WO2022028085A1 - Pulvérisation destinée au traitement de la spondylose cervicale et procédé de préparation associé - Google Patents

Pulvérisation destinée au traitement de la spondylose cervicale et procédé de préparation associé Download PDF

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WO2022028085A1
WO2022028085A1 PCT/CN2021/098701 CN2021098701W WO2022028085A1 WO 2022028085 A1 WO2022028085 A1 WO 2022028085A1 CN 2021098701 W CN2021098701 W CN 2021098701W WO 2022028085 A1 WO2022028085 A1 WO 2022028085A1
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parts
extract
ethanol
root
medicinal
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PCT/CN2021/098701
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Chinese (zh)
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刘杰
许敏
郝洪慧
张亚欣
陈克欣
江玉娟
高超
潘瑞雪
王莉
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山东明仁福瑞达制药股份有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/31—Brassicaceae or Cruciferae (Mustard family), e.g. broccoli, cabbage or kohlrabi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/236—Ligusticum (licorice-root)
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/264—Aristolochia (Dutchman's pipe)
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    • A61K36/32—Burseraceae (Frankincense family)
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/18—Magnoliophyta (angiosperms)
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    • A61K36/906—Zingiberaceae (Ginger family)
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Definitions

  • the invention belongs to the technical field of external preparations for cervical spondylosis, in particular to a quick-acting spray for treating cervical spondylosis and a preparation process.
  • Cervical spondylosis also known as cervical spondylosis, is mainly caused by long-term strain of the cervical spine or intervertebral disc disease resulting in compression of the cervical spinal cord, nerve roots or vertebral arteries, resulting in pain, numbness, dizziness and other symptoms.
  • Traditional Chinese medicine regards cervical spondylosis as arthralgia, and believes that its pathological manifestations are usually caused by external injury, deficiency of qi and blood, feeling of wind, cold and dampness, while dizziness, dizziness, tinnitus and other symptoms are mostly related to turbidity, liver wind, and deficiency. .
  • Cervical spondylosis of liver and kidney deficiency, qi and blood deficiency type includes most of the symptoms of vertebral artery type, root type and cervical spondylosis myelopathy.
  • a large number of medical writings also contain theories and treatment experiences related to the clinical manifestations of cervical spondylosis. Based on the theory of traditional Chinese medicine and traditional Chinese medicine, the treatment of cervical spondylosis has rich experience and advantages.
  • the present invention aims to provide a kind of external spray for cervical spondylosis, based on the technical purpose, the present invention provides the following technical solutions:
  • a first aspect of the present invention provides a pharmaceutical composition for cervical spondylosis, the pharmaceutical composition comprises the following medicinal flavors in parts by weight: 15-20 parts of white mustard seeds, 10-15 parts of ginger, 15-20 parts of triangular ridges, 7-10 parts of Curcuma, 15-20 parts of Vitex, 15-18 parts of Yantuo Root, 7-10 parts of Baimancao Root, 15-25 parts of Myrrh, 15-25 parts of Chuanxiong, 5-15 parts of Sichuan Pepper, 5-10 parts of Bone-seeking Herb, 5-10 parts of Qingfeng Vine, 5-10 parts of Qinjie, 12-20 parts of Millennium Health, 10-15 parts of papaya, 5-10 parts of walnut oil.
  • White mustard seeds the seeds of the cruciferous plant Sinapis alba L.
  • White mustard seeds contain white mustard glycosides, sinapine, myrosinase, fat, protein and mucilage.
  • Sexual and spicy warm. Enter the lung and stomach meridians. Relieves phlegm, warms the middle and dissipates cold, clears the collaterals and relieves pain.
  • the main active ingredient benzyl isothiocyanate has a broad-spectrum antibacterial effect, and has antibacterial effect on yeast, 20 kinds of fungi and dozens of other strains.
  • Ginger is the fresh rhizome of Zingiber officinale Rosc. Processing method: remove impurities, wash, and cut into thick slices when used. Pungent in nature, lukewarm. Returns the lung, spleen and stomach meridians. Relieves the exterior and dispels cold, warms the middle to stop vomiting, resolves phlegm and stops cough. For wind-cold cold, stomach-cold vomiting, cough with cold phlegm. It can be used clinically for rheumatism pain and low back pain.
  • Triangular is the dried tuber of Sparganium stoloniferum Buch.-Ham. The taste is pungent, bitter, and flat. Return to the liver and spleen meridians. Detoxify blood, eliminate accumulation and relieve pain. It is used for stagnant mass, blood stasis and amenorrhea, and swelling and pain due to food accumulation.
