Composition for relaxing shoulders, activating meridians and relieving pain as well as preparation method and application thereof in preparation of medicine for treating rotator cuff injury

Abstract

The invention provides a composition for relaxing shoulders, activating meridians and relieving pain as well as a preparation method and application thereof in preparation of a medicine for treating rotator cuff injury. The composition for relaxing shoulders, activating meridians and relieving pain comprises rhizoma wenyujin concisum, radix paeoniae alba, radix clematidis, corydalis tuber, notopterygium root, cassia twig, gentiana macrophylla, kadsura pepper stem, mulberry twig, angelica sinensis, ligusticum wallichii, frankincense and honey-fried licorice root. Wherein the rhizoma wenyujin concisum, the radix paeoniae alba, the radix clematidis and the rhizoma corydalis are used for activating meridians to stop pain and are used as monarch drugs, the notopterygium root, the cassia twig, the gentiana macrophylla, the kadsura pepper stem and the ramulus mori are used as ministerial drugs, the angelica sinensis, the ligusticum wallichii and the frankincense are used for promoting blood circulation to remove blood stasis, promoting qi circulation to stop pain and are used as adjuvant drugs, and the honey-fried licorice root is used for relieving spasm to stop pain and harmonizing the drugs and is used The medicines are compatible to achieve the effects of relaxing shoulders, activating meridians and relieving pain. The composition capable of relaxing shoulders, activating meridians and relieving pain is prepared into granules and patches, and the granules and the patches are combined internally and externally and can directly reach disease sites so as to achieve the effect of treating rotator cuff injuries.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a shoulder-relaxing, collateral-draining and analgesic composition, a preparation method thereof and an application thereof in preparing a medicine for treating rotator cuff injuries. Background Art

[0002] Rotator cuff injury is a common shoulder disease. Its essence is the damage of one or more tendon tissues in the supraspinatus tendon, teres minor tendon, infraspinatus tendon and subscapularis tendon that make up the rotator cuff. Rotator cuff injury is a very common disease. Among people over 60 years old, 25% of them are troubled by rotator cuff injury, and among people over 80 years old, this proportion reaches 50%. With the damage of tendons and the formation of scar tissue, the stability of the shoulder joint may decrease. This may lead to abnormal movement and force distribution of the shoulder joint, increase the pressure on other structures in the joint, and may further develop into osteoarthritis of the shoulder joint. Rotator cuff injury is one of the most common diseases in the field of orthopedics.

[0003] The treatment of rotator cuff injury has always been one of the hot topics in medical research. At present, physical therapy, surgical treatment and drug therapy are the main treatment methods, but each method has some limitations. Physical therapy plays an important role in the treatment of rotator cuff injury. In addition to the conventional main treatment methods, new physical therapies that have emerged in recent years, such as high-intensity focused ultrasound and laser therapy, have also attracted widespread attention from researchers. Although these new technologies have improved the treatment effect, reduced the patient's pain perception and shortened the recovery period. However, physical therapy, as an auxiliary treatment method, needs to work in synergy with other treatment methods. Surgical treatment plays an important role in rotator cuff injury, especially in severe cases. However, due to the invasiveness, irreversibility and certain risks of surgery, patients' acceptance is relatively low. Drug therapy is an area of ​​concern in rotator cuff injury.

[0004] In addition to traditional drugs such as nonsteroidal drugs and PRP, research on new biological drugs is also emerging. These drugs may work by regulating inflammatory responses, promoting soft tissue repair and other mechanisms. Although drug therapy has some side effects, it is safer than surgical treatment and is relatively well accepted by patients. Finding more effective drugs is an urgent problem to be solved in order to improve the treatment effect and quality of life of patients with rotator cuff injuries. Summary of the invention

[0005] The purpose of the present invention is to provide a shoulder-relaxing, collateral-draining and analgesic composition, a preparation method thereof and an application thereof in the preparation of a drug for treating rotator cuff injury. The shoulder-relaxing, collateral-draining and analgesic composition of the present invention can be taken orally or applied externally to treat rotator cuff injury, and has significant therapeutic effect.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The invention provides a shoulder-relaxing, collateral-draining and analgesic composition, which comprises the following raw materials in parts by weight: 15-25 parts of turmeric slices, 15-25 parts of white peony root, 8-12 parts of clematis root, 25-35 parts of corydalis, 8-12 parts of notopterygium root, 3-8 parts of cassia twig, 8-12 parts of gentiana macrophylla, 15-25 parts of kadzuvine vine, 25-35 parts of mulberry twig, 25-35 parts of angelica sinensis, 6-11 parts of ligusticum chuanxiong, 5-10 parts of frankincense and 3-8 parts of roasted liquorice.

[0008] Preferably, the shoulder-relieving, collateral-draining and analgesic composition is used to prepare patches and granules.

[0009] Preferably, the patch further comprises 0.5-1 parts of graphene, 300-400 parts of hot melt adhesive and 3-8 parts of gingerol.

[0010] More preferably, the preparation method of the patch comprises: crushing turmeric slices, white peony root, clematis root, corydalis, notopterygium, cinnamon twig, gentiana macrophylla, kadura vine, mulberry branch, angelica, ligusticum chuanxiong, frankincense and licorice, mixing them with graphene, gingerol and melted hot melt adhesive, and applying them on the patch to obtain the patch.

[0011] Preferably, the granules further include a filler, a binder, a lubricant and a preservative; the filler is one or more of β-cyclodextrin, mannitol and lactose, the binder is one or more of hydroxypropyl methylcellulose, povidone K90 and sucrose, the lubricant is one or more of polyethylene glycol 4000, magnesium lauryl sulfate and talc, and the preservative is tea polyphenols, chitosan and lysozyme.

[0012] More preferably, the preparation method of the granules comprises: crushing turmeric slices, white peony root, clematis root, corydalis, notopterygium and cassia twig and mixing them with water, and after composite enzyme enzymolysis and composite microbial fermentation, concentrating the fermentation liquid to obtain clear paste 1; crushing gentiana, kelp, mulberry branch, angelica, ligusticum, frankincense and licorice root and extracting them with solvent, and concentrating the extract to obtain clear paste 2; mixing clear paste 1, clear paste 2, filler, adhesive, lubricant and preservative in a weight ratio of 1:1:(2-3):(1-2):(0.2-0.5):(0.05-0.1), granulating and drying to obtain the granules.

[0013] More preferably, the complex enzyme is composed of xylanase, ligninase and ficin in a weight ratio of (1-3):(2-5):(2-4), the enzymolysis temperature is 50-60°C, the pH value is 5-6, and the time is 1-3h.

[0014] More preferably, the composite microorganism is composed of Bacillus cereus and Pediococcus pentosaceus in a weight ratio of 1:2-5, the fermentation temperature is 30-35°C, the pH value is 6-7, and the fermentation time is 1-3 days.

