Traditional Chinese medicine composition for delayed fracture healing

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for delayed fracture healing. In the traditional Chinese medicine composition, the traditional Chinese medicine composition is prepared from abelmoschus manihot, dried alum, leech, centipede, scorpion, hedgehog hide, liquorice, elderberry, oroxylum indicum, uncaria rhynchophylla, medlar, safflower, pawpaw, radix curcumae, radix stephaniae tetrandrae, fried mustard seed, citron, fried rice sprout, fried malt and fructus polygoni orientalis, all the medicines are combined, and the effect is exact. In the formula, the compatibility of monarch, minister, assistant and guide is scientific and reasonable, the raw materials are various and are different from the general effect of enhancing a single medicine, a synergistic relationship is adopted, and the traditional Chinese medicine composition can effectively relieve swelling and pain, promote blood stasis dissipation, smooth channels and blood circulation, nourish muscles and bones, promote fracture to delay healing and reduce the pain of a patient.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology and relates to a traditional Chinese medicine composition for delayed fracture healing. Background Technology

[0002] The phenomenon of a fracture failing to heal completely or failing to fully heal within the normal healing time is called delayed union or nonunion. Delayed union and nonunion are different stages in the process of fracture healing disorders. Delayed union can be considered a precursor to nonunion, and appropriate treatment of delayed union can prevent the occurrence of nonunion. Their causes are mainly biological and biomechanical factors.

[0003] Modern medicine believes that delayed fracture healing is mainly caused by systemic, local, and drug-related factors. Among these, local factors are the primary cause of delayed fracture healing. Therefore, repositioning of the fracture ends and appropriate internal and external fixation are key to completely resolving the root cause of the problem. Due to poor local blood circulation, insufficient tissue perfusion, and nutritional deficiencies, healing is delayed. Therefore, promoting local blood circulation is an important condition for successful healing.

[0004] While in-depth research on the impact of diabetes on fracture healing is still lacking, it is undeniable that diabetic patients are more prone to delayed or nonunion of fractures. Diabetes is a chronic metabolic disease that causes various complications across multiple systems throughout the body, including those affecting blood circulation, bone metabolism, and nerve function. These factors contribute to delayed fracture healing and a higher rate of nonunion in diabetic patients.

[0005] Glucocorticoids possess a variety of effects, including anti-inflammatory, antiviral, anti-immune, and anti-shock properties. Due to their beneficial and unique pharmacological effects, many patients must take them long-term. However, long-term use of high doses of glucocorticoids can adversely affect bones, causing glucocorticoid-induced osteoporosis and leading to pathological fractures. Currently, glucocorticoids are the third leading cause of osteoporosis after secondary estrogen deficiency and age-related factors. Fractures are one of the most serious side effects of glucocorticoid-induced osteoporosis. Glucocorticoid-induced fractures often result in delayed healing, have a very high disability rate, and lack effective prevention and treatment methods. Fractures caused by glucocorticoid-induced osteoporosis are a common clinical condition, characterized by rapid onset and difficult healing, posing a significant challenge in orthopedic clinical practice.

[0006] Surgical treatment of delayed union and nonunion of fractures is the most common treatment method today, with the aim of promoting fracture healing and restoring limb function.

[0007] Currently, there is still a lack of effective and non-toxic Chinese medicine combinations for treating delayed fracture healing. Summary of the Invention

[0008] In view of this, the present invention provides a traditional Chinese medicine composition for delayed fracture healing.

[0009] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition for delayed fracture healing.

[0010] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition for delayed fracture healing in the preparation of drugs for delayed fracture healing.

