Externally-applied traditional Chinese medicine composition for treating waist and leg pain and preparation method of externally-applied traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and particularly discloses an externally applied traditional Chinese medicine composition for treating lumbocrural pain and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 10 to 15g of radix angelicae sinensis, 8 to 12g of rhizoma chuanxiong, 8 to 12g of frankincense, 8 to 12g of myrrh, 8 to 12g of caulis spatholobi, 3 to 8g of yellow ginger, 8 to 12g of rhizoma drynariae, 8 to 12g of herba lycopodii, 8 to 12g of sticktight, 8 to 12g of radix puerariae, 10 to 15g of cortex eucommiae, 10 to 15g of herba taxilli, 10 to 15g of radix rehmanniae, 3 to 8g of cortex phellodendri, 3 to 8g of radix scutellariae, 8 to 12g of ramulus uncariae cum uncis, 3 to 8g of semen cassiae, 3 to 8g of rhizoma gastrodiae, 8 to 12g of radix angelicae and 10 to 15g of rumex nepalensis. The traditional Chinese medicine has the beneficial effects that through scientific compatibility, the Chinese angelica and the ligusticum wallichii which are used for promoting blood circulation to remove blood stasis and the lycopodium clavatum and the sticktight which are used for dispelling wind and eliminating dampness cooperate to improve local microcirculation and eliminate inflammatory edema; eucommia ulmoides and loranthus parasiticus which are liver and kidney tonifying medicines enhance the tissue repair capacity. Heat-clearing collateral-dredging medicines such as cortex phellodendri and radix scutellariae can inhibit inflammatory response and reduce skin irritation.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, in particular to an external application traditional Chinese medicine composition for treating waist and leg pain and a preparation method thereof. Background Art

[0002] Low back and leg pain is a common clinical symptom, often caused by invasion of wind, cold, and dampness, poor circulation of Qi and blood, or trauma and strain. It is commonly seen in conditions such as lumbar disc herniation, sciatica, and arthritis. Currently, Western medicine treatments often use nonsteroidal anti-inflammatory drugs, physical therapy, or surgical intervention, but these methods are associated with significant side effects and a high risk of recurrence. Traditional Chinese medicine (TCM) external treatments primarily involve the application of Chinese herbal medicines, which, through transdermal absorption, activate blood circulation, dispel wind and dampness, and relax tendons and meridians. These treatments are characterized by significant efficacy and high safety.

[0003] Existing topical Chinese medicine formulas often use a single ingredient to promote blood circulation or dispel dampness, such as safflower and frankincense-based compresses. However, these formulas have limited effectiveness in alleviating deep-seated cold-dampness blockages. Formulas containing Chuanwu and Caowu, while effective in warming the meridians and dispelling cold, have toxic components that can easily cause skin irritation. Therefore, there is an urgent need to develop a topical Chinese medicine composition with streamlined ingredients, scientifically formulated ingredients, and both high efficacy and safety to meet clinical needs. Summary of the Invention

[0004] The present invention is to solve the above problems and proposes an external application Chinese medicine composition for treating waist and leg pain and a preparation method thereof.

[0005] The technical solution of the present invention is achieved as follows:

[0006] A Chinese medicine composition for external application for treating waist and leg pain, comprising the following components by weight:

[0007] Angelica 10-15 grams, Chuanxiong 8-12 grams, frankincense 8-12 grams, myrrh 8-12 grams, Millettia reticulata 8-12 grams, turmeric 3-8 grams, Drynaria fortunei 8-12 grams, Lycopodiella striata 8-12 grams, Bidens pilosa 8-12 grams, Pueraria lobata 8-12 grams, Eucommia ulmoides 10-15 grams, Viscum album 10-15 grams, Rehmannia glutinosa 10-15 grams, Phellodendron amurense 3-8 grams, Scutellaria baicalensis 3-8 grams, Uncaria rhynchophylla 8-12 grams, Cassia seed 3-8 grams, Gastrodia elata 3-8 grams, Angelica dahurica 8-12 grams, Rheum officinale 10-15 grams.

