Traditional Chinese medicine composition for treating wind-cold-dampness arthralgia type lumbago and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia type lumbago and application thereof. The traditional Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 20 to 40 parts of radix stephaniae tetrandrae, 20 to 40 parts of radix clematidis, 5 to 15 parts of radix angelicae sinensis, 5 to 15 parts of rhizoma chuanxiong, 20 to 40 parts of fructus chaenomelis, 5 to 15 parts of fructus foeniculi, 5 to 15 parts of frankincense, 20 to 40 parts of herba lycopodii, 5 to 15 parts of lignum sappan, 5 to 15 parts of borneol, 5 to 15 parts of menthol and 20 to 40 parts of vaseline. The traditional Chinese medicine composition has the effects of dispelling cold and wind, eliminating dampness, regulating qi and blood, warming and activating meridians and relieving swelling and pain, clinical experiments show that the traditional Chinese medicine composition can obviously improve clinical symptoms of patients with wind-cold-dampness arthralgia type lumbago and has high clinical application value in the aspect of treating wind-cold-dampness arthralgia type lumbago.

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 wind-cold-dampness arthralgia type low back pain and application thereof. Background Art

[0002] Low back pain is a very common symptom in clinical practice. It can occur all year round and is often caused by lumbar disc herniation, lumbar muscle strain, etc., which has a serious adverse impact on the patient's quality of life. In the field of traditional Chinese medicine, low back pain is included in the category of "arthralgia". Traditional Chinese medicine has a long history of research on low back pain and has a profound understanding of it. "Suwen Bi Lun Pian" clearly points out that "wind, cold, and dampness are mixed together to form arthralgia", which lays a theoretical foundation for the understanding of the cause of low back pain.

[0003] The pathogenesis of wind-cold-dampness-arthralgia type lumbago is mainly due to the invasion of the human waist by external evils such as wind, cold and dampness. Among them, cold evil has the characteristics of contraction and stagnation. After invading the waist, it will cause the qi and blood in the waist meridians to stagnate, and the pain will be caused by the blockage, which makes the waist pain severe and aggravated by cold, and the limbs will become cold; damp evil is heavy and sticky, and the dampness tends to go down. After invading the human body, it is easy to block the normal operation of the meridians and blood, resulting in poor circulation of qi and blood, which is manifested as heaviness and pain in the waist. The patient feels that it is difficult to turn the side. In rainy weather, the pain will be aggravated because the dampness is more prevalent; wind evil is good at moving and changing frequently, often mixed with cold evil and damp evil to invade the human body, causing the pain to wander and the condition is prone to recurrence. In addition, from the perspective of TCM viscera and meridian theory, the kidney governs the waist and legs, and the waist is the home of the kidney. If the patient is born with deficiencies or suffers from kidney deficiency and physical weakness, the kidney qi is weak. On the one hand, they are unable to resist external evils, making it easier for wind, cold and dampness to invade the waist meridians. On the other hand, it affects the normal operation and nourishment of qi and blood in the waist meridians, causing malnutrition of the waist muscles and bones, making the pain lingering and difficult to heal, and the pain does not subside even when lying still.

[0004] In modern medicine, there are various treatments for low back pain. Western medicine usually uses drugs, such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, injectable drugs, etc., or physical therapy, such as heat therapy and massage, to relieve pain symptoms. However, although these treatments can relieve patients' pain in the short term, the long-term effects are not ideal, and long-term use of drugs will cause many adverse reactions to the digestive system, cardiovascular system, liver and kidney function, etc. At the same time, Western medicine treatment mostly focuses on symptom relief, and it is difficult to fundamentally solve the cause of low back pain, causing many patients' pain symptoms to recur frequently after treatment and cannot be completely eliminated. Most patients even need to undergo surgical intervention again.

[0005] Compared with symptomatic treatment of Western medicine, traditional Chinese medicine has shown unique advantages in the treatment of low back pain, especially in the treatment of wind-cold-dampness-arthralgia type low back pain. Many prescriptions recorded in "Golden Chamber Synopsis", such as Shenqi Pills for low back pain caused by kidney deficiency and Ganjiang Lingshu Decoction for low back pain caused by cold and dampness, reflect the idea of ​​traditional Chinese medicine on syndrome differentiation and treatment of low back pain, and these prescriptions have always been valued by later generations. Traditional Chinese medicine attaches great importance to syndrome differentiation and treatment. For low back pain caused by wind-cold-dampness-arthralgia, it is mostly treated by methods such as dispelling cold and dampness, regulating qi and blood, warming the meridians and unblocking the collaterals, and reducing swelling and relieving pain, thereby effectively improving the patient's condition.

