• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    The present invention relates to a biological film-forming agent for facilitating healing of wounds and for coating and protecting biological organs, damaged cells, wound surfaces, organs and damaged sites of organs, and surfaces of a wound reaching soft tissues such as muscles and fascia, periosteum or bone cortex. Also provided is a biological film-forming agent for suppressing exudation of intracellular fluid from damaged cells, suppressing the expansion of inflammatory reactions and secondary inflammatory reactions resulting from the production of fibrin and eliminating the harmful effects caused by fibrin formation. stabilized during healing.
    公开号:FR3028414A1
    申请号:FR1560937
    申请日:2015-11-16
    公开日:2016-05-20
    发明作者:Ryoichi Hiraiwa
    申请人:Lilac Laboratory Co Ltd；
    IPC主号:
    专利说明:

    [0001] TECHNICAL FIELD [0001] The present invention relates to a dressing that can form an extremely thin porous film having water-repellent and degreasing properties on wound surfaces and damaged cells for coating wound surfaces and damaged cells to prevent skin damage. exsudation of intracellular fluid from the damaged cells, and thus suppress inflammatory reactions, relieve spontaneous pain and facilitate healing. The present invention relates to a biological film-forming agent which serves as a coating in contact with cells and a protective agent for the internal and external surfaces of various organs, for coating and protecting wound surfaces, various organs and damaged sites of various organs protect as well as wound surfaces that reach soft tissues such as muscles and fascia, periosteum and bone cortex in order to suppress intestinal edema accompanying inflammatory reactions at suture sites or due to anastomosis vascular and open surgery and to prevent the development of adhesive ileus and the like.
    [0002] STATE OF THE ART [0002] There are known dressings of wound surfaces such as gauze, bandages, the Sofra-Tulle adhesive patch, the polyurethane films of spraying agents, the silicone gauze, the trafermine preparations, cultured epidermis, bone marrow stem cells for regenerative therapy and IPS cells. However, the use of conventional products that simply cover the wound surfaces does not suppress the continuous exudation of intracellular fluid from the damaged cells, so that acute inflammatory reactions occur not only at the wound surfaces, but also at the level of the skin surrounding the wounds, which results in a strong associated pain and a large amount of inflammatory exudate. Continuous exudation creates a favorable state for bacterial infections and, as a result, frequent replacements of dressings and several symptomatic treatments such as disinfectants, antibiotic ointments, powders and topical anti-inflammatory agents are necessary in order to avoid secondary bacterial infections and inflammatory reactions. [0003] In practical medical use, the use of all conventional dressings is associated with undesirable effects of adherence of wound surfaces due to inflammatory exudate and stabilized fibrin in the exudate which acts as a component of biological adhesive and thus bleeds due to detachment of wound surfaces each time the dressings are replaced. This may result not only in further tissue damage, but also in continuous inflammatory reactions, not only at the wound surfaces but also at the edges and around the wounds, and this is a major cause of induction of strong pigmentations, hyperplasia of collagen fibers and thus scarring and agglomeration after healing, and development of hypertrophic scars and keloids depending on the body area and body constitution. DESCRIPTION OF THE INVENTION [Problems to be Solved by the Invention] [0004] It is an object of the present invention to reduce fat, which is harmful to wound healing, and to suppress fibrin production and exudation. of intracellular fluid by forming, in contrast to conventional therapeutic agents, an extremely thin, water repellent and degreasing film which has tissue affinity for damaged surfaces and damaged cells. As a result, inflammatory reactions may be suppressed, pain may be reduced, the amount of exudate may be reduced and secondary bacterial inflammation may be prevented. Thus, cleaning of contaminated wounds or treatment of complicated wounds can be omitted, complex wound surfaces can be kept dry only by application, secondary tissue damage and stabilized fibrin pain and adherence of surfaces. Wounds resulting from the use of conventional dressings such as gauze can be avoided and an optimal environment and preferable conditions for wound healing can be provided, so that early healing can be achieved and various adverse effects can be achieved. after healing, as the pigmentations can be remarkably eliminated. [0005] A porous, water-repellent film means a film that does not inhibit the transpiration of water in the body (eg, sweat) through a gap in the film, although the film has a water-repellent property. It is considered that the water transpiration function, the degreasing function and the agglomeration function of the proteins are strongly related to each other. Here, the agglomeration function of the proteins is obtained by the