[0008] Furthermore, the invention comprises the following components by weight: 12 grams of angelica sinensis, 10 grams of chuanxiong, 10 grams of frankincense, 10 grams of myrrh, 10 grams of millettia reticulata, 5 grams of turmeric, 10 grams of drynaria rhizome, 10 grams of striata herb, 10 grams of bidens pilosa, 10 grams of kudzu root, 12 grams of eucommia ulmoides, 12 grams of mistletoe, 12 grams of rehmannia glutinosa, 5 grams of phellodendron amurense, 5 grams of scutellaria baicalensis, 10 grams of uncaria rhynchophylla, 5 grams of cassia seed, 5 grams of gastrodia elata, 10 grams of angelica dahurica, and 12 grams of rheum officinale.

[0009] A method for preparing an external application Chinese medicine composition for treating waist and leg pain comprises the following steps:

[0010] Step 1: Pretreatment of medicinal materials:

[0011] Dry the medicinal materials containing volatile oil components, such as turmeric, gastrodia elata, angelica dahurica, Chuanxiong, and angelica sinensis, at a low temperature of 40-50°C until the humidity is ≤15% to avoid high temperature damage to the active ingredients;

[0012] The resinous medicinal materials frankincense and myrrh are made into vinegar to reduce irritation and enhance the blood circulation effect;

[0013] The woody medicinal materials including Eucommia ulmoides, Morus alba, Pueraria root, Uncaria rhynchophylla, Drynaria fortunei, Millettia reticulata, Phellodendron amurense, Scutellaria baicalensis, Rehmannia glutinosa, Rheum officinale, Cassia seed, Lycopodiella cuneata, and Bidens pilosa are sliced and cut into sections, and then steamed for 20 minutes to soften the fibers to facilitate the release of the effective ingredients.

[0014] Step 2: Crushing in stages:

[0015] Coarsely grind Rehmannia root, Rheum officinale, Drynaria fortunei, Eucommia bark, Morus alba, Pueraria root, Millettia spatholobi, and Herba Lycopodii into 80-100 mesh;

[0016] Grind turmeric, Gastrodia elata, Angelica dahurica, Chuanxiong, Angelica sinensis and Cassia seed into 40-60 mesh size;

[0017] Coarsely crush Bidens pilosa and Uncaria rhynchophylla into 20-40 mesh;

[0018] Frankincense, myrrh, scutellaria baicalensis and phellodendron amurense are ultra-finely ground to above 200 meshes to improve the transdermal absorption rate.

[0019] Step 3: Mixing: Mix the crushed herbs evenly.

[0020] Step 4: Matrix preparation and paste formation: Mix honey and rice vinegar in a mass ratio of 1:1, heat to 50-60°C, and slowly add to the medicinal powder while stirring at a speed of 200-300 rpm to form a uniform paste.

[0021] Step 5: Multi-stage sterilization:

[0022] After applying the ointment on sterile gauze, it was irradiated with ultraviolet light for 30 minutes for primary sterilization;

[0023] After packaging, place it in a low-temperature steam sterilizer for 30 minutes for final sterilization at a sterilization temperature of 60°C and a pressure of 0.1 MPa to avoid high temperature destroying the efficacy of the drug.

[0024] Step 6. Packaging and storage: Vacuum package with aluminum foil composite film, protect from light and moisture, and store in a cool and dry place.

[0025] Furthermore, the frankincense and myrrh vinegar in step 1 are soaked in rice vinegar for 24 hours.

[0026] Furthermore, in step 4, when the drug powder becomes a paste, 1%-3% of a transdermal enhancer is added and stirring is continued for 10 minutes to enhance drug permeability.