[0006] At present, there are many traditional Chinese medicine prescriptions and methods for treating wind-cold-dampness arthralgia type low back pain in the prior art, such as a fumigation traditional Chinese medicine composition for low back pain disclosed in application No. 2017114596485, and its preparation method and application patent. The composition includes the following raw materials in parts by weight: 18-22 parts of Clematidis, 18-22 parts of Cyathula capitata, 18-22 parts of Herba Eucommiae, 12-18 parts of Radix Paeoniae Rubra, 12-18 parts of Radix Chuanxiong, 8-12 parts of Radix Angelicae Sinensis, 8-12 parts of Stephania Tetrandrae, 8-12 parts of Cortex Acanthopanacis, 8-12 parts of Rhizoma Chuanxiong, 8-12 parts of Cinnamon Twig, 5-8 parts of Radix Aconiti Kusnezoffii, 5-8 parts of Scorpio, 5-8 parts of Carthamus Tinctorius, 2-5 parts of Asarum, and 1-3 parts of Scolopendra. This prescription uses Angelica dahurica, Clematidis, Chuanxiong, Chuanduan, Cyathula officinalis, Scolopendra subspinipes, Scorpion, and Safflower as the main ingredients for dredging the waist meridians, focusing on dredging the waist meridians and blood, and improving the pain and poor mobility caused by meridian blockage. Acanthopanax acanthopanax promotes blood circulation, removes blood stasis and replenishes qi, helping from the level of qi and blood, enhancing the body's ability to promote the circulation of qi and blood, and promoting the circulation of qi and blood in the waist. Parasitic, Gentiana macrophylla, and Angelica sinensis replenish blood, nourish the tendons and veins by replenishing blood, nourish the waist tendons and bones, and relieve the discomfort caused by blood deficiency or poor blood circulation. Chuanwu and Caowu reduce inflammation, play a role in the inflammatory response that may accompany low back pain, and reduce the stimulation and damage of local inflammation to tissues. Eucommia ulmoides nourishes the kidney, starting from the perspective of internal organs, considering the close relationship between the kidney and the waist, and uses the method of tonifying the kidney to strengthen the waist and enhance the physiological function of the waist. Red peony root and Stephania tetrandra detoxify, help to remove possible pathological products in the body, and make the meridians more unobstructed. Cinnamon twigs dispel cold and dampness, and target the cause of wind-cold-dampness-arthralgia type low back pain, dispel the evil of cold and dampness, and improve the state of cold and dampness stagnation in the waist. Asarum dispels wind and cold, clears the orifices and relieves pain, and enhances the overall wind-dispelling and cold-dispelling power of the prescription. At the same time, its orifice-clearing effect helps to improve local paresthesia caused by meridian blockage. The overall treatment principle mainly revolves around dispelling wind and dampness, promoting blood circulation and removing blood stasis, and is combined with comprehensive conditioning such as tonifying the kidney and replenishing qi. However, due to the large number of drug types, the targeted synergistic effect between the drugs may not be prominent enough, and the efficacy of each drug is relatively scattered, and the targeted intervention for certain specific symptoms or pathological links is not accurate enough.

[0007] Application No. 2020101451297 discloses a blood-activating and stasis-removing paste and its preparation method and application patent, which includes sesame oil, a Chinese medicine composition and yellow ochre; the Chinese medicine composition includes the following components: angelica dahurica, sparganium, curcuma, angelica, papaya, chuanxiong, radix schizonepetae, rhubarb, schizonepeta, radix scutellariae, rhubarb, schizonepetae, schizonepetae, radix scutellariae, angelica dahuricae, radix pubescens, radix scutellariae ... From the perspective of its composition drugs, through the superposition of a large number of drugs with the effects of promoting blood circulation (such as Trillium, Curcuma, Carthami, Leech, etc.), dispelling wind (such as Angelica dahurica, Clematis, Nepeta, Saposhnikovia, etc.), and unblocking meridians (such as Rhizoma Dioscoreae, Herba Lycopodii, Herba Polygoni Multiflori, etc.), the intention is to treat low back pain and related bone diseases from multiple angles and multiple targets. Many drugs work together in the hope of achieving the purpose of strongly improving blood circulation in the waist, dispelling wind evil, and unblocking meridians, so as to relieve pain, reduce swelling, and restore joint mobility. However, precisely because the drugs are numerous and complicated, on the one hand, there may be complex drug interactions, and it is difficult to accurately grasp the specific contribution and mutual influence of each drug in the compound; on the other hand, the dosage of each component is relatively scattered, and it is difficult to concentrate on the key pathological links of low back pain for precise treatment, and the overall targeting is not accurate enough. In addition, the prescription contains some highly toxic drugs, such as Strychnos nux vomica, which require more caution in terms of safety and dosage control. If used improperly, it may cause adverse reactions such as poisoning and cause harm to patients, limiting its safety and wide applicability in clinical applications.

[0008] Application No. 2014100499486 discloses a Chinese medicine composition and its application patent, which is composed of the following components in parts by weight: 47-53 parts of Artemisia argyi, 2-7 parts of Asarum cyrtonema, 2-7 parts of Angelica dahurica, 2-7 parts of Stephania tetrandra, 2-7 parts of Ephedra sinica, 2-7 parts of Achyranthes bidentata, 2-7 parts of Pittosporum tobira bark, 2-7 parts of dried ginger, 2-7 parts of Clematidis, 2-7 parts of Epimedium, 2-7 parts of Olibanum, and 0.5-4.5 parts of Myrrh. This prescription uses the warming and unblocking effects of warm and hot drugs such as Artemisia argyi, Asarum cyrtonema, Angelica dahurica, and dried ginger, as well as the synergy of drugs such as Clematidis, Ephedra sinica, and Pittosporum tobira through external heat to help the drug power achieve the purpose of warming and unblocking the meridians, so as to improve the blocked state of qi and blood in the waist meridians and relieve pain. Among them, mugwort warms the meridians and stops bleeding, dispels cold and relieves pain, northern asarum dispels cold and dispels wind, relieves pain and opens the orifices, white angelica dispels wind and relieves pain, reduces swelling and discharges pus, and dried ginger warms the middle and dispels cold, restores yang and unclogs the meridians. These drugs together provide the main power for warming and unblocking the meridians. Clematis removes rheumatism and unclogs the meridians, ephedra induces sweating and relieves the exterior, clears the lungs and relieves asthma, and promotes diuresis and reduces swelling. Its dispersing power helps to dispel wind and dampness, and Pittosporum bark removes rheumatism, unclogs the meridians, kills insects and relieves itching, and assists in enhancing the function of unblocking the meridians. At the same time, drugs such as Achyranthes bidentata and Epimedium in the prescription have certain effects of nourishing the liver and kidneys, which can be regarded as a method of strengthening the body on the basis of warming and unblocking the meridians, strengthening the tendons and bones by nourishing the liver and kidneys, and enhancing the support and function of the waist. However, its treatment principle is relatively focused on using the power of external hot compresses to enable the medicinal power to play the role of warming and unblocking the meridians. In terms of the specific treatment of low back pain with drugs, such as the in-depth elimination of wind, cold and dampness, and the precise improvement of qi and blood stasis, its comprehensive effects are relatively weak, and its mode of action is relatively single. It mainly relies on warm stimulation and limited drug efficacy to relieve symptoms, and its ability to comprehensively regulate and cure complex diseases is relatively insufficient.

