Traditional Chinese medicine composition for treating rotator cuff injury and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating rotator cuff injury and application thereof. The invention provides a traditional Chinese medicine composition, which is prepared from the following ingredients in parts by mass: 2 to 9 parts of herba lycopodii, 1.5 to 9 parts of radix clematidis, 2 to 9 parts of herba speranskiae tuberculatae, 2 to 9 parts of exocarpium benincasae, 1 to 4.5 parts of herba saussureae involucratae, 1 to 4.5 parts of stauntonia chinensis, 1 to 4.5 parts of cortex acanthopanacis, 0.6 to 3.6 parts of pericarpium zanthoxyli and 0.6 to 3.6 parts of flos carthami. The lycopodium clavatum, the radix clematidis, the garden balsam stem, the exocarpium benincasae, the snow lotus herb, the stauntonia chinensis, the cortex acanthopanacis, the pericarpium zanthoxyli and the flos carthami are compatible, the effects of relaxing the muscles and stimulating the blood circulation and eliminating cold to stop pain are achieved, the good effects of promoting blood circulation and relieving pain are achieved, the good effect of relieving shoulder pain, upper limb ache and back neck pain of a patient suffering from the rotator cuff injury is achieved, and the remarkable curative effect is achieved when the traditional Chinese medicine is used for treating the rotator cuff injury.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating rotator cuff injuries and an application thereof. Background Art

[0002] The rotator cuff, also known as the rotator cuff, is a group of tendon complexes wrapped around the humeral head. The front of the humeral head is the subscapularis tendon, the top is the supraspinatus tendon, the back is the infraspinatus tendon and the teres minor tendon. It is attached to the greater tuberosity of the humerus and the edge of the anatomical neck of the humerus. Its inner surface is closely connected to the joint capsule, and the outside is the subdeltoid bursa. The movement of these tendons causes the shoulder joint to rotate internally, externally, and upward, but more importantly, these tendons stabilize the humeral head on the glenoid fossa, playing an extremely important role in maintaining the stability and mobility of the shoulder joint.

[0003] Rotator cuff injuries increase with age, and the main clinical manifestations are shoulder pain, dysfunction and even muscle atrophy, which seriously affect limb function. Pain is the main symptom of rotator cuff injury. Shoulder pain usually leads to a decline in the patient's physical fitness and behavioral ability, and is more obvious in the elderly. The treatment of joint pain involves surgical treatment, medication, physical therapy, etc. Oral medications are usually the first choice for conservative treatment in clinical practice. Currently, oral non-steroidal anti-inflammatory drugs are mainly used to relieve shoulder pain caused by rotator cuff injuries, but they increase the burden on the heart and kidneys, are prone to damage the gastrointestinal tract, and have other side effects. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating rotator cuff injury and its application, which can effectively relieve shoulder pain, upper limb soreness and back neck pain in patients with rotator cuff injury and has a significant therapeutic effect on the treatment of rotator cuff injury.

[0005] The invention provides a traditional Chinese medicine composition, which comprises the following components in parts by mass: 2-9 parts of lycopodii herba, 1.5-9 parts of clematis radix, 2-9 parts of radix spatholobi, 2-9 parts of wax gourd peel, 1-4.5 parts of snow lotus, 1-4.5 parts of wild papaya, 1-4.5 parts of acanthopanax cortex, 0.6-3.6 parts of Sichuan pepper and 0.6-3.6 parts of safflower.

[0006] Preferably, the following components are included, calculated by weight: 3-6 parts of lycopodii herba, 3-6 parts of scutellaria baicalensis, 3-6 parts of wax gourd peel, 1.5-3 parts of wild papaya, 1.5-3 parts of acanthopanax bark, 2-6 parts of clematis, 1.5-3 parts of snow lotus, 1.2-1.8 parts of Sichuan pepper and 1.2-1.8 parts of safflower.

