A Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy and its preparation method

Abstract

The invention provides a method for preparing a traditional Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy. The traditional Chinese medicine composition comprises, by weight, 5-10 parts of peach kernel, 3-10 parts of safflower, 10-15 parts of raw rehmannia, 5-15 parts of angelica, 5-12 parts of red peony root, 3-9 parts of chuanxiong, 5-15 parts of salvia miltiorrhiza, 3-10 parts of corydalis, 3-9 parts of notopterygium root, 3-9 parts of angelica pubescens, 4.5-9 parts of siler, 1.5-3 parts of processed chuanwu, 5-10 parts of tuckahoe, 9 parts of astragalus root, 1.5-10 parts of tuckahoe, 1.5-2 parts of processed chuanwu, 5-10 parts of tuckahoe, 9 parts of astragalus root, 1.5-2 parts of processed chuanwu, 1.5-10 parts of tuckahoe ... The traditional Chinese medicine composition of the present invention has the effects of reducing spinal canal pressure to reset the protrusion, relieving nerve compression, repairing damaged annulus fibrosus, and achieving the treatment of lumbar disc herniation with radiculopathy.

Description

Technical Field

[0001] The invention relates to the technical field of Chinese medicine compositions, and in particular to a method for preparing a Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy. Background Art

[0002] Lumbar disc herniation with radiculopathy is one of the most common low back and leg pain diseases in clinical practice. About 85%-90% of patients with lumbar disc herniation have radiculopathy symptoms. Generally, patients are more likely to choose conservative treatment unless there is an obvious surgical indication from the beginning. This disease is caused by degeneration of the lumbar disc, which, under the action of external force, causes the fibrous ring to rupture, the nucleus pulposus to protrude, and the nerve roots to stimulate or compress, causing low back pain, sciatica radiating pain in the lower limbs and other symptoms. This disease is mostly caused by external force, fatigue, wind, cold and dampness after the degeneration of the intervertebral disc.

[0003] The lower back is the center of systemic stress and is a common site for lumbar disc herniation. When the annulus fibrosus ruptures, the protruding nucleus pulposus compresses or squeezes the dura mater and nerve roots, which is the root cause of low back and leg pain. If the nerve roots are not compressed, only the posterior longitudinal ligament is stimulated, resulting in low back pain. If the posterior longitudinal ligament is broken and the nerve roots are compressed, the pain is mainly Leg pain Mainly. Patients with lumbar disc herniation and radiculopathy have abnormal sensation of the skin innervated by the affected nerve roots. In the early stage, it is mostly skin allergy, and gradually numbness, tingling, and decreased sensation appear. L3 / 4 disc herniation compresses the L4 nerve root, causing abnormal sensation of the skin on the anterior medial side of the lower leg; L4 / 5 disc herniation compresses the L5 nerve root, causing abnormal sensation of the skin on the anterior lateral side of the lower leg, the anterior medial side of the dorsum of the foot, and the sole of the foot; L5 / S1 disc herniation compresses the S1 nerve root, causing abnormal sensation of the skin on the posterior lateral side of the lower leg and the dorsum of the foot; central herniation is manifested by numbness in the saddle area and dysfunction of the bladder and anal sphincter.

[0004] Chinese Patent No.: CN110585414B, a Chinese medicine composition for treating sciatica caused by lumbar disc herniation and its application, using aconite tip, aconite tip, arisaema, realgar, camphor, clove, dried ginger, evodia rutaecarpa, etc., the drug preparation is an ointment, paste, gel, papuan, coating or aerosol, and the disease has been studied in depth, and good clinical results have been achieved. However, the preparation method of a Chinese medicine composition for treating lumbar disc herniation with radiculopathy of the present invention analyzes the cause and pathogenesis of the disease, starts from the theory, method, prescription and medicine, and reasonably matches, and adopts a unique dosage form of external medicine of traditional Chinese medicine-black plaster, which is applied to the diseased intervertebral disc site, so that the drug can directly reach the diseased site to play a role. The black plaster is simple and convenient to use, has significant clinical effects, and is worth promoting. Summary of the invention

[0005] In view of this, the present invention proposes a method for preparing a Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy to solve the above problems.

[0006] The technical solution of the present invention is achieved in this way:

[0007] A traditional Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy comprises, by weight, 5-10 parts of peach kernel, 3-10 parts of safflower, 10-15 parts of raw rehmannia, 5-15 parts of angelica, 5-12 parts of red peony root, 3-9 parts of chuanxiong, 5-15 parts of salvia miltiorrhiza, 3-10 parts of yanhusuo, 3-9 parts of notopterygium root, 3-9 parts of pubescens, 4.5-9 parts of siler, 1.5-3 parts of processed chuanwu, 5-10 parts of tuckahoe, 9-30 parts of astragalus, 6-12 parts of cibotium barometz, 10-15 parts of drynaria, 3-9 parts of cassia twig, 10-15 parts of eucommia bark, 3-12 parts of lycopodiella cuneata, 4.5-9 parts of toosendan, 6-15 parts of cyathula, 9-15 parts of parasitic plant, 3-10 parts of frankincense and 3-10 parts of myrrh.

[0008] Further, the composition, by weight, includes 10 parts of peach kernel, 10 parts of safflower, 15 parts of raw rehmannia, 15 parts of angelica, 10 parts of red peony root, 9 parts of chuanxiong, 15 parts of salvia miltiorrhiza, 10 parts of Corydalis, 9 parts of Notopterygium wilfordii, 9 parts of Angelica dahurica, 9 parts of Saposhnikovia divaricata, 3 parts of processed Chuanwu, 10 parts of Poria, 9 parts of Astragalus, 10 parts of Cibotium barometz, 10 parts of Drynaria fortunei, 9 parts of cinnamon twig, 10 parts of Eucommia bark, 10 parts of Lycopodiella cuneata, 9 parts of Toosendan fruit, 10 parts of Cyathula capitata, 10 parts of Viscum album, 10 parts of frankincense and 10 parts of myrrh.