[0015] More preferably, the solvent is an ethanol solution with a volume percentage of 65%-85%, the extraction temperature is 40-50°C, the number of times is 1-3 times, each time for 1-3 hours.

[0016] The present invention also provides the use of the shoulder-relaxing, collateral-draining and analgesic composition in the preparation of a medicine for treating rotator cuff injuries.

[0017] The invention also provides another shoulder-relaxing, collateral-draining and analgesic composition, which comprises the following raw materials in parts by weight: 12-18 parts of cassia twig, 12-18 parts of white peony root, 12-18 parts of angelica sinensis, 28-32 parts of vinegar corydalis, 28-32 parts of tuckahoe, 7-11 parts of notopterygium wilfordii, 28-32 parts of astragalus, 12 parts of ginger pinellia, 28-32 parts of radix speranskiae radix, 12 parts of cyperus rotundus, 28-32 parts of rhizoma cyperi, 7-11 parts of gentiana macrophylla, 7-11 parts of clematis, 28-32 parts of millettia reticulata, 28-32 parts of turmeric slices, 28-32 parts of mulberry branches, 5 parts of honeyed licorice, 12-18 parts of pittosporum tobira bark, 7-11 parts of stir-fried mustard seeds, 12-18 parts of tangerine peel, 12-18 parts of angelica dahurica and 7-11 parts of bupleurum.

[0018] Preferably, the raw materials include: 15 parts of cinnamon twig, 15 parts of white peony root, 15 parts of angelica, 30 parts of vinegar Corydalis, 30 parts of Poria, 9 parts of Notopterygium, 30 parts of Astragalus, 12 parts of Pinellia ternata, 30 parts of Radix Polygoni Multiflori, 12 parts of Cyperus rotundus, 30 parts of Rhizoma Cyperi, 9 parts of Gentiana macrophylla, 9 parts of Radix Clematis, 30 parts of Millettia reticulata, 30 parts of Curcuma longa, 30 parts of Morus twig, 5 parts of honeyed licorice, 15 parts of Pittosporum tobira bark, 9 parts of stir-fried mustard seeds, 15 parts of dried tangerine peel, 15 parts of Angelica dahurica and 9 parts of Radix Bupleuri.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The invention provides a shoulder-relaxing, collateral-draining and analgesic composition comprising: turmeric slices, white peony root, clematis root, corydalis root, notopterygium root, cinnamon twig, gentiana macrophylla, kadura strychnine, mulberry twig, angelica root, chuanxiong root, frankincense and licorice root. Among them, turmeric slices, white peony root, clematis root and corydalis root are monarch drugs for collateral-draining and analgesic, notopterygium root, cinnamon twig, gentiana macrophylla, kadura strychnine, mulberry twig are minister drugs for removing rheumatism, warming meridians and dispersing cold, angelica root, chuanxiong root and frankincense are adjuvant drugs for promoting blood circulation and removing blood stasis, promoting qi and relieving pain, and licorice root is a guiding drug for relieving acute pain and harmonizing various drugs. The compatibility of various drugs plays the role of shoulder-relaxing, collateral-draining and analgesic. The shoulder-relaxing, collateral-draining and analgesic composition is made into granules and patches, which are used internally and externally, and can directly reach the diseased area to achieve the effect of treating rotator cuff injury. DETAILED DESCRIPTION

[0021] The invention provides a shoulder-relaxing, collateral-draining and analgesic composition, which comprises the following raw materials in parts by weight: 15-25 parts of turmeric slices, 15-25 parts of white peony root, 8-12 parts of clematis root, 25-35 parts of corydalis, 8-12 parts of notopterygium root, 3-8 parts of cassia twig, 8-12 parts of gentiana macrophylla, 15-25 parts of kadzuvine vine, 25-35 parts of mulberry twig, 25-35 parts of angelica sinensis, 6-11 parts of ligusticum chuanxiong, 5-10 parts of frankincense and 3-8 parts of roasted liquorice.

[0022] The turmeric slices of the present invention have the functions of breaking blood, promoting qi and blood circulation, and relieving pain by dredging menstruation. Breaking blood and promoting qi circulation can promote the circulation of qi and blood in the shoulder, dissipate blood stasis, and relieve pain and swelling; it is good at dredging the meridians of the upper limbs. The rotator cuff is located in the shoulder and belongs to the category of upper limbs. The turmeric slices can directly reach the diseased area, dredge the meridians of the shoulder, and make the qi and blood flow smoothly, and there will be no pain if the meridians are unblocked. For the pain and poor activity caused by the obstruction of meridians after the rotator cuff injury, it has good analgesic and joint activity recovery functions, helps patients relieve pain, and improves the range of motion of the shoulder. It has the effects of dispelling wind and dampness, can dispel the evil of rheumatism in the shoulder, relieve the pain and heaviness caused by rheumatism blocking the meridians, and can be used in combination with other anti-rheumatic drugs to enhance the therapeutic effect.

[0023] The white peony root of the present invention has the effects of promoting blood circulation and relieving pain, and dredging meridians. On the one hand, it can nourish damaged tendons and veins, and provide a material basis for tendon and vein repair; on the other hand, it can enhance the nourishing and regulating function of tendons, and relieve the pain of shoulder muscle spasm.

[0024] The Clematis chinensis of the present invention has the effects of removing rheumatism, unblocking meridians and relieving pain. Rotator cuff injury is often accompanied by blocked shoulder meridians, qi and blood stagnation, pain, limited movement and other symptoms. Clematis chinensis can dredge the shoulder meridians, make the qi and blood flow smoothly, thereby alleviating pain and improving shoulder movement function.

[0025] The Corydalis yanhusuo of the present invention has the functions of dredging collaterals, relieving pain, and promoting blood circulation and qi. Rotator cuff injury can cause obvious pain. Corydalis yanhusuo contains a variety of alkaloids, such as tetrahydropalmatine, which act on the human nervous system, can effectively block pain transmission, produce significant analgesic effect, relieve the severe pain caused by rotator cuff injury, and relieve the pain for patients; rotator cuff injury often causes poor local qi and blood circulation, qi stagnation and blood stasis, which affects injury repair. Corydalis yanhusuo can relieve qi stagnation in blood and blood stagnation in qi, so that qi and blood are unobstructed. It promotes blood circulation, can timely transport nutrients to the injured part, take away metabolic waste, create good conditions for tissue repair, and accelerate the healing of rotator cuff injury.

[0026] The notopterygium root of the present invention has the functions of dispelling cold, dispelling wind and dampness, and relieving pain. Notopterygium root has good effects of dispelling wind and cold, relieving pain, and improving blood circulation in the shoulder and alleviating inflammatory response for shoulder pain, stiffness, and other symptoms caused by rotator cuff injury due to exogenous wind, cold and dampness, and blocking meridians.