[0007] Preferably, the composition comprises the following components by weight: 3 parts of smilax glabra, 3 parts of smilax glabra, 3 parts of wax gourd peel, 1.5 parts of wild papaya, 1.5 parts of acanthopanax bark, 1.5 parts of clematis, 0.9 parts of snow lotus, 0.9 parts of Sichuan pepper and 0.9 parts of safflower;

[0008] Or, it includes the following components: 2 parts of Lycopodiella ciliata, 2 parts of Radix Penicillae, 2 parts of wax gourd peel, 1 part of wild papaya, 1 part of Acanthopanax cortex, 2 parts of Clematis chinensis, 1 part of Snow Lotus, 0.6 parts of Sichuan pepper and 0.6 parts of safflower.

[0009] Preferably, the dosage form of the Chinese medicine composition includes powder.

[0010] Preferably, the powder of the traditional Chinese medicine composition can pass through a 10-mesh sieve.

[0011] The present invention also provides the use of the traditional Chinese medicine composition described in the above technical solution in preparing a medicine for treating rotator cuff injury.

[0012] The present invention also provides a Chinese medicine hot compress pack, which comprises the Chinese medicine composition described in the above technical solution.

[0013] The present invention also provides a method for preparing the Chinese medicine hot compress pack described in the above technical solution, comprising the following steps:

[0014] Mixing striata herb, radix striatae, wax gourd peel, wild papaya, acanthopanax bark, clematis root, snow lotus, Sichuan pepper and safflower, drying, crushing, passing through a 10-mesh sieve, collecting the sieved material to obtain Chinese medicine powder;

[0015] The Chinese medicine powder is put into a cloth bag to obtain the Chinese medicine hot compress bag.

[0016] Preferably, the drying temperature is 60° C. to 100° C., and the drying time is 1 h to 3 h.

[0017] Preferably, the specification of the Chinese medicine hot compress bag is 100g to 200g per bag.

[0018] Beneficial effects:

[0019] The invention provides a Chinese medicine composition, which comprises the following components by weight: 2-9 parts of spatholobi, 1.5-9 parts of clematis, 2-9 parts of spatholobi, 2-9 parts of wax gourd peel, 1-4.5 parts of snow lotus, 1-4.5 parts of wild papaya, 1-4.5 parts of acanthopanax peel, 0.6-3.6 parts of Sichuan pepper and 0.6-3.6 parts of safflower. The clematis, spatholobi, spatholobi, wax gourd peel, snow lotus, wild papaya, acanthopanax peel, Sichuan pepper and safflower of the invention are compatible, can relax muscles and activate blood circulation, dispel cold and relieve pain, have good blood circulation and analgesic effects, have good relief effects on shoulder pain, upper limb soreness and back neck pain in patients with rotator cuff injury, are used for treating rotator cuff injury, and have significant therapeutic effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required to be used in the embodiments are briefly introduced below.

[0021] Figure 1 is the chromatogram of the reference substance hydroxysafflor yellow A;

[0022] Figure 2 This is the chromatogram of hydroxysafflor yellow A of the Chinese medicine composition of Example 1;

[0023] Figure 3 This is the chromatogram of hydroxysafflor yellow A of the Chinese medicine composition of Comparative Example 1;

[0024] Figure 4 is the standard curve of hydroxysafflor yellow A. DETAILED DESCRIPTION

[0025] The invention provides a traditional Chinese medicine composition, which comprises the following components in parts by mass: 2-9 parts of lycopodii herba, 1.5-9 parts of clematis radix, 2-9 parts of radix spatholobi, 2-9 parts of wax gourd peel, 1-4.5 parts of snow lotus, 1-4.5 parts of wild papaya, 1-4.5 parts of acanthopanax cortex, 0.6-3.6 parts of Sichuan pepper and 0.6-3.6 parts of safflower.

[0026] In the present invention, the Chinese medicine composition includes 2 to 9 parts of Herba Lycopodii in terms of mass fractions. As an embodiment, the Chinese medicine composition includes 3 to 6 parts of Herba Lycopodii; as another embodiment, the Chinese medicine composition includes 5 parts of Herba Lycopodii. In a specific embodiment of the present invention, any value can be taken within the range of 2 to 9, such as 2, 2.5, 3, 4, 5, 6, 7, 8 or 9. As an embodiment, the Herba Lycopodii is a Herba Lycopodii decoction piece listed in the Chinese Pharmacopoeia.

