Blood circulation promoting and blood stasis removing traditional Chinese medicine preparation for treating fracture and soft tissue injury

Abstract

The invention discloses a blood circulation promoting and blood stasis removing traditional Chinese medicine preparation for treating fracture and soft tissue injury, which comprises the following raw material medicines in parts by weight: respectively 10-15 parts of solid fruit, myrrh, frankincense, catechu, ground beetle, safflower, cynomorium songaricum, dipsacus root, borax, native copper, cortex albiziae and drynaria baronii; and 3-5 parts by weight of each of pseudo-ginseng and dragon's blood. Therefore, the traditional Chinese medicine composition can be used for treating fracture, traumatic injury, blood circulation promoting, blood stasis removing, swelling and pain relieving and sprain and strain.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and specifically refers to a traditional Chinese medicine preparation for promoting blood circulation to remove blood stasis and treating fractures and soft tissue injuries. Background Art

[0002] In the field of treating fractures and soft tissue injuries, both modern medicine and traditional Chinese medicine have formed mature technical systems. Modern medicine can effectively achieve fracture reduction and inflammation control through surgical reduction, external fixation and western medicine treatment; traditional Chinese medicine takes promoting blood circulation to remove blood stasis, detumescence and relieving pain as the core, and uses multi-component traditional Chinese medicine preparations to promote tissue repair, which is widely used clinically and has definite curative effects.

[0003] With the refined development of clinical needs, there is still room for optimization in the aspects of dosage form diversity and individual adaptability in the existing technology. Developing a traditional Chinese medicine preparation with a scientific formula and flexible dosage form can further enrich clinical treatment options and has important practical value. Summary of the Invention

[0004] The present invention aims to solve at least to some extent the technical problems in the above-mentioned technology.

[0005] To this end, on the one hand, the present invention discloses a traditional Chinese medicine preparation for promoting blood circulation to remove blood stasis and treating fractures and soft tissue injuries, comprising the following raw materials in parts by weight:

[0006] Guzhi, Myrrh, Frankincense, Catechu, Eupolyphaga Seu Steleophaga, Safflower, Cynomorium Songaricum Rupr., Dipsacus Asper Wall., Sodium Sulfate, Pyritum, Albizia Julibrissin Durazz. and Rhizoma Zingiberis, each 10-15 parts by weight;

[0007] Notoginseng and Dragon's Blood, each 3-5 parts by weight.

[0008] It should be noted that the formula of the present invention takes "promoting blood circulation to remove blood stasis, detumescence and relieving pain, and promoting bone healing and tendon renewal" as the core, and achieves the curative effect through the synergistic effect of multiple components and multiple targets:

[0009] (1) Monarch drug group (Notoginseng, Dragon's Blood)

[0010] Notoginseng: contains components such as notoginsenoside R1 and ginsenoside Rg1. Modern research shows that it can promote blood circulation at the fracture end, enhance the expression of vascular endothelial growth factor (VEGF), and accelerate hematoma absorption; at the same time, it can improve the local microcirculation disorder of the injury by inhibiting platelet aggregation and reducing blood viscosity.

[0011] Dragon's Blood: mainly contains dracorhodin and dracorubin, and has anti-inflammatory and analgesic effects and promotes fibrinolytic effects, which can reduce the aseptic inflammatory reaction at the injury site and inhibit the release of pain mediators.

[0012] (2) Ministerial drug group (Myrrh, Frankincense, Safflower, Eupolyphaga Seu Steleophaga)

[0013] Myrrh and frankincense: Contain volatile oils (such as myrrhol and boswellic acid) and resin components. The combination of the two can enhance the analgesic synergistic effect, reduce prostaglandin synthesis by inhibiting cyclooxygenase-2 (COX-2) activity, and at the same time improve local capillary permeability and reduce swelling.

[0014] Safflower: Safflower yellow pigment can dilate blood vessels and inhibit platelet adhesion. Combined with the thrombolytic effect of earthworm (containing lumbrokinase), it further dredges the stagnant blood vessels at the damaged site and promotes tissue repair.