[0011] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for delayed fracture healing, prepared from the following raw materials in parts by weight: 35-45 parts of Hibiscus rosa-sinensis flower, 55-70 parts of alum, 4-8 parts of leech, 2-3 parts of centipede, 2-3 parts of scorpion, 10-15 parts of hedgehog skin, 10-15 parts of licorice, 10-15 parts of elderberry, 10-15 parts of butterfly flower, 55-65 parts of uncaria, 4-6 parts of wolfberry, 6-10 parts of safflower, 15-25 parts of papaya, 10-15 parts of turmeric, 10-15 parts of Stephania tetrandra, 25-35 parts of stir-fried mustard seed, 15-20 parts of citron, 10-15 parts of stir-fried germinated barley, 20-25 parts of stir-fried malt, and 15-20 parts of Polygonum hydropiper seed.

[0012] In this invention, when a proportion, equivalent, temperature, concentration, time, mesh size, parts by weight, weight ratio, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, it should be understood as specifically disclosing all ranges formed by any pairing of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range "25-35" is disclosed, the described range should be interpreted as including the ranges "25-35", "25-34", "25-33", "25-32", "25-31", "25-30", "25-29", "25-28", "25-27", "25-26", "26-35", "26-34", "26-33", "26-32", "26-31", "26-30", "26-29", "26-28", "26-27", "27-35", "27-34", "27-33", "27-32", "27-31", and "27-30". "27-29", "27-28", "28-35", "28-34", "28-33", "28-32", "28-31", "28-30", "29-35", "29-34", "29-33", "29-32", "29-31", "29-30", "30-35", "30-34", "30-33", "30-32", "30-31", "31-35", "31-34", "31-33", "31-32", "32-35", "32-34", "32-33", "33-35", "33-34", "34-35", etc. When a numerical range is described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within the range, and all numerical values ​​within the range are capable of achieving the effects of the present invention.

[0013] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in parts by weight: 40 parts of okra flower, 63 parts of alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seed, 16 parts of citron, 13 parts of fried germinated rice, 21 parts of fried malt, and 17 parts of water hyacinth seed.

[0014] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in parts by weight: 35 parts of okra flower, 70 parts of alum, 4 parts of leech, 3 parts of centipede, 2 parts of scorpion, 10 parts of hedgehog skin, 15 parts of licorice, 10 parts of elderberry, 10 parts of butterfly flower, 55 parts of uncaria, 4 parts of wolfberry, 10 parts of safflower, 25 parts of papaya, 10 parts of turmeric, 15 parts of fangji, 25 parts of fried mustard seed, 20 parts of citron, 10 parts of fried germinated rice, 20 parts of fried malt, and 15 parts of water hyacinth seed.

[0015] As a preferred technical solution of the present invention, it is prepared from the following raw materials, in parts by weight: 40 parts of okra flower, 55 parts of alum, 6 parts of leech, 3 parts of centipede, 2 parts of scorpion, 11 parts of hedgehog skin, 10 parts of licorice, 15 parts of elderberry, 10 parts of butterfly flower, 60 parts of uncaria, 6 parts of wolfberry, 6 parts of safflower, 25 parts of papaya, 15 parts of turmeric, 10 parts of fangji, 30 parts of fried mustard seed, 15 parts of citron, 15 parts of fried germinated barley, 21 parts of fried malt, and 20 parts of water hyacinth seed.

[0016] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for delayed fracture healing, comprising the following steps: mixing the raw materials, adding purified water at a ratio of 1:8-10, decocting twice, each time for 60-90 minutes, and combining the filtrates.

[0017] As a preferred technical solution of the present invention, the preparation method of the traditional Chinese medicine composition for delayed fracture healing includes the following steps: mixing the raw materials, adding purified water at a ratio of 1:9, decocting twice, each time for 90 minutes, and combining the filtrates.

[0018] A third aspect of the present invention provides a traditional Chinese medicine preparation of a traditional Chinese medicine composition for delayed fracture healing, characterized in that the traditional Chinese medicine preparation is made from the above-mentioned traditional Chinese medicine composition for delayed fracture healing as raw material.

[0019] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients. The dosage form of the traditional Chinese medicine preparation is granules, pills, capsules, tablets, powders, or oral liquids.

[0020] A fourth aspect of the invention provides the use of the traditional Chinese medicine composition for delayed fracture healing in the preparation of a medicament for the prevention or use in delayed fracture healing.