[0009] In short, other people generally follow the principle of promoting blood circulation and removing blood stasis, dispelling wind and dampness to treat wind-cold-dampness-type lumbago, aiming to remove pathogenic factors such as wind, cold, and dampness, improve the stagnation of qi and blood in the meridians, thereby relieving pain and restoring waist function. On the basis of following the traditional theory of traditional Chinese medicine, the present invention pays more attention to the unique advantages of precise medication, synergistic overall conditioning, etc., and can provide more effective and comprehensive treatment for patients with wind-cold-dampness-type lumbago. Summary of the invention

[0010] The purpose of the present invention is to propose a Chinese medicine composition (trade name: Jitongzhi) specifically for treating wind-cold-dampness arthralgia type lumbago, through precise drug compatibility and application, it aims to effectively relieve the cold pain and heaviness of the waist caused by wind-cold-dampness arthralgia, unfavorable turning, aggravated pain when it is cloudy or rainy or cold, cold limbs, conscious unfavorable turning, unreduced pain when lying still, pale tongue, white and greasy fur, deep and tight pulse and other symptoms. The composition can dispel cold, remove wind and dampness, regulate qi and blood, warm the meridians and dredge the collaterals, reduce swelling and relieve pain, and is suitable for patients with wind-cold-dampness arthralgia type lumbago invading the waist, especially for patients with long-term repeated attacks and difficult to cure. The present invention provides an innovative treatment method based on traditional Chinese medicine theory and modern pharmacological research.

[0011] The invention provides a traditional Chinese medicine composition for treating wind-cold-dampness arthralgia type lumbago. The traditional Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 20-40 parts by weight of Stephania tetrandra, 20-40 parts by weight of Clematis chinensis, 5-15 parts by weight of Angelica sinensis, 5-15 parts by weight of Ligusticum chuanxiong, 20-40 parts by weight of Papaya, 5-15 parts by weight of Fennel, 5-15 parts by weight of Olibanum, 20-40 parts by weight of Lycopodiella cuneata, 5-15 parts by weight of Sappanwood, 5-15 parts by weight of Borneolum, 5-15 parts by weight of Menthol and 20-40 parts by weight of Vaseline.

[0012] The traditional Chinese medicine composition for treating wind-cold-dampness arthralgia type low back pain is prepared by extracting the following raw materials in parts by weight: 30 parts by weight of Stephania tetrandra, 30 parts by weight of Clematidis, 10 parts by weight of Angelica sinensis, 10 parts by weight of Ligusticum chuanxiong, 30 parts by weight of Papaya, 10 parts by weight of Fennel, 10 parts by weight of Frankincense, 30 parts by weight of Lycopodiella cuneata, 10 parts by weight of Sappanwood, 10 parts by weight of Borneolum, 10 parts by weight of Menthol and 30 parts by weight of Vaseline.

[0013] The preparation method of the Chinese medicine composition for treating wind-cold-dampness arthralgia type low back pain comprises the following steps:

[0014] Step 1: Grind Stephania tetrandra, Clematis chinensis, Chinese angelica, Chuanxiong, papaya, fennel, lycopodiella cuneata, sappan wood, borneol, and menthol into fine powder and set aside;

[0015] Step 2: deep-fry the frankincense over a slow fire until it becomes golden yellow, filter it to remove the residue, heat vaseline to fully dissolve it, and combine it with the deep-fried frankincense to prepare an ointment base;

[0016] Step 3: Mix the powder obtained in step 1 with the ointment base in step 2, stir evenly to make a paste, and seal and store after cooling for later use.

[0017] The Chinese medicine composition for treating wind-cold-dampness arthralgia type lumbago is used in preparing medicine for treating wind-cold-dampness arthralgia type lumbago.

[0018] In step 2, frankincense is processed. Frying operation is performed on frankincense by slow fire. During frying, frankincense is evenly heated by slow fire, so that some volatile components in frankincense are removed, thereby effectively reducing its irritating smell. Continue to fry frankincense until it presents a golden appearance. At this time, the frankincense texture becomes crisp, which is conducive to subsequent further processing. Then the frankincense after frying is filtered to remove the residue therein. Then vaseline is placed in a specific container, heated to it, so that vaseline is fully dissolved, and stirring operation is performed in due time during the dissolution process to ensure the uniformity of vaseline. The fried frankincense that has been previously filtered and de-slaged is added to vaseline, fully mixed, and frankincense is evenly dispersed in vaseline by means of stirring. Finally, the mixed frankincense and vaseline mixture is placed in a cool place to solidify naturally, thereby forming the required ointment base.

