Efficient analgesic pharmaceutical composition as well as preparation method and application thereof

Abstract

The invention relates to a pharmaceutical composition for efficiently easing pain. The composition is prepared from 50 to 200 parts of radix angelicae sinensis, 50 to 200 parts of radix angelicae dahuricae, 50 to 200 parts of semen armeniacae amarae, 50 to 200 parts of radix scrophulariae, 50 to 200 parts of fructus gleditsiae, 50 to 200 parts of radix aconiti agrestis, 100 to 500 parts of green onion, 50 to 300 parts of frankincense, 2200 to 2600 parts of gum, 2200 to 2600 parts of rosin, 50 to 300 parts of myrrh, 100 to 500 parts of beewax, 50 to 200 parts of zinc oxide, 50 to 200 parts of wintergreen oil, 100 to 200 parts of menthol, 100 to 200 parts of borneol and 800 to 1500 parts of peppermint oil. The pharmaceutical composition disclosed by the invention has the advantages of quick response, high effective rate, high significant efficiency, low adverse reaction occurrence rate, safety, effectiveness, convenience in use, good patient compliance and the like, and the pain recurrence rate is remarkably reduced and the pain recurrence interval period is remarkably prolonged.

Description

Technical Field

[0001] The present invention belongs to the field of biomedicine, and specifically relates to a highly effective analgesic pharmaceutical composition, a preparation method thereof, and an application thereof. Background Art

[0002] Various acute injuries, chronic strains, invasion of wind, cold and dampness, fractures, dislocations, soft tissue injuries and the resulting damage to the meridians and blood, blockage of qi and blood, poor circulation function, poor circulation, etc., will cause pathological damage and pain to the skin, subcutaneous fascia, muscles, tendons, ligaments, joint capsules, intervertebral discs and other tissues. The main manifestations of diseases such as neck, shoulder, waist and leg pain, osteoarthritis, and fasciitis are pain in the affected area, limited movement, and poor flexion and extension. The pain and limited movement are progressively aggravated, seriously affecting the patient's life, health and quality of life. Those with severe conditions may even lose their ability to work, and some patients are forced to undergo surgery, which brings a heavy economic burden to patients, their families and society.

[0003] At present, the mode of treating pain mainly includes physical therapy and medicine. Physical therapy includes acupuncture, hot compress, ultrashort wave, electromagnetic wave etc., but there are defects such as unremarkable therapeutic effect, long course of treatment, poor patient compliance. Medicine includes celecoxib, ibuprofen, indomethacin, diclofenac diethylamine emulsion ointment, glucosamine sulfate, chondroitin sulfate, sodium hyaluronate, lidocaine, glucocorticoid, neurotrophic drugs, cytokines, analgesic patches etc., but there are problems such as poor therapeutic activity, slow onset, many adverse reactions (such as allergy, erythema, itching etc.), high pain recurrence rate and short pain recurrence interval period. For this reason, it is urgent to develop efficient analgesic and safe and effective pharmaceutical composition to meet clinical needs. Summary of the invention

[0004] The invention aims to provide a pharmaceutical composition for effectively relieving pain. The composition contains, by weight, 50-200 parts of angelica sinensis, 50-200 parts of angelica dahurica, 50-200 parts of apricot kernel, 50-200 parts of figwort, 50-200 parts of gleditsia sinensis, 50-200 parts of aconite, 100-500 parts of onion, 50-300 parts of frankincense, 2200-2600 parts of gum incense, 2200-2600 parts of rosin, 50-300 parts of myrrh, 100-500 parts of beeswax, 50-200 parts of zinc oxide, 100-200 parts of menthol, 100-200 parts of borneol, 50-200 parts of wintergreen oil and 800-1500 parts of peppermint oil.

[0005] In the preferred technical scheme of the present invention, the composition contains, by weight, 100-130 parts of angelica sinensis, 100-130 parts of angelica dahurica, 100-130 parts of apricot kernel, 100-130 parts of Scrophularia ningpoensis, 100-130 parts of Gleditsia sinensis, 100-130 parts of Aconitum kusnezoffii, 200-400 parts of onion, 150-200 parts of frankincense, 2300-2500 parts of gum incense, 2300-2500 parts of rosin, 150-200 parts of myrrh, 200-400 parts of beeswax, 100-150 parts of zinc oxide, 150-180 parts of menthol, 150-180 parts of borneol, 100-150 parts of wintergreen oil and 900-1200 parts of peppermint oil.

