WO2017181373A1 - Produit de protéine adhésive de moule et son application servant à supprimer une inflammation de tissu mou - Google Patents

Produit de protéine adhésive de moule et son application servant à supprimer une inflammation de tissu mou Download PDF

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Publication number
WO2017181373A1
WO2017181373A1 PCT/CN2016/079768 CN2016079768W WO2017181373A1 WO 2017181373 A1 WO2017181373 A1 WO 2017181373A1 CN 2016079768 W CN2016079768 W CN 2016079768W WO 2017181373 A1 WO2017181373 A1 WO 2017181373A1
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WO
WIPO (PCT)
Prior art keywords
mussel mucin
soft tissue
mussel
tissue inflammation
mucin
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PCT/CN2016/079768
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English (en)
Chinese (zh)
Inventor
高敏
Original Assignee
江阴市本特塞缪森生命科学研究院有限公司
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Application filed by 江阴市本特塞缪森生命科学研究院有限公司 filed Critical 江阴市本特塞缪森生命科学研究院有限公司
Priority to PCT/CN2016/079768 priority Critical patent/WO2017181373A1/fr
Priority to PCT/CN2017/081307 priority patent/WO2017181977A1/fr
Publication of WO2017181373A1 publication Critical patent/WO2017181373A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams

Definitions

  • the present invention relates generally to the fields of pharmaceuticals, medical products, health care products, and food technology, and more particularly to mussel mucin products and their use in inhibiting inflammation of soft tissues.
  • Soft tissue refers to the subcutaneous tissue, muscle, tendon, ligament, joint capsule and other tissues of the human body.
  • Soft tissue inflammation refers to a large class of microcirculatory disorders and aseptic inflammation caused by direct or indirect violence or long-term chronic strain of soft tissue.
  • causes of soft tissue inflammation include knives, falls, beatings, contusions, puncture wounds, abrasions, sports injuries, etc.
  • the clinical manifestations are mainly swelling and pain. Local oozing, edema, and severe pain in the acute phase. In the late stage, muscle, tendon adhesion, ischemic contracture, inflammation around the joints, and even joint stiffness may occur.
  • Soft tissue inflammation treatment usually chooses different methods according to different degrees. Mild inflammation often uses physical therapy such as cold compress, hot compress and massage.
  • Severe inflammation is often treated with non-steroidal anti-inflammatory drugs.
  • drugs include aspirin, acetaminophen, indomethacin, naproxen, naproxen, diclofenac, ibuprofen, nimesulide, rofecoxib, celecoxib, etc., mainly through inhibition
  • the synthesis of prostaglandins exerts its anti-inflammatory, anti-rheumatic, analgesic, antipyretic and anticoagulant effects.
  • FDA US Food and Drug Administration
  • Mussel adhesive protein also known as Mytilus edulis foot protein (Mefp)
  • Mefp Mytilus edulis foot protein
  • Mytilus coruscus A special protein secreted by Perna viridis. Mussels are usually attached in groups to the reefs on the coast or to the bottom of the ship, and have the ability to withstand wave impacts in the offshore. In fact, mussels can be attached extremely strongly to the substrate of any material, such as metal, wood, glass, and the like. The main reason for the above characteristics of mussels is that they can form and store this special mucin in the girth of the foot. The mussels release the mucin through the foot silk to a solid surface such as rock to form a water-resistant combination. Fix yourself.
  • Mussel mucin has two structural features: (1) containing lysine, which has a high loading of positive charge; (2) containing 3,4 dihydroxyphenylalanine (DOPA, dopa). The cells and tissues of the human body are negatively charged.
  • Mussel mucin plays a protective and therapeutic role by tightly binding cells and tissues through the electrostatic interaction between its own positive charge and the negative charge of cells and tissues.
  • dopa oxidation produces ortho-dioxins, which can be cross-linked with unoxidized dopa to form a membrane or a network scaffold, which promotes the protein to adhere more closely and firmly to the surface of the human body, thereby protecting.
  • Mussel mucin is a macromolecular protein that is completely degraded in the human body for about 3-10 days. Its ability to attach to cell tissues is excellent, so that mussel mucin can be stabilized locally and continue to function.
  • mussel mucin has the above characteristics, its current application field is very limited.