[0019] Usage: The Chinese medicine composition can be prepared as an external ointment and applied directly to the painful area once a day. Massage appropriately after each application to promote absorption. Apply an appropriate amount of ointment to the affected area daily and massage for 5-10 minutes each time to promote drug absorption. After continuous use for 2 to 4 weeks, the symptoms are significantly improved.

[0020] The present invention is a modification of Professor Jiang Hong, a famous Chinese medicine doctor in Jiangsu Province, based on the Song Dynasty Taiping Huimin Hejiju Fang - Myrrh Jiangshengdan combined with the famous Chinese medicine classic prescription "Xiaosui Huahe Tang", which has the effects of promoting blood circulation and removing blood stasis, dispelling wind and removing dampness, and is mainly used to treat soreness and pain in the waist, lying still without restlessness, pain and numbness in the lower limbs, and difficulty urinating. The tongue coating is slippery and greasy, the tongue is dark purple, and the pulse is stringy and slippery.

[0021] Etiology analysis: From the perspective of etiology, according to the classical theory of traditional Chinese medicine, the invasion of wind, cold and dampness is the key to the wind-cold-dampness-bi type of low back pain. As stated in "Suwen·Bi Lun Pian": "Wind, cold and dampness are mixed together and become Bi", wind evil is good at changing, and its nature is wandering. It can cooperate with cold evil and dampness to invade the waist, making the pain area show wandering characteristics, just like the invisible wind, wantonly shuttling between the waist meridians. Cold evil has the nature of contraction and stagnation. After invading the waist, it will cause the waist meridians and tendons to contract and block the normal circulation of qi and blood. Stagnation of qi and blood will cause pain. This is in line with the statement in "Bian Que Xin Shu·Bi Bing" that "cold evil gathers between the flesh... Bi is the stagnation of qi and blood." Dampness is heavy and sticky, and it is difficult to dissipate when it stays in the waist, making the blockage of the waist meridians more serious. Dampness often entangles with cold, aggravating the pathological state of cold and dampness, just like wet mud accumulating in a river channel, blocking the smooth flow of water.

[0022] In terms of the relationship with the internal organs, the waist is the home of the kidneys, and the rise and fall of the kidney's essence and qi are closely related to the function of the waist. If the kidney is deficient due to inadequate endowment or excessive strain after birth, the body will be deficient in positive qi, and the ability to resist external evil will be reduced, and wind, cold and dampness will easily take advantage of the opportunity to enter the waist. When the kidney qi is weak, it is not only unable to effectively warm the qi and blood of the waist meridians, but once the external evil invades, it is even more difficult to drive the evil out, resulting in lingering low back pain that is difficult to cure. "Suwen·Mai Yao Jingwei Lun" records: "The waist is the home of the kidneys. If it cannot be turned, the kidneys will be exhausted." It clearly points out the close connection between the kidney and the waist in physiology and pathology. If the kidney essence and qi are injured internally, the waist and legs will be sore and weak; if the kidney qi is weak and the external evil invades, the low back pain will be lingering and the symptoms will worsen.

[0023] From the perspective of Qi and blood circulation, after the invasion of wind, cold and dampness into the waist, the Qi and blood in the waist meridians are blocked. As the classics say, "If it is not smooth, there will be pain." This state of Qi and blood stasis is an important mechanism for the occurrence of low back pain. The invasion of evil Qi disrupts the normal circulation of Qi and blood in the waist, causing the meridians to be blocked, and pain is caused by the blockage. This is the core understanding of TCM on the pathogenesis of pain, which is reflected in the symptoms of low back pain.

[0024] Mechanism of drug action: The Chinese medicine composition of the present invention strictly follows the classic principle of "monarch, minister, assistant and envoy" in traditional Chinese medicine in terms of the compatibility of medicinal materials, and integrates the in-depth research of modern medicine on the functions of drugs, showing significant advantages in many aspects, and provides a more excellent, safe and comprehensive solution for the treatment of wind-cold-dampness type low back pain.

[0025] Effect of the main drug: In this external plaster prescription, Stephania tetrandra and Clematidis radix play the important role of the main drug. Stephania tetrandra, with a cold nature and bitter taste, belongs to the bladder meridian and the lung meridian, and has excellent effects of dispelling wind and relieving pain, promoting water flow and reducing swelling. It can effectively dispel wind evil in the meridians and relieve pain symptoms, especially for patients with rheumatic arthralgia and water stagnation, its diuretic and detumescent effects can reduce limb swelling and improve the condition. Clematidis radix, with a warm nature and a spicy and salty taste, belongs to the bladder meridian, is good at dispelling rheumatism, unblocking meridians, relieving pain and eliminating bone joints. Its characteristics of passing through the twelve meridians enable it to strongly dispel the rheumatic evil in the human body's meridians, and significantly relieve symptoms such as joint pain and flexion and extension difficulties. They mainly target the wind, cold and dampness evil in the pathogenic evil, and play a leading role in unblocking the blockage in the meridians. The two are combined to double the power of dispelling rheumatism, and accurately target the core symptoms such as joint pain and flexion and extension difficulties caused by wind, cold and dampness. Play a leading therapeutic role, laying a solid foundation for dispelling evil for the entire prescription.