[0027] The cinnamon twig of the present invention has the functions of promoting yang and transforming qi, harmonizing the Ying and Wei, dispelling cold and relieving pain, and warming and unblocking the meridians. On the one hand, its function of promoting yang and transforming qi can enhance the yang of the human body, promote the circulation of qi and blood, and help repair damaged rotator cuff tissues; on the other hand, its functions of dispelling cold and relieving pain and warming and unblocking the meridians can dispel the cold evil in the shoulder, eliminate the pain caused by cold stagnation and qi stagnation, improve the blood circulation in the shoulder, and restore the normal function of the tendons and veins.

[0028] The qinjiao of the present invention has the functions of removing rheumatism, relaxing tendons and collaterals, and clearing away heat. For the meridian contracture and flexion and extension difficulties that may occur after rotator cuff injury, qinjiao can play the role of relaxing tendons and collaterals and improve shoulder movement disorders. At the same time, its function of clearing away heat has a certain effect of alleviating the local stagnation of heat symptoms that may occur after injury.

[0029] The Pieris pulcherrima of the present invention has the effects of removing rheumatism, unblocking meridians and relieving pain. Pieris pulcherrima can effectively improve the blocked meridians of the shoulder, alleviate the pain caused by the blocked meridians, and enhance the circulation of qi and blood in the shoulder, and has a positive effect on the rehabilitation after rotator cuff injury.

[0030] The mulberry branch of the present invention has the functions of removing rheumatism and benefiting joints, can guide the medicinal power to the shoulder, specifically targets rheumatic pain and poor mobility of shoulder joints, can significantly improve the activity function of the shoulder, relieve pain and stiffness, and promote the recovery of rotator cuff injury.

[0031] The angelica of the present invention has the functions of nourishing blood, activating blood circulation, regulating menstruation and relieving pain. In the treatment of rotator cuff injury, angelica can nourish the damaged tendons and veins by nourishing blood, and can promote blood circulation in the shoulder, dissipate blood stasis, reduce swelling and pain, provide a good blood supply for the repair of damaged tissues, and promote the recovery of injuries.

[0032] The Chuanxiong of the present invention has the functions of promoting blood circulation, promoting qi, dispelling wind and relieving pain. Chuanxiong can not only promote blood circulation, but also promote qi circulation, so that qi and blood can flow smoothly, enhance the effects of promoting blood circulation, removing blood stasis, unblocking meridians and relieving pain of the whole prescription, and has a good effect of relieving pain caused by qi stagnation and blood stasis caused by rotator cuff injury, while improving the qi and blood circulation of the shoulder and promoting injury repair.

[0033] The frankincense of the present invention has the functions of promoting blood circulation, relieving pain, and reducing swelling and promoting tissue regeneration. For blood stasis, pain and swelling after rotator cuff injury, frankincense can promote blood circulation and dissipate blood stasis, thereby alleviating pain and swelling. At the same time, its myogenic effect helps to promote the repair and regeneration of damaged tissues and promote the healing of rotator cuff injury.

[0034] The roasted licorice root of the present invention has the functions of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, and harmonizing various medicines. In the prescription, the roasted licorice root can, on the one hand, tonify the spleen and stomach, promote the biochemical transformation of qi and blood, and provide a material basis for injury repair; on the other hand, it can harmonize the medicinal properties of various medicines in the prescription, so that each medicine can work synergistically to achieve the purpose of treating rotator cuff injury.

[0035] The shoulder-relaxing, collateral-draining and analgesic composition of the present invention comprises turmeric slices, white peony root, clematis root and corydalis root as main drugs for collateral-draining and analgesic, angelica root, cinnamon twig, gentiana macrophylla, kelp and mulberry twig as assistant drugs for removing rheumatism, warming the meridians and dispersing cold, angelica root, ligusticum chuanxiong and frankincense as adjuvant drugs for promoting blood circulation and removing blood stasis, promoting qi and relieving pain, and licorice root as guiding drug for relieving urgency and relieving pain and harmonizing various drugs. The compatibility of various drugs plays the role of shoulder-relaxing, collateral-draining and analgesic, promotes injury repair from multiple aspects, relieves pain and improves shoulder function according to the etiology and pathogenesis of rotator cuff injury.

[0036] The shoulder-relieving, collateral-draining and analgesic composition of the present invention is preferably used for preparing patches and granules.

[0037] The patch of the present invention also preferably includes 0.5-1 parts of graphene, 300-400 parts of hot melt adhesive and 3-8 parts of gingerol. The graphene-loaded drug percutaneous administration of the present invention can penetrate the effective ingredients in the traditional Chinese medicine directly to the lesion, and the targeted release can improve the drug permeability and efficacy. In addition, the graphene can provide physical support for the repair of the rotator cuff tissue, guide the growth and arrangement of cells, promote the repair and reconstruction of the rotator cuff tissue according to the normal tissue structure, and help to restore the mechanical properties and functions of the rotator cuff; the hot melt adhesive has toughness and plasticity, and can adhere the crushed traditional Chinese medicine and graphene to the patch, so that the graphene and the traditional Chinese medicine will not fall off or separate, maintain the stability of the patch components, ensure the continuous effect of the drug, can fit the skin surface tightly, form good adhesion, so that the plaster maintains a relatively fixed position on the skin, is not easy to shift or fall off, and can prolong the drug's action time and improve the utilization efficiency of the drug; the gingerol improves local blood circulation and brings more nutrients and immune cells to the rotator cuff injury site, which is helpful for tissue repair and resistance to inflammation, and enhances skin permeability, so that the drug can more easily penetrate the skin and reach the rotator cuff injury, improve the local concentration of the drug, and enhance the therapeutic effect.

[0038] The preparation method of the patch of the present invention preferably comprises: crushing turmeric, white peony root, clematis root, corydalis root, notopterygium root, cinnamon twig, gentiana macrophylla, kadyotis root, mulberry branch, angelica root, ligusticum chuanxiong, frankincense and licorice root, mixing with graphene, gingerol and melted hot melt adhesive, and applying on the patch to obtain the patch. The crushed particle size is preferably 100-200 mesh, more preferably 180 mesh.

[0039] The granules of the present invention preferably also include a filler, a binder, a lubricant and a preservative; the filler is preferably one or more of β-cyclodextrin, mannitol and lactose, the binder is preferably one or more of hydroxypropyl methylcellulose, povidone K90 and sucrose, the lubricant is preferably one or more of polyethylene glycol 4000, magnesium lauryl sulfate and talc, the preservative is preferably tea polyphenols, chitosan and lysozyme; the enzyme activity of the lysozyme is 8,000-15,000 U / g.

[0040] The preparation method of the granules of the present invention preferably comprises: crushing turmeric slices, white peony root, clematis root, corydalis root, notopterygium and cassia twig and mixing them with water, and after compound enzyme enzymolysis and compound microbial fermentation, concentrating the fermentation liquid to obtain clear paste 1; crushing gentiana macrophylla, ramie grosvenori, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice root and extracting them with a solvent, and concentrating the extract to obtain clear paste 2; and mixing clear paste 1, clear paste 2, a filler, an adhesive, a lubricant and a preservative in a weight ratio of 1:1:(2-3):(1-2):(0.2-0.5):(0.05-0.1), granulating and drying to obtain the granules.

