WO2018113200A1 - 消炎止痛快速愈合外用中药制剂及其制备方法 - Google Patents

消炎止痛快速愈合外用中药制剂及其制备方法 Download PDF

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WO2018113200A1
WO2018113200A1 PCT/CN2017/087249 CN2017087249W WO2018113200A1 WO 2018113200 A1 WO2018113200 A1 WO 2018113200A1 CN 2017087249 W CN2017087249 W CN 2017087249W WO 2018113200 A1 WO2018113200 A1 WO 2018113200A1
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chinese medicine
inflammatory
analgesic
medicine preparation
rapid healing
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PCT/CN2017/087249
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English (en)
French (fr)
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易翠林
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上海活尔生物科技有限公司
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Priority claimed from CN201710272867.6A external-priority patent/CN108210584A/zh
Application filed by 上海活尔生物科技有限公司 filed Critical 上海活尔生物科技有限公司
Priority to EP17825353.0A priority Critical patent/EP3369428B1/en
Priority to ES17825353T priority patent/ES2785030T3/es
Priority to US15/740,808 priority patent/US11246900B2/en
Publication of WO2018113200A1 publication Critical patent/WO2018113200A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/716Clematis (leather flower)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/02Medicinal preparations containing materials or reaction products thereof with undetermined constitution from inanimate materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/614Cnidaria, e.g. sea anemones, corals, coral animals or jellyfish
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/618Molluscs, e.g. fresh-water molluscs, oysters, clams, squids, octopus, cuttlefish, snails or slugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/10Bryophyta (mosses)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11Pteridophyta or Filicophyta (ferns)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/286Carthamus (distaff thistle)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/50Fumariaceae (Fumitory family), e.g. bleeding heart
    • A61K36/505Corydalis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/66Papaveraceae (Poppy family), e.g. bloodroot
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/714Aconitum (monkshood)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Definitions

  • the invention relates to the technical field of external traditional Chinese medicine preparations, in particular to an anti-inflammatory and analgesic rapid healing external-use traditional Chinese medicine preparation and a preparation method thereof, which are used for treating pain of bone joints, muscles and soft tissues and rapidly healing superficial wounds.
  • Bone and joint muscle pain is a major class of illnesses. According to the World Health Organization survey, there are currently about 350 million people suffering from various rheumatoid bone diseases worldwide, which is the largest category of diseases in the medical field. The number of such patients in China is about 130 million. According to statistics, 65% of patients did not receive effective treatment. At present, there are many methods for treating such diseases, mainly physical therapy, medical treatment and surgical treatment in severe cases. Because physical therapy takes a long time, surgical treatment is traumatic and costly. Oral drugs need to be absorbed by the gastrointestinal tract, side effects are large, and the effect is slow. Therefore, patients are treated with topical Chinese medicine.
  • the external Chinese medicine preparations for treating such diseases mainly include tinctures, ointments, sprays and the like. Due to the differences in the formulation, dosage form and preparation process of each traditional Chinese medicine preparation, the therapeutic effects vary greatly. At present, there are few externally used drugs for anti-inflammatory and analgesic effects on bones, joints, muscles and soft tissues, and the general external medicines have limited therapeutic effects. Basically, there is no cure for the lesions. Most of them need internal and external cooperation, and the side effects of internal medicines on the body will be It is more obvious than external use, and it has a long time to go to the lesion, and it has a slow effect.
  • the band-aid has temporary hemostasis and protects the wounds. It is the most commonly used surgical medicine in people's lives. At present, the annual production capacity of Bondi Band-Aid has exceeded 100 billion pieces, and the annual production of China Band-Aids has reached 7 billion pieces. However, Band-Aids should not be used for too long, otherwise the skin around the wound and the wound will become white and soft, which will lead to secondary infection of the bacteria and cause the wound to deteriorate.
  • the present invention provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine preparation and a preparation method thereof.
  • Its product features are: novel Chinese medicine group, unique preparation process, fast transdermal absorption, anti-inflammatory pain and wounds
  • the healing effect is remarkable without any side effects, and the use is simple and convenient.
  • the variety of nutrients contained in the product can also nourish injured cells and tissues, and promote cell regeneration and repair.