[0009] A method for preparing a Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy comprises the following steps:

[0010] (1) crushing frankincense, myrrh, salvia miltiorrhiza, lycopodiella ciliata, safflower, siler, and cyathula officinalis to prepare a mixed powder;

[0011] (2) Mix and soak peach kernel, Radix Rehmanniae, Radix Angelicae Sinensis, Radix Paeoniae Rubrae, Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Notopterygii, Radix Angelicae Pubescentis, Radix Aconiti Lateralis, Poria, Radix Astragali, Rhizoma Cibotii, Rhizoma Drynariae, Rhizoma Cinnamomi, Eucommia Bark, Herba Lycopodii, Fructus Toosendan, Herba Viscume and sesame oil, and heat the sesame oil to obtain a medicinal oil;

[0012] (3) heating the drug oil to 320-330° C. to obtain an oil liquid;

[0013] (4) adding Hongshengdan to the oil, mixing, and preparing a plaster;

[0014] (5) pouring the refined plaster into a container, stirring it into a mass, and soaking it for 3-7 days to obtain a plaster for removing fire poison;

[0015] (6) heating the plaster for removing heat and poison, and sprinkling the mixed powder obtained in step (1) on it to obtain a finished product.

[0016] Furthermore, the mixed powder in step (1) is sieved through a 80-100 mesh sieve.

[0017] Furthermore, in step (2), the mixing and soaking time is 7.5-8.5 hours.

[0018] Furthermore, in step (2), the mixed fragrance oil is heated to 200-230°C.

[0019] Furthermore, in step (4), the mass ratio of Hongshengdan to oil is 500mL:180-240g.

[0020] Furthermore, in step (6), the heating temperature of the plaster for removing heat poison is 60-80°C.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] The Chinese medicine composition of the present invention has the effect of reducing spinal canal pressure to reset the protrusion, relieve nerve compression, and repair damaged annulus fibrosus to achieve the effect of treating lumbar disc herniation accompanied by radiculopathy. The Chinese medicine composition of the present invention can inhibit inflammatory cytokines and promote collagen production during the recovery process of the lumbar spine, thereby achieving the purpose of treating lumbar disc herniation. The present invention has been clinically tested and has a good therapeutic effect.

[0023] For patients with lumbar disc herniation accompanied by radiculopathy, the pathogenic factors are mostly caused by external force, fatigue, wind, cold and dampness after disc degeneration. Through the synergistic effect of various Chinese medicinal ingredients, the effects of promoting blood circulation and removing blood stasis, promoting blood circulation and activating collaterals, benefiting the liver and kidneys, strengthening tendons and bones, and removing rheumatism and relieving pain are achieved. Modern pharmacological research has the effects of relieving spasms, relieving pain, anti-inflammatory, improving chondrocytes, and regulating cellular immune balance. Traditional Chinese medicine believes that "the principle of external treatment is the principle of internal treatment, and the medicine for external treatment is the medicine for internal treatment. The difference is the method". This Chinese medicine composition is made into a plaster and applied locally to play a role, so that the drug effect reaches the diseased area directly, which can improve the main clinical symptoms and signs of patients with lumbar disc herniation accompanied by radiculopathy and improve the quality of life. This plaster for external use has the characteristics of simple application, convenience, safety, few toxic and side effects, and high efficiency.

[0024] This disease is mostly caused by external force, fatigue, invasion of wind, cold and dampness. In the prescription, peach red, astragalus, Duhuo and Eucommia are the main ingredients for promoting blood circulation and unblocking collaterals, dispelling wind and relieving numbness, and benefiting liver and kidney. After external force and fatigue, there will be internal blood stasis, qi stagnation and blood stasis. The assistant ingredients are Rehmannia, Angelica, Red Peony Root, Chuanxiong, Salvia miltiorrhiza, Myrrha, Toosendan Fructus and Corydalis to activate it; add Notopterygium, Saposhnikovia and Chuanwu to dispel wind and relieve exterior symptoms, overcome dampness, dredge the menstruation and relieve numbness and pain; Chuanwu, Cibotium barometz and Viscum album have the effect of dispelling rheumatism and relieving pain; and Chuanwu and cinnamon twig can warm the meridians, dispel cold and relieve pain; assisted by Poria cocos to promote diuresis and reduce swelling, and promote the discharge of water and dampness; fibrous ring rupture is mostly caused by kidney deficiency, and Cibotium barometz, Drynaria fortunei, Eucommia barometz and Viscum album can replenish the liver and kidney and strengthen tendons and bones; Achyranthes bidentata is the messenger to lead the medicine to the meridians. The formula of this plaster is rigorous, containing modified versions of Taohong Siwu Decoction and Duhuo Jishe Decoction. The drug powder included in the production is a modified version of Gentongping Powder (frankincense, myrrh, safflower, Achyranthes bidentata, and Smilax glabra). It has the effects of promoting blood circulation, unblocking meridians, relaxing muscles and relieving pain. It is an effective prescription with experience in treating nerve root symptoms.

[0025] The Chinese medicine composition for treating lumbar disc herniation with radiculopathy of the present invention comprises peach kernel, safflower, raw rehmannia, angelica, red peony root, chuanxiong, salvia miltiorrhiza, corydalis, notopterygium, angelica pubescens, saposhnikovia divaricata, processed chuanwu, tuckahoe, astragalus, cibotium barometz, drynariae, cassia twig, eucommia bark, schizonepeta tenuifolia, toosendan, chuanxiong, mistletoe, frankincense and myrrh. The efficacy of the medicine, modern pharmacology, etc. are described as follows:

[0026] Peach kernel: promotes blood circulation and removes blood stasis, moistens the intestines and promotes bowel movements, relieves cough and asthma. "Compendium of Materia Medica" states: "Peach kernel is good at breaking blood, dispersing but not collecting, purging but not replenishing." Modern pharmacological effects: Peach kernel decoction and extract have analgesic, anti-inflammatory, antibacterial and anti-allergic effects.