[0026] Functions of ministerial drugs: Angelica sinensis, Chuanxiong, Herba Lycopodii, and Papaya are ministerial drugs. Angelica sinensis replenishes blood, activates blood circulation, regulates menstruation and relieves pain, while Chuanxiong activates blood circulation, promotes qi circulation, and relieves wind and pain. The two are a classic combination of promoting blood circulation and removing blood stasis, which can promote blood circulation and improve pain caused by stagnation of qi and blood. For patients with wind-cold-dampness arthralgia, qi and blood are often not smooth, either due to qi and blood deficiency caused by long-term illness, or due to cold and dampness blocking the flow of qi and blood. The combination of Angelica sinensis and Chuanxiong can not only replenish blood to nourish the body, but also activate blood circulation to relieve arthralgia, playing a role in taking both qi and blood into account. It works synergistically with anti-rheumatic drugs to make the meridians unobstructed and qi and blood flow normally. Papaya relaxes muscles and activates collaterals, and cooperates with Angelica sinensis and Chuanxiong to dredge meridians, activate blood circulation and promote qi circulation, while further relieving muscle cramps and joint discomfort caused by poor qi and blood circulation. The relaxing and activating collaterals effect of papaya helps to improve local blood circulation, enhance the blood circulation effect of Angelica sinensis and Chuanxiong, and make qi and blood reach the painful part more smoothly. Herba Lycopodii is good at dispelling wind and dampness. It can dispel wind, cold and dampness in the meridians for the cause of rheumatic arthralgia. It works synergistically with the main drugs in the prescription, such as Radix Stephaniae and Radix Clematis, to enhance the prescription's efficacy in dispelling wind and dampness, and effectively relieve the symptoms of joint pain and muscle soreness caused by rheumatism. It can relax the tendons and activate the collaterals, improve the tendon and vein spasm and poor joint flexion and extension in the painful area. For the limited limb movement caused by rheumatic arthralgia, Herba Lycopodii can play an important therapeutic role, stretching the tendons and veins and making the joints more flexible. Herba Lycopodii and papaya cooperate to further enhance the prescription's effect of dredging the meridians and relieving muscle and joint spasm, and assist the main drugs in dispelling rheumatism and unblocking the meridians.

[0027] Adjuvant effect: fennel, frankincense, and sappan wood are adjuvants. Fennel can warm and dredge the meridians and dispel the evil of cold and dampness. In prescriptions, on the one hand, it can use its warm nature to play a role in dispelling cold. It can effectively relieve the symptoms of local cold pain, cramps, etc. caused by cold and dampness for the cold and dampness factors of rheumatic arthralgia. On the other hand, it can regulate qi and stomach, and prevent other drugs from being too nourishing or pungent, which will affect the spleen and stomach function. Frankincense can promote blood circulation and dissipate blood stasis, and improve the state of qi and blood stasis in the pain area. Wind-cold-damp arthralgia is often accompanied by poor blood circulation. The blood circulation and qi-promoting effect of frankincense can promote the circulation of qi and blood and relieve pain. At the same time, its analgesic effect directly acts on the pain area and relieves the patient's pain. For local swelling, inflammation, etc. that may occur due to rheumatic arthralgia, frankincense has the effect of reducing swelling. In addition, in some arthralgias with a long course of disease or traumatic factors, the myogenic effect of frankincense helps to promote the repair of damaged tissues. Sappan wood can promote blood circulation in the pain area and eliminate blood stasis. In the process of wind-cold-dampness-arthralgia, blood stasis often occurs. The blood-activating and blood-dispelling effect of Su Mu helps improve local blood supply and relieve pain and swelling caused by blood stasis. For local swelling and pain caused by wind-dampness-arthralgia or other reasons, Su Mu has the effect of reducing swelling and relieving pain. Su Mu and frankincense, together with Angelica sinensis and Chuanxiong, enhance the blood-activating and blood-dispelling effect of the prescription, and have a good therapeutic effect on symptoms such as pain and swelling caused by blood stasis. They can improve local blood circulation, promote the dissipation of blood stasis, and relieve pain and swelling caused by blood stasis.

[0028] The role of the drug: Borneol and menthol are the drugs. Borneol is cold in nature, but its running power is very strong. It can guide the drugs to penetrate the skin and penetrate into the diseased area, enhance the penetration and absorption of the drugs, and make the drug effect better play in the waist meridians; menthol is cool and dispersing, which can assist borneol in playing a transdermal role. Moreover, its small amount of application in a large group of warm drugs is not enough to change the warm nature of the whole prescription. Instead, it can use its cool feeling to relieve local pain and discomfort, and at the same time prevent adverse reactions such as local skin discomfort caused by other drugs being too warm and dry to a certain extent, and cooperate with other drugs to treat wind-cold-dampness-type low back pain. Borneol and menthol can guide other drugs in the prescription to the lesion site, that is, the rheumatic pain site. Their volatility and permeability enable them to act quickly on the local area and play a therapeutic role. The heat-clearing, analgesic, and itching-relieving effects of borneol and menthol coordinate with other drugs in the prescription to play a role in treating rheumatic pain. They play an auxiliary and coordinating role in the prescription, making the overall efficacy of the prescription more perfect. The cool feeling and comfort brought by borneol and menthol can improve the patient's feelings during the treatment process and improve the patient's compliance. Patients are more likely to accept and adhere to the prescription, thereby improving the treatment effect. Borneol is slightly cold, menthol is cool, and the Fangji, Clematidis, fennel, frankincense, and Lycopodiella ciliata in the prescription are mostly warm drugs, which may cause some warm side effects, such as dry mouth, irritability, etc. These two medicines can balance the heat of these warm drugs to a certain extent, prevent the prescription from being too warm as a whole, and avoid excessive warm and dryness and damage to yin and blood. For the local heat symptoms that may occur in wind-cold-damp arthralgia, such as red, swollen, hot and painful joints, the heat-clearing effect of these two medicines can directly clear away heat evil. It can reduce the local heat sensation, relieve the pain and discomfort caused by heat evil, so that the prescription can not only eliminate the evil of wind-cold-dampness in the treatment process, but also deal with the possible heat syndrome.

