Composition for treating rheumatism, rheumatoid, red and swollen joints, fracture and hyperostosis as well as preparation method and application of composition

Abstract

The invention provides a composition for treating rheumatism, rheumatoid, red and swollen joints, fracture and hyperostosis and a preparation method and application thereof.The composition is prepared from, by weight, 3-100 parts of lycopodium clavatum, 5-90 parts of garden balsam stems, 5-80 parts of unprocessed radix aconiti, 5-70 parts of unprocessed radix aconiti kusnezoffii, 3-100 parts of unprocessed frankincense, 5-70 parts of myrrh, 3-65 parts of cortex acanthopanacis, 5-70 parts of cortex erythrinae and 10-80 parts of asarum. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-75 parts of cassia twig, 5-80 parts of yam rhizome, 10-90 parts of radix stephaniae tetrandrae, 5-100 parts of rheum officinale, 5-85 parts of fructus gardeniae, 5-89 parts of sappan wood, 3-75 parts of radix salviae miltiorrhizae, 3-100 parts of semen brassicae, 5-75 parts of pinellia ternate, 5-100 parts of pepper, 5-90 parts of pawpaw, 5-85 parts of radix clematidis, 3-100 parts of erodium stephanianum willd and 6-90 parts of herba siegesbeckiae. The composition disclosed by the invention can take effect quickly, has good effects of promoting blood circulation to remove blood stasis, promoting qi circulation to relieve pain, eliminating arthralgia and removing stasis, has a good curative effect on rheumatism, rheumatoid, red and swollen joints and hyperostosis, and is free of stimulation, short in application / application time, remarkable in curative effect and free of relapse. And the bone healing speed of a fracture patient is obviously promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a composition for treating rheumatism, rheumatoid arthritis, joint swelling, bone fracture and bone hyperplasia, and a preparation method and application thereof. Background Art

[0002] Arthritis is a common and frequently-occurring disease in clinical practice, and is also a stubborn disease. It is caused by external pathogens taking advantage of the weakness to invade the limbs, meridians, muscles, and joints of the body, blocking the meridians, and causing poor circulation of qi and blood, leading to a type of disease in which the limbs and joints become red, swollen, hot, and painful, which seriously affects the quality of life of patients. Arthritis is equivalent to gouty arthritis, rheumatoid arthritis, rheumatoid arthritis, reactive arthritis, myofibrositis, ankylosing spondylitis, and hyperplastic osteoarthritis (osteophyte disease) in modern medicine. Rheumatic arthritis itself is also a degenerative bone lesion. Patients often have other symptoms, and oral medications have superimposed conflicts and side effects. Some external plasters have a long use time and are prone to allergies. Most Chinese medicines have many flavors, are not easily absorbed, have no obvious therapeutic effect, take a long time to treat, and only treat the symptoms but not the root cause, and the condition is prone to relapse.

[0003] Falls, tumbles, collisions, traffic accidents, etc. can easily cause bone injuries. As the saying goes, "It takes a hundred days to heal a broken bone", which means that the recovery period of bone injuries is long and the treatment methods used are also complicated. Traditional Chinese medicine for bone injury treatment mainly focuses on promoting bone healing, but lacks methods to focus on how to exert the efficacy of the medicine for a long time and other sensitive reactions caused by direct application on the skin.

[0004] Therefore, during the treatment process, people need an external application treatment method that is easy and comfortable, safe and non-irritating, quickly effective, short in application time, and has significant therapeutic effects, so as to save treatment time and reduce economic burden and life pressure. Summary of the invention

[0005] In view of this, the present invention provides a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia, as well as a preparation method and application thereof.