[0021] Furthermore, the delayed fracture healing refers to delayed fracture healing caused by diabetes or glucocorticoids.

[0022] The beneficial effects of the traditional Chinese medicine composition of this invention for delayed fracture healing are as follows: The *Bianzheng Lu* (Record of Differential Diagnosis) states in its section on bone setting: "The method of internal treatment must begin with promoting blood circulation and removing blood stasis. If blood is not circulating, blood stasis cannot be removed, and if blood stasis is not removed, bones cannot heal." Blood stasis is a pathological product of fractures. If blood stasis persists, it obstructs the meridians and affects the flow of qi and blood. Fracture healing is a process of "removing blood stasis and new bone joining." Prolonged blood stasis hinders fracture healing.

[0023] In this invention's herbal composition, okra flower and alum are the principal ingredients; leech, centipede, scorpion, hedgehog skin, licorice, elderberry, butterfly flower, and uncaria are the assistant ingredients, assisting the principal ingredients in their effects and enhancing their efficacy; wolfberry, safflower, papaya, turmeric, fangji, stir-fried mustard seed, citron, stir-fried germinated rice, and stir-fried malt are the adjuvant ingredients; and water lily seed is the guiding ingredient, harmonizing the other ingredients. The formulation of this invention features a scientifically sound combination of principal, assistant, adjuvant, and guiding ingredients. The multiple ingredients do not enhance the efficacy of a single herb in the conventional way, but rather exhibit a synergistic relationship, effectively reducing swelling and pain, promoting the dissipation of blood stasis, unblocking the flow of qi and blood in the meridians, nourishing tendons and bones, promoting delayed fracture healing, and reducing patient suffering.

[0024] The herbal composition of this invention significantly increases the expression of type I collagen fibers and bone density in diabetic rats with fractures, and significantly promotes the healing of refractory fractures. Each component of the herbal composition of this invention is indispensable in promoting delayed fracture healing and has a synergistic effect.

[0025] The herbal composition of this invention significantly increases the maximum load in rats with glucocorticoid-induced osteoporotic fractures, enhances bone stiffness, increases bone density, and promotes the healing of refractory fractures. Each component of the herbal composition of this invention is indispensable in promoting delayed fracture healing and has a synergistic effect. Attached Figure Description

[0026] Figure 1 To compare the expression levels of type I collagen in each group with those in the normal control group, & P < 0.05 && P < 0.01; compared with the model control group, P < 0.05 P < 0.01; compared with experimental group 1, # P < 0.05 ## P < 0.01.

[0027] Figure 2 For comparison of bone and callus density in each group, note: compared with the normal control group, & P < 0.05 && P < 0.01; compared with the model control group, P < 0.05; compared with experimental group 1, # P < 0.05.

[0028] Figure 3To compare the callus bone density of each group with that of the normal control group, & P < 0.05 && P < 0.01; compared with the model control group, P < 0.05 P < 0.01; compared with experimental group 1, # P < 0.05 ## P < 0.01.

[0029] Figure 4 For comparison of the maximum load in each group, compared with the normal control group, & P < 0.05 && P < 0.01; compared with the model control group, P < 0.05 P < 0.01; compared with experimental group 1, # P < 0.05. Detailed Implementation

[0030] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0031] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0032] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0033] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be readily apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0034] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0035] Example 1: A traditional Chinese medicine composition for delayed fracture healing 40 parts of okra flower, 63 parts of alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seed, 16 parts of citron, 13 parts of fried germinated barley, 21 parts of fried malt, and 17 parts of water hyacinth seed.

[0036] Mix all the raw materials, add purified water at a ratio of 1:9, decoct twice, 90 minutes each time, and combine the filtrates.

