A traditional Chinese medicine composition, its preparation method and application

Abstract

The present invention provides a traditional Chinese medicine composition, a preparation method thereof and an application, belonging to the technical field of traditional Chinese medicine. The traditional Chinese medicine composition of the present invention comprises raw materials in the following parts by weight: 3-5 parts of Atractylodes lancea, 3-5 parts of Gentiana macrophylla, 7-9 parts of Ligusticum chuanxiong, 10-14 parts of Carthamus tinctorius, 3-5 parts of Notopterygium incisum, 10-14 parts of Angelica sinensis, 10-14 parts of Cyathula officinalis, 3-5 parts of Cyperus rotundus, and 7-9 parts of Glycyrrhiza uralensis. Based on the situation of stasis in patients with arthralgia syndrome, the present invention performs drug compatibility for those with stasis in arthralgia syndrome, and has a significant therapeutic effect on arthralgia syndrome caused by wind, cold, dampness and stasis.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition, a preparation method thereof, and an application thereof. Background Art

[0002] Bi syndrome refers to a class of diseases mainly characterized by soreness, numbness, limited flexion and extension of limb joints and muscles, and even joint swelling and heat due to pathogenic factors such as wind, cold, dampness, and heat invading the body surface and meridians of the human body. As the saying goes, "The combination of wind, cold, and dampness leads to Bi syndrome", which includes diseases with clear diagnoses such as rheumatoid arthritis, scapulohumeral periarthritis, cervical spondylosis, lumbar disc herniation, and knee arthritis, as well as chronic pain diseases with no abnormalities found in experimental examinations and imaging examinations. "Compendium of Treatment and Syndromes·Volume 3·External Body Section" states that: "Due to internal deficiency of primordial essence, when attacked by the three pathogenic factors, they cannot be dispelled in time, flowing and accumulating in the meridians, and becoming Bi syndrome over time", believing that the pathogenesis of Bi syndrome is deficiency in origin and excess in superficiality. Bi syndrome is based on deficiency of vital qi, and pathogenic factors such as wind, cold, dampness, heat, and phlegm invade the limbs, joints, and muscles, flowing through the meridians as the superficiality, while the key pathogenesis of Bi syndrome is the blockage of the meridians.

[0003] Currently, many clinical patients with Bi syndrome have a lingering illness. Patients may present symptoms of blood stasis or phlegm nodulation. Those with long-term Bi syndrome may show the phenomenon of phlegm and blood stasis blocking the meridians. Therefore, for those with a long-term illness that does not heal, the joints and limbs can have obvious pain, like pricking by a needle, and the location is relatively fixed, with more obvious pain at night, a deep and unsmooth pulse, and a dark tongue with ecchymoses or purplish spots. Currently, clear moxa sticks are commonly used in clinical moxibustion. Therefore, providing a moxibustion composition that acts on wind, cold, dampness, and stasis has positive significance for relieving the symptoms of patients with Bi syndrome. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide a traditional Chinese medicine composition for relieving the symptoms of patients with Bi syndrome, which can directly reach the affected area and has the effects of promoting blood circulation to remove blood stasis, dispelling wind and dampness, promoting qi circulation to relieve pain, and dredging joints.

[0005] In order to achieve the above-mentioned invention purpose, the present invention provides the following technical solutions:

[0006] A traditional Chinese medicine composition for moxibustion, comprising the following raw materials in parts by weight: Atractylodes lancea 3 - 5 parts, Gentiana macrophylla 3 - 5 parts, Ligusticum wallichii 7 - 9 parts, Carthamus tinctorius 10 - 14 parts, Notopterygium incisum 3 - 5 parts, Angelica sinensis 10 - 14 parts, Cyathula officinalis 10 - 14 parts, Cyperus rotundus 3 - 5 parts, Glycyrrhiza uralensis 7 - 9 parts.

[0007] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Atractylodes lancea 4 parts, Gentiana macrophylla 4 parts, Ligusticum wallichii 8 parts, Carthamus tinctorius 12 parts, Notopterygium incisum 4 parts, Angelica sinensis 12 parts, Cyathula officinalis 12 parts, Cyperus rotundus 4 parts, Glycyrrhiza uralensis 8 parts.

[0008] Another purpose of the present invention is to provide a moxibustion composition, comprising moxa floss and the above-mentioned traditional Chinese medicine composition.

[0009] Preferably, the mass ratio of the moxa floss to the traditional Chinese medicine composition is 3 - 6:1 - 2.

[0010] Another object of the present invention is to provide a preparation method of the above-mentioned moxibustion composition, comprising the following steps: weighing each raw material drug in the moxa floss and the traditional Chinese medicine composition according to the proportion, crushing the raw materials in the traditional Chinese medicine composition and mixing them with the moxa floss, and drying to obtain the product.

[0011] Preferably, Atractylodes lancea, Gentiana macrophylla, Ligusticum chuanxiong, Notopterygium incisum, Angelica sinensis, Cyperus rotundus, Glycyrrhiza uralensis and Cyathula officinalis in the traditional Chinese medicine composition are dried before crushing, and the drying temperature is 150 - 170 °C.