combination of the agent of the present invention and the proteins. When the functions described above are combined, the function of suppressing fibrin production is considered to be obtained. As a result of the study on the interaction of aluminum chloride, cyclodextrin and water and the physicochemical effects of the combination of these materials, it has been found that an interfacial surface having strong hydrophobic and hydrophobic properties has been formed and the emulsion formed by the horny layer of the skin, sweat and sebum is thus demulsified. In addition, the degreasing property is improved because the encapsulation of fat such as sebum is promoted by cyclodextrin. In addition, the degreasing property is favored because the formed film is porous and thus does not inhibit the transpiration of water from the body. In addition, the film reduces friction so that friction between various members and external friction can be reduced (slip effect). The present invention is the result of the application of these properties. [0007] Fig. 1 is a photographic image showing a state of application of the agent of the present invention containing hydrated aluminum chloride on the skin to cover the skin surface and the entire stratum corneum. , which repels water, as one of the examples of the water-repellent action. It has been found that aluminum chloride, cyclodextrin and water interact to prevent the exudation of intracellular hydrophilic components such as proteins, amino acids and glucose from damaged cells on the surfaces of the body. wound or damaged vessels and encapsulate or absorb lipophilic components including emulsions, thereby providing an extremely optimal environment and preferable conditions for healing wounds. The various components exuded from damaged cells and damaged vessels form, together with the water repellent film, degreaser and permeable to water vapor together with aluminum chloride, cyclodextrin and water, and the film prevents 5 l Exudation of intracellular fluid from the damaged cells, resulting in suppression of fibrin production and attenuation of inflammatory reactions according to a number of case results on wound surfaces, damaged cells and damaged vessels. When applied to dermal wound sites, effects can be obtained in that edema and pain are markedly attenuated and the amount of exudate is remarkably reduced, even in the case of severe damage to the skin. skin such as burns or deep wounds reaching the subcutaneous fat. [0009] As a result of the suppression of stabilized fibrin production, this results in an improved detachment of the gauze or conventional dressings and another wound is not induced, so that exudation at the level of the surfaces wounds in conventional wound healing and exudation of intracellular fluid are significantly suppressed. In addition, pigmentation of the skin after inflammation, hypertrophic scars and keloids that occur due to the continuous expansion of inflammatory reactions can be substantially prevented. The present invention is not directed to hemostasis, but it is an invention that facilitates an action opposite to hemostasis. When applied to wound surfaces, although the mechanism of action is unknown, the present invention may immediately stop petechial hemorrhage (haemorrhage due to rupture of capillary vessels to the lower layer of the dermal papillae). ) and can stop the effusive bleeding (haemorrhage due to rupture in venules in the middle to upper dermis) in 2 minutes, which is shorter than the time required with the platelets. [0011] In addition, it has also been found that a water-repellent degreasing film is formed on the target surface of various members represented by the surface of a wound, the friction is reduced and the lubricating power is increased, and therefore the present invention can provide a useful effect in the case of intestinal adhesive ileus which accompanies inflammatory edema of the intestine during open surgery. [0012] It has also been found that a water-repellent degreasing film is formed and fixed on the surface of damaged cells deteriorating over time from organs excised during organ transplantation, for example, by inhibiting thus the exudation of intracellular fluid and having a protective effect of the organs. [Means for solving the problem] The present invention provides a biological film-forming agent for coating the surface of a skin wound and a subcutaneous tissue and a damaged cell, characterized in that the biological film-forming agent comprises chloride of aluminum, a cyclodextrin and water. According to a particular characteristic, the biological film-forming agent is an aqueous solution having a pH in a range from 1.8 to 7. According to another particular characteristic, the concentration of the aluminum chloride is 0.005 to 20.0% by weight. . According to another particular characteristic, the concentration of the cyclodextrin is 0.1 to 45% by weight per 100 parts of water.
    [0003] According to another particular characteristic, the biological film-forming agent is porous. According to another particular characteristic, the biological film-forming agent covers an organ, a damaged site of the organ, and the surface of a wound reaching the periosteum or the bone cortex.