[0037] Example 2: A traditional Chinese medicine composition for delayed fracture healing 35 parts of okra flower, 70 parts of alum, 4 parts of leech, 3 parts of centipede, 2 parts of scorpion, 10 parts of hedgehog skin, 15 parts of licorice, 10 parts of elderberry, 10 parts of butterfly flower, 55 parts of uncaria, 4 parts of wolfberry, 10 parts of safflower, 25 parts of papaya, 10 parts of turmeric, 15 parts of fangji, 25 parts of fried mustard seed, 20 parts of citron, 10 parts of fried germinated barley, 20 parts of fried malt, and 15 parts of water hyacinth seed.

[0038] Mix all the raw materials, add purified water at a ratio of 1:8, decoct twice, 80 minutes each time, and combine the filtrates.

[0039] Example 3: A traditional Chinese medicine composition for delayed fracture healing 40 parts of yellow hibiscus flowers, 55 parts of dried alum, 6 parts of leech, 3 parts of centipede, 2 parts of scorpion, 11 parts of hedgehog skin, 10 parts of licorice, 15 parts of elderberry, 10 parts of wood butterfly, 60 parts of uncaria, 6 parts of wolfberry, 6 parts of safflower, 25 parts of papaya, 15 parts of turmeric, 10 parts of fangji, 30 parts of fried mustard seeds, 15 parts of citron, 15 parts of fried germinated barley, 21 parts of fried malt, and 20 parts of water hyacinth seeds.

[0040] Mix all the raw materials, add purified water at a ratio of 1:10, decoct twice, 70 minutes each time, and combine the filtrates.

[0041] Example 4: A traditional Chinese medicine composition for delayed fracture healing 45 parts of okra flowers, 63 parts of alum, 8 parts of leech, 2 parts of centipede, 3 parts of scorpion, 15 parts of hedgehog skin, 10 parts of licorice, 13 parts of elderberry, 15 parts of butterfly flower, 65 parts of uncaria, 6 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 35 parts of fried mustard seeds, 16 parts of citron, 10 parts of fried germinated rice, 25 parts of fried malt, and 17 parts of water hyacinth seeds.

[0042] Mix all the raw materials, add purified water at a ratio of 1:8, decoct twice, 60 minutes each time, and combine the filtrates.

[0043] Example 5: A traditional Chinese medicine composition for delayed fracture healing 45 parts of okra flower, 55 parts of alum, 6 parts of leech, 3 parts of centipede, 2 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 10 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 6 parts of safflower, 15 parts of papaya, 15 parts of turmeric, 15 parts of fangji, 30 parts of fried mustard seed, 15 parts of citron, 13 parts of fried germinated barley, 25 parts of fried malt, and 15 parts of water hyacinth seed.

[0044] Mix all the raw materials, add purified water at a ratio of 1:9, decoct twice, 75 minutes each time, and combine the filtrates.

[0045] Example 6: A traditional Chinese medicine composition for delayed fracture healing 40 parts of okra flower, 63 parts of alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seed, 16 parts of citron, 13 parts of fried germinated barley, 21 parts of fried malt, and 17 parts of water hyacinth seed.

[0046] Mix all the raw materials, add purified water at a ratio of 1:10, decoct twice, 80 minutes each time, and combine the filtrates.

[0047] Comparative Example 1 63 parts of dried alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of wood butterfly, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seed, 16 parts of citron, 13 parts of fried germinated rice, 21 parts of fried malt, and 17 parts of water hyacinth seed.

[0048] Compared with Example 1, the difference is that it does not contain okra flowers, while the other components and amounts remain the same.

[0049] The preparation method is the same as in Example 1.

[0050] Comparative Example 2 40 parts of okra flower, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seed, 16 parts of citron, 13 parts of fried germinated barley, 21 parts of fried malt, and 17 parts of water hyacinth seed.

[0051] Compared with Example 1, the difference is that it does not contain alum, while the other components and their amounts remain the same.

[0052] The preparation method is the same as in Example 1.

[0053] Comparative Example 3 40 parts of okra flowers, 63 parts of alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of fangji, 30 parts of fried mustard seeds, 16 parts of citron, 13 parts of fried germinated rice, 21 parts of fried malt, and 17 parts of water hyacinth seeds.