[0041] The pulverization is ultrafine pulverization, and the pulverized particle size is preferably 800-1000 mesh. The present invention uses ultrafine pulverization to pre-treat the traditional Chinese medicine, the particle size becomes smaller, the specific surface area increases, and the effective ingredients in the traditional Chinese medicine can be transferred from the cell to the extracellular space, thereby improving the dissolution of the active substance.

[0042] The composite enzyme of the present invention is preferably composed of xylanase, ligninase and ficin according to a weight ratio of (1-3): (2-5): (2-4), more preferably 2: 4: 3, the enzymolysis temperature is preferably 50-60 ° C, more preferably 55 ° C, the pH value is preferably 5-6, more preferably 5.5, and the time is preferably 1-3h, more preferably 2h. The enzymatic activity of the xylanase is preferably 40,000-80,000 U / g, more preferably 50,000 U / g, the enzymatic activity of the ligninase is preferably 100,000-200,000 U / g, more preferably 150,000 U / g, the enzymatic activity of the ficin is preferably 200,000-400,000 U / g, more preferably 300,000 U / g, and the dosage of the composite enzyme is preferably 0.3%-0.6% of the weight of the turmeric slices, white peony root, clematis root, corydalis, notopterygium and cassia twig, more preferably 0.5%. The enzymatic hydrolysis step of the present invention can further destroy the cell walls of the traditional Chinese medicine, further dissolve the effective ingredients in the cells, and decompose the protein components in the traditional Chinese medicine into small molecule peptides, amino acids and compounds with biological activity, so as to change the chemical structure of the effective ingredients of the extract and give the extract stronger pharmacological activity.

[0043] The composite microorganism of the present invention is preferably composed of Bacillus cereus and Pediococcus pentosaceus in a weight ratio of 1:2-5, more preferably 1:3. The Bacillus cereus is Bacillus cereus 116, the preservation number is CCTCC No: M 2017803, from the China Center for Type Culture Collection, disclosed in the patent CN108441440A, and the bacterial activity is 5×10 9 -1×10 10 CFU / g, more preferably 8×10 9CFU / g; the Pediococcus pentosaceus is (Pediococcus pentosaceus), the preservation number is CGMCC No.20682, which comes from the General Microbiological Center of the China Microbiological Culture Collection Administration Committee, and is disclosed in the CN112535656A patent. The bacterial activity is 8×10 10 -2×10 11 CFU / g, more preferably 1×10 11 CFU / g. The inoculation amount of the composite microorganism is preferably 1%-2% of the weight of the turmeric slices, white peony root, clematis root, corydalis root, notopterygium root and cinnamon twig, more preferably 1.5%, the fermentation temperature is preferably 30-35°C, more preferably 33°C, the pH value is preferably 6-7, more preferably 6.5, and the time is preferably 1-3d, more preferably 2d. The composite microorganism of the present invention ferments traditional Chinese medicine, which can biotransform the chemical components in the traditional Chinese medicine, so that it has better anti-inflammatory, analgesic and tissue repair promoting abilities, which is helpful for the treatment of rotator cuff injuries.

[0044] The solvent of the present invention is preferably an ethanol solution with a volume percentage of 65%-85%, more preferably an ethanol solution with a volume percentage of 70%, the solid-liquid ratio of the extraction is preferably 1:10-15g / mL, more preferably 1:12g / mL, the extraction temperature is preferably 40-50°C, more preferably 45°C, the number of times is preferably 1-3 times, more preferably 2 times, preferably 1-3h each time, more preferably 2h each time. The method of ethanol extraction can improve the dissolution effect of the active substance, and dissolve in ethanol, so that the effective ingredients in the traditional Chinese medicine are more extracted, so that the prepared granules have better efficacy.

[0045] The present invention also provides the use of the shoulder-relaxing, collateral-draining and analgesic composition in the preparation of a medicine for treating rotator cuff injuries.

[0046] The method for treating rotator cuff injury with the soothing shoulder, unblocking meridians and relieving pain composition of the present invention is as follows: taking 10g of granules each time, 3 times a day, with warm water; cleaning the affected area, applying 10g of the patch to the affected area, one patch each time, once a day.

[0047] In the present invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0048] The technical solutions in the present invention will be described clearly and completely below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0049] In the following embodiments, unless otherwise specified, all of them are conventional methods.

[0050] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0051] The hot melt adhesive used in the embodiments and comparative examples is produced by Foshan Shunde Qigu Hot Melt Adhesive Co., Ltd., model number is 1331, and the main components are rubber and resin.

[0052] Example 1

[0053] Patches

[0054] 20 parts by weight of turmeric slices, 23 parts by weight of white peony root, 11 parts by weight of clematis root, 33 parts by weight of corydalis, 11 parts by weight of notopterygium root, 6 parts by weight of cinnamon twig, 11 parts by weight of gentiana macrophylla, 23 parts by weight of kadzu vine, 33 parts by weight of mulberry twig, 33 parts by weight of angelica sinensis, 10 parts by weight of chuanxiong, 8 parts by weight of frankincense and 6 parts by weight of roasted liquorice are respectively weighed, and crushed to less than 180 mesh respectively, and mixed to obtain powder; 0.8 parts by weight of graphene, 350 parts by weight of melted hot melt adhesive and 5 parts by weight of gingerol are mixed with the powder, sterilized to obtain a jelly; 10 g of the jelly is applied on a patch to obtain a patch.

[0055] Example 2

[0056] Patches

[0057] 15 parts by weight of turmeric slices, 15 parts by weight of white peony root, 8 parts by weight of clematis root, 25 parts by weight of corydalis, 8 parts by weight of notopterygium root, 3 parts by weight of cinnamon twig, 8 parts by weight of gentiana macrophylla, 15 parts by weight of kadura vine, 25 parts by weight of mulberry twig, 25 parts by weight of angelica sinensis, 6 parts by weight of chuanxiong, 5 parts by weight of frankincense and 3 parts by weight of licorice are respectively weighed, and crushed to less than 200 meshes, and mixed to obtain powder; 0.5 parts by weight of graphene, 300 parts by weight of melted hot melt adhesive and 3 parts by weight of gingerol are mixed with the powder, sterilized to obtain a jelly; 10 g of the jelly is applied on the patch to obtain a patch.

