Medicine for treating limb joint spasm pain and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine composition preparation, in particular to a medicine for treating limb joint pain and a preparation method thereof. Comprising the following components in parts by weight: 50-100 parts of radix saposhnikoviae, 30-50 parts of radix cynanchi paniculati, 15-25 parts of flos carthami, 10-30 parts of crotalaria sessiliflora, 15-25 parts of radix sophorae flavescentis, 20-40 parts of radix clematidis, 5-15 parts of liquorice, 25-35 parts of herba houttuyniae and 15-25 parts of wikstroemia indica. The preparation method comprises the following steps: weighing the components, crushing and sieving; extracting with hot water, filtering, collecting an extracting solution, and concentrating; extracting with ethanol, filtering, collecting an extracting solution, and concentrating; and combining the concentrated extractum, and drying to obtain the medicine for treating the limb joint spasm pain. The preparation method is safe and non-toxic; by using the medicine, the spasm frequency can be obviously reduced, the symptom can be obviously improved, and the daily life and exercise ability of a patient can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine composition preparation, and particularly relates to a drug for treating limb joint contracture pain and a preparation method thereof. Background Art

[0002] Stroke is a cerebrovascular disease characterized by sudden rupture or blockage of cerebral blood vessels leading to brain tissue damage, and is the third leading cause of human death after malignant tumors and ischemic heart disease (IHD). Stroke is the most common cerebrovascular disease, with characteristics such as high mortality, recurrence rate, and disability rate, posing a major threat to the life, health, and quality of life of patients. It not only has a high mortality rate, but also ultimately results in a high disability rate among survivors, being an important factor causing long-term disability in humans. Research shows that about 4% to 42.6% of stroke patients will experience spasm, and 2% to 13% of them may lead to severe disability. Limb joint spasm is a common sequela after stroke, characterized by involuntary muscle contraction and enhanced velocity-dependent stretch reflex, resulting in movement disorders. The clinical manifestations are increased muscle tone, overactive tendon reflexes, obvious impairment of upper and lower limb functions, and limited joint movement. If not intervened in time, persistent spasm will hinder the recovery of normal movement patterns and greatly affect the daily life of patients. Due to the different innervation areas and muscle action modes of the peripheral nerves in the upper and lower limbs, patients with limb joint spasm after stroke usually show a coordinated movement pattern of flexor muscles in the upper limb and extensor muscles in the lower limb. Specifically, in the affected upper limb, it shows flexion spasm dominated by flexor muscles, while in the lower limb, it shows extensor-dominated rigidity spasm. This will not only cause pain, but also affect the patient's sleep, mood, and mental state. Therefore, early treatment of spasm is crucial for the recovery of limb function after stroke.

[0003] Currently, it is considered that limb joint contracture pain is caused by the accumulation of wind-dampness, and drugs for dispelling wind-dampness and dredging collaterals are often used for treatment. Most patients with this symptom have been suffering from the disease for years and can also have an attack when their body has no external or internal invasion. It is even more severe on rainy and cloudy days. However, there are some patients who usually do not have pain or limited stretching in their limb joints. It often occurs when they are invaded by exogenous wind-cold pathogens. They develop limb joint contracture pain when obvious external symptoms such as fever, aversion to cold, sweating, and headache appear, or maintain the state of limb joint contracture pain even after the external symptoms disappear. For this type of limb joint contracture pain after the disappearance of external symptoms, it is difficult to achieve curative effects by using conventional drugs for dispelling wind-dampness and dredging collaterals.

[0004] At the current stage, there is no specific treatment method or drug for limb joint spasm after stroke. Traditional treatment methods mainly emphasize reducing the frequency of spasm, alleviating risk factors, and reducing the severity of spasm. Physical therapy, exercise therapy, drug therapy, and surgical therapy are the most common conventional treatment methods. However, in practical applications, due to the side effects of drug therapy, the invasiveness of local treatment, and the economic burden of the patients themselves, it is difficult to achieve the expected control of spasm even with multiple treatment methods. Therefore, it is crucial to find a new non-invasive, economical, safe, and effective treatment plan for limb joint spasm.

[0005] Traditional Chinese medicine has attracted global attention for its unique theoretical framework and treatment methods. Therefore, developing a new type of drug in combination with traditional Chinese medicine theory is of great significance for improving the symptoms of limb joint pain. Summary of the Invention

[0006] In order to solve the above problems, the present invention provides a drug for treating limb joint pain and its preparation method.