[0006] The technical solution of the present invention is achieved in this way:

[0007] A composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia comprises the following raw materials in parts by weight: 3-100 parts of smilax china, 5-90 parts of radix spatholobi, 5-80 parts of raw radix aconiti kusnezoffii, 5-70 parts of raw kusnezoffii, 3-100 parts of raw frankincense, 5-70 parts of myrrh, 3-65 parts of acanthopanax bark, 5-70 parts of pittosporum tobira bark, 10-80 parts of asarum, 6-75 parts of cassia twig, 5-80 parts of radix scutellariae, 10-90 parts of tetrandra, 5-100 parts of rhubarb, 5-85 parts of gardenia, 5-89 parts of sappan wood, 3-75 parts of salvia miltiorrhiza, 3-100 parts of white mustard seeds, 5-75 parts of pinellia, 5-100 parts of zanthoxylum bungeanum, 5-90 parts of papaya, 5-85 parts of angelica sinensis, 3-100 parts of geranium and 6-90 parts of siegesbeckia.

[0008] A method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia, comprising the following specific steps:

[0009] S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappan Wood, Salvia Miltiorrhizae, Semen Sinapis, Pinellia, Zanthoxylum, Papaya, Polygonum aviculare, Herba Glycyrrhizae and Herba Siegesbeckiae to obtain a mixed powder, add the mixed powder into an ethanol solution for soaking, perform microwave extraction, and obtain a filtrate and a filter residue;

[0010] S2, placing the filter residue of S1 in a supercritical CO2 extraction device for extraction to obtain an extract, combining it with the filtrate of S1, and concentrating it under reduced pressure to obtain a Chinese medicine extract;

[0011] S3, adding the Chinese herbal medicine extract to the glucose-phosphate buffer solution and mixing evenly to obtain an aqueous phase;

[0012] S4, dissolving vitamin E, cholesterol and phospholipids in an organic solvent, heating in a water bath and vacuum evaporating to remove the organic solvent, to obtain an oil phase;

[0013] S5. Gradually add the water phase to the oil phase, vortex and oscillate evenly during the process, continue heating in a water bath and performing reduced-pressure rotary evaporation, high-pressure homogenization, and freeze-drying to obtain the target composition.

[0014] Furthermore, in step S1, the solid-liquid ratio of the mixed powder to the ethanol solution is 1:10-15 g / mL; the concentration of the ethanol solution is 40-70% v / v; the soaking time is 10-12 h; and the microwave extraction is performed at 400-500 W and 60-80° C. for 4-6 h.

[0015] Furthermore, in step S2, the static extraction is first performed at a pressure of 20-30 MPa for 20-30 min, and then the dynamic extraction is performed at 15 L / min for 30-40 min.

[0016] Furthermore, in step S3, the solid-liquid ratio of the traditional Chinese medicine extract to the glucose-phosphate buffer solution is 1:4-6 g / mL; the pH of the glucose-phosphate buffer solution is 7.5-8.0, and the mass fraction is 5-10 wt%.

[0017] Furthermore, in step S4, the mass ratio of vitamin E, cholesterol and phospholipid is 1:0.3-0.5:3-5; the organic solvent is ethanol or methanol; the solid-liquid ratio of vitamin E, cholesterol and phospholipid to organic solvent is 1:3-5 g / mL; the water bath heating temperature is 40-50°C and the time is 1-3h.

[0018] Furthermore, in step S5, the mass ratio of the water phase to the oil phase is 1-3:1; the temperature of the continued water bath heating is 55-65° C., and the time is 1-2 h.

[0019] A method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia, and application of the obtained composition in preparing external medicine preparations.

[0020] Furthermore, the external pharmaceutical preparation includes: ointment, gel, spray or film.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. The composition preparation provided by the present invention has a rapid onset of action, has good effects of promoting blood circulation and removing blood stasis, promoting qi and relieving pain, removing numbness and dispersing knots, has good therapeutic effects on rheumatism, rheumatoid arthritis, joint swelling and bone hyperplasia, and has no irritation, short application time, significant therapeutic effect and no recurrence. It significantly promotes the bone healing speed of fracture patients without side effects.