[0027] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 1.5 to 9 parts of Clematis. As an embodiment, the Chinese medicine composition includes 2 to 6 parts of Clematis; as another embodiment, the Chinese medicine composition includes 3 parts of Clematis. In a specific embodiment of the present invention, any value can be taken within the range of 1.5 to 9, such as 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8 or 9.

[0028] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 2 to 9 parts of herb. As an embodiment, the Chinese medicine composition includes 3 to 6 parts of herb; as another embodiment, the Chinese medicine composition includes 4 to 5 parts of herb. In a specific embodiment of the present invention, any value can be taken within the range of 2 to 9, such as 2, 2.5, 3, 4, 5, 6, 7, 8 or 9. As an embodiment, the herb is a herb slice of herb listed in the Chinese Pharmacopoeia.

[0029] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 2 to 9 parts of wax gourd peel. As an embodiment, the Chinese medicine composition includes 3 to 6 parts of wax gourd peel; as another embodiment, the Chinese medicine composition includes 4 to 5 parts of wax gourd peel. In a specific embodiment of the present invention, any value can be taken within the range of 2 to 9, such as 2, 2.5, 3, 4, 5, 6, 7, 8 or 9. As an embodiment, the wax gourd peel is a wax gourd peel decoction piece listed in the Chinese Pharmacopoeia.

[0030] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 1 to 4.5 parts of snow lotus. As an embodiment, the Chinese medicine composition includes 1.5 to 3 parts of snow lotus; as another embodiment, the Chinese medicine composition includes 2 to 2.5 parts of snow lotus. In a specific embodiment of the present invention, any value can be taken within the range of 1 to 4.5, such as 1, 1.5, 2, 2.5, 3, 4 or 4.5. As an embodiment, the snow lotus is a snow lotus decoction piece listed in the Chinese Pharmacopoeia.

[0031] In the present invention, based on the mass fraction of the lycopodii herba, the Chinese medicine composition includes 1 to 4.5 parts of wild papaya. As an embodiment, the Chinese medicine composition includes 1.5 to 3 parts of wild papaya; as another embodiment, the Chinese medicine composition includes 2 to 2.5 parts of wild papaya. In a specific embodiment of the present invention, any value can be taken within the range of 1 to 4.5, such as 1, 1.5, 2, 2.5, 3, 4 or 4.5. As an embodiment, the wild papaya is a wild papaya decoction piece listed in the Chinese Pharmacopoeia.

[0032] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 1 to 4.5 parts of Acanthopanax Cortex. As an embodiment, the Chinese medicine composition includes 1.5 to 3 parts of Acanthopanax Cortex; as another embodiment, the Chinese medicine composition includes 2 to 2.5 parts of Acanthopanax Cortex. In a specific embodiment of the present invention, any value can be taken within the range of 1 to 4.5, such as 1, 1.5, 2, 2.5, 3, 4 or 4.5. As an embodiment, the Acanthopanax Cortex is the Acanthopanax Cortex decoction pieces listed in the Chinese Pharmacopoeia.

[0033] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 0.6 to 3.6 parts of Sichuan pepper. As an embodiment, the Chinese medicine composition includes 1.2 to 1.8 parts of Sichuan pepper; as another embodiment, the Chinese medicine composition includes 1.5 parts of Sichuan pepper. In a specific embodiment of the present invention, any value can be taken within the range of 0.6 to 3.6, such as 0.6, 0.9, 1.0, 1.5, 2, 2.5, 3, 3.5 or 3.6. As an embodiment, the Sichuan pepper is a Sichuan pepper slice listed in the Chinese Pharmacopoeia.

[0034] In the present invention, based on the mass fraction of the herb, the Chinese medicine composition includes 0.6 to 3.6 parts of safflower. As an embodiment, the Chinese medicine composition includes 0.9 to 3.2 parts of safflower; as another embodiment, the Chinese medicine composition includes 1.2 to 1.8 parts of clematis. In a specific embodiment of the present invention, any value can be taken within the range of 0.6 to 3.6, such as 0.6, 0.8, 1.0, 1.2, 1.8, 2.0, 3.0, 3.5 or 3.6. The present invention uses safflower as the main drug, which has the effects of promoting blood circulation, dredge menstruation, dispersing blood stasis and relieving pain.