[0007] The first object of the present invention is to provide a drug for treating limb joint pain, which comprises the following components by weight parts: 50 - 100 parts of Saposhnikovia divaricata, 30 - 50 parts of Cynanchum paniculatum, 15 - 25 parts of Carthamus tinctorius, 10 - 30 parts of Crotalaria sessiliflora, 15 - 25 parts of Sophora flavescens, 20 - 40 parts of Clematis chinensis, 5 - 15 parts of Glycyrrhiza uralensis, 25 - 35 parts of Houttuynia cordata, and 15 - 25 parts of Wikstroemia indica.

[0008] Preferably, 60 - 80 parts of Saposhnikovia divaricata, 30 - 40 parts of Cynanchum paniculatum, 15 - 25 parts of Carthamus tinctorius, 15 - 25 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 25 - 35 parts of Clematis chinensis, 8 - 12 parts of Glycyrrhiza uralensis, 25 - 30 parts of Houttuynia cordata, and 15 - 20 parts of Wikstroemia indica.

[0009] Preferably, 70 parts of Saposhnikovia divaricata, 30 parts of Cynanchum paniculatum, 20 parts of Carthamus tinctorius, 20 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 30 parts of Clematis chinensis, 10 parts of Glycyrrhiza uralensis, 30 parts of Houttuynia cordata, and 20 parts of Wikstroemia indica.

[0010] Preferably, 50 parts of Saposhnikovia divaricata, 30 parts of Cynanchum paniculatum, 20 parts of Carthamus tinctorius, 20 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 30 parts of Clematis chinensis, 10 parts of Glycyrrhiza uralensis, 30 parts of Houttuynia cordata, and 20 parts of Wikstroemia indica.

[0011] The second object of the present invention is to provide a preparation method of a drug for treating limb joint pain, which comprises the following steps: S1. Weigh Saposhnikovia divaricata, Cynanchum paniculatum, Carthamus tinctorius, Crotalaria sessiliflora, Sophora flavescens, Clematis chinensis, Glycyrrhiza uralensis, Houttuynia cordata, and Wikstroemia indica according to the weight parts, remove dust and impurities, pulverize, and pass through an 80 - 120 - mesh sieve to obtain a mixture; S2. Add water with a volume 3 - 5 times that of the mixture, and soak at room temperature for 20 - 48 h; after soaking, reflux extract 3 times at 85 - 95 °C, stir for 10 - 30 min after extraction, and filter to collect the extract; after extraction, combine the 3 extracts, remove water by rotary evaporation under reduced pressure, and concentrate to obtain extract A; S3. Add anhydrous ethanol with a volume 2 - 4 times that of the mixture, and soak at room temperature for 5 - 12 h; after soaking, reflux extract 3 times at 65 - 75 °C, filter to collect the extract; after extraction, combine the 3 extracts, remove water by rotary evaporation under reduced pressure, and concentrate to obtain extract B; S4. Combine extract A and extract B, and dry to obtain the drug for treating limb contracture pain.

[0012] Preferably, in step S1, after pulverization, it is sieved through a 100 - mesh sieve.

[0013] Preferably, in step S2, the temperature for each reflux extraction is 90 °C, and the extraction time is 2 - 4 h.

[0014] Preferably, in step S3, the temperature for each reflux extraction is 70 °C, and the extraction time is 2 - 4 h.

[0015] Preferably, in step S2, the temperature for rotary evaporation under reduced pressure is 70 - 80 °C; in step S3, the temperature for rotary evaporation under reduced pressure is 60 - 70 °C.

[0016] Preferably, the drying in step S4 is freeze - drying.

[0017] Compared with the prior art, the present invention can achieve the following beneficial effects: The method for preparing the drug of the present invention extracts the active ingredients through steps such as water extraction and alcohol extraction. The method is safe and non - toxic. The prepared pharmaceutical composition has a good effect on reducing the attack frequency and improving the symptoms of patients with peripheral contracture limb joint spasm. For the treatment of limb joint spasm with external contraction, using traditional Chinese medicine compound can significantly reduce the frequency of spasm, significantly improve the symptoms, and improve the daily life and motor ability of patients. It provides a new exploration way for the treatment of limb joint spasm with traditional Chinese medicine and promotes the development of traditional Chinese medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a flowchart of a method for preparing a drug for treating limb contracture pain according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. In the following description, the same modules are denoted by the same reference numerals. In the case of the same reference numerals, their names and functions are also the same. Therefore, their detailed descriptions will not be repeated.