[0054] Compared with Example 1, the difference is that it does not contain elderberry or oroxylum indicum, while the other components and their amounts remain the same.

[0055] The preparation method is the same as in Example 1.

[0056] Study on the effect of the traditional Chinese medicine composition of this invention on the healing of diabetic fractures 1. Experimental Methods Forty-two SPF-grade SD rats, weighing 180-220g, were used, and six rats were randomly selected as the normal control group.

[0057] Except for the normal control group, rats in other groups were used to establish models: Streptozotocin (STZ) was prepared as a 1% solution in 0.1 mmol / L citrate-sodium citrate buffer at pH 4.2. A single intraperitoneal injection of 50 mg / kg of streptozotocin was administered. All streptozotocin solutions were to be prepared immediately before use. Qualitative urine glucose and blood glucose were measured 24 hours after injection. After successful model establishment, body weight and blood glucose were measured periodically. Rats with decreased body weight and a random non-fasting blood glucose level >13.8 mmol / L were considered to have successfully developed diabetes. Rats that died from diabetes or whose blood glucose levels did not meet the above criteria were discontinued during the experiment and replaced immediately.

[0058] Six rats were used as the normal control group, while an equal volume of physiological saline was injected into the peritoneum as a blank control.

[0059] Thirty rats that successfully developed the model were selected and randomly divided into four groups: model control group, experimental group 1, control group 1, control group 2, and control group 3, with six rats in each group.

[0060] All rats in each group suffered oblique fractures of the right tibia, and all rats were given the same normal diet.

[0061] The gavage protocols for each group are shown in Table 1.

[0062] Table 1. Gavage regimens for each group of rats Each group was administered the medication by gavage once daily for 42 consecutive days.

[0063] 2. Detection indicators 2.1 Expression of Type I collagen fibers in callus In week 6, X-rays were taken to observe callus growth. After anesthetizing the rats, bone mineral density was measured at the fracture site. The rats were then sacrificed, the fracture fragments were cut open and removed, and immediately placed in liquid nitrogen for preservation. Real-time RT-PCR was used to quantitatively detect the expression level of type I collagen mRNA in the rats.

[0064] 2.2 Bone mineral density testing at fracture ends Dual-energy X-ray absorptiometry was used with a bone densitometer and the accompanying small animal software to measure the total bone mineral density (BMD) of the right femur and the callus, as well as the BMD at 10 mm above and below the midpoint of the callus, in rats.

[0065] Bone mineral density is expressed as the amount of bone minerals per unit area (g / cm³). 2 ).

[0066] 3. Statistical Methods Data processing was performed using GraphPad Prism 6.0 software, with the measurement data presented in... ±s indicates that statistical differences between groups were compared using one-way ANOVA, and P<0.05 indicates that the difference was statistically significant.

[0067] 4. Experimental Results 4.1 Effects on the expression of type I collagen fibers in rat callus Table 2. Expression levels of type I collagen fibers in each group Note: Compared with the normal control group, & P < 0.05 && P < 0.01; Compared with the model control group, P < 0.05 P < 0.01; Compared with Experiment 1, # P < 0.05 ## P < 0.01.

[0068] The results are shown in Table 1. Figure 1 The expression level of type I collagen fibers in the model control group was lower than that in the normal control group.

[0069] The expression levels of type I collagen fibers in rats in experimental group 1, control group 1, control group 2, and control group 3 were higher than those in the model control group.

[0070] The expression level of type I collagen fibers in rats in Experiment 1 was higher than that in Control Group 1, Control Group 2, and Control Group 3.

[0071] 4.2 Effects on bone mineral density of fractured bone and callus in rats Table 3 Bone density at fracture sites in each group Note: Compared with the normal control group, & P < 0.05 && P < 0.01; Compared with the model control group, P < 0.05; compared with experimental group 1, # P < 0.05.

[0072] The results are shown in Table 3. Figure 2 The bone and callus density of rats in the model control group was lower than that in the normal control group.

