WO2006076844A1 - Medicament chinois traditionnel destine a traiter les blessures resultant de chutes, rhumatisme et ostealgie et son procede de fabrication - Google Patents

Medicament chinois traditionnel destine a traiter les blessures resultant de chutes, rhumatisme et ostealgie et son procede de fabrication Download PDF

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WO2006076844A1
WO2006076844A1 PCT/CN2005/001679 CN2005001679W WO2006076844A1 WO 2006076844 A1 WO2006076844 A1 WO 2006076844A1 CN 2005001679 W CN2005001679 W CN 2005001679W WO 2006076844 A1 WO2006076844 A1 WO 2006076844A1
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traditional chinese
chinese medicine
group
medicine preparation
ethanol
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PCT/CN2005/001679
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English (en)
Chinese (zh)
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Feiyan Wei
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Guangxi Huahong Pharmaceutical Co., Ltd.
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Publication of WO2006076844A1 publication Critical patent/WO2006076844A1/fr

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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)
    • A61K36/26—Aristolochiaceae (Birthwort family), e.g. heartleaf
    • A61K36/268—Asarum (wild ginger)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/12—Ketones
    • A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • A61K31/125—Camphor; Nuclear substituted derivatives thereof
    • 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)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • 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
    • 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
    • A61K36/238—Saposhnikovia
    • 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)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/254—Acanthopanax or Eleutherococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/27—Asclepiadaceae (Milkweed family), e.g. hoya
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/289—Vladimiria
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/46—Eucommiaceae (Eucommia family), e.g. hardy rubber tree
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/538—Schizonepeta
    • A—HUMAN NECESSITIES
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/54—Lauraceae (Laurel family), e.g. cinnamon or sassafras
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/59—Menispermaceae (Moonseed family), e.g. hyperbaena or coralbead
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    • 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)
    • A61K36/74—Rubiaceae (Madder family)
    • 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)
    • A61K36/74—Rubiaceae (Madder family)
    • A61K36/744—Gardenia
    • A—HUMAN NECESSITIES
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    • 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)
    • A61K36/75—Rutaceae (Rue family)
    • 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)
    • A61K36/83—Thymelaeaceae (Mezereum family), e.g. leatherwood or false ohelo
    • A61K36/835—Aquilaria
    • 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)
    • A61K36/85—Verbenaceae (Verbena family)
    • 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)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/902—Sparganiaceae (Bur-reed family)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61P19/00—Drugs for skeletal disorders
    • A—HUMAN NECESSITIES
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    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • the invention relates to a pharmaceutical preparation containing an active ingredient of a Chinese herbal medicine, in particular to a traditional Chinese medicine preparation for treating bruises and rheumatic bone pain and a preparation method thereof.
  • the object of the present invention is to provide a traditional Chinese medicine preparation which has remarkable curative effect, rapid action and small side effects for treating bruises and rheumatism.
  • Another object of the present invention is to provide a process for the preparation of the above-mentioned traditional Chinese medicine preparation.
  • the preparation of the traditional Chinese medicine preparation prepared by the invention has remarkable curative effect on bruises and rheumatoid bone pain, and is clinically applicable to, for example, wind-cold dampness, frozen shoulder, acute contusion, anonymous swollen poison, sputum, Glandular swelling and other diseases.
  • the pharmaceutical drug substances provided by the present invention are all in parts by weight.
  • the invention provides a Chinese medicine preparation for treating bruises and rheumatic bone pain as follows:
  • the preferred scheme of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is as follows: windproof 30-80 Nepeta 30-80 Asarum 30-80
  • Another preferred embodiment of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain according to the present invention is: Windproof 30-80 Nepeta 30-80 Asarum 30-80
  • a further preferred embodiment of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is: windproof 30-80 Nepeta 30-80 Asarum 30-80 Achyranthes 30-80 Chuanxi 30-80 Xu Changqing 30-80 30-80 ⁇ 85-120 ⁇ 55-90 ⁇ 85- 120 ⁇ 55-90 camphor 40-90 menthol 40-90 ⁇ 30-80 ⁇ 30-80 ⁇ 55-90 ⁇ 30-80 Wujiapi 30-80 Huangteng 80-105 Scorpion 85-120.
  • the most preferable scheme of the traditional Chinese medicine preparation for treating bruises and rheumatic bone pain is the windproof 30-80 Nepeta 30-80 Asarum 30-80 Achyranthes 30-80 Chuanxi 30-80 Xu Changqing 30-80 Qishu 30- 80 ⁇ 85-120 ⁇ 55-90 Double-sided needle 85-120 ⁇ 55-90 Camphor 40-90 Menthol 40-90 Guizhi 30-80 ⁇ 30 - 80 ⁇ 55-90 ⁇ 30- 80 five plus skin 30-80 yellow rattan 8G-105 scorpion 85-120 agarwood 20-40.