  • Curcuma Curcuma phaeocaulis Val., Curcuma Kwangsiensis S.G.Lee et C.F.Liang or Curcuma wenyujin Y.H.Chenet C.Ling dried rhizomes. Pungent, bitter, warm in nature. Return to the liver and spleen meridians. Activating qi and breaking blood, eliminating accumulation and relieving pain. It is used for sputum mass, blood stasis, amenorrhea, and pain due to food accumulation; it can be used for early cervical cancer.
  • Curcuma rhizome contains volatile oil, the main components in the oil are curzenone (curzenone) accounting for 44.93%, borneol (borneo1) accounting for 4.28%, pormacrone accounting for 6.16%, and also contain ⁇ - and ⁇ -pinene pinene, camphene, limonene, l,8-cineole, terpinen, isborneol, caryophyllene , curcumene, caryophyllene epoxide, turme, ar-turmerone, cudione and curcurmenol, isocurcumenol (isourecumenol) et al. Another contains difuro curcumenone (difurocumenone), curcuma glycol (aerugi-diol). Curcuma curcuminoids also contain antioxidant activity of curcuminoids (curcuminoids) compounds.
  • Curcuma curcuma has good anti-inflammatory and antithrombotic effects. Its aqueous extract can significantly inhibit platelet aggregation, reduce blood viscosity, and shorten the electrophoresis time of red blood cells. It also has a very significant inhibitory effect on thrombosis in rats. . The volatile oil part can play a good inhibitory effect on a variety of inflammations.
  • Vitex is the dry ripe fruit of the Verbena plant Vitex trifolia L.var.simplicifolia Cham. or Vitex trifolia L.. The taste is pungent, bitter, slightly cold. Returns to the bladder, liver and stomach meridians. Evacuate the wind and heat, clear the leader. It is used for wind-heat cold headache, swollen gums, red eyes and tears, dark eyes, dizziness.
  • Vitex volatile oil, trace alkaloids and vitamin A; the fruit contains vitexicarpin, namely casticin. Vitex fruit contains a small amount (0.01%) of vitexine (viTCMLIBicin) and 2.60% of fatty oil, the main components are myristic acid, palmitic acid, stearic acid ), palmitoleic acid (palmitoleicid), oleic acid (oleic acid) and linoleic acid (linoleic acid) and 0.90% unsaponifiables are a small amount of paraffin (paraffin), ⁇ -tocopherol ( ⁇ -tocopherol) and ⁇ - Sitosterol ( ⁇ -sitosterol).
  • paraffin paraffin
  • ⁇ -tocopherol ⁇ -tocopherol
  • ⁇ -sitosterol ⁇ - Sitosterol
  • the volatile oil of vine leaves contains ⁇ - and ⁇ -pinene (pinene), phenol (phenol) 1,8-cineole (1,8-cineole) and ⁇ -terpineol ( ⁇ -terpineol).
  • Pharmacological effects include sedative and analgesic effects, effective for neuropathic headache, hypertension, and for sedating the body temperature center.
  • Yan Tuo Root is Rodgersia sambucifolia Hemsl. of the saxifrage family Rodgersia sambucifolia Hemsl., with rhizomes and roots used as medicine.
  • the taste is bitter, astringent, and cool. Clearing heat and cooling blood, regulating menstruation and relieving pain.
  • White grass root which is the grass root Pennisetum flaccidum Griseb. Sweet, cold. Clearing heat and cooling blood, diuretic. Indications for acute nephritis, hematuria, epistaxis, cough due to lung heat, stomach heat and polydipsia.
  • Myrrh is the oleoresin resin exuded from the bark of the trunk of the olive family myrrh, Commiphora myrrha Engl. [C.molmol Engl.] and the same species of plants.
  • the taste is bitter, flat. Disperse blood and remove blood stasis, reduce swelling and relieve pain. Treatment of falls, golden sores, muscles and bones, pains in confidants, dysmenorrhea, amenorrhea, swelling and pain of carbuncle, hemorrhoid leakage, and blindness.
  • Chuanxiong is the dry rhizome of Ligusticum chuanxiong Hort. (or Ligusticum wallichii Franch.) of the Umbelliferae. Sexual and spicy, warm. Return to the liver, gallbladder, pericardium. Function Indications: Activating blood and promoting qi, dispelling wind and relieving pain. For irregular menstruation, amenorrhea dysmenorrhea, abdominal pain in Zhengjia, tingling pain in the chest and flank, swelling and pain when falling, headache, rheumatic arthralgia.
  • the main pharmacological effects include sedative effects on the central nervous system.
  • the volatile oil of Chuanxiong has inhibitory effect on the activity of animal brain in a small amount, and has excitatory effect on the respiratory center, vascular motor center and spinal cord reflex center.