[0073] The bone and callus density of rats in Experimental Group 1, Control Group 1, Control Group 2, and Control Group 3 were higher than those in the model control group.

[0074] The bone and callus density of rats in Experiment 1 group were higher than those in Control Group 1, Control Group 2, and Control Group 3.

[0075] The herbal composition of this invention significantly increases the expression of type I collagen fibers and bone density in diabetic rats with fractures, and significantly promotes the healing of refractory fractures. Each component of the herbal composition of this invention is indispensable in promoting delayed fracture healing and has a synergistic effect.

[0076] Study on the effect of the traditional Chinese medicine composition of this invention on the healing of glucocorticoid-induced osteoporotic fractures 1. Experimental Methods Twenty-four SPF-grade SD rats, weighing 180-220g, were randomly divided into a normal control group, a model control group, experimental group 1, and control group 3, with six rats in each group.

[0077] Normal control group: Rats were given intramuscular injections of 1 mL / kg of physiological saline three times a week for 8 weeks. After that, surgery was performed to induce a fracture of the right femur in the rats, and the fracture site was internally fixed with metal. Routine anti-infection treatment was given on the 3rd day after surgery, and penicillin 1 million U / kg was administered intramuscularly. Starting on the 2nd day after surgery, distilled water 10 mL / kg was administered by gavage once a day for 8 weeks.

[0078] Model control group: rats were given intramuscular injection of dexamethasone 1 mg / kg once a day for 3 weeks. After 8 weeks, the right femur of the rats was fractured by surgery and the fracture site was internally fixed with metal. The routine anti-infection treatment after surgery was the same as that of the baseline group. Starting from the second day after surgery, the rats were given distilled water 10 mL / kg by gavage once a day for 8 weeks.

[0079] Experimental Group 1: For the first 8 weeks, the model was established in the same way as the control group. On the second day after fracture surgery, the herbal composition from Example 1 was administered by gavage at a dose of 43.5 g / kg (calculated as crude drug) once a day. This continued for 8 weeks.

[0080] Control group 3: For the first 8 weeks, the model was established as in the control group. On the second day after fracture surgery, the control group received the same traditional Chinese medicine composition as control group 3 via gavage, 43.5 g / kg (calculated as crude drug), once daily. This continued for 8 weeks. 2. Detection indicators 2.1 Bone callus and bone density testing Dual-energy X-ray absorptiometry was used with a bone densitometer and the accompanying small animal software to measure the bone density of rat callus and the bone density 10 mm above and below the midpoint of the callus.

[0081] Bone mineral density is expressed as the amount of bone minerals per unit area (g / cm³). 2 ).

[0082] 2.2 Maximum Load Detection Using a biomaterials experimental instrument, a three-point bending test of the femur on the operated side was performed. The span of the fulcrum was 20 mm, the center was vertical, the femur was at a 90° angle to the load, the load was applied at a rate of 5 mm / min, and the maximum load of each sample was measured and calculated.

[0083] 3. Statistical Methods Data processing was performed using GraphPad Prism 6.0 software, with the measurement data presented in... ±s indicates that statistical differences between groups were compared using one-way ANOVA, and P<0.05 indicates that the difference was statistically significant.

[0084] 4. Experimental Results 4.1 Effects on bone mineral density of fractured bone and callus in rats See results Figure 3 The bone density of callus in the model control group was lower than that in the normal control group.

[0085] The bone density of callus in experimental group 1 and control group 3 rats was higher than that in the model control group.

[0086] The bone density of the callus in experimental group 1 rats was higher than that in control group 3.

[0087] 4.2 Effect on maximum load in rats See results Figure 4 The maximum load of rats in the model control group was lower than that in the normal control group.

[0088] The maximum load of rats in Experiment 1 and Control 3 was higher than that of the model control group.

[0089] The maximum load of rats in Experiment 1 was higher than that in Control Group 3.