[0027] Safflower: promotes blood circulation and menstruation, removes blood stasis and relieves pain. "Compendium of Materia Medica" says: "Safflower is a medicine for breaking blood, promoting blood circulation, harmonizing blood and regulating blood." Modern pharmacological effects: decoction, water extract, safflower yellow pigment can dilate peripheral blood vessels and lower blood pressure. Safflower yellow pigment has an immunosuppressive effect.

[0028] Raw Rehmannia root: clears heat and cools blood, nourishes yin and produces body fluid. "Shennong's Herbal Classic" states: "It cures fractures and broken tendons, injuries, removes blood stasis, fills the bone marrow, grows muscles, and when made into soup, removes cold and heat accumulation and numbness. The raw one is the best." Modern pharmacological effects: The water extract has antihypertensive, sedative, anti-inflammatory and anti-allergic effects.

[0029] Angelica sinensis: nourishes blood and regulates menstruation, promotes blood circulation and relieves pain, moistens the intestines and promotes bowel movements. Essential medicine for promoting blood circulation and removing blood stasis. "Compendium of Materia Medica" states: "It can treat headaches, heart and stomach pains, moisten the intestines, stomach, tendons, bones, and skin, treat carbuncle, discharge pus and relieve pain, and nourish blood." Modern pharmacological effects: Angelica sinensis and its sodium ferulate have significant anti-thrombotic effects.

[0030] Red peony root: clears heat and cools blood, dissipates blood stasis and relieves pain. "Shennong's Herbal Classic" says: "It can treat abdominal pain caused by evil qi, remove blood stasis, break up hard masses, treat cold and heat hernia, relieve pain, and promote urination." Modern pharmacological effects: The paeoniflorin contained in it has sedative, antispasmodic, anti-inflammatory and analgesic effects.

[0031] Chuanxiong: Activates blood circulation and qi, dispels wind and relieves pain. It is a qi medicine in the blood. "Compendium of Materia Medica" says: "It is pungent in taste and yang in nature. Its qi is good at moving without the state of yin coagulation and stickiness. Although it enters the blood, it can remove all wind and regulate all qi." Modern pharmacological effects: It can reduce the surface activity of platelets, inhibit platelet aggregation, and prevent the formation of thrombus; it can accelerate the absorption of local hematoma of fracture and promote the formation of bone callus.

[0032] Danshen: promotes blood circulation and regulates menstruation, removes blood stasis and relieves pain, cools blood and eliminates carbuncle, relieves restlessness and calms the mind. "Rihuazi Bencao" says: "It nourishes blood and calms the mind, regulates joints, treats cold and heat fatigue, joint pain, and limb paralysis." Modern pharmacological effects: It can improve microcirculation and promote blood flow; it can promote the healing of fractures and skin incisions. It has a sedative and analgesic effect on the central nervous system. It has anti-inflammatory and anti-allergic effects.

[0033] Yanhusuo: activating blood circulation, promoting qi circulation, and relieving pain. "Compendium of Materia Medica" states: "Yanhusuo can promote qi stagnation in blood and blood stagnation in qi, so it can specifically treat all kinds of pain in the body. Its use is wonderful. Yanhusuo can activate blood circulation and transform qi, and it is the first-class medicine." Modern pharmacological effects: Yanhusuo B has significant analgesic, hypnotic, sedative and tranquilizing effects; A and Ulcerin also have obvious analgesic effects, and have certain hypnotic, sedative and tranquilizing effects; B and Ulcerin have the effect of relaxing muscles.

[0034] Qianghuo: dispel cold, dispel wind and dampness, relieve pain. "Zhenzhu Nang" says: "relieve pain in joints." Modern pharmacological effects: Volatile oil has anti-inflammatory, analgesic and antipyretic effects.

[0035] Duhuo: dispel rheumatism, relieve pain, and relieve the symptoms. The main drug for dispelling rheumatism and arthralgia. "Compendium of Materia Medica" says: "It is specially used to treat rheumatism in the lower abdomen, pain and arthralgia in the feet, and itching and cramps." Modern pharmacological effects: It has anti-inflammatory, analgesic and sedative effects; it has an inhibitory effect on platelet aggregation.

[0036] Saposhnikovia divaricata: dispel wind and relieve exterior symptoms, overcome dampness and relieve pain, stop spasms. It can treat a variety of skin diseases, dredge meridians, calm wind, and is a moisturizer for wind medicine. It is a general medicine for treating wind. "Shennong's Herbal Classic" says: "Wind spreads throughout the body, causing pain and numbness in the joints, and fullness." Modern pharmacological effects: It has antipyretic, anti-inflammatory, sedative, analgesic, anticonvulsant, and anti-allergic effects.

[0037] Chuanwu: dispels rheumatism, promotes menstruation and relieves pain. "Changsha Yaojie" says: "Aconitum, warm and dry, descends downward, its nature is rapid, opens the pores, and expels cold and dampness very quickly. It is effective for rheumatism, beriberi, cold hernia, cold accumulation, heart and stomach pain, etc." Modern pharmacological effects: Chuanwu has obvious anti-inflammatory and analgesic effects; aconitine has obvious local anesthetic effects.

[0038] Poria: diuresis, invigorating spleen, calming the mind. A key medicine for diuresis and swelling. "Shibuzhai Medical Book" says: "Poria can promote diuresis. Poria can also promote dampness." Modern pharmacological effects: It has diuretic, sedative, anti-tumor, blood sugar lowering, and increases myocardial contractility. Poria polysaccharide has the effect of enhancing immune function.