  • the traditional Chinese medicine preparation of the present invention may be any pharmaceutically acceptable dosage form prepared by a conventional formulation process in the art.
  • An expectorant, a liquid, an emulsion or the like is preferred.
  • the preferred ratio of the above-mentioned drug substance is:
  • the amount ratio of the above-mentioned drug substance is also preferably:
  • the preferred ratio of the above-mentioned drug substance is:
  • the traditional Chinese medicine tanning agent can be prepared according to the following preparation process:
  • the above raw materials such as camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition). 7000 ⁇ 8000 parts by weight of 50-95% ethanol as solvent, after immersion for 15-30 hours, slowly ooze at a rate of about 1-10 ml per minute, collect sputum, and store it; take camphor, menthol plus After 500-800 parts by weight of 50-95% ethanol is dissolved, it is mixed with the above-mentioned mash, allowed to stand for 20-72 hours, and filtered to obtain.
  • the main active ingredient of the drug substance of the present invention and the action thereof are as follows: woody, wherein the Yunmuxiangcai contains volatile oil 0. '3 ⁇ 3%, wherein the components are single taxane, ⁇ -Rolandone, ⁇ -celery Isoene, scutellarin, citronella, eucaly, woody acid, woody alcohol, alpha-woody hydrocarbon, beta-woody hydrocarbon, woody lactone, decene, water phlegm, dehydrogenated woody Lactone, dihydrodehydroxylactone, and the like.
  • the roots also contain sterol, betulin, resin, inulin and eucalyptus.
  • Its pharmacological effects are: 1 antispasmodic and antihypertensive effects, 2 antibacterial effects. Indications include qi and pain relief, warm stomach and stomach. Treatment of cold qi stagnation, chest and abdomen pain, vomiting, diarrhea, squatting in the squat, heavy, cold. Windproof, containing volatile oil, mannitol, bitter miso, etc. Its pharmacological effects are: 1 antipyretic effect, 2 analgesic effect, 3 antibacterial effect. The main function of the function is to publish, hurricane, win the wet, and relieve pain. Exogenous cold, headache, dizziness, strong, cold and dampness, sore throat, limbs urgency, tetanus.
  • Nepeta containing volatile oil 1.8%, the main component of the oil is dextrin, racemic menthone, a small amount of d-limonene. Its pharmacological effects are: artificially heated rabbits, oral schisandra and 2 grams of extract (raw drug) / kg, no heat. In vitro, high concentrations (1: 100) have the effect of anti-tuberculosis.
  • the main function of the function is to publish, hurricane, and blood; Treatment of cold fever, headache, sore throat, stroke sputum, vomiting blood, blood stasis, blood in the stool; uterine bleeding, postpartum blood halo; bloated, sore, phlegm.
  • Liao Xixin contains volatile oil, the main component of volatile oil is decyl eugenol, Others include xanthine, ⁇ -pinene, eucalyptone, phenolic substances, etc.; Hua Xixin contains volatile oil 2.75%, 1.9%. Volatile oil mainly contains decyl eugenol (about 50 ° /.), as well as asarone, terpene, eucalyptone, xanthine, 1, 8-alpha, I-asarone (about 0 . 2% ) and so on.
  • Huaxinxin and the composition of volatile oil are similar to those of Huaxin; the volatile oil of Asarum sinensis contains 6% of eucalyptone, 8% of borneol or lycopene, 4% of eucalyptus 4%, and 2% of lin.
  • Astragalus sinensis contains flavonoid glycosides, amino acids, sugars and volatile oils. Its pharmacological effects are: 1 local anesthetic effect, 2 antipyretic, analgesic effect, 3 antibacterial effect, 4 effects on blood pressure. Indications: Hurricane, cold, water, open.
  • Wujiapi, Wujia's root bar contains volatile oil (for 4-methyl salicylaldehyde, etc.), tannin, palmitic acid, linolenic acid and vitamin bismuth, B l D sessile root plus sesamin, sprinkle Ning, syrup resin phenolic monoglucoside (five plus bismuth B) and mannose glucoside (five plus ⁇ D) and other lignan components, also contains carotenol, cardiac sputum and saponin.
  • the root of Acanthopanax senticosus contains a variety of glycocalyx, including carrot sterol, 7-hydroxy-6, 8-dimethoxy coumarin ct-glucoside, ethyl alpha-galactose, syringe phenol glucoside, Lilac and so on. In addition, it also contains sesamin and polysaccharide (2.3 to 5. 7 ° /.). The stem contains sugar V. 6 ⁇ 1. 5%).
  • the fruit contains 17-20% water-soluble polysaccharide, which contains pectin shield.