    [0004] According to another particular characteristic, water is water contained in a biological fluid. According to another particular characteristic, the dosage form of the biological film-forming agent is an aqueous solution, and the pH is increased to at least 2.8 by deacidification of the aqueous solution with an alkaline agent and addition of a flocculation agent. to filter a flocculated precipitate generated. According to one variant, the dosage form of the biological film-forming agent is a powder, and the pH is increased to at least 2.8 by addition of an alkaline powder to the biological film-forming agent. In order to form a biological film-forming agent, water is an essential component, and a biological film-forming agent is formed into a film under the following conditions. An example of formulation is, relative to 100 g of water, in weight ratio, 0.1 to 25% of aluminum chloride and 0.1 to 45% of cyclodextrin. The aluminum chloride may be anhydrous or hydrated, and although the effect is less, aluminum hydroxychloride, alum or a basic aluminum chloride polymer may be used. To use on a wound site containing excess water (biological fluid) such as leakage of blood or exudate, a dosage form of powder may be preferable because while absorbing the excess of exudate, a simulated crust containing a fine powder can be formed and a film can be more effectively formed at a complex boundary at the wound site. A fine powder is produced by suitably adding the main agents of the present invention, the aluminum chloride powder and the cyclodextrin powder, to the basic auxiliary powder which is advantageous in forming the powder. . The main purpose of using the basic auxiliary agent for powder formation is to reduce the agglomeration of the powder due to the hygroscopic and deliquescent nature of the aluminum chloride compound and to improve the property of spraying as well as improving the fluidity and dispersibility of a powdered agent. Examples of basic spray auxiliaries include silicic anhydride, Trichosanthes kirilowii, starch such as corn starch and phosphoric acid modified starch and other powdered agents such as zinc oxide and talc. The cyclodextrin (hereinafter abbreviated CD) used in the present invention can, by interaction with water and aluminum chloride, demulsify and absorb hydrophobic substances such as sebum or emulsion. of sebum and water in sweat. In the present invention, cyclodextrin refers primarily to α-CD, β-CD, -y-CD and mixtures thereof, and may include derivatives thereof. [Effects of the invention] Since the degreasing property and the protein agglomeration function are favored and fibrin production is suppressed, the inflammatory reaction and the immunological reaction are suppressed and the possibility of Application to and improvement of the following symptoms and diseases is facilitated by the effect of an increase in lubrication: (1) Use for reducing inflammatory reactions and relieving pain after aphthous stomatitis and tooth extraction, and anti-inflammatory effect on dental leakage; (2) use to stably guarantee an effect in surgery, a reduction in the period of hospitalization and to facilitate rehabilitation by coating and protecting the organs after surgery and a reduction of inflammatory reactions in the field of surgery cerebral, spinal and neurosurgery; (3) use for thrombus reduction, omission and rejection due to an immunological reaction (inflammatory reaction) in the transplanted vessels by microsurgery and capillary anastomosis and to prevent necrosis of skin flaps in the field of plastic surgery, reconstructive surgery and organ transplantation; (4) during microsurgery in the field of plastic surgery, avoid thrombi in transplanted vessels, protect grafts and vessels, suppress vascular edema and improve engraftment; (5) Use for the suppression and relief of symptoms of irritating sensations accompanying bronchial stenosis by foreign bodies in the airway epithelium in patients with asthma and patients with COPD (Respiratory Distress Syndrome) chronic) (bronchoscopic use); (6) use for the significant suppression of systemic pain in severe burns, reduction of inflammatory reactions, early healing of wounds without relying on skin grafting or epidermis in culture, prevention of bacterial infection secondary, reducing the admission period, to facilitate rehabilitation and 30 for the reduction of ugliness; (7) use for relieving pain of peptic ulcer (endoscopic use) and for reducing inflammatory reactions; (8) use for pain relief and anti-inflammatory effect on anal fissure by use of the intra-anal canal and to promote the anti-inflammatory effect by combined use with petrolatum or a lubricant; (9) use for the suppression of the irritating sensation of foreign substances