[0006] In a preferred embodiment of the present invention, the composition optionally contains a pharmaceutically acceptable carrier.

[0007] In a preferred technical solution of the present invention, the pharmaceutically acceptable carrier is selected from any one of antioxidants, preservatives, acid-base regulators, or a combination thereof.

[0008] In the preferred technical scheme of the present invention, the antioxidant is selected from any one of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, vitamin E, dibutyl benzoic acid, butylated hydroxyanisole (BHA), dibutyl hydroxytoluene, propyl gallate (PG), niacinamide, acetylcysteine, tert-butylhydroquinone (TBHQ), 2,6-di-tert-butyl-p-cresol (BHT), tert-butyl-p-cresol, and disodium diacetate or a combination thereof.

[0009] In a preferred technical solution of the present invention, the composition contains 5-100 parts of antioxidant, preferably 10-50 parts.

[0010] In the preferred technical scheme of the present invention, the composition contains, by weight, 110 parts of angelica sinensis, 110 parts of angelica dahurica, 110 parts of apricot kernel, 110 parts of Scrophularia ningpoensis, 110 parts of Gleditsia sinensis, 110 parts of Aconitum kusnezoffii, 200 parts of shallot, 170 parts of frankincense, 2480 parts of gum incense, 2480 parts of rosin, 170 parts of myrrh, 300 parts of beeswax, 100 parts of zinc oxide, 150 parts of menthol, 150 parts of borneol, 100 parts of wintergreen oil, 960 parts of peppermint oil and 10 parts of 2,6-di-tert-butyl-p-cresol.

[0011] The angelica in the composition is a "holy medicine for the blood family" and a blood-qi medicine. It has the effects of harmonizing blood and replenishing blood, promoting blood circulation and relieving pain, consolidating qi and blood, helping blood stasis and dispersing hardness, promoting blood circulation and removing blood stasis, promoting tissue regeneration and dispelling wind, reducing swelling and relieving pain. It is used to treat muscle and bone pain, numbness of hands and feet, blood stasis, female amenorrhea and other symptoms.

[0012] The Angelica dahurica in the composition has the effects of dispelling cold, reducing swelling and relieving pain, promoting blood circulation and promoting qi, dispelling wind and relieving itching, clearing the nasal passages, drying dampness and stopping leukorrhea. It is used to reduce swelling and discharge pus, and is mainly used to treat colds caused by wind and cold, arthralgia, dispelling wind and relieving itching. It can be used to treat colds, headaches, rheumatism, allergic rhinitis and sinusitis.

[0013] The almonds in the composition are rich in flavonoids and polyphenols, protein, fat, sugar and amygdalin, and have the effects of relieving cough and asthma, lowering cholesterol, moisturizing the intestines and promoting bowel movements, losing weight, nourishing the lungs, etc., effectively controlling the cholesterol content in the human body, and reducing the risk of heart disease and various chronic diseases. It can be used to treat lung diseases, coughs and other diseases.

[0014] The Scrophularia in the composition has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dispersing nodules, clearing heat and detoxifying, nourishing yin and moistening dryness, nourishing yin and promoting body fluid. It is used to relieve symptoms such as febrile disease damaging yin, red tongue and thirst, body fluid damage and constipation, and red and swollen eyes.

[0015] The Gleditsia sinensis in the composition has the effects of dispersing nodules and relieving swelling, removing phlegm and relieving cough, expelling and killing roundworms, enhancing gastric juice secretion and intestinal peristalsis, and promoting defecation.

[0016] The Aconitum in the composition contains a large amount of wood polysaccharide, which has the effects of dispelling wind and dampness, warming the meridians, relieving pain and bleeding, and regulating endocrine. It is used to treat rheumatoid arthritis, synovitis, lumbar and leg caves, neuralgia, dysmenorrhea in women, etc.

[0017] The onions in the composition contain substances such as protein and carbohydrates, and have the effects of dispelling exterior pathogens and inducing sweat, stimulating appetite and digestion, regulating blood lipids and the like.

[0018] The frankincense in the composition has the effects of pungent fragrance, dispersing warmth, promoting blood circulation and removing blood stasis, relieving pain, promoting blood circulation and relaxing muscles, promoting qi and relieving stagnation, reducing swelling and promoting tissue regeneration, and can help the external medicine to penetrate deeply.