[0027] Analysis of the medicinal properties of the medicine in the present invention:

[0028] Angelica sinensis: Sweet and pungent in flavor, warm in nature, enters the Liver, Heart, and Spleen meridians; its main functions are to nourish blood, activate blood circulation, regulate menstruation and relieve pain, moisten dryness and lubricate the intestines, and treat various symptoms of blood deficiency, irregular menstruation, amenorrhea, dysmenorrhea, accumulation of masses, metrorrhagia, abdominal pain due to deficiency and cold, paralysis, numbness of the skin, constipation due to dry intestines, heaviness after dysentery, carbuncles, ulcers, and injuries from falls;

[0029] Chuanxiong: Pungent in flavor, warm in nature; enters the Liver, Gallbladder, and Pericardium meridians; Functions and indications: Promotes blood circulation and qi, dispels wind and relieves pain; used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to abdominal masses, stabbing pain in the chest and ribs, swelling and pain from falls, headaches, and rheumatic pain.

[0030] Frankincense: Pungent and bitter in taste, warm in nature; enters the heart, liver, and spleen meridians. Functions and indications: regulating qi and activating blood circulation, relieving pain, and expelling toxins; treats qi and blood stagnation, heart and abdominal pain, carbuncle swelling, traumatic injuries, dysmenorrhea, and postpartum blood stasis and stinging pain;

[0031] Myrrh: bitter and pungent in taste, neutral in nature, non-toxic, enters the twelve meridians, functions and indications: dispersing blood and removing blood stasis, reducing swelling and relieving pain; treating falls, wounds, tendons and bones, pain in the heart and abdomen, masses, amenorrhea, swelling and pain in carbuncles, hemorrhoids, and eye problems;

[0032] Millettia reticulata: Bitter, sweet, and warm; enters the liver and kidney meridians; known as a bleeding plant, its functions and indications: tonifying blood, activating blood circulation, and unblocking meridians; combined with angelica sinensis to tonify blood, warm the meridians and activate the collaterals; "New Reference to Medicinal Pieces": Millettia reticulata removes blood stasis, generates new blood, and unclogs the meridians; treats summer heat rash and wind-blood stasis; modern medical research shows it has anti-cancer effects;

[0033] Turmeric: spicy, slightly warm, enters the lung, spleen and stomach meridians; effects: diaphoresis, warming the middle and stopping vomiting, warming the lungs and stopping coughs, detoxifying fish and crabs, and detoxifying drugs;

[0034] Drynaria fortunei: bitter, warm; enters the kidney and liver meridians; functions and indications: tonifies the kidney and strengthens bones, heals injuries and relieves pain; used for kidney deficiency, low back pain, tinnitus and deafness, loose teeth, falls, sprains, fractures and tendons; externally used for alopecia areata and vitiligo;

[0035] Herba Stretching Grass: slightly bitter and pungent in taste, warm in nature; enters the liver, spleen, and kidney meridians; functions and indications: dispels wind and dampness, relaxes tendons and activates collaterals; used for joint pain and difficulty in flexion and extension;

[0036] Bidens pilosa: bitter in taste, slightly cold in nature; enters the liver, lung, and large intestine meridians; benefits: clears heat and detoxifies, promotes blood circulation and dissipates blood stasis; indications: used for colds and fever, sore throat, intestinal carbuncle, snake bites, falls, low back pain, and concussion;

[0037] Pueraria root: sweet, pungent, and cool in flavor; enters the spleen and stomach meridians. Functions and indications: relieves muscle tension, reduces fever, promotes the production of body fluids, promotes the exfoliation of rashes, and relieves diarrhea. It is used for exogenous fever, headache, stiff neck and back pain, thirst, polydipsia, measles that does not break out, dysentery, and diarrhea; and stiff neck and pain due to hypertension.

[0038] Eucommia ulmoides: sweet in flavor, warm in nature; enters the liver and kidney meridians; functions and indications: nourishes the liver and kidneys, strengthens the tendons and bones, and stabilizes pregnancy; treats soreness of the waist and knees, weakness of the feet and knees, dribbling urine, itchy genitals, miscarriage, and hypertension;

[0039] Mulberry parasite: bitter and sweet; neutral in nature; enters the liver and kidney meridians; functions and indications: nourishes the liver and kidneys, strengthens the tendons and bones, dispels rheumatism, and stabilizes pregnancy; used for soreness of the waist and knees, weakness of the tendons and bones, hemiplegia of the limbs, rheumatic pain, dizziness, restless fetuses, and metrorrhagia;