[0020] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and do not constitute a limitation of the present invention.

[0021] In the present invention, the pharmacology of each drug is as follows: The root of Saposhnikovia root is used for medicinal purposes. It is pungent and sweet, warm in nature, and belongs to the bladder, liver, and spleen meridians. It has the functions of dispelling wind and dampness, and is mainly used to treat colds, headaches, fever, joint pain, and tetanus; it has the functions of sweating, expectoration, wind dispelling, release of the body, and analgesia, and is used to treat colds, headaches, joint pains throughout the body, neuralgia, etc. In addition, Saposhnikovia leaf and flower can also be used for medicinal purposes.

[0022] Xu Changqing is pungent, warm and aromatic. It enters the liver and stomach meridians. Efficacy: dispel wind and relieve pain, promote blood circulation and dredge collaterals, relieve itching, and detoxify snake venom. Indications: (1) rheumatic pain, abdominal pain, toothache, postoperative pain, cancer pain; (2) swelling and pain caused by falls; (3) urticaria, eczema, stubborn ringworm; (4) poisonous snake bites. It has the functions of dispelling wind, promoting blood circulation and dredge collaterals, relieving itching, and detoxifying snake venom. It has strong analgesic effect and is good at treating rheumatic eczema, itching, poisonous snake bites, severe pain caused by arthritis, and pain caused by internal and external injuries.

[0023] Safflower, with a pungent and warm nature, enters the heart and liver meridians. Its main effects and functions include promoting blood circulation and menstruation, dispersing blood stasis and relieving pain. Safflower can be used to treat amenorrhea, dysmenorrhea, lochia retention, accumulation of masses, chest pain, abdominal pain due to stasis, stabbing pain in the chest and ribs, injuries from falls, sores, swelling and pain, etc. Safflower enters the blood of the heart and liver, has a pungent, dispersing, warming and unblocking medicinal property, can promote blood circulation and menstruation, dispersing blood stasis and relieving pain, so it is a blood-activating and blood-stasis-removing medicine, and is widely used for blood stasis in internal medicine, surgery, gynecology, and traumatology.

[0024] Nongjili, a cold-natured herbal medicine, has the effects of clearing away heat and purging fire, detoxifying and removing dampness, and can be used to treat a variety of diseases. Its main ingredients include Nongjili acid, folic acid, vitamin C, anthraquinone, terpenoid compounds, polyphenols, etc., which have multiple functions such as regulating immunity, clearing away heat and detoxifying, regulating qi and blood, and removing toxins. It can be used to treat infectious diseases, dissipate heat and relieve summer heat, regulate endocrine, and promote sleep.

[0025] Sophora flavescens, also known as sage grass, is the dried root of the leguminous plant Sophora flavescens. It is cold and bitter in nature and enters the lung and stomach meridians. Traditional Chinese medicine believes that Sophora flavescens is cold and bitter in nature and has the effects of clearing away heat and detoxifying, reducing swelling and relieving pain.

[0026] Clematis chinensis, its root and stem are used as medicine, which has the effects of rheumatism, dredge meridians, and eliminate bone choking. In modern clinical practice, its new uses are constantly being discovered, such as the treatment of gallstones, heel spurs, heel pain, esophageal cancer, etc. However, it should be noted that people with qi and blood deficiency and pregnant women should be cautious when taking it.

[0027] Licorice is also known as Guolao, sweet grass, Ural licorice, and sweet root. The medicinal parts are the roots and rhizomes, with a slight smell and a special sweet taste. Functions and indications: clearing away heat and detoxification, removing phlegm and relieving cough, and treating abdominal pain, etc. Houttuynia cordata is pungent in taste and cold in nature. It belongs to the lung meridian. It can clear away heat and detoxify, reduce swelling and treat sores, promote diuresis and remove dampness, clear away heat and stop diarrhea, strengthen the stomach and help digestion. It is used to treat lung abscesses, sores and swelling, hemorrhoids, blood in stool, and heat accumulation in the spleen and stomach caused by real heat, heat toxins, dampness, and rapid heat. Modern pharmacological experiments have shown that this product has antibacterial, antiviral, immunity-enhancing, and diuretic effects.