  • the products are obviously superior to the similar products in the market in treating bone and joint, muscle and soft tissue pain and rapid healing of superficial wounds.
  • this product can not only quickly penetrate the affected area directly, but also play the role of anti-inflammatory and analgesic, as well as the effect of rapid hemostasis and rapid healing of superficial wounds. It is safer, more convenient and more effective than using band-aid. It is colorless, odorless and can be used in any allergies.
  • the invention provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine preparation, comprising the following parts by weight:
  • the anti-inflammatory analgesic rapid healing topical Chinese medicine preparation comprises the following parts by weight:
  • the invention also provides a preparation method of an anti-inflammatory, analgesic and rapid healing topical Chinese medicine preparation, comprising the following steps:
  • A1 Weigh the raw materials according to the ratio of raw materials, such as Corydalis, Coleus, Stretching Grass, Clematis, and safflower, and crush the wall. Mix the above raw materials after pulverization and extract them in a sealed temperature-controlled extraction tank. Ingredients, the extract is distilled under reduced pressure to form an alcohol-free concentrate;
  • the maifan stone, the sea stone flower and the oyster shell are pulverized and mixed, and the active ingredients are extracted in a closed temperature-controlled extraction tank;
  • the extract obtained in the step A1 and the step A2 is mixed, and the mixed liquid is sheared at a high speed for 20 minutes by a super-shear homogenizer to obtain an anti-inflammatory and analgesic rapid healing external Chinese medicine tanning agent.
  • the extracted temperature is 40-60 ° C
  • the extracted solvent is 50-70% by mass of ethanol, or water.
  • the extracted temperature is 40-60 ° C
  • the extracted solvent is 60% by mass of ethanol.
  • the extracted temperature is 40-60 ° C
  • the extracted solvent is sulfuric acid having a mass fraction of 10%.
  • the dosage form of the formulation comprises an elixir, spray or ointment.
  • the anti-inflammatory and analgesic rapid healing external Chinese medicine preparation is used for: external application, sputum application, spraying, smearing or application.
  • the anti-inflammatory and analgesic rapid healing of the external Chinese medicine preparation is an expectorant, a few drops of the liquid directly drip in the affected area, repeated rubbing with a finger until completely absorbed; thus repeated 3-4 times, 2-3 times a day.
  • the present invention has the following beneficial effects:
  • the anti-inflammatory and analgesic rapid healing external Chinese medicine preparation of the invention is based on anti-inflammatory, analgesic and nutritional repair of injured cells and tissues.
  • the characteristic is that the traditional Chinese medicine group is unique, the ratio is reasonable, the preparation process is advanced, the active ingredient content is high, and the absorption is high. It is fast and has no stimulating effect on the skin. It is easy to use and directly acts on the lesion. The effect is fast and remarkable, and it has no side effects on various organs of the human body. It is ideal for the treatment of people with bone, joint, muscle and soft tissue pain, and after a period of continuous use, the affected area can basically achieve satisfactory recovery. For the people with superficial small wounds, the anti-inflammatory and analgesic effects of the invention are also very prominent.
  • results of the multiple skin irritation test and the skin allergy test of the present invention are all negative, and the patient has no allergic concerns. Therefore, the traditional Chinese medicine preparation of the invention has the exact curative effect, is non-allergic and safe and non-toxic, and has broad development prospects and good social benefits.
  • the following examples also provide a preparation method of an anti-inflammatory analgesic rapid healing topical Chinese medicine preparation, comprising the following steps:
  • A1 weigh the roots of the genus Corydalis, the grass, the grass, the safflower, the safflower, and the smashing, and mix the above raw materials after pulverization, using 50-70% ethanol, or water as a solvent. Extracting the active ingredient in a closed temperature-controlled extraction tank, and then distilling the extract to a non-alcoholic concentrate;
  • the maifan stone, the sea stone flower and the oyster shell are pulverized and mixed, and the active ingredient is extracted in a closed temperature-controlled extraction tank by using 2-10% sulfuric acid, or 2-20% acetic acid, or water as a solvent;
  • the extract obtained in the step A1 and the step A2 is mixed, and the mixed liquid is sheared at a high speed for 20 minutes by a super-shear homogenizer to prepare an anti-inflammatory and analgesic rapid healing external-use traditional Chinese medicine preparation.