[0040] Rehmannia root: sweet in flavor, warm in nature; enters the liver and kidney meridians; functions and indications: nourishes yin and replenishes blood; treats yin deficiency and blood deficiency, weakness of waist and knees, cough due to fatigue and bone steaming, spermatorrhea, metrorrhagia, irregular menstruation, thirst, frequent urination, deafness, and blurred vision;

[0041] Huang Bai: bitter in taste, cold in nature, enters the kidney meridian, bladder meridian, and large intestine meridian. Functions and indications: clearing away heat and detoxifying, purging fire and drying dampness. It is mainly used to treat acute bacterial dysentery, acute enteritis, acute icteric hepatitis, urinary tract infection and other inflammations. It can also be used externally to treat burns, otitis media, acute conjunctivitis, etc.

[0042] Scutellaria root: bitter in flavor, cold in nature; enters the lung, gallbladder, spleen, large intestine, and small intestine meridians; functions: clears heat and dampness, purges fire and detoxifies, stops bleeding, and stabilizes the fetus; indications: used for damp-heat, summer-heat dampness, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung-heat cough, high fever and thirst, vomiting and epistaxis due to blood heat, carbuncles, sores, and fetal restlessness;

[0043] Uncaria rhynchophylla: sweet, cooling; enters the Liver and Pericardium meridians; functions and indications: clears heat and soothes the liver, calms wind and calms convulsions; used for headaches and dizziness, colds with convulsions, epilepsy and convulsions, eclampsia during pregnancy, and hypertension;

[0044] Cassia seed: sweet, bitter, cold, slightly salty in nature, enters the liver and large intestine meridians, clears the liver and improves eyesight, moistens the intestines and promotes bowel movements, used for red and painful eyes, photophobia and excessive tearing, headache, dizziness, blurred vision, and constipation;

[0045] Gastrodia elata: sweet in taste, neutral in nature; enters the Liver meridian; Functions and indications: soothes the liver, calms wind, and stops spasms; used for headache, dizziness, limb numbness, infantile convulsions, epilepsy, and tetanus;

[0046] Angelica dahurica: Pungent in flavor, warm in nature; enters the lung, spleen, and stomach meridians; functions and indications: dispels cold, dispels wind and relieves pain, clears the nasal passages, dries dampness and stops leukorrhea, reduces swelling and discharges pus, dispels wind and relieves itching; used for colds, headaches, toothaches, rheumatic pain, sinusitis, leukorrhea, sores, carbuncles, and swelling.

[0047] Rhubarb: bitter in taste, cold in nature; enters the spleen, stomach, large intestine, liver, and heart meridians; Efficacy: has the effects of purging and attacking accumulation, clearing away heat and purging fire, cooling blood and detoxifying, removing blood stasis and promoting menstruation, and promoting dampness and jaundice; Indications: Used for constipation caused by excess heat, vomiting and epistaxis due to blood heat, red eyes and swollen throat, carbuncle and sore treatment, abdominal pain due to intestinal carbuncle, amenorrhea due to blood stasis, postpartum blood stasis, traumatic injuries, damp-heat dysentery, jaundice and dark urine, stranguria, edema; external treatment of burns and scalds.

[0048] By adopting the above technical solution, the beneficial effects of the present invention are:

[0049] 1. Through scientific compatibility, the blood-activating and stasis-removing drugs Angelica sinensis and Chuanxiong, along with the wind-removing and dampness-removing drugs Herba Lycopodii and Herba Bidens pilosa, synergize to improve local microcirculation and eliminate inflammatory edema; the liver-tonifying and kidney-tonifying drugs Eucommia ulmoides and Herba Moriparae enhance tissue repair capacity; the heat-clearing and collateral-dredging drugs Phellodendron chinense and Radix Scutellariae baicalensis inhibit inflammatory responses and reduce skin irritation;

[0050] 2. Abandon toxic ingredients such as Chuanwu and Caowu, and choose natural and mild medicinal materials, suitable for long-term external application;

[0051] 3. Low-temperature crushing technology is used to retain the activity of the active ingredients, and honey and rice vinegar are used as the matrix to enhance the transdermal absorption rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0053] Figure 1 is a table of clinical trial results of the present invention; DETAILED DESCRIPTION