[0012] Preferably, the raw materials in the traditional Chinese medicine composition are crushed to pass through a 300 - 600 mesh sieve.

[0013] Preferably, the moxa floss is laid flat, the crushed traditional Chinese medicine composition is evenly spread, and then dried after rolling into a stick.

[0014] Another object of the present invention is to provide the application of the above-mentioned traditional Chinese medicine composition or the moxibustion composition obtained by the above-mentioned moxibustion composition or the above-mentioned preparation method in the preparation of a drug for treating arthralgia syndrome.

[0015] Preferably, the arthralgia syndrome includes rheumatoid arthritis, scapulohumeral periarthritis, cervical spondylosis, lumbar disc herniation, knee arthritis, chronic pain diseases.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The present invention provides a traditional Chinese medicine composition. Based on the situation of stasis in patients with arthralgia syndrome, drug compatibility is carried out for those with stasis in arthralgia syndrome, which can promote blood circulation to remove stasis, dispel wind and dampness, promote qi and relieve pain, dredge meridians and collaterals, and has a significant therapeutic effect on arthralgia syndrome caused by wind, cold, dampness and stasis. Specific Embodiments

[0018] The present invention provides a traditional Chinese medicine composition, comprising the following raw materials in parts by weight: Atractylodes lancea 3 - 5 parts, Gentiana macrophylla 3 - 5 parts, Ligusticum chuanxiong 7 - 9 parts, Carthamus tinctorius 10 - 14 parts, Notopterygium incisum 3 - 5 parts, Angelica sinensis 10 - 14 parts, Cyathula officinalis 10 - 14 parts, Cyperus rotundus 3 - 5 parts, Glycyrrhiza uralensis 7 - 9 parts. Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Atractylodes lancea 4 parts, Gentiana macrophylla 4 parts, Ligusticum chuanxiong 8 parts, Carthamus tinctorius 12 parts, Notopterygium incisum 4 parts, Angelica sinensis 12 parts, Cyathula officinalis 12 parts, Cyperus rotundus 4 parts, Glycyrrhiza uralensis 8 parts.

[0019] In the traditional Chinese medicine composition of the present invention, safflower is pungent, dispersing, warm and dredging, belonging to the heart and liver meridians. It is good at promoting blood circulation to remove stasis, dredging the meridians, reducing swelling and relieving pain, and has the effects of promoting blood circulation to dredge the meridians and dispelling stasis to relieve pain; chuanxiong is pungent, fragrant, dispersing, warm and dredging, belonging to the liver, gallbladder and pericardium meridians. It ascends to the head vertex, descends to the blood sea, promotes qi and blood circulation internally, and disperses wind-cold externally, and has the effects of promoting blood circulation and qi movement, dispelling wind and relieving pain; angelica is sweet and can tonify and moisten, pungent, warm and dispersing, belonging to the liver, heart and spleen meridians. It is good at tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, moistening the intestines and relaxing bowel movements, and can dispel cold. The combination of safflower, chuanxiong and angelica promotes blood circulation to remove stasis, and they together serve as the monarch drugs, playing a leading role in targeting the disease in the formula.

[0020] Notopterygium root is pungent, dispersing, bitter and drying, warm, dredging, ascending and dispersing, with a strong and intense qi. It belongs to the bladder and kidney meridians, mainly acting on the exterior and the upper part, dispersing wandering wind and cold-dampness in the exterior, and dredging the joints to relieve pain, and has the effects of relieving exterior syndrome and dispelling cold, dispelling wind and removing dampness, and relieving pain; gentian is bitter, purging, pungent, dispersing, slightly cold and can clear heat, mild and not dry. It belongs to the stomach, liver and gallbladder meridians. It not only dispels wind and removes dampness, and concurrently penetrates the exterior pathogen to dredge the meridians, but also induces the excretion of damp-heat to benefit the gallbladder and reduce jaundice, and has the effects of dispelling wind-dampness, clearing damp-heat, relieving arthralgia pain and removing deficiency heat; atractylodes rhizome is bitter, drying, pungent, dispersing, fragrant, warm and transforming. It belongs to the spleen and stomach meridians. It can dry dampness and strengthen the spleen, reach the four limbs and muscle surface, dispel cold-dampness and relieve arthralgia and relieve exterior syndrome; cyperus rotundus is pungent, fragrant, dispersing, slightly bitter, slightly descending, slightly sweet and can harmonize, mild and not biased. It belongs to the liver, spleen and triple energizer meridians. It is good at soothing the liver and regulating qi to relieve pain, and has the effects of soothing the liver and regulating qi, regulating menstruation and relieving pain. The four herbs of notopterygium root, gentian, atractylodes rhizome and cyperus rotundus dispel wind and remove dampness, promote qi and blood circulation, and relieve pain, assisting safflower, chuanxiong and angelica to exert the effects of promoting blood circulation, dispelling wind and relieving pain, and are the ministerial drugs of the formula.