[0035] In the present invention, as an embodiment, the dosage form of the Chinese medicine composition includes powder. As an embodiment, the powder of the Chinese medicine composition can pass through a 10-mesh sieve; as another embodiment, the powder of the Chinese medicine composition can pass through a 45-mesh sieve.

[0036] The present invention uses spatholobi, spatholobi, wax gourd peel, wild papaya, Acanthopanax bark, clematis, snow lotus, Sichuan pepper and safflower in a compatibility, wherein spatholobi is the main drug, which can dispel wind and dampness, relax muscles and activate blood circulation and relieve pain. Wax gourd peel can dispel dampness and reduce swelling, clear away heat and detoxify; spatholobi can dispel wind and dampness, disperse blood stasis and reduce swelling, detoxify and relieve pain, and wax gourd peel can help the main drug to relax muscles and activate blood circulation, disperse blood stasis and reduce swelling and relieve pain, and they are all ministerial drugs. Wild papaya can dispel wind and relieve pain, Acanthopanax bark can nourish the liver and kidney, strengthen tendons and bones, and can be used as a dampness-removing and swelling aid, clematis can dispel wind and dredge collaterals to relieve pain, and snow lotus can dispel wind and dampness, strengthen tendons and bones, and tonify kidney yang, and the four drugs are used together as adjuvant drugs. Safflower can promote blood circulation and menstruation, disperse blood stasis and relieve pain, and Sichuan pepper can be used as a fragrant dampness-removing and warming meridians and dispersing cold as a guiding drug. All the drugs are used together, and the functions of dispelling wind and dampness, warming meridians and dispersing blood stasis and relieving pain, promoting blood circulation and dredge collaterals, and tonifying kidney, strengthening tendons and bones are achieved, and the disease of stubborn arthritis is overcome together. The Chinese medicine composition provided by the invention can relax muscles and activate blood circulation, dispel cold and relieve pain, has good blood circulation and analgesic effects, has a good effect of alleviating shoulder pain, upper limb soreness and back neck pain in patients with rotator cuff injury, and is used for treating rotator cuff injury with significant therapeutic effect.

[0037] In view of the effects of the traditional Chinese medicine composition provided by the present invention, the use of the traditional Chinese medicine composition in the preparation of a medicine for treating rotator cuff injury also falls within the protection scope of the present invention.

[0038] The present invention also provides a Chinese medicine hot compress pack, which comprises the Chinese medicine composition described in the above technical solution.

[0039] The present invention also provides a method for preparing the Chinese medicine hot compress pack described in the above technical solution, comprising the following steps:

[0040] Mixing striata herb, radix striatae, wax gourd peel, wild papaya, acanthopanax bark, clematis root, snow lotus, Sichuan pepper and safflower, drying, crushing, passing through a 10-mesh sieve, collecting the sieved material to obtain Chinese medicine powder;

[0041] The Chinese medicine powder is put into a cloth bag to obtain the Chinese medicine hot compress bag.

[0042] In the present invention, as an embodiment, the drying temperature is 60°C to 100°C; as another embodiment, the drying temperature is 80°C. As an embodiment, the drying time is 1h to 3h; as another embodiment, the drying time is 2h. As an embodiment, the specification of the Chinese medicine hot compress bag is 100g to 200g / bag; as another embodiment, the specification of the Chinese medicine hot compress bag is 150g / bag.

[0043] The Chinese medicine hot compress bag provided by the present invention has the effects of relaxing muscles and activating blood circulation, dispelling cold and relieving pain, can be used for external hot compress treatment of rotator cuff injury, and has a good effect on alleviating shoulder pain in patients with rotator cuff injury.