[0054] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0055] A traditional Chinese medicine composition for external application for treating pain in the waist and legs comprises the following components by weight: 12 grams of angelica sinensis, 10 grams of chuanxiong, 10 grams of frankincense, 10 grams of myrrh, 10 grams of millettia reticulata, 5 grams of zingiber officinale, 10 grams of drynaria rhizome, 10 grams of striata herb, 10 grams of bidens pilosa, 10 grams of kudzu root, 12 grams of eucommia ulmoides, 12 grams of mistletoe, 12 grams of rehmannia root, 5 grams of phellodendron amurense, 5 grams of scutellaria baicalensis, 10 grams of uncaria rhynchophylla, 5 grams of cassia seed, 5 grams of gastrodia elata, 10 grams of angelica dahurica, and 12 grams of rheum officinale.

[0056] A method for preparing an external application Chinese medicine composition for treating waist and leg pain comprises the following steps:

[0057] Step 1: Pretreatment of medicinal materials:

[0058] Dry the medicinal materials containing volatile oil components, such as turmeric, gastrodia elata, angelica dahurica, Chuanxiong, and angelica sinensis, at a low temperature of 40-50°C until the humidity is ≤15% to avoid high temperature damage to the active ingredients;

[0059] The resinous medicinal materials frankincense and myrrh are made into vinegar to reduce irritation and enhance the blood circulation effect;

[0060] The woody medicinal materials including Eucommia ulmoides, Morus alba, Pueraria root, Uncaria rhynchophylla, Drynaria fortunei, Millettia reticulata, Phellodendron amurense, Scutellaria baicalensis, Rehmannia glutinosa, Rheum officinale, Cassia seed, Lycopodiella cuneata, and Bidens pilosa are sliced and cut into sections, and then steamed for 20 minutes to soften the fibers to facilitate the release of the effective ingredients.

[0061] Step 2: Crushing in stages:

[0062] Grind Rehmannia root, Rheum officinale, Drynaria fortunei, Eucommia bark, Morus alba, Pueraria root, Millettia spatholobi, and Herba Lycopodii into 80-100 meshes using a shearing grinder. Control the humidity to ≤12% to prevent adhesion. Steam and soften the herbs before grinding. Grinding increases their specific surface area, promoting the release of water-soluble components (such as catalpol in Rehmannia root).

[0063] Grind turmeric, Gastrodia elata, Angelica dahurica, Chuanxiong, Chinese angelica, and Cassia seed to a medium size of 40-60 mesh. Add inert gas protection (such as nitrogen) during the grinding process to reduce the loss of volatile oil and balance the retention and release efficiency of the components. The Cassia seed needs to be shelled before grinding.

[0064] Coarsely grind Bidens pilosa and Uncaria rhynchophylla into 20-40 meshes using a hammer crusher to avoid oxidation of active ingredients caused by excessive grinding;

[0065] Frankincense, myrrh, scutellaria baicalensis, and phellodendron amurense are ultrafinely ground to above 200 mesh to improve transdermal absorption rate. Low-temperature airflow grinding technology (temperature ≤ 40°C) is used to avoid damage to the ingredients caused by frictional heat. When the frankincense is ground to 200 mesh, the dissolution rate of ferulic acid increases by 25%.

[0066] Step 3: Mixing: Mix the crushed herbs evenly.

[0067] Step 4: Matrix preparation and paste formation: Mix honey and rice vinegar in a mass ratio of 1:1, heat to 50-60°C, and slowly add to the medicinal powder while stirring at a speed of 200-300 rpm to form a uniform paste.

[0068] Step 5: Multi-stage sterilization:

[0069] After applying the ointment on sterile gauze, it was irradiated with ultraviolet light for 30 minutes for primary sterilization;

[0070] After packaging, place it in a low-temperature steam sterilizer for 30 minutes for final sterilization at a sterilization temperature of 60°C and a pressure of 0.1 MPa to avoid high temperature destroying the efficacy of the drug.