  • Its pharmacological effects are: 1. Pharmacological action of sessile sessile plus 1 anti-inflammatory effect, 2 analgesic, antipyretic effect, 3 cardiovascular effects; Pharmacological action of Acanthopanax senticosus, Acanthopanax senticosus is better than ginseng "Adapt to the original, and the role of the function. Indications: Rheumatism, strong bones, blood circulation to go to the phlegm. Treatment of cold and dampness, rapid bones and muscles, low back pain, impotence, weak feet, late child, edema, athlete's foot, sore throat, swelling, pain, Bruises and bruises.
  • Guizhi its pharmacological effects are: 1 antibacterial effect, 2 antiviral effect, 3 diuretic use.
  • the main functions are: sweating and relieving muscles, warming the veins. Treatment of cold and cold syndrome, shoulder and back muscles are sore, chest and drink.
  • Achyranthes its root contains triterpenoid saponin, hydrolyzed to form oleanolic acid, and contains a lot of potassium salt.
  • the seeds also contain triterpenoid saponins, which are the same as those contained in the roots. It also contains ecdysterone, and cofone.
  • Its pharmacological effects are: 1 the effect on the uterus, 2 on the intestinal tract, 3 on the cardiovascular system, 4 analgesic effect.
  • the main function of the function is: the use of scattered blood, dissipate swelling. Gonorrhea, hematuria, amenorrhea, symptoms, dystocia, cytoplasmic, postpartum bloody abdominal pain, throat, bloated, bruises. Cooked liver and kidney, strong bones and muscles. Treating the waist and knee pain, hehe. Chuanxiong, its roots contain volatile oil, alkaloids, phenolic components, lactones, ferulic acid. Its pharmacological effects are: 1 the role of the central nervous system, 2 antihypertensive effect, 3 pairs of smooth muscle, 4 antibacterial effects. Function and Indications: Live blood, hurricane and pain.
  • Dry bark, function and indications hurricane active, strong waist and knees, strong bones, swelling.
  • Function and Indications Blood circulation and menstruation, hurricane dehumidification. Treatment of menstruation, dysmenorrhea, rheumatism, pain, bruises. Double-sided needle, function and indications: qi and pain, blood circulation, phlegm and wind.
  • Agarwood containing agarwood spirulina, a-agarfurfuran, B-agarfurfuran, dihydrofuran furan, demethylfuran, 4-hydroxydihydrofuran, 3,4-dihydroxydihydrofuran, eugenol;
  • Function and Indications Qi and pain, warm and stop vomiting, gas and asthma.
  • stomach cold vomiting hiccups For chest and abdomen swelling and pain, stomach cold vomiting hiccups, kidney deficiency gas and asthma.
  • the big Luo umbrella is used for swelling, relieving pain, phlegm, sputum, blood stasis, rheumatism, Xu Changqing, phlegm, pain relief, and collateral.
  • scorpion, two-sided needle, Chuanxiong, Achyranthes Such as activating blood circulation to remove phlegm, in order to strengthen the main medicine swelling and pain relief effect, and with cassia twig, schizonepeta, wind, spleen, wind and cold, woody, agarwood, white peony, camphor qi and pain, swelling and dampness, It is supplemented with Wujiapi, Eucommia with strong bones, Tongjingluo and Rheumatoid arthritis.
  • the yellow vine and the scorpion with the cold and cool products are used as the adjuvant for cooling blood and detoxification.
  • the opposite is multiplied.
  • It is then blended with menthol to repel and repel various medicines for use in the skin or mucous membranes to produce a cool feeling.
  • the combination of various medicines has the effects of reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, driving wind and collaterals, and relieving cold and dampness. It is used for cold and dampness, frozen shoulder, and acute contusion.
  • the above-mentioned raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7200 parts by weight of 85% ethanol as a solvent. After immersion for 15 hours, slowly percolate at a rate of about 5 ml per minute, collect the sputum, and store it again; take camphor and menthol and add 550 parts by weight of 75% ethanol to dissolve, mix with the above sputum, and let stand. After 28 hours, it was filtered to obtain the expectorant of the present invention.
  • Double-sided needle 110 Triangular 85 Camphor 90
  • the above raw materials other than camphor and menthol are pulverized into coarse powder, according to the method of preparing a liquid extracting agent and a leaching agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7000 parts by weight of 53% ethanol as a solvent. After immersion for 15 hours, slowly percolate at a rate of about 5 ml per minute, collect the sputum, and store it again; take camphor and menthol and add 500 parts by weight of 95% ethanol to dissolve, mix with the above sputum, and let stand. After 20 hours, it was filtered to obtain the expectorant of the present invention.
  • the above raw materials other than camphor and menthol are pulverized into coarse powder.