[0019] The myrrh in the composition is mainly used to break up stagnant blood, and has the effects of promoting blood circulation and relieving pain, reducing swelling and promoting tissue regeneration. It is used to treat symptoms such as blood stasis, pain caused by carbuncle, swelling and pain.

[0020] The gum incense (also known as white gum incense) in the composition is the resin of Liquidambar formosana of the Hamamelidaceae family. It contains flavonoids and volatile oil components, and has the effects of drying Xie Riwusu, promoting tissue regeneration, reducing swelling, healing wounds, activating blood circulation, stopping bleeding, clearing heat, relieving pain, and detoxifying. It is used as an auxiliary treatment for Xie Riwusu disease, Bamu disease, numbness, anthrax, skin itching, turbid heat, scabies, baldness, knife wounds and other diseases.

[0021] The rosin in the composition is the oleoresin exuded from the pine plant of the genus Pinus of the pine family, and is the solid resin remaining after the volatile oil is removed by distillation or extraction. Rosin has the effects of dispelling wind and dampness, draining pus and removing toxins, promoting tissue regeneration and relieving pain, and is commonly used to prevent and treat carbuncle, malignant ulcer, scrofula, paralysis, scabies, white baldness, leprosy, arthritis, wounds, sprains, leucorrhea in women, thromboangiitis obliterans, psoriasis, impetigo, chronic tracheitis and the like.

[0022] The beeswax in the composition is the wax secreted by insects of the family Apidae, which has the effects of detoxification, tissue regeneration, astringency, sore healing, dysentery prevention, hemostasis, and analgesia, and is used to prevent and treat ulcers, ecthyma erosion, trauma, burns, and the like.

[0023] The zinc oxide in the composition has the functions of promoting wound healing, relieving itching, antibacterial, moisturizing, protecting, absorbing oil and moisture, etc., and is used to treat acute dermatitis, subacute dermatitis, eczema, prickly heat, small-area skin ulcers and other diseases.

[0024] The wintergreen oil (also known as methyl o-hydroxybenzoate, methyl salicylate or methyl salicylate) in the composition is obtained by steam distillation of holly leaves, can promote blood circulation, and is used to treat muscle pain, joint pain, neuralgia and other diseases.

[0025] The peppermint oil (also known as peppermint essential oil) in the composition is mainly extracted from the stems, leaves and flowers of peppermint by water distillation or subcritical low-temperature extraction. The main components include menthol and menthone, which have antispasmodic, analgesic, anti-inflammatory, antioxidant effects, throat clearing and moisturizing, and eliminating bad breath.

[0026] The menthol in the composition is white crystals extracted from the leaves and stems of mint. It is the main component of mint and peppermint essential oils, has cooling and antipruritic effects, and is used to treat headaches and rhinitis, pharyngitis, laryngitis and other diseases.

[0027] The borneol in the composition has the effects of invigorating the mind, clearing away heat and relieving pain, and is used to treat fever coma, convulsions, stroke and phlegm syncope, qi stagnation and sudden syncope, coma due to evil spirits, red eyes, mouth ulcers, sore throat, pus in the ear canal and other diseases.

[0028] In the preferred technical scheme of the present invention, the preservative is selected from any one of phenol, cresol, benzoic acid, sodium benzoate, potassium benzoate, sodium dehydroacetate, chlorobutanol, benzyl alcohol, sorbic acid, potassium sorbate, sodium sorbate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, calcium propionate, sodium diacetate, phenoxyethanol methylparaben propyl, phenoxyethanol methylisothiazolinone, methylparaben, methylparaben, ethylparaben, and propylparaben, or a combination thereof.

[0029] In a preferred technical solution of the present invention, the preservative contained in the composition is 0.1-5%, preferably 0.2-4%, more preferably 0.5-2%.

[0030] In a preferred technical solution of the present invention, the composition optionally contains an acid-base regulator.

[0031] In the preferred technical scheme of the present invention, the acid-base regulator is selected from any one of lactic acid, sodium lactate, triethanolamine, sodium hydroxide, hydrochloric acid, citric acid, sodium citrate, citric acid, sodium citrate, acetic acid, tartaric acid, oleic acid, diisopropanolamine, and diethanolamine, or a combination thereof.

[0032] In a preferred technical solution of the present invention, the composition has a pH of 5-8, preferably a pH of 6-7.5.