[0028] Rhizoma Leonuri, nature and flavor, meridians: bitter, cold, toxic, enters lung and stomach meridians. The medicinal parts are the root and root bark. Clears away heat and detoxifies, dissipates stagnation and expel water. Used for lung heat cough, mumps, scrofula, rheumatic arthralgia, sores, carbuncle, swelling and toxicity, edema and abdominal distension.

[0029] Example 1 This embodiment provides a medicine for treating limb spasm, which comprises the following components by weight: 70 parts of Saposhnikovia divaricata, 30 parts of Cynanchum chinense, 20 parts of Carthamus tinctorius, 20 parts of Nongjili, 20 parts of Sophora flavescens, 30 parts of Clematidis, 10 parts of Licorice, 30 parts of Houttuynia cordata and 20 parts of Rhizoma Dioscoreae.

[0030] The preparation method specifically comprises the following steps: S1. According to the above parts by weight, weighed Fangfeng, Cynanchum, safflower, Nongjili, Sophora flavescens, Clematis, licorice, Houttuynia cordata and the brother Wang, remove dust and impurities, crushed, through a 100 mesh sieve to obtain a mixture; S2. Add 4 times the volume of water to the mixture and soak at room temperature for 24 hours; after soaking, reflux extract at 90°C for 3 times, each time for 2-4 hours, stir for 15 minutes after extraction, and collect the extract by suction or filtration; after extraction, combine the 3 extracts, remove water by reduced pressure rotary evaporation at 75°C, and concentrate to obtain extract A; S3. Add 3 times the volume of anhydrous ethanol to the mixture and soak at room temperature for 10 hours; after soaking, reflux and extract at 70°C for 3 times, each time for 2 to 4 hours, and collect the extract by suction or filtration; after extraction, combine the 3 extracts, remove water by vacuum rotary evaporation at 60 to 70°C, and concentrate to obtain extract B; preferably, the vacuum rotary evaporation temperature is 65°C; S4. Combine extract A and extract B, freeze-dry at -4°C to obtain a medicine for treating limb spasm.

[0031] Example 2 This embodiment provides a medicine for treating arthritis, comprising the following components in parts by weight: 75 parts of Saposhnikovia divaricata, 30 parts of Cynanchum chinense, 18 parts of Carthamus tinctorius, 15 parts of Nongjili, 20 parts of Sophora flavescens, 35 parts of Clematis chinensis, 8 parts of Licorice, 28 parts of Houttuynia cordata and 20 parts of Rhizoma Dioscoreae. The preparation method is the same as that of Example 1.

[0032] Example 3 This embodiment provides a drug for treating limb joint contracture pain, comprising the following components in parts by weight: 70 parts of Ledebouriella seseloides, 35 parts of Cynanchum paniculatum, 18 parts of Carthamus tinctorius, 15 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 35 parts of Clematis chinensis, 8 parts of Glycyrrhiza uralensis, 28 parts of Houttuynia cordata, and 20 parts of Wikstroemia indica. The preparation method is the same as that in Embodiment 1.

[0033] Example 4 This embodiment provides a drug for treating limb joint contracture pain, comprising the following components in parts by weight: 100 parts of Ledebouriella seseloides, 30 parts of Cynanchum paniculatum, 18 parts of Carthamus tinctorius, 15 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 20 parts of Clematis chinensis, 8 parts of Glycyrrhiza uralensis, 28 parts of Houttuynia cordata, and 20 parts of Wikstroemia indica. The preparation method is the same as that in Embodiment 1.

[0034] Example 5 This embodiment provides a drug for treating limb joint contracture pain, comprising the following components in parts by weight: 80 parts of Ledebouriella seseloides, 30 parts of Cynanchum paniculatum, 25 parts of Carthamus tinctorius, 15 parts of Crotalaria sessiliflora, 15 parts of Sophora flavescens, 35 parts of Clematis chinensis, 8 parts of Glycyrrhiza uralensis, 25 parts of Houttuynia cordata, and 25 parts of Wikstroemia indica. The preparation method is the same as that in Embodiment 1.

[0035] Example 6 This embodiment provides a drug for treating limb joint contracture pain, comprising the following components in parts by weight: 50 parts of Ledebouriella seseloides, 30 parts of Cynanchum paniculatum, 20 parts of Carthamus tinctorius, 20 parts of Crotalaria sessiliflora, 20 parts of Sophora flavescens, 30 parts of Clematis chinensis, 10 parts of Glycyrrhiza uralensis, 30 parts of Houttuynia cordata, and 20 parts of Wikstroemia indica. The preparation method is the same as that in Embodiment 1.