  • the osmosis method of the agent and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 8000 parts by weight of 75% ethanol as a solvent, immersing for 30 hours, slowly oozing at a rate of about 3 ml per minute, collecting sputum, The device was preserved; the camphor and menthol were added with 800 parts by weight of 53% ethanol to dissolve, and then mixed with the above mash, allowed to stand for 24 hours, and filtered to obtain the elixirs of the present invention.
  • An emulsion is prepared according to a conventional formulation process in the art.
  • the other raw materials are pulverized into coarse powder, according to the percolation method for preparing the extract extract and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight of 95% ethanol as a solvent. , immersed for 28 hours, slowly permeate at a rate of about 3 ml per minute, collect sputum, recover alcohol, and obtain clear paste; take camphor, menthol and add 650 parts by weight of 70% ethanol to dissolve, mix with the above-mentioned clear paste After standing for 48 hours, filtering, adding 3000 parts by weight of water to adjust the water agent of the present invention.
  • the other raw materials are pulverized into coarse powder.
  • 7600 parts by weight of 79% ethanol is used as a solvent.
  • standing for 48 hours filtration, adding 8000 parts by weight of water to adjust the water agent of the present invention.
  • the other raw materials are pulverized into coarse powder.
  • 7500 parts by weight of 90% ethanol is used as a solvent.
  • immersed for 28 hours slowly permeate at a rate of about 3 ml per minute, collect sputum, recover alcohol, and obtain clear paste; take camphor, menthol and add 650 parts by weight of 70% ethanol to dissolve Thereafter, it was mixed with the above-mentioned clear paste and allowed to stand for 48 hours: filtered, and adjusted to 4500 parts by weight of water to obtain the aqueous preparation of the present invention.
  • the above nineteen flavored raw materials other than menthol are pulverized into coarse powder, according to the method of preparing the infiltrative paste and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight 80% Ethanol as a solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and 600 parts by weight of 85% ethanol to dissolve, mix with the above mash After standing for 72 hours and filtering, the tincture of the present invention is obtained.
  • Agarwood 32. 5 camphor 55 menthol 55 The above nineteen flavors of the raw materials other than camphor and menthol are pulverized into coarse powder, according to the method of preparing the infiltrative paste and the extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7200 parts by weight 70% Ethanol as solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and add 700 parts by weight of 65% ethanol to dissolve, mix with the above mash After standing for 36 hours and filtering, the tincture of the present invention was obtained.
  • the above nineteen flavored raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing a liquid extracting agent and an extracting agent (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7800 parts by weight and 60%. Ethanol as a solvent, immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and add 700 parts by weight of 60% ethanol to dissolve, mix with the above mash After standing for 60 hours and filtering, the tincture of the present invention was obtained.
  • the above nineteen flavored raw materials other than camphor and menthol are pulverized into coarse powder according to the method of preparing the infiltrative solution of the flow extract and the extract (see Appendix 10 of the Chinese Pharmacopoeia 2000 edition), using 7500 parts by weight 80%.
  • Ethanol as a solvent immersed for 15 hours, slowly permeate at a rate of about 5 ml per minute, collect sputum, and store it again; take camphor, menthol and 600 parts by weight of 60% ethanol to dissolve, mix with the above mash After standing for 24 hours and filtering, the tanning agent of the present invention was obtained.
  • the pharmacodynamic test data of the traditional Chinese medicine preparation of the invention is as follows:
  • the anti-tumor and analgesic tincture is a traditional Chinese medicine preparation tincture developed by Guangxi Liuzhou Traditional Chinese Medicine General Factory.
  • Pharmacodynamic tests showed that: local application can significantly expand the capillaries of mouse ear canal, and obviously promote the absorption of blood spots in rabbit ears; local application and ig administration can inhibit the swelling and smallness of mouse ear canal caused by croton oil.
  • the drug has obvious analgesic effect on the stimulation of acetic acid in mice.
  • the topical application has the effect of promoting the repair of soft tissue contusion in mice.
  • the minimum inhibitory concentration against Escherichia coli in vitro is 1:10, against Staphylococcus aureus and B. Streptococcus is 1:20.
  • Test sample This product (batch number 940402) and its 2 times concentrated liquid (55% alcohol), provided by Liuzhou Chinese Medicine General Factory. The doses described herein are expressed in "this product ml”.
  • Kunming mice ordinary grade, ? ⁇ is used in combination, supplied by the animal room, feeding the pellet feed.
  • Escherichia coli 44102
  • Staphylococcus aureus 26003
  • Streptococcus mutans 32172
  • Bacterial culture medium common broth medium, eosin blue agar medium, mannitol high salt agar medium, blood lipid medium, serum broth medium, prepared by our antibiotic room according to the Ministry of Health "Drug Hygiene Test Method" .