[0033] In the preferred technical solution of the present invention, the preparation of the composition comprises the following steps:

[0034] (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add the required amount of sesame oil under stirring, heat to 110°C-130°C, extract for 3-4 hours, then add the required amount of scallion, extract for another 10-30 minutes, filter, and collect the filtrate;

[0035] (2) Add the required amount of gum rosin, frankincense, rosin, myrrh, beeswax, wintergreen oil, zinc oxide, menthol, borneol, peppermint oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate under stirring, heat to 50-55° C., mix well, and obtain the product.

[0036] In the preferred technical scheme of the present invention, the mass ratio of (the total amount of angelica, angelica dahurica, apricot, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii): sesame oil is (60-120):(90-120), preferably (65-85):(95-115).

[0037] The sesame oil (also called sesame oil, sesame oil) described in the present invention is a fatty oil prepared by pressing the mature seeds of Sesamumind i cum L. of the Sesamaceae family, and is rich in unsaturated fatty acids (such as oleic acid, linoleic acid, etc.), sesamin, protein, vitamin E, lecithin, sucrose, calcium, phosphorus, iron, etc., and has the effects of growing muscles, relieving pain, eliminating carbuncle, mending skin cracks, resisting inflammation, delaying aging, protecting blood vessels and throat, moistening intestines and relieving constipation, replenishing energy, and the like.

[0038] According to a preferred technical solution of the present invention, the composition is an external preparation.

[0039] According to a preferred technical solution of the present invention, the external preparation is selected from any one of ointments, creams, gels and patches.

[0040] According to the preferred technical solution of the present invention, the patch size is 1-20 cm×1-20 cm.

[0041] According to the preferred technical solution of the present invention, the coating thickness of the drug storage layer of the patch is 0.10-2.5 mm.

[0042] The object of the present invention is to provide a method for preparing a highly effective analgesic pharmaceutical composition. The composition contains, by weight, 50-200 parts of angelica sinensis, 50-200 parts of angelica dahurica, 50-200 parts of apricot kernel, 50-200 parts of Scrophularia ningpoensis, 50-200 parts of Gleditsia sinensis, 50-200 parts of Aconitum kusnezoffii, 100-500 parts of scallion, 50-300 parts of frankincense, 2200-2600 parts of gum incense, 2200-2600 parts of rosin, 50-300 parts of myrrh, 100-500 parts of beeswax, 50-200 parts of zinc oxide, 100-200 parts of menthol, 100-200 parts of borneol, 50-200 parts of wintergreen oil and 800-1500 parts of peppermint oil. The method comprises the following steps:

[0043] (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add the required amount of sesame oil, heat to 110-130° C. under stirring conditions, extract for 3.5-4 hours, then add the required amount of scallion, extract for 10-30 minutes, filter, and collect the filtrate;

[0044] (2) Add the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, wintergreen oil, peppermint oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate under stirring, heat to 50-55° C., mix well, and obtain the product.

[0045] In the preferred technical scheme of the present invention, the mass ratio of (the total amount of angelica, angelica dahurica, apricot, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii): sesame oil is (60-120):(90-120), preferably (65-85):(95-115).

[0046] In a preferred technical solution of the present invention, the drug composition is coated on a non-woven fabric, covered with release paper, sliced, and packaged to prepare an external patch.

[0047] In the preferred technical scheme of the present invention, the composition contains, by weight, 100-130 parts of angelica sinensis, 100-130 parts of angelica dahurica, 100-130 parts of apricot kernel, 100-130 parts of Scrophularia ningpoensis, 100-130 parts of Gleditsia sinensis, 100-130 parts of Aconitum kusnezoffii, 200-400 parts of onion, 150-200 parts of frankincense, 2300-2500 parts of gum incense, 2300-2500 parts of rosin, 150-200 parts of myrrh, 200-400 parts of beeswax, 100-150 parts of zinc oxide, 150-180 parts of menthol, 150-180 parts of borneol, 100-150 parts of wintergreen oil and 900-1200 parts of peppermint oil.

[0048] In a preferred embodiment of the present invention, the composition optionally contains a pharmaceutically acceptable carrier.

[0049] In a preferred technical solution of the present invention, the pharmaceutically acceptable carrier is selected from any one of antioxidants, preservatives, acid-base regulators, or a combination thereof.