[0058] Example 3

[0059] Patches

[0060] 25 parts by weight of turmeric slices, 25 parts by weight of white peony root, 12 parts by weight of clematis root, 35 parts by weight of corydalis, 12 parts by weight of notopterygium root, 8 parts by weight of cinnamon twig, 12 parts by weight of gentiana macrophylla, 25 parts by weight of kadura vine, 35 parts by weight of mulberry twig, 35 parts by weight of angelica sinensis, 11 parts by weight of chuanxiong, 10 parts by weight of frankincense and 8 parts by weight of licorice root are respectively weighed and crushed to less than 180 mesh, and mixed to obtain powder; 1 part by weight of graphene, 400 parts by weight of melted hot melt adhesive and 8 parts by weight of gingerol are mixed with the powder, sterilized to obtain a jelly; 10 g of the jelly is applied on a patch to obtain a patch.

[0061] Example 4

[0062] Granules

[0063] (1) Weigh 18 parts by weight of turmeric slices, 18 parts by weight of white peony root, 9 parts by weight of clematis root, 28 parts by weight of corydalis, 9 parts by weight of notopterygium root, 4 parts by weight of cinnamon twig, 9 parts by weight of gentiana macrophylla, 18 parts by weight of kadzu vine, 28 parts by weight of mulberry twig, 28 parts by weight of angelica sinensis, 8 parts by weight of ligusticum chuanxiong, 7 parts by weight of frankincense and 4 parts by weight of glycyrrhiza uralensis, and grind them into pieces smaller than 900 meshes respectively;

[0064] (2) Mix the crushed turmeric slices, white peony root, clematis root, corydalis root, notopterygium root and cinnamon twig to obtain a mixed powder I, mix it with water 10 times the weight of the powder I, add 0.5% of the weight of the powder I in the form of a composite enzyme, perform enzymolysis at 55° C. and pH 5.5 for 2 hours, and inactivate the enzyme at 85° C. for 15 minutes; inoculate 1.5% of the weight of the powder I in the form of a composite microorganism, ferment at 33° C. and pH 6.5 for 2 days, filter, and perform reduced pressure distillation, concentration, and sterilization of the fermentation filtrate to obtain a clear paste 1 with a relative density of 1.1;

[0065] The complex enzyme is composed of xylanase, ligninase and ficin according to a weight ratio of 2:4:3, the enzyme activity of xylanase is 50,000 U / g, the enzyme activity of ligninase is 150,000 U / g, and the enzyme activity of ficin is 300,000 U / g;

[0066] The composite microorganisms consisted of Bacillus cereus (CCTCC No: M 2017803) and Pediococcus pentosaceus (CGMCC No. 20682) in a weight ratio of 1:3. The bacterial activity of Bacillus cereus was 8×10 10 CFU / g, the enzyme activity of Pediococcus pentosaceus is 1×10 11 CFU / g;

[0067] (3) Mix the crushed gentiana macrophylla, kelp, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice root to obtain a mixed powder II, add a 70% ethanol solution by volume at a solid-liquid ratio of 1:12 g / mL, extract at 45°C for 2 h, filter, add a 70% ethanol solution by volume to the filter residue at a solid-liquid ratio of 1:12 g / mL, extract at 45°C for 2 h, combine the filtrate, concentrate by reduced pressure distillation, and sterilize to obtain a clear paste 2 with a relative density of 1.2;

[0068] (4) mixing the clear paste 1, the clear paste 2, the filler, the binder, the lubricant and the preservative in a weight ratio of 1:1:2.5:1.5:0.3:0.08, granulating, drying and sterilizing to obtain granules;

[0069] The filler is composed of β-cyclodextrin, mannitol and lactose in a weight ratio of 4:3:2;

[0070] The binder is composed of hydroxypropyl methylcellulose, povidone K90 and sucrose in a weight ratio of 2:1:1.5;

[0071] The lubricant is composed of polyethylene glycol 4000, magnesium lauryl sulfate and talc in a ratio of 2:2:1;

[0072] The preservative is composed of tea polyphenols, chitosan and lysozyme in a ratio of 1:1:1, and the enzyme activity of lysozyme is 10,000 U / g.

[0073] Example 5

[0074] Granules

[0075] (1) Weigh 15 parts by weight of turmeric slices, 15 parts by weight of white peony root, 8 parts by weight of clematis root, 25 parts by weight of corydalis, 8 parts by weight of notopterygium root, 3 parts by weight of cinnamon twig, 8 parts by weight of gentiana macrophylla, 15 parts by weight of kadura vine, 25 parts by weight of mulberry twig, 25 parts by weight of angelica sinensis, 6 parts by weight of ligusticum chuanxiong, 5 parts by weight of frankincense and 3 parts by weight of glycyrrhiza uralensis, and grind them into pieces smaller than 800 meshes respectively;

[0076] (2) Mix the crushed turmeric slices, white peony root, clematis root, corydalis root, notopterygium root and cassia twig to obtain a mixed powder I, mix it with water 8 times the weight of the powder I, add 0.3% of the weight of the powder I, perform enzymolysis at 50° C. and pH 5 for 3 hours, and inactivate the enzyme at 80° C. for 20 minutes; inoculate 1% of the weight of the powder I with a composite microorganism, ferment at 30° C. and pH 6 for 3 days, filter, and decompress the fermentation filtrate to obtain a clear paste 1 with a relative density of 1.2;

[0077] The complex enzyme is composed of xylanase, ligninase and ficinase in a weight ratio of 1:2:2, the enzyme activity of xylanase is 40,000 U / g, the enzyme activity of ligninase is 100,000 U / g, and the enzyme activity of ficinase is 200,000 U / g;

[0078] The composite microorganisms consisted of Bacillus cereus (CCTCC No: M 2017803) and Pediococcus pentosaceus (CGMCC No. 20682) in a weight ratio of 1:2. The bacterial activity of Bacillus cereus was 5×10 9 CFU / g, the enzyme activity of Pediococcus pentosaceus was 8×10 10 CFU / g;

[0079] (3) The crushed gentiana macrophylla, kadzu vine, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice root were mixed to obtain a mixed powder II, and a 60% ethanol solution was added at a solid-liquid ratio of 1:10 g / mL, and the mixture was extracted at 40° C. for 3 h, filtered, and the filtrate was concentrated by vacuum distillation and sterilized to obtain a clear paste 2 with a relative density of 1.2;

[0080] (4) mixing the clear paste 1, the clear paste 2, the filler, the binder, the lubricant and the preservative in a weight ratio of 1:1:2:1:0.2:0.05, granulating, drying and sterilizing to obtain granules;

[0081] The filler is composed of β-cyclodextrin, mannitol and lactose in a weight ratio of 3:2:1;

[0082] The binder is composed of hydroxypropyl methylcellulose, povidone K90 and sucrose in a weight ratio of 1:0.5:1;

[0083] The lubricant is composed of polyethylene glycol 4000, magnesium lauryl sulfate and talc in a ratio of 1:1:0.5;

[0084] The preservative is composed of tea polyphenols, chitosan and lysozyme in a ratio of 1:0.5:0.2, and the enzyme activity of lysozyme is 8,000 U / g.