  • Chuanxiong decoction can inhibit the spontaneous activity of model animals, prolong the sleep time of sodium pentobarbital, and resist the excitatory effect of caffeine (20mg/kg).
  • Chuanxiong can also reduce heart rate, dilate coronary blood vessels, increase coronary blood flow, and improve myocardial hypoxia.
  • Ligustrazine in Chuanxiong can prolong the platelet aggregation time in vitro, deaggregate the aggregated platelets, and eliminate the formed thrombus.
  • Sichuan pepper which is recorded in the "Chinese Pharmacopoeia", the dried and mature peel (sichuan pepper) and seeds (pepper head) of pepper (Shu pepper, Sichuan pepper, red pepper, red pepper, Dahongpao) Zantho xylum bungeanum Maxim. Sexual and spicy, warm. Return to the spleen, stomach and kidney meridians. Warm in pain, insecticide and itching. For abdominal cold pain, vomiting and diarrhea, abdominal pain due to parasite accumulation, ascariasis; external treatment of eczema and itching.
  • Sichuan pepper peel is love grass brain accounting for 75.73%, and also contains myrcene, limonene, ⁇ - and ⁇ -phellandrene, ⁇ - and ⁇ -pinene, sabinene, ⁇ -ocimene-X, ⁇ -ocimene-Y ( ⁇ -ocimene-Y), 1,8-cineole, a-terpinene, O-methylacetophenone, a-nonanone, Linalool, 4-terpinenol, alpha-terpineol, beta- and gamma-elemene (elemene), trans-syringene, 2-undecanone (2-undecanone), terpineol acetate , Humulene, 1-methoxy-4-(1-propenyl)benzene [1-methoxy-4-(1-propenyl)benzene], ⁇ and ⁇ -piperene, eugenol
  • Geraniol contained in Sichuan pepper can inhibit the spontaneous activity of rats, and also has the effect of repelling insects; the dilute alcohol solution of Sichuan pepper has a local anesthetic effect.
  • Walnut kernel the seed of Juglans regia L. Sweet, warm. Returns to the kidney, lung, and large intestine meridians. Invigorating the kidney, warming the lung, moistening the intestines. Used for soreness and weakness of waist and knees, impotence, nocturnal emission, dyspnea and cough, constipation.
  • walnut oil that is, oil obtained by pressing walnut kernels, is used.
  • Bone-seeking wind is the aerial part of Aristolochiamollissima Hance, a herbaceous plant of the Aristolochiaceae family. The taste is pungent, bitter, and flat. Return to the liver meridian. Dispelling wind and dredging collaterals, relieving pain. For rheumatism arthralgia, stomach pain, testicular swelling and pain, traumatic injury embolism. It can be clinically used to treat rheumatism and rheumatoid arthritis, and also has anti-tumor effect.
  • Green vine the cane of the ivy ivy or hairy green vine.
  • Green cane stems and roots contain chemical components: sinoacutine (sinoacutine), acutumine (acutumine), N-nor acutumine (N-acutumidine), michelalbine, stepharine, sinomenine, disinomenine, magnoflorine, tetrahydroepiberberine ( sinactine), isosinomenine, tuduranine, stigmasierol, beta-sitosterol, syringaresinol and methyl hexadecanoate ( methyl palmitate).
  • the clinical therapeutic effects include analgesic and sedative effects on the nervous system, and have a good remission effect on joint inflammation.
  • sinomenine can reduce the contractility of the myocardium, inhibit the self-discipline induced by the adrenal cord, reduce the excitability of the atrial myocardium in animal models, prolong the functional refractory period, improve arrhythmia, and also have the effect of resisting myocardial ischemia and protecting reperfusion injury. .
  • Qinjie is the dry root of Gentianaceae Gentiana Gentiana macrophylla Pall., Twist Qinjie Gentiana straminea Maxim., Rhizoma chinensis Gentiana crassicaulis Duthie ex Burk. or Xiaoqinji Gentiana dahurica Fisch. Return to the stomach, liver and gallbladder meridians. Rheumatism, clearing damp heat, relieving arthralgia. It is used for rheumatic arthralgia, muscle spasm, joint pain, hot flashes in the sun, and fever due to chancre accumulation in children.
  • the main medicinal ingredients are alkaloids: gentianine, gentianine and quinine C; it also contains volatile oils and sugars.
  • Its pharmacological effects include anti-arthritis effect, and also has analgesic effect on the central nervous system.
  • Its ethanol infusion has inhibitory effects on Bacillus anthracis, Staphylococcus, Typhoid Bacillus, Pneumococcus, Shigella, and Vibrio cholera in vitro. .