[0050] In the preferred technical scheme of the present invention, the antioxidant is selected from any one of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, vitamin E, dibutyl benzoic acid, butylated hydroxyanisole (BHA), dibutyl hydroxytoluene, propyl gallate (PG), niacinamide, acetylcysteine, tert-butylhydroquinone (TBHQ), 2,6-di-tert-butyl-p-cresol (BHT), tert-butyl-p-cresol, and disodium diacetate or a combination thereof.

[0051] In a preferred technical solution of the present invention, the composition contains 5-100 parts of antioxidant, preferably 10-50 parts.

[0052] In the preferred technical scheme of the present invention, the composition contains, by weight, 110 parts of angelica sinensis, 110 parts of angelica dahurica, 110 parts of apricot kernel, 110 parts of Scrophularia ningpoensis, 110 parts of Gleditsia sinensis, 110 parts of Aconitum kusnezoffii, 200 parts of shallot, 170 parts of frankincense, 2480 parts of gum incense, 2480 parts of rosin, 170 parts of myrrh, 300 parts of beeswax, 100 parts of zinc oxide, 150 parts of menthol, 150 parts of borneol, 100 parts of wintergreen oil, 960 parts of peppermint oil and 10 parts of 2,6-di-tert-butyl-p-cresol.

[0053] In the preferred technical scheme of the present invention, the preservative is selected from any one of phenol, cresol, benzoic acid, sodium benzoate, potassium benzoate, sodium dehydroacetate, chlorobutanol, benzyl alcohol, sorbic acid, potassium sorbate, sodium sorbate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, calcium propionate, sodium diacetate, phenoxyethanol methylparaben propyl, phenoxyethanol methylisothiazolinone, methylparaben, methylparaben, ethylparaben, and propylparaben, or a combination thereof.

[0054] In a preferred technical solution of the present invention, the preservative contained in the composition is 0.1-5%, preferably 0.2-4%, more preferably 0.5-2%.

[0055] In a preferred technical solution of the present invention, the composition optionally contains an acid-base regulator.

[0056] In the preferred technical scheme of the present invention, the acid-base regulator is selected from any one of lactic acid, sodium lactate, triethanolamine, sodium hydroxide, hydrochloric acid, citric acid, sodium citrate, citric acid, sodium citrate, acetic acid, tartaric acid, oleic acid, diisopropanolamine, and diethanolamine, or a combination thereof.

[0057] In a preferred technical solution of the present invention, the composition has a pH of 5-8, preferably a pH of 6-7.5.

[0058] Another object of the present invention is to provide use of the pharmaceutical composition of the present invention in preparing a medicament for preventing and treating related diseases or complications caused by pain and discomfort.

[0059] According to the preferred technical solution of the present invention, the pain is selected from the group consisting of pain caused by pathological damage or injury to fascia, muscles, tendons, ligaments, joint capsules, and intervertebral discs caused by shoulder arthritis, lumbar arthritis, knee arthritis, soft tissue injury, cervical shoulder, waist and leg strain, acute trauma, chronic strain, or invasion of wind, cold and dampness, and any one of fractures, dislocations, joint pain, cervical shoulder, waist and leg pain, osteoarthritis, and fasciitis or their complications.

[0060] According to a preferred technical solution of the present invention, the shoulder arthritis is selected from any one of scapulohumeral periarthritis, rotator cuff injury or their complications.

[0061] According to a preferred technical solution of the present invention, the lumbar arthritis is selected from any one of lumbar disc herniation, lumbar spinal stenosis, lumbar muscle strain or their complications.

[0062] In a preferred technical solution of the present invention, the pain and discomfort are selected from any one of pain in the affected area, limited movement, soreness of waist and knees, morning stiffness, soreness and swelling of limbs, difficulty in flexion and extension, and fatigue.

[0063] The preferred technical solution of the present invention comprehensively considers factors such as the patient's condition, medication, age, gender, type of pain, and the size of the pain area at the lesion site, selects an appropriate dosage and course of treatment, and covers the prepared pharmaceutical composition or its patch on the patient's painful or affected area.

[0064] Unless otherwise specified, when the present invention relates to the percentage between liquids, the percentage is volume / volume percentage; when the present invention relates to the percentage between liquids and solids, the percentage is volume / weight percentage; when the present invention relates to the percentage between solids and liquids, the percentage is weight / volume percentage; the rest are weight / weight percentages.