  • the extracted temperature is 40-60 ° C
  • the extracted solvent is 50-70% ethanol, or water.
  • the extracted temperature is 40-60 ° C
  • the extracted solvent is 2-10% sulfuric acid, or 2-20% acetic acid, or water.
  • Dosage forms of the formulations include elixirs, sprays or ointments.
  • the present embodiment provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine tanning agent, which is prepared from the following raw materials in parts by weight:
  • the above-mentioned anti-inflammatory and analgesic rapid healing method for the treatment of external traditional Chinese medicine tincture Step one, weigh the raw materials of the genus Corydalis, the grass, the glutinous grass, the clematis, the safflower and the smashing according to the raw material formula, and crush the above-mentioned raw materials.
  • step two maifan stone, sea stone flower and oyster shell
  • step two maifan stone, sea stone flower and oyster shell
  • step two maifan stone, sea stone flower and oyster shell
  • the mixture is mixed with 10% sulfuric acid as a solvent, and the active ingredient is extracted at 40 degrees in a closed temperature-controlled extraction tank; finally, the extracts of step 1 and step 2 are mixed, and the mixed liquid is superhigh-speed using a super-shear homogenizer. After 20 minutes of cutting, the anti-inflammatory and analgesic rapid healing of the traditional Chinese medicine tincture was obtained.
  • the present embodiment provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine tanning agent, which is prepared from the following raw materials in parts by weight:
  • the preparation method of the anti-inflammatory analgesic and rapid healing external-use traditional Chinese medicine tanning agent is the same as that in the first embodiment.
  • the present embodiment provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine tanning agent, which is prepared from the following raw materials in parts by weight:
  • the preparation method of the anti-inflammatory analgesic and rapid healing external-use traditional Chinese medicine tanning agent is the same as that in the first embodiment.
  • the anti-inflammatory and analgesic rapid healing external Chinese medicine tincture prepared by the above Examples 1-3 was observed and analyzed by the trial condition of 46 patients, including 7 cases of cervical vertebrae hyperplasia, 9 cases of lumbar disc herniation and 6 cases of frozen shoulder. There were 10 cases of senile knee pain, 3 cases of gout, 5 cases of soft tissue and tendon injury, and 6 cases of superficial trauma of fingers and legs. The treatment efficiency was 98%.
  • the effective judgment of treatment is based on the pain or numbness of the waist and leg joints, the loss or disappearance of the numbness; the bone joint stiffness or movement restriction is obviously relieved or the activity is fully restored; the symptoms of swelling and pain of muscle and soft tissue disappear obviously;
  • Mr. Deng, 77 suffered from gout for many years, and his right thumb was red and swollen all year round. Every time you need to be treated with infusion and anti-inflammatory treatment, it usually takes about 14 days to relieve, which is very painful. A few years ago, Mr. Deng had another episode of gout. When the oral medication was not relieved, he began to try the product of the invention, and applied the product directly to the thumb of the right foot, rubbing it 15 times each time. Pain symptoms are significantly reduced. Thereafter, the product was used every day when the affected area was painful. Three days later, the symptoms of swelling and pain in the right foot disappeared, and the fourth day, the shoes could be walked normally. This disease is only a topical application of the present invention. It is not hospitalized for infusion treatment as usual, and it also eliminates the concern that oral drugs have side effects on liver and kidney, and the phenomenon of redness and swelling of the right foot's thumb disappears.
  • Ms. Li 43 years old, walked two empty stairs while walking, and her right foot was on her back. She was taken to the hospital for emergency treatment. The results of the film examination showed a fracture of the bone and severe contusion of the soft tissue, and the ankle was severely bruised. The attending doctor suggested to cast plaster, but Ms. Li was forced to go to the provincial government to open the congress, and did not want to take time off. Therefore, she did not agree to cast the plaster. She went home and directly applied the product of the invention, once every half hour, and bruised before going to bed that night. Basically spread, the swelling is obvious, and there is no pain. The next day, the product was applied four times a day, 10-12 drops each time, the bruise completely subsided, and there was no discomfort. On the third day, I put on my high heels and took the train to the provincial meeting. After two months, the film was reviewed and returned to normal.
