Tendon relaxing and pain relieving ointment and preparation process thereof
By preparing the Shujin and Disposal Pain of Chinese Medicine, such as angelica, Baiyan, Chuanxiong, etc., the problem of poor efficacy of the existing treatment of fracture muscles was solved, and a significant improvement in acute chronic orthopedic pain and diseases were achieved.
Patent Information
- Application Number
- CN202411436453.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-15
- Publication Date
- 2025-01-28
Smart Images

Figure SMS_2 
Figure SMS_3 
Figure SMS_4
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a muscle-relaxing and pain-relieving ointment and a preparation process thereof. Background Art
[0002] TCM orthopedic diseases include acute and chronic bone diseases, including acute traumatic orthopedic diseases and chronic degenerative orthopedic diseases. TCM orthopedic diseases include a wide range of diseases, the most representative of which include acute traumatic diseases such as distal radius fracture, hip fracture, vertebral compression fracture, as well as degenerative diseases such as lumbar disc herniation, lumbar spinal stenosis and senile osteoarthritis.
[0003] Lumbar disc herniation is a common and frequently occurring clinical disease. In recent years, the incidence rate has been increasing and the patients are getting younger, which has had a serious impact on the patients' work and life. Distal radius fracture is one of the more frequent osteoporotic fractures. Distal radius fracture not only affects the patients' daily life and treatment, but also increases the patients' disability and mortality rates. Elderly knee osteoarthritis not only seriously affects the patients' quality of life, but also increases the risk of comorbidities in patients.
[0004] In the Chinese medicine system, orthopedic pain generally has the clinical characteristics of deficiency of the root and excess of the symptoms; the causes include wind, cold, dampness, qi stagnation, phlegm, sprains, blood stasis, etc.; Qi and blood blockage causes limb pain, and wind, cold and dampness attack, weak qi and blood, and lack of transportation and transformation can lead to the formation of arthritis. Liver and kidney deficiency, weak tendons and bones; or wind, cold and dampness, meridian blockage; or qi stagnation and blood stasis, pain due to blockage. At present, there are many types of external preparations for the treatment of fractures and tendon injuries, and the efficacy is uneven. Therefore, under the treatment concept of treating the symptoms and strengthening the root, it is necessary to provide a muscle-relaxing and pain-relieving ointment that is effective in treating acute and chronic orthopedic pain diseases. Summary of the invention
[0005] The present invention is to solve the above problems and proposes a muscle-relaxing and pain-relieving ointment and a preparation process thereof.
[0006] The technical solution of the present invention is achieved in this way:
[0007] A muscle-relaxing and pain-relieving paste is composed of the following raw materials in parts by weight: 30-80 parts of angelica sinensis, 30-80 parts of white peony root, 30-80 parts of ligusticum chuanxiong, 30-80 parts of pittosporum tobira bark, 30-80 parts of millettia spatholobi, 30-80 parts of cyathulae, 30-80 parts of clematis root, 30-80 parts of angelica dahurica, 30-80 parts of pubescens, 30-80 parts of dipsaccharum officinale, 30-80 parts of atractylodes, 30-80 parts of cassia twig, 30-80 parts of drynaria, 30-80 parts of eucommia, 30-80 parts of corydalis, 30-80 parts of cibotium barometz, 30-80 parts of radix spatholobi, 20-30 parts of frankincense, 20-30 parts of myrrh, 20-30 parts of tuckahoe, 20-30 parts of nyx mandshuricae, 20-30 parts of parsley, 20-30 parts of scorpion, 15,000 parts of small-milled sesame oil, and 5,000 parts of red lead.
[0008] Further, the invention is composed of the following raw materials in parts by weight: 40-60 parts of angelica sinensis, 40-60 parts of white peony root, 40-60 parts of chuanxiong, 40-60 parts of pittosporum tobira bark, 40-60 parts of millettia spatholobi, 40-60 parts of cyathula, 40-60 parts of clematis root, 40-60 parts of angelica dahurica, 40-60 parts of dipsaccharum officinale, 40-60 parts of atractylodes, 40-60 parts of cassia twig, 40-60 parts of drynaria, 40-60 parts of eucommia, 40-60 parts of corydalis, 40-60 parts of cibotium barometz, 40-60 parts of radix polygoni pubescens, 20-30 parts of frankincense, 20-30 parts of myrrh, 20-30 parts of poria, 20-30 parts of henbane fructus, 20-30 parts of parsley, 20-30 parts of scorpion, 15,000 parts of sesame oil, and 5,000 parts of red lead.
[0009] Further, it is composed of the following raw materials in parts by weight: 50 parts of angelica sinensis, 50 parts of white peony root, 50 parts of chuanxiong, 50 parts of pittosporum tobira bark, 50 parts of millettia reticulata, 50 parts of cyathula capitata, 50 parts of clematis root, 50 parts of angelica dahurica, 50 parts of angelica pubescens, 50 parts of dipsaccharum officinale, 50 parts of atractylodes, 50 parts of cassia twig, 50 parts of drynaria, 50 parts of eucommia, 50 parts of corydalis, 50 parts of cibotium bark, 50 parts of radix polygoni lobatae, 25 parts of frankincense, 25 parts of myrrh, 25 parts of poria, 25 parts of henbane fructus, 25 parts of parsley, 25 parts of scorpion, 15,000 parts of sesame oil, and 5,000 parts of red lead.