[0023] 2. The present invention utilizes liposome technology to store Chinese herbal extracts safely and stably in liposomes, thereby increasing bioavailability and patient comfort. The Chinese herbal extracts are first encapsulated in the aqueous medium of the polar layer, and the structural integrity of the liposomes and the stability of the drugs are maintained through dual regulation of glucose and pH, while achieving the effects of sustained release and super strong penetration. The affected area can better absorb the drug ingredients, enhance the efficacy, have no side effects, and reduce the treatment time. DETAILED DESCRIPTION

[0024] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0025] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0026] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0027] Example 1

[0028] The composition for treating rheumatism, rheumatoid arthritis, joint redness and swelling, fracture and bone hyperplasia comprises the following raw materials in parts by weight: 50 parts of smilax china, 50 parts of radix polygoni avicularis, 50 parts of raw chuanwu, 40 parts of raw kusnezoffii, 55 parts of raw frankincense, 50 parts of myrrh, 40 parts of acanthopanax bark, 40 parts of pittosporum tobira bark, 45 parts of asarum, 50 parts of cassia twig, 40 parts of radix polygoni multiflori, 50 parts of tetrandra, 55 parts of rhubarb, 45 parts of gardenia, 47 parts of sappan wood, 45 parts of salvia miltiorrhiza, 52 parts of white mustard seeds, 50 parts of pinellia, 50 parts of zanthoxylum bungeanum, 40 parts of papaya, 35 parts of angelica sinensis, 52 parts of geranium and 48 parts of siegesbeckia.

[0029] The preparation method of the above-mentioned composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia comprises the following specific steps:

[0030] S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappanwood, Salvia Miltiorrhizae, Semen Sinapis, Semen Pinelliae, Zanthoxylum, Chaenomeles Sinensis, Herba Polygoni Multiflori, Herba Glechomae, and Herba Siegesbeckiae to obtain a mixed powder. Add the mixed powder into a 50% v / v ethanol solution at a solid-liquid ratio of 1:13 g / mL and soak for 11 h. Perform microwave extraction (450 W, 70°C) for 5 h to obtain a filtrate and a residue.

[0031] S2, placing the filter residue of S1 in a supercritical CO2 extraction device for extraction, first static extraction for 25 min at a pressure of 25 MPa, then dynamic extraction for 35 min at 15 L / min, to obtain an extract, which is combined with the filtrate of S1, and concentrated under reduced pressure to obtain a Chinese medicine extract;

[0032] S3, adding the Chinese herbal medicine extract to 8 wt % glucose-phosphate buffer solution (pH=7.5-8.0) at a solid-liquid ratio of 1:5 g / mL and mixing well to obtain an aqueous phase;

[0033] S4, according to the solid-liquid ratio of 1:4g / mL, vitamin E, cholesterol and phospholipids in a mass ratio of 1:0.4:4 were dissolved in anhydrous ethanol, heated in a water bath at 45°C for 2h, and the organic solvent was removed by vacuum rotary evaporation to obtain an oil phase;

[0034] S5. Gradually add the water phase into the oil phase with a mass ratio of 2:1 between the water phase and the oil phase. Vortex evenly during the process. Continue heating in a water bath at 60°C for 1.5h. Vacuum evaporation, high pressure homogenization, and freeze drying to obtain the target composition.

[0035] Example 2

[0036] A composition for treating rheumatism, rheumatoid arthritis, joint redness and swelling, fracture and bone hyperplasia comprises the following raw materials in parts by weight: 5 parts of smilax china, 10 parts of radix polygoni avicularis, 10 parts of raw chuanwu, 20 parts of raw kusnezoffii, 3 parts of raw frankincense, 8 parts of myrrh, 5 parts of acanthopanax bark, 8 parts of pittosporum tobira bark, 15 parts of asarum, 10 parts of cassia twig, 6 parts of radix polygoni multiflori, 20 parts of stephania tetrandra, 8 parts of rhubarb, 15 parts of gardenia, 5 parts of sappan wood, 13 parts of salvia miltiorrhiza, 10 parts of white mustard seeds, 5 parts of pinellia, 5 parts of zanthoxylum bungeanum, 10 parts of papaya, 15 parts of angelica sinensis, 9 parts of geranium herb and 10 parts of siegesbeckia herb.