  • Qianjianjian is the dried rhizome of Homalomena occulta (Lour.) Schott, a plant of the Araceae family. Bitter, acrid, warm in nature. Return to the liver and kidney meridians. Dispel rheumatism, strengthen muscles and bones, activate blood and relieve pain. For wind-cold-dampness arthralgia, cold pain in the waist and knees, and numbness in the lower limbs. Usage and dosage Oral: decoction, 9-15g; or soaked in wine. External application: appropriate amount, grind into powder and apply for application.
  • Papaya is the dry near-ripe fruit of the Rosaceae plant Chaenomeles speciosa (Sweet) Nakai. Sexual sour, warm. Return to the liver and spleen meridians. Pinggan Shujin, and stomach dampness. It is used for damp arthralgia, soreness and pain in waist and knee joints, vomiting and diarrhea, tendons, beriberi and edema.
  • the main components of papaya fruit include malic acid, tartaric acid, citric acid and saponins, as well as oleanolic acid.
  • hepatoprotective effects which can prevent hepatocyte swelling and ballooning, and promote hepatocyte repair, significantly reducing serum alanine aminotransferase levels.
  • papaya also has a strong antibacterial effect. Fresh papaya juice and papaya decoction have obvious bacteriostatic effect on intestinal bacteria and staphylococcus.
  • the above-mentioned drug combination contains many medicinal flavors containing volatile oil components.
  • the present invention considers that the volatile oil component itself has a good transdermal effect in the external preparation, and can prolong the time that the drug stays on the skin surface. Further, in terms of the selection of the external preparation, the present invention considers that the drug particles in the ointment are large and the penetration rate is relatively low. For symptoms such as pain and numbness in patients with cervical spondylosis, the use of liquid preparations can significantly improve the drug penetration rate and achieve rapid pain relief.
  • the present invention optimizes the existing pharmaceutical formulations for treating rheumatism and cervical spondylosis, and cuts the existing formulations into prescriptions to obtain the pharmaceutical formulations described in the present invention. .
  • the second aspect of the present invention provides the application of the pharmaceutical composition of the first aspect in the preparation of an anti-cervical spondylosis preparation.
  • a third aspect of the present invention provides a quick-acting spray for treating cervical spondylosis, the quick-acting spray comprising the extract of the pharmaceutical composition described in the first aspect and pharmaceutically necessary excipients.
  • the fourth aspect of the present invention provides the preparation method of the quick-acting spray for treating cervical spondylosis according to the third aspect, the preparation method comprising the following steps: extracting the volatile oil components in white mustard seed, ginger, curcuma, vine seed and Sichuan peppercorn , the volatile oil and walnut oil are mixed to obtain the oil phase; the medicinal residues after the volatile oil extraction is completed and the three-edge, yantuo root, Baimancao root, Chuanxiong, Bone-seeking grass, Qingfengteng, Qinhuang, papaya are combined to add alcohol and extract to obtain Alcohol extract, concentrate described alcohol extract to obtain extract; Myrrh and Millennium Health are broken into powder for use;
  • the spray is obtained by dissolving the extract, powder and oil phase in a high-concentration alcohol solution and then mixing with pharmaceutical excipients.
  • the present invention formulates the existing medicines for treating rheumatism and cervical spondylosis, and provides a spray form with advantages for treating cervical spondylosis. According to the characteristics of each component in the medicine, the present invention reasonably designs an extraction method, and obtains a medicinal liquid with stable shape, which has analgesic and bactericidal effects, and can effectively relieve the pain of the cervical spine. Cold and other mechanisms to achieve the therapeutic effect on cervical spondylosis.
  • the present invention proposes a quick-acting spray for the treatment of cervical spondylosis and a preparation process.
  • a first aspect of the present invention provides a pharmaceutical composition for cervical spondylosis, the pharmaceutical composition comprises the following medicinal flavors in parts by weight: 15-20 parts of white mustard seeds, 10-15 parts of ginger, 15-20 parts of triangular ridges, 7-10 parts of Curcuma, 15-20 parts of Vitex, 15-18 parts of Yantuo Root, 7-10 parts of Baimancao Root, 15-25 parts of Myrrh, 15-25 parts of Chuanxiong, 5-15 parts of Sichuan Pepper, 5-10 parts of Bone-seeking Herb, 5-10 parts of Qingfeng Vine, 5-10 parts of Qinjie, 12-20 parts of Millennium Health, 10-15 parts of papaya, 5-10 parts of walnut oil.