[0071] Step 6. Packaging and storage: Vacuum package with aluminum foil composite film, protect from light and moisture, and store in a cool and dry place.

[0072] In this embodiment, the frankincense and myrrh vinegar in step 1 are soaked in rice vinegar for 24 hours.

[0073] In this embodiment, in step 4, after the drug powder becomes a paste, 1%-3% of azone, a transdermal enhancer, is added, and stirring is continued for 10 minutes to enhance drug permeability.

[0074] Dosage and Administration: Apply externally to the affected area 1-2 times a day, each time for 0.5-1 hour. One course of treatment is 7 consecutive days.

[0075] Pharmacological analysis:

[0076] Eucommia ulmoides, mistletoe, and drynariae are the main herbs. Eucommia ulmoides: warm in nature, enters the liver and kidney meridians, nourishes the liver and kidneys, strengthens the tendons and bones, and targets liver and kidney deficiency, the root cause of low back and leg pain. Mistletoe: dispels rheumatism, nourishes the liver and kidneys, and also nourishes blood, strengthening tendons and bones. Drynariae: nourishes the kidneys and strengthens bones, heals injuries, and relieves pain, specifically treating injuries from falls and kidney deficiency and low back pain. Together, these three herbs serve as the main herbs, directly replenishing liver and kidney deficiency, strengthening tendons and bones, and fundamentally addressing the underlying cause of low back and leg pain.

[0077] Angelica sinensis, Chuanxiong rhizome, frankincense, myrrh, and Millettia spatholobi serve as assistant herbs. Angelica sinensis and Chuanxiong rhizome: invigorate blood circulation, promote qi circulation, and relieve pain, alleviating localized pain caused by qi and blood stasis. Frankincense and myrrh: resin-based herbs that invigorate blood circulation, dissipate blood stasis, reduce swelling, and alleviate pain, making them particularly effective in treating traumatic injuries and intractable pain. Millettia spatholobi: invigorate blood circulation, invigorate blood circulation, relax tendons and activate collaterals, and unblock joints. These herbs assist the main herbs in dredging the meridians, eliminating blood stasis, and alleviating pain, addressing the pathological mechanism of "pain due to obstruction."

[0078] Herba Lycopodii, Herba Bidens, Uncaria rhynchophyllae, Gastrodia elata, Phellodendron amurense, Scutellaria baicalensis, and Cassia seed serve as adjuvants, acting both synergistically and restrictively. Herba Lycopodii and Herba Bidens: dispel wind and dampness, relax tendons and activate collaterals, and relieve joint stiffness caused by rheumatic obstruction. Uncaria rhynchophyllae and Gastrodia elata: calm the liver and calm wind, targeting pain caused by internal liver wind or tendon spasms (such as sciatica). Phellodendron amurense and Scutellaria baicalensis: clear heat and dry dampness, preventing prolonged stasis from turning into heat or accumulation of damp-heat. Cassia seed: clears the liver and improves eyesight, also moistening the intestines, assisting in clearing heat without damaging yin. Dispel wind and dampness to eliminate external pathogens, calm the liver and clear heat to control internal wind, preventing the dominant and auxiliary herbs from being excessively warm and dry. Combined cold and warm herbs are used to harmonize the medicinal properties and avoid skin irritation from topical applications.

[0079] Angelica dahurica, Pueraria root, Turmeric (Zhilong), and Rhubarb are guiding herbs, acting as both meridian guides and harmonizers. Angelica dahurica: Pungent and warm, dispersing wind and relieving pain, guides the herbs upward to the head, face, and body surface, enhancing transdermal absorption. Pueraria root: Soothes muscles, reduces fever, elevates yang, and clears rashes, guiding the herbs deep into the muscle fascia. Turmeric (Zhilong): Invigorates blood circulation and qi, guiding the herbs into the bloodstream and enhancing local penetration. Rhubarb: Clears heat and detoxifies, cools blood and disperses blood stasis, preventing blood heat and stasis, while also acting as a harmonizer. It guides the herbs directly to the affected area (the waist and legs), harmonizing the overall cold and heat of the formula and promoting transdermal absorption.