[0090] The herbal composition of this invention significantly increases the maximum load in rats with glucocorticoid-induced osteoporotic fractures, enhances bone stiffness, increases bone density, and promotes the healing of refractory fractures. Each component of the herbal composition of this invention is indispensable in promoting delayed fracture healing and has a synergistic effect.

[0091] Observation on the efficacy of the traditional Chinese medicine composition of this invention in treating delayed fracture healing I. Materials and Methods 1. Clinical Data Sixty patients with delayed fracture healing who visited the outpatient clinic were selected and randomly divided into two groups: Group 1 of this invention and the control group, with 30 patients in each group. There were no statistically significant differences in gender, age, and disease duration between the two groups.

[0092] 2. Diagnostic criteria The diagnostic criteria for delayed fracture healing in Traditional Chinese Medicine (TCM) are based on the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine" (ZY / T001.1-94) issued by the State Administration of Traditional Chinese Medicine.

[0093] 3. Inclusion criteria Patients must meet the above diagnostic criteria; be ≥60 years old; undergo appropriate surgery based on their actual condition after admission; have no mental abnormalities; and be aware of this study and have signed their informed consent.

[0094] 4. Exclusion Criteria Allergy to the study drug; concurrent fractures in other locations; concurrent malignant tumors; concurrent rickets, osteomalacia, or renal tubular osteodystrophy; infectious fractures.

[0095] 5. Treatment methods Control group: The fracture ends were repositioned and appropriately fixed internally and externally. The patient was given alfacalcidol soft capsules orally, 1 capsule twice a day.

[0096] Example 1 group: The fracture ends were repositioned and appropriately fixed internally and externally. The herbal decoction of Example 1 was taken orally twice a day.

[0097] Both groups received continuous treatment for 12 weeks.

[0098] 6. Clinical efficacy The efficacy evaluation criteria were formulated with reference to the "Traditional Chinese Medicine Orthopedics and Traumatology".

[0099] Significant effect, X-ray shows blurred fracture with continuous callus passing through the fracture line, no swelling or pain, no percussion pain, good recovery of lower limb function, able to walk continuously on flat ground for 3 minutes without crutches, taking no less than 30 steps; Effective; X-ray shows callus formation has begun, with mild pain, improved lower limb function, and limited local movement. Ineffective; X-ray showed no callus formation and no improvement in lower limb function.

[0100] Overall effectiveness = (Number of cases with significant effects + Number of cases with effective results) / Total number of cases × 100%.

[0101] During treatment, the occurrence of adverse reactions in the two groups was recorded, and their incidence rate was calculated.

[0102] 7. Statistical Methods Data processing was performed using GraphPad Prism 6.0 software, with the measurement data presented in... ±s indicates that statistical differences between groups were compared using one-way ANOVA, and P<0.05 indicates that the difference was statistically significant.

[0103] II. Results 1. Comparison of clinical efficacy The effective rate and total effective rate of the first group of this invention are better than those of the control group, as shown in Table 4.

[0104] Table 4 Comparison of clinical efficacy between the two groups 2. Adverse Reactions Both groups of patients had only mild symptoms and no serious adverse reactions occurred, as shown in Table 5.

[0105] Table 5 Comparison of adverse reaction rates between the two groups The traditional Chinese medicine composition of this invention has good clinical efficacy and safety for patients with delayed fracture healing, and has broad market prospects.

[0106] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for delayed fracture healing, characterized in that, The traditional Chinese medicine composition for delayed fracture healing consists of the following herbs, in parts by weight: 35-45 parts of Hibiscus rosa-sinensis flower, 55-70 parts of alum, 4-8 parts of leech, 2-3 parts of centipede, 2-3 parts of scorpion, 10-15 parts of hedgehog skin, 10-15 parts of licorice, 10-15 parts of elderberry, 10-15 parts of butterfly flower, 55-65 parts of uncaria, 4-6 parts of wolfberry, 6-10 parts of safflower, 15-25 parts of papaya, 10-15 parts of turmeric, 10-15 parts of Stephania tetrandra, 25-35 parts of stir-fried mustard seed, 15-20 parts of citron, 10-15 parts of stir-fried germinated barley, 20-25 parts of stir-fried malt, and 15-20 parts of Polygonum hydropiper seed.