[0010] A preparation process of a muscle-relaxing and pain-relieving ointment comprises the following steps:
[0011] Step 1: Prepare the raw materials, remove impurities, mildew, and insect-infested Chinese medicinal materials, then clean the Chinese medicinal materials except frankincense and myrrh, dry them in the sun, break them into powder, and pass them through an 80-mesh sieve;
[0012] Step 2: Soaking and decocting; put the crushed Chinese medicinal materials into a decoction container, add sesame oil, soak for 36-48 hours, and then decoct at 300℃-330℃ until the oil is dripping into beads, then stop the fire;
[0013] Step 3: Immediately add red lead, frankincense, and myrrh, stirring constantly to mix well and prevent scorching, until it gradually becomes a thick paste. Spray the ointment with cold water to solidify it. Then, put the ointment in a container, melt it over low heat, add fine ingredients, stir well, and spread the ointment evenly on the plaster cloth to make a plaster patch.
[0014] Sources of Chinese herbal medicines or medicinal materials: The Chinese herbal medicines and medicinal materials used in the preparation of this preparation are purchased from Hubei Yaosheng Chinese Medicine Technology Co., Ltd.; each purchased variety and batch is accompanied by a factory inspection report and certificate of conformity. After inspection and testing by the Xiangyang Public Inspection and Testing Center (inspection is not scheduled), Herba Cynoglossi and Herba Nandinae meet the relevant provisions of the 2018 edition of the "Quality Standards for Traditional Chinese Medicines in Hubei Province" under Herba Cynoglossi and Herba Nandinae; Pittosporum tobira meets the relevant provisions of the 1977 edition of the "Chinese Pharmacopoeia" under Pittosporum tobira; the varieties and quality of the remaining 19 flavors meet the relevant provisions of the 2020 edition of the "Chinese Pharmacopoeia" under the relevant provisions of each item.
[0015] Note: Regarding Paris polyphylla, we used the dried rhizome of Paris polyphylla Smithvar.yunnanensis(Franch.)Hand.-Mazz., a plant of the Liliaceae family.
[0016] The effects of the Chinese medicinal material of the present invention are as follows:
[0017] Angelica: Processing method: remove impurities, wash, moisten thoroughly, cut into thin slices, dry in the sun or at low temperature. Functions and indications: nourish blood and activate blood circulation, regulate menstruation and relieve pain, moisten the intestines and relieve constipation. Used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, asthenic abdominal pain, rheumatic arthralgia, injuries from falls, carbuncle, ulcer, dry intestine and constipation. Wine Angelica activates blood circulation and regulates menstruation. Used for amenorrhea and dysmenorrhea, rheumatic arthralgia, injuries from falls.
[0018] White Peony Root: Preparation method: Wash, moisten thoroughly, slice thinly, and dry. Functions and indications: Nourishes blood and regulates menstruation, restrains yin and stops sweating, softens the liver and stops pain, and suppresses liver yang. Used for blood deficiency, chlorosis, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, headache and dizziness.
[0019] Chuanxiong: Processing method: remove impurities, separate into large and small, wash, moisten thoroughly, cut into thick slices, and dry. Functions and indications: promote blood circulation and qi, dispel wind and relieve pain. Used for chest pain, heart pain, chest and flank pain, swelling and pain due to falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to lumps, headache, and rheumatic pain.
[0020] Pittosporum tobira bark: Preparation method: Take the original medicinal material, remove impurities, soak it for a while, wash it, moisten it thoroughly, cut it into strips, and dry it. Functions and indications: Remove rheumatism, dredge meridians, and relieve pain. Used for pain in the waist, knees, shoulders, and back; external treatment of skin eczema.
[0021] Millettia reticulata: Functions and indications: promoting blood circulation and replenishing blood, regulating menstruation and relieving pain, relaxing tendons and activating collaterals. Used for irregular menstruation, dysmenorrhea, amenorrhea, rheumatic pain, numbness and paralysis, and blood deficiency and chlorosis.
[0022] Sichuan Cyathula: Processing method: remove impurities and rhizome, wash, moisten, slice thinly, and dry. Functions and indications: remove blood stasis and promote menstruation, promote joint function, promote diuresis and relieve stranguria. Used for amenorrhea, retained placenta, injuries from falls, rheumatic arthralgia, foot paralysis and muscle spasm, hematuria and stranguria.
[0023] Clematidis: Processing method: remove impurities, wash, moisten, cut into sections, and dry. Functions and indications: dispel rheumatism and dredge meridians. Used for rheumatic pain, numbness of limbs, spasm of tendons and veins, and difficulty in flexion and extension.
[0024] Duhuo: Processing method: remove impurities, wash, moisten thoroughly, cut into thin slices, dry in the sun or at low temperature. Functions and indications: dispel wind and dampness, relieve numbness and relieve pain. Used for wind-cold-dampness arthralgia, pain in the waist and knees, headache caused by Shaoyin hidden wind, and headache caused by wind-cold and dampness.