[0039] Cinnamon twig: induces sweating and relieves muscle pain, warms and dredges the meridians, and helps yang and transforms qi. "Compendium of Materia Medica" states: "It removes pathogens from the exterior. It cures rheumatism and joint pain." Modern pharmacological effects: Cinnamaldehyde has analgesic, sedative, and anticonvulsant effects.

[0040] Astragalus: replenishes Qi and strengthens the spleen, raises Yang and lifts the sunken, strengthens the body's defense and consolidates the exterior, promotes diuresis and reduces swelling, removes toxins and regenerates muscles. "Compendium of Materia Medica" says: "It is a medicine that replenishes the lungs and strengthens the spleen, strengthens the body's defense and restrains sweat, and dispels wind and transports toxins." Modern pharmacological effects: It can promote metabolism, resist fatigue, and promote the renewal of serum and liver proteins. It can enhance and regulate the body's immune function, promote the interferon system, and improve the body's resistance to disease.

[0041] Cibotium barometz: dispels rheumatism, nourishes the liver and kidneys, and strengthens the waist and knees. "Compendium of Materia Medica" states: "It can warm and nourish the liver and kidneys, regulate all meridians, strengthen the waist and knees, strengthen the spine, benefit the joints, and drive away paralysis and paralysis." Modern pharmacological effects: It has anti-inflammatory, analgesic, and anti-platelet aggregation effects.

[0042] Drynaria: promotes blood circulation and heals injuries, nourishes the kidney and strengthens bones. "Kaibao Materia Medica" says: "It is used to force blood, stop bleeding, and heal injuries." Modern pharmacological effects: It can promote bone absorption of calcium, increase blood calcium and blood phosphorus levels, and is beneficial to fracture healing; it improves cartilage cells and delays degenerative changes in bone cells. In addition, drynaria dihydroflavonoid glycosides have obvious analgesic and sedative effects.

[0043] Eucommia: nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes pregnancy. "Shennong's Herbal Classic" states: "It can treat back pain, nourish the middle, benefit the meridians, strengthen the tendons and bones, and strengthen the will." Modern pharmacological effects: It has the function of regulating the balance of cellular immunity.

[0044] Stretching grass: dispel rheumatism, relax muscles and activate collaterals. "Supplement to Materia Medica" says: "The patient has suffered from rheumatism for a long time, with cold and painful feet and knees, numb skin, and weak energy." Modern pharmacological effects: It has obvious analgesic effect.

[0045] Toosendan fruit: promotes qi flow, relieves pain, kills insects. "Ben Jing Feng Yuan" says: "It is bitter and cold, and can guide dampness and heat downward through the infiltration channel." Modern pharmacological effects: It has anti-inflammatory and anti-cancer effects. It can excite the smooth muscle of the intestine, increasing its tension and contraction force.

[0046] Sichuan Cyathula: It can promote blood circulation and menstruation, nourish the liver and kidney, strengthen tendons and bones, promote diuresis and clear the forest, and guide fire downward. It has the effect of promoting blood circulation and removing blood stasis, and has the characteristics of dredging and lowering. "Shennong's Herbal Classic" says: "It can treat cold and dampness, paralysis, and cramps in the limbs." Modern pharmacological effects: It has anti-inflammatory and analgesic effects, and can improve the body's immune function.

[0047] Mulberry parasite: dispels rheumatism, nourishes the liver and kidneys, strengthens tendons and bones, and stabilizes pregnancy. "Shennong's Herbal Classic" says: "It cures back pain and strengthens the back of children." Modern pharmacological effects: The decoction or infusion has a significant inhibitory effect on polio virus and various enteroviruses in vitro, and can inhibit the growth of typhoid bacillus and staphylococcus.

[0048] Frankincense: It can promote blood circulation, relieve pain, reduce swelling and promote tissue regeneration. "Compendium of Materia Medica" states: "Frankincense can promote blood circulation, dispel wind, relax muscles and relieve pain." Modern pharmacological effects: It has the effects of analgesia, anti-inflammatory, increasing white blood cells, and can accelerate the exudation of inflammation and promote wound healing.

[0049] Myrrh: promotes blood circulation and relieves pain, reduces swelling and promotes tissue regeneration. "Medical Records of Chinese and Western Medicine" states: "Its ability to promote ventilation and blood circulation is also good for treating wind-cold-dampness arthralgia, numbness of the whole body, and paralysis of the limbs; frankincense and myrrh, when used together, are a medicine for promoting the flow of zang-fu organs and meridians." Modern pharmacological effects: It has an inhibitory effect on many fungi. DETAILED DESCRIPTION

[0050] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0051] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0052] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can be obtained from commercial sources.

[0053] Example 1

[0054] By weight, the composition comprises 10 parts of peach kernel, 10 parts of safflower, 15 parts of raw rehmannia, 15 parts of angelica, 12 parts of red peony root, 9 parts of ligusticum chuanxiong, 15 parts of salvia miltiorrhiza, 10 parts of corydalis, 3 parts of notopterygium root, 3 parts of angelica pubescens, 4.5 parts of siler, 1.5 parts of processed aconite, 5 parts of tuckahoe, 9 parts of astragalus, 6 parts of cibotium barometz, 10 parts of drynaria, 3 parts of cassia twig, 10 parts of eucommia, 3 parts of lycopodiella cuneata, 4.5 parts of toosendan, 6 parts of cyathula, 9 parts of mistletoe, 3 parts of frankincense and 3 parts of myrrh.

