dispersing and warming, it enters the heart and liver meridians, promotes blood circulation and unblocks the meridians, disperses blood stasis and eliminates masses and relieves pain.

[0055] 4.2 Assistant herbs: Angelica sinensis: nourishes blood and promotes blood circulation, regulates menstruation and relieves pain; Ligusticum chuanxiong: bitter, pungent, dispersing and warming, can dispel wind and cold externally, and promote blood circulation and relieve pain internally; Paeonia lactiflora: clears heat and cools blood, promotes blood circulation and removes blood stasis; Eupolyphaga sinensis: breaks up blood stasis and promotes tendon and bone healing; Corydalis yanhusuo (vinegar-processed): regulates qi and relieves pain.

[0056] 4.3. Adjuvant herbs: Sappanwood, frankincense, and myrrh promote blood circulation, remove blood stasis, reduce swelling, promote tissue regeneration, and relieve pain; 4.4. Medicinal herbs: Tangerine peel regulates qi and harmonizes the middle jiao, protecting the spleen and stomach; Licorice, sweet and neutral, nourishes and harmonizes, which can not only work with Angelica sinensis and Paeonia lactiflora to relieve spasms, promote tissue regeneration and stop pain, but also harmonize the effects of other herbs.

[0057] Comparative Example 1 The comparative example is the same as Example 1, except that Panax notoginseng is not added.

[0058] Comparative Example 2 The comparative example is the same as Example 1, except that safflower is not added.

[0059] Comparative Example 3 The comparative example is the same as Example 1, except that Angelica sinensis is not added.

[0060] Test case 1. Experimental group setup This study summarized 219 patients who received this drug for fractures and sprains between January 2019 and December 2023. Among them, 106 patients (48.4%) were young and middle-aged (18-59 years old); 78 patients (35.62%) were in the pre-elderly stage (60-74 years old); and 35 patients (15.98%) were over 75 years old. There were 99 male patients (45.22%) and 120 female patients (54.78%). The mean age was 57.78 ± 16.99 years. Patients were grouped by gender, age, and disease duration.

[0061] The patients were treated with the compositions of Examples 1 to 6 of the present invention, and Comparative Examples 1, 2 and 3 respectively.

[0062] 2. Observation indicators The efficacy was analyzed after two courses of treatment to observe the improvement in local pain, tenderness, swelling, and joint mobility after medication.

[0063] 2.1 Symptom Scoring Standards 0 points, no pain or pain disappeared, no tenderness, no swelling, and normal joint movement; 2 points, slight pain, but does not affect activity, mild tenderness, mild swelling, and slightly limited joint movement; 4 points, significant pain, slight movement possible, obvious tenderness, moderate swelling, and significantly limited joint movement; 6 points, severe pain, inability to move, intense tenderness, severe swelling, and severely limited joint movement.

[0064] 2.2 Clinical efficacy assessment Cure: Compared with the healing time of similar fractures, the healing time of fractures treated with this therapy is shortened by 1 / 3; Significant effect: Compared with the healing time of similar fractures, the healing time of fractures treated with this therapy is shortened by 1 / 3 to 1 / 4; Effective: Compared with the healing time of similar fractures, the fracture healing time is shortened by 1 / 4 to 1 / 5; Ineffective: Compared with the healing time of similar fractures, the fracture healing time was not significantly shortened, and in fact, it was even less effective. To extend.