  • the medicinal flavors and the parts by weight in the pharmaceutical composition are as follows: 16-18 parts of white mustard seeds, 12-14 parts of ginger, 16-18 parts of tri-lens, 7-10 parts of curcuma, and 16-18 parts of vitex , 16-18 parts of Yantuo root, 7-10 parts of Baimancao root, 16-18 parts of myrrh, 16-18 parts of Chuanxiong, 5-15 parts of Sichuan pepper, 5-10 parts of Bone-seeking grass, 5- 10 servings, 5-10 servings of Qinjie, 16-18 servings of Millennium Health, 10-15 servings of papaya, 5-10 servings of walnut oil.
  • the medicinal flavors and the parts by weight in the pharmaceutical composition are as follows: 16-18 parts of white mustard seeds, 12-14 parts of ginger, 16-18 parts of triangular, 8-9 parts of Curcuma radix, 16-18 parts of Vitex japonica parts, 16-18 parts of Yantuo root, 8-9 parts of Baimancao root, 16-18 parts of myrrh, 16-18 parts of Chuanxiong, 5-15 parts of Sichuan peppercorns, 8-9 parts of Bone-seeking grass, 8 parts of green vine -9 copies, 8-9 copies of Qinjie, 16-18 copies of Millennium Health, 10-15 copies of papaya, 8-9 copies of walnut oil.
  • the medicinal flavors and the parts by weight in the pharmaceutical composition are as follows: 16 parts of white mustard seeds, 14 parts of ginger, 16 parts of triangular ridges, 8 parts of Curcuma curcuma, 16 parts of Vitex chinensis, 18 parts of Tuo Root, 8 parts of Baimancao Root, 16 parts of Myrrh, 16 parts of Chuanxiong, 8 parts of Sichuan Pepper, 8 parts of Bone-seeking Herb, 8 parts of Qingfengteng, 8 parts of Qinjie, 15 parts of Millennium Health, 10 parts of Papaya, 8 servings of walnut oil.
  • the medicinal flavors and the parts by weight in the pharmaceutical composition are as follows: 18 parts of white mustard seeds, 12 parts of ginger, 18 parts of triangularis, 8 parts of Curcuma radix, 17 parts of Vitex seeds, 16 parts of yantuo root, 8 parts of Baimancao root, 16 parts of myrrh, 16 parts of Chuanxiong, 8 parts of Sichuan peppercorns, 8 parts of Bone-seeking grass, 9 parts of Qingfengteng, 9 parts of Qinjie, 15 parts of Millennium Health, 12 parts of papaya , 9 parts of walnut oil.
  • the medicinal flavors and the parts by weight in the pharmaceutical composition are as follows: 17 parts of white mustard seeds, 13 parts of ginger, 17 parts of triangularis, 8 parts of Curcuma radix, 17 parts of Vitex seeds, 18 parts of Yantuo root, 8 parts of Baimancao root, 18 parts of myrrh, 18 parts of Chuanxiong, 13 parts of Sichuan pepper, 8 parts of Bone-seeking grass, 9 parts of Qingfengteng, 9 parts of Qinjie, 17 parts of Millennium Health, 12 parts of papaya , 8 parts of walnut oil.
  • the pharmaceutical composition also has other flavors, and the other flavors include but are not limited to one or a mixture of borneol, camphor, propolis, and ethanol.
  • the second aspect of the present invention provides the application of the pharmaceutical composition of the first aspect in the preparation of an anti-cervical spondylosis preparation.
  • a third aspect of the present invention provides a quick-acting spray for treating cervical spondylosis, the quick-acting spray comprising the extract of the pharmaceutical composition described in the first aspect and pharmaceutically necessary excipients.
  • the fourth aspect of the present invention provides the preparation method of the quick-acting spray for treating cervical spondylosis according to the third aspect, the preparation method comprising the following steps: extracting the volatile oil components in white mustard seed, ginger, curcuma, vine seed and Sichuan peppercorn , the volatile oil and walnut oil are mixed to obtain an oil phase; the medicinal residues after the volatile oil extraction is completed and the triangular, yantuo root, Baimancao root, Chuanxiong, Bone-seeking grass, Qingfengteng, Qinhuang, papaya are combined and added into the alcohol solution for extraction to obtain Alcohol extract, concentrate described alcohol extract to obtain extract; Myrrh and Millennium Health are broken into powder for use;
  • the spray is obtained by dissolving the extract, powder and oil phase in a high-concentration alcohol solution and then mixing with pharmaceutical excipients.
  • the volatile oil extraction method includes but is not limited to steam extraction, solvent extraction, supercritical fluid extraction or pressing.
  • the preparation method of the extract is as follows:
  • the medicinal residues are combined with Sanleng, Yantuo root, Baimancao root, Chuanxiong, Bone seeking grass, Qingfengteng, Qinjing, and papaya, and then add alcohol solution for extraction, transfer the extraction solution for use, and continue to add alcohol solution for reflux extraction.