[0055] Example 2

[0056] The invention comprises 5 parts of peach kernel, 3 parts of safflower, 10 parts of raw rehmannia, 5 parts of angelica, 5 parts of red peony root, 3 parts of ligusticum chuanxiong, 5 parts of salvia miltiorrhiza, 3 parts of corydalis, 9 parts of notopterygium root, 12 parts of angelica dahurica, 9 parts of siler, 3 parts of processed aconite, 10 parts of tuckahoe, 9 parts of astragalus, 6 parts of cibotium barometz, 10 parts of drynaria, 9 parts of cassia twig, 10 parts of eucommia, 10 parts of lycopodiella cuneata, 9 parts of toosendan, 10 parts of cyathula capitata, 10 parts of mistletoe, 10 parts of frankincense and 10 parts of myrrh.

[0057] Example 3

[0058] By weight, the composition comprises 5 parts of peach kernel, 3 parts of safflower, 10 parts of raw rehmannia, 5 parts of angelica, 5 parts of red peony root, 3 parts of ligusticum chuanxiong, 5 parts of salvia miltiorrhiza, 3 parts of yanhusuo, 3 parts of notopterygium root, 3 parts of angelica root, 4.5 parts of siler, 1.5 parts of processed aconite, 9 parts of tuckahoe, 30 parts of astragalus, 12 parts of cibotium barometz, 15 parts of drynaria, 9 parts of cassia twig, 15 parts of eucommia bark, 12 parts of lycopodiella cuneata, 9 parts of toosendan, 15 parts of cyathula capitata, 15 parts of mistletoe, 10 parts of frankincense and 10 parts of myrrh.

[0059] Example 4

[0060] The composition comprises, by weight, 10 parts of peach kernel, 10 parts of safflower, 15 parts of raw rehmannia, 15 parts of angelica, 10 parts of red peony root, 9 parts of ligusticum chuanxiong, 15 parts of salvia miltiorrhiza, 10 parts of yanhusuo, 9 parts of notopterygium root, 9 parts of pubescens, 9 parts of siler, 3 parts of processed aconite, 10 parts of tuckahoe, 9 parts of astragalus, 10 parts of cibotium barometz, 10 parts of drynaria, 9 parts of cassia twig, 10 parts of eucommia, 10 parts of lycopodiella cuneata, 9 parts of toosendan, 10 parts of cyathula capitata, 10 parts of mistletoe, 10 parts of frankincense and 10 parts of myrrh.

[0061] The preparation method of the Chinese medicine composition of Examples 1-4 is:

[0062] Grind frankincense, myrrh, salvia miltiorrhiza, lycopodiella ciliata, safflower, saposhnikovia divaricata, and rhizoma cyrtonema into fine powder, sieve (100 mesh sieve), grind into fine powder, and prepare mixed powder.

[0063] Extract the effective ingredients from the remaining medicine and make it into black plaster.

[0064] 1. To extract the active ingredients, first soak it in sesame oil for 8 hours, then heat the oil to about 220℃, remove the residue from the fried liquid and keep the medicinal oil.

[0065] 2. Oil refining: Continue to boil the above medicinal oil until the temperature of the medicinal oil reaches 320℃, so as to refine water drops into pearls.

[0066] 3. Fry the red shengdan until dry, remove the water, pass through a 100-mesh sieve, put the red shengdan in a fine sieve and sprinkle it evenly in the oil, and mix it thoroughly. For every 500 ml of oil, add 240g of red shengdan in summer, 180g in winter, and 210g in spring and autumn.

[0067] 4. To remove fire poison, pour the refined plaster slowly into the pre-prepared tank in a thin stream, stir in one direction to make the plaster into a clumping mass, and soak for 7 days.

[0068] 5. To make the plaster, place the plaster for removing heat and poison in a pot and heat it over low heat to melt it. The temperature should be controlled at 60-80℃. After spreading it, sprinkle the powder on it.

[0069] The efficacy of this Chinese medicine composition: promoting blood circulation and removing blood stasis, unblocking meridians and activating collaterals, benefiting the liver and kidneys, strengthening tendons and bones, removing rheumatism and relieving pain. By adjusting the dosage of the drug, the efficacy of the drug is emphasized. Example 1 focuses on promoting blood circulation and removing blood stasis, unblocking meridians and relieving pain; Example 2 focuses on warming the meridians and dispelling cold, removing rheumatism and relieving pain; Example 3 focuses on tonifying the liver and kidneys, strengthening tendons and bones, unblocking collaterals and relieving pain; Example 4 is for patients whose syndrome differentiation is not very obvious. Combined with TCM syndrome differentiation and treatment, it is applied to patients with different syndromes. This Chinese medicine composition is made into a plaster for external application to treat patients with lumbar disc herniation accompanied by radiculopathy. Referring to the "Clinical Guidance Principles for New Chinese Medicines" and combined with the research progress of this disease, the course of treatment is 28 days. Take 1 course of treatment as the experimental observation time. 1 patch per week, a total of 4 patches for 1 course of treatment.

[0070] Experimental Example 1

[0071] The present invention has conducted a systematic clinical study on 120 patients with lumbar disc herniation and radiculopathy, all of whom were from Zoucheng Traditional Chinese Medicine Hospital. From June 2021 to December 2022, patients who were diagnosed and treated in the outpatient clinic and met the requirements for inclusion in the study were excluded, and all patients were diagnosed by clinical physical examination, lumbar disc CT and other examinations.

[0072] The efficacy was evaluated by evaluating the patient's visual analog pain score (VAS), lumbar spine function score (JOA) and other evaluation indicators. The efficacy evaluation criteria are as follows:

[0073] 1. Visual Analog Scale (VAS) to assess pain severity: Draw a long straight line on paper and divide it into 10 equal parts. The closest point represents no pain and is recorded as 0, the farthest point represents the most severe pain and is recorded as 10, and the middle is divided into nine points representing different pain severity. Measure the patient once before and after treatment.