[0025] Dipsacus root: Preparation method: Wash, moisten thoroughly, cut into thick slices, and dry. Functions and indications: Nourish the liver and kidney, strengthen tendons and bones, heal fractures, and stop metrorrhagia. It is used for liver and kidney deficiency, soreness of waist and knees, rheumatism, injuries from falls, fractures caused by tendons, metrorrhagia, and miscarriage. Dipsacus root with wine is mostly used for rheumatism, injuries from falls, fractures caused by tendons. Dipsacus root with salt is mostly used for soreness of waist and knees.
[0026] Atractylodes: Processing method: remove impurities, wash, moisten thoroughly, cut into thick slices, and dry. Functions and indications: dry dampness and strengthen the spleen, dispel wind and cold, and improve eyesight. Used for dampness blocking the middle jiao, abdominal distension, diarrhea, edema, beriberi, rheumatic arthralgia, colds, night blindness, and blurred vision.
[0027] Cinnamon twig: Processing method: remove impurities, wash, moisten thoroughly, cut into thick slices, and dry. Functions and indications: sweating and relieving muscles, warming and unblocking meridians, assisting yang and transforming qi, balancing and descending qi. Used for colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid retention, edema, palpitations, and running pig.
[0028] Broken Bone Brush: Processing method: remove impurities, wash, moisten thoroughly, cut into thick slices, and dry. Functions and indications: Healing injuries and relieving pain, tonifying the kidney and strengthening bones; external use to eliminate wind and remove spots. Used for falls, sprains, fractures of tendons and bones, kidney deficiency and low back pain, weakness of tendons and bones, tinnitus, deafness, loose teeth; external treatment of alopecia areata and vitiligo.
[0029] Eucommia: Processing method: scrape off the remaining rough skin, wash, cut into pieces or shreds, and dry. Functions and indications: nourish the liver and kidney, strengthen the tendons and bones, and stabilize the fetus. Used for liver and kidney deficiency, sore waist and knees, weak tendons and bones, dizziness, bleeding during pregnancy, and restless fetus.
[0030] Corydalis yanhusuo: Processing method: remove impurities, wash, dry, cut into thick slices or crush when used. Functions and indications: promote blood circulation, promote qi circulation, relieve pain. Used for chest and flank pain, abdominal pain, chest pain, amenorrhea, dysmenorrhea, postpartum blood stasis, swelling and pain due to falls.
[0031] Cibotium barometz: Processing method: remove impurities; if not sliced, wash, soak, cut into thick slices, and dry. Functions and indications: remove rheumatism, nourish liver and kidney, strengthen waist and knees. Used for rheumatic pain, sore waist and knees, and weakness of lower limbs.
[0032] Radix Pseudostellariae: Processing method: remove impurities, moisten slightly, cut into sections, and dry. Functions and indications: dispel rheumatism, promote blood circulation, and relieve pain. Used for rheumatic arthralgia, tendon and bone contracture; used externally to treat sores, swellings and toxins.
[0033] Frankincense: Preparation method: Take clean frankincense and stir-fry it with vinegar until the surface is shiny. For every 100kg of frankincense, use 5kg of vinegar. Functions and indications: Promote blood circulation and relieve pain, reduce swelling and promote tissue regeneration. Used for chest pain, heart pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to lumps, rheumatic pain, muscle spasm, traumatic injury, carbuncle, ulcer.
[0034] Myrrh: Preparation method: Take clean myrrh, stir-fry according to the vinegar roasting method (General Rule 0213) until the surface is shiny. For every 100kg of myrrh, use 5kg of vinegar. Functions and indications: Disperse blood stasis and relieve pain, reduce swelling and promote tissue regeneration. Used for chest pain, heart pain, stomach pain, dysmenorrhea, amenorrhea, postpartum blood stasis, abdominal pain due to lumps, rheumatic pain, traumatic injuries, carbuncle, ulcers.
[0035] Poria: Processing method: soak, wash, steam slightly after moistening, peel off the skin in time, cut into blocks or thick slices, and dry in the sun. Functions and indications: diuresis and dampness, spleen strengthening, and heart calming. Used for edema, oliguria, phlegm and fluid, dizziness and palpitations, spleen deficiency and poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia.
[0036] Nantian Xianzi: Processing method: remove impurities such as peel and branches, and sieve out ash. Functions and indications: invigorate the spleen and stomach, clear away heat and detoxify, and reduce swelling. Used for indigestion, pharyngitis, mastitis, snake and insect bites, and scabies.
[0037] Paris polyphylla: Processing method: remove impurities, wash, moisten, slice, and dry. Functions and indications: clear away heat and detoxify, reduce swelling and relieve pain, cool the liver and calm the nerves. Used for furuncle, carbuncle, sore throat, snake and insect bites, falls and injuries, and convulsions.
[0038] Whole scorpion: Processing method: remove impurities, wash and dry. Functions and indications: calm wind and calm spasms, dredge meridians and relieve pain, attack poison and disperse knots. Used for internal movement of liver wind, spasms and convulsions, infantile convulsions, stroke and oral cavity Hemiplegia, tetanus, rheumatism, migraine, sores, scrofula.
[0039] Red lead was purchased from Hubei Yaosheng Traditional Chinese Medicine Technology Co., Ltd. and complies with the standard GB 1705-86.