[0021] Cyathula root is slightly bitter, purging, sweet, promoting diuresis and percolation, mild and slightly cold, good at descending, belonging to the liver and kidney meridians. It promotes diuresis and purges, not only expels stasis and dredges the meridians, promotes diuresis and dredges the joints, but also promotes urination and discharges stranguria, and guides the medicine, blood and fire downward, and is the adjuvant drug of the formula.

[0022] Licorice is sweet, tonifying, moistening, soothing and slow-acting, mild and slightly cold in nature, warm after being roasted, belonging to the heart, lung, spleen and stomach meridians. It has the effects of tonifying qi and replenishing the middle, resolving phlegm and relieving cough, detoxifying, relieving spasm and pain, and moderating the properties of the medicine. It can guide the medicine into the interior, harmonize the properties of the medicine, help the monarch and ministerial drugs to exert their effects, and reduce drug irritation, and is the messenger drug of the formula.

[0023] All the herbs in the formula are simple in composition and potent in effect. They can promote blood circulation to remove stasis, dispel wind and remove dampness, promote qi and blood circulation, relieve pain, dredge the meridians and collaterals, and have a good therapeutic effect on arthralgia syndrome.

[0024] The present invention also provides an moxibustion composition, which includes moxa floss and the above-mentioned traditional Chinese medicine composition, and has a good therapeutic effect on arthralgia syndrome.

[0025] In the present invention, the mass ratio of moxa floss to the traditional Chinese medicine composition is 3-6:1-2, preferably 5:2. The research of the present invention finds that increasing the proportion of the medicinal powder will affect the combustion of the moxa stick, resulting in the situation of extinguishing halfway due to insufficient combustion, while reducing the proportion of the medicinal powder will affect the efficacy, resulting in unremarkable treatment effects. The ratio of moxa floss to the traditional Chinese medicine composition provided by the present invention can enable the moxa stick to burn sufficiently, effectively stimulate acupoints, stimulate the activity of meridian qi, and relieve the arthralgia syndrome of patients.

[0026] The present invention also provides a preparation method of the above-mentioned moxibustion composition, comprising the following steps: weighing each raw medicinal material in moxa floss and the traditional Chinese medicine composition according to the ratio, pulverizing the raw materials in the traditional Chinese medicine composition and mixing them with moxa floss, and obtaining the product after drying. In the present invention, the raw medicinal materials are pulverized to pass through a 300-600 mesh sieve, preferably a 400-500 mesh sieve. The pulverization particle size can enable the medicinal powder to burn sufficiently after being mixed with moxa floss, avoiding scalding caused by dropping during the combustion process due to too large particles.

[0027] After weighing each raw medicinal material in the traditional Chinese medicine composition in the present invention, Atractylodes lancea, Gentiana macrophylla, Ligusticum chuanxiong, Notopterygium incisum, Angelica sinensis, Cyperus rotundus, Glycyrrhiza uralensis and Cyathula officinalis are dried and then pulverized. The drying temperature is 150-170 °C. Atractylodes lancea, Gentiana macrophylla, Ligusticum chuanxiong, Notopterygium incisum, Angelica sinensis, Cyperus rotundus and Glycyrrhiza uralensis are dried for 3-8 minutes, and Cyathula officinalis is dried for 10-25 minutes.

[0028] The preparation method of the moxibustion composition in the present invention further comprises: spreading the moxa floss flat, evenly sprinkling the pulverized traditional Chinese medicine composition, rolling it into a stick and drying it. The drying temperature is 20-25 °C, and the drying time is 100 minutes. As an implementable method, the present invention takes 20 g of moxa floss, evenly spreads it on a mulberry paper with a length of 25-30 cm and a width of 12-16 cm, then evenly scatters 8 g of the traditional Chinese medicine composition powder, folds the two ends of the mulberry paper by a total of 5-9 cm, rolls it tightly into a stick, bonds and seals it, and dries it at a low temperature of 20-25 °C to obtain a moxa stick. The prepared moxa stick is 20-21 cm long, 1.7-1.8 cm in diameter, has a fragrant smell, does not go out after being lit, and has a special smoke.

[0029] The present invention also provides the application of the above-mentioned moxibustion composition or the moxibustion composition obtained by the above-mentioned preparation method in the preparation of a drug for treating arthralgia syndrome.

[0030] The arthralgia syndrome described in the present invention includes rheumatoid arthritis, scapulohumeral periarthritis, cervical spondylosis, lumbar intervertebral disc herniation, knee arthritis, and chronic pain diseases.

[0031] After the drug for treating arthralgia syndrome described in the present invention is lit, it is suspended for moxibustion at a position 4-5 cm above the skin. The suspension moxibustion time is 15-25 minutes. For the drug for treating arthralgia syndrome, it is prohibited for patients with wounds, ulcers, blisters or eczema on the skin.