[0074] 2. Judgment criteria of efficacy of lumbar spine function score (JOA)

[0075] Clinical control: Low back and leg pain is basically eliminated, straight leg raising test is negative, normal work is resumed, symptoms, signs and daily activity scores are improved by ≥ 90%

[0076] Clinically significant effect: Low back and leg pain was partially eliminated, straight leg raising test was negative, normal work was basically restored, symptoms, signs and daily activity scores improved by 70%-89%

[0077] Clinical progress: mild back and leg pain, suspected positive straight leg raising test, partial recovery of normal work, symptoms, signs and daily activity scores improved by 50%-69%

[0078] Clinical ineffectiveness: no improvement in low back and leg pain, positive straight leg raising test, inability to work normally, improvement in symptoms, signs and daily activity scores <50%

[0079] Improvement rate = [(post-treatment score - pre-treatment score) / (full score 29 points - pre-treatment score)] × 100%

[0080] Treatment group: 30 cases were selected according to the random number table method according to the order of consultation and were treated with the medicine of the present invention for one course of treatment.

[0081] Control group: 30 cases were randomly selected according to the order of visit and were treated with oral methylcobalamin tablets and ibuprofen sustained-release capsules for one course of treatment.

[0082] There was no significant difference in age, gender, condition, and course of disease between the two groups of patients after statistical processing.

[0083] Treatment method: Treatment group: Apply to the affected intervertebral disc, 1 patch per week, 4 patches for a course of treatment. Control group: Oral administration of methylcobalamin tablets, 0.5 mg, three times a day, for 28 days; oral administration of ibuprofen sustained-release capsules, 0.3 g, twice a day, for 7 days.

[0084] Observation indicators and methods

[0085] Refer to the standards of "Clinical Guidance for New Chinese Medicines" and "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes".

[0086] In the treatment group, there were 60 cases, 15 were cured, 21 were markedly effective, 19 were effective, 5 were ineffective, and the total effective rate was 91.67%; in the control group, there were 60 cases, 9 were cured, 18 were markedly effective, 21 were effective, 13 were ineffective, and the total effective rate was 78.3%. The difference in the effective rate between the two groups was statistically significant, and the treatment group was significantly better than the control group.

[0087] Through the following clinical cases, TCM syndrome differentiation and treatment were given, and this preparation was applied, referring to the "Clinical Guidance Principles for New Chinese Medicines" and combined with the research progress of this disease. The course of treatment was 28 days, 1 patch per week, and a total of 4 patches as a course of treatment. All the patients were from Zoucheng Traditional Chinese Medicine Hospital.

[0088] Case 1

[0089] Sun, female, 45 years old, visited the hospital on June 28, 2022.

[0090] Chief complaint: pain in waist and left buttock accompanied by numbness and pain in left lower limb for more than 1 year, aggravated and unfavorable waist movement for more than half a month. One year ago, the patient had pain in waist, left buttock, numbness and pain in the back of left lower limb and the outside of left calf without obvious reason. Oral medication, acupuncture, massage treatment, significantly relieved after treatment, symptoms recurred from time to time, half a month ago, the symptoms worsened after bending over to work, and unfavorable waist pain and movement symptoms appeared, the pain was like a needle prick when it was severe, and the symptoms worsened when turning over and bending over; oral medication, acupuncture, massage treatment, the effect was not good, for further treatment, he came to our hospital for treatment. Chinese medicine inspection, smell, palpation: the complexion is good, the voice is strong, the breath is even, there is no special smell, the tongue coating is thin and white, the tongue is dark with ecchymosis, and the pulse is stringy and astringent. Physical examination: gait is normal, lumbar physiological curvature becomes shallow, waist and left buttocks have obvious tenderness points, waist activity is limited, straight leg raising test left (-), right (-), strengthening test (+), left buttocks and left lower limb lateral, posterior radiating pain, left calf lateral palpation contrast right calf lateral sensitivity is high, left calf medial, left dorsum of foot palpation contrast right calf medial, right dorsum of foot no difference, both lower limb muscle strength and muscle tension are normal, toe end blood flow sensory activity can. CT shows: 1, lumbar degeneration 2, L2 / 3, L3 / 4, L5 / S1 intervertebral disc herniation 3, L4 / 5 intervertebral disc bulge. Diagnosed as: Chinese medicine diagnosis: low back pain (stagnation of qi and blood stasis), Western medicine diagnosis: lumbar disc herniation with radiculopathy. It is suggested that the patient be hospitalized, but the patient refuses, and the black plaster prepared by embodiment 1 is applied externally on the affected part of the lumbar spine in the outpatient department, and each patch is applied for 7 days, and 4 patches are a course of treatment. After applying 2 patches, the symptoms were significantly relieved, and after applying another 2 patches, the symptoms basically disappeared. A telephone follow-up was made 1 month later, and the symptoms disappeared, and the effect was satisfactory.

[0091] Case 2

[0092] Ding, female, 56 years old, visited the hospital on October 12, 2021.