[0080] Special compatibility instructions:

[0081] Rehmannia root: nourishes yin and replenishes blood, controls the warming and drying nature of the main and auxiliary herbs, and prevents damage to yin.

[0082] Rhubarb, Phellodendron amurense and Scutellaria baicalensis: The three work together to clear heat, but Rhubarb tends to cool the blood, Phellodendron amurense tends to dry out dampness, and Scutellaria baicalensis tends to purge fire, with a clear division of labor.

[0083] Frankincense and Myrrh: A classic medicinal pair that enhances blood circulation and relieves pain, especially suitable for external application.

[0084] Overall compatibility characteristics:

[0085] Treat both the symptoms and the root cause: the main medicine nourishes the liver and kidneys to treat the root cause, the auxiliary medicine promotes blood circulation and removes blood stasis to treat the symptoms, and the adjuvant medicine eliminates evil and unclogs the meridians.

[0086] Balance of cold and heat: Warming the liver and kidneys and clearing away heat and dampness can be used together to avoid skin heat toxins caused by external application of medicines.

[0087] Transdermal enhancement: Angelica dahurica, Pueraria lobata, turmeric and other meridian-guiding herbs, combined with honey and rice vinegar, significantly improve the transdermal absorption rate.

[0088] Safety: Abandon toxic medicinal materials such as Chuanwu and Strychnos nux vomica, and replace them with Phellodendron amurense and Scutellaria baicalensis to reduce irritation and make it suitable for long-term external application.

[0089] Applicable certificate type:

[0090] Liver and kidney deficiency: Weakness in the waist and knees, aggravated by exertion. Qi and blood stasis: Fixed stabbing pain, worse at night. Rheumatic arthritis: Heaviness in the joints, aggravated by rainy days. Combined damp-heat: Localized redness, swelling, heat, and pain, with a greasy yellow coating on the tongue.

[0091] In summary, the Chinese medicine composition of the present application focuses on nourishing the liver and kidneys, promoting blood circulation and removing blood stasis, supplemented by dispelling wind and dampness, clearing heat and unblocking meridians. The main, secondary, auxiliary and guiding ingredients are clearly layered, and both internal and external aspects are cultivated. It targets the complex pathogenesis of low back and leg pain, while taking into account the safety and permeability of external application preparations, and is in line with the principles of "holistic view" and "differential diagnosis and treatment" of traditional Chinese medicine.

[0092] Clinical trials:

[0093] A total of 120 patients (stratified by main symptoms: 50 cases of lumbar disc herniation, 40 cases of knee arthritis, and 30 cases of frozen shoulder) were treated and observed, including 65 males and 55 females, with a 7-day treatment period and a 7-day follow-up period.

[0094] Drug use:

[0095] Apply externally twice a day (once in the morning and once in the evening), each time for 0.5-1 hour; apply the medicine evenly to the affected area, cover with sterile gauze and fix it. Do not use other analgesics or physical therapy during treatment. Figure 1 .

[0096] Clinical cases:

[0097] Case 1: Zhang, male, 52 years old, suffered from lumbar disc herniation and sciatica. He suffered from low back pain and numbness and weakness in the lower limbs when the disease occurred, and was unable to move. He relied on taking anti-inflammatory and analgesic drugs and nerve nourishing drugs for treatment for 5 years without being cured. After using the medicine of the present invention for 7 days of external application, the pain was relieved and the ability to move was significantly restored.

[0098] Case 2: Ms. Li, 48 years old, suffered from knee arthritis. After long-distance walking or long-term standing, her knee joints became swollen and painful. After using the drug of the present invention for 3 days, the swelling subsided and the pain was relieved.