[0032] The technical solution provided by the present invention will be described in detail below in conjunction with embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0033] Embodiment 1

[0034] An moxibustion composition includes moxa floss and a traditional Chinese medicine composition with a mass ratio of 5:2.

[0035] The traditional Chinese medicine composition includes the following raw materials in parts by weight: Atractylodes lancea 4 parts, Gentiana macrophylla 4 parts, Ligusticum wallichii 8 parts, Carthamus tinctorius 12 parts, Notopterygium incisum 4 parts, Angelica sinensis 12 parts, Cyathula officinalis 12 parts, Cyperus rotundus 4 parts, Glycyrrhiza uralensis 8 parts.

[0036] Preparation method: Thoroughly dry Atractylodes lancea, Gentiana macrophylla, Ligusticum wallichii, Notopterygium incisum, Angelica sinensis, Cyperus rotundus, and Glycyrrhiza uralensis at a drying temperature of 160°C for 5 minutes, and thoroughly dry Cyathula officinalis at a drying temperature of 160°C for 15 minutes. Crush all the raw material drugs in the traditional Chinese medicine composition into fine powder, mix them evenly after passing through a 400-mesh sieve. Take 20 g of moxa floss, evenly spread it on a mulberry paper with a length of 27 cm and a width of 15 cm, then evenly sprinkle 8 g of the above powder, fold the two ends of the mulberry paper by a total of 6 cm, roll it tightly into a strip, bond and seal it, and dry it at 22°C for 100 min to obtain the moxibustion stick.

[0037] Embodiment 2

[0038] An moxibustion composition includes moxa floss and a traditional Chinese medicine composition with a mass ratio of 5:2.

[0039] The traditional Chinese medicine composition includes the following raw materials in parts by weight: Atractylodes lancea 3 parts, Gentiana macrophylla 3 parts, Ligusticum wallichii 8 parts, Carthamus tinctorius 12 parts, Notopterygium incisum 3 parts, Angelica sinensis 12 parts, Cyathula officinalis 10 parts, Cyperus rotundus 3 parts, Glycyrrhiza uralensis 9 parts.

[0040] Preparation method: Thoroughly dry Atractylodes lancea, Gentiana macrophylla, Ligusticum wallichii, Notopterygium incisum, Angelica sinensis, Cyperus rotundus, and Glycyrrhiza uralensis at a drying temperature of 160°C for 5 minutes, and thoroughly dry Cyathula officinalis at a drying temperature of 160°C for 15 minutes. Crush all the raw material drugs in the traditional Chinese medicine composition into fine powder, mix them evenly after passing through a 450-mesh sieve. Take 20 g of moxa floss, evenly spread it on a mulberry paper with a length of 26 cm and a width of 13 cm, then evenly sprinkle 8 g of the above powder, fold the two ends of the mulberry paper by a total of 6 cm, roll it tightly into a strip, bond and seal it, and dry it at 25°C for 100 min to obtain the moxibustion stick.

[0041] Embodiment 3

[0042] An moxibustion composition includes moxa floss and a traditional Chinese medicine composition with a mass ratio of 5:2.

[0043] The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Atractylodes lancea 5 parts, Gentiana macrophylla 5 parts, Ligusticum wallichii 9 parts, Carthamus tinctorius 13 parts, Notopterygium incisum 5 parts, Angelica sinensis 14 parts, Cyathula officinalis 12 parts, Cyperus rotundus 5 parts, and Glycyrrhiza uralensis 8 parts.

[0044] The preparation method is the same as that of Example 1.

[0045] Comparative Example 1

[0046] The difference between this comparative example and Example 1 is that Ligusticum wallichii is not added to the traditional Chinese medicine composition.

[0047] Comparative Example 2

[0048] The difference between this comparative example and Example 1 is that Gentiana macrophylla and Notopterygium incisum are not added to the traditional Chinese medicine composition.

[0049] Comparative Example 3

[0050] The difference between this comparative example and Example 1 is that the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Rehmannia glutinosa 2 parts, Ligusticum wallichii 2 parts, Carthamus tinctorius 1 part, Paeonia lactiflora 1 part, Angelica sinensis 2 parts, Salvia miltiorrhiza 2 parts, Aurantii Fructus Immaturus 1 part, and Citri Reticulatae Viride Pericarpium 1 part.

[0051] The preparation method is as follows: Rehmannia glutinosa, Ligusticum wallichii, Paeonia lactiflora, Angelica sinensis, Salvia miltiorrhiza, Aurantii Fructus Immaturus, and Glycyrrhiza uralensis are dried at 160 °C for 5 min. All the drugs are crushed into fine powder, passed through a 400-mesh sieve, and mixed evenly. The remaining preparation steps are the same as those of Example 1.

[0052] Comparative Example 4

[0053] The difference between this comparative example and Example 1 is that the mass ratio of moxa floss to the traditional Chinese medicine composition is 5:4. The prepared moxa stick burns incompletely and is easy to extinguish, and the smell is relatively pungent, so it cannot be used normally in clinical practice.