[0065] 3. Efficacy statistics: Comparison of clinical symptom scores (x±s) before and after treatment is shown in Table 1. Table 1 compares the clinical symptom scores (x±s) of 25 patients before and after treatment in Example 1. (Unit: points) ; Table 2 compares the clinical symptom scores (x±s) of 25 patients before and after treatment in Example 2. (Unit: points) ; Table 3 compares the clinical symptom scores (x±s) of 25 patients before and after treatment in Example 3. (Unit: points) ; Table 4 compares the clinical symptom scores (x±s) of 24 patients before and after treatment in Example 4. (Unit: points) ; Table 5 compares the clinical symptom scores (x±s) of 24 patients before and after treatment in Example 5. (Unit: points) ; Table 6 compares the clinical symptom scores (x±s) of 24 patients before and after treatment in Example 6. (Unit: points) ; Table 7 compares the clinical symptom scores (x±s) of 24 patients in Example 1 before and after treatment. (Unit: points) ; Table 8 compares the clinical symptom scores (x±s) of 24 patients in Example 2 before and after treatment. (Unit: points) ; Table 9 compares the clinical symptom scores (x±s) of 24 patients in Example 3 before and after treatment. (Unit: points) ; Table 10 compares the clinical efficacy of patients before and after treatment [n(%)].

[0066] From Tables 1 to 9 and Table 10, the cure rate of Examples 1 to 6 of the present invention is 100%, and the ineffectiveness rate is 0. In contrast, Comparative Examples 1 to 3 had ineffective cases, and the number of generally cured cases was not as high as that of Examples 1 to 6. In terms of clinical symptom scores and cure rates of Examples 1 to 6, there is no significant difference between Examples 1 to 6 of the present invention, with Example 1 showing better results and the other examples being slightly inferior.

[0067] The bone-setting composition of this invention showed high efficacy in treating patients with swelling and pain caused by falls, sprains, and fractures, with a total effective rate of 100%, indicating that the prescription has a significant improvement effect on some patients. The efficacy in elderly patients over 60 years of age was slightly lower than that in middle-aged and younger patients, possibly related to the age of the patients. The effective rate for middle-aged and younger patients was 100%, while the effective rate for elderly patients was 94.94%. The effective rate for female patients was slightly higher than that for male patients (97.67% for women and 97.18% for men), but the difference was not significant, possibly due to the smaller sample size.

[0068] No significant adverse reactions were reported in the 219 patients, indicating that Qi Hong Jie Gu Wan has a high safety profile. A few patients experienced mild gastrointestinal discomfort, which may be related to frankincense, myrrh, and ground beetle, but these symptoms resolved spontaneously without discontinuation of the medication.

[0069] The bone-setting composition of the present invention has significant clinical efficacy for swelling and pain caused by sprains, fractures, etc., with a total effective rate of 100% and good safety. The local pain, tenderness, swelling and joint mobility symptoms scores are significantly improved after treatment.

[0070] Fracture healing is a highly complex process of wound repair, divided into three stages: hematoma organization, primary callus formation, and callus remodeling. Traditional Chinese medicine believes that fractures and muscle injuries can cause blood stasis and qi stagnation, leading to poor blood circulation, swelling, and pain. Fracture healing is a process of "removing blood stasis, generating new blood and bone, and repairing and healing the fracture." Therefore, when treating fractures with medication, drugs that promote blood circulation, remove blood stasis, and relieve pain should be used. Qi Hong Jie Gu Wan (Seven Red Bone-Setting Pill) primarily treats the pathological reactions in the early and middle stages of fractures by promoting blood circulation and removing blood stasis. When blood is activated, blood stasis is removed; when blood stasis is removed, new blood is generated; and when new blood is generated, bone heals. After a fracture, local hematoma leads to a decrease in hematocrit, an increase in blood viscosity, and an increase in erythrocyte aggregation, resulting in slow and stagnant blood flow, forming blood stasis syndrome, which in turn affects bone tissue repair. Currently, Chinese medicine preparations used on the market to treat sprains and fractures can be roughly divided into two categories: one mainly focuses on promoting blood circulation and relieving pain, while the other mainly focuses on bone and muscle repair. There is currently no traditional Chinese medicine preparation on the market that can simultaneously promote blood circulation, promote tissue regeneration and reduce swelling, and also heal bones and tendons to treat injuries from falls and blows. Qi Hong Jie Gu Wan (Seven Red Bone-Setting Pills) fills this gap. The formula contains Panax notoginseng, which is sweet, warm, and slightly bitter; it promotes blood circulation and stops bleeding, relieves pain, stops bleeding without leaving stasis, and resolves stasis without harming the body's vital energy. Safflower is pungent, dispersing, and warming, entering the heart and liver meridians; it promotes blood circulation and unblocks the meridians, disperses blood stasis, and eliminates masses and relieves pain. These two herbs are the principal herbs. Angelica sinensis nourishes and invigorates blood, unblocks meridians, and relieves pain. Ligusticum chuanxiong is bitter, purgative, pungent, and warming; it dispels wind and cold externally and promotes blood circulation, removes stasis, and relieves pain internally. Paeonia lactiflora clears heat and cools the blood, promotes blood circulation and removes stasis. Eupolyphaga sinensis breaks up blood stasis, removes blood stasis, and heals bones and tendons. These four herbs are the assistant herbs. The formula is supplemented with sappanwood, frankincense, and myrrh to invigorate blood circulation, remove blood stasis, reduce swelling, promote tissue regeneration, and relieve pain; tangerine peel regulates qi and harmonizes the middle jiao, protecting the spleen and stomach; licorice root serves as the guiding herb, its sweet and neutral properties harmonizing and complementing both angelica and red peony root to relieve spasms, promote tissue regeneration, and stop pain, while also harmonizing the effects of the other herbs. The entire formula combines dispersing and tonifying effects, invigorating blood circulation, removing blood stasis, reducing swelling and relieving pain, as well as promoting bone healing, tendon regeneration, and stopping bleeding. It can be used for any injury, blood stasis, swelling, and pain, regardless of whether there is a fracture.