[0037] The preparation method of the above-mentioned composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia comprises the following specific steps:

[0038] S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappanwood, Salvia Miltiorrhizae, Semen Sinapis, Semen Pinelliae, Zanthoxylum, Chaenomeles Sinensis, Herba Polygoni Multiflori, Herba Glechomae, and Herba Siegesbeckiae to obtain a mixed powder. Add the mixed powder into a 40% v / v ethanol solution at a solid-liquid ratio of 1:10 g / mL and soak for 10 h. Perform microwave extraction (400 W, 60-80° C.) for 4 h to obtain a filtrate and a residue.

[0039] S2, placing the filter residue of S1 in a supercritical CO2 extraction device for extraction, first static extraction for 20 min at a pressure of 20 MPa, then dynamic extraction for 30 min at 15 L / min, to obtain an extract, which is combined with the filtrate of S1, and concentrated under reduced pressure to obtain a Chinese medicine extract;

[0040] S3, adding the Chinese herbal medicine extract to a 5wt% glucose-phosphate buffer solution (pH=7.5-8.0) at a solid-liquid ratio of 1:4 g / mL and mixing well to obtain an aqueous phase;

[0041] S4, according to the solid-liquid ratio of 1:3g / mL, vitamin E, cholesterol and phospholipids in a mass ratio of 1:0.3:3 were dissolved in anhydrous ethanol, heated in a water bath at 40°C for 1h, and the organic solvent was removed by vacuum rotary evaporation to obtain an oil phase;

[0042] S5. Gradually add the water phase into the oil phase with a mass ratio of 1:1 between the water phase and the oil phase. Vortex evenly during the process. Continue heating in a water bath at 55°C for 1 hour. Vacuum evaporation, high pressure homogenization, and freeze drying to obtain the target composition.

[0043] Example 3

[0044] The composition for treating rheumatism, rheumatoid arthritis, joint redness and swelling, fracture and bone hyperplasia comprises the following raw materials in parts by weight: 100 parts of smilax china, 80 parts of radix polygoni avicularis, 75 parts of raw chuanwu, 60 parts of raw kusnezoffii, 68 parts of raw frankincense, 70 parts of myrrh, 60 parts of acanthopanax bark, 70 parts of pittosporum tobira bark, 60 parts of asarum, 75 parts of cassia twig, 65 parts of radix polygoni multiflori, 70 parts of tetrandra, 85 parts of rhubarb, 85 parts of gardenia, 89 parts of sappan wood, 60 parts of salvia miltiorrhiza, 80 parts of white mustard seeds, 75 parts of pinellia, 80 parts of zanthoxylum bungeanum, 59 parts of papaya, 80 parts of angelica sinensis, 100 parts of geranium and 70 parts of siegesbeckia.

[0045] The preparation method of the above-mentioned composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia comprises the following specific steps:

[0046] S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappanwood, Salvia Miltiorrhizae, Semen Sinapis, Semen Pinelliae, Zanthoxylum, Chaenomeles Sinensis, Herba Polygoni Multiflori, Herba Glechomae, and Herba Siegesbeckiae to obtain a mixed powder. Add the mixed powder into a 70% v / v ethanol solution at a solid-liquid ratio of 1:15 g / mL and soak for 12 h. Perform microwave extraction (500 W, 80°C) for 6 h to obtain a filtrate and a residue.

[0047] S2, placing the filter residue of S1 in a supercritical CO2 extraction device for extraction, first static extraction for 30 min at a pressure of 30 MPa, then dynamic extraction for 40 min at 15 L / min, to obtain an extract, which is combined with the filtrate of S1, and concentrated under reduced pressure to obtain a Chinese medicine extract;

[0048] S3, adding the Chinese herbal medicine extract to 10wt% glucose-phosphate buffer solution (pH=7.5-8.0) at a solid-liquid ratio of 1:6g / mL and mixing evenly to obtain an aqueous phase;

[0049] S4, according to the solid-liquid ratio of 1:5g / mL, vitamin E, cholesterol and phospholipids in a mass ratio of 1:0.5:5 were dissolved in anhydrous ethanol, heated in a water bath at 50°C for 3h, and the organic solvent was removed by vacuum rotary evaporation to obtain an oil phase;

[0050] S5. Gradually add the water phase into the oil phase with a mass ratio of 3:1 between the water phase and the oil phase. Vortex evenly during the process. Continue heating in a water bath at 65°C for 2h. Vacuum evaporation, high pressure homogenization, and freeze drying to obtain the target composition.