[0054] Example 4

[0055] This example compared the effects of different moxa sticks

[0056] 1. Selection of cases: Patients with unilateral knee joint pain symptoms, diagnosed as knee osteoarthritis by Western medicine, excluding patients with severe knee joint trauma and surgery; patients with lumbar arthralgia symptoms, diagnosed as lumbar disc herniation by Western medicine, excluding patients with lumbar disc prolapse and surgery.

[0057] 2. The patients are randomly divided into 6 groups, with 20 patients with unilateral knee joint pain symptoms and 20 patients with lumbar arthralgia symptoms in each group. There are no statistically significant differences in general data such as age, gender, and disease course among the patients in each group. The 6 groups are treated with the moxa sticks provided in Examples 1-3 and Comparative Examples 1-3 respectively.

[0058] Treatment method: For patients with unilateral knee pain symptoms, select Xuehai (SP10), Liangqiu (ST34), Dubi (ST35), Yinlingquan (SP9), Heding (EX-LE2), and Weizhong (BL40); for patients with lumbar arthralgia symptoms, select Guanyuanshu (BL26) on both sides, Huantiao (GB30) and Chengfu (BL36) on the left side, Weizhong (BL40) and Chengshan (BL57) on the left leg, and Yongquan (KI1) on both sides. Install the moxibustion stick on the moxibustion rack, fix it at the above acupoint positions, keep a distance of 4 - 5 cm from the skin, perform suspended moxibustion for 20 minutes, once a day for a total of 10 times. After the treatment, the subjects drink 200 mL of warm water.

[0059] 3. Observation indicators

[0060] Before the first treatment and after the last treatment, evaluate the following indicators of each group of patients respectively.

[0061] 3.1 VAS score

[0062] Use a movable scale about 10 cm long, with 10 scales marked on one side, and the two ends are the "0" - point end and the "10" - point end respectively. The patient marks the corresponding position on the ruler that can represent their pain level, and scores are given according to the position marked by the patient.

[0063] 0 cm: 0 points, painless, without any pain sensation; 1 - 3 cm: 1 - 3 points, mild pain, does not affect work and life; 4 - 6 cm: 4 - 6 points, moderate pain, affects work, does not affect life; 7 - 10 cm: 7 - 10 points, severe pain, intense pain, affects work and life.

[0064] 3.2 Range of motion of joints (ROM angle)

[0065] The patient lies in the prone position, and is measured using a goniometer (0° - 180°). Place the axis of the goniometer at the lateral epicondyle of the femur, the fixed arm is parallel to the longitudinal axis of the femur, and the moving arm is parallel to the longitudinal axis of the tibia. At this time, the patient actively flexes and extends the affected knee or waist, and records the maximum value of joint movement. Among them, for patients with unilateral knee pain symptoms, measure the extension and flexion angles of the affected knee joint, and for patients with lumbar arthralgia, measure the anterior flexion and posterior extension angles of the waist.

[0066] 3.3 WOMAC score

[0067] By the same physician, assist the patient to fill in the survey content according to the content in Table 1. The WOMAC score table consists of three parts, with a total of 24 questions. 5 are related to pain, 2 evaluate the joint stiffness level, and 17 evaluate the joint function.

[0068] The problem scoring range for the three parts is 0-10. 0 indicates no pain, painless (0), and 10 indicates extreme pain, very painful (10). The larger the number, the stronger the pain felt; the smaller the number, the weaker the pain felt. Evaluate the degree of pain, stiffness, or movement disorder felt in the past 48 hours. Evaluate the severity of OA: mild < 80 points, moderate 80-120 points, severe > 120 points.

[0069] Table 1 WOMAC Evaluation

[0070]

[0071]

[0072] 3.4 TCM Syndrome Score

[0073] According to the "Guiding Principles for Clinical Research of New Chinese Medicines", the symptoms recorded in Table 2 are scored respectively according to the severity of the condition. The higher the score, the more severe the symptoms.

[0074] Table 2 TCM Syndrome Score Scale

[0075]

[0076]

[0077] 3.5 Patients with unilateral knee pain symptoms detect the infrared temperature of each moxibustion acupoint, and patients with lumbar arthralgia symptoms detect the local temperature of the patient at L3-S1 (between the third lumbar vertebra and the first sacral vertebra).

[0078] 4. Efficacy Judgment

[0079] Efficacy = [(syndrome score before treatment - syndrome score after treatment) / syndrome score before treatment] × 100. Marked effect is when the efficacy ≥ 50%, effective is when the efficacy ≥ 35% and < 50%, ineffective is when the efficacy < 35%. The effective rate = marked effect + effective.

[0080] 5. Results

[0081] 5.1 VAS Score

[0082] The mean VAS score of each group of patients is shown in Table 3. Compared with the control group, the moxa stick provided by the present invention can effectively relieve the pain of patients.