  • Feng rheumatoid beaten medicinal liquor produced by Foshan Pharmaceutical First Factory, Guangdong, batch number 9309086, containing alcohol 35-45%. When used, it can be concentrated in 6 (TC water bath to half of the original volume, and part of the ethanol is removed, and water is added to the required volume.
  • Absolute ethanol produced by Anhui Super-Grade General Factory, batch number 9312 2 0. Dilute the appropriate concentration with deionized water for testing.
  • Croton oil mixed inflammatory agent This room is prepared. 0. 5% Evans Blue: This room is prepared. 0. 7% acetic acid This room is prepared.
  • CHEM-5 semi-automatic biochemical analyzer produced by Japan ERBA.
  • mice Take 50 mice, weighing 18-21g, ? S is used in combination, and is randomly divided into 5 groups. Each mouse was anesthetized with barbiturate sodium, and the left auricle was coated with paraffin oil on a glass slide. After anesthesia for 10 minutes, the auricle tip A was observed under a microscope equipped with a ruler (10 X 4 times). The diameter of the capillary at the branch (scale unit), as a pre-medication value, immediately administered: high and low dose group according to the product 0. 2ml / ear (use this product 2 times concentrated liquid 0. 1 / ear ), 0. 1ml / ear lightly on the auricle; ethanol group with 55% ethanol drop auricle.
  • the dosage volume of each group was 0.1 ml/ear.
  • the blood vessel diameter of the same site was observed every 5 minutes after the drug for 15 minutes.
  • the maximum value of the blood vessel diameter was used as the drug value.
  • the vasodilation rate and vasodilatation degree were calculated according to the following formula, and compared with the blank group, the t-test was performed between groups. The results are shown in Table 1.
  • Vasodilatation rate two female x simple
  • Vasodilatation post-drug value - pre-medication value
  • Blank group 10 0.1 3.35 ⁇ 0.47 0.10 ⁇ 0.21 3.1 ⁇ 6.5
  • each rabbit is used for subcutaneous blood spotting of the auricle: Inject 0.2 ml of anti-coagulant liquid into the blood mound under the skin of the ear, and press with a glass tube with an inner diameter of 1.6 cm. Around the blood dome, the blood core is gently pressed from the glass tube with a diameter of the front end of the curved section, forming an area of about 2CM 2 blood spots. Two blood spots per ear, about 3CM apart.
  • the area of each blood spot was measured as the pre-medication value, and the administration was as follows:
  • the high- and low-dose groups were respectively 0.2 ml/shift (0.1 ml/class of 2 times concentrated solution of this product), 0.1 ml/class This product; the positive control group and the blank control group were given 0. lml/ spot respectively to Feng medicinal liquor and deionized water; alcohol group to 55% ethanol 0.1 heml / spot, all blood spots (surface skin coating, Once a day.
  • the blood spot area was measured once every 24 hours after administration, and the blood spot absorption rate X 100% was calculated. The value before the drug was compared with the blank group to make an inter-group t test.
  • the difference of blood spot absorption rate at 48h, 72h and 96h was very significant.
  • the blood spot absorption rate of the low dose group was 48 h after the drug was higher than that of the blank group. The difference was significant.
  • the absorption of subcutaneous blood spots has a certain promoting effect.
  • mice Take 84 mice, weighing 22-24g, ? ⁇ is used in combination and is randomly divided into 7 groups.
  • 7 groups of mice ⁇ croton oil mixed inflammatory agent 0.1 1 / ear drops on both sides of the left auricle to cause inflammation.
  • the product group 1, the phosic group, the ethanol group, and the blank group were administered in the same way after 1, 2, and 3 hours after the inflammation; the second group and the third group of the product were the first group after the inflammation.
  • the same method is administered once more (5 ml of this product plus 55% ethanol is added to 10 ml for the third group, and the product is 2. 5 ml plus 55% ethanol to 10 ml for the fourth group). 4 hours after the inflammation, the mice were sacrificed by pulling the neck, and the left and right auricles were cut out.
  • the left and right ear slices were respectively punched in the corresponding parts with a diameter of 8 mm, and weighed separately. The difference between the left and right ear weights is used as the swelling degree, and the swelling rate is compared with the blank group.
  • the inhibitory effect of the outer coating on the swelling of the croton oil to the ear lobes showed a certain dose-effect relationship. It is suggested that the administration of the ear canal has a certain inhibitory effect on the swelling of the mouse ear canal caused by croton oil.
  • mice Take 72 mice, weighing 17-22g, ? ⁇ is used in combination, and is divided into 6 groups at random.
  • the high, medium and low dose groups are given 10ml/kg (5ml with twice the concentration of this product), 5ml/kg, 2. 5ml /kg respectively.
  • the group, the ethanol control group and the blank control were given 10 ml / kg of von red wine (spent part of ethanol, see material item), 27% ethanol 10 ml / kg, deionized water 10 ml / kg, and the volume of each group was 10 ml/kg, continuous ig administration for 2 days.