[0040] The small-mill sesame oil is purchased from Hubei Hanlaoxiang Grain and Oil Food Co., Ltd. (an edible vegetable oil manufacturer) and is pressed using traditional methods. This edible vegetable oil complies with the agricultural standard "NY / T751-2017 Green Food Edible Vegetable Oil (Currently Valid)" issued by the Ministry of Agriculture and Rural Affairs.
[0041] The above technical scheme is adopted, and the beneficial effects of the present invention are as follows: the ointment of the present invention uses angelica and white peony root as the main drugs to attack and clear the meridians, relieve pain and relieve constipation, and benefit the tendons and bones; Chuanxiong, Pittosporum tobira bark, Millettia spatholobi, Cyathula officinalis, Clematidis, Dipsacus asper, and Atractylodes as the auxiliary drugs, which can not only help the main drugs to dredge the meridians and remove numbness, but also promote blood circulation and remove blood stasis, promote qi and relieve pain; Cassia twig, Bone-breaking, Eucommia bark, Corydalis yanhusuo, Cibotium barometz, Herba spermatis, frankincense, myrrh, Poria, Hyssopus nantianensis, Paris polyphylla, and the whole Scorpion is an adjuvant, and the combination of other drugs helps the main and auxiliary drugs to disperse blood stasis and relieve pain, and also replenish blood, set bones, repair tendons, and regenerate tissue; red lead and sesame oil help the drugs penetrate the skin and enter the meridians as adjuvants; the whole formula is compatible, which can dispel wind and dampness, dredge meridians and relieve pain, promote blood circulation and remove blood stasis, and repair bones and repair tendons. It has a good effect on patients with painful diseases such as wind-cold-dampness arthralgia, tendon injuries and bone injuries caused by qi stagnation and blood stasis, such as contusions, fractures, rheumatism, periarthritis of the shoulder, arthritis, tenosynovitis, cervical spondylosis, and lumbar disc herniation. DETAILED DESCRIPTION
[0042] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0043] A muscle-relaxing and pain-relieving ointment is composed of the following raw materials in parts by weight: 50 parts of angelica sinensis, 50 parts of white peony root, 50 parts of chuanxiong, 50 parts of pittosporum tobira bark, 50 parts of millettia spatholobi, 50 parts of cyathula, 50 parts of clematis root, 50 parts of angelica dahurica, 50 parts of angelica pubescens, 50 parts of dipsaccharum officinale, 50 parts of atractylodes, 50 parts of cassia twig, 50 parts of drynariae, 50 parts of eucommia bark, 50 parts of corydalis, 50 parts of cibotium bark, 50 parts of radix polygoni lobatae, 25 parts of frankincense, 25 parts of myrrh, 25 parts of tuckahoe, 25 parts of henbane fructus, 25 parts of parsley, 25 parts of scorpion, 15,000 parts of sesame oil and 5,000 parts of red lead.
[0044] The preparation process comprises the following steps:
[0045] Step 1: Prepare the raw materials, remove impurities, mildew, and insect-infested Chinese medicinal materials, then clean the Chinese medicinal materials except frankincense and myrrh, dry them in the sun, break them into powder, and pass them through an 80-mesh sieve;
[0046] Step 2: Soaking and decocting; put the crushed Chinese medicinal materials into a decoction container, add sesame oil, soak for 36-48 hours, and then decoct at 300℃-330℃ until the oil is dripping into beads, then stop the fire;
[0047] Step 3: Immediately add red lead, frankincense, and myrrh, stirring constantly to mix well and prevent scorching, until it gradually becomes a thick paste. Spray the ointment with cold water to solidify it. Then, put the ointment in a container, melt it over low heat, add fine ingredients, stir well, and spread the ointment evenly on the plaster cloth to make a plaster patch.