[0044] In the present invention, as an embodiment, the method of using the Chinese medicine hot compress bag is as follows: soak the Chinese medicine hot compress bag with water, put it in a steamer and steam it for 30 minutes, apply hot compress to the affected area for 20 to 30 minutes, twice a day. As an embodiment, the soaking time is 5 minutes. As an embodiment, the Chinese medicine hot compress bag is stored in a cool place after use, and each Chinese medicine hot compress bag can be reused for 7 days.

[0045] To further illustrate the present invention, a Chinese medicine composition for treating rotator cuff injury and its application provided by the present invention are described in detail below in conjunction with the accompanying drawings and embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0046] Example 1

[0047] (1) A Chinese medicine composition, comprising, by weight, 3 parts of Herba Lycopodii, 3 parts of Herba Schizonepetae, 3 parts of Wax Gourd Peel, 1.5 parts of Papaya, 1.5 parts of Acanthopanax Cortex, 1.5 parts of Clematis, 0.9 parts of Snow Lotus, 0.9 parts of Sichuan Pepper and 0.9 parts of Carthamus Tinctorius.

[0048] (2) Weigh the Chinese herbal medicine slices (one portion is 10 g) according to the prescription amount of step (1), select, dry (water content ≤ 8%), crush, pass through a 10-mesh sieve, and distribute them in a cloth bag according to a specification of 150 g / bag to obtain a Chinese herbal hot compress pack.

[0049] Example 2

[0050] (1) A Chinese medicine composition, comprising, by weight, 2 parts of Herba Lycopodii, 2 parts of Herba Scutellariae, 2 parts of Wax Gourd Peel, 2 parts of Papaya, 1 part of Acanthopanax Cortex, 1 part of Clematis, 0.6 parts of Snow Lotus, 0.9 parts of Sichuan Pepper and 0.6 parts of Carthamus Tinctorius.

[0051] (2) Weigh the Chinese herbal medicine slices according to the prescription amount of step (1), select, dry (water content ≤ 8%), crush, pass through a 10-mesh sieve, and distribute them in a cloth bag according to a specification of 150 g / bag to obtain a Chinese herbal hot compress pack.

[0052] Comparative Example 1

[0053] Same as Example 1, except that safflower is not added.

[0054] Test Example 1

[0055] 1. Testing instruments

[0056] Agilent 1260 HPLC instrument, quaternary pump, automatic sample injector, chemical workstation; electronic balance (TB-215D, Denver Instrument Co., Ltd.).

[0057] 2. Detection Method

[0058] High performance liquid chromatography (HPLC): chromatographic column: Agilent 1260Kromasil C18 column, 4.6mm×250mm, column temperature 30℃; mobile phase is acetonitrile-methanol-0.7% phosphoric acid aqueous solution (the volume ratio of acetonitrile, methanol and 0.7% phosphoric acid is 2:26:72), flow rate 1.0mL / min; detection wavelength 403nm, injection volume 10μL, theoretical plate number of hydroxysafflor yellow A (HSYA) peak is 3000, and the retention time Rt of HSYA under this chromatographic condition is 12.726min.

[0059] 3. Preparation of test samples

[0060] (1) Take 150 g of the Chinese medicine composition in the Chinese medicine hot compress bag obtained in Example 1, crush it, grind it into powder and pass it through a 45-mesh sieve, accurately weigh 13 g, add 100 mL of 25% v / v methanol solution, weigh it, extract it with 250W ultrasonic wave for 40 min, let it cool to room temperature and weigh it again, make up the lost weight with 25% v / v methanol solution, and filter it to obtain the test solution.

[0061] (2) Take 150 g of the Chinese medicine composition in the Chinese medicine hot compress bag obtained in Comparative Example 1, extract it according to the method of step (1), and finally obtain a negative control solution.

[0062] (3) Take 150 g of hydroxysafflor yellow A reference substance (batch number 1162-971224, provided by China Food and Drug Inspection Institutes) and extract it according to the method of step (1) to finally obtain a reference substance solution.

[0063] 4. Specificity testing

[0064] 10 μL of each of the reference solution, negative control solution and test solution was taken, and HPLC determination was performed according to the conditions of step 3.1 of test example 1 to obtain chromatograms of the reference, negative control and test solution. The results showed that the chromatographic peak in the test solution was consistent with the retention time of the reference hydroxysafflor yellow A; no chromatographic peak appeared in the negative control solution at the corresponding position, indicating that there was no interference, indicating that the determination method was specific ( Figures 1 to 3 ).