[0036] Application example: Through clinical application, evaluate the effects of the drugs for treating limb joint contracture pain prepared in Examples 1 - 6 on the attack frequency and symptom improvement of patients with abductive limb joint spasm after stroke.

[0037] 94 patients with abductive limb joint spasm after stroke who visited our hospital from January 2022 to December 2023 were randomly divided into two groups: a traditional Chinese medicine group and a rehabilitation group, with 47 patients in each group. In the traditional Chinese medicine group, there were 25 males and 22 females, aged 35 - 70 years, with an average age of 41 ± 5.7 years. In the rehabilitation group, there were 23 males and 24 females, aged 33 - 69 years, with an average age of 39.2 ± 4.8 years. The patients in the rehabilitation group received conventional stroke symptom treatment and rehabilitation training, while the patients in the traditional Chinese medicine group took the drug for treating limb joint contracture pain while receiving conventional treatment and rehabilitation training. Both groups of patients received continuous treatment for one month. Record the number of limb joint spasm attacks before and after treatment in both groups of patients. Compare the spasm degrees of the elbow joint, wrist joint, knee joint, and ankle joint, the Clinical Spasm Index (CSI) score, the Fugl - Meyer Assessment Scale (FMA) score, and the Activities of Daily Living (ADL) score before and after treatment in both groups of patients, and compare the clinical curative effects of the two groups of patients.

[0038] Inclusion and exclusion criteria: (1) Inclusion criteria: Patients diagnosed with joint spasm of the contracted limb after stroke by CT or MRI examination; presenting symptoms such as limb hemiplegia and aggravated muscle tension; Brunnstrom stage II to IV, modified Ashworth scale grade 1 to 3; under seventy years old; not taking muscle relaxants or sedatives in the past two weeks; able to cooperate with the learning with a clear consciousness. (2) Exclusion criteria: Patients with limb joint spasm caused by other reasons; no obvious dysfunction of important organs such as the heart, liver, and kidneys; concurrent malignant tumors; accompanied by autoimmune diseases, endocrine system diseases, and blood system diseases; cognitive impairment or mental illness; history of transient ischemic attack, subarachnoid hemorrhage, traumatic brain injury, cerebral parasite disease, craniocerebral trauma; subjects who participated in other research experiments within 3 months or received other relevant treatments or used prohibited treatments during this study, which may interfere with the research results; poor compliance, non-cooperation with treatment, or premature drug withdrawal.

[0039] Treatment methods: (1) Rehabilitation group: 47 patients in the rehabilitation group received conventional symptomatic treatment for stroke and rehabilitation training. This included maintaining blood pressure, blood sugar, and blood lipids, giving neuroprotection, antiplatelet aggregation, intravenous thrombolysis, infusion, and providing psychological counseling to help patients reduce mental burden, build confidence, and actively cooperate with treatment. The rehabilitation training used neurodevelopmental treatment (NDT) methods such as Bobath, Brunnstrom, Roed techniques, and occupational therapy (OT), aiming to inhibit upper limb spasm, finger flexion spasm, lower limb spasm, and perform dorsiflexion training on the ankle joint. Tailored training methods were selected according to the specific conditions of the patients' limb joint spasm, emphasizing individualized treatment, and using a one-on-one approach. According to the improvement of the patients' functional status, the treatment method was adjusted in a timely manner, and 1-2 training methods were selected for each affected area. Each training session lasted 50 minutes, three times a week, with a one-day interval, and a total of four weeks of training. (2) Chinese medicine group: There were 47 cases in the Chinese medicine group, and the drugs for treating limb joint pain of the present invention were added on the basis of conventional treatment and rehabilitation training. The rehabilitation training plan was the same as that of the rehabilitation group.

[0040] The effects were monitored after one month of continuous treatment in both groups. The observation indicators were as follows: (1) Spasm frequency: Record the incidence of limb joint spasm in both groups of patients before and after treatment; (2) Degree of joint spasm: Compare the degree of joint spasm in the elbow joint, wrist joint, knee joint, and ankle joint of the two groups of patients before and after treatment. The degree of elbow joint spasm is determined by the angle between the extension line of the radius and the extension line of the humerus when the forearm is flexed inward. The degree of wrist joint spasm is judged by observing the angle between the extension line of the second metacarpal bone and the radius during spasm. With the vertical position of the fibula and femur as a reference, the degree of knee joint spasm is determined by the maximum angle between the fibula and the reference line when the patient flexes the knee joint. The degree of ankle joint spasm is measured by the angle between the sole of the foot and the reference line, with the angle between the horizontal plane of the lateral malleolus and the vertical line in the supine position of the patient as the reference point.