[0071] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A bone-setting traditional Chinese medicine composition, characterized in that, The ingredients include the following parts by weight: Angelica sinensis 13-17 parts, Carthamus tinctorius 7-13 parts, Panax notoginseng 7-11 parts, Ligusticum chuanxiong 8-12 parts, Corydalis yanhusuo (processed with vinegar) 8-10 parts, Paeonia lactiflora 8-10 parts, Citrus reticulata 8-10 parts, Boswellia carterii (stir-fried with wheat bran) 4-8 parts, Commiphora myrrha (stir-fried with wheat bran) 4-8 parts, Sappanwood 4-6 parts, Eupolyphaga sinensis 5-7 parts, and Glycyrrhiza uralensis 2-4 parts.

2. The bone-setting traditional Chinese medicine composition according to claim 1, characterized in that, The ingredients include the following parts by weight: Angelica sinensis 14-16 parts, Carthamus tinctorius 8-12 parts, Panax notoginseng 8-10 parts, Ligusticum chuanxiong 9-11 parts, Corydalis yanhusuo (processed with vinegar) 8-10 parts, Paeonia lactiflora 8-10 parts, Citrus reticulata 8-10 parts, Boswellia carterii (stir-fried with wheat bran) 5-7 parts, Commiphora myrrha (stir-fried with wheat bran) 5-7 parts, Sappanwood 4-6 parts, Eupolyphaga sinensis 5-7 parts, and Glycyrrhiza uralensis 2-4 parts.

3. The bone-setting traditional Chinese medicine composition according to claim 2, characterized in that, The ingredients include the following parts by weight: 15 parts Angelica sinensis, 10 parts Carthamus tinctorius, 9 parts Panax notoginseng, 10 parts Ligusticum chuanxiong, 9 parts Corydalis yanhusuo (processed with vinegar), 9 parts Paeonia lactiflora, 9 parts Citrus reticulata peel, 6 parts Boswellia carterii (stir-fried with wheat bran), 6 parts Commiphora myrrha (stir-fried with wheat bran), 5 parts Sappanwood, 6 parts Eupolyphaga sinensis, and 3 parts Glycyrrhiza uralensis.

4. The method for preparing the bone-setting traditional Chinese medicine composition according to claims 1-3, characterized in that, Grind all the raw materials into powder, pass through a 180-mesh sieve, and then take the powder as a medicine.

5. The method for preparing the bone-setting traditional Chinese medicine composition according to claim 4, characterized in that, The powdered raw materials are mixed with water, made into pills, and then taken orally.

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