WO2018188197A1 - 一种抗菌消炎药剂及其制备方法 - Google Patents

一种抗菌消炎药剂及其制备方法 Download PDF

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WO2018188197A1
WO2018188197A1 PCT/CN2017/090998 CN2017090998W WO2018188197A1 WO 2018188197 A1 WO2018188197 A1 WO 2018188197A1 CN 2017090998 W CN2017090998 W CN 2017090998W WO 2018188197 A1 WO2018188197 A1 WO 2018188197A1
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parts
inflammatory agent
antibacterial
antibacterial anti
mixed
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PCT/CN2017/090998
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English (en)
French (fr)
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皮志华
皮定业
周庆良
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重庆立见科技发展有限责任公司
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Publication of WO2018188197A1 publication Critical patent/WO2018188197A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/22—Boron compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/618—Salicylic acid; Derivatives thereof having the carboxyl group in position 1 esterified, e.g. salsalate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288—Taraxacum (dandelion)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions

Definitions

  • the invention relates to the field of wound repair preparations, in particular to an antibacterial anti-inflammatory medicament and a preparation method thereof.
  • Inflammation is a very common and very important pathological process in the human body. It mainly refers to the defensive response of living tissue with vascular system to damage factors composed of bacteria and viruses. Traumatic infections on the surface and most common and frequently-occurring diseases of major organs are inflammatory diseases.
  • the vascular response is the central link in the inflammatory process.
  • Inflammation is the "inflammation” that people usually say, and it is a kind of defense response of the body to stimulation, which is characterized by redness, swelling, heat, pain and functional disorders.
  • the damage factor directly or indirectly causes tissue and cell destruction, and on the other hand, through the inflammatory hyperemia and oozing reaction, to dilute, kill and surround the damage factor.
  • damaged tissue is repaired and healed by regeneration of parenchymal and mesenchymal cells.
  • antibiotics are currently used in the treatment of inflammation. This antibiotic antibacterial agent is prone to dependence and drug resistance, and is not easy to cause rapid healing of wound tissue.
  • a first object of the present invention is to provide an antibacterial anti-inflammatory agent which has a broad-spectrum and long-acting bactericidal function, and can efficiently promote healing of wound repair, so that wound tissue can heal quickly and eliminate scars.
  • a second object of the present invention is to provide a method for producing the above-mentioned antibacterial anti-inflammatory agent, which is mild in process and easy to realize, and by controlling the mixing order of the raw materials, an antibacterial anti-inflammatory agent having a good dispersion and being clear and transparent can be obtained.
  • An antibacterial anti-inflammatory agent the raw material of the antibacterial anti-inflammatory agent comprises, by weight:
  • a method for preparing the above antibacterial anti-inflammatory agent comprising:
  • Sodium tetraborate and propylene glycol are mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 80-100 ° C; then slowly added glycerin to mix evenly, and then slowly add ascorbic acid when the temperature is lowered to 60-70 ° C. After mixing with phenoxyethanol, the antibacterial liquid was obtained and filtered.
  • the antibacterial anti-inflammatory agent of the present invention is achieved by an acid-base ionization exchange reaction.
  • glycerin can form a certain thickness of the barrier film at the wound surface, which can effectively protect the wound surface from contact with the outside atmosphere, and also has certain antibacterial and moisturizing effects, so as to avoid the wound surface. Secondary infection damage.
  • ascorbic acid interacts with sodium tetraborate to form sodium tetraborate and sodium ascorbate. Ascorbic acid has direct bactericidal effect. Sodium tetraborate itself has antiseptic effect. After sodium hydrogen tetraborate exchanges hydrogen ions, it becomes sodium hydrogen tetraborate.
  • sodium tetraborate Due to the active nature of hydrogen atoms, sodium tetraborate has enhanced polarity after hydrogen is obtained, and the molecular activity is enhanced. It can quickly move to the wound surface in the barrier film formed by glycerin and efficiently promote wound healing.