  • Commercial mussel mucin products are Cell-Tak from BD Biosciences, MAP Trix from Kollodis, Korea, and Hydrogel from Biopolymer, Sweden. These products are either used directly in the mussel mucin solution state, or are stored as lyophilized powder formulations and dissolved prior to use. Their primary application is limited to microscopic cell adhesion and tissue adhesives. Mussel mucin has also been reported for use in the repair of fetal membranes, as a coating against seawater corrosion, and as a drug-loaded stent for the heart.
  • Mussel mucin used herein refers to Mytilus edulis Linnaeus, Mytilus coruscus or Perna viridis from the Mytilidae bivalve mollusc. 11 subclasses of mussel mucin, currently known as purified from marine mussels: mefp1, mefp-2, mefp-3, mefp-4, mefp-5, mefp-6, collagen pre-COL- A mixture of one or more of P, pre-COL-D, pre-COL-NG, foot silk matrix proteins PTMP and DTMP.
  • the mussel mucin used herein may have a pH of 1.0 to 7.0 in an aqueous solution, and particularly may be in the range of pH 3.0 to 6.5 to make the therapeutic effect better.
  • the mussel mucin used herein can be obtained by the following preparation method, for example, a method for separating and purifying mussel mucin using mixed adsorption chromatography in Chinese Patent No. ZL200710179491.0, a kind of carboxy using Chinese Patent No. ZL200710179492.5 Method for purifying mussel mucin by methyl ion exchange chromatography, one of Chinese patent number ZL200910087567.6 is separated and purified by salting out and dialysis Mussel mucin method and the like.
  • the mussel mucin used herein may be in the form of a solution or a lyophilized powder, in particular, the concentration of mussel mucin in the product may be 0.1-15.0 mg/ml, and when the concentration is too low, the effect of mussel mucin Not large, when the concentration is too high, it can cause cytotoxicity, skin irritation, etc., which is not conducive to the treatment of soft tissue inflammation.
  • the mussel mucin used herein can also be prepared as a liquid agent by combining it with an excipient.
  • An exemplary mussel mucin liquid preparation is prepared by dissolving or diluting mussel mucin solution mother liquor or lyophilized powder to a certain concentration or pH, and the solution for dissolving or diluting may be water, physiological saline, phosphate solution, vinegar. Acid solution, borate solution, and the like.
  • the pH of mussel mucin in the final product may be pH 1.0-7.0, and in particular, the therapeutic effect may be better in the range of pH 3.0-6.5.
  • the mussel mucin used herein can also be prepared as a gelling agent in combination with an excipient.
  • An exemplary mussel mucin gel is prepared by mixing a mussel mucin solution or a lyophilized powder with a gel matrix material, which may be selected from the group consisting of cellulose derivatives, carbomers, and seaweeds. Acid salt, tragacanth, gelatin, pectin, carrageenan, gellan gum, starch, xanthan gum, cationic guar gum, agar, non-cellulosic polysaccharide, ethylene polymer, acrylic resin, polyvinyl alcohol or poly One of carboxyvinyl or any combination thereof.
  • the mussel mucin used herein can be used as a main raw material to prepare a medicine using a pharmaceutically acceptable carrier.
  • the drug may be a liquid agent or a gel.
  • the drug may be administered by oral, spray, injection, targeted topical sustained release, targeted administration, and may be administered at a low temperature or in a heated manner.
  • the mussel mucin used herein can be used as a main raw material to prepare a medical device.
  • the term medical device as used herein refers to materials that are used directly or indirectly to the human body and other similar or related items.
  • the medical device may be a liquid agent, a gel, or a foaming agent.
  • the medical device can be used by oral, spray, injection, targeted local sustained release, targeted administration, and can be administered at a low temperature or in a heated manner.
  • the mussel mucin used in this article can be used as a main raw material, in the field of health care products or foods.
  • Acceptable excipients prepare health supplements or foods.
  • the health care product or food may be a liquid agent or a gel.
  • the health supplement or food may be administered by oral, spray, injection, targeted topical sustained release, targeted administration, and may be administered at a low temperature or in a heated manner.
  • Another object of the invention is to provide the use of mussel mucin products to inhibit soft tissue inflammation.
  • mussel mucin can alleviate various soft tissue inflammations such as muscles, ligaments, fascia, tendons, synovial membranes, fat, joint capsules, and contusions or lacerations of lymphoid tissues.