[0085] Example 6

[0086] Granules

[0087] (1) Weigh 25 parts by weight of turmeric slices, 25 parts by weight of white peony root, 12 parts by weight of clematis root, 35 parts by weight of corydalis, 12 parts by weight of notopterygium root, 8 parts by weight of cinnamon twig, 12 parts by weight of gentiana macrophylla, 25 parts by weight of kadura vine, 35 parts by weight of mulberry twig, 35 parts by weight of angelica sinensis, 11 parts by weight of ligusticum chuanxiong, 10 parts by weight of frankincense and 8 parts by weight of glycyrrhiza uralensis, and grind them into pieces less than 1000 mesh respectively;

[0088] (2) Mix the crushed turmeric slices, white peony root, clematis root, corydalis root, notopterygium root and cassia twig to obtain a mixed powder I, mix it with water 15 times the weight of the powder I, add 0.6% of the weight of the powder I in the form of a composite enzyme, perform enzymolysis at 60° C. and pH 6 for 1 hour, and inactivate the enzyme at 90° C. for 10 minutes; inoculate 2% of the weight of the powder I in the form of a composite microorganism, ferment at 35° C. and pH 7 for 1 day, filter, and perform reduced pressure distillation, concentration and sterilization of the fermentation filtrate to obtain a clear paste 1 with a relative density of 1.3;

[0089] The complex enzyme is composed of xylanase, ligninase and ficinase in a weight ratio of 3:5:4, the enzyme activity of xylanase is 80,000 U / g, the enzyme activity of ligninase is 200,000 U / g, and the enzyme activity of ficinase is 400,000 U / g;

[0090] The composite microorganisms consisted of Bacillus cereus (CCTCC No: M 2017803) and Pediococcus pentosaceus (CGMCC No. 20682) in a weight ratio of 1:5. The bacterial activity of Bacillus cereus was 1×10 10 CFU / g, the enzyme activity of Pediococcus pentosaceus is 2×10 11 CFU / g;

[0091] (3) Mix the crushed gentiana macrophylla, kelp, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice root to obtain a mixed powder II, add an ethanol solution with a volume percentage of 85% at a solid-liquid ratio of 1:15 g / mL, extract at 50° C. for 1 h, filter, extract the residue twice according to the above extraction method, combine the filtrate, concentrate and sterilize by vacuum distillation to obtain a clear paste 2 with a relative density of 1.3;

[0092] (4) mixing the clear paste 1, the clear paste 2, the filler, the binder, the lubricant and the preservative in a weight ratio of 1:1:3:2:0.5:0.1, granulating, drying and sterilizing to obtain granules;

[0093] The filler is composed of β-cyclodextrin, mannitol and lactose in a weight ratio of 5:4:3;

[0094] The binder is composed of hydroxypropyl methylcellulose, povidone K90 and sucrose in a weight ratio of 3:2:2;

[0095] The lubricant is composed of polyethylene glycol 4000, magnesium lauryl sulfate and talc in a ratio of 3:3:2;

[0096] The preservative is composed of tea polyphenols, chitosan and lysozyme in a ratio of 1:2:2, and the enzymatic activity of lysozyme is 15,000 U / g.

[0097] Comparative Example 1

[0098] Patches

[0099] 11 parts by weight of Notopterygium wilfordii, 11 parts by weight of Angelica dahurica, 6 parts by weight of cinnamon twig, 11 parts by weight of Gentiana macrophylla, 23 parts by weight of Piper mescalineata, 33 parts by weight of Morus alba, 33 parts by weight of Angelica sinensis, 10 parts by weight of Rhizoma Chuanxiong, 8 parts by weight of frankincense, 8 parts by weight of costusroot and 6 parts by weight of Glycyrrhiza uralensis are respectively weighed, and crushed to less than 180 mesh, and mixed to obtain powder; the powder is mixed with graphene, melted hot melt adhesive and gingerol in a weight ratio of 208:0.8:350:5, and sterilized to obtain a jelly; 10 g of the jelly is applied on a patch to obtain a patch.

[0100] The difference between this comparative example and Example 1 is that Curcuma longa, White Peony Root, Clematis Root and Corydalis yanhusuo are omitted, and Angelica dahurica and Aucklandia lappa are added.

[0101] Comparative Example 2

[0102] Granules

[0103] The specific implementation method is the same as that of Example 4, except that turmeric slices, white peony root, clematis root and Corydalis root are omitted, and 9 parts by weight of Angelica dahurica and 7 parts by weight of costus root are added; turmeric slices, white peony root, clematis root and Corydalis root are omitted in step (2), and Angelica dahurica is added; costus root is added in step (3), and the preparation method remains unchanged.

[0104] Comparative Example 3

[0105] Granules

[0106] The specific implementation is the same as that of Example 4, except that step (2) is to first perform fermentation and then perform enzymolysis.

[0107] Comparative Example 4

[0108] Granules

[0109] The specific implementation method is the same as that of Example 4, except that the composite enzyme in step (2) is composed of cellulase, pectinase and papain in a weight ratio of 2:4:3, the enzymatic activity of cellulase is 50,000 U / g, the enzymatic activity of pectinase is 150,000 U / g, and the enzymatic activity of papain is 300,000 U / g; the enzymatic hydrolysis temperature is 50°C, the pH value is 5, and the time is 2h.

[0110] Comparative Example 5

[0111] Granules

[0112] The specific implementation method is the same as that of Example 4, except that the composite microorganism in step (2) is Bacillus subtilis and Lactobacillus plantarum According to the weight ratio of 1:3, the bacterial activity of Bacillus subtilis is 8×10 10 CFU / g, the enzyme activity of Lactobacillus plantarum is 1×10 11 CFU / g, fermentation temperature was 37℃, pH value was 7, and time was 2d.

[0113] Comparative Example 6

[0114] Granules

[0115] The specific implementation is the same as that of Example 4, except that the ethanol solution in step (3) is replaced by an aqueous solution.

[0116] The Chinese medicine formula of Comparative Examples 1 and 2 is derived from the Qubi Decoction in Volume 3 of "Medical Awakening" (in the formula, Qianghuo, Duhuo and Guizhi are the main medicines, which can dispel wind and dampness, warm the meridians and dissipate cold; Qinjiao, Haifengteng and Morus alba are the ministerial medicines, which help the main medicine to dispel wind and dampness and dredge the meridians; Angelica, Chuanxiong, Frankincense and Aucklandia are the adjuvants, which can promote blood circulation, remove blood stasis, promote qi and relieve pain; Licorice relieves urgency and relieves pain, and harmonizes the medicines, which is the guiding medicine. The combination of the medicines has the effects of warming the meridians and dispersing cold, removing dampness and dredge the meridians, and promoting qi and relieving pain).