[0051] Comparative Example 1

[0052] The difference from Example 1 is that: there are no geranium, white mustard seeds and pittosporum tobira bark, and the rest is consistent with Example 1.

[0053] Comparative Example 2

[0054] The difference from Example 1 is that the preparation method is different, and the rest is consistent with Example 1.

[0055] That is, the preparation method of the composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia in this comparative example comprises the following specific steps:

[0056] S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappanwood, Salvia Miltiorrhizae, Semen Sinapis, Semen Pinelliae, Zanthoxylum, Chaenomeles Sinensis, Herba Polygoni Multiflori, Herba Glechomae, and Herba Siegesbeckiae to obtain a mixed powder. Add the mixed powder into a 50% v / v ethanol solution at a solid-liquid ratio of 1:13 g / mL and soak for 11 h. Perform microwave extraction (450 W, 70°C) for 5 h to obtain a filtrate and a residue.

[0057] S2. The filter residue of S1 is placed in a supercritical CO2 extraction device for extraction. First, static extraction is performed at a pressure of 25 MPa for 25 min, and then dynamic extraction is performed at 15 L / min for 35 min to obtain an extract. The extract is combined with the filtrate of S1 and concentrated under reduced pressure to obtain the target composition.

[0058] Test Example 1 - Effect of Bone Hyperplasia

[0059] (1) A total of 600 patients were selected, including 300 males and 300 females, aged between 30 and 60 years old. Their clinical symptoms included local pain, numbness, swelling, and functional impairment caused by bone hyperplasia in the cervical spine, lumbar spine, knee joint, and heel.

[0060] (2) The compositions of Examples 1-3 and Comparative Examples 1-2 were prepared into ointments, gels, sprays or films. Taking the ointment as an example, the patients were divided into 6 groups, corresponding to the Example 1-3 group, the Comparative Example 1-2 group and the commercial group. The Example 1-3 group, the Comparative Example 1-2 group and the commercial group applied the corresponding ointments of the compositions of Examples 1-3 and Comparative Examples 1-2 and the commercially available bone hyperplasia ointment (purchased from Nanyang Yicong Industrial Co., Ltd.) to the affected part, once a day. After 2 months of treatment, the efficacy results were statistically analyzed, and the results are shown in Table 1. The standard of cure refers to the disappearance of pain symptoms in the affected part, the recovery of physical fitness, normal activity function, the disappearance of the hyperplasia site found by X-ray or CT scan, and no recurrence in 1 year of follow-up; the standard of marked effect refers to the alleviation of symptoms in the affected part, the patient feels good, the physical fitness is basically restored, and the activity function is basically normal; the standard of ineffectiveness refers to the unchanged or even aggravated symptoms in the affected part.

[0061] Total effective rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%

[0062] It should be noted that before treatment, there was no significant difference in age, gender, disease course and disease site classification in each group after statistical processing, P>0.05.

[0063] Table 1

[0064] Group Number of cases / case Cured / case Significantly effective / case Valid / Example Invalid / Example Total effective rate / % Example 1 100 92 4 4 0 100 Example 2 100 90 6 3 1 99 Example 3 100 91 5 4 0 100 Comparative Example 1 100 85 4 9 2 98 Comparative Example 2 100 80 7 10 3 97 Commercially available group 100 75 8 12 5 95

[0065] As can be seen from Table 1, the compositions prepared in Examples 1-3 of the present invention have good therapeutic effects on patients with bone hyperplasia in different parts of the body according to clinical observations, with a cure rate of 90%-92% and a total effective rate of 900%-100%, which are superior to the drugs in Comparative Examples 1-2 and the commercially available group, and have better clinical choices.