  • phenoxyethanol has a good bactericidal effect, can enhance the bactericidal and antiseptic effect of the antibacterial anti-inflammatory agent, and can also enhance the stability of the antibacterial anti-inflammatory agent and change its odor. Phenoxyethanol is used in combination with other components, and has synergistic effect, so that the obtained antibacterial anti-inflammatory agent has a broad-spectrum and long-acting bactericidal effect.
  • the method for preparing the antibacterial anti-inflammatory agent has mild process conditions and is easy to realize, and by controlling the mixing order of the components in the raw materials, the dispersibility between the components is good, which is favorable for the acid-base ionization exchange reaction to be fully carried out, and
  • the transparent antibacterial anti-inflammatory agent is clarified, and the antibacterial anti-inflammatory agent is more effective and more stable in nature.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw material of the antibacterial anti-inflammatory agent is in parts by weight. include:
  • glycerin can form a certain thickness of the barrier film at the wound surface, which can effectively protect the wound surface from direct contact with the outside atmosphere, and also has certain antibacterial and moisturizing effects to avoid wounds. It was damaged by secondary infection.
  • Ascorbic acid has a direct bactericidal action at the wound covered by the glycerin barrier film; ascorbic acid interacts with sodium tetraborate to form sodium tetraborate and sodium ascorbate.
  • Sodium tetraborate has the functions of antiseptic and decontamination and cleansing wounds. It has enhanced the function of antiseptic and decontamination and cleansing wounds by proton exchange to sodium tetraborate.
  • the sodium tetraborate has enhanced polarity after hydrogen is obtained, and the molecular activity is enhanced, so that the antibacterial anti-inflammatory agent has good permeability, and the wound can be quickly cleaned and promoted healing.
  • Phenoxyethanol has a good bactericidal effect, can enhance the antiseptic effect of the antibacterial anti-inflammatory agent, and at the same time enhance its stability and change its odor. Phenoxyethanol is used in combination with other components, and has synergistic effect, so that the obtained antibacterial anti-inflammatory agent has a broad-spectrum and long-acting bactericidal effect.
  • the raw material further comprises, in parts by weight, 0.5 to 1 part of arctiin and 1 to 2 parts of atractyl alcohol. Based on years of creative labor and research, the inventors have found that the addition of these two compounds to the above-mentioned antibacterial anti-inflammatory agents can significantly improve the antibacterial ability of the antibacterial anti-inflammatory agent, and at the same time enhance the healing speed of the wound.
  • Arctiin a molecular formula of C 27 H 34 O 11 , belongs to the lignan compound and its structure is as shown in formula (I):
  • the raw material further comprises a skin penetration enhancer, and the skin penetration enhancer is from 5 to 10 parts by weight.
  • the skin penetration enhancer is from 5 to 10 parts by weight.
  • the skin penetration enhancer is selected from the group consisting of dimethyl sulfoxide, propoxyethanol, methyl salicylate, and hyaluronic acid.
  • Dimethyl sulfoxide is highly hygroscopic and can cause reversible conformational changes in protein structure in the cell membrane. It can replace the bound water in the stratum corneum of the skin and form a loose structure, thereby increasing drug penetration. ability.
  • propoxyethanol can enhance the penetrating ability of the agent, thereby enhancing the antibacterial ability of the agent, and can also act as a flavoring agent, so that the smell of the agent is relatively pleasant.
  • hyaluronic acid can increase the intercellular substance gelatinous adhesion in the wound tissue, so that the viscosity of the agent is increased, which is beneficial to promote the formation of a network structure of the fiber cells, alleviate the inflammation and avoid the formation of scars.
  • Methyl salicylate has a swelling, anti-inflammatory and analgesic effect, and also acts as a solvent to promote the interaction between the components in the raw material.
  • the raw material further comprises a pro-activating agent, and the pro-activator is 10 to 20 parts by weight.
  • the prophylactic agent is selected from the group consisting of dandelion slurry and/or borneol.
  • the dandelion slurry is a fresh milk of dandelion. It is white, has anti-inflammatory and detoxifying effects, and is rich in organic active ingredients such as organic acids, choline and volatile oil, which is beneficial to promote wound healing.
  • Borneol which is a crystal obtained by extracting the resin of dipterocarp and the processed oil of volatile oil, has antibacterial and anti-inflammatory effects, and at the same time can gather sore muscles, which can further enhance the repair function of the medicament.
  • the healing agent can enhance the repair function of the agent, promote the conversