Traditional Chinese medicine composition for treating fracture and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating fracture and a quality control method and application thereof, and the traditional Chinese medicine composition for treating fracture is prepared from the following raw materials: morinda officinalis, ground beetle and native copper. The traditional Chinese medicine composition disclosed by the invention has an obvious treatment effect on animal models of fracture and femoral head necrosis, and can promote fracture healing, relieve the degree of femoral head necrosis, improve bone metabolism and increase bone density. The traditional Chinese medicine composition provides a new choice for treatment of fracture and femoral head necrosis, and has further research and development values.

Description

Technical field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating fractures and a preparation method thereof. [Background Technology]

[0002] Fractures and femoral head necrosis are common and difficult to treat diseases in the field of orthopedics. Every year, millions of people worldwide suffer fractures due to trauma, osteoporosis or abnormal bone metabolism. As a difficult orthopedic disease, femoral head necrosis is mostly secondary to trauma, hormone use or alcoholism, and its incidence rate is increasing year by year. Current clinical treatments mainly include surgical fixation, bone transplantation, artificial joint replacement and drug intervention, but there are problems such as long healing period, high risk of complications and high medical costs. For example, although traditional fracture fixation can restore the anatomical structure, it cannot directly promote callus formation; in the early stage of femoral head necrosis, core decompression is often used, but joint replacement is often required in the middle and late stages, and postoperative functional recovery is limited.

[0003] In terms of drug treatment, although bisphosphonates can inhibit osteoclast activity, long-term use may lead to jaw osteonecrosis. Biologics such as BMP (bone morphogenetic protein) can induce osteogenesis, but they are expensive and carry the risk of immunogenicity. Therefore, the development of safe, effective, and innovative drugs with synergistic multi-target effects has become a research hotspot.

[0004] Traditional Chinese medicine has a long history in treating bone injuries, with classic prescriptions such as "Jiegu Qili Powder" and "Xugu Huoxue Decoction" still used in clinical practice today. However, traditional Chinese medicine has the following shortcomings:

[0005] Single-pronged combinations often use Drynaria fortunei and natural copper as the main ingredients, focusing on promoting blood circulation and tendon strengthening while neglecting kidney nourishment and strengthening the body. For example, the natural copper-Drynaria fortunei combination described in the "Compendium of Chinese Materia Medica" promotes calcium and phosphorus deposition but lacks a core mechanism for regulating bone metabolism.

[0006] Limitation of target action: Traditional prescriptions mostly focus on a single pathological link (such as hematoma absorption or bone mineralization) and lack the regulation of the entire process of "inflammation-angiogenesis-bone reconstruction".

[0007] The preparation process is crude: although the water decoction method is simple to operate, the extraction rate of effective ingredients is low, and high temperature can easily destroy heat-sensitive ingredients. [Summary of the invention]

[0008] To address the above technical problems, the present invention provides a traditional Chinese medicine composition for treating fractures and a method for preparing the same. The traditional Chinese medicine composition of the present invention demonstrates significant efficacy in the treatment and prevention of fractures or femoral head necrosis, and its preparation process is simple and easy to control. The traditional Chinese medicine composition of the present invention provides a new option for the treatment of fractures and femoral head necrosis and is worthy of further research and development.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] A traditional Chinese medicine composition for treating fractures is prepared from the following raw materials: Morinda officinalis, Eupolyphaga sinensis, and natural copper.

[0011] Furthermore, it is prepared from the following raw materials in parts by weight: 1-3 parts of Morinda officinalis, 9-12 parts of Eupolyphaga sinensis, and 3-6 parts of natural copper.

[0012] Preferably, it is prepared from the following raw materials in parts by weight: 2 parts of Morinda officinalis, 10 parts of Eupolyphaga sinensis, and 5 parts of natural copper.

[0013] The present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating fracture, comprising the following steps: taking Morinda officinalis and Eupolyphaga sinensis, decocting them with water, combining the decoctions and adding natural copper powder to obtain the composition.

[0014] The present invention also provides another method for preparing the above-mentioned traditional Chinese medicine composition for treating fractures, comprising the following steps:

[0015] Step 1) Take clean natural copper, calcine it to dark red according to the calcination and quenching method, quench it with vinegar until the surface turns gray, dry it, crush it and sieve it for later use; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder and set aside;

[0016] Step 2) taking the reserved earthworms in proportion, adding 50-80% ethanol aqueous solution in an amount of 2-10 times the total weight of the earthworms, ultrasonically extracting at 10-30° C. for 30-120 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, or further drying to a moisture content of ≤6%, to obtain active ingredient A for standby use;

[0017] Step 3) Take the reserved Morinda officinalis, add 20-60 times the total weight of the deep eutectic solvent, extract at 40-60°C for 10-60 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, or further dry to a moisture content of ≤6% to obtain active ingredient B for standby use; the deep eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2;

[0018] Step 4), taking the reserved natural copper of step 1), the active ingredient A of step 2) and the active ingredient B of step 3), mixing them or further adding auxiliary materials to prepare a preparation, that is, obtaining.

[0019] Furthermore, in the step 1), the natural copper is crushed and sieved to a particle size of ≤80 mesh.

[0020] Furthermore, in step 3), the preparation method of the deep eutectic solvent is: weighing choline chloride and urea according to the molar ratio, adding the two to a sealed container, and magnetically stirring at 400-800 rpm at 70-90° C. for 1-2 hours until a uniform and transparent deep eutectic liquid is formed.

[0021] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating fractures in preparing medicine for treating fractures or femoral head necrosis.

[0022] The raw material sources of the present invention are as follows:

[0023] Morinda officinalis, this product is the dried root of Morinda officinalis How, a plant of the Rubiaceae family.

[0024] Eupolyphaga sinensis Walker, this product is the dried body of the female insect of the Blattidae family, Eupolyphaga sinensis Walker or Steleophaga plancyi (Boleny).

[0025] Native copper is a sulfide mineral of the pyrite family, mainly containing iron disulfide (FeS2).

[0026] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0027] (1) The present invention uses Morinda officinalis as the main drug, and is combined with Eurycoma longifolia and natural copper to achieve the effects of tonifying the kidney and strengthening bones, breaking blood and removing blood stasis, and reconnecting bones and tendons. In the prescription, Morinda officinalis is warm and tonifying the kidney yang, strengthening tendons and bones, and promoting callus formation by activating the BMP-2 signaling pathway of osteoblasts, providing a material basis for fracture repair; Eurycoma longifolia is the auxiliary drug, and large doses are used to enhance the power of breaking blood and removing blood stasis, reconnecting tendons and bones. Its salty and cold nature can soften and disperse nodules, improve blood circulation in the necrotic area of the femoral head and the fracture end, and promote hematoma organization and neovascularization; natural copper is the guiding drug, containing trace elements such as zinc and copper that directly participate in the mineralization of bone matrix, guide the drug into the bone to enhance the toughness of the callus, and cooperate with Morinda officinalis to achieve the vertical regulation of "tonifying the kidney-producing marrow-strengthening bones". The whole prescription is centered on tonifying the kidney and strengthening bones, breaking through the traditional compatibility framework, and forming three major innovations:

[0028] ① Innovation in the combination of monarch and minister: Morinda officinalis is used as the main agent to warm the kidney and replenish essence, replacing traditional blood-activating and blood-stasis-removing drugs, in line with the theory that "kidney controls bone and marrow production", and by enhancing bone marrow hematopoietic function and osteoblast activity, it builds a metabolic basis for fracture healing; Scolopendra subspinipes is used as the core minister, and its high-dose application forms a dynamic balance of "breaking and replenishing", which not only clears blood stasis but also promotes the connection of tendons and bones.

[0029] ② Targeted enhancement of drug efficacy: Natural copper has been upgraded from a traditional adjuvant to a guiding drug. Its trace elements directly participate in the mineralization process of callus, and together with the bone-forming effect of Morinda officinalis, it forms a two-way regulation of "bone matrix synthesis-mineralization deposition", significantly improving the mechanical strength of callus; the alkaloid components contained in Eurycoma longifolia can inhibit the activity of osteoclasts, reduce bone absorption, and form a "destruction and construction combined" bone reconstruction regulation with the osteogenesis-promoting effect.

[0030] ③ Optimized Indications: This prescription streamlines its heat-clearing and dampness-removing components, focusing on the core pathogenesis of "kidney deficiency and blood stasis." It is more suitable for mid-to-late stage fractures or osteoporotic fractures in the elderly. Its kidney-tonifying effect can improve bone microstructural degeneration, while its blood-activating effect targets the blood stasis that hinders fracture healing. It is particularly suitable for patients with liver and kidney deficiency and localized blood stasis. Through the three-step synergy of "warming the kidney, activating blood circulation, and consolidating bones," it achieves a full-cycle intervention from bone marrow regeneration to callus remodeling. Clinically, it can significantly shorten fracture healing time and reduce the risk of complications such as femoral head necrosis.

[0031] (2) Animal experiments have shown that the Chinese medicine composition of the present invention has a significant therapeutic effect on animal models of fractures and femoral head necrosis, promoting fracture healing, reducing the degree of femoral head necrosis, improving bone metabolism, and increasing bone density. Its mechanism of action may be related to regulating bone metabolism, promoting bone formation, and inhibiting bone resorption. This Chinese medicine composition provides a new option for the treatment of fractures and femoral head necrosis and is worthy of further research and development. [Specific implementation method]

[0032] Example 1: Preparation and application of the Chinese medicine composition for treating fractures of the present invention

[0033] Prescription: Morinda officinalis 2g, Eupolyphaga sinensis 10g, and natural copper 5g.

[0034] Preparation method: Take Morinda officinalis and Eucommia ulmoides, add water and boil for 20 minutes for the first decoction and 25 minutes for the second decoction. Combine the decoctions and then add natural copper powder.

[0035] In this embodiment, the native copper is a wrought product.

[0036] The specific forging method is as follows: take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Rules 0213 of the 2020 Edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it for later use.

[0037] Typical cases:

[0038] 1, 52 years old male, caused right femoral neck fracture (Garden IV type) because of traffic accident, row open reduction and internal fixation 3 months after operation, X-ray showed that fracture line is clear, callus growth is slow, local tenderness is obvious, and hip joint movement is limited.Take 1 dose of Chinese medicine composition of the present invention every day, divide 2 times warm clothes, continuous medication 12 weeks.Medication pain alleviated after 4 weeks, and 6 weeks' review X-ray showed that callus formation increases, and in the time of 12 weeks, fracture line is fuzzy, and can support the weight-bearing part walking of cane.

[0039] 2. A 78-year-old woman suffered a left intertrochanteric fracture (Evans type III) after a fall. She underwent closed reduction and PFNA fixation. One week after surgery, her bone density (T) score was -3.2. She was treated with the Chinese herbal composition of the present invention, calcium supplements, and vitamin D for 12 weeks. An 8-week follow-up X-ray showed a blurred fracture line and good callus quality. At 7 months, her bone density (T) score had improved to -2.5.

[0040] 3. A 23-year-old male athlete suffered a right ankle fracture (Weber B type) with severe soft tissue swelling and poor wound healing 2 weeks after surgery. He was treated with the Chinese medicinal composition of the present invention for 6 weeks. The swelling subsided at 4 weeks, and X-rays at 6 weeks showed good alignment of the fracture ends and callus formation.

[0041] Example 2: Preparation of a Chinese medicine composition for treating fractures of the present invention

[0042] Prescription: Morinda officinalis 2g, Eupolyphaga sinensis 10g, and natural copper 5g.

[0043] Preparation method: Step 1), take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder, and set aside;

[0044] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 65% ethanol aqueous solution in an amount of 8 times the total weight of Eupolyphaga sinensis, ultrasonically extracting at 23° C. for 90 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0045] Step 3) Take the reserved Morinda officinalis, add a low eutectic solvent in an amount 30 times the total weight of Morinda officinalis, perform ultrasonic extraction at 50°C for 50 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, and further dry to a moisture content of ≤6% to obtain an active ingredient B for standby use; the low eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2; the preparation method of the low eutectic solvent is as follows: weigh the choline chloride and urea according to the molar ratio, add the two to a sealed container, and stir magnetically at 80°C and 600 rpm for 1.5 hours until a uniform and transparent low eutectic liquid is formed;

[0046] Step 4), taking the reserved natural copper of step 1), the active ingredient A of step 2), and the active ingredient B of step 3), adding auxiliary materials to prepare capsules, and obtaining the product.

[0047] Example 3: Preparation of a Chinese medicine composition for treating fractures of the present invention

[0048] Prescription: Morinda officinalis 1g, Eupolyphaga sinensis 9g, and natural copper 3g.

[0049] Preparation method: Step 1), take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder, and set aside;

[0050] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 50% ethanol aqueous solution in an amount twice the total weight of Eupolyphaga sinensis, ultrasonically extracting at 10° C. for 30 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0051] Step 3) Take the reserved Morinda officinalis, add 20 times the total weight of Morinda officinalis to the low eutectic solvent, perform ultrasonic extraction at 40°C for 10 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, and further dry to a moisture content of ≤6% to obtain active ingredient B for standby use; the low eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2; the preparation method of the low eutectic solvent is as follows: weigh the choline chloride and urea according to the molar ratio, add the two to a sealed container, and stir magnetically at 400 rpm at 70°C for 1 hour until a uniform and transparent low eutectic liquid is formed;

[0052] Step 4), taking the reserved natural copper in step 1), the active ingredient A in step 2), and the active ingredient B in step 3), adding auxiliary materials and preparing tablets to obtain.

[0053] Example 4: Preparation of a Chinese medicine composition for treating fractures of the present invention

[0054] Prescription: Morinda officinalis 3g, Eupolyphaga sinensis 12g, and natural copper 6g.

[0055] Preparation method: Step 1), take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder, and set aside;

[0056] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 80% ethanol aqueous solution in an amount 10 times the total weight of Eupolyphaga sinensis, ultrasonically extracting at 30° C. for 120 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0057] Step 3) Take the reserved Morinda officinalis, add 60 times the total weight of Morinda officinalis to the low eutectic solvent, extract at 60°C for 60 minutes by ultrasonication, filter, recover the solvent from the filtrate, concentrate under reduced pressure, and further dry to a moisture content of ≤6% to obtain active ingredient B for standby use; the low eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2; the preparation method of the low eutectic solvent is as follows: weigh the choline chloride and urea according to the molar ratio, add the two to a sealed container, and stir magnetically at 800 rpm at 90°C for 2 hours until a uniform and transparent low eutectic liquid is formed;

[0058] Step 4), taking the reserved natural copper in step 1), the active ingredient A in step 2), and the active ingredient B in step 3), adding auxiliary materials to prepare granules, thus obtaining.

[0059] Comparative Example 1:

[0060] The difference from Example 2 is that the prescription of Comparative Example 1 does not contain Morinda officinalis.

[0061] Prescription: 10g of Chinese earthworm and 5g of natural copper.

[0062] Preparation method: Step 1), take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush the earthworm to coarse powder and set aside;

[0063] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 65% ethanol aqueous solution in an amount of 8 times the total weight of Eupolyphaga sinensis, ultrasonically extracting at 23° C. for 90 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0064] Step 3), taking the natural copper prepared in step 1) and the active ingredient A in step 2), adding auxiliary materials and preparing capsules, thus obtaining the product.

[0065] Comparative Example 2:

[0066] The difference from Example 2 is that in step 1) of Comparative Example 2, natural copper vinegar is quenched until the surface is dark brown.

[0067] Prescription: Morinda officinalis 2g, Eupolyphaga sinensis 10g, and natural copper 5g.

[0068] Preparation method: Step 1), take clean natural copper, calcine it according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia) until it turns dark red, quench it with vinegar until the surface turns dark brown, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder, and set aside;

[0069] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 65% ethanol aqueous solution in an amount of 8 times the total weight of Eupolyphaga sinensis, ultrasonically extracting at 23° C. for 90 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0070] Step 3) Take the reserved Morinda officinalis, add a low eutectic solvent in an amount 30 times the total weight of Morinda officinalis, perform ultrasonic extraction at 50°C for 50 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, and further dry to a moisture content of ≤6% to obtain an active ingredient B for standby use; the low eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2; the preparation method of the low eutectic solvent is as follows: weigh the choline chloride and urea according to the molar ratio, add the two to a sealed container, and stir magnetically at 80°C and 600 rpm for 1.5 hours until a uniform and transparent low eutectic liquid is formed;

[0071] Step 4), taking the reserved natural copper of step 1), the active ingredient A of step 2), and the active ingredient B of step 3), adding auxiliary materials to prepare capsules, and obtaining the product.

[0072] Comparative Example 3:

[0073] The difference from Example 2 is that in the preparation method of Comparative Example 3, the effective ingredients of Morinda officinalis were extracted with water. The details are as follows:

[0074] Prescription: Morinda officinalis 2g, Eupolyphaga sinensis 10g, and natural copper 5g.

[0075] Preparation method: Step 1), take clean natural copper, calcine it to dark red according to the calcination and quenching method (General Chapter 0213 of the 2020 edition of the Chinese Pharmacopoeia), quench it with vinegar until the surface turns gray, dry it, crush it and sieve it to a particle size of ≤80 mesh, and set aside; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder, and set aside;

[0076] Step 2) taking the reserved Eupolyphaga sinensis in proportion, adding 65% ethanol aqueous solution in an amount of 8 times the total weight of Eupolyphaga sinensis, ultrasonically extracting at 23° C. for 90 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, and further drying to a moisture content of ≤6% to obtain active ingredient A, which is set aside;

[0077] Step 3) Take the reserved Morinda officinalis, add 30 times the total weight of water to the Morinda officinalis, extract at 90°C for 50 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, and further dry to a moisture content of ≤6% to obtain active ingredient B for standby use;

[0078] Step 4), taking the reserved natural copper of step 1), the active ingredient A of step 2), and the active ingredient B of step 3), adding auxiliary materials to prepare capsules, and obtaining the product.

[0079] The following experimental studies verify the technical effects of the present invention:

[0080] Experiment 1: Application research of the Chinese medicine composition of the present invention

[0081] 1. Experimental Purpose

[0082] To evaluate the efficacy of a specific Chinese herbal medicine combination in animal models of fracture and femoral head necrosis.

[0083] 2. Experimental Materials

[0084] 1. Experimental Animals

[0085] Healthy adult white rabbits weighing 2.5-3.0 kg, half male and half female, were provided by a traditional Chinese medicine university. The animals were housed in a clean animal room with room temperature maintained at 23-25°C and relative humidity at 40%-60%, with free access to food and water. The animals were acclimated for one week. The animals were randomly divided into a normal control group, a model control group, a Chinese medicine combination group, and a positive control group, with 12 rabbits in each group.

[0086] 2. Experimental drugs

[0087] Chinese medicine composition: The Chinese medicine compositions of Examples 2 to 4 and Comparative Examples 1 to 3 were selected and prepared with distilled water to contain 1 g / ml of the crude drug.

[0088] Positive control drug: Select Xianling Gubao Capsule and prepare it with distilled water to contain 1g / ml of crude drug.

[0089] 3. Experimental Methods

[0090] 1. Establishment of animal model

[0091] Fracture Model: Rabbits were anesthetized with 30 mg / kg of 3% sodium pentobarbital injected into the ear vein. After successful anesthesia, the animals were placed in a supine position on the operating table. The right hind limb was shaved and disinfected. A 3-cm longitudinal incision was made on the lateral side of the femur. The skin, subcutaneous tissue, and fascia were dissected layer by layer, and the vastus lateralis muscle was separated to expose the femoral shaft. A transverse fracture was created in the mid-shaft of the femoral shaft using a bone saw. Internal fixation was performed with Kirschner wires, and the incision was sutured layer by layer. Postoperatively, 400,000 units of penicillin were administered intramuscularly for three consecutive days to prevent infection.

[0092] Femoral head necrosis model: A hormone-induced femoral head necrosis model was established. Rabbits were injected with methylprednisolone 20 mg / kg intravenously twice a week for 3 weeks while restricting their activity to promote the development of femoral head necrosis.

[0093] 2. Animal grouping and drug administration

[0094] Dosage and Method: The TCM combination group was given a solution containing 2.0 g / kg of the crude drug, the positive control group was given a solution of 0.2 g / kg of Xianling Gubao capsule, and the normal and model control groups were given an equal volume of distilled water. All groups were administered via gavage once daily for 8 weeks.

[0095] 3. Observation indicators

[0096] Fracture healing: At 2, 4, 6, and 8 weeks after administration, X-ray examinations were performed on the fracture model animals to observe the fracture healing status, and the Lane-Sandhu callus scoring standard was used to score the callus growth.

[0097] Femoral head necrosis: At 8 weeks after administration, the femoral head necrosis model animals were sacrificed, and the bilateral femoral heads were obtained for hematoxylin-eosin (HE) and Masson staining to observe the pathological histological changes of the femoral heads. The degree of femoral head necrosis was staged using the Association for the Study of Microcirculation in Bone (ARCO) staging standard.

[0098] Bone density: Dual-energy X-ray absorptiometry (DXA) was used to detect the bone density of the animal femur.

[0099] IV. Experimental Procedure

[0100] 1. After the model is successfully established, start administering the drug and observe the general condition of the animal daily, including its mental state, diet, and activity.

[0101] 2. After 2, 4, 6, and 8 weeks of administration, X-ray examinations were performed on the fracture model animals to observe the fracture healing status.

[0102] 3. After 8 weeks of administration, the femoral head necrosis model animals were sacrificed, and the bilateral femoral heads were taken for pathological histological examination and bone density detection.

[0103] 5. Experimental results.

[0104] As shown in Table 1.

[0105] Table 1 Comparison of bone repair effects in different experimental groups

[0106]

[0107] From Table 1 we can see that:

[0108] 1. Fracture healing score: The normal group scored close to the full score (10 points), and the model group scored the lowest. The Example 2 group was significantly better than the Comparative Example 1-3 groups (△ mark) and better than the positive control drug, but there was no significant difference among the Example 2 / 3 / 4 groups (P>0.05).

[0109] 2. Femoral head necrosis staging: The higher the ARCO stage, the more severe it is (0 = normal, 4 = most severe); the model group had the highest stage, the Example 2 group showed significant improvement (** mark), and the control group was partially effective but weaker than Example 2.

[0110] 3. Bone density: The bone density of the Example 2 group was significantly improved (** mark), while the control group (△) had some improvement but the effect was weaker.

[0111] Statistical difference: P values of Example 2 vs. Comparative Examples 1 / 2 / 3 were all < 0.01 (** or △ marks), and P values between the Example 2 / 3 / 4 groups were > 0.05 (no mark).

[0112] Conclusion: This experimental result demonstrates that the Chinese herbal composition of the present invention has a significant therapeutic effect in animal models of fractures and femoral head necrosis, promoting fracture healing, reducing the severity of femoral head necrosis, and increasing bone density. Its mechanism of action may be related to regulating bone metabolism, promoting bone formation, and inhibiting bone resorption. This Chinese herbal composition of the present invention provides a new option for the treatment of fractures and femoral head necrosis and is worthy of further research and development.

[0113] The above description is a detailed description of the preferred embodiments of the present invention, but the embodiments are not intended to limit the scope of the patent application of the present invention. Any equivalent changes or modifications completed under the technical spirit suggested by the present invention should fall within the patent scope covered by the present invention.

Claims

1. A Chinese medicine composition for treating fractures, characterized in that: It is prepared from the following raw materials: Morinda officinalis, Eupolyphaga sinensis, and natural copper.

2. The Chinese medicine composition for treating fracture according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 1-3 parts of Morinda officinalis, 9-12 parts of Eupolyphaga sinensis, and 3-6 parts of natural copper.

3. The Chinese medicine composition for treating fracture according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 2 parts of Morinda officinalis, 10 parts of Eupolyphaga sinensis and 5 parts of natural copper.

4. A method for preparing the traditional Chinese medicine composition for treating fractures according to any one of claims 1 to 3, characterized in that: The method comprises the following steps: taking Morinda officinalis and Eupolyphaga sinensis, adding water to boil, combining the decoctions and then adding natural copper powder to obtain the product.

5. A method for preparing the traditional Chinese medicine composition for treating fractures according to any one of claims 1 to 3, characterized in that: The steps include: Step 1) Take clean natural copper, calcine it to dark red according to the calcination and quenching method, quench it with vinegar until the surface turns gray, dry it, crush it and sieve it for later use; crush Morinda officinalis and Eupolyphaga sinensis to coarse powder and set aside; Step 2) taking the reserved earthworms in proportion, adding 50-80% ethanol aqueous solution in an amount of 2-10 times the total weight of the earthworms, ultrasonically extracting at 10-30° C. for 30-120 minutes, filtering to obtain an ethanol extract; concentrating the ethanol extract under reduced pressure, or further drying to a moisture content of ≤6%, to obtain active ingredient A for standby use; Step 3) Take the reserved Morinda officinalis, add 20-60 times the total weight of the deep eutectic solvent, extract at 40-60°C for 10-60 minutes, filter, recover the solvent from the filtrate, concentrate under reduced pressure, or further dry to a moisture content of ≤6% to obtain active ingredient B for standby use; the deep eutectic solvent is composed of choline chloride and urea, and the molar ratio of choline chloride to urea is 1:2; Step 4), taking the reserved natural copper in step 1), the active ingredient A in step 2), and the active ingredient B in step 3), mixing them or further adding auxiliary materials to prepare a preparation, that is, obtaining the product.

6. The method for preparing the traditional Chinese medicine composition for treating fracture according to claim 5, characterized in that: In the step 1), the natural copper is crushed and sieved to a particle size of ≤80 mesh.

7. The method for preparing the traditional Chinese medicine composition for treating fracture according to claim 5, characterized in that: In step 3), the preparation method of the deep eutectic solvent is as follows: choline chloride and urea are weighed according to the molar ratio, the two are added to a sealed container, and magnetically stirred at 400-800 rpm at 70-90° C. for 1-2 hours until a uniform and transparent eutectic liquid is formed.

8. Use of the traditional Chinese medicine composition for treating fractures according to any one of claims 1 to 3 in the preparation of medicines for treating fractures or femoral head necrosis.

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