  • the extract is combined with the reflux extract and then concentrated to obtain a concentrate, ethanol is added to the concentrate until the ethanol concentration reaches 75-80%, the precipitation part is discarded, and the filtrate is concentrated to obtain the extract.
  • the extraction of medicinal materials by means of leaching before reflux extraction can effectively increase the dissolution of bactericidal components, especially for Staphylococcus aureus, Pseudomonas aeruginosa and other bacterial species that are easily retained on the skin surface.
  • increasing the bactericidal effect of the spray can effectively prevent and treat inflammation that may be caused by moist skin.
  • the alcohol solution is a 75-85% ethanol solution.
  • the alcohol solution extracted by reflux is 65-75% ethanol solution.
  • the temperature of the heating and refluxing is 80-95°C.
  • the preparation method of the extract is as follows: the medicinal residues after extracting the volatile oil and the three-edge, yantuo root, white man grass root, chuanxiong, bone seeking grass, green wind vine, Qin Jun and papaya were combined and added with 75% ethanol to extract at a volume ratio of 1:2.
  • the extraction solution was transferred for later use, and 2 times the volume of 70% ethanol was added to the remaining medicinal materials for heating and refluxing at 85°C. and the reflux extract were combined and concentrated into 1/4 volume, and 95% ethanol was added to the concentrated extract until the total concentration of ethanol in the system was 80%. It is further concentrated to an extract with a density of 1.2 by vacuum decompression, and the temperature of the water bath should not exceed 60°C during concentration.
  • the preparation method of the extract is as follows: the medicinal residues after extracting the volatile oil and the three-edge, yantuo root, white man grass root, chuanxiong, bone seeking grass, green wind vine, Qin Jun and papaya were combined and added with 80% ethanol to extract at a volume ratio of 1:1.5. The extract was transferred for use, and 3 times the volume of 70% ethanol was added to the remaining medicinal materials for heating and refluxing at 95 ° C. The above extraction was carried out.
  • the liquid and the reflux extract were combined and concentrated into 1/4 volume, 95% ethanol was added to the concentrated extract until the total concentration of ethanol in the system was 75%, 3000r/min was centrifuged for 10min, filtered and the filtrate was retained, and further concentrated to For the extract with a density of 1.2, the temperature of the water bath should not exceed 60°C when concentrating.
  • the preparation method of the extract is as follows: the medicinal residues after extracting the volatile oil and the three-edge, yantuo root, white man grass root, chuanxiong, bone seeking grass, green wind vine, Qinjie and papaya were combined and added with 80% ethanol to extract at a volume ratio of 1:1.5. The extract was transferred for use, and 3 times the volume of 70% ethanol was added to the remaining medicinal materials for heating and refluxing at 80°C, and the above extraction was carried out.
  • the liquid and the reflux extract were combined and concentrated into 1/4 volume, 95% ethanol was added to the concentrated extract until the total concentration of ethanol in the system was 75%, 3000r/min was centrifuged for 10min, filtered and the filtrate was retained, and further concentrated to For the extract with a density of 1.2, the temperature of the water bath should not exceed 60°C when concentrating.
  • the myrrh and millennium jian are pulverized into micropowder or ultrafine powder.
  • a quick-acting spray for cervical spondylosis is provided, and the preparation method of the quick-acting spray is as follows: weigh 16 g of white mustard seeds, 14 g of ginger, 16 g of triangular ridges, 8 g of curcuma radix, 16 g of vitex seeds, 16 g of yantuo Root 18g, Baimancao Root 8g, Myrrh 16g, Chuanxiong 16g, Sichuan pepper 8g, Bonegrass 8g, Qingfengteng 8g, Qinjie 8g, Millennium Health 15g, Papaya 10g, Walnut oil 8g.
  • Soak mustard seed, ginger, curcuma, vine seed and Sichuan pepper in three times the volume of water for 3 hours, extract volatile oil components by steam extraction method for 6 hours, and collect the volatile oil components.
  • the volatile oil obtained by extraction was combined with walnut oil to obtain an oil phase.
  • the medicinal residues after extracting the volatile oil are combined with triangular, yantuo root, Baimancao root, Chuanxiong, Bone-seeking grass, Qingfengteng, Qinjie, and papaya, and 75% ethanol is added to extract at a volume ratio of 1:2.
  • the extraction solution is for use, add 2 times the volume of 70% ethanol to the remaining medicinal materials and heat under reflux at 85°C, combine the above extraction solution and reflux extraction solution into 1/4 volume, and add 95% to the concentrated extraction solution.