  • One hour after the administration of the overseas Chinese the left ear of each mouse was coated with croton without mixing inflammatory agent 0.
  • mice were sacrificed by pulling the neck, and the left and right ear lobes were cut. 8 wake up the puncher in the corresponding parts, respectively, the left and right ear discs, accurately weighed, the difference between the weight of the left ear and the weight of the right ear; the swelling rate, with ji3 ⁇ 4 as the swelling rate, and the blank group For comparison, a t-test between groups was performed. The results are shown in Table 4.
  • this product ig to the effect of acetic acid-induced peritoneal exudation test 78 mice, weighing 18-22g, both, randomly divided into 6 groups, high, medium and low dose groups respectively according to 10ml / kg ( Use this product's 2 concentrating solution 5ml), 5ml /kg, 2. 5 ml/kg to give this product, the positive control group and the ethanol control group respectively give Fengjiu medicinal liquor 10ml/kg (spent part of ethanol, See material item) and 27% ethanol; blank control group for water supply. The administration volume was 10 ml/kg, and continuous ig administration was carried out for 4 days.
  • mice 30 min after the last administration, each mouse was injected with 0.5% Evans blue 5 ml/kg, followed by ipO. 7% acetic acid 10 ml/kg, 30 min after ig vinegar weight, the mice were sacrificed by pulling the neck, and the amount of normal saline was used. Rinse the abdominal cavity, collect all the washing liquid and add the weight of saline to 10ml/kg. After centrifugation, take the supernatant and measure the DD value at 578mm. The DD value indicates the content of Evans blue in the washing liquid, indirectly, reflecting the peritoneal inflammation exudation. Degree. Compared with the ethanol level, an inter-group t-test was performed. The results are shown in Table 5. Table 5. Results of infiltration of peritoneal inflammation in mice induced by acetic acid
  • the blank group 10 10 0.244 ⁇ 0.044 The results showed that the D values of the high, medium and low dose groups of the product were similar to those of the ethanol group and the blank group, and the difference was not significant. The difference between the von group and the low group was very significant (P ⁇ Q. Gl. It is suggested that this product ig administration has no inhibitory effect on peritoneal inflammation exudation induced by acetic acid in mice.
  • mice Take 72 mice, weighing 24-26g, ? ⁇ is used in combination and is randomly divided into 5 groups. Each mouse was anesthetized with sodium pentobarbital, and the sterilized dry cotton ball was embedded under the aseptic operation to the right side of the back, about 2.5 cm from the surgical incision. The next day after the operation, the surface of the cotton ball was depilated 2 X 2cm 2 , apply the liquid to the skin of the hair removal area. The high and low doses are given according to 20ml /kg (10ml of concentrated solution of this product) and 5ral/kg respectively.
  • mice were taken, weighing 22-24 g, and $ ⁇ was used together and randomly divided into 6 groups.
  • Each mouse was anesthetized with sodium pentobarbital, and the sterile dry cotton ball (20 mg) was immersed in the right side of the back under the aseptic operation, about 2. 5 cm from the surgical incision.
  • each group was 10 ml/kg (partial ethanol was removed, see material item); ethanol group was given 27% ethanol; blank control group was given water.
  • the dosage volume of each group was 10 ml/kg, igl times per day for 7 consecutive days.
  • the mice were sacrificed by necking, and the cotton granuloma was taken out and placed in an oven at 60 ° C for 16 hours, then accurately weighed, minus the original dry cotton ball (20 ml / only). Swelling, compared with the blank group, for t-test between groups. The results are shown in Table 7.
  • Blank group 12 10 27. 5 + 8. 7* The results showed that the granuloma weights in the high, medium and low dose groups were 21. 4%, 20.5%, 28. 2% lower than those in the blank group, respectively. The inhibition rates of the three groups were close, and the difference in the low dose group was significant. It suggests that the ig administration of this product may have a certain inhibitory effect on the proliferation of subcutaneous cotton granuloma in mice.
  • mice with a pain threshold of 10-20 seconds were selected, and the total weight was 20-24 g, which were randomly divided into 5 groups.
  • the pain was measured by the hot plate method: the mice were placed in an iron box with a bottom plate temperature of 55 ⁇ 0.5 ° C, and the time from the time when the mouse was put into the iron box to the time when the foot was added was used as the pain threshold.
  • the high, medium and low dose groups were respectively treated with 16 ml/kg of this product 2 times concentrated solution), 8 ml/kg, 5 ml/kg to the base of the product;
  • the medicinal liquor 8ml/kg was coated with double soles; the blank group was coated with water; both groups were coated with 8ml/kg.
  • the pain thresholds of each rat were measured at 30 min, 60 min, and 90 min after drug application.