in intranasal administration and the reduction of nasal discharge and nasal obstruction by reduction of inflammatory reactions in allergic rhinitis; (10) use for protection of the tympanic membrane after drainage, protection of the ossicle of the ear and anti-inflammatory effect in the case of otitis media; (11) use for attenuation of inflammatory reactions after probing with a candle for the lacrimal duct, coating and protection of the damaged nasolacrimal duct epithelium in inflammatory obstruction of the nasolacrimal duct; (12) control of abrasion and skin laceration wounds, incision wounds and tears reaching the skin and subcutaneous tissues, fascia, muscles, cartilage, periosteum or bones, facilitation of crust formation and epidermization, reduction of trauma and surgical wound healing period and removal of traumatic skin pigmentation and scarring; (13) reduction of acute inflammatory reactions (swelling, edema, pain), suppression of persistent inflammatory reactions, prevention of necrosis of muscle and bone tissue and sequestration due to secondary infection, and to avoid amputation of the leg as a last resort in the case of an open fracture; (14) prevention of contracture of scars, avoidance of functional deficiencies and conduct disorders such as contracture in flexion and limitation of extension and avoidance of skin dysmorphogenesis by avoiding and suppressing inflammatory reactions by a three-dimensional coating of damaged cells to suppress fibroblast activities and suppress collagen fiber hyperplasia to result in the earliest and most appropriate wound healing process in aspects of finger flexor burns and toes and neck of the condyle of the lower jaw; (15) as a local cancer therapy, to mix with an anti-cancer drug and to apply or spray on a primary cancer site or a metastatic cancer site to coat the cancer site and prevent metastasis. disseminated, and achieve cancer reduction. Possibility of convenient use for cancer cells as well as various organ tissues in vivo without any detrimental effect, even in prolonged use, so that it may be another way that can effectively and cheaply carry out a therapy conventional cancer; (16) to prevent anastomotic leakage in gastrointestinal, hepatobiliary, respiratory and gynecological surgery. To reduce the period until the onset of inflammatory edema after surgery, reduce the admission period and facilitate rehabilitation; and (17) to infiltrate regenerated tissues with IPS cells, epidermis in culture, cornea or the like and increase engraftment at affected sites.
    [0005] BRIEF DESCRIPTION OF THE DRAWINGS [0017] Fig. 1 is a photographic image of a thin film of aluminum chloride coating a skin surface or the entire stratum corneum while repelling water; FIG. 2 is an observation of the formation of a water-repellent degreasing film which exhibits haemostatic action immediately after the direct application of an aqueous solution according to Example 1 of the present invention without disinfection; Figure 3 is a photographic image showing that a scar is not elevated, has already lost its redness or stiffness, and is maturing; Figure 4 shows the case of a back of a right hand touched by a second degree burn (superficial) due to contact with the lid of a saucepan; Fig. 5 is a photographic image showing the state one week after Fig. 4; Figure 6 is a photographic image showing the haemostatic action of Example 1 (case study 3) on effusive haemorrhage observed after removal of a molluscum contagiosum; Fig. 7 is a photographic image showing a 2nd degree burn accompanied by a 20 mm edematous blister extending between the thumb and forefinger of the right hand; Figure 8 is a photographic image showing the state one week after Figure 7 when the epidermization is complete; Figure 9 is a photographic image showing the initiation of epidermization with a raised crust; Fig. 10 is a photographic image showing the condition of the patient of Fig. 9 after 24 days; Figure 11 is a photographic image showing the state 7 days after the treatment with the formulation of Example 3; Fig. 12 is a photographic image showing the state 11 days after the treatment with the formulation of Example 3; Fig. 13 is a photographic image showing state 14 15 days after treatment with the formulation of Example 3; Fig. 14 is a photographic image showing the state 20 days after treatment with the formulation of Example 3; Fig. 15 is a photographic image showing the state 24 days after treatment with the formulation of Example 3; Fig. 16 is a photographic image showing the state 36 days after treatment with the formulation of Example 3; Fig. 17 is a photographic image showing the state 39 days after the treatment with the formulation of Example 3; Fig. 18 is a photographic image showing the