[0117] Test Example 1

[0118] Cell assay

[0119] The MTT method was used to detect the effects of the active ingredients in Examples 4-6 and Comparative Examples 2-6 on the proliferation of mouse tendon stem cells HSPCELL-347. Mouse tendon stem cells (primary) were purchased from Hefei Xingpeptide Biotechnology Co., Ltd.

[0120] The clear paste 1 and the clear paste 2 in Examples 4-6 and Comparative Examples 2-6 were mixed in equal weights, freeze-dried, and the corresponding powders were obtained, and then experimental tests were performed.

[0121] Mouse tendon stem cells (passage 3) in the logarithmic growth phase were collected and seeded in 96-well plates at a cell density of 5000 cells / 100 μL DMEM complete medium per well.

[0122] After the cells adhered to the wall, the powders of Examples 4-6 and Comparative Examples 2-6 were added to the complete DMEM medium at a concentration of 5 μg / mL. Subsequently, 10 μL of 5 mg / mL MTT working solution was added to each well and the cells were incubated at 37°C and 5% CO. 2 The culture was continued for 4 hours under the same conditions. A blank group (the only difference from the other groups was that no drug powder was added) was set up at the same time, with three replicates in each group. After the culture was completed, the absorbance of each well at 490 nm was measured using a full-wavelength microplate reader. The specific results are shown in Table 1.

[0123] Table 1 Absorbance of each group

[0124] Group OD value Blank Group 0.206±0.028 Example 4 0.732±0.013 Example 5 0.727±0.008 Example 6 0.718±0.024 Comparative Example 2 0.403±0.046 Comparative Example 3 0.602±0.075 Comparative Example 4 0.556±0.032 Comparative Example 5 0.573±0.056 Comparative Example 6 0.534±0.043

[0125] It can be seen from the data in Table 1 that both the examples and the comparative examples can improve the proliferation of mouse tendon stem cells, and the improvement effect of the examples is more obvious than that of the comparative examples. It can be seen from the data of Example 4 and Comparative Example 2 that different Chinese medicine prescriptions have a significant effect on the proliferation of tendon stem cells; it can be seen from the data of Example 4 and Comparative Example 3 that the order of enzymatic hydrolysis and fermentation has little effect on the proliferation of tendon stem cells; it can be seen from Example 4 and Comparative Examples 4-5 that different composite enzymes and composite microorganisms have different effects on the proliferation of tendon stem cells; it can be seen from Example 4 and Comparative Example 6 that different solvents have a greater effect on the proliferation of tendon stem cells. It can be seen that the Chinese medicine combination, enzymatic hydrolysis, fermentation and solvent extraction of the present invention are crucial to the proliferation of tendon stem cells, and the preparation method of the present invention can efficiently promote the proliferation of mouse tendon stem cells.

[0126] Test Example 2

[0127] Acute toxicity test in rats

[0128] Thirty SD rats aged 7 weeks and weighing 210-220 g were selected and randomly divided into three groups: Example 1 group, Comparative Example 1 group and matrix material group (prepared by mixing 0.8 parts by weight of graphene, 350 parts by weight of melted hot melt adhesive and 5 parts by weight of gingerol). Each group was further divided into an intact skin group and a damaged skin group.

[0129] The rats were depilated on both sides of their backs, and the rats in the damaged skin group were marked with a "#" on their skin with a syringe needle, and bleeding was used as the standard. The jelly of Example 1, the jelly of Comparative Example 1, and the matrix material containing no drug were applied to the left skin of each group of rats, and the right side was covered with gauze dipped in saline. After applying for 24 hours, the test substance remaining on the skin was removed with warm water, and the rats were raised normally for 15 days. The weight, appearance signs, behavioral activities, diet and drinking water of the rats were observed to determine whether there were poisoning symptoms. The average weight of the rats in each group is shown in Table 2.

[0130] Table 2 Body weight of rats in each group

[0131]

[0132] As shown in Table 2, the weight of rats in different groups increased to varying degrees, and the difference was not significant. During the 15d feeding process, the fur of rats in each group was smooth and shiny, without poisoning phenomena and allergic phenomena such as body surface damage, swelling, slow movement, drowsiness, coma, and shortness of breath, and there was no significant reduction in food intake and water intake, and no death. It can be seen that the patch of Example 1, Comparative Example 1 and the matrix material had no acute toxic reaction to rats, and the safety was high.

[0133] Test Example 3

[0134] Clinical trials

[0135] Diagnostic criteria: Western medicine diagnostic criteria are based on the diagnostic criteria for rotator cuff injuries in the Clinical Diagnosis and Treatment Guidelines - Orthopedics. The diagnostic criteria for TCM syndrome classification are based on the classification of qi stagnation and blood stasis in rotator cuff injuries in TCM tendon injury. The main manifestations are: early rotator cuff injury, shoulder pain, swelling, limited shoulder joint movement, night pain, fixed pain, dark tongue or ecchymosis, and stringy or astringent pulse.

[0136] Inclusion criteria: meeting the diagnostic criteria of traditional Chinese and Western medicine; age 30-70 years old; Neer stage I-II.

[0137] Exclusion criteria: patients who had received other treatments in the past 2 weeks; patients with giant rotator cuff tears defined by Cofield classification; patients with severe shoulder osteoarthritis, shoulder dislocation, fracture, etc.; patients with autoimmune diseases or severe organic lesions; patients with mental illness and inability to cooperate; and patients during pregnancy and lactation.

[0138] According to the above criteria, 160 patients with rotator cuff injury were selected and divided into four groups, with 40 cases in each group. There was no statistical difference in age, disease course, and severity of symptoms among the groups.

[0139] Oral + external use group: take 10g of Example 4 granules each time, 3 times a day, with warm water; clean the affected area, apply 10g of Example 1 patch to the affected area, one patch each time, once a day; the average course of the cases was 2.53 months, Neer stage I 30 cases, II stage 10 cases.

[0140] Oral group: 10 g of Example 4 granules were taken each time, 3 times a day, with warm water; the average course of the cases was 2.32 months, and there were 31 cases in stage Ⅰ and 9 cases in stage Ⅱ according to Neer stage.

[0141] For external use, the affected area was cleaned and 10 g of the patch of Example 1 was applied to the affected area, one patch each time, once a day. The average course of the disease was 2.39 months, and there were 30 cases in stage I and 10 cases in stage II according to Neer staging.

[0142] Comparative example group: take 10g of comparative example 2 granules each time, 3 times a day, with warm water; clean the affected area, apply 10g of comparative example 1 patch to the affected area, one patch each time, once a day; the average course of the cases was 2.45 months, with 28 cases in stage I and 12 cases in stage II according to Neer stage.

[0143] The observation indicators included visual analog pain VAS score and UCLA shoulder score.