[0083] Table 3 VAS Score Results

[0084]

[0085]

[0086] 5.2 Range of motion (ROM angle) of joints

[0087] The mean values of the changes in the range of motion of joints for each group of patients are shown in Table 4, and the mean values of the changes in the range of motion of the lumbar spine are shown in Table 5. It can be seen that the range of motion of joints in each group of patients has improved after moxibustion. Among them, after using the moxa stick provided by the present invention, the improvement effect of the range of motion of joints in patients is better than that of the comparative example.

[0088] Table 4 Range of motion of the knee joint

[0089]

[0090] Table 5 Range of motion of the lumbar spine

[0091]

[0092] 5.3 WOMAC score

[0093] The mean values of the WOMAC scores for each group of patients are shown in Table 6. It can be seen that the WOMAC scores of patients have decreased after moxibustion treatment, and the improvement effect is better after treatment with the moxa stick provided by the present invention.

[0094] Table 6 Results of WOMAC score

[0095]

[0096] 5.4 Clinical efficacy

[0097] The clinical efficacy of each group of patients is shown in Table 7. It can be seen that the effective rate can reach 90% or more after using the moxa stick of the present invention. Compared with the comparative example, the treatment effect of the present invention is better.

[0098] Table 7 Clinical efficacy

[0099]

[0100] Typical cases

[0101] 1. Lv XX, female, 70 years old, suffering from knee bi, right knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint is pain and limited movement in the right knee joint for 10 years, aggravated for 2 years. She has been in good health and denies a history of drug or food allergies.

[0102] Acupoint selection: Xuehai (SP10), Liangqiu (ST34), Dubi (ST35), Yinlingquan (SP9), Heding (EX-LE2), Weizhong (BL40). Install the moxibustion stick of Example 1 on the moxibustion rack, fix it at the above acupoint positions, 4 - 5 cm away from the skin, and perform suspended moxibustion for 20 minutes. Start the treatment with the Tongbi moxibustion stick on March 4th, once a day for a total of 10 times. After the treatment, instruct the subject to drink 200 mL of warm water. The scoring indexes before and after treatment are shown in Table 8. After using the moxibustion stick of the present invention, the acupoint temperature of the patient rises, the pain is relieved, the curative effect reaches 52.3%, the pain improvement is 62.5%, and the knee arthralgia symptoms of the patient are effectively relieved. The moxibustion stick of the present invention is effective for this patient.

[0103] Table 8 Scoring indexes before and after treatment

[0104]

[0105] 2. Liu, female, 71 years old, suffering from knee arthralgia, knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint is swelling and pain of both knees accompanied by limited mobility for 2 years, aggravated for one week, aggravated by squatting, getting up, going upstairs and downstairs, and occasional locking sensation in the right knee. She has a history of hypertension, and denies drug and food allergies.

[0106] Acupoint selection: Xuehai (SP10), Liangqiu (ST34), Dubi (ST35), Yinlingquan (SP9), Heding (EX-LE2), Weizhong (BL40). Install the moxibustion stick of Example 1 on the moxibustion rack, fix it at the above acupoints, 4 - 5 cm away from the skin, and perform suspended moxibustion for 20 minutes. Start the treatment with the Tongbi moxibustion stick on March 4th, once a day for a total of 11 times. After the treatment, instruct the subject to drink 200 mL of warm water. The scoring indexes before and after treatment are shown in Table 9. The moxibustion stick of the present invention raises the acupoint temperature of the patient, and the curative effect of the present invention on this patient is 53.5% ， The pain improvement is 57.1%, and the present invention effectively relieves the symptoms of swelling and pain of the patient's knee joint.

[0107] Table 9 Scoring indexes before and after treatment

[0108]

[0109] 3. Yan, male, 57 years old, suffering from knee arthralgia, knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint is intermittent pain in both knee joints for more than 10 years, aggravated for 2 months, especially when squatting and walking for a long time, aggravated by fatigue and relieved by rest. He has a healthy past history and denies drug and food allergies.

[0110] Acupoint selection: Xuehai, Liangqiu, Dubi, Yinlingquan, Heding, Weizhong. The moxibustion strip of Example 1 is installed on the moxibustion frame, fixed on the above acupoints, 4-5cm away from the skin, and suspended for 20min. Tongbi moxibustion moxibustion strip treatment was started on March 17, once a day, for a total of 14 times. After the end, the subject was asked to drink 200mL of warm water. The scoring indicators before and after treatment are shown in Table 10. The moxibustion strip of the present invention increases the temperature of the patient's acupoints, effectively relieves the symptoms of knee pain in patients, and the therapeutic effect of the present invention on the patient is 60%, and the pain is improved by 62.5%.