  • Ms. Fan 52 years old, has a wound that is not easy to heal. Every time there is a wound on his hand, he is very susceptible to infection. One time, the fruit knife touched the finger, and after she rinsed directly with the faucet water, the product of the invention was dripped on the wound, and the blood was stopped immediately, and the wound was basically healed after two hours. On the same day, she was able to use the bruised hand to wash the dishes directly with water.
  • the present embodiment provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine spray, which is prepared from the following raw materials in parts by weight:
  • the above-mentioned anti-inflammatory and analgesic rapid healing topical Chinese medicine spray preparation method Step one, according to the raw material formula, the raw materials of the genus Corydalis, the grass, the grass, the safflower, the safflower, and the smashing, and the smashing of the above raw materials are Mixing, using 50% ethanol as a solvent, extracting the active ingredient at 60 ° C in a closed temperature-controlled extraction tank, and then concentrating the extract to a non-alcohol concentrate under reduced pressure; Step 2, maifan stone, sea stone flower and oyster shell After pulverization, the mixture is mixed with 2% sulfuric acid as a solvent, and the active ingredient is extracted at 60 ° C in a closed temperature-controlled extraction tank; finally, the extracts of step 1 and step 2 are mixed, and the mixed liquid is superhigh-speed using a super-shear homogenizer. After 20 minutes of cutting, the anti-inflammatory and analgesic rapid healing healing topical Chinese medicine spray can be prepared.
  • the present embodiment provides an anti-inflammatory and analgesic rapid healing topical Chinese medicine ointment, which is prepared from the following raw materials in parts by weight:
  • the above-mentioned anti-inflammatory and analgesic rapid healing topical Chinese medicine ointment preparation method Step one, according to the raw material formula, the raw materials of the genus Corydalis, the grass, the glutinous grass, the safflower, the safflower, and the smashing are broken, and the pulverized raw materials are mixed.
  • the anti-inflammatory and analgesic rapid healing external Chinese medicine sprays and ointments prepared by using the above Examples 4 and 5 are excellent for the treatment of bone joints, muscles and soft tissue pain by observing and analyzing the patient's trial condition, and after a period of time Continuous use, the affected area can basically achieve a satisfactory degree of recovery.
  • the anti-inflammatory and analgesic effects of the invention are also very prominent.

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Abstract

本发明提供了一种消炎止痛快速愈合外用中药制剂及其制备方法,所述中药制剂包括以下重量份数的各组分:延胡索30~80;麦饭石20~90;制草乌20~50;伸筋草10~45;威灵仙10~40;红花10~40;海石花5~40;牡蛎壳5~35。该中药可治疗肌肉和软组织疼痛。对于表浅小伤口,也有治疗作用。

Description

消炎止痛快速愈合外用中药制剂及其制备方法 技术领域
本发明涉及外用中药制剂技术领域,具体涉及一种消炎止痛快速愈合外用中药制剂及其制备方法,用于治疗骨关节、肌肉和软组织疼痛以及快速愈合表浅伤口。
背景技术
骨关节和肌肉疼痛是一大类病症。世界卫生组织调查显示:全球目前约有3.5亿人患有各种风湿骨病,是医学领域中最为庞大的一类疾患。而中国的这类病患者约为1.3亿人。据统计其中65%的患者未得到有效的治疗。目前治疗此类病的方法很多,主要有物理治疗、药物治疗及严重时的手术治疗。由于物理治疗需时较长,手术治疗创伤大、费用高,口服药物需经胃肠道吸收、副作用大且见效慢,所以患者多选用外用中药治疗。目前治疗这类病的外用中药制剂主要有酊剂、膏剂、喷剂等。由于每种中药制剂在组方、剂型、制备工艺等方面的不同,治疗效果差异很大。目前,对骨关节、肌肉和软组织消炎止痛通用的外用治疗药物较少,而且一般外用药物治疗效果有限,能彻底治愈病灶的基本上没有,大部分需要内外配合,而内服药物对身体的副作用会比外用药明显,且到过病灶处时间长,见效慢。
另外,针对伤口整齐干净、出血不多而又不需要缝合的表浅伤口,创可贴具有暂时止血,保护创面的作用,是人们生活中最常用的一种外科用药。目前,邦迪创可贴全球年生产量已经超过1000亿片,中国创可贴年产达到了70亿片左右。但是创可贴不宜使用时间过长,否则会使伤口和伤口周围的皮肤发白、变软,从而导致细菌的继发感染,造成伤口恶化。
再者,目前市场上所有的消炎止痛类外用中药制剂都只含消炎、止痛以及舒经活血的成分,缺乏可以滋养受伤的细胞和组织并促进细胞再生和修复的营养成分。
发明内容
针对现有技术中的缺陷,本发明提供了一种消炎止痛快速愈合外用中药制剂及其制备方法。其产品特点是:中药组方新颖、制备工艺独特、透皮吸收快、消炎止痛及伤口 愈合效果显著且无任何副作用、使用简单方便。同时,产品里所含的多种营养成分还可以营养受伤的细胞和组织,快速促进细胞再生和修复。产品在治疗骨关节、肌肉和软组织疼痛以及表浅伤口快速愈合方面均明显优于目前市场同类产品。值得一提的是,本品不仅能快速透皮吸收直达患处,起到消炎止痛的作用,还有使表浅伤口快速止血并快速愈合的效果,比用创可贴更加安全、方便、有效,且液体无色无味、任何过敏体质均可使用。
本发明的目的是通过以下技术方案实现的:
本发明提供了一种消炎止痛快速愈合外用中药制剂,包括以下重量份数的各组分:
Figure PCTCN2017087249-appb-000001
上述各组分的含量若不在该范围内,则无法获得本发明的效果。
优选地,所述的消炎止痛快速愈合外用中药制剂包括以下重量份数的各组分:
Figure PCTCN2017087249-appb-000002
本发明还提供了一种消炎止痛快速愈合外用中药制剂的制备方法,包括以下步骤:
A1、按原料配比称取延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,在密闭的温控提取罐中提取其有效成分,再将提取液减压蒸馏制成无醇浓缩液;
A2、将麦饭石、海石花和牡蛎壳粉碎后混合,在密闭的温控提取罐中提取其有效成分;
A3、将步骤A1和步骤A2制得的提取液混合,混合后的液体用超剪切均质机高速剪切20分钟即制得消炎止痛快速愈合外用中药搽剂。
优选地,所述步骤A1中,提取的温度为40-60℃,提取的溶剂为质量分数50-70%的乙醇,或者水。
更优选地,所述步骤A1中,提取的温度为40-60℃,提取的溶剂为质量分数60%的乙醇。
优选地,所述步骤A2中,提取的温度为40-60℃,提取的溶剂为质量分数2-10%的硫酸,2-20%醋酸,或者水。
更优选地,所述步骤A2中,提取的温度为40-60℃,提取的溶剂为质量分数10%的硫酸。
优选地,所述制剂的剂型包括搽剂、喷雾剂或膏剂。
本发明所述的消炎止痛快速愈合外用中药制剂的使用方法为:外用适量涂搽、喷雾、涂抹或敷贴。所述的消炎止痛快速愈合外用中药制剂为搽剂时,将数滴药液直接滴于患痛处,用手指反复揉搽直至完全被吸收;如此反复3-4遍,每日2-3次。
现有技术相比,本发明具有如下的有益效果:
本发明所述的消炎止痛快速愈合外用中药制剂其以消炎、止痛、营养修复受伤细胞和组织为组方依据,特点是中药组方独特,配比合理,制备工艺先进,有效成分含量高,吸收快,且无乙醇制剂对皮肤的刺激作用,使用方便,直接作用于病灶处,疗效快且显著,对人体各脏器无副作用。对于骨关节、肌肉和软组织疼痛人群的治疗效果十分理想,而且经过一段时间的连续使用,患处基本可以达到满意的恢复程度。对于表浅小伤口的人群来说,本发明消炎止痛、愈合伤口的效果也十分突出。
本发明经多次皮肤刺激试验及皮肤变态反应试验结果均为阴性,患者无任何过敏担忧。因此本发明的中药制剂疗效确切快速,无过敏且安全无毒,具有广阔的开发前景和良好的社会效益。
具体实施方式
下面结合具体实施例对本发明进行详细说明。以下实施例将有助于本领域的技术人 员进一步理解本发明,但不以任何形式限制本发明。应当指出的是,对本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进。这些都属于本发明的保护范围。
下述实施例提供了一种消炎止痛快速愈合外用中药制剂,包括以下重量份数的各组分:
Figure PCTCN2017087249-appb-000003
以下实施例还提供了一种消炎止痛快速愈合外用中药制剂的制备方法,包括以下步骤:
A1、按原料配比称取延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,用50-70%乙醇,或者水作溶剂,在密闭的温控提取罐中提取其有效成分,再将提取液减压蒸馏制成无醇浓缩液;
A2、将麦饭石、海石花和牡蛎壳粉碎后混合,用2-10%硫酸,或者2-20%醋酸,或者水做溶剂,在密闭的温控提取罐中提取其有效成分;
A3、将步骤A1和步骤A2制得的提取液混合,混合后的液体用超剪切均质机高速剪切20分钟即制得消炎止痛快速愈合外用中药制剂。
所述步骤A1中,提取的温度为40-60℃,提取的溶剂为50-70%乙醇,或者水。
所述步骤A2中,提取的温度为40-60℃,提取的溶剂为2-10%硫酸,或者2-20%醋酸,或者水。
所述制剂的剂型包括搽剂、喷雾剂或膏剂。
实施例1
本实施例提供了一种消炎止痛快速愈合外用中药搽剂,由下述原料按重量份配制而成:
Figure PCTCN2017087249-appb-000004
Figure PCTCN2017087249-appb-000005
上述消炎止痛快速愈合外用中药搽剂制法:步骤一,按原料配方称取原料延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,用60%乙醇作溶剂,在密闭的温控提取罐中40度提取其有效成分,然后将提取液减压浓缩成无醇浓缩液;步骤二,将麦饭石、海石花和牡蛎壳粉碎后混合,用10%硫酸做溶剂,在密闭的温控提取罐中40度提取其有效成分;最后将步骤一和步骤二各提取液混合,混合后的液体用超剪切均质机高速剪切20分钟即制得消炎止痛快速愈合外用中药搽剂。