state at the first consultation obtained with the formulation of Example 5; Fig. 19 is a photographic image showing the state 2 months after treatment with the formulation of Example 5; Fig. 20 is a photographic image showing the state at the first consultation obtained with the formulation of Example 6; Fig. 21 is a photographic image showing the state 10 days after treatment with the formulation of Example 6. Embodiment of the Invention [0018] According to the present invention, an active ingredient, the hydrated aluminum, is preferably used in the practical range of 0.005% to 20% by weight given the high acidity of the latter and its nature irritating the tissues. The pH of aluminum chloride is less affected by the concentration and is as low as about pH 1.9. Aluminum chloride has a strong tissue-irritating nature, so that it is preferably further adjusted to a pH of 2.8 to 6.0 in practical use. A basic component, water, may be purified water or pure water or, depending on the conditions of application (mucosa, conjunctiva), a physiological saline solution such as an isotonic solution containing chloride sodium as the main component may be preferable. If the dosage form is a powder, water contained in a biological fluid such as sweat, runny nose, tear fluid, saliva, bronchial and tracheal secretions, blood, inflammatory exudate, gastric mucus and gastric juice, mucus of the small intestine, pleural fluid, ascites fluid, water wetting the surface of retroperitoneal organs, water wetting the heart vessels and large vessels in the mediastinum , cervical losses, vaginal discharge, and discharge of the anal gland can be used as the main component water. When the agent causes an itching sensation and an increase in pain, the pH can be raised to at least 2.8 by deacidification of the agent with an alkaline agent such as sodium hydroxide and by adding a caustic agent. flocculation such as xanthan gum, guar gum, soluble starch and poly (acrylic acid) to filter generated flocculated precipitates which contain aluminum chloride and aluminum hydroxide. Thus, the tingling sensation is reduced and safe use is made possible without causing acidic histological damage in all organs of the body. If the dosage form is a powder, the pH may be raised to at least 2.8 by arbitrary addition of alkaline powders such as silica, sodium carbonate and potassium hydroxide. Thus, the tingling sensation is reduced and safe use is made possible without causing acidic histological damage in all organs of the body. The cyclodextrin that may be used for the present invention may be an α-, β- or γ-cyclodextrin or a mixture thereof. Preferably, a hydroxyalkyl β-cyclodextrin is economically advantageous. Examples for α-cyclodextrin and γ-cyclodextrin are omitted; however, α-cyclodextrin and γ-cyclodextrin did not show a significant difference in function with 13-cyclodextrin. [0021] The dosage forms which can be used for the present invention are lotions, sprays, powders, ointments, creams, tinctures and the like. However, when using the wound washing agent, the agent can be incorporated in detergents such as surfactants. One advantage of the dosage forms is that a sufficient amount can be applied to permeate through the wound surfaces and the surrounding skin. [0022] Optionally, drugs such as antibiotics, a humectant such as propylene glycol and glycerol, an ordinary viscosity adjusting agent such as gelatin, hydroxymethylcellulose and hydroxyethylcellulose may be added arbitrarily to produce viscosity. [0023] Preferable examples are described hereinafter in detail. <Example 1> Base Components 1 and 2 were dissolved in 500 ml of purified water, followed by the addition of 3, 4, 5 and 6 and the mixture was stirred. 1. Aluminum Chloride Hexahydrate 45.50 g 2. p-Cyclodextrin 6.50 g 3. Xanthan Gum 1.50 g 4. Glycerol 20.0 g 5. Propylene Glycol 20.0 g 6. Hydroxide solution 10% sodium 15.0 g 7. 70% ethanol preparation 9.0 g In the present example, in order to reduce the irritant nature on the affected areas due to the acidity of the aluminum chloride, 3 0% of the 10% sodium hydroxide solution was added to neutralize, the precipitate formed was removed by filtration and the pH was adjusted to 3.9. The resulting solution had no action as a bactericidal agent and exhibited fungal growth after one week of storage at normal temperature to form spherical foam-like colonies. As a result, the 70% ethanol preparation was added as a fungicide. [0024] <Case 1 of Example 1> 5 Example of use for knee abrasion: an abrasion of a maximum size of 15 mm x 15 mm in a boy of 10 years. The boy had fallen several times so that the same site had been scraped off for 3 years, so that the outside of the wound surface showed the formation of a raised hypertrophic scar.