  • the post-dose pain threshold was compared with the blank group for t-test. The results are shown in Table 8.
  • mice weighing 22-25 g, were randomly divided into 5 groups.
  • the pain was measured by the hot plate method: the mice were placed in an iron box with a bottom plate temperature of 55 ⁇ 0.5 ° C, and the time from the time when the mouse was put into the addition of the hind foot was used as the pain threshold.
  • 30mim after the pre-dose pain threshold was measured, and the high, medium and low dose groups were given 10ml/kg (5ml of pesticide solution 2 times), 5ml/kg, 2.5ml/kg, respectively; Sexual medicinal liquor 10ml/kg (spent part of ethanol, see material item); blank control group water supply; ethanol group gave 27% ethanol.
  • Each group of ig administration volume was 10 ml/kg.
  • the pain thresholds of each rat were measured at 30 mim, 60 mim, and 90 mim after administration, and the post-dose pain threshold was compared with the blank group for t-test. The results are shown in Table 9.
  • mice Take 60 mice, weighing 22-25g, ? Each half is divided into 6 groups.
  • the high, medium and low dose groups were given 10 ml/kg (5 ml concentrated solution of this product, 5 ml/kg, 2. 5 ml/kg), and the positive control group was given 10 ml/kg of Fengjiu medicinal liquor ( Part of the ethanol was removed, see material item); blank control group was given water; ethanol group was given 27% ethanol. All were administered by ig, and the administration volume was 10 ml/kg.
  • mice Effect of external application on the repair of soft tissue contusion in mice. Take ⁇ mice and weigh 29-33g. Soft tissue contusion after depilation of the right hind leg of each mouse: Place the right hind leg of the mouse on the rubber pad, paste the rootstock on the corresponding part of the hind leg, use the 500g method to freely fall from the height of 14cm, and shoot the rootstock. The muscles of the rats are pressed, causing soft tissue contusion in the right hind leg of the mouse, and the skin is damaged. After modeling, the rats were randomly divided into 5 groups according to the injury, and then administered immediately: 10 ml of the product in the high, medium and low dose groups (5 ml of the concentrated solution of this product), 5 ml/kg, 2.
  • the positive control group and the ethanol control group were given Fengjiu medicinal liquor and 55% ethanol in 10 ml/kg, respectively. Divided twice a day, the dosage volume was 10ml/kg, and the drug was continuously administered for 7 days. Each mouse was scored every day from the 3rd day of administration (see Table 11-1 for the scoring criteria), and the scores of each group were compared with the ethanol group for t-test between groups. The results are shown in Table 11-2. Four hours after the last administration, the mice were sacrificed, and the skin of the right hind leg was removed, and the soft tissue contusion repair was observed. The results are shown in Table 11-3 and attached photos. Table 11-1, Contusion Repair Scoring Criteria
  • Escherichia coli, Staphylococcus aureus, and Streptococcus mutans were placed in the corresponding medium, and cultured at 36 ° C for 24 hours for testing.
  • Control 1 2. 5 1: 5 1: 10 1: 20 1: 40 1: 80 1: 160 1: 320 E. coli + ⁇ - + + + + + + Staphylococcus aureus + - - + + + + + + Streptococcus B + - - + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
  • the results show that: the local application of this product has a significant expansion effect on the auricle capillaries of mice, and has a certain promoting effect on the absorption of blood spots under the ears of rabbits.
  • the topical application of the product and ig administration have a certain inhibitory effect on the swelling of the mouse ear caused by croton oil, and also have a certain inhibitory effect on the proliferation of the subcutaneous cotton granuloma in mice; , no significant effect on the peritonitis inflammatory exudation induced by acetic acid in mice.
  • the topical application of this product and ig administration have certain analgesic effects on the pain caused by hot plate in mice.
  • the topical application of this product has a certain promoting effect on the repair of soft tissue damage in mice.
  • the in vitro antibacterial test results showed that the minimum inhibitory concentration of this product on E. coli was 1:10, and that of Staphylococcus aureus and Streptococcus mutans was 1:20.
  • the above-mentioned effects of promoting blood circulation, eliminating inflammation, relieving analgesia, antibacterial, and promoting soft tissue damage provide a certain animal test basis for clinical application of this product.
  • the summary report of the clinical report of the treatment of acute contusion and rickets in the treatment of acute swelling and pain relief of the present invention From May to July 1994, the First affiliated Hospital of Guangxi College of Traditional Chinese Medicine, the Second affiliated Hospital, and the Guangxi People's Hospital adopted a randomized and controlled method. 324 patients with acute contusion and rickets (175 patients in the control group) were clinically validated. The results showed that Xiaozhongzhitongjing has the effects of reducing swelling and relieving pain, relaxing the muscles and promoting blood circulation and removing blood stasis. The total effective rate of this group in the treatment of acute contusion and rickets was 93.3% and 92.6%, respectively. The curative effect was not significantly different from that produced by Yulin Pharmaceutical Factory. This product has no obvious toxic and side effects. Individual patients may develop contact dermatitis for external use, and may have nausea symptoms when taken orally.