[0099] 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 principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for external application for treating waist and leg pain, characterized in that: The following components are included in parts by weight: Angelica 10-15 grams, Chuanxiong 8-12 grams, frankincense 8-12 grams, myrrh 8-12 grams, Millettia reticulata 8-12 grams, turmeric 3-8 grams, Drynaria fortunei 8-12 grams, Lycopodiella striata 8-12 grams, Bidens pilosa 8-12 grams, Pueraria lobata 8-12 grams, Eucommia ulmoides 10-15 grams, Viscum album 10-15 grams, Rehmannia glutinosa 10-15 grams, Phellodendron amurense 3-8 grams, Scutellaria baicalensis 3-8 grams, Uncaria rhynchophylla 8-12 grams, Cassia seed 3-8 grams, Gastrodia elata 3-8 grams, Angelica dahurica 8-12 grams, Rheum officinale 10-15 grams.

2. The external application Chinese medicine composition for treating low back and leg pain according to claim 1, characterized in that: The ingredients include the following by weight: 12 grams of angelica, 10 grams of chuanxiong, 10 grams of frankincense, 10 grams of myrrh, 10 grams of millettia reticulata, 5 grams of turmeric, 10 grams of drynaria, 10 grams of smilax china, 10 grams of bidens pilosa, 10 grams of kudzu root, 12 grams of eucommia, 12 grams of mistletoe, 12 grams of rehmannia, 5 grams of phellodendron, 5 grams of scutellaria, 10 grams of uncaria rhynchophylla, 5 grams of cassia seed, 5 grams of gastrodia elata, 10 grams of angelica dahurica, and 12 grams of rheum officinale.

3. A method for preparing an external application Chinese medicine composition for treating low back and leg pain, characterized in that: The following steps are involved: Step 1: Pretreatment of medicinal materials: Dry the medicinal materials containing volatile oil components, such as turmeric, gastrodia elata, angelica dahurica, Chuanxiong, and angelica sinensis, at a low temperature of 40-50°C until the humidity is ≤15% to avoid high temperature damage to the active ingredients; The resinous medicinal materials frankincense and myrrh are made into vinegar to reduce irritation and enhance the blood circulation effect; The woody medicinal materials including Eucommia ulmoides, Morus alba, Pueraria root, Uncaria rhynchophylla, Drynaria fortunei, Millettia reticulata, Phellodendron amurense, Scutellaria baicalensis, Rehmannia glutinosa, Rheum officinale, Cassia seed, Lycopodiella cuneata, and Bidens pilosa are sliced and cut into sections, and then steamed for 20 minutes to soften the fibers to facilitate the release of the effective ingredients. Step 2: Crushing in stages: Coarsely grind Rehmannia root, Rheum officinale, Drynaria fortunei, Eucommia bark, Morus alba, Pueraria root, Millettia spatholobi, and Herba Lycopodii into 80-100 mesh; Grind turmeric, Gastrodia elata, Angelica dahurica, Chuanxiong, Angelica sinensis and Cassia seed into 40-60 mesh size; Coarsely crush Bidens pilosa and Uncaria rhynchophylla into 20-40 mesh; Frankincense, myrrh, scutellaria baicalensis and phellodendron amurense are ultra-finely ground to above 200 meshes to improve the transdermal absorption rate. Step 3: Mixing: Mix the crushed herbs evenly. Step 4: Matrix preparation and paste formation: Mix honey and rice vinegar in a mass ratio of 1:1, heat to 50-60°C, and slowly add to the medicinal powder while stirring at a speed of 200-300 rpm to form a uniform paste. Step 5: Multi-stage sterilization: After applying the ointment on sterile gauze, it was irradiated with ultraviolet light for 30 minutes for primary sterilization; After packaging, place it in a low-temperature steam sterilizer for 30 minutes for final sterilization at a sterilization temperature of 60°C and a pressure of 0.1MPa to avoid high temperature destroying the efficacy of the drug. Step 6. Packaging and storage: Vacuum package with aluminum foil composite film, protect from light and moisture, and store in a cool and dry place.

4. The method for preparing the external application Chinese medicine composition for treating low back and leg pain according to claim 1, wherein: In the step 1, the frankincense and myrrh vinegar are soaked in rice vinegar for 24 hours.

5. The method for preparing the external application Chinese medicine composition for treating low back and leg pain according to claim 1, wherein: In step 4, when the drug powder becomes a paste, 1%-3% of a transdermal enhancer is added and the mixture is stirred for 10 minutes to enhance drug permeability.

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