  • % ethanol to the total concentration of ethanol in the system is 80%, let stand overnight in 4 °C environment, filter and retain the filtrate part, and further concentrate to the extract with a density of 1.2 by vacuum decompression, the water bath temperature should not exceed 1.2 during concentration. 60°C.
  • a quick-acting spray for cervical spondylosis is provided, and the preparation method of the quick-acting spray is as follows: weigh 18 g of white mustard seeds, 12 g of ginger, 18 g of triangular ridges, 8 g of Curcuma radix, 17 g of Vitex japonica, 17 g of Yan Tuo Root 16g, Baimancao Root 8g, Myrrh 16g, Chuanxiong 16g, Sichuan Pepper 8g, Bonegrass 8g, Qingfengteng 9g, Qinjie 9g, Millennium Health 15g, Papaya 12g, Walnut Oil 9g, Borneol 4g.
  • Soak mustard seeds, ginger, curcuma seeds, vine seed and Sichuan pepper in three times the volume of water for 4 hours, extract volatile oil components by supercritical fluid extraction, and collect the volatile oil components.
  • the volatile oil obtained by extraction was combined with walnut oil to obtain an oil phase.
  • the medicinal residues after extracting the volatile oil are combined with triangular, yantuo root, Baimancao root, Chuanxiong, Bone-seeking grass, Qingfengteng, Qinjie, and papaya, and 80% ethanol is added to extract at a volume ratio of 1:1.5.
  • the extraction solution is for use, add 3 times the volume of 70% ethanol to the remaining medicinal materials, and heat and reflux at 95 ° C.
  • the above extraction solution and reflux extract are combined and concentrated to 1/4 volume, and added to the concentrated extraction solution.
  • the total concentration of ethanol in the system is 75% from 95% ethanol, centrifuged at 3000r/min for 10min to filter and retain the filtrate, and further concentrated to an extract with a density of 1.2.
  • the temperature of the water bath should not exceed 60°C during concentration.
  • a quick-acting spray for cervical spondylosis is provided, and the preparation method of the quick-acting spray is as follows: weigh 17 g of white mustard seeds, 13 g of ginger, 17 g of triangular ridges, 8 g of Curcuma radix, 17 g of Vitex japonica, 17 g of Radix Root. 18g, Baimancao Root 8g, Myrrh 18g, Chuanxiong 18g, Sichuan Pepper 13g, Bonegrass 8g, Qingfengteng 9g, Qinjie 9g, Millennium Health 17g, Papaya 12g, Walnut Oil 8g.
  • Soak mustard seeds, ginger, curcuma seeds, vine seed and Sichuan pepper in three times the volume of water for 4 hours, extract volatile oil components by supercritical fluid extraction, and collect the volatile oil components.
  • the volatile oil obtained by extraction was combined with walnut oil to obtain an oil phase.
  • the medicinal residues after extracting the volatile oil are combined with triangular, yantuo root, Baimancao root, Chuanxiong, Bone-seeking grass, Qingfengteng, Qinjie, and papaya, and 80% ethanol is added to extract at a volume ratio of 1:1.5.
  • the extraction solution is for use, add 3 times the volume of 70% ethanol to the remaining medicinal materials, heat and reflux at 80 ° C, combine the above extraction solution and reflux extraction solution into 1/4 volume, and add to the concentrated extraction solution.
  • the total concentration of ethanol in the system is 75% from 95% ethanol, centrifuged at 3000r/min for 10min to filter and retain the filtrate, and further concentrated to an extract with a density of 1.2.
  • the temperature of the water bath should not exceed 60°C during concentration.
  • a quick-acting spray for cervical spondylosis is provided, which is different from Example 1 in that in this example, the extract, the oil phase and the powder are mixed for later use, and 0.1 ml of vitamin E, 0.8 g Diisooctyl succinate sodium sulfonate was added a small amount of 95% ethanol to dissolve, and then mixed with the solid phase and continued to add 95% ethanol until 95% was 2 times the volume of the solid phase to obtain a medicinal liquid, and the medicinal liquid was Fill an aerosol bottle with a propellant to get an aerosol spray.