[0048] Explanation of the prescription: This preparation is based on the principle of compatibility of monarch, minister, assistant and envoy. In the prescription, the angelica root is sweet and heavy, belonging to the liver, heart and spleen meridians, replenishing blood and promoting blood circulation, and tonifying and moving; white peony root is bitter, sour, sweet and slightly cold in nature, belonging to the liver, spleen and meridians, and has the effects of dispelling wind and relieving pain, promoting blood circulation and removing blood stasis, and regulating immunity; the two are used together as the monarch drug, attacking and unblocking, dispelling pain and relieving constipation, and benefiting tendons and bones, and are mainly used to treat rheumatism, blood stasis pain, cramps, paralysis, dryness, and astringency. Ligusticum chuanxiong has a warm nature and is used to treat cold arthralgia, tendon spasm, and acute wounds. It is an important medicine for healing wounds. Pittosporum tobira bark is bitter and pungent in taste and neutral in nature. It enters the liver and spleen meridians and dispels wind, dries dampness, and is pungent in taste and can promote qi circulation, dredge meridians, and relieve pain. It is neutral in nature and has no bias towards cold or heat, so it can be used for both cold arthralgia and hot arthralgia, especially for rheumatic arthralgia, limb spasm, and pain in the waist and knees. Millettia spatholobi is bitter and slightly sweet in taste and warm in nature. It enters the liver and kidney meridians and can promote blood circulation, regulate menstruation, and relax tendons and activate meridians. Cyathula officinalis is sweet, slightly bitter, and neutral in nature. Liver and kidney meridians, dispersing and descending, promoting blood circulation and dredge meridians, dispelling wind and dampness, and dredge joints; Clematis is warm in nature, pungent and salty in taste, and belongs to the bladder meridian, and has the functions of dispelling rheumatism and dredge meridians; Angelica dahurica clears away heat and detoxifies, dispels wind and dampness, dispels cold and dampness; Dipsacus can strengthen tendons and bones, nourish liver and kidney, and dredge blood vessels; Atractylodes macrocephala is mainly used to treat wind-cold-dampness arthralgia and dead muscles, expel wind and water swelling between the skin, benefit the blood between waist and navel, and dredge the middle jiao; the combination of several medicines can not only help the monarch medicine to dredge meridians and remove arthralgia, but also promote blood circulation and remove blood stasis, promote qi and relieve pain, so it is the minister medicine. Cinnamon twig can induce sweating and relieve exterior symptoms, promote yang and transform qi, warm the meridians and dredge meridians, and harmonize Ying and Wei; Drynariae is warm in nature and bitter in taste. It belongs to the liver and kidney meridians. It can tonify kidney and strengthen bones, heal injuries and relieve pain; Eucommia ulmoides is sweet and warm in taste, and belongs to the liver and kidney meridians, and can tonify liver and kidney, strengthen tendons and bones; Corydalis can promote blood circulation, disperse blood stasis, regulate qi, and relieve pain; Cibotium barometz is bitter and sweet in taste and warm in nature. It belongs to the liver and kidney meridians. It can dispel rheumatism, nourish the liver and kidney, strengthen the waist and knees, and is used for rheumatic arthralgia, soreness of the waist and knees, and weakness of the lower limbs; Radix Phellodendri can reduce swelling and relieve pain, dispel wind and dampness, relax muscles and promote blood circulation; Radix Rhizoma Cynoglossi can nourish the kidney and benefit the essence, promote the flow of qi and blood, relieve urgency, relieve pain and promote tissue regeneration; Poria can promote diuresis and reduce swelling, and penetrate dampness; Fructus Nandinae can clear away heat and detoxify, reduce swelling and relieve pain; Rhizoma Paris can clear away heat and detoxify, reduce swelling and relieve pain; Scorpion can calm the wind, attack toxins and disperse knots, and dredge meridians to relieve pain; the combination of these medicines can help the monarch and minister medicines to disperse blood stasis and relieve pain, and also replenish blood, set bones, continue tendons, and promote tissue regeneration, so they are adjuvants; red lead and sesame oil help the drugs penetrate the skin and enter the meridians as adjuvants; the whole formula is compatible to promote blood circulation and remove blood stasis, set bones and continue tendons, dispel wind and dampness, and relax muscles and activate meridians.
[0049] This prescription has the effects of promoting blood circulation and removing blood stasis, setting bones and tendons, dispelling wind and dampness, and relaxing muscles and tendons. It is mainly used to treat injuries from falls, fractures, rheumatism, periarthritis of the shoulder, arthritis, tenosynovitis, cervical spondylosis, and lumbar disc herniation.
[0050] Treatment plan:
[0051] (1) Disease classification: It is mainly used to treat fractures and tendon injuries caused by liver and kidney deficiency, qi stagnation and blood stasis.
[0052] (2) TCM diagnostic criteria: taking into account both “fundamental deficiency” and “excessive symptoms”, manifested as pain, swelling, or chills, back pain or sore eyes, sore waist and knees, pale tongue, thin white fur, and stringy or fine pulse.
[0053] (3) Reference standard for clinical cure or improvement: Refer to the TCM symptom efficacy evaluation in the "Guidelines for Clinical Research of New Chinese Medicines" and dynamically observe the changes in TCM syndromes (the higher the score, the more severe the clinical symptoms). Clinical control: clinical symptoms and signs disappear or basically disappear, and the symptom score decreases by ≥90%;
[0054] Markedly effective: clinical symptoms and signs are significantly improved, and the symptom score is reduced by more than 70% and less than 90%;
[0055] Effective: clinical symptoms and signs are improved, and the symptom score is reduced by more than 30% and less than 90%;
[0056] Ineffective: Clinical symptoms and signs are not obvious or even aggravated, and the symptom score is reduced by less than 30%.
[0057] (4) Prescription and preparation method: Strictly follow the traditional Chinese medicine processing technology, 50g of Angelica sinensis, 50g of White Peony Root, 50g of Chuanxiong, 50g of Pittosporum tobira, 50g of Millettia Spatholobi, 50g of Cyathula officinalis, 50g of Clematidis, 50g of Angelica dahurica, 50g of Angelica pubescens, 50g of Dipsacus asper, 50g of Atractylodes macrocephala, 50g of Cinnamomum cassia, 50g of Drynariae Rhizoma, 50g of Eucommia ulmoides, 50g of Corydalis yanhusuo, 50g of Cibotium barometz, 50g of Herba Polygoni Multiflori, 25g of Frankincense, 25g of Myrrh, 25g of Poria, 25g of Nantianxianzi, 25g of Paris polyphylla (Paridis yunnanensis), 25g of Scorpio, 15kg of edible earth-pressed small-milled sesame oil, and 5kg of red lead. Make 2000 black plasters.