[0029] Matrix function: Vaseline is used as a matrix in this external treatment formula, which has the function of lubricating and protecting the skin. It can make the drug adhere to the skin surface better, prolong the contact time between the drug and the skin, and facilitate the absorption and efficacy of the drug. At the same time, vaseline can also prevent the drug from over-stimulating the skin and reduce the occurrence of adverse reactions such as allergies.

[0030] The Chinese medicine composition of the present invention not only focuses on improving the local symptoms of wind-cold-dampness-type lumbago, such as effectively relieving pain, heaviness, soreness, numbness and other discomforts in muscles, tendons and bones, but also quickly relieves the patient's pain through the treatment methods directly acting on the waist such as dispelling wind and cold, removing dampness and unblocking collaterals, reducing swelling and relieving pain; at the same time, it pays more attention to conditioning from the overall level. Starting with regulating qi and blood, through the blood-tonifying and blood-activating effects of drugs such as angelica and Chuanxiong, the patient's body qi and blood are sufficient and run smoothly, the body's ability to resist exogenous evil is enhanced, the normal nourishment and operation of qi and blood in the waist meridians are promoted, and sufficient nutritional support is provided for the waist tendons and bones, so as to achieve the purpose of treating both the symptoms and the root causes. Long-term use helps to fundamentally improve the condition, effectively reduce the possibility of recurrence, and enable patients to obtain a more lasting and stable therapeutic effect.

[0031] Unconventional medication has unexpected effects: The present invention innovatively uses two cold drugs, borneol and menthol, which seems to be contrary to the conventional practice of not using cold drugs for wind-cold-dampness-type low back pain. However, in actual treatment, it has played an unexpectedly good role in many aspects. On the one hand, when local heat symptoms appear during wind-cold-dampness-type arthralgia, such as redness, swelling, heat and pain in the joints, the heat-clearing effect of borneol and menthol can directly clear away the heat evil, quickly reduce local heat sensation and pain discomfort, and effectively respond to changes in the condition; on the other hand, in prescriptions dominated by warm drugs, they play a key role in balancing the medicinal properties, preventing the overall medicinal properties of the prescription from being too warm, and avoiding warm side effects such as dry mouth and irritability, thereby protecting the patient's body from the harm of warm dryness and avoiding damage to yin and blood.

[0032] Focus on safety and avoid potential risks: While pursuing therapeutic effects, the present invention attaches great importance to drug safety. The use of highly toxic drugs such as Strychnos nux vomica in Prescription 2 is deliberately avoided to reduce potential risks of drugs and ensure the safety of patients during long-term use. This medication strategy minimizes the adverse effects of drugs on the patient's body while ensuring efficacy, making the prescription more suitable for long-term use by patients and providing patients with a safe and reliable treatment option.

[0033] In summary, the Chinese medicine composition of the present invention shows unique advantages and significant innovation in treating wind-cold-dampness-type lumbago. Its precise compatibility of medicinal materials, the treatment concept of combining the whole and the local, and the unique medication strategy together constitute a more effective, safe and comprehensive treatment plan, bringing new hope to the majority of patients with wind-cold-dampness-type lumbago.

[0034] Clinical effect: The Chinese medicine composition of the present invention has been verified by clinical trials, showing that it has significant efficacy in treating wind-cold-dampness-type low back pain caused by low back diseases. In the experiment, patients experienced significant pain relief and improved daily quality of life through continuous use of the ointment of the composition. Especially for those patients who have been using non-steroidal anti-inflammatory drugs for a long time but have poor efficacy, the present invention provides an effective alternative therapy with higher safety and fewer side effects.

[0035] Comprehensive advantages: The present invention not only has a solid foundation in traditional Chinese medicine theory, but also combines the research results of modern pharmacology and long-term clinical practice to prove its effects in dispelling wind and cold, removing dampness and dredge meridians, warming meridians and relieving pain, and regulating qi and blood. The preparation process of the present invention is simple, the raw materials are easily available, the cost is low, and it is suitable for large-scale promotion and application. The Chinese medicine composition provides a safe and effective treatment option for patients with wind-cold-dampness arthralgia type low back pain, and has a wide range of clinical application prospects. DETAILED DESCRIPTION

[0036] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms fall within the scope limited by the appended claims of the application equally.