[0144] Visual Analog Pain VAS score: used for pain assessment, the higher the score, the more obvious the pain. The scoring standard uses a straight line or ruler about 10 cm long, with the two ends marked as 0 and 10 respectively, where 0 points: means the patient does not feel any pain; 1-3 points: indicates mild pain, which the patient can usually tolerate and does not affect daily life; 4-6 points: indicates moderate pain, the patient feels obvious discomfort, which may affect sleep and daily life; 7-9 points: indicates severe pain, the patient's pain is severe and unbearable, seriously affecting sleep and daily life; 10 points: indicates severe pain, which the patient usually cannot tolerate and requires emergency treatment. Scoring before treatment and one month after treatment.

[0145] UCLA shoulder scoring system: assesses shoulder function, including pain, functional activity, flexion strength, flexion range of motion, and satisfaction. The total score is 35 points. The higher the score, the better the recovery of shoulder function. The scores were taken before treatment and one month after treatment.

[0146] Efficacy criteria: Cured: shoulder movement function returns to normal and clinical symptoms disappear; Markedly effective: clinical symptoms are significantly alleviated and shoulder range of motion is significantly increased; Effective: clinical symptoms and shoulder movement are improved to varying degrees; Ineffective: no obvious improvement.

[0147] Total effective rate (%) = (cured cases + markedly effective cases + effective cases) ÷ 40 cases × 100%.

[0148] After one month of treatment, the visual analog pain VAS scores, UCLA shoulder joint scores and clinical efficacy of each group before and after treatment were statistically analyzed. The specific results are shown in Tables 3-5.

[0149] Table 3 Visual analog pain VAS scores of each group before and after treatment

[0150] Group Before treatment After treatment Oral + topical group 6.34±0.53 2.24±0.60 Oral group 6.25±0.75 3.68±0.33 External use group 6.30±0.83 3.06±0.72 Comparative group 6.22±0.68 2.67±0.41

[0151] Table 4 UCLA shoulder joint scores before and after treatment in each group

[0152] Group Before treatment After treatment Oral + topical group 14.75±0.47 37.84±0.83 Oral group 15.13±0.28 26.75±0.48 External use group 14.64±0.82 28.43±0.26 Comparative group 14.83±0.93 30.58±0.96

[0153] Table 5 Clinical efficacy of each group

[0154] Group Cured (case) Significantly effective (example) Valid (Example) Invalid (Example) Total effective rate (%) Oral + topical group 20 11 7 2 95 Oral group 8 12 10 10 75 External use group 10 10 12 8 80 Comparative group 12 15 7 6 85

[0155] As shown in Tables 3-5, the visual analog pain VAS score and UCLA shoulder joint score before treatment are not much different; after treatment, compared with the oral group, the external group and the comparative group, the oral + external group can significantly reduce the visual analog pain VAS score and improve the UCLA shoulder joint score, indicating that the oral and external Shujiantongluo analgesic composition of the present invention has a synergistic effect, can significantly reduce the pain in the rotator cuff injury site, improve the range of motion, muscle strength and patient satisfaction of the shoulder, significantly improve the functional activity of the rotator cuff, and thus improve the therapeutic effect of the rotator cuff injury. Comparison of the data of the comparative group and the oral + external group shows that the Shujiantongluo analgesic composition of the present invention is more effective in treating rotator cuff injuries than the traditional Qubi Decoction.

[0156] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A shoulder-relaxing, collateral-draining and analgesic composition, characterized in that: The invention comprises the following raw materials in parts by weight: 15-25 parts of turmeric slices, 15-25 parts of white peony root, 8-12 parts of clematis root, 25-35 parts of corydalis, 8-12 parts of notopterygium root, 3-8 parts of cassia twig, 8-12 parts of gentiana macrophylla, 15-25 parts of kadzuvine vine, 25-35 parts of mulberry branch, 25-35 parts of angelica sinensis, 6-11 parts of ligusticum chuanxiong, 5-10 parts of frankincense and 3-8 parts of roasted liquorice.

2. The shoulder-relieving, collateral-draining and analgesic composition according to claim 1, characterized in that: The shoulder-relieving, collateral-draining and analgesic composition is used for preparing patches and granules.

3. The shoulder-relieving, collateral-draining and analgesic composition according to claim 2, characterized in that: The patch also includes 0.5-1 parts of graphene, 300-400 parts of hot melt adhesive and 3-8 parts of gingerol.

4. The shoulder-relieving, collateral-draining and analgesic composition according to claim 3, characterized in that: The preparation method of the patch comprises: crushing turmeric slices, white peony root, clematis root, corydalis, notopterygium, cassia twig, gentiana macrophylla, kadyotis diffusa, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice, mixing them with graphene, gingerol and melted hot melt adhesive, and applying them on the patch to obtain the patch.

5. The shoulder-relieving, collateral-draining and analgesic composition according to claim 2, characterized in that: The granules also include a filler, a binder, a lubricant and a preservative; the filler is one or more of β-cyclodextrin, mannitol and lactose, the binder is one or more of hydroxypropyl methylcellulose, povidone K90 and sucrose, the lubricant is one or more of polyethylene glycol 4000, magnesium lauryl sulfate and talc, and the preservative is tea polyphenols, chitosan and lysozyme.

6. The shoulder-relieving, collateral-draining and analgesic composition according to claim 5, characterized in that: The preparation method of the granules comprises: crushing turmeric slices, white peony root, clematis root, corydalis root, notopterygium root and cassia twig and mixing them with water, performing compound enzyme enzymolysis and compound microbial fermentation, and concentrating the fermentation liquid to obtain a clear paste 1; crushing gentiana macrophylla, kelp, mulberry branch, angelica sinensis, ligusticum chuanxiong, frankincense and licorice root and extracting them with a solvent, and concentrating the extract to obtain a clear paste 2; mixing the clear paste 1, the clear paste 2, a filler, an adhesive, a lubricant and a preservative according to a weight ratio of 1:1:(2-3):(1-2):(0.2-0.5):(0.05-0.1), granulating and drying to obtain the granules.

7. The shoulder-relieving, collateral-draining and analgesic composition according to claim 6, characterized in that: The complex enzyme is composed of xylanase, ligninase and ficin according to a weight ratio of (1-3):(2-5):(2-4), the enzymolysis temperature is 50-60°C, the pH value is 5-6, and the time is 1-3h.

8. The shoulder-relieving, collateral-draining and analgesic composition according to claim 6, characterized in that: The composite microorganism is composed of Bacillus cereus and Pediococcus pentosaceus in a weight ratio of 1:2-5, the fermentation temperature is 30-35°C, the pH value is 6-7, and the fermentation time is 1-3 days.

9. The shoulder-relieving, collateral-draining and analgesic composition according to claim 6, characterized in that: The solvent is an ethanol solution with a volume percentage of 65%-85%, the extraction temperature is 40-50°C, the number of times is 1-3 times, and each time is 1-3 hours.

10. Use of the shoulder-relieving, collateral-draining and analgesic composition according to any one of claims 1 to 9 in the preparation of a drug for treating rotator cuff injuries.

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