  • Musitis refers to chronic inflammation of muscles or tendons and attachments or tendon sheaths due to chronic damage, wind and cold dampness, infection, muscle spasms and other factors.
  • Ligamentitis is a chronic, non-red, non-swelling, non-fever, painful aseptic inflammatory injury.
  • the treatment of ligamentitis is based on physiotherapy, supplemented by non-steroidal anti-inflammatory drugs such as fenbide.
  • Fasciitis is a non-specific inflammation that occurs in the myofascial fascia. Can occur in all parts of the body, more common in the waist, the posterior tibial and the scapular region.
  • Non-steroidal anti-inflammatory drugs such as ibuprofen and diclofenac are commonly used drugs for the treatment of fasciitis.
  • Tendinitis refers to the degenerative pathological changes of tendon collagen fibers caused by excessive use of muscle fibers and repeated intense pulling. In addition to involving the tendon itself, it can also involve the tendon sheath. In most cases, it is often associated with the degeneration of collagen tissue in the affected tendon, so it is now known as tendinopathy. Tendinitis uses non-steroidal anti-inflammatory drugs to relieve pain, severe pain, and local injection of steroids. However, multiple injections of steroids weaken the strength of the tendon and cause the tendon to break.
  • Synovitis is a form of aseptic inflammation caused by joint sprains and multiple intra-articular injuries. Abnormal function of the synovial membrane can cause the joint fluid to fail to form and absorb normally, and the joint will produce fluid accumulation. The morphological changes of the synovial membrane can also invade the articular cartilage. If it is not treated in time, it will lead to osteoarthritis of the joints, and there is a disability crisis.
  • Lipitis is inflammation caused by damage to connective tissue between the lobule and the lobule composed of subcutaneous fat cells.
  • the clinical manifestations lack specificity.
  • the subcutaneous nodules or plaques are light red to tan, and the size and number are uncertain, and the pain and tenderness are conscious.
  • Joint capsule inflammation is an acute or chronic inflammation of the joint capsule. It is caused by direct violent injury, joint flexion, extension, abduction, external rotation, etc., caused by repeated, long-term, continuous friction and compression. Clinical manifestations include pain, localized tenderness, limited mobility, and swelling.
  • the treatment of joint capsule is treated with rest or affected part of the brakes and high-dose non-steroidal anti-inflammatory drugs, if necessary, anesthesia sedatives.
  • Lymphadenitis is caused by acute and chronic inflammation involving lymph nodes in the drainage area to which the lymph nodes belong.
  • Non-specific inflammation, infection of the upper extremities, breast, chest wall, back and ventral wall above the umbilicus causes axillary lymphadenitis; infection of the lower extremities, the ventral wall of the umbilicus, perineum and buttocks may occur in the inguinal lymphadenitis; head, face, mouth, neck Infection of the parts and shoulders, causing lymphadenitis in the submandibular and neck.
  • mussel mucin can be used to treat soft tissue inflammation caused by contusions or lacerations of muscles, ligaments, fascia, tendons, synovial membranes, fat, joint capsules, lymphoid tissues, and the like.
  • the mussel mucin of the present invention can be used externally, directly acts on the affected part by transdermal absorption, and can also be absorbed to exert an anti-inflammatory pharmacological action.
  • mussel mucin as a broad-spectrum anti-inflammatory agent does not cause damage to other tissues or organs.
  • the mussel mucin application according to embodiment 1, wherein the mussel mucin concentration may be from 0.1 to 15.0 mg/ml.
  • Mussel mucin application according to embodiment 1, wherein the mussel mucin in the final product may be in the range of pH 1.0-7.0, in particular in the range of pH 3.0-6.5.
  • the mussel mucin application according to any one of embodiments 1 to 5, wherein the soft tissue inflammation is selected from the group consisting of: muscle, ligament, fascia, tendon, synovium, fat, joint capsule, lymphoid tissue contusion or Soft tissue inflammation caused by laceration.
  • composition can be used by oral, spray, injection, targeted local sustained release, targeted administration.
  • a medicament for the treatment of soft tissue inflammation comprising mussel mucin and a pharmaceutically acceptable carrier, wherein the mussel mucin is present in a concentration of from 0.1 to 15.0 mg/ml.