[0093] Chief complaint: low back pain accompanied by numbness and pain in the right lower limb for more than one month, aggravated for 5 days. The patient developed low back pain and numbness and pain in the right lower limb after a lumbar sprain one month ago. He had received infusion treatment, and the symptoms were relieved after treatment. Five days ago, the above symptoms worsened after he stood up from sitting for a long time. The anterior medial calf was obviously numb, and the pain was more severe when flexing and extending the waist. The relief was not obvious after rest, so he came to our hospital for treatment. Chinese medicine inspection, smell, and palpation: the complexion is good, the voice is strong, the breathing is even, there is no special smell, the tongue coating is pale, the tongue is dark purple, and the pulse is stringy. Physical examination: the physiological curvature of the lumbar spine has become shallow, and the tenderness on both sides of the 3rd, 4th, and 5th vertebrae is obvious. The straight leg raising test is left (-) and right (+). The sensitivity of palpation of the anterior medial side of the right calf is high compared with that of the anterior medial side of the right calf, and the muscle strength of both lower limbs is normal. CT shows: 1. Lumbar degeneration 2. L2 / 3, L4 / 5 intervertebral disc bulging 3. L3 / 4 intervertebral disc protruding to the right 4. L5 / S1 intervertebral disc protrusion. Chinese medicine diagnosis: low back pain (Qi stagnation and blood stasis), Western medicine diagnosis: lumbar disc protrusion with radiculopathy. Give the black plaster prepared in Example 1 to apply the affected part in the 3rd and 4th parts of the lumbar spinous process as the center, each patch is applied for 7 days, and 4 patches are a course of treatment. After applying 1 patch, the symptoms are alleviated, and after continuing to apply 3 patches, the symptoms disappear basically. Telephone return visit after 1 month, the patient's self-reported normal work and life, the symptoms disappear, and the effect is satisfactory.

[0094] Case 3

[0095] Mr. Yang, male, 63 years old, visited the hospital on July 16, 2021.

[0096] Chief complaint: numbness and pain in both lower limbs for more than 3 years, aggravated for 1 week. The patient developed numbness in both lower limbs after being tired and cold 3 years ago, especially in the left lower limb. The symptoms worsened every time it was cloudy, rainy, and cold. Hot compress treatment relieved the symptoms. The symptoms worsened after using air conditioning 1 week ago. Chinese medicine inspection, smell, and palpation: the complexion is good, the voice is low, the breath is even, there is no special smell, the tongue is pale, the tongue coating is white and greasy, and the pulse is slow. Physical examination: normal gait, shallow lumbar physiological curvature, obvious tender points in the waist and buttocks, cord-like nodules can be touched, waist movement is good, straight leg raising test left (+), right (-), bilateral anterolateral calf and dorsum of foot skin palpation feels thick skin, bilateral lower limb muscle strength and muscle tension are normal, and toe blood flow sensation activity is good. CT shows: 1. Lumbar vertebral bone hyperplasia 2. L4 / 5, L5 / S1 intervertebral disc herniation. Diagnosis: Chinese medicine diagnosis: low back pain (cold dampness obstruction), Western medicine diagnosis: lumbar disc herniation with radiculopathy. The black plaster prepared in Example 2 was applied externally on the 4th, 5th and sacral 1 parts of the lumbar spine for 1 course of treatment. A telephone follow-up was made 1 month later, and the symptoms of numbness and pain in the lower limbs were basically gone, and the effect was satisfactory.

[0097] Case 4

[0098] Kong, female, 68 years old, visited the hospital on November 9, 2021.

[0099] Chief complaint: low back pain accompanied by numbness of right lower limb for more than 10 years, aggravated for more than 2 months. The patient developed low back pain after fatigue 10 years ago, dull pain, no treatment, gradually developed numbness of right thigh lateral and anterolateral calf, intermittent oral medication, symptoms recurred from time to time, 2 months ago felt sore waist, weakness, lower limb numbness aggravated. Chinese medicine observation, smell, palpation: the complexion is good, the voice is weak, the breath is even, no special smell, the tongue is pale and thin, the pulse is deep and fine. Physical examination: normal gait, shallow lumbar physiological curvature, tender points on both sides of the lumbar spine and iliac spine, nodules can be touched, waist movement is good, straight leg raising test left (-), right 60° (+), right anterolateral palpation of the right calf is less sensitive than the left calf, the muscle strength and muscle tension of both lower limbs are normal, and the blood flow sensation and activity of the toes are good. CT showed: 1. Lumbar degeneration 2. L2 / 3, L3 / 4 intervertebral disc bulge and protrude, compressing the dura mater sac 3. L4 / 5, L5 / S1 intervertebral disc protrusion. Diagnosis: Chinese medicine diagnosis: low back pain (liver and kidney deficiency), Western medicine diagnosis: lumbar disc protrusion with radiculopathy. The black plaster prepared in Example 3 was applied externally to the affected part of the lumbar spine. A telephone visit was made one month later, and the symptoms disappeared, with satisfactory results.

[0100] Case 5

[0101] Li, female, 61 years old, visited the hospital on September 22, 2022.

[0102] Chief complaint: low back pain accompanied by numbness of the left lower limb for more than one month. The patient had low back pain and numbness of the left thigh lateral side without obvious reasons one month ago. The symptoms did not worsen after fatigue or cold, and the waist movement was OK. Since the onset of the disease, there was no aversion to cold, fever, headache, dizziness, good appetite, and normal bowel movements. Chinese medicine observation, smell, and palpation: the complexion was OK, the voice was strong, the breath was even, there was no special smell, the tongue was pale with thin fur, and the pulse was slow. Physical examination: normal gait, shallow lumbar physiological curvature, no obvious tenderness points on both sides of the lumbar spine and the iliac spine, the waist movement was OK, the straight leg raising test was left (-), right (-), no abnormalities were found in palpation of both lower limbs, the muscle strength and muscle tension of both lower limbs were normal, and the blood supply and sensory activity of the toes were OK. CT showed: 1. Lumbar degeneration 2. L2 / 3, L3 / 4 intervertebral disc bulged and protruded, compressing the dura mater sac 3. L4 / 5, L5 / S1 intervertebral disc bulged. Diagnosis: Chinese medicine diagnosis: low back pain, Western medicine diagnosis: lumbar disc herniation with radiculopathy. The black plaster prepared in Example 4 was applied to the lumbar spine with the 3 / 4 spinous process as the center. After 1 course of treatment, a telephone visit was made and the symptoms basically disappeared, with satisfactory results.