[0041] (3) Evaluate the spasm condition, limb motor function, and activities of daily living ability The clinical spasticity index (CSI) was used to evaluate the spasm condition of the patients, including three dimensions: tendon reflex (0 - 4 points), muscle tone (0 - 8 points), and spasm (0 - 4 points), with a total of 16 points. 0 - 9 points indicate mild spasm, 10 - 12 points indicate moderate spasm, and 13 - 16 points indicate severe spasm. The higher the score, the more severe the spasm.

[0042] The Fugl-Meyer assessment scale (FMA) was used to grade the limb motor function of the patients into 3 levels, with a total score of 100 points (66 points for the upper limb and 34 points for the lower limb). Less than 50 points indicates severe motor impairment, 50 - 84 points indicates obvious motor impairment, 85 - 95 points indicates moderate motor impairment, and 96 - 99 points indicates mild motor impairment. The higher the score, the better the limb motor function.

[0043] The activities of daily living (ADL) scale was used to evaluate the ability of patients to perform daily activities, including dressing, eating, bathing, grooming, controlling defecation, controlling urination, using the toilet, transferring between the bed and chair, walking, and climbing stairs. The total score is 100 points. Below 20 points indicates complete disability, 20 - 40 points indicates moderate functional impairment, 40 - 60 points indicates moderate functional impairment, and above 60 points indicates basic self-care ability. The higher the score, the stronger the daily living ability.

[0044] Establish the evaluation criteria for clinical treatment effects: According to the reduction of muscle tone in patients, establish the evaluation criteria for treatment effects. If the muscle tension is reduced to grade 0, it is considered cured; if the muscle tension drops by 2 grades or more, it indicates a significant effect; a reduction of 1 grade in muscle tension is considered effective; if the reduction of muscle tension is less than 1 grade or there is no significant improvement, it is considered ineffective. The total effective rate is calculated as the sum of the cure rate, significant effective rate, and effective rate.

[0045] In the traditional Chinese medicine group, there were 25 males and 22 females, aged 35 - 70 years old, with an average disease course of (5.35 ± 0.87) weeks. The types of stroke included 38 cases of cerebral hemorrhage and 9 cases of cerebral infarction. In the rehabilitation group, there were 23 males and 24 females, aged 33 - 69 years old, with an average disease course of (5.32 ± 0.82) weeks. The classification of stroke included 35 cases of cerebral hemorrhage and 12 cases of cerebral infarction. There were no statistically significant differences in the general data between the two groups (P < 0.05), and the baseline data of the two groups were balanced and comparable, with the least impact on subsequent research.

[0046] Results: (1) Number of spasm attacks before and after treatment in the two groups: Before treatment, there was no statistically significant difference in the number of limb joint spasms between the two groups of patients (P < 0.05). After treatment, the number of spasm attacks in the traditional Chinese medicine group was (1.63 ± 0.24) times / week, which was lower than that in the rehabilitation group ((2.08 ± 0.33) times / week), and the difference was statistically significant (P < 0.05); see Table 1. The study found that the drug for treating limb contracture pain of the present invention is superior to conventional rehabilitation treatment in reducing the number of spasm attacks in patients with limb spasm.

[0047] Table 1 Comparison of the number of limb joint spasm attacks before and after treatment in the two groups (times / week)

[0048] (2) Joint spasm conditions before and after treatment in the two groups: Before treatment, there was no statistically significant difference in the spasm degree of the elbow joint, wrist joint, knee joint, and ankle joint between the two groups of patients (P < 0.05). After the treatment, the spasm degree of the joints in both groups was significantly improved. The spasm degree of the elbow joint in the traditional Chinese medicine group was (14.41 ± 1.27), the spasm degree of the wrist joint was (11.27 ± 1.23), the spasm degree of the knee joint was (21.25 ± 3.05), the spasm degree of the elbow joint in the traditional Chinese medicine group was (14.41 ± 1.27), the spasm degree of the wrist joint in the traditional Chinese medicine group was (11.27 ± 1.23), the spasm degree of the ankle joint in the traditional Chinese medicine group was (21.25 ± 3.05), and the spasm degree of the ankle joint in the traditional Chinese medicine group was (21.25 ± 3.05). The spasm degree of the ankle joint ((10.64 ± 1.33)) was lower than that of the traditional Chinese medicine group in the same period, and the difference was statistically significant (P < 0.05); see Table 2. The above results indicate that the drug for treating limb contracture pain of the present invention can effectively relieve the spasm of the elbow joint, wrist joint, knee joint, and ankle joint in patients with externally contracted limb joint spasm, relieve joint spasm, and maintain joint function.