[0037] Embodiment 1: Take 30g of Stephania tetrandra, 30g of Clematidis, 10g of Angelica sinensis, 10g of Chuanxiong, 30g of Papaya, 10g of Fennel, 10g of Olibanum, 30g of Herba Lycopodiellae, 10g of Sappan, 10g of Borneol, 10g of Menthol, and 30g of Vaseline, and the preparation steps are as follows: 1. Medicinal material crushing: crush Stephania tetrandra, Clematidis, Angelica sinensis, Rhizoma Lycopodiellae, Papaya, Fennel, Herba Lycopodiellae, Sappan, Borneol, and Menthol into fine powder, sieve for standby use. 2. Preparation of ointment base: fry frankincense with slow fire until it presents a golden appearance, filter, remove residue, take another Vaseline and heat it to fully dissolve it, and combine it with the fried frankincense to prepare an ointment base; 3. Mix and stir: mix the powder obtained in step 1 with the ointment base in step 2, stir evenly, make a paste, and seal and store it for standby use after cooling. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0038] Embodiment 2: Take 20g of Stephania tetrandra, 40g of Clematidis, 5g of Angelica sinensis, 15g of Ligusticum chuanxiong, 20g of Papaya, 15g of Cuminum officinale, 5g of Olibanum, 40g of Herba Lycopodiellae, 5g of Sappan wood, 15g of Borneolum, 5g of Menthol, and 40g of Vaseline, and the preparation steps are as follows: 1. Medicinal material crushing: crush Stephania tetrandra, Clematidis, Angelica sinensis, Ligusticum chuanxiong, Papaya, Cuminum officinale, Herba Lycopodiellae, Sappan wood, Borneolum, and Menthol into fine powder, sieve for standby use. 2. Preparation of ointment base: fry the frankincense with slow fire until it presents a golden appearance, filter, remove the residue, take another Vaseline and heat it to fully dissolve it, and combine it with the fried frankincense to prepare an ointment base; 3. Mix and stir: mix the powder obtained in step 1 with the ointment base in step 2, stir evenly, make a paste, and seal and store it for standby use after cooling. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0039] Embodiment 3: Take 40g of Stephania tetrandra, 20g of Clematidis, 15g of Angelica sinensis, 5g of Chuanxiong, 40g of Papaya, 5g of Cuminum foenicum, 15g of Olibanum, 20g of Herba Lycopodiellae, 15g of Sappan wood, 5g of Borneol, 15g of Menthol, and 20g of Vaseline, and the preparation steps are as follows: 1. Medicinal material crushing: crush Stephania tetrandra, Clematidis, Angelica sinensis, Rhizoma Lycopodiellae, Papaya, Cuminum foenicum, Herba Lycopodiellae, Sappan wood, Borneol, and Menthol into fine powder, sieve for standby use. 2. Preparation of ointment base: fry the frankincense with slow fire until it presents a golden appearance, filter, remove the residue, take another Vaseline and heat it to fully dissolve it, and combine it with the fried frankincense to prepare an ointment base; 3. Mix and stir: mix the powder obtained in step 1 with the ointment base in step 2, stir evenly, make a paste, and seal and store it for standby use after cooling. ④Cooling and packaging: Cool the mixed ointment to room temperature, place it in a sealed container, seal it and keep it for later use. The ointment needs to be kept away from light, high temperature and humid environment to ensure the stability of the efficacy.

[0040] Example 4: Clinical study

[0041] This clinical study selected patients with wind-cold-dampness-type low back pain from the Department of Orthopedics of Suzhou Traditional Chinese Medicine Hospital from January 2024 to August 2024, who met the inclusion and exclusion criteria, and the patients agreed to participate in this clinical observation. A total of 50 cases were collected, and the Chinese medicine ointment prepared from the Chinese medicine composition of the present invention was used for treatment, and the relevant indicators of Chinese medicine symptoms and related signs scores were observed.

[0042] 1. Inclusion criteria

[0043] Case inclusion criteria: ① History of lumbar disease; ② Diagnosed with wind-cold-dampness-type lumbar pain: symptoms include cold and heavy pain in the waist, difficulty turning, aggravated pain in rainy or cold weather, cold limbs, difficulty turning, pain that does not subside when lying still, pale tongue, greasy white tongue coating, and deep and tight pulse; ③ No other related treatments (such as long-term use of hormone drugs and non-steroidal anti-inflammatory drugs) in the past 3 months; ④ Voluntary participation in this study and signing of the informed consent form.

[0044] 2. Exclusion criteria

[0045] Case exclusion criteria: ① Patients with other serious diseases, such as urinary system and reproductive system diseases; ② Patients with serious cardiovascular diseases, liver and kidney dysfunction or tumor history; ③ Pregnant or lactating women; ④ Patients with a history of severe skin allergies or allergies to Chinese medicine ingredients; ⑤ Patients with mental illness or unable to cooperate with the trial.

[0046] 3. Shedding and rejection criteria

[0047] The dropout and exclusion criteria for cases are as follows: ① The subjects have poor compliance and cannot persist in treatment; ② The subjects have serious adverse reactions, such as abnormal neurological function; ③ The subjects develop other serious diseases during the clinical trial; ④ The treatment is effective, but the efficacy cannot be determined when other treatments are added.

[0048] 4. Evaluation indicators

[0049] The efficacy was observed after 2 weeks and 4 weeks, mainly observing the VAS score and Oswestry score of the patients on the 14th and 28th days. Efficacy evaluation: cured: pain disappeared, daily activities were restored, and the Oswestry score decreased by more than 80%; markedly effective: pain was significantly relieved, and the Oswestry score decreased by 50%-80%; effective: pain was relieved, and the Oswestry score decreased by 20%-50%; ineffective: no significant improvement in symptoms before and after treatment, and the Oswestry score decreased by less than 20%. Efficacy index = (VAS score before treatment - VAS score after treatment) / VAS score before treatment × 100%.