上述消炎止痛快速愈合外用中药搽剂使用方法:外用适量涂搽。将数滴药液直接滴于患痛处,用手指反复揉搽直至完全被吸收。如此反复3-4遍,每日2-3次。
实施例2
本实施例提供了一种消炎止痛快速愈合外用中药搽剂,由下述原料按重量份配制而成:
Figure PCTCN2017087249-appb-000006
所述消炎止痛快速愈合外用中药搽剂的制备方法与实施例1相同。
实施例3
本实施例提供了一种消炎止痛快速愈合外用中药搽剂,由下述原料按重量份配制而成:
Figure PCTCN2017087249-appb-000007
所述消炎止痛快速愈合外用中药搽剂的制备方法与实施例1相同。
利用上述实施例1-3制得的消炎止痛快速愈合外用中药搽剂,通过对46例患者试用情况进行观察分析,其中颈椎骨增生7例,腰间盘突出9例,肩周炎6例,老年性膝关节疼痛10例,痛风3例,软组织及筋腱损伤5例,手指及腿部表浅外伤6例,治疗有效率均达98%。治疗有效率的判断依据为:腰腿和骨关节的疼痛、麻木感减轻或消失;骨关节僵直或活动受限得到明显缓解或完全恢复活动功能;肌肉和软组织的肿痛症状明显消失;表浅小伤口在数小时后基本愈合,伤处可直接沾水。
以下提供几例具体使用本发明所述的消炎止痛快速愈合外用中药搽剂的病例,以下患者使用的都是实施例1制得的产品。
典型病例1
王先生,65岁,十一年腰间盘突出病史,常年因疼痛无法直腰走路。疼痛严重时经常采用牵引、频谱理疗、针灸、按摩、涂药、贴膏药等方式减缓疼痛和麻木症状,效果均不理想。试用本品第二天腰痛感即明显减轻。每天早晚各涂搽一次,每次用量10-12滴,半个月后用完一瓶(25ml),疼痛症状基本没有了。此后,每天一次,又坚持用了6瓶,直至完全没有了腰间盘突出的任何疼痛症状。此后至今五年多,腰间盘突出没有复发过。
典型病例2
匡女士,女,53岁,患颈椎骨质增生七年。患处僵硬刺痛,严重时头晕恶心、手臂麻木。此病困扰多年,贴过各种各样的膏药,拔过火罐,做过牵引和小刀术,但都只能暂时缓解,很快又出现压迫症状。试用本发明产品,早晚各一次滴在后颈部揉擦吸收,每次用量10~12滴。两天后,感觉颈肩部的僵硬有所缓解,连续使用半个月后,感觉脖子不疼了,头晕也明显减轻了。用了3瓶后(每瓶25ml),颈椎部已经完全感觉不到 疼痛了。至今四年过去了,症状没有任何复发,效果非常理想。
典型病例3
邓先生,77岁,患痛风多年,右脚的大拇指常年红肿。每次发病都需要住院输液消炎治疗,一般需要治疗14天左右才能缓解,非常痛苦。几年前,邓先生痛风再次发作,在吃口服药无缓解的情况下,开始试用本发明产品,将本产品直接涂抹在右脚的患病大拇指上揉擦,每次用15滴,随后疼痛症状明显减轻。此后,每天每当患处疼痛时即使用本产品,三天后,右脚指肿痛症状消失,第四天就能穿鞋正常散步了。这次发病只是局部外用本发明产品,没有像往常一样住院输液治疗,也免去了口服药物对肝肾有副作用的担心,而且右脚的大拇指常年红肿的现象也消失了。
典型病例4
赵先生,45岁,由于运动不当,导致左膝盖半月板损伤,核磁共振检查膝关节有积液。平时上下楼梯疼痛明显。试用本发明产品,当天就缓解了疼痛症状,连续涂搽患部两个月,每天一次,每次10-12滴,症状完全没有了。核磁共振复查结果,膝关节积液已经完全消失,半月板损伤也愈合了。至今,三年过去了,旧症一次也没复发过。
典型病例5
李女士,43岁,走路时踩空两级楼梯,右脚脚背着地,当时就被送往医院急诊。拍片检查结果,有骨裂且软组织严重挫伤,脚踝严重淤肿。主治医生建议打石膏,但李女士碍于要去省里开代表大会,不想请假,所以没同意打石膏,回家直接涂搽本发明产品,每半小时涂搽一次,当晚睡前淤青已经基本散开,消肿很明显,也没有任何疼痛了。第二天一整天涂搽本品四次,每次10-12滴,淤肿完全消退,也没有任何不适感。第三天周一直接穿上高跟鞋坐火车去省里开会了。两个月后拍片复查,完全恢复正常。
典型病例6
范女士,52岁,伤口不易愈合体质,每次手上有伤口,都极易感染。某次,水果刀碰伤手指,她直接龙头水冲洗后,在伤口处滴上本发明产品,血立即止住,伤口两个小时后就基本愈合了。当天她就又能用这只碰伤的手直接沾水洗碗了。
典型病例7
戚女士,51岁。左胳膊由于十年前蚊虫叮咬导致的几处红肿溃烂感染,多年来一直时好时坏。偶然机会试用了本发明的外用中药搽剂,当时正值几处伤口均溃烂流脓。在患处滴上本发明产品十个小时后,所有溃烂面均基本结痂,连续使用本品七天,患处基本恢复正常。
典型病例8