2. The traditional Chinese medicine composition for delayed fracture healing according to claim 1, characterized in that, The traditional Chinese medicine composition for delayed fracture healing consists of the following herbs in parts by weight: 40 parts of Hibiscus syriacus flower, 63 parts of alum, 6 parts of leech, 2 parts of centipede, 3 parts of scorpion, 11 parts of hedgehog skin, 11 parts of licorice, 13 parts of elderberry, 12 parts of butterfly flower, 60 parts of uncaria, 5 parts of wolfberry, 8 parts of safflower, 20 parts of papaya, 11 parts of turmeric, 11 parts of Stephania tetrandra, 30 parts of stir-fried mustard seed, 16 parts of citron, 13 parts of stir-fried germinated barley, 21 parts of stir-fried malt, and 17 parts of Polygonum hydropiper seed.

3. The traditional Chinese medicine composition for delayed fracture healing according to claim 1, characterized in that, The traditional Chinese medicine composition for delayed fracture healing consists of the following herbs in parts by weight: 35 parts of Hibiscus syriacus flower, 70 parts of alum, 4 parts of leech, 3 parts of centipede, 2 parts of scorpion, 10 parts of hedgehog skin, 15 parts of licorice, 10 parts of elderberry, 10 parts of butterfly flower, 55 parts of uncaria, 4 parts of wolfberry, 10 parts of safflower, 25 parts of papaya, 10 parts of turmeric, 15 parts of Stephania tetrandra, 25 parts of stir-fried mustard seed, 20 parts of citron, 10 parts of stir-fried germinated barley, 20 parts of stir-fried malt, and 15 parts of Polygonum hydropiper seed.

4. The traditional Chinese medicine composition for delayed fracture healing according to claim 1, characterized in that, The traditional Chinese medicine composition for delayed fracture healing consists of the following herbs in parts by weight: 40 parts of Hibiscus syriacus flower, 55 parts of alum, 6 parts of leech, 3 parts of centipede, 2 parts of scorpion, 11 parts of hedgehog skin, 10 parts of licorice, 15 parts of elderberry, 10 parts of butterfly flower, 60 parts of uncaria, 6 parts of wolfberry, 6 parts of safflower, 25 parts of papaya, 15 parts of turmeric, 10 parts of Stephania tetrandra, 30 parts of stir-fried mustard seed, 15 parts of citron, 15 parts of stir-fried germinated barley, 21 parts of stir-fried malt, and 20 parts of Polygonum hydropiper seed.

5. The method for preparing the traditional Chinese medicine composition for delayed fracture healing according to any one of claims 1-4, characterized in that, The preparation method includes the following steps: mixing the raw materials, adding purified water at a ratio of 1:8-10, decocting twice, each time for 60-90 minutes, and combining the filtrates.

6. The method for preparing the traditional Chinese medicine composition for delayed fracture healing according to claim 5, characterized in that, The preparation method includes the following steps: mixing the raw materials, adding purified water at a ratio of 1:9, decocting twice for 90 minutes each time, and combining the filtrates.

7. A traditional Chinese medicine preparation of a traditional Chinese medicine composition for delayed fracture healing, characterized in that, The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition for delayed fracture healing as described in any one of claims 1-4.

8. The traditional Chinese medicine preparation according to claim 7 for delayed fracture healing, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients, and the dosage form of the traditional Chinese medicine preparation is granules, pills, capsules, tablets, powders or oral liquids.

9. Use of the traditional Chinese medicine composition for delayed fracture healing according to any one of claims 1-4 in the preparation of a medicine for the prevention or use of delayed fracture healing.

10. The use of the traditional Chinese medicine composition for delayed fracture healing according to claim 9, characterized in that, The delayed fracture healing refers to delayed fracture healing caused by diabetes or glucocorticoids.

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