[0058] (5) Dosage plan: Apply externally to the affected area. Change the dressing every 3 days.
[0059] (6) Contraindications and precautions: Patients who are allergic to the ingredients in the prescription are contraindicated. Patients with local skin damage, skin tumors, etc. should use with caution.
[0060] Drug safety testing:
[0061] (1) A total of 78 patients who met the diagnostic criteria for lumbar disc herniation, distal radius fracture, and knee osteoarthritis were selected. All of them were outpatients or inpatients of Zaoyang Houde Rehabilitation Hospital from January 2015 to December 2019. According to the principle of random grouping of cases in the clinical trial research plan, the clinical trial was divided into a treatment group of 40 cases and a control group of 38 cases. A randomized, positive drug parallel controlled clinical trial method was adopted. There were 40 cases in the treatment group, including 27 males and 13 females, with an average age of (36.4±4.82) years, a course of disease of 1 to 7 days, and an average of (3.0±1.5) days. There were 38 cases in the control group, including 24 males and 14 females, with an average age of (37.8±4.41) years, a course of disease of 1 to 7 days, and an average of (2.9±1.3) days. There was no significant difference in gender, age, average course of disease, and medication compliance between the treatment group and the control group (P>0.05), and they were comparable. Stata 10.0 statistical software was used for statistical analysis. The measurement data were analyzed by t test, paired t test, etc., and the count data were analyzed by corrected chi-square test, Fisher's exact test, etc. The rank data were analyzed by Wilcoxon rank test.
[0062] (2) Inclusion criteria:
[0063] Patients who met the diagnostic criteria for lumbar disc herniation, distal radius fracture, and knee osteoarthritis and signed the informed consent were selected.
[0064] (3) Exclusion criteria and termination criteria:
[0065] Those who are unwilling to accept observation measures; those who have taken drugs of the same category 2 weeks before treatment; those with severe cardiovascular and cerebrovascular diseases and malignant tumors; those who have used other drugs to treat the disease after the onset of the disease; those with allergic constitutions, mental illness patients; alcoholics or those with a history of other drug abuse.
[0066] (4) Safety observation:
[0067] General physical examination items (body temperature, respiration, pulse, blood pressure, etc.); routine examination of blood, urine and stool; liver function (ALT) and kidney function (BUN, Scr); electrocardiogram examination.
[0068] (5) Treatment methods:
[0069] Treatment group: A total of 40 patients diagnosed with acute and chronic bone loss at Zaoyang Houde Rehabilitation Hospital from January 2015 to December 2019, including 27 males and 13 females.
[0070] Control group: 38 patients admitted in the same period were matched according to age, disease type and gender, including 24 males and 14 females. The control group was treated with Voltaren tablets (Beijing Novartis Pharmaceutical Co., Ltd., National Medicine Standard No.: H10980297), oral, 25 mg once, tid. The course of treatment was 7 days.
[0071] (6) Treatment results:
[0072] The comparison by gender, age, course of disease, and severity of illness is shown in the following table:
[0073]
[0074] Note: There was no significant difference in gender (x2 value 0.162) and severity of illness (x2 value 1.399) between the two groups of cases after comparison (P>0.05), and they were comparable. There was no significant difference in age (P value 0.689) and course of disease (P value 0.291) after comparison (P>0.05), and they were comparable. The results showed that there was no significant difference in gender, age, course of disease, and severity of illness between the two groups of patients after statistical processing, and they were comparable.
[0075] Comparison of safety indicators between the two groups before and after treatment:
[0076]
[0077] (7) Experimental conclusion: There were no significant changes in blood and urine routine tests, liver and kidney function, and electrocardiograms in the two groups of cases before and after treatment, indicating that the safety of the drugs in both the treatment and control groups was good. The results showed that there were no obvious toxic and side effects during the treatment process, and the safety was good and reliable.
[0078] Clinical trials:
[0079] Chronic bone and muscle diseases are another type of bone and muscle system injury corresponding to the bone and muscle injury caused by acute trauma, and the proportion of outpatients is gradually increasing. It may be due to the mistreatment of acute injuries, or the decompensation of chronic cumulative injuries, coupled with the pathological and physiological changes in the body's internal environment during aging. Clinically, it often presents a complex manifestation of local bone and muscle injuries and overall dysfunction of certain internal organs. In terms of treatment, external use of Chinese medicine is indispensable. Shujin Qutong Paste takes into account the advantages of low cost, fast efficacy and few side effects, providing a new means for the diagnosis and treatment of clinical bone and muscle diseases.
[0080] (1) Clinical data:
[0081] A total of 500 patients diagnosed with acute and chronic bone loss in Zaoyang Houde Rehabilitation Hospital from May 2018 to December 2023 were selected, including 240 males and 260 females, aged 22 to 79 years.
[0082] (2) Treatment methods and course of treatment:
[0083] Apply externally to the affected area and change the dressing every 3 days.