[0065] 5. Preparation of Standard Curve

[0066] 4, 6, 8, 10, 12, and 14 μL of the reference solution were accurately drawn, and the peak area was determined by HPLC according to the conditions of step 2. The natural logarithm of the reference quality was used as the abscissa x, and the natural logarithm of the peak area was used as the ordinate y to draw a standard curve and calculate the regression equation. The results showed that the regression equation was y = 3061.1171x-115.2596 (r 2 =0.9999), and hydroxysafflor yellow A is a straight line in the mass range of 0.5112μg to 1.7891μg, with a good linear relationship ( Figure 4 ).

[0067] 6. Precision testing

[0068] According to step 4, the reference solution was injected repeatedly to examine the precision of the method. The results showed that RSD = 0.21% (n = 6), and the precision met the requirements.

[0069] 7. Stability test

[0070] The test solutions were taken at 0h, 1h, 2h, 4h, 6h and 8h after preparation, and the test solutions were measured according to step 4. The stability was investigated according to the new drug stability test regulations of the State Food and Drug Administration. The results showed that the precision RSD was 0.57%, which showed good stability.

[0071] 8. Reproducibility test

[0072] The Chinese medicine composition in the Chinese medicine hot compress bag obtained in the same batch of Example 1 was measured 6 times according to step 4. The results showed that the content of hydroxysafflor yellow A was 0.83 mg / g, RSD=0.99%≦2% (n=6), and the reproducibility of the measurement method of the Chinese medicine hot compress bag was good.

[0073] 9. Sample recovery rate test

[0074] The sample addition recovery method was adopted to take the Chinese medicine composition (the content of hydroxysafflor yellow A was 0.83 mg / g) in the Chinese medicine hot compress bag obtained in the same batch of Example 1, add a certain amount of hydroxysafflor yellow A reference substance, and perform HPLC determination according to the conditions of step 2. The recovery rate was calculated according to the following formula. The results are shown in Table 1.

[0075]

[0076] Table 1 Test results of the recovery rate of hydroxysafflor yellow A

[0077]

[0078] According to Table 1, in 6 experiments, the average recovery rate of hydroxysafflor yellow A was 98.65% and the RSD was 0.61%. The results showed that this method had a good recovery rate.

[0079] 9. Take 3 batches (batch numbers are 231102, 231106, and 231125, respectively) of the Chinese medicine composition in the Chinese medicine hot compress bag obtained in Example 1, prepare the test sample solution according to step 3, take 10 μL for injection according to step 4, measure the peak area, and substitute it into the regression equation to calculate the content of hydroxysafflor yellow A. The results are shown in Table 2.

[0080] Table 2 Test results of the recovery rate of hydroxysafflor yellow A

[0081]

[0082] According to Table 2, the average content of hydroxysafflor yellow A in the Chinese medicine composition in the Chinese medicine hot compress bag obtained in Example 1 is 0.83 mg / g. Based on the extraction conversion rate of 70% of the effective ingredient hydroxysafflor yellow A, each gram of the Chinese medicine composition contains hydroxysafflor yellow A (C 27 H 32 O 16 ) content is not less than 0.581 mg / g.

[0083] Test Example 2

[0084] Clinical efficacy

[0085] 1. Clinical data

[0086] 1.1 General information: 120 patients with acute rotator cuff injury admitted to Hebei Yanda Hospital from July 2023 to June 2024 were selected as the research subjects. They were randomly divided into a control group and a treatment group according to a random number table, with 60 cases in each group. This study has been reviewed and approved by the hospital ethics committee.

[0087] 1.2 Inclusion and Exclusion Criteria:

[0088] 1.2.1 Inclusion criteria: (1) met the diagnostic criteria for rotator cuff injury; (2) MRI showed partial rotator cuff tear <1 cm; (3) aged between 18 and 45 years; (4) unilateral rotator cuff injury; (5) had not received hormone treatment or taken any medication in the past 6 months; (6) voluntarily joined this study and signed the informed consent form for clinical research.