  • an external preparation for treating rheumatism and cervical spondylosis comprising the following raw materials by weight: 15 parts of white mustard seeds, 10 parts of ginger, 15 parts of triangularis, 7 parts of Curcuma radix, 15 parts of Vitex seeds, 7 parts of raw grass black, 15 parts of Yantuo root, 7 parts of Baimancao root, 15 parts of myrrh, 15 parts of Chuanxiong, 5 parts of Sichuan pepper, 15 parts of Wei Lingxian, 5 parts of windproof, 10 parts of borneol, 5 parts of white wine, 10 parts of walnut oil; its preparation method may further comprise the steps:
  • S1 Select the following materials as preparation raw materials: white mustard seeds, ginger, triangularis, curcuma, vines, raw grass black, yantuo root, white man grass root, myrrh, Chuanxiong, Sichuan peppercorns, Wei Lingxian, Fangfeng, liquor , washed and dried;
  • S2 mash and grind the raw material after cleaning and drying in S1, and filter through a 200-mesh sieve to obtain medicinal powder;
  • a quick-acting spray for cervical spondylosis is provided.
  • the medicinal residues after extracting the volatile oil are mixed with Sanleng, Yantuogen, Baimancaogen, Chuanxiong , Bone-seeking grass, green vine, quince, and papaya were combined and added 2 times the volume of 70% ethanol at 85 ° C for heating and refluxing, and the above-mentioned extract and the reflux extract were combined and concentrated into 1/4 volume.
  • a quick-acting spray for cervical spondylosis is provided, which is different from Embodiment 1 in that, in this embodiment, 75% ethanol is added to all the medicinal flavors except myrrh and Millennium Health by volume.
  • the ratio is 1:2 for leaching, transfer the leaching solution for use, add 2 times the volume of 70% ethanol to the remaining medicinal materials for heating and reflux at 85°C, and combine the above leaching solution and refluxing extract to concentrate to 1/4 volume.
  • the temperature of the water bath should not exceed 60°C when concentrating. After mixing the obtained extract and powder, 2 times the volume of 95% ethanol was added to dissolve to obtain a medicinal liquid.
  • the drug solutions in Examples 1-4 were concentrated to remove the solvent, and then dissolved in water again to prepare high and low dose groups, so that the solid drug concentrations were 2 mg/mL and 1.0 mg/mL, respectively.
  • the inhibitory effect of the above drugs on Staphylococcus aureus and Pseudomonas aeruginosa was verified by the drug sensitive paper disc agar diffusion method.
  • the agar plates were coated with 0.5 McFarland units of Staphylococcus aureus and Pseudomonas aeruginosa suspensions, respectively. After being placed in a 35°C constant temperature incubator for 18-24 hours, the size of the inhibition zone was measured. The results are shown in Table 1 below:
  • the medicinal liquids in Examples 1-4 and Comparative Example 3 have good bactericidal effects, which on the one hand can effectively prevent the spoilage of medicinal liquids, clean the skin surface, prevent Skin inflammation caused by long-term medication; on the other hand, it can also be demonstrated that the method provided by the present invention can effectively increase the dissolution of the active ingredient in the medicine.
  • the bactericidal effect of the Chinese medicinal liquid in Comparative Example 2 is significantly lower than that prepared by other methods.
  • the leaching step is not used, but alcohol is directly added for reflux extraction, which may be the bactericidal active ingredient in the above medicinal flavor. Inactivation occurred during the high temperature reflux process, and the low temperature leaching method may effectively retain the activity of this part of the bactericidal substances. Therefore, the present invention adopts the method of low temperature treatment as much as possible in the subsequent treatment process to retain the bactericidal active part.
  • the Chinese medicinal liquids of Examples 1-4 and Comparative Examples 2-3 were taken as the high-dose group, and the low-dose group was obtained by doubling the dilution as the experimental group, and the control group was smeared with 95% ethanol.
  • the pain model was prepared by intraperitoneal injection of 0.6% acetic acid with a concentration of 0.1 mL/10 g.bw.

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Abstract

Pulvérisation destinée au traitement de la spondylose cervicale et son procédé de préparation, les matières premières pour préparer la pulvérisation comprenant du Semen brassicae, du gingembre, du Rhizoma sparganii, du Curcuma zedoary, du Fructus viticis, de la racine de Rodgersia sambucifolia hemsl, du Radix Euphorbiae humifusae, de la myrrhe, du Ligusticum wallichii, du Pericarpium zanthoxyli, de l'Isotrema mollissimum, du Caulis sinomenii, de la gentiane à grandes feuilles, de l'Homalomena occulta, de la papaye et de l'huile de noix. La pulvérisation présente les effets de stérilisation et de soulagement de la douleur, et d'élimination de la douleur musculaire provoquée par la spondylose cervicale.
PCT/CN2021/098701 2020-08-06 2021-06-07 Pulvérisation destinée au traitement de la spondylose cervicale et procédé de préparation associé WO2022028085A1 (fr)

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CN111956770A (zh) * 2020-08-06 2020-11-20 山东明仁福瑞达制药股份有限公司 一种治疗颈椎病的速效喷剂及制备工艺

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