[0065] Compared with the prior art, the present invention has the following beneficial effects:

[0066] 1. The present invention scientifically screens and assembles the components and proportions of the analgesic composition, and uses sesame oil to extract the effective ingredients in angelica, angelica dahurica, almond, Scrophularia ningpoensis, Gleditsia sinensis, Aconitum kusnezoffii, and Allium scallion, and then adds the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, wintergreen oil, peppermint oil, and 2,6-di-tert-butyl-p-cresol to prepare the analgesic composition, and utilizes the borneol, menthol, peppermint oil and other transdermal absorption enhancers in the composition to significantly improve the transdermal absorption and bioavailability of the effective ingredients The prepared composition has the effects of promoting muscle growth, relieving pain, eliminating carbuncle and swelling, mending skin cracks, cooling, and promoting transdermal absorption. It can effectively prevent and treat muscle agglomeration and stiffness, and significantly improve symptoms such as soft tissue injury, chronic strain of the neck, shoulders, waist, legs and other parts, and residual pain or pain discomfort in the late stage of injury. It has the advantages of fast onset, cooling and good transdermal absorption, excellent analgesic and anti-inflammatory effects, low irritation (redness, swelling, itching), safety and effectiveness, easy use, good patient compliance, etc., and significantly reduces the recurrence rate of pain and significantly prolongs the interval between pain recurrences.

[0067] 2. The medicinal materials used to prepare the pharmaceutical composition of the present invention are widely available, and have the advantages of simple operation, better cost, green and environmental protection, and suitability for industrial production. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 In the study on the analgesic effect of the analgesic composition of the present invention, # indicates a significant difference from the blank group (P < 0.05), and * indicates a significant difference from the control group (P < 0.05);

[0069] Figure 2 In the study on the anti-inflammatory effect of the analgesic composition of the present invention, # indicates a significant difference from the blank group (P < 0.05), and * indicates a significant difference from the control group (P < 0.05). DETAILED DESCRIPTION

[0070] The details of the present invention are further explained and described below in conjunction with specific embodiments, but the protection scope of the present invention is not limited thereto.

[0071] Example 1 Preparation of the analgesic composition of the present invention

[0072] Composition of the analgesic composition:

[0073] Components Weight(g) Angelica 110 Angelica dahurica 110 almond 110 Scrophularia 110 Pig Tooth Gleditsia 110 Aconitum kusnezoffii 110 onion 200 mastic 170 Glue fragrance 2480 rosin 2480 Myrrh 170 beeswax 300 Zinc Oxide 100 Menthol 150 Borneol 150 Wintergreen Oil 100 peppermint 960 2,6-Di-tert-butyl-p-cresol 10

[0074] The preparation of the analgesic composition comprises the following steps:

[0075] (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add 1000 g of sesame oil under stirring conditions, heat to 120° C. and extract for 3.5 h, then add the required amount of scallion, extract for 15 min, filter and collect the filtrate;

[0076] (2) Add the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, peppermint oil, wintergreen oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate, heat to 50° C., and maintain for 1 hour to prepare an ointment;

[0077] (3) Spread the ointment on non-woven fabric, cover with release paper, slice, each ointment weighs 5.0 g, package, and prepare a patch.

[0078] Example 2 Preparation of the analgesic composition of the present invention

[0079] Composition of the analgesic composition:

[0080] Components Weight(kg) Angelica 11 Angelica dahurica 11 almond 11 Scrophularia 11 Pig Tooth Gleditsia 11 Aconitum kusnezoffii 11 onion 10 mastic 17 Glue fragrance 200 rosin 200 Myrrh 17 beeswax 30 Zinc Oxide 10 Menthol 15 Borneol 15 Wintergreen Oil 10 peppermint 50 2,6-Di-tert-butyl-p-cresol 1

[0081] The preparation of the analgesic composition comprises the following steps:

[0082] (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add 100 kg of sesame oil under stirring conditions, heat to 120° C. and extract for 3.5 h, then add the required amount of scallion, extract for 10 min, filter and collect the filtrate;

[0083] (2) Add the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, peppermint oil, wintergreen oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate, heat to 50° C., and maintain for 1 hour to prepare an ointment;

[0084] (3) Spread the ointment on non-woven fabric, cover with release paper, slice, each ointment weighs 5.0 g, package, and prepare a patch.