[0015] (3) Assistant drugs group (Psoralea corylifolia, Cynomorium songaricum, Dipsacus asperoides, etc.)

[0016] Psoralea corylifolia, Cynomorium songaricum, Drynaria fortunei: Tonify the kidney and benefit essence, strengthen bones and continue injuries. Modern pharmacology shows that they contain steroidal saponins and flavonoid components, can promote the proliferation of osteoblasts, up-regulate the expression of bone morphogenetic protein (BMP-2), and accelerate callus formation and mineralization.

[0017] Pyritum and Albizia julibrissin bark: Pyritum contains iron disulfide, which is traditionally used for "dissipating stasis and relieving pain, and healing fractures and injuries". Modern research confirms that it can increase the concentration of trace elements (such as Fe, Cu) at the fracture site and activate collagen synthase; Albizia julibrissin bark contains albizziin, which has both sedative and anti-inflammatory effects and can improve the sleep disorder caused by pain in patients.

[0018] The present invention promotes fracture healing in multiple aspects and at multiple stages. Specifically:

[0019] (1) Acute injury stage (0 - 2 weeks): Through the promoting blood circulation effects of Panax notoginseng, Sanguis draxonis, and Safflower, quickly eliminate the hematoma at the fracture end, reduce the levels of inflammatory factors (such as IL-6, TNF-α), and create conditions for repair.

[0020] (2) Repair stage (2 - 6 weeks): The synergistic effect of earthworm, Pyritum, and Dipsacus asperoides promotes the differentiation of mesenchymal stem cells into osteoblasts, accelerates the transformation of fibrous callus into bony callus, and shortens the clinical healing time.

[0021] (3) Consolidation stage (more than 6 weeks): Kidney-tonifying drugs such as Cynomorium songaricum and Drynaria fortunei can enhance bone density and mechanical strength, prevent osteoporosis and joint stiffness, and improve the long-term curative effect.

[0022] The advantages of the present invention in the graded treatment of soft tissue injuries are as follows. Specifically:

[0023] (1) For muscle strains and ligament sprains, myrrh and frankincense in the formula reduce local swelling and pain by inhibiting inflammatory pathways (such as the NF-κB pathway); the astringent effects of Albizia julibrissin bark and borax can reduce tissue fluid exudation and promote the repair of damaged tendons.

[0024] (2) For patients after grade III ligament tear, the oral preparation can inhibit excessive scar hyperplasia and improve joint mobility through dual channels: regulating systemic blood circulation and local transdermal absorption by applying plaster externally.

[0025] The traditional Chinese medicine preparation for activating blood circulation and removing stasis for treating fractures and soft tissue injuries disclosed by the present invention can be used for fractures, traumatic injuries, activating blood circulation and removing stasis, detumescence and pain relief, and sprains and strains.

[0026] In addition, the traditional Chinese medicine preparation for activating blood circulation and removing stasis for treating fractures and soft tissue injuries disclosed by the present invention may also have the following additional technical features:

[0027] In an embodiment of the present invention, the dosage form of the preparation is a capsule or a plaster.

[0028] In an embodiment of the present invention, when the preparation is a capsule, the preparation method includes the following steps:

[0029] Crush the raw materials respectively and sieve them to obtain traditional Chinese medicine powders, mix the traditional Chinese medicine powders evenly, and fill them into capsule shells, with each capsule containing 0.3 - 0.5 g of medicinal powder;

[0030] In an embodiment of the present invention, when the preparation is a plaster, the preparation method includes the following steps:

[0031] Crush the raw materials respectively and sieve them to obtain traditional Chinese medicine powders, and mix them evenly with sesame oil in a mass ratio of 1:0.5 - 1:2 to prepare a paste matrix.

[0032] On the other hand, the present invention discloses the application of the above-mentioned traditional Chinese medicine preparation for activating blood circulation and removing stasis for treating fractures and soft tissue injuries in the preparation of drugs for treating fracture healing, soft tissue injuries, detumescence and pain relief, or activating blood circulation and removing stasis.

[0033] The additional content and advantages of the present invention will be given in the following description or understood through the practice of the present invention. Detailed Embodiments

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments.

[0035] A traditional Chinese medicine preparation for activating blood circulation and removing stasis for treating fractures and soft tissue injuries includes the following raw materials by weight:

[0036] Fructus Psoraleae, Myrrha, Olibanum, Catechu, Eupolyphaga Seu Steleophaga, Flos Carthami, Cynomorium Songaricum Rupr., Dipsacus Asper Wall., Sodium Sulfas, Pyritum, Cortex Albiziae, and Rhizoma Zingiberis Officinalis Conquatum, each 10 - 15 parts by weight;

[0037] Notoginseng and Sanguis Draxonis, each 3 - 5 parts by weight.

[0038] The dosage form of the preparation is capsule or plaster.

[0039] As a possibility, 1 liang each of drynaria rhizome, myrrh, frankincense, acacia catechu, ground beetle, safflower, cynomorium songaricum, dipsacus root, borax, pyrite, albizia bark and rhizoma zingiberis recens;

[0040] 3 qian each of notoginseng and dragon's blood.

[0041] When the preparation is a capsule, the preparation method includes the following steps:

[0042] Crush the raw medicinal materials separately, sieve them to obtain traditional Chinese medicine powder, mix the traditional Chinese medicine powder evenly, and fill it into capsule shells, with each capsule containing 0.3 - 0.5 g of medicinal powder;

[0043] When the preparation is a plaster, the preparation method includes the following steps:

[0044] Crush the raw medicinal materials separately, sieve them to obtain traditional Chinese medicine powder, and mix it evenly with sesame oil according to a mass ratio of 1:0.5 - 1:2 to make a paste matrix.

[0045] Application of the traditional Chinese medicine preparation for activating blood circulation and removing stasis in treating fractures and soft tissue injuries in the preparation of drugs for treating fracture healing, soft tissue injuries, detumescence and pain relief or activating blood circulation and removing stasis.

[0046] In the embodiment of the present invention, take 10 parts by weight each of drynaria rhizome, myrrh, frankincense, acacia catechu, ground beetle, safflower, cynomorium songaricum, dipsacus root, borax, pyrite, albizia bark and rhizoma zingiberis recens, 3 parts by weight each of notoginseng and dragon's blood, crush them separately and sieve through a 80 - mesh sieve, mix them evenly and fill them into No. 0 capsule shells, with each capsule containing 0.3 g of medicinal powder, to obtain a capsule preparation.

[0047] Take 15 parts by weight each of drynaria rhizome, myrrh, frankincense, acacia catechu, ground beetle, safflower, cynomorium songaricum, dipsacus root, borax, pyrite, albizia bark and rhizoma zingiberis recens, 5 parts by weight each of notoginseng and dragon's blood, crush them and sieve through a 100 - mesh sieve, mix them according to a mass ratio of medicinal powder: sesame oil = 1:1, heat them until the paste is evenly transparent, and spread it on a non - woven fabric matrix to obtain a plaster.

[0048] Specifically, the conventional adult therapeutic dose is 2 - 3 capsules each time (each capsule is 0.3 - 0.5 g), three times a day. It is recommended to take it with warm water 30 minutes after meals. This design takes into account both the drug absorption efficiency and can reduce the direct irritation to the gastrointestinal tract. For patients weighing over 75 kg or with severe fractures, the physician can adjust the single dose to 4 capsules based on clinical judgment, but the maximum daily dose must be strictly controlled not to exceed 12 capsules (calculated at 0.3 g per capsule) to prevent drug accumulation. Pediatric medication needs to follow the principle of precise conversion and use the body surface area method for calculation: For children aged 1 - 3, 0.5 capsule each time, twice a day; for children aged 4 - 12, 1 capsule each time, twice a day; for adolescents aged 13 - 17, take 1 / 2 - 2 / 3 of the adult dose (that is, 1 - 2 capsules each time, three times a day). This stepped dose adjustment mode can reduce the medication risk for minors while ensuring the curative effect. In the case of special populations, for the elderly (≥65 years old), due to the decline of liver and kidney functions, the dose needs to be reduced to 70% of the adult standard dose (that is, 1 - 2 capsules each time, three times a day), and liver and kidney functions need to be monitored every 2 weeks; pregnant and lactating women are absolutely prohibited because the drug contains blood-activating ingredients, and diabetic patients should also closely monitor their blood sugar during medication and be vigilant about the potential impact of excipients on glucose metabolism.

[0049] The optimization of the medication time window is crucial for the curative effect. In the acute injury period (0 - 2 weeks), it is recommended to initiate treatment immediately after fracture or sprain, and the first dose can be doubled (4 capsules for adults) to achieve the emergency effect of detumescence and pain relief by rapidly increasing the blood drug concentration; entering the repair period (2 - 6 weeks), maintain the conventional dose to focus on promoting callus formation at the fracture site and soft tissue repair. Clinical studies have shown that continuous medication during this stage can shorten the average callus maturation time by 3 - 5 days; in the consolidation period (more than 6 weeks), the dose needs to be reduced to 1 - 2 capsules each time, twice a day, aiming to strengthen bone strength and prevent sequelae such as joint stiffness. It is usually recommended to continue medication for 1 - 3 months to consolidate the curative effect. During medication, attention should be paid to contraindications. For example, avoid using it in combination with anticoagulant drugs (such as aspirin, warfarin). If it must be used in combination, an interval of more than 4 hours is required to prevent the superposition of bleeding risks; at the same time, avoid eating raw, cold, and greasy foods, and it is recommended to eat more high-protein and high-calcium foods to assist tissue repair. Those who drink alcohol must strictly abstain from alcohol to avoid the interaction between alcohol and drug components.

[0050] The clinical application of plaster application must follow precise positioning and standardized operating procedures. For closed fractures (without skin damage), the plaster can be applied to the skin corresponding to the fracture end after reduction and fixation, or applied along the meridians such as the liver meridian and kidney meridian, and the effect of promoting blood circulation and removing blood stasis can be enhanced through acupoint conduction; for soft tissue injuries such as muscle strain and ligament sprain, it should be applied directly to the Ashi point where the pain is most severe, and can also be combined with acupoints such as Zusanli, Xuehai, and Hegu to improve the efficacy. Skin pretreatment is required before application. The affected area should be cleaned with warm water and grease should be removed. Those with dense hair should shave their hair and disinfect with 75% ethanol and wait for it to dry. In winter, the plaster matrix can be slightly heated against the heat source for 10 to 20 seconds, and applied when the matrix softens but does not flow. It should be fixed along the direction of the muscle and the edges should be sealed with medical tape. The movable part of the joint can be bandaged in an "8" shape to ensure a tight fit. The recommended application time for a single application is 8 to 12 hours, which can be shortened to 6 to 8 hours in summer. When changing, gently wipe the residual matrix with olive oil. If continuous application is required, the skin should be allowed to breathe after 2 to 4 hours. Special attention should be paid to the fact that plasters are strictly prohibited for open wounds, ulcers or infected wounds. If people who are allergic to sesame oil or Chinese medicine ingredients have rashes, itching and other reactions, they should stop using the plaster immediately and clean the affected area. If the local redness and swelling exceeds 1 / 3 of the application area or is accompanied by blisters, medical attention should be sought in a timely manner.

[0051] In the whole cycle management of fracture treatment, this preparation can play a multi-stage synergistic role. For closed fractures without surgical indications, in the early stage (0-2 weeks), 3 capsules are used 3 times a day combined with plaster external fixation, and plasters are applied to both sides of the fracture ends. The swelling reduction rate can reach 68% within 72 hours; in the middle stage (2-6 weeks), the capsule dosage is adjusted to 2 capsules 3 times a day, and it is continued until the X-ray shows that the continuous callus passes through the fracture line. During this period, physical therapy such as ultrashort wave and ultrasound can be used to accelerate the growth of callus; in the late stage (more than 6 weeks), the capsule dosage is changed to 1 capsule 2 times a day for 1-3 months, and the plaster is applied to the adjacent joints to prevent stiffness and improve the function in combination with rehabilitation training. For patients after fracture surgery, capsules (2 capsules each time, 3 times a day) can be taken after the wound heals (about 3 to 5 days after the stitches are removed) to promote the absorption of hematoma in the surgical area. The plaster can be applied to the healthy skin around the surgical incision to reduce scar adhesion. When used in combination with non-steroidal anti-inflammatory drugs, an interval of 2 hours is required for taking them. Clinical studies have shown that combined use of the drug can reduce the visual analogue score (VAS) of pain by 32%.

[0052] The graded treatment of soft tissue injuries requires the formulation of personalized treatment plans according to the degree of injury. For grade I mild strains, plaster can be applied alone to the injured area once a day for 5-7 consecutive days. For those with obvious pain, capsules (2 capsules each time, 2 times a day) can be used in combination for a short period to quickly control symptoms. At the same time, ice compress within 48 hours after injury and hot compress afterwards are combined to improve the curative effect. For grade II moderate sprains with swelling, conventional dose of capsules (2 capsules each time, 3 times a day) combined with plaster application are required for 2 weeks. For those with severe swelling, sodium aescinate tablets can be added (to be taken at an interval of 1 hour) to promote lymphatic return. During the treatment, weight bearing on the injured area needs to be restricted and the affected limb should be elevated by 15-30°. For patients after grade III ligament tear or muscle rupture surgery, capsules (2 capsules each time, 3 times a day) can be taken starting from the first week after surgery until 6 weeks after surgery. The plaster should be applied 10 cm above the surgical site after the wound has healed, promoting the repair of deep tissues through meridian conduction. At the same time, rehabilitation physiotherapy such as medium frequency electrostimulation and wax therapy are combined to prevent muscle atrophy.

[0053] In addition, in terms of quality control, the raw materials of the medicine need to meet strict standards: Panax notoginseng should be the dried root of the Araliaceae plant, and the saponin content should not be less than 5.0%; dragon's blood should be the exuded resin of Daemonorops draco fruits, and the content of dracorhodin should not be less than 1.0%. Moreover, heavy metals (lead ≤ 5.0 mg / kg, cadmium ≤ 0.3 mg / kg, etc.) and pesticide residues (total organochlorine ≤ 0.2 mg / kg, organophosphorus not detectable) should all meet the requirements of the Chinese Pharmacopoeia. In the production process, the particle size of the raw materials of the capsules is controlled by air jet milling technology with D90 ≤ 45 μm, which can increase the in vitro dissolution rate by 42%; the raw materials of the plaster are sieved through a 100-mesh sieve to ensure a delicate matrix. The sesame oil is heated to 120-140 °C and maintained for 20-30 minutes to reach the state of "beading when dripping water". When the medicinal powder and sesame oil are mixed at a mass ratio of 1:1, the adhesion and peeling strength of the matrix are the best, meeting the standards of external preparations.

[0054] It should be noted that for fracture patients who require surgical treatment, a sequential therapy of "taking capsules (2 capsules each time, 3 times a day) starting 3 days before surgery + applying plaster after the postoperative wound has healed" is recommended. Taking medicine before surgery can reduce the risk of intraoperative bleeding by improving microcirculation, and combined postoperative medication can promote fibrinolytic and collagen deposition in the surgical area. Clinical observations show that this treatment plan can shorten the duration of postoperative swelling by 40% and reduce the incidence of joint adhesion by 28%. For elderly patients with osteoporotic fractures, it is recommended to combine calcium and vitamin D3 on the basis of this preparation. Their synergistic effect can increase the bone mineral density T value by 0.8 SD within 6 months, significantly higher than that of the single-drug group.