  • a medical device for treating inflammation of a soft tissue comprising a mussel mucin and a carrier acceptable for use in the field of medical devices, wherein the concentration of mussel mucin may be from 0.1 to 15.0 mg/ml.
  • a health supplement/food for treating soft tissue inflammation comprising mussel mucin and a health care product or a carrier acceptable for the food field, wherein the mussel mucin concentration may be from 0.1 to 15.0 mg/ml.
  • soft tissue inflammation may be selected from the group consisting of muscles, ligaments, fascia, tendons, synovium, fat, joint capsule, and contusion or crack of lymphoid tissue. Soft tissue inflammation caused by injury.
  • the use of mussel mucin in a health care product or food for treating soft tissue inflammation wherein the soft tissue inflammation can be selected from the group consisting of: muscle, ligament, fascia, tendon, synovium, fat, joint capsule, lymphoid tissue. Soft tissue inflammation caused by contusion or laceration.
  • Example 1 Application of mussel mucin gel drug in the treatment of leg muscle injury.
  • the mussel mucin solution was taken, mixed with guar gum and glycerol at a volume ratio of 2:1:1, and water was added thereto, and the pH was adjusted to 3.0 with citric acid to prepare a mussel mucoprotein content of 1.5 mg/ml.
  • Shell mucin gel drug was taken, mixed with guar gum and glycerol at a volume ratio of 2:1:1, and water was added thereto, and the pH was adjusted to 3.0 with citric acid to prepare a mussel mucoprotein content of 1.5 mg/ml.
  • Shell mucin gel drug was taken, mixed with guar gum and glycerol at a volume ratio of 2:1:1, and water was added thereto, and the pH was adjusted to 3.0 with citric acid to prepare a mussel mucoprotein content of 1.5 mg/ml.
  • Shell mucin gel drug was taken, mixed with guar gum and glycerol at a volume ratio of 2:1:1, and water was added thereto, and the pH was adjusted to 3.0
  • Example 2 Application of mussel mucin liquid medical device in the treatment of ankle ligament injury.
  • a mussel mucin solution having a concentration of 0.5 mg/ml was prepared, diluted 5 times with 0.001% acetic acid, and the mussel mucin content was 0.1 mg/ml to obtain a mussel mucin liquid medical device.
  • the selected cases were randomly assigned to the control group or the experimental group.
  • the control group was treated with Yunnan Baiyao aerosol for 3 times a day.
  • the dosage should be able to cover the affected area evenly.
  • the selected cases were sprayed with mussel mucin liquid medicine for 3 times a day.
  • the dosage should be able to cover the affected area evenly.
  • the pain in the control group was not relieved.
  • the pain in the affected area was significantly weakened in the test group within 20-40 minutes.
  • the visual analog VAS score was 4.0-6.0 before treatment to 1.0-3.0, and the analgesic time lasted 2-5 hours. Also, as the use interval is extended, no dependence is exhibited.
  • Example 3 Application of mussel mucin liquid medicine in the treatment of fasciitis.
  • a mussel mucin solution having a concentration of 10.0 mg/ml was diluted with 0.01% citric acid to a mussel mucin content of 1.0 mg/ml to obtain a mussel mucin liquid medicine.
  • Example 4 Application of mussel mucin gel medical device in the treatment of tendon injury.
  • Example 5 Application of mussel mucin gel medical device in the treatment of knee joint synovitis.
  • Example 6 Application of mussel mucin liquid medicine in the treatment of tonsillitis.
  • a mussel mucin solution having a concentration of 10.0 mg/ml was diluted with 0.01% citric acid to a mussel mucin content of 0.5 mg/ml to obtain a mussel mucin liquid medicine.
  • Ten patients with acute tonsillitis diagnosed by otolaryngologists were collected. The clinical manifestations of the patients were systemic fever and sore throat. The selected cases were randomly assigned to the control group or the experimental group. The control group was treated with oral penicillin twice a day. The test group was treated with mussel mucin liquid medicine and sprayed on the throat 3 times a day. . After 2 days of treatment, the fever symptoms of the control group disappeared and the sore throat was relieved; the fever symptoms disappeared and the sore throat was relieved in the test group. After 4 days of treatment, all the patients in the control group and the test group had normal body temperature and the symptoms of sore throat disappeared. It can be seen that mussel mucin liquid medicine can be used for the treatment of tonsillitis.