[0085] Example 3 Preparation of the analgesic composition of the present invention

[0086] Composition of the analgesic composition:

[0087]

[0088]

[0089] The preparation of the analgesic composition comprises the following steps:

[0090] (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add 1000 kg of sesame oil under stirring conditions, heat to 120° C., extract for 3.5 h, then add the required amount of scallion, extract for 10 min, filter, and collect the filtrate;

[0091] (2) Add the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, peppermint oil, wintergreen oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate, heat to 50° C., and maintain for 1 hour to prepare an ointment;

[0092] (3) Spread the ointment on non-woven fabric, cover with release paper, slice, each ointment weighs 5.0 g, package, and prepare a patch.

[0093] Comparative Example 1 Preparation of analgesic composition

[0094] Composition of the analgesic composition:

[0095]

[0096] The preparation of the analgesic composition comprises the following steps:

[0097] 1) Weigh the required amount of angelica, angelica dahurica, apricot, Scrophularia ningpoensis, Gleditsia sinensis, Aconite, frankincense, gum incense, rosin, myrrh, and shallot, add 1.3 times 95% ethanol solution, heat and reflux for extraction, centrifuge, collect the centrifuge liquid and concentrate it under reduced pressure (65°C) to 54g extract / 100g raw medicinal materials;

[0098] 2) Spread the prepared extract on non-woven fabric, cover with release paper, slice, each ointment weighs 5.0 g, package, and prepare a patch.

[0099] Test Example 1 Study on the analgesic effect of the analgesic composition of the present invention

[0100] Thirty Kunming mice weighing 20±2g were selected, half of them were male and half were female, and randomly divided into a blank group, a control group and a test group, with 10 mice in each group. One day before medication, the abdomen of the mice was depilated with 8% sodium sulfide.

[0101] Blank group: no drug was applied to the abdomen of mice;

[0102] Control group: 10 g / kg of the patch of comparative example 1 was applied to the abdomen of mice;

[0103] Test group: 10 g / kg of the patch of Example 1 was applied to the abdomen of mice.

[0104] 30 minutes after applying the patch, the test animals were intraperitoneally injected with 0.6% glacial acetic acid (0.01 mL / g body weight), and the number of twisting (including abdominal depression, extension of hind limbs, buttocks elevation, crawling, etc.) of the test animals within 20 minutes was recorded. The results are shown in Figure 1 Compared with the blank group and the control group, the analgesic composition of the present invention has a significant analgesic effect.

[0105] Test Example 2 Study on the anti-inflammatory effect of the analgesic composition of the present invention

[0106] Thirty SD rats weighing 140-160 g were selected and randomly divided into a blank group, a control group and a test group, with 10 rats in each group. The circumference of the plantar circumference of the right hind paw of the test animals was measured before drug administration.

[0107] Blank group: no drug was applied to the plantar part of the right hind foot of rats;

[0108] Control group: 10 g / kg of the patch of comparative example 1 was applied to the plantar part of the right hind foot of rats;

[0109] Test group: rats were applied with 10 g / kg of the patch of Example 1 on the plantar part of the right hind paw.

[0110] 30 minutes after administration, the patch was torn off, and 0.1 mL of 0.1% carrageenan was injected subcutaneously into the plantar of the right hind paw of the test animal. The plantar circumference of the right hind paw of the test animal was measured before inflammation, 1 h after inflammation, 2 h after inflammation, and 4 h after inflammation. After measurement, the original patch was re-applied and fixed, and the difference before and after inflammation was calculated as the average swelling degree of each rat. Figure 2 Compared with the blank group and the control group, the analgesic composition of the present invention has a significant effect of inhibiting swelling.

[0111] The above description of the specific embodiments of the present invention does not limit the present invention. Those skilled in the art may make various changes or modifications based on the present invention. As long as they do not depart from the spirit of the present invention, they should all fall within the scope of protection of the claims of the present invention.

Claims

1. A pharmaceutical composition for effectively relieving pain, comprising, by weight, 50-200 parts of angelica sinensis, 50-200 parts of angelica dahurica, 50-200 parts of apricot kernel, 50-200 parts of Scrophularia ningpoensis, 50-200 parts of Gleditsia sinensis, 50-200 parts of Aconitum kusnezoffii, 100-500 parts of onion, 50-300 parts of frankincense, 2200-2600 parts of gum incense, 2200-2600 parts of rosin, 50-300 parts of myrrh, 100-500 parts of beeswax, 50-200 parts of zinc oxide, 100-200 parts of menthol, 100-200 parts of borneol, 50-200 parts of wintergreen oil and 800-1500 parts of peppermint oil.