[0084] (3) Efficacy criteria:
[0085] After one course of treatment, the clinical symptoms and signs of the two groups of patients were significantly improved compared with those before treatment, and there was a significant difference in the efficacy before and after. Referring to the evaluation of TCM symptom efficacy in the "Guidelines for Clinical Research of New Chinese Medicines", the changes in TCM syndromes were dynamically observed (the higher the score, the more severe the clinical symptoms). Clinical control: clinical symptoms and signs disappeared or basically disappeared, and the symptom score decreased by ≥90%; marked effect: clinical symptoms and signs were significantly improved, and the symptom score decreased by more than 70% and less than 90%; effective: clinical symptoms and signs were improved, and the symptom score decreased by more than 30% and less than 90%; ineffective: clinical symptoms and signs were not obvious, or even aggravated, and the symptom score decreased by less than 30%.
[0086] (4) Statistical results:
[0087] Efficacy analysis: Among 500 patients with acute and chronic musculoskeletal diseases, there were 124 cases of lumbar disc herniation, 176 cases of distal radius fracture, and 200 cases of knee osteoarthritis.
[0088]
[0089] From the above table, we can see that the effective rate of Shujin Qutong Ointment in treating lumbar disc herniation is 96.80%, the effective rate in treating distal radius fracture is 93.18%, and the effective rate in treating knee osteoarthritis is 92.00%.
[0090] TCM syndrome score: Among the 500 patients, 100% suffered from pain and limited activity.
[0091] Comparison of TCM syndrome scores:
[0092] Symptoms or signs Number of cases Clinical control Significant effect Improvement invalid statistics pain 500(100%) 23.56 16.52 23.34 34.4 P<0.05 Limited activity 500(100%) 22.14 19.30 27.56 31.00 P<0.05
[0093] From the above table, we can see that pain and limited movement are the main clinical manifestations of acute and chronic myositis. After the intervention of Shujin Qutong ointment, the improvement of pain and limited movement is significant.
[0094] Prescription changes: The Shujin Qutong Paste has been prepared strictly according to the original formula and used for patients and clinical practice. The prescription, preparation method, usage and dosage have not changed.
[0095] Analyze the combined medication or concomitant treatment, and explain the role of each drug or treatment method and preparation prescription in the combined medication or concomitant treatment in the treatment of the disease.
[0096] Treatment group: A total of 500 patients diagnosed with acute and chronic muscle and bone loss were enrolled in Zaoyang Houde Rehabilitation Hospital from May 2018 to December 2023, including 240 males and 260 females, aged 22 to 79 years old. The experimental group was treated with external application of Shujin Qutong ointment (124 cases of lumbar disc herniation, 176 cases of distal radius fracture, and 200 cases of knee osteoarthritis).
[0097] Control group: 500 patients (124 cases of lumbar disc herniation, 176 cases of distal radius fracture, 200 cases of knee osteoarthritis) admitted in the same period were matched according to age, disease type and gender. The control group was treated with Voltaren tablets (Beijing Novatis Pharmaceutical Co., Ltd., National Medicine Standard No.: H10980297), oral, 25 mg once, tid. The course of treatment was 7 days.
[0098]
[0099] Conclusion: For the diagnosis and treatment of lumbar disc herniation, Shujin Qutong ointment (efficacy 96.80%) is significantly better than oral Voltaren (efficacy 19.40%); for the diagnosis and treatment of distal radius fracture, Shujin Qutong ointment (efficacy 93.18%) is significantly better than oral Voltaren (efficacy 77.27%); for the treatment of knee osteoarthritis, Shujin Qutong ointment (efficacy 92.00%) is significantly better than oral Voltaren (efficacy 80.00%).
[0100] Features of the pain-relieving cream:
[0101] A. Dispel wind and relieve pain, activate blood circulation and remove blood stasis, attack the meridians, relieve pain, promote bowel movements, and benefit tendons and bones.
[0102] Arthritis and tendon injuries generally have the clinical characteristics of deficiency in the root and excess in the superficial. Limb pain can be caused by wind, cold, dampness, blood stasis, qi stagnation, phlegm and fluid obstruction. External attack of wind, cold and dampness, weak qi and blood, and lack of transportation and transformation can cause arthritis. Liver and kidney deficiency, weak tendons and bones, and twisting and bruising, or wind, cold and dampness, meridian blockage, qi stagnation and blood stasis, pain due to obstruction. In the prescription, angelica is sweet and heavy, belongs to the liver, heart, and spleen meridians, replenishes blood and promotes blood circulation, and replenishes the middle and moves; white peony root is bitter, sour, sweet, and slightly cold in nature, belongs to the liver, spleen, and meridians, and has the effects of dispelling wind and relieving pain, promoting blood circulation and removing blood stasis, and regulating immunity. The two are used together as the main medicine, attacking to clear, dispelling pain and relieving constipation, and benefiting tendons and bones. They are mainly used to treat rheumatism, blood stasis pain, cramps, paralysis, dryness, and astringency. Chuanxiong has warm nature and is used to treat cold arthritis, muscle spasms, and acute wounds, so it is an important medicine for healing wounds. Pittosporum tobira bark tastes bitter and pungent, is neutral in nature, and enters the liver and spleen meridians, dispels wind and dampness. Its pungent taste can promote qi circulation, dredge meridians and relieve pain. It is neutral in nature and has no bias towards cold or heat, so it can be used for both cold arthritis and hot arthritis, and is especially effective for rheumatic arthritis, cramps in the limbs, and pain in the waist and knees.
[0103] B. Take both specimen and sample into consideration.