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Abstract

L'invention concerne une application d'une protéine adhésive de moule ou d'une formulation de cette dernière servant à supprimer une inflammation de tissu mou. L'invention concerne plus particulièrement l'application d'une protéine adhésive de moule ou d'une formulation de cette dernière pour traiter des contusions ou des lacérations d'un muscle, d'un ligament, d'un fascia, d'un tendon, d'une synovie, de graisse, d'un ligament capsulaire ou du tissu lymphoïde; l'invention permet de supprimer des symptômes tels que la rougeur, le gonflement, la chaleur ou la douleur provoquée par une inflammation de tissu mou.
PCT/CN2016/079768 2016-04-20 2016-04-20 Produit de protéine adhésive de moule et son application servant à supprimer une inflammation de tissu mou WO2017181373A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/CN2016/079768 WO2017181373A1 (fr) 2016-04-20 2016-04-20 Produit de protéine adhésive de moule et son application servant à supprimer une inflammation de tissu mou
PCT/CN2017/081307 WO2017181977A1 (fr) 2016-04-20 2017-04-20 Produit de protéine adhésive de moule et son utilisation pour inhiber une inflammation de tissu mou

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PCT/CN2016/079768 WO2017181373A1 (fr) 2016-04-20 2016-04-20 Produit de protéine adhésive de moule et son application servant à supprimer une inflammation de tissu mou

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PCT/CN2017/081307 WO2017181977A1 (fr) 2016-04-20 2017-04-20 Produit de protéine adhésive de moule et son utilisation pour inhiber une inflammation de tissu mou

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020143744A1 (fr) * 2019-01-10 2020-07-16 Jiangyin Mucocare Pharmaceutical Co., Ltd. Nouvelles formulations contenant des antagonistes des récepteurs des leucotriènes

Citations (2)

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Publication number Priority date Publication date Assignee Title
CN103520766A (zh) * 2013-09-25 2014-01-22 高敏 贻贝粘蛋白液体产品、其制备方法及其应用
CN105477674A (zh) * 2014-10-10 2016-04-13 北京铂铱电气科技有限公司 一种基于壳聚糖与海洋贻贝粘蛋白的止血复合材料及其制备方法

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Publication number Priority date Publication date Assignee Title
CN103520766A (zh) * 2013-09-25 2014-01-22 高敏 贻贝粘蛋白液体产品、其制备方法及其应用
CN105477674A (zh) * 2014-10-10 2016-04-13 北京铂铱电气科技有限公司 一种基于壳聚糖与海洋贻贝粘蛋白的止血复合材料及其制备方法

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ZHU, YAOYAO ET AL.: "The Reasearch Progress on Mussel Adhesive Proteins", ADVANCES IN MARINE SCIENCE, vol. 32, no. 4, 31 October 2014 (2014-10-31), pages 560 - 570 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020143744A1 (fr) * 2019-01-10 2020-07-16 Jiangyin Mucocare Pharmaceutical Co., Ltd. Nouvelles formulations contenant des antagonistes des récepteurs des leucotriènes

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