[0111] Table 10 Scoring indicators before and after treatment

[0112]

[0113] 4. Wang, 63 years old, was admitted to the hospital on June 8, 2023. The main complaint was that the intermittent pain and numbness in the left lower limb worsened for 20 days. The patient underwent lumbar internal fixation surgery in a hospital in Tianjin in 2021. After the surgery, he was left with residual neuralgia symptoms such as low back pain, pain and numbness in the left lower limb. 20 days ago, there was no obvious cause for the residual neuralgia symptoms to worsen after surgery. The symptoms did not improve after rest. He had been treated with oral and topical medications. Now, for further treatment, he was admitted to the hospital by our outpatient department for "lumbar disc herniation and lumbar internal fixation surgery". Symptoms at admission: pain and numbness in the posterior part of the left lower limb, numbness of both feet, good appetite, poor sleep, and regular bowel movements. He was previously healthy. He denied a history of drug and food allergies. History of surgery: The patient reported that he "underwent lumbar internal fixation surgery in a hospital in Tianjin in 2021". Chinese medicine diagnosis: lumbar arthralgia, syndrome type: qi stagnation and blood stasis type. Western medicine diagnosis: lumbar disc herniation, after lumbar internal fixation surgery.

[0114] Acupoint selection: Guanyuanshu on both sides, Huantiao acupoint on the left side, Chengfu acupoint, Weizhong acupoint, Chengshan acupoint, and Yongquan acupoint on both sides. The moxibustion of Example 1 is installed on the moxibustion frame, 4-5cm away from the skin, and suspended for 20min. On June 12, Tongbi moxibustion moxibustion strips were used for treatment, three times a week, for a total of 6 times. After the end, the subjects were asked to drink 200mL of warm water. The scoring indicators before and after treatment are shown in Table 11. After using the moxibustion strips of the present invention, the patient's pain was significantly reduced, the joint activity of the left lower limb was significantly improved, the Holden walking ability score was increased, the patient's walking ability was significantly improved, the efficacy reached 51.4%, and the pain was improved by 75%. The present invention effectively alleviated the patient's lumbar arthritis symptoms.

[0115] Table 11 Scoring indicators before and after treatment

[0116]

[0117] 5. Mr. Wang, male, 61 years old, was admitted to the hospital on June 10, 2023 with lumbar arthritis, lumbar disc herniation, qi stagnation and blood stasis type. He complained of intermittent pain in the lumbar sacral area and right lower limb, with limited movement for 5 days. He had a healthy history and denied a history of drug or food allergies.

[0118] Acupoint selection: Guanyuanshu on both sides, Huantiao point on the left side, Chengfu point, Weizhong point, and Chengshan point, and Yongquan points on both sides. Install the moxibustion of Example 1 on the moxibustion rack, keep it 4 - 5 cm away from the skin, and suspend moxibustion for 20 minutes. Start the treatment with the Tongbi moxibustion stick on June 10th, three times a week for a total of 6 times. After the treatment, ask the subject to drink 200 mL of warm water. The scoring indexes before and after the treatment are shown in Table 12. After using the moxibustion stick of the present invention, the pain of the patient is significantly reduced, the joint movement of the left lower limb is significantly improved, the Holden walking ability score increases, the walking ability of the patient is significantly improved, the curative effect reaches 40%, and the pain is improved by 75%. The present invention effectively relieves the lumbago symptoms of the patient.

[0119] Table 12 Scoring indexes before and after the treatment

[0120]

[0121] 6. Zhang, female, 66 years old, suffering from knee bi syndrome, left knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint is that the left knee joint has pain and limited movement for more than half a year, which is aggravated when squatting, standing up, going upstairs and downstairs. She has a history of hypertension and a history of old cerebral infarction, and denies drug and food allergies.

[0122] Acupoint selection: Xuehai, Liangqiu, Dubi, Yinlingquan, Hedong, and Weizhong point. Install the moxibustion stick of Comparative Example 1 on the moxibustion rack, fix it at the above acupoint positions, keep it 4 - 5 cm away from the skin, and suspend moxibustion for 20 minutes. Start the treatment with the Tongbi moxibustion stick on March 4th, once a day for a total of 10 times. After the treatment, ask the subject to drink 200 mL of warm water. The scoring indexes before and after the treatment are shown in Table 13. The moxibustion stick provided by Comparative Example 1 can improve the pain of the patient to a certain extent. However, according to the TCM syndrome integral of the patient, which was 38 points at admission and 25 points at discharge, it can be seen that the curative effect of this moxibustion stick on treating the knee bi syndrome of the patient is 34.2%. The pain score was 7 points at admission and 4 points at discharge, and the improvement rate was 42.9%, both lower than those of the example.

[0123] Table 13 Scoring indexes before and after the treatment

[0124]

[0125] 7. Wang, female, 60 years old, suffering from knee bi syndrome, knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint is that the right knee joint has swelling, pain and limited movement for more than 10 days, which is aggravated when squatting, standing up, going upstairs and downstairs. She has a history of hypertension and denies drug and food allergies.