[0104] Arthritis is often caused by weakness after a long time. The bone-drying herb in the prescription is warm in nature and bitter in taste. It enters the liver and kidney meridians. It can nourish the kidney and strengthen bones, heal injuries and relieve pain; Eucommia ulmoides is sweet and warm in taste, and enters the liver and kidney meridians. It can nourish the liver and kidney, strengthen tendons and bones; Corydalis yanhusuo promotes blood circulation, disperses blood stasis, regulates qi and relieves pain; Cibotium barometz is bitter and sweet in taste and warm in nature. It enters the liver and kidney meridians. It can dispel rheumatism, nourish the liver and kidney, strengthen the waist and knees, and is used for rheumatic arthralgia, sore waist and knees, and weakness of the lower limbs; Radix radix scutellariae reduces swelling and relieves pain, dispels wind and dampness, relaxes tendons and promotes blood circulation; Rhizoma rutaecarpa nourishes the kidney and replenishes essence, promotes the flow of qi and blood, relieves urgency, relieves pain and promotes tissue regeneration. The combination of these medicines can treat the symptoms and replenish the deficiency, achieving the effect of taking both the symptoms and the root causes into consideration.
[0105] C. Take the middle focus into consideration.
[0106] The Atractylodes macrocephala in the prescription can protect the middle jiao. The middle jiao is the core of the mediation of transportation and transformation. Strengthening the transportation and transformation of the middle jiao will help further promote the movement of qi.
[0107] 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 muscle-relaxing and pain-relieving ointment, characterized in that: The invention is composed of the following raw materials in parts by weight: 30-80 parts of angelica sinensis, 30-80 parts of white peony root, 30-80 parts of ligusticum chuanxiong, 30-80 parts of pittosporum tobira bark, 30-80 parts of millettia spatholobi, 30-80 parts of cyathula officinalis, 30-80 parts of clematis root, 30-80 parts of angelica dahurica, 30-80 parts of dipsaccharum officinale, 30-80 parts of atractylodes, 30-80 parts of cassia twig, 30-80 parts of drynariae, 30-80 parts of eucommia bark, 30-80 parts of corydalis yanhusuo, 30-80 parts of cibotium bark, 30-80 parts of radix spatholobi, 20-30 parts of frankincense, 20-30 parts of myrrh, 20-30 parts of tuckahoe, 20-30 parts of nymphaeaceae, 20-30 parts of parsley, 20-30 parts of scorpion, 15000 parts of small-milled sesame oil and 5000 parts of red lead.
2. The muscle-relaxing and pain-relieving ointment according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 40-60 parts of angelica sinensis, 40-60 parts of white peony root, 40-60 parts of chuanxiong, 40-60 parts of pittosporum tobira bark, 40-60 parts of millettia spatholobi, 40-60 parts of cyathula, 40-60 parts of clematis root, 40-60 parts of angelica dahurica, 40-60 parts of dipsaccharum officinale, 40-60 parts of atractylodes, 40-60 parts of cassia twig, 40-60 parts of drynaria, 40-60 parts of eucommia, 40-60 parts of corydalis, 40-60 parts of cibotium barometz, 40-60 parts of radix spatholobi, 20-30 parts of frankincense, 20-30 parts of myrrh, 20-30 parts of tuckahoe, 20-30 parts of henbane fructus, 20-30 parts of parsley, 20-30 parts of scorpion, 15000 parts of small-milled sesame oil and 5000 parts of red lead.
3. The muscle-relaxing and pain-relieving ointment according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 50 parts of angelica sinensis, 50 parts of white peony root, 50 parts of chuanxiong, 50 parts of pittosporum tobira bark, 50 parts of millettia spatholobi, 50 parts of cyathula officinalis, 50 parts of clematis root, 50 parts of angelica dahurica, 50 parts of pubescens, 50 parts of dipsaccharum officinale, 50 parts of atractylodes, 50 parts of cassia twig, 50 parts of drynariae, 50 parts of eucommia bark, 50 parts of corydalis yanhusuo, 50 parts of cibotium bark, 50 parts of radix polygoni lobatae, 25 parts of frankincense, 25 parts of myrrh, 25 parts of tuckahoe, 25 parts of henbane fructus, 25 parts of parsley, 25 parts of scorpion, 15,000 parts of sesame oil and 5,000 parts of red lead.
4. A muscle-relieving and pain-relieving ointment according to any one of claims 1 to 3, characterized in that: The preparation process of the muscle-relieving and pain-relieving ointment comprises the following steps: Step 1: Prepare the raw materials, remove impurities, mildew, and insect-infested Chinese medicinal materials, then clean the Chinese medicinal materials except frankincense and myrrh, dry them in the sun, break them into powder, and pass them through an 80-mesh sieve; Step 2: Soaking and decocting; put the crushed Chinese medicinal materials into a decoction container, add sesame oil, soak for 36-48 hours, and then decoct at 300℃-330℃ until the oil is dripping into beads, then stop the fire; Step 3: Immediately add red lead, frankincense, and myrrh, stirring constantly to mix well and prevent scorching, until it gradually becomes a thick paste. Spray the ointment with cold water to solidify it. Then, put the ointment in a container, melt it over low heat, add fine ingredients, stir well, and spread the ointment evenly on the plaster cloth to make a plaster patch.