杨女士,22岁,留学俄罗斯的芭蕾舞演员,演出时脚部严重扭伤,涂搽本品三天后肿痛完全消失,第五天就可以重新参加芭蕾舞的演出了。
实施例4
本实施例提供了一种消炎止痛快速愈合外用中药喷雾剂,由下述原料按重量份配制而成:
Figure PCTCN2017087249-appb-000008
上述消炎止痛快速愈合外用中药喷雾剂制法:步骤一,按原料配方称取原料延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,用50%乙醇作溶剂,在密闭的温控提取罐中60℃提取其有效成分,然后将提取液减压浓缩成无醇浓缩液;步骤二,将麦饭石、海石花和牡蛎壳粉碎后混合,用2%硫酸做溶剂,在密闭的温控提取罐中60℃提取其有效成分;最后将步骤一和步骤二各提取液混合,混合后的液体用超剪切均质机高速剪切20分钟即制得消炎止痛快速愈合外用中药喷雾剂。
实施例5
本实施例提供了一种消炎止痛快速愈合外用中药膏剂,由下述原料按重量份配制而成:
Figure PCTCN2017087249-appb-000009
Figure PCTCN2017087249-appb-000010
上述消炎止痛快速愈合外用中药膏剂制法:步骤一,按原料配方称取原料延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,用水作溶剂,在密闭的温控提取罐中50℃提取其有效成分,然后将提取液减压浓缩成无醇浓缩液;步骤二,将麦饭石、海石花和牡蛎壳粉碎后混合,用20%醋酸做溶剂,在密闭的温控提取罐中60℃提取其有效成分;最后将步骤一和步骤二各提取液混合,混合后的液体用超剪切均质机高速剪切20分钟,然后进行浓缩,即制得消炎止痛快速愈合外用中药膏剂。
利用上述实施例4和5制得的消炎止痛快速愈合外用中药喷雾剂和膏剂,通过对患者试用情况进行观察分析,对于骨关节、肌肉和软组织疼痛人群的治疗效果十分理想,而且经过一段时间的连续使用,患处基本可以达到满意的恢复程度。对于表浅小伤口的人群来说,本发明消炎止痛、愈合伤口的效果也十分突出。
本发明具体应用途径很多,以上所述仅是本发明的优选实施方式。应当指出,以上实施例仅用于说明本发明,而并不用于限制本发明的保护范围。对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以做出若干改进,这些改进也应视为本发明的保护范围。

Claims (8)

  1. 一种消炎止痛快速愈合外用中药制剂,其特征在于,包括以下重量份数的各组分:
    Figure PCTCN2017087249-appb-100001
  2. 根据权利要求1所述的消炎止痛快速愈合外用中药制剂,其特征在于,包括以下重量份数的各组分:
    Figure PCTCN2017087249-appb-100002
  3. 一种根据权利要求1或2所述的消炎止痛快速愈合外用中药制剂的制备方法,其特征在于,包括以下步骤:
    A1、按原料配比称取延胡索、制草乌、伸筋草、威灵仙、红花并进行破壁粉碎,将粉碎后的上述各原料混合,在密闭的温控提取罐中提取其有效成分,再将提取液减压蒸馏制成无醇浓缩液;
    A2、将麦饭石、海石花和牡蛎壳粉碎后混合,在密闭的温控提取罐中提取其有效成分;
    A3、将步骤A1和步骤A2制得的提取液混合,混合后的液体用超剪切均质机高速 剪切20分钟即制得消炎止痛快速愈合外用中药制剂。
  4. 根据权利要求3所述的消炎止痛快速愈合外用中药制剂的制备方法,其特征在于,所述步骤A1中,提取的温度为40-60℃,提取的溶剂为质量分数50-70%的乙醇,或者水。
  5. 根据权利要求4所述的消炎止痛快速愈合外用中药制剂的制备方法,其特征在于,所述步骤A1中,提取的温度为60℃,提取的溶剂为质量分数60%的乙醇。
  6. 根据权利要求3所述的消炎止痛快速愈合外用中药制剂的制备方法,其特征在于,所述步骤A2中,提取的温度为40-60℃,提取的溶剂为质量分数2-10%的硫酸,2-20%的醋酸,或者水。
  7. 根据权利要求6所述的消炎止痛快速愈合外用中药制剂的制备方法,其特征在于,所述步骤A2中,提取的温度为40-60℃,提取的溶剂为质量分数10%的硫酸。
  8. 根据权利要求1或2任一项所述的消炎止痛快速愈合外用中药制剂,所述制剂的剂型包括搽剂、喷雾剂或膏剂。
PCT/CN2017/087249 2016-12-21 2017-06-06 消炎止痛快速愈合外用中药制剂及其制备方法 WO2018113200A1 (zh)

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