[0126] Acupoint selection: Xuehai (SP10), Liangqiu (ST34), Dubi (ST35), Yinlingquan (SP9), Heding (EX-LE2), Weizhong (BL40). Install the moxibustion stick of Comparative Example 2 on the moxibustion rack, fix it at the above acupoint positions, keep a distance of 4 - 5 cm from the skin, and perform suspended moxibustion for 20 minutes. Start the treatment with the Tongbi Moxibustion Stick on March 4th, once a day for a total of 11 times. After the treatment, instruct the subject to drink 200 mL of warm water. The scoring indexes before and after the treatment are shown in Table 14. It can be seen that after using the moxibustion stick provided in Comparative Example 2, the score of the patient's arthritis index (WOMAC) increased, from 26 points at admission to 38 points at discharge; the score of traditional Chinese medicine syndrome increased, from 33 points at admission to 38 points at discharge. During the treatment, the patient had severe joint stiffness and related walking problems were more serious than before, and dry mouth with less saliva, tinnitus, oral ulcers and other conditions occurred during the treatment, which was considered as the upward extension of deficient fire. That is, this moxibustion stick could not improve the knee bi syndrome of the patient.

[0127] Table 14 Scoring Indexes before and after the Treatment

[0128]

[0129] 8. Patient Xue, female, 49 years old, suffering from knee bi syndrome, knee osteoarthritis, of the kidney deficiency and blood stasis type. The main complaint was bilateral knee swelling, pain and limited movement for 6 months, aggravated for 1 month, more severe in the left knee, with occasional locking sensation. She had a normal past medical history and denied drug and food allergies.

[0130] Acupoint selection: Xuehai (SP10), Liangqiu (ST34), Dubi (ST35), Yinlingquan (SP9), Heding (EX-LE2), Weizhong (BL40). Install the moxibustion stick of Comparative Example 3 on the moxibustion rack, fix it at the above acupoint positions, keep a distance of 4 - 5 cm from the skin, and perform suspended moxibustion for 20 minutes. Start the treatment with the Tongbi Moxibustion Stick on March 17th, once a day for a total of 14 times. After the treatment, instruct the subject to drink 200 mL of warm water. The scoring indexes before and after the treatment are shown in Table 15. After using the moxibustion stick provided in Comparative Example 3, the improvement of the infrared temperature difference at the acupoints of the patient was not obvious. The infrared temperature of Liangqiu acupoint was 34.92 °C at admission and 35.57 °C at discharge, and the infrared temperature of Yinlingquan acupoint was 35.30 °C at admission and 35.38 °C at discharge. Compared with the admission time, the patient still had obvious discomfort. The score of traditional Chinese medicine syndrome was 38 points at admission and 31 points at discharge, and the curative effect was 18.4%. The patient reported that the symptoms were not improved significantly.

[0131] Table 15 Scoring Indexes before and after the Treatment

[0132]

[0133] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and modifications can be made, and these improvements and modifications should also be regarded as the protection scope of the present invention.

Claims

1. An moxibustion composition, characterized in that, It is composed of moxa floss and a traditional Chinese medicine composition, and the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 3-5 parts of Atractylodes lancea, 3-5 parts of Gentiana macrophylla, 7-9 parts of Ligusticum chuanxiong, 10-14 parts of Carthamus tinctorius, 3-5 parts of Notopterygium incisum, 10-14 parts of Angelica sinensis, 10-14 parts of Cyathula officinalis, 3-5 parts of Cyperus rotundus, 7-9 parts of Glycyrrhiza uralensis; The mass ratio of the moxa floss to the traditional Chinese medicine composition is 3-6:1-2.

2. The moxibustion composition according to claim 1, wherein The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 4 parts of Atractylodes lancea, 4 parts of Gentiana macrophylla, 8 parts of Ligusticum chuanxiong, 12 parts of Carthamus tinctorius, 4 parts of Notopterygium incisum, 12 parts of Angelica sinensis, 12 parts of Cyathula officinalis, 4 parts of Cyperus rotundus, 8 parts of Glycyrrhiza uralensis.

3. The preparation method of the moxibustion composition according to claim 1 or 2, characterized in that, It includes the following steps: Weigh each raw material medicine in the moxa floss and the traditional Chinese medicine composition according to the proportion, crush the raw materials in the traditional Chinese medicine composition and mix them with the moxa floss, and obtain the product after drying.

4. The preparation method according to claim 3, wherein The Atractylodes lancea, Gentiana macrophylla, Ligusticum chuanxiong, Notopterygium incisum, Angelica sinensis, Cyperus rotundus, Glycyrrhiza uralensis and Cyathula officinalis in the traditional Chinese medicine composition are dried before crushing, and the drying temperature is 150-170 °C.

5. The preparation method according to claim 3, wherein The raw materials in the traditional Chinese medicine composition are crushed to pass through a 300-600 mesh sieve.

6. The preparation method according to claim 3, characterized in that, Lay the moxa floss flat, evenly sprinkle the crushed traditional Chinese medicine composition, and dry it after rolling into a stick.

7. Use of the moxibustion composition according to claim 1 or 2 or the moxibustion composition obtained by the preparation method according to any one of claims 3-6 in the preparation of a drug for treating arthralgia syndrome.

8. The application according to claim 7, wherein The arthralgia syndrome includes rheumatoid arthritis, scapulohumeral periarthritis, cervical spondylosis, lumbar intervertebral disc herniation, knee arthritis.

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