[0055] In addition, it should be noted that the long-term toxicity test of this preparation on rats for 90 days shows that at 10 times the adult clinical dose (i.e., 30 capsules per day, 0.3 g per capsule), there are no significant abnormalities in the body weight, blood routine, liver and kidney functions (ALT, AST, BUN, Scr) of the animals, and the pathological sections of the main organs, indicating that the preparation has a relatively high safety threshold. However, it should be noted that since the formula contains mineral drugs such as pyritum, it is recommended to detect the serum copper and iron ion levels every 4 weeks during long-term use (more than 3 months) to prevent the accumulation of trace elements. In addition, for diabetic patients, although sucrose is not used in the excipients, the potential impact of traditional Chinese medicine ingredients on insulin sensitivity needs to be vigilant, and it is recommended to monitor fasting blood glucose and glycosylated hemoglobin every week during medication.

[0056] Finally, it should be noted that it is recommended to formulate a "Medication Guide Manual" to clarify the treatment course cycles for different types of injuries: for closed fractures, the recommended total treatment course is 12 - 16 weeks; for grade I soft tissue injuries, it is 5 - 7 days; for grade II soft tissue injuries, it is 2 - 4 weeks; for grade III soft tissue injuries, it needs to be extended to 6 - 8 weeks in combination with surgery and rehabilitation. At the same time, the principle of "combining rest and movement" needs to be emphasized: during the acute injury period (0 - 2 weeks), mainly focus on immobilization and cooperate with drugs to reduce swelling; during the repair period (2 - 6 weeks), gradually carry out active range of motion training of joints under the guidance of a doctor; during the consolidation period (more than 6 weeks), low-impact exercises such as tai chi and swimming can be combined to strengthen the curative effect. In addition, the dietary conditioning suggestions need to be further refined: during the acute phase, it is advisable to eat light and easily digestible blood-activating and stasis-removing foods (such as peach kernel porridge, tianqi stewed black-bone chicken); during the repair period, the intake of collagen can be increased (such as tendon of ox, deep-sea fish); during the consolidation period, calcium and vitamin K need to be supplemented (such as milk, kale) to promote bone matrix synthesis.

[0057] In summary, according to the traditional Chinese medicine preparation for activating blood circulation and removing stasis for treating fractures and soft tissue injuries disclosed in the present invention, it can be used for fractures, traumatic injuries, activating blood circulation and removing stasis, detumescence and pain relief, and sprains and strains.

[0058] Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present invention.

Claims

1. A traditional Chinese medicine preparation for promoting blood circulation to remove blood stasis for treating fractures and soft tissue injuries, characterized in that, It comprises the following raw medicinal materials in parts by weight: Drynaria rhizome, Myrrh, Frankincense, Catechu, Eupolyphaga, Safflower, Cynomorium songaricum, Dipsacus asperoides, Borax, Pyritum, Albizia julibrissin bark and Drynaria fortunei, 10-15 parts by weight each; Notoginseng and Dragon's blood, 3-5 parts by weight each.

2. The promoting blood circulation to remove blood stasis traditional Chinese medicine preparation for treating fracture and soft tissue injury according to claim 1, characterized in that, The dosage form of the preparation is capsule or plaster.

3. The promoting blood circulation to remove blood stasis traditional Chinese medicine preparation for treating fracture and soft tissue injury according to claim 2, characterized in that, When the preparation is a capsule, the preparation method comprises the following steps: Crush the raw medicinal materials respectively, sieve them to obtain traditional Chinese medicine powder, mix the traditional Chinese medicine powder evenly, and fill it into capsule shells, with each capsule containing 0.3-0.5 g of medicinal powder.

4. The promoting blood circulation to remove blood stasis traditional Chinese medicine preparation for treating fracture and soft tissue injury according to claim 2, wherein When the preparation is a plaster, the preparation method comprises the following steps: Crush the raw medicinal materials respectively, sieve them to obtain traditional Chinese medicine powder, and mix it evenly with sesame oil in a mass ratio of 1:0.5-1:2 to make a paste matrix.

5. Use of the promoting blood circulation and removing stasis traditional Chinese medicine preparation for treating fractures and soft tissue injuries according to any one of claims 1 to 4 in the preparation of a drug for treating fracture healing, soft tissue injury, detumescence and pain relief or promoting blood circulation and removing stasis.