[0103] Case 6

[0104] Mr. Xu, male, 55 years old, visited the hospital on May 18, 2022.

[0105] Chief complaint: low back pain, numbness and pain in the right buttocks and right lower limb for more than half a year. The patient developed low back pain after being tired and cold half a year ago. The low back pain is mainly on both sides of the spine, the pain is not severe, the waist can move, and the right iliac spine, buttocks, and the back of the right lower limb are numb and painful. Chinese medicine inspection, smell, and palpation: the complexion is good, the voice is strong, the breath is even, there is no special smell, the tongue is pale with thin white fur, and the pulse is gentle. Physical examination: normal gait, shallow lumbar physiological curvature, tenderness on both sides of the lumbar spine, tenderness on the right iliac spine, buttocks, and the back of the right lower limb, the waist can move, straight leg raising test left (-), right (-), no abnormalities in palpation of both lower limbs, normal muscle strength and muscle tension of both lower limbs, and the blood supply and sensory activity of the toes can be felt. CT shows: 1. Lumbar bone hyperplasia, lumbar degeneration 2. L2 / 3, L3 / 4 intervertebral disc bulging, compressing the dura mater sac 3. L4 / 5, L5 / S1 intervertebral disc herniation. Diagnosis: Chinese medicine diagnosis: low back pain, Western medicine diagnosis: lumbar disc herniation with radiculopathy. The black plaster prepared in Example 4 was applied to the lumbar spine with the 3rd and 4th vertebrae as the center. After 2 patches, the symptoms were significantly relieved. After 1 course of treatment, a telephone visit showed that the symptoms basically disappeared, and the effect was satisfactory.

[0106] Experimental Example 2

[0107] Inflammatory factor test:

[0108] 3 mL of blood was drawn from the patient's cubital vein, sealed in a test tube, and centrifuged and a small amount of the supernatant was taken for enzyme-linked immunosorbent assay (ELISA) detection. The tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and other indicators were recorded before and after treatment. The number of participants was 50.

[0109] Table 1 Comparison of inflammatory factors between the two groups

[0110]

[0111] The experimental results show that the Chinese medicine composition of the present invention has an inhibitory effect on TNF-α and IL-1β, and achieves the purpose of relieving radicular pain by inhibiting inflammatory factors such as TNF-α and IL-1β.

[0112] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy, characterized in that: The composition comprises, by weight, 5-10 parts of peach kernel, 3-10 parts of safflower, 10-15 parts of raw rehmannia, 5-15 parts of angelica, 5-12 parts of red peony root, 3-9 parts of ligusticum chuanxiong, 5-15 parts of salvia miltiorrhiza, 3-10 parts of corydalis, 3-9 parts of notopterygium root, 3-9 parts of angelica pubescens, 4.5-9 parts of siler, 1.5-3 parts of processed chuanwu, 5-10 parts of tuckahoe, 9-30 parts of astragalus, 6-12 parts of cibotium barometz, 10-15 parts of drynaria, 3-9 parts of cassia twig, 10-15 parts of eucommia bark, 3-12 parts of lycopodiella cuneata, 4.5-9 parts of toosendan, 6-15 parts of cyathula, 9-15 parts of mistletoe, 3-10 parts of frankincense and 3-10 parts of myrrh; The preparation method of the Chinese medicine composition for treating lumbar disc herniation accompanied by radiculopathy comprises the following steps: (1) crushing frankincense, myrrh, salvia miltiorrhiza, lycopodiella ciliata, safflower, siler, and cyathula officinalis to prepare a mixed powder; (2) Mix and soak peach kernel, Radix Rehmanniae, Radix Angelicae Sinensis, Radix Paeoniae Rubrae, Rhizoma Chuanxiong, Rhizoma Corydalis, Rhizoma Notopterygii, Radix Angelicae Pubescentis, processed Rhizoma Chuanwu, Poria, Radix Astragali, Rhizoma Cibotii, Rhizoma Drynariae, Rhizoma Cinnamomi, Rhizoma Eucommiae, Fructus Toosendan, Herba Viscum Alatae and sesame oil, and heat the sesame oil to obtain a medicinal oil; (3) heating the drug oil to 320-330° C. to obtain an oil liquid; (4) adding Hongshengdan to the oil, mixing, and preparing a plaster; (5) pouring the refined plaster into a container, stirring it into a mass, and soaking it for 3-7 days to obtain a plaster for removing fire poison; (6) heating the plaster for removing heat and poison, and sprinkling the mixed powder obtained in step (1) on it to obtain a finished product.

2. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: The composition, by weight, includes 10 parts of peach kernel, 10 parts of safflower, 15 parts of raw rehmannia, 15 parts of angelica, 10 parts of red peony root, 9 parts of ligusticum chuanxiong, 15 parts of salvia miltiorrhiza, 10 parts of yanhusuo, 9 parts of notopterygium root, 9 parts of pubescens, 9 parts of siler, 3 parts of processed aconite, 10 parts of tuckahoe, 9 parts of astragalus, 10 parts of cibotium barometz, 10 parts of drynaria, 9 parts of cassia twig, 10 parts of eucommia, 10 parts of smilax china, 9 parts of toosendan, 10 parts of cyathula, 10 parts of mistletoe, 10 parts of frankincense and 10 parts of myrrh.

3. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: The mixed powder in step (1) is passed through a 80-100 mesh sieve.

4. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: In step (2), the mixing and soaking time is 7.5-8.5 hours.

5. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: In step (2), the sesame oil is heated to 200-230°C.

6. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: In step (4), the mass ratio of Hongshengdan to oil is 500mL:180-240g.

7. The Chinese medicine composition for treating lumbar disc herniation with radiculopathy according to claim 1, characterized in that: In step (6), the heating temperature of the plaster for removing heat poison is 60-80°C.

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