[0050] 5. Dosage method and results: The 50 patients with wind-cold-dampness-type lumbago caused by waist diseases were given the Chinese medicine ointment prepared by Example 1 of the present invention on the first day after the visit. An appropriate amount of ointment was applied to the affected area every day, and massaged for 5 to 10 minutes each time to promote drug absorption. The ointment was used continuously for 2 to 4 weeks. The results showed that 5 cases of TCM syndrome were cured, 22 cases were markedly effective, 15 cases were effective, 8 cases were ineffective, and the total effective rate was 84%.

[0051] 6. Typical Cases

[0052] Case 1: Mr. Sun, male, Suzhou Traditional Chinese Medicine Hospital, clinic number: G709155851. The main reason for the visit was "low back pain involving the left lower limb for 1 year". The patient had low back pain involving the left lower limb without obvious inducement 1 year ago, with slightly limited activity, no obvious history of trauma, and no limb numbness. He came to our hospital for treatment. During the course of the disease, the patient had good appetite and sleep, regular bowel movements, dark purple tongue, white greasy fur, and stringy pulse. Physical examination: lumbar percussion pain (+), radiating pain (±), no obvious abnormality in muscle strength, knee tendon reflex, patellar clonus (-), ankle clonus (-), no numbness in the saddle area. Lumbar disc CT plain scan showed: L3 / L4, L4 / L5 disc bulge; L5 / S1 disc herniation. Diagnosed as lumbar disc herniation, Chinese medicine diagnosis of arthralgia-wind cold dampness arthralgia, given the Chinese medicine ointment prepared in Example 1 of the present invention, once a day, massage for 5-10 minutes each time, treatment for 14 days. After treatment, the patient's waist pain and range of motion were significantly improved, and there was no obvious radiating pain in the left lower limb. Continue to give the above-mentioned treatment, and the above-mentioned symptoms completely disappeared after 28 days of review.

[0053] Case 2: Qiu, female, Suzhou Traditional Chinese Medicine Hospital, clinic number: G709155605. Seek medical treatment for "low back pain involving right lower limb for half a year". Half a year ago, the patient had low back pain involving right lower limb without obvious cause, numbness of skin on the posterior and lateral sides of right calf, slightly limited activity, no obvious history of trauma, and usually drove for a long time, so he came to our hospital for treatment. During the course of the disease, the patient's appetite and sleep were good, bowel movements were regular, tongue was dark purple, tongue coating was white and greasy, and pulse was stringy. Physical examination: lumbar vertebrae were slightly swollen, right sciatic tuberosity was tender, radiated to the right lower limb, and the skin on the posterior and lateral sides of right calf was numb. Lumbar MRI: L5 / S1 intervertebral disc herniation, HIZ. Diagnosed as lumbar disc herniation, Chinese medicine diagnosis was arthralgia-wind-cold-damp arthralgia, and the Chinese medicine ointment prepared in Example 1 of the present invention was applied once a day, massaged for 5-10 minutes each time, and treated for 14 days. After treatment, the patient's low back pain and range of motion were significantly improved, and there was no obvious radiating pain in the left lower limb. The above treatment plan was continued, and the above symptoms completely disappeared after a follow-up examination 28 days later.

[0054] In summary, the Chinese medicine composition for treating low back pain of the present invention is used to treat low back pain caused by wind, cold and dampness, and has the effects of dispelling wind and cold, removing dampness and dredging meridians, warming the meridians and relieving pain, and regulating qi and blood, and the clinical symptoms of traditional Chinese medicine are significantly improved.

[0055] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. A Chinese medicine composition for treating wind-cold-dampness arthralgia type low back pain, characterized in that: The traditional Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 20-40 parts by weight of Stephania tetrandra, 20-40 parts by weight of Clematidis, 5-15 parts by weight of Angelica sinensis, 5-15 parts by weight of Ligusticum chuanxiong, 20-40 parts by weight of Papaya, 5-15 parts by weight of Fennel, 5-15 parts by weight of Olibanum, 20-40 parts by weight of Lycopodiella cuneata, 5-15 parts by weight of Sappanwood, 5-15 parts by weight of Borneol, 5-15 parts by weight of Menthol and 20-40 parts by weight of Vaseline.

2. The Chinese medicine composition for treating wind-cold-dampness arthralgia type low back pain according to claim 1, characterized in that: The Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 30 parts by weight of Stephania tetrandra, 30 parts by weight of Clematidis, 10 parts by weight of Angelica sinensis, 10 parts by weight of Ligusticum chuanxiong, 30 parts by weight of Papaya, 10 parts by weight of Fennel, 10 parts by weight of Olibanum, 30 parts by weight of Lycopodiella cuneata, 10 parts by weight of Sappanwood, 10 parts by weight of Borneol, 10 parts by weight of Menthol and 30 parts by weight of Vaseline.

3. The Chinese medicine composition for treating wind-cold-dampness arthralgia type low back pain according to claim 1, characterized in that: The preparation method comprises the following steps: Step 1: Grind Stephania tetrandra, Clematis chinensis, Chinese angelica, Chuanxiong, papaya, fennel, lycopodiella cuneata, sappan wood, borneol, and menthol into fine powder and set aside; Step 2: deep-fry the frankincense over a slow fire until it becomes golden yellow, filter it to remove the residue, heat vaseline to fully dissolve it, and combine it with the deep-fried frankincense to prepare an ointment base; Step 3: Mix the powder obtained in step 1 with the ointment base in step 2, stir evenly to make a paste, and seal and store after cooling for later use.

4. Use of the Chinese medicine composition for treating anemofrigid-dampness-type lumbago according to claim 1 in preparing a medicine for treating anemofrigid-dampness-type lumbago.