[0066] Test Example 2 - Rheumatism Effect

[0067] 1. Modeling and grouping: 80 SPF male SD rats (200 ± 20 g) were purchased and randomly divided into a blank group, a model group, a positive drug group, Example 1-3 groups and a comparative example 1-2 group, with 10 rats in each group. Except for the blank group, each rat in the other groups was injected with 0.25 mL of the prepared 1 mg / mL type II collagen (4 mg / mL type II collagen was dissolved in 0.1 mol / L acetic acid to make a 2 mg / mL solution, which was mixed with precooled Freund's complete adjuvant and made into a mass concentration of 1 mg / mL type II collagen) through the base of the tail, the back, and the plantar of the right hind foot to induce inflammation. After 2 weeks, 0.1 mL was injected at scattered points at the base of the tail to enhance the immune effect.

[0068] 2. Administration method: From the day of modeling, the Example 1-3 group and the Comparative Example 1-2 group were administered with the prepared composition at a volume of 0.1 mL per 100 g at the inflamed site, bandaged with transparent adhesive tape for 3 hours, once a day; the blank group and the model group were replaced with an equal amount of physiological saline, and the positive drug group was administered with topical diclofenac sodium, and treated in the same manner as above. The drug was stopped on the 31st day after inflammation, and observation was continued for 7 days.

[0069] a. Swelling: The volume of the (primary) inflammatory foot before and 35 days after inflammation was measured using the drainage volume method, and the degree of swelling and swelling inhibition rate were calculated.

[0070] Swelling degree = post-inflammatory volume - pre-inflammatory volume

[0071] Swelling inhibition rate = (swelling degree of model group - swelling degree of experimental group) / swelling degree of model group × 100%.

[0072] b. Arthritis index: The degree of joint lesions in the whole body was recorded from the 7th day after inflammation was induced, and the arthritis index was calculated on the 35th day according to the following scoring criteria: 0 point for no redness or swelling; 1 point for redness or swelling of the little toe joint; 2 points for swelling of the big toe joint and toes; 3 points for swelling of the paw below the ankle joint; 4 points for swelling of the entire paw including the ankle joint. The accumulated scores of each joint were the arthritis index of each rat.

[0073] The results are shown in Table 2.

[0074] Table 2

[0075]

[0076]

[0077] It can be seen from Table 2 that, compared with Comparative Examples 1-2, the compositions of Examples 1-3 of the present invention can reduce inflammation, reduce swelling, relieve arthritis, and have good prospects for treating rheumatic diseases.

[0078] Test Example 3-Rabbit Fracture Experiment

[0079] 60 healthy male rabbits aged 10 to 12 months and weighing 250±50g were selected and divided into 6 groups, each with 10 rabbits in one group. The left radius of the rabbit was artificially fractured. After the fracture was repositioned in vitro, the compositions of Examples 1-3 and Comparative Examples 1-2 were applied externally to the fracture site, respectively, and fixed, and the rabbits were raised in a single cage in the same manner. Four weeks after the injury, each week was an observation day, and fracture X-ray filming, wound healing, pathology, and histochemistry were performed. The results of the callus shadow area are shown in Table 3.

[0080] Table 3

[0081]

[0082] As can be seen from Table 3, through observation of the compositions of Examples 1-3 of the present invention, it is found that the compositions of Examples 1-3 of the present invention are significantly superior to Comparative Examples 1-2 in callus formation and fracture healing. At the same time, Examples 1-3 of the present invention have the characteristics of early appearance of callus shadow, fast callus growth rate, high callus shadow density, early appearance of new bone, and large trabecular area.