    [0006] FIG. 2 is an observation of the formation of a water-repellent degreasing film which exhibits a haemostasis action immediately after the direct application of an aqueous solution according to Example 1 of the present invention without disinfection. Formation of a film immediately after the application of Example 1 after the injury and consultation: with the consent of the patient's mother, the patient received 10 mL of Example 1 and Example 1 was applied once a day after taking a bath with gauze replacement. The patient had another consultation after 33 days (Figure 3). As shown in FIG. 3, although it is a hypertrophic scar secondary site with repeated flexing and stretching, the scar was not elevated, had already lost its redness or stiffness, and was undergoing maturation. Pigmentation did not appear after inflammation. [0025] <Case 2 of Example 1> Example of use for the back of a right hand with a 2nd degree burn: a 55-year-old woman who had touched the lid of a saucepan was affected on the the back of the right hand with a 2nd degree (superficial) burn (Fig. 4). The patient applied Example 1 once a day with gauze replacement. The patient had another consultation after one week (Fig. 5). Epidermal formation was completed at a site with blister formation and almost no pigmentation after inflammation was observed. Generally, the completion of epidermalization in a 2nd degree burn requires 14 days or more, the blister tends to be broken, the top of the blister tends to adhere to the gauze when gauze is replaced, erosion occurs. may occur, scarring may be long and a hypertrophic scar may appear; however, in this case, a clean epidermis was observed 7 days after the injury (Fig. 5). At the time of the injury (at the first consultation) (Fig. 4) and at a second visit (7 days after the injury) (Fig. 5). [0026] <Case 3 of Example 1> 5 Example of use to demonstrate the hemostatic action on an effusive hemorrhage observed after removal of a molluscum contagiosum: 6 year old boy. A molluscum contagiosum was removed with a puncture device and Example 1 was applied immediately afterwards with cotton wool. The effusive haemorrhage from the affected site was stopped in 10 seconds (Fig. 6) haemostatic action eg 1. <Case 4 of Example 1> 2-year-old girl. The patient received an iron on October 26 and was affected by a second degree burn on her right hand. After consulting a dermatologist and having been prescribed an antibiotic ointment and a disinfectant, the patient presented with an enlarged blister and experienced severe pain, and therefore consulted the present inventor on October 30, who is a dermatologist and a plastic surgeon. At the first visit, the patient was diagnosed with a 2nd degree burn accompanied by a 20 mm edematous blister that extended between the thumb and forefinger of her right hand (Fig. 7). As shown in Fig. 7, as the blast formation area of the 2nd degree burn (at the first consultation) on the right hand is small, the blister is dense and filled so that it causes severe pain, if although the blister was immediately perforated and Example 1 was applied. Nonsteroidal anti-inflammatory ointment was then applied. In the inventor's experience, antibiotic ointment was unnecessary and therefore was not used. The parents of the patient were invited to apply Example 1 30 once a day in the evening with the fingers, regardless of the contamination, then apply a nonsteroidal anti-inflammatory ointment, cover with the gauze and fix with a mesh bandage. Another consultation was done after 1 week (Figure 8). At the second visit (after one week), the patient replied that she had no pain at the pain degree survey. As shown in FIG. 8, the epidermization was complete, the top of the blister began to desquamate and no keloid or hypertrophic scar formation was observed. The parents of the patient were asked to apply only the formulation of Example 1 until the original color of the skin 5 is restored. A pediatric 2nd degree burn where the epidermis is thinner than in adults may become severe and, in the case of the affected site in this case, a finger extension disorder may be observed due to the hypertrophic scar or stiffening of the scar. Therefore, it is important to suppress inflammatory reactions and promote healing. As described above, the present invention allows rapid healing that could not be achieved with the conventional technique. The present invention can also be applied to severe burns with an extended area at many sites, provides pain relief and early healing, and does not cause an ugly scar or disorderly function. Thus, the present invention is also excellent in ease of use and financial aspect. <Example 2> The basic components 1 and 2 were dissolved in 500 ml of saline, followed by the addition of 3, 4 and 5, and the mixture was stirred. 1. Aluminum chloride hexahydrate 60.0 g 5.0 g 20.0 g 20.0 g 9.0 g 2. p-cyclodextrin 3. glycerol 4. Propylene glycol 5. Preparation of 70% ethanol In the present example, in order to reduce the irritating nature at the affected areas due to the low acidity of the pH 1.9 aluminum chloride, components 3 and 4 were added as buffering agents. The aqueous solution containing the basic components had a weak bacteriostatic or bactericidal action and fungal growth appeared after one week storage at normal temperature to form spherical foam-like colonies. Therefore, the 70% ethanol preparation of component 5 was added as a fungicide. <Case 5 of Example 2> Example of abrasion on the left forearm. The patient struck at rock level 5 on the left forearm during a mountain climb so that he suffered abrasion. The depth of the wound reached the middle to upper dermis. Immediately after the escalation, Example 2 was applied. At the time of application, the patient experienced stinging pain due to the acidity of aluminum chloride hexahydrate, which disappeared from the affected site within 10 seconds. Without the aid of a conventional dressing, Example 2 only was applied continuously twice a day (in the morning and after taking a bath). After the consultation, crust formation was already observed and, 4 days after the injury, it was observed that the crust was raised and epidermization started (Fig. 9). 24 days after the injury, the skin color already corresponded to that of the surrounding skin without scar and no pigmentation after inflammation at the edges of the scar was observed (Fig. 10). Figure 9 shows the condition 4 days after the injury and Figure 10 shows the condition 24 days after the injury. <Example 3> The basic components 1 and 2 were dissolved in 500 ml of purified water, followed by the addition of 3, 4, 5 and 6, and the mixture was stirred. 1. Aluminum Chloride Hexahydrate 60.0 g 2. Hydroxypropyl-β-cyclodextrin 5.0 g 20.0 g 20.0 g 3. Glycerol 9.0 g 150.0 g 4. Propylene glycol 5. Preparation of 70% ethanol 6. 10% Sodium Hydroxide In the present example, in order to reduce the irritating nature of the affected areas due to the acidity of the aluminum chloride, the solution was neutralized with water. sodium hydroxide and adjusted to pH 3.5, and the precipitate was removed by filtration. Example [0033] Case Study 6 of Example 3 Example of Use for a Skin Lesion After Debridement of Skin Necrosis Due to Infectious Atheroma in the Left Femoral Region: Elderly Man 60 years.