[0089] 1.2.2 Exclusion criteria: (1) patients with severe gastrointestinal diseases and heart, liver, and kidney dysfunction; (2) patients with metal or non-metal contents in the shoulder joint; (3) patients with concurrent infection or malignant tumor; (4) pregnant or lactating women; (5) patients with invasive treatment of the affected shoulder, such as acupuncture, micro-acupuncture, etc.; (6) patients with a history of ipsilateral shoulder surgery; (7) patients receiving other related treatments at the same time that may affect the results of this study.

[0090] 2. Treatment Methods

[0091] (1) Control group: oral administration of ibuprofen sustained-release capsules (Fenbid, SmithKline Pharmaceuticals, specification 0.3g × 20 capsules), 1 capsule at a time for adults, twice a day, for 4 consecutive weeks. Before taking the medicine and 1 week after taking the medicine, liver and kidney function should be checked regularly, and the medicine should be stopped immediately if any discomfort occurs.

[0092] (2) Treatment group: Take the Chinese medicine hot compress bag obtained in Example 1, soak it in water at room temperature for 5 minutes, wring it dry to prevent water from dripping, and steam it in a steamer for 30 minutes; when using the Chinese medicine bag, the patient lies flat on the Chinese medicine bag, and the affected skin can directly contact the Chinese medicine bag. When the back of the hand feels that the Chinese medicine bag is not hot, it is the best temperature. Apply it twice a day, 20 minutes each time. Put a piece of plastic cloth on the bed, put a towel on it, and spread the steamed Chinese medicine bag on the towel; after applying the Chinese medicine bag, store it in a cool place. Each Chinese medicine bag can be reused for 3 days.

[0093] 3. Observation indicators

[0094] Before treatment and 2 weeks after treatment, the two groups of patients were compared in terms of three indicators: visual analogue scale (VAS) score for shoulder pain, Constant-Murley shoulder function score, and isokinetic muscle strength test, to observe the peripheral shoulder pain, improvement of shoulder joint function, and recovery of peripheral shoulder muscle strength in patients with rotator cuff injury. The VAS score is subjectively assessed by the patients themselves, with a score range of 0 to 10. The higher the score, the higher the pain. The Constant-Murley shoulder function score is assessed by doctors and patients together, with a full score of 100. The score is positively correlated with shoulder joint function. The higher the score, the better the improvement of shoulder joint function. The isokinetic muscle strength test tests the peak torque value of the patient's shoulder external rotation / internal rotation at different angular velocities (60o / s and 180o / s). The higher the value, the better the recovery of muscle strength.

[0095] All data were analyzed using IBM SPSS26.0 statistical software. The measured data were expressed as x±s. VAS scores, Constant-Murley scores and isokinetic muscle strength test values ​​followed a normal distribution and were compared using the t-test. P < 0.05 was considered statistically significant. The results are shown in Tables 3 and 4.

[0096] Table 3 Comparison of VAS scores and Constant-Murley scores between the control group and the treatment group

[0097]

[0098] Note: Compared with the group before treatment, 0.05; compared with the control group after treatment, ★P<0.05

[0099] Table 4 Comparison of peak torque values ​​of shoulder joint external rotation / internal rotation between the control group and the treatment group

[0100]

[0101] Note: Compared with the group before treatment, P<0.05; compared with the control group after treatment, P<0.05

[0102] According to Table 3, before treatment, there was no statistically significant difference in VAS scores and Constant-Murley scores between the two groups of patients (P>0.05). After 4 weeks of treatment, the VAS scores and Constant-Murley scores of the two groups of patients were improved compared with those before treatment within the group (P<0.05); and the VAS scores and Constant-Murley scores of the treatment group were more significantly improved than those of the control group, and the difference was statistically significant (P<0.05). It shows that both Fenbid and the Chinese medicine hot compress pack provided by the present invention can relieve the pain caused by rotator cuff injury, but the Chinese medicine hot compress pack has a better effect in relieving pain; both Fenbid and the Chinese medicine hot compress pack of the present invention can improve the shoulder joint function of patients with rotator cuff injury, but the effect of the Chinese medicine hot compress pack on improving shoulder joint function is more obvious.