[0049] Table 2 Comparison results of joint spasm in the two groups before and after treatment

[0050] (3) Comparison of the clinical spasticity CSI index between the two groups before and after treatment: Before the start of treatment, there were no significant differences between the two groups of patients in terms of tendon reflex, muscle tone, and clonus scores (P < 0.05). After treatment, the scores of both groups decreased; among them, the tendon reflex score of the traditional Chinese medicine group was (1.23 ± 0.15) points, the muscle tone score was (3.27 ± 0.38) points, and the clonus score was (2.01 ± 0.22) points, all of which were lower than those of the rehabilitation group during the same period, and the differences were statistically significant (P < 0.05); the results are shown in Table 3. This confirmed that after the treatment with the self-made traditional Chinese medicine compound decoction in the traditional Chinese medicine group, all CSI scores were significantly improved, and the severity of spasticity was significantly alleviated.

[0051] Table 3 Comparison results of CSI index between the two groups before and after treatment

[0052] (4) FMA and ADL scores of the two groups before and after treatment: FMA and ADL scores are key indicators for measuring the limb movement ability and daily living ability of patients. Before treatment, there were no statistically significant differences in FMA and ADL scores between the two groups of patients (P < 0.05). After treatment, the FMA and ADL scores of both groups of patients were higher than the pre-treatment levels. The FMA score of the traditional Chinese medicine group was (78.94 ± 8.82) points, higher than that of the rehabilitation group (65.41 ± 7.11) points; the ADL score was (77.94 ± 7.98) points, higher than that of the rehabilitation group (65.81 ± 7.03) points, and the differences were statistically significant (P < 0.05); the results are shown in Table 4. The data in the table indicate that when the traditional Chinese medicine group treats limb joint spasm caused by external contraction, it can significantly improve the limb function and quality of daily life of patients, contribute to postoperative recovery, and quickly resume normal life.

[0053] Table 4 Comparison results of FMA and ADL scores between the two groups before and after treatment

[0054] (5) Comparison of the clinical efficacy between the two groups: After treatment, 21 cases in the traditional Chinese medicine group were completely recovered, 13 cases were markedly effective, 11 cases were effective, and 2 cases had no improvement. The overall clinical effective rate of the traditional Chinese medicine group was 95.74%, and the overall clinical effective rate of the rehabilitation group was 80.85%. The clinical efficacy of the traditional Chinese medicine group was significantly higher than that of the rehabilitation group, and the difference was statistically significant (P < 0.05); the results are shown in Table 5. The research results show that by combining rehabilitation therapy, the traditional Chinese medicine compound of the present invention has superior clinical efficacy in treating limb joint spasm induced by external factors.

[0055] Table 5 Comparison results of clinical efficacy between the two groups

[0056] At present, the treatment of limb joint spasm in Western medicine mainly includes drug interventions such as baclofen, physical therapies such as heat therapy and electrical stimulation, and surgical treatments such as plastic surgery and neurosurgery. Existing technologies have reported that intramuscular injection of a new type of botulinum toxin type A, NT201, can effectively relieve upper limb spasm after stroke, and is a feasible and well-tolerated long-term treatment option that can significantly improve dysfunction, muscle hypertonia, and daily spasm. The understanding and treatment methods of traditional Chinese medicine for limb joint spasm are significantly different. The combined use of the herbs in the present invention can not only fundamentally improve the cerebral circulation of patients, promote the recovery of stroke, but also promote blood circulation in the affected area, reduce smooth muscle tension, relax muscles and joints, and restore the function of limb joints, so as to achieve the purpose of relieving limb joint spasm, effectively reducing the frequency of spasm, improving spasm symptoms, and enhancing the treatment effect.