    [0007] The patient was aware of an asymptomatic, elastic and soft skin mass of 1 to 2 cm diameter on the frontal side of the left femoral distal region without paying attention since about March 2014. The mass gradually increased and the patient had the first consultation on September 26, 2014, with unbearable pain. Medical history: alcoholic cirrhosis (+), the patient takes oral ursodeoxycholic acid, tablets containing proheparum, portolac powder, pellets containing Livact, spironolactone tablets, Nexium capsules and capsules containing Vitamedine. At the first consultation, an infectious atheroma with a diameter of 6 cm and a skin necrosis of 3/4 on the rostral side were observed. Therefore, under local anesthesia using lidocaine containing 1% epinephrine, the dead skin was removed by debridement, the contents of the atheroma removed and the wound cleaned. Figures 11 to 17 show images over time since immediately after treatment with the formulation of Example 3 after incision of infectious atheroma with skin necrosis and wound cleansing. The change of the case as a function of time is shown. - October 2 (7 days after treatment) (Fig. 11) Adhesion of fibrin and clot, ulceration. - October 6 (11 days after treatment) (Fig. 12) Observation of hyperplasia of granulation tissue, erosive inflammation at the edge of the wound. - October 9 (14 days after treatment) (Fig. 13) Stabilization of granulation tissue, epidermization at the wound margin. -14 October (20 days after treatment) (Fig 14) Hyperplasia of benign granulation tissue, initiation of epidermis 35 - 18 October (24 days after treatment) (Fig. 15) Completion of 1/4 of epidermis 3028414 18 - 27 October (36 days after treatment) (Fig. 16) 3/4 completion of epidermization, observation of scar reduction in vertical direction - 30 October (39 days after treatment ) (Fig. 17) 5 Completion of 100% of the epidermis, observation of a pink color which indicates the evolution towards the maturation and the reduction of the whole of the scar. No hypertrophic scar formation is observed. <Example 4> For 100 g of base powder, 10 g of aluminum chloride hexahydrate and 10 g of [3-CD were introduced into a ceramic ball mill and milled for 30 minutes for obtain an antipruritic agent powder which was a milled mixture passing through a sieve of 300 mesh (48 mesh) mesh size. The base powder was prepared by mixing 5 g of silica, 35 g of zinc flower, 40 g of talc and 20 g of corn starch. <Example 5> 20 For 100 g of base powder, 10 g of aluminum hydroxychloride and 10 g of α-CD were introduced into a ceramic ball mill and ground for about 25 minutes for obtain an antipruritic agent powder which was a milled mixture passing through a sieve of mesh size 300 μm (48 mesh). The base powder was prepared by mixing 5 g of silica, 35 g of zinc flower, 40 g of talc and 20 g of corn starch. [0037] <Case of Example 5> A 26-year-old man who consulted on November 1, 2014 and who wanted to remove a pigmented nevus on his back using a carbon dioxide gas laser. At the first consultation, the 6 mm raised pigmentary naevus could be observed below the left shoulder blade. Under local anesthesia, a spray treatment was performed using a carbon dioxide gas laser manufactured by NOYA in superpulsed mode (S-2) (Fig. 18). From the same day, the patient began using the agent of the present invention. The agent was applied to the affected site once a day after bathing with a gauze pad. On 29 December, that is 2 months after the first consultation, the patient consulted again (Fig. 19). The affected site was cured, forming a circular mark that was not perceptible. The patient was very satisfied. In the laser treatment of carbon dioxide gas, since the thermal energy is high, this results in a wound margin and a thermal burn. In particular, when applied to a large lesion as in this case, there is a strong possibility that keloids and a hollow scar are formed. However, using the agent of the present invention, the effect of the treatment was satisfactory for the patient without the aid of antibacterial agents or disinfectants. <Example 6> For 100 g of base powder, 7 g of aluminum chloride hexahydrate and 8 g of y-CD were introduced into a ceramic ball mill and milled for about 15 minutes for obtain an antipruritic agent powder which was a milled mixture passing through a sieve of 300 mesh (48 mesh) mesh size. The base powder was prepared by mixing 5 g of silica, 35 g of zinc flower, 35 g of talc and 20 g of corn starch. [0039] <Case of Example 6> Woman aged 40 years. On November 16, boiling water was poured onto her right ankle joint at her home and she suffered a superficial 2nd degree burn. She used a commercial chemical, but became anxious because an edematous blister developed. She consulted on November 17. At the first consultation, a 30 cm flask with a band-like shape could be observed. From the same day, the patient began using the agent of the present invention. Antibacterial and disinfectant agents have not been used. From the third day after the start of treatment, the pain has disappeared. On November 27, which was the tenth day since the beginning of treatment, the patient consulted again. The crust was coming off and the epidermis seemed almost complete (therapy completed) (Fig. 21).