2. The composition of claim 1, wherein the composition comprises, by weight, 100-130 parts of angelica sinensis, 100-130 parts of angelica dahurica, 100-130 parts of apricot kernel, 100-130 parts of figwort, 100-130 parts of gleditsia sinensis, 100-130 parts of aconite, 200-400 parts of shallot, 150-200 parts of frankincense, 2300-2500 parts of gum incense, 2300-2500 parts of rosin, 150-200 parts of myrrh, 200-400 parts of beeswax, 100-150 parts of zinc oxide, 150-180 parts of menthol, 150-180 parts of borneol, 100-150 parts of wintergreen oil and 900-1200 parts of peppermint oil.

3. The composition according to any one of claims 1 to 2, which optionally contains a pharmaceutically acceptable carrier, preferably any one or a combination of an antioxidant, a preservative, and an acid-base regulator.

4. The composition of any one of claims 1 to 3, wherein the antioxidant is selected from any one of sodium sulfite, sodium bisulfite, sodium metabisulfite, sodium thiosulfate, vitamin C, vitamin E, dibutyl benzoic acid, butylated hydroxyanisole (BHA), dibutyl hydroxytoluene, propyl gallate (PG), niacinamide, acetylcysteine, tert-butylhydroquinone (TBHQ), 2,6-di-tert-butyl-p-cresol (BHT), tert-butyl-p-cresol, and disodium diacetate or a combination thereof.

5. The composition according to any one of claims 1 to 4, wherein the antioxidant contained in the composition is 5 to 100 parts, preferably 10 to 50 parts.

6. The composition according to any one of claims 1 to 5, comprising, by weight, 110 parts of angelica sinensis, 110 parts of angelica dahurica, 110 parts of apricot kernel, 110 parts of Scrophularia ningpoensis, 110 parts of Gleditsia sinensis, 110 parts of Aconitum kusnezoffii, 200 parts of Allium sativum, 170 parts of frankincense, 2480 parts of gum incense, 2480 parts of rosin, 170 parts of myrrh, 300 parts of beeswax, 100 parts of zinc oxide, 150 parts of menthol, 150 parts of borneol, 100 parts of wintergreen oil, 960 parts of peppermint oil and 10 parts of 2,6-di-tert-butyl-p-cresol.

7. The composition according to any one of claims 1 to 6, wherein the composition has a pH of 5 to 8, preferably a pH of 6 to 7.

5.

8. The composition according to any one of claims 1 to 7, which is an external preparation, preferably any one of an ointment, a cream, a gel, and a patch.

9. A method for preparing a highly effective analgesic pharmaceutical composition according to any one of claims 1 to 8, wherein the composition contains, by weight, 50-200 parts of angelica sinensis, 50-200 parts of angelica dahurica, 50-200 parts of apricot kernel, 50-200 parts of Scrophularia ningpoensis, 50-200 parts of Gleditsia sinensis, 50-200 parts of Aconitum kusnezoffii, 100-500 parts of Allium sativum, 50-300 parts of frankincense, 2200-2600 parts of gum incense, 2200-2600 parts of rosin, 50-300 parts of myrrh, 100-500 parts of beeswax, 50-200 parts of zinc oxide, 100-200 parts of menthol, 100-200 parts of borneol, 50-200 parts of wintergreen oil and 800-1500 parts of peppermint oil, and the method comprises the following steps: (1) Weigh the required amount of angelica, angelica dahurica, apricot kernel, Scrophularia ningpoensis, Gleditsia sinensis and Aconitum kusnezoffii, add the required amount of sesame oil, heat to 110-130° C. under stirring conditions, extract for 3.5-4 hours, then add the required amount of scallion, extract for 10-30 minutes, filter, and collect the filtrate; (2) Add the required amount of gum, frankincense, rosin, myrrh, beeswax, zinc oxide, menthol, borneol, wintergreen oil, peppermint oil and 2,6-di-tert-butyl-p-cresol to the collected filtrate under stirring, heat to 50-55° C., mix well, and obtain the product.

10. Use of the highly effective analgesic pharmaceutical composition according to any one of claims 1 to 8 in the preparation of a medicament for preventing and treating related diseases or complications caused by pain and discomfort.

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