[0083] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia, characterized in that: The invention comprises the following raw materials in parts by weight: 3-100 parts of striata herb, 5-90 parts of radix polygoni lobatae, 5-80 parts of raw aconite, 5-70 parts of raw aconite, 3-100 parts of raw frankincense, 5-70 parts of myrrh, 3-65 parts of acanthopanax bark, 5-70 parts of pittosporum tobira bark, 10-80 parts of asarum, 6-75 parts of cassia twig, 5-80 parts of radix polygoni multiflori, 10-90 parts of tetrandra, 5-100 parts of rhubarb, 5-85 parts of gardenia, 5-89 parts of sappan wood, 3-75 parts of salvia miltiorrhizae, 3-100 parts of white mustard seeds, 5-75 parts of pinellia, 5-100 parts of zanthoxylum bungeanum, 5-90 parts of papaya, 5-85 parts of angelica sinensis, 3-100 parts of geranium, and 6-90 parts of siegesbeckia herb.

2. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 1, characterized in that: The specific steps include: S1. Grind together Herba Lycopodii, Herba Polygoni Multiflori, Raw Radix Aconiti Kusnezoffii, Raw Frankincense, Myrrha, Cortex Acanthopanacis, Cortex Pittosporum, Asarum, Cinnamomum Cassiae, Radix Dioscoreae, Radix Stephaniae, Rhubarb, Gardenia, Sappan Wood, Salvia Miltiorrhizae, Semen Sinapis, Pinellia, Zanthoxylum, Papaya, Polygonum aviculare, Herba Glycyrrhizae and Herba Siegesbeckiae to obtain a mixed powder, add the mixed powder into an ethanol solution for soaking, perform microwave extraction, and obtain a filtrate and a filter residue; S2, placing the filter residue of S1 in a supercritical CO2 extraction device for extraction to obtain an extract, combining it with the filtrate of S1, and concentrating it under reduced pressure to obtain a Chinese medicine extract; S3, adding the Chinese herbal medicine extract to the glucose-phosphate buffer solution and mixing evenly to obtain an aqueous phase; S4, dissolving vitamin E, cholesterol and phospholipids in an organic solvent, heating in a water bath and vacuum evaporating to remove the organic solvent, to obtain an oil phase; S5. Gradually add the water phase to the oil phase, vortex and oscillate evenly during the process, continue heating in a water bath and performing reduced-pressure rotary evaporation, high-pressure homogenization, and freeze-drying to obtain the target composition.

3. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 2, characterized in that: In step S1, the solid-liquid ratio of the mixed powder to the ethanol solution is 1:10-15 g / mL; the concentration of the ethanol solution is 40-70% v / v; the soaking time is 10-12 hours; and the microwave extraction is performed at 400-500W and 60-80°C for 4-6 hours.

4. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 2, characterized in that: In step S2, the static extraction is first performed at a pressure of 20-30 MPa for 20-30 min, and then the dynamic extraction is performed at 15 L / min for 30-40 min.

5. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 2, characterized in that: In step S3, the solid-liquid ratio of the traditional Chinese medicine extract to the glucose-phosphate buffer solution is 1:4-6 g / mL; the pH of the glucose-phosphate buffer solution is 7.5-8.0, and the mass fraction is 5-10 wt%.

6. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 2, characterized in that: In step S4, the mass ratio of vitamin E, cholesterol and phospholipid is 1:0.3-0.5:3-5; the organic solvent is ethanol or methanol; the solid-liquid ratio of vitamin E, cholesterol and phospholipid to organic solvent is 1:3-5 g / mL; the water bath heating temperature is 40-50°C and the time is 1-3h.

7. The method for preparing a composition for treating rheumatism, rheumatoid arthritis, joint swelling, fracture and bone hyperplasia according to claim 2, characterized in that: In step S5, the mass ratio of the water phase to the oil phase is 1-3:1; the temperature of the continued water bath heating is 55-65° C., and the time is 1-2 h.

8. Use of the composition obtained by the preparation method according to any one of claims 2 to 7 in the preparation of external pharmaceutical preparations.

9. The use according to claim 8, characterized in that The external pharmaceutical preparation includes: ointment, gel, spray or film.

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