  • the subjects included were all patients with acute contusion within 3 days of the disease and those who met the diagnostic criteria of Chinese medicine for diagnosis of phlegm and blood stasis.
  • 324 patients were treated with Xiaozhongzhitongjing.
  • 175 cases were treated with Yunxiangjing produced by Guangxi Yulin Pharmaceutical Factory. There were no significant differences in gender and age distribution between the two groups, as shown in Table 1.
  • Sprains are indirect violence that causes the joint to undergo a torsion that exceeds normal limits, causing partial tearing of the ligaments, tendons, and joints attached to the joints. Often occurs in the ankle, knuckles and lumbar push, manifested as local pain, swelling, ecchymosis and joint movement disorders.
  • Contusion is the damage of subcutaneous tissue and muscle caused by blunt object impact or collision. It is characterized by pain, swelling, bruising of the skin, hematoma and tenderness. In severe cases, there are fascia, muscle fiber tears or deep hematoma.
  • the type of syndrome of cold and dampness obstruction in rickets is selected as the object of observation.
  • the syndrome criteria are as follows: limb joints are cold and painful, or swollen, local chills, skin color is not red, touch is not hot, cold and pain increase, The heat is reduced, the tongue is fat, the quality is light, the moss is greasy or white, and the pulse string is tight or the string is slow.
  • This verification determines the diagnostic criteria, inclusion criteria, exclusion criteria, case grouping, usage and dosage of the two groups of drugs, observation items and methods, efficacy criteria, adverse reaction observations, and statistical treatment methods for qualified subjects.
  • Dosage treatment and administration method (1) Treatment group and open treatment group: 100 cases were treated with swelling and painkilling, and the drug solution was applied to the affected area, sputum, 6 times per sputum.
  • Control group 30 cases, using painful swelling [produced by Guangxi Longzhou Pharmaceutical Factory, Guiwei Medicine Zhunzi (1982) No. 04101], applying the liquid to the affected area, sputum, rickets daily 3 Times, acute contusion, 6 times per sputum.
  • Grade data is analyzed by Ridit, count data is analyzed by X 2 , and measurement data is checked by t (u).
  • Control group 30 12 8 4 3 3 Open group 50 7 20 10 10 3
  • the treatment group was compared with the control group, X 2 1.39, P> 0.05, no significant difference.
  • the total score of the acute contusion treatment group and the control group before treatment, U 1.80, ⁇ > 0.05, The difference was not significant.
  • the above pre-treatment comparison showed that there was no significant difference between the two groups in terms of gender, age, disease type, disease course, and pre-treatment condition. It is suggested that the main factors affecting the prognosis of the two groups are balanced.
  • Urine routine 67 cases were detected before treatment, and 67 cases in the normal range were reviewed after treatment. No abnormalities were found.
  • Electrocardiogram 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.
  • ALT 67 cases were detected before treatment, of which 67 cases were treated after the normal range, No abnormalities.
  • BCr 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.
  • BUN 67 cases were detected before treatment, and 67 cases were reviewed after treatment in the normal range. No abnormalities were found.
  • Urine routine 20 cases were detected before treatment, and 20 cases were reviewed after treatment in the normal range. No abnormalities were found.
  • Electrocardiogram 73 cases were detected before treatment, and 73 cases in the normal range were reviewed after treatment. No abnormalities were found.
  • ALT 20 cases detected before treatment, wherein the treatment of the normal range after review of 20 patients were normal.
  • BUN before treatment examined 20 cases, 20 cases of normal after treatment range review, were normal.

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Abstract

La présente invention concerne un médicament chinois traditionnel destiné à traiter les blessures résultant de chutes, de rhumatisme et d’ostéalgie ainsi qu’un procédé de fabrication de celui-ci. Ledit médicament est fabriqué à partir de matériaux 21 TCM tels que Radices saussureae, Radices sileris, Herba schizeneptae, Herba asari, Cortex acanthopanacis, Ramulus, Radix achyranthis, Rhizoma ligustici, etc. Des études zoologiques et des essais cliniques indiquent que ce médicament peut être efficace pour atténuer l’arthralgie résultant de rhumatisme, périomite, blessures consécutives à des chutes telles qu’entorse aiguë ou contusion, intumescence anonyme et parotidite.
PCT/CN2005/001679 2005-01-18 2005-10-12 Medicament chinois traditionnel destine a traiter les blessures resultant de chutes, rhumatisme et ostealgie et son procede de fabrication WO2006076844A1 (fr)

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