    权利要求:
    Claims (9)
    [0001]
    REVENDICATIONS1. A biological film-forming agent for coating the wound surface of the skin and a subcutaneous tissue and a damaged cell, characterized in that the biological film-forming agent comprises aluminum chloride, a cyclodextrin and water.
    [0002]
    2. Biological film forming agent according to claim 1, characterized in that the biological film-forming agent is an aqueous solution having a pH in a range of 1.8 to 7.
    [0003]
    3. Biological film forming agent according to claim 1 or 2, characterized in that the concentration of the aluminum chloride is 0.005 to 20.0% by weight.
    [0004]
    4. Biological film forming agent according to any one of claims 1 to 3, characterized in that the concentration of the cyclodextrin is 0.1 to 45% by weight per 100 parts of water.
    [0005]
    5. Biological film-forming agent according to any one of claims 1 to 4, characterized in that the biological film-forming agent is porous.
    [0006]
    6. Biological film-forming agent according to any one of claims 1 to 5, characterized in that the biological film-forming agent covers an organ, a damaged site of the organ, and the surface of a wound reaching the periosteum or the bone cortex.
    [0007]
    7. Biological film-forming agent according to any one of claims 1 to 6, characterized in that the water is water contained in a biological fluid. 25
    [0008]
    8. Biological film-forming agent according to any one of claims 1 to 7, characterized in that a dosage form of the biological film-forming agent is an aqueous solution, and the pH is increased to at least 2.8 by deacidification of the aqueous solution with an alkaline agent and addition of a flocculating agent to filter a flocculated precipitate generated. 3028414 21
    [0009]
    9. Biological film-forming agent according to any one of claims 1 to 7, characterized in that a dosage form of the biological film-forming agent is a powder, and the pH is increased to at least 2.8 by addition of a alkaline powder with biological film-forming agent.
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    同族专利:
    公开号 | 公开日
    GB2532353A|2016-05-18|
    US10064975B2|2018-09-04|
    GB2532353B|2017-04-12|
    ITUB20155628A1|2017-05-16|
    CA2966724C|2017-12-05|
    JP5796728B1|2015-10-21|
    FR3028414B1|2018-09-07|
    DE102015222429A1|2016-05-19|
    GB201520179D0|2015-12-30|
    US20160136324A1|2016-05-19|
    WO2016080158A1|2016-05-26|
    JP2016093467A|2016-05-26|
    CA2966724A1|2016-05-26|
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    法律状态:
    2016-10-13| PLFP| Fee payment|Year of fee payment: 2 |
    2017-08-30| PLFP| Fee payment|Year of fee payment: 3 |
    2018-01-05| PLSC| Publication of the preliminary search report|Effective date: 20180105 |
    2018-11-07| PLFP| Fee payment|Year of fee payment: 4 |
    2019-09-11| PLFP| Fee payment|Year of fee payment: 5 |
    2020-09-17| PLFP| Fee payment|Year of fee payment: 6 |
    2021-10-12| PLFP| Fee payment|Year of fee payment: 7 |
    优先权:
    申请号 | 申请日 | 专利标题
    JP2014246275A|JP5796728B1|2014-11-17|2014-11-17|A biofilm for the purpose of promoting wound healing and coveringand protecting living organs.|
    JP2014246275|2014-11-17|
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