[0057] The present invention has confirmed the effectiveness of the combination of traditional Chinese medicine compound and rehabilitation therapy in improving limb joint spasm after stroke. Future research will seek to increase the sample size to further verify the efficacy of the self-made traditional Chinese medicine compound combined with rehabilitation therapy in relieving limb joint spasm caused by external contraction. Follow-up studies will extend the follow-up period for further investigation and to address these drawbacks. In summary, for the treatment of limb joint spasm caused by external contraction, the use of traditional Chinese medicine compound can significantly reduce the frequency of spasm, remarkably improve symptoms, and enhance the daily living and motor abilities of patients. This method has considerable value in the treatment of limb joint spasm caused by external factors and is worthy of clinical promotion.

[0058] It should be understood that various forms of the processes shown above can be used, with steps reordered, added, or deleted. For example, the steps recited in the disclosure of the present invention can be executed in parallel, sequentially, or in a different order, as long as the desired results of the technical solutions disclosed in the present invention can be achieved, and no limitations are imposed herein.

[0059] The above specific embodiments do not constitute a limitation on the protection scope of the present invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the protection scope of the present invention.

Claims

1. A drug for treating limb spasm, characterized in that: The composition comprises the following components by weight: 50-100 parts of siler, 30-50 parts of cynanchum, 15-25 parts of safflower, 10-30 parts of aconite, 15-25 parts of sophora flavescens, 20-40 parts of clematis, 5-15 parts of liquorice, 25-35 parts of houttuynia cordata and 15-25 parts of radix strychnifoliae.

2. A drug for treating arthralgia according to claim 1, characterized in that: The invention comprises 60-80 parts of siler, 30-40 parts of cynanchum, 15-25 parts of safflower, 15-25 parts of aconite, 20 parts of sophora flavescens, 25-35 parts of clematis, 8-12 parts of liquorice, 25-30 parts of houttuynia cordata and 15-20 parts of radix spatholobi.

3. A drug for treating arthralgia according to claim 1, characterized in that: The composition comprises 70 parts of siler, 30 parts of cynanchum, 20 parts of safflower, 20 parts of aconite, 20 parts of sophora flavescens, 30 parts of clematis, 10 parts of liquorice, 30 parts of houttuynia cordata and 20 parts of radix spatholobi.

4. A drug for treating arthralgia according to claim 1, characterized in that: The composition comprises 50 parts of siler, 30 parts of cynanchum, 20 parts of safflower, 20 parts of aconite, 20 parts of sophora flavescens, 30 parts of clematis, 10 parts of liquorice, 30 parts of houttuynia cordata and 20 parts of radix spatholobi.

5. A method for preparing a drug for treating limb spasm according to any one of claims 1 to 4, characterized in that: The steps include: S1. Weigh according to weight proportions of windproof, Cynanchum, safflower, agricultural Jili, Sophora flavescens, Clematis, licorice, Houttuynia cordata and the brother king, remove dust and impurities, crush, through 80 ~ 120 mesh sieve to obtain a mixture; S2. Add 3 to 5 times the volume of water to the mixture and soak at room temperature for 20 to 48 hours; after soaking, reflux extract at 85 to 95°C for 3 times, stir for 10 to 30 minutes after extraction, and filter and collect the extract; after extraction, combine the 3 extracts, remove water by rotary evaporation under reduced pressure, and concentrate to obtain extract A; S3. Add 2 to 4 times the volume of anhydrous ethanol to the mixture and soak at room temperature for 5 to 12 hours; after soaking, reflux extract at 65 to 75°C for 3 times, and collect the extract by filtration; after extraction, combine the 3 extracts, remove water by rotary evaporation under reduced pressure, and concentrate to obtain extract B; S4. Combine extract A and extract B, and dry them to obtain a medicine for treating limb spasm.

6. A method for preparing a drug for treating arthralgia according to claim 5, characterized in that: In the step S1, the powder is crushed and then passed through a 100-mesh sieve.

7. The method for preparing a drug for treating arthralgia according to claim 5, characterized in that: The temperature of each reflux extraction in step S2 is 90° C., and the extraction time is 2 to 4 hours.

8. The method for preparing a drug for treating arthralgia according to claim 7, characterized in that: The temperature of each reflux extraction in step S3 is 70° C., and the extraction time is 2 to 4 hours.

9. The method for preparing a drug for treating arthralgia according to claim 8, characterized in that: The temperature of the reduced pressure rotary evaporation in step S2 is 70-80°C; the temperature of the reduced pressure rotary evaporation in step S3 is 60-70°C.

10. The method for preparing a drug for treating arthralgia according to claim 8, characterized in that: The drying in step S4 is freeze drying.

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