[0103] According to Table 4, before treatment, at 60o / second and 180o / second angular velocities, there was no statistically significant difference in the external rotation / peak torque of the shoulder joint between the two groups of patients (P>0.05); after 4 weeks of treatment, the peak torque of the external rotation / internal rotation of the shoulder joint of the two groups of patients was improved compared with that before treatment within the group (P<0.05); and the treatment group was more significantly improved than the control group, and the difference was statistically significant (P<0.05). It shows that both Fenbid and the Chinese medicine hot compress pack provided by the present invention can restore the strength of the shoulder muscles, but the Chinese medicine hot compress pack has a better effect in restoring the strength of the shoulder muscles.

[0104] It can be seen from the above content that the technical solution provided by the present invention can significantly reduce the pain of patients, improve the shoulder joint function of patients with rotator cuff injuries, and restore the shoulder periarticular muscle strength of patients with rotator cuff injuries, and has obvious clinical efficacy.

[0105] Although the above embodiment describes the present invention in detail, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments based on this embodiment without creativity, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition, characterized in that: Calculated by weight, the composition includes: 2-9 parts of lycopodii herba, 1.5-9 parts of clematis radix, 2-9 parts of radix spatholobi, 2-9 parts of wax gourd peel, 1-4.5 parts of snow lotus, 1-4.5 parts of wild papaya, 1-4.5 parts of acanthopanax bark, 0.6-3.6 parts of Sichuan pepper and 0.6-3.6 parts of safflower.

2. The Chinese medicine composition according to claim 1, characterized in that: Calculated by weight, the composition includes: 3-6 parts of lycopodii herba, 3-6 parts of scutellaria baicalensis, 3-6 parts of wax gourd peel, 1.5-3 parts of wild papaya, 1.5-3 parts of acanthopanax bark, 2-6 parts of clematis, 1.5-3 parts of snow lotus, 1.2-1.8 parts of Sichuan pepper and 1.2-1.8 parts of safflower.

3. The Chinese medicine composition according to claim 1, characterized in that The composition comprises the following components by weight: 3 parts of smilax glabra, 3 parts of smilax glabra, 3 parts of wax gourd peel, 1.5 parts of wild papaya, 1.5 parts of acanthopanax bark, 1.5 parts of clematis, 0.9 parts of snow lotus, 0.9 parts of Sichuan pepper and 0.9 parts of safflower; Or, it includes the following components: 2 parts of Lycopodiella ciliata, 2 parts of Radix Penicillae, 2 parts of wax gourd peel, 1 part of wild papaya, 1 part of Acanthopanax cortex, 2 parts of Clematis chinensis, 1 part of Snow Lotus, 0.6 parts of Sichuan pepper and 0.6 parts of safflower.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The dosage form of the traditional Chinese medicine composition includes powder.

5. The Chinese medicine composition according to claim 4, characterized in that: The powder of the traditional Chinese medicine composition can pass through a 10-mesh sieve.

6. Use of the Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating rotator cuff injury.

7. A Chinese medicine hot compress pack, characterized in that: The Chinese medicine hot compress pack comprises the Chinese medicine composition according to any one of claims 1 to 5.

8. The method for preparing the Chinese medicine hot compress pack according to claim 7, characterized in that: The steps include: Mixing striata herb, radix striatae, wax gourd peel, wild papaya, acanthopanax bark, clematis root, snow lotus, Sichuan pepper and safflower, drying, crushing, passing through a 10-mesh sieve, collecting the sieved material to obtain Chinese medicine powder; The Chinese medicine powder is put into a non-woven fabric bag to obtain the Chinese medicine hot compress bag.

9. The preparation method according to claim 8, characterized in that: The drying temperature is 60° C. to 100° C., and the drying time is 1 h to 3 h.

10. The preparation method according to claim 8, characterized in that: The specification of the Chinese medicine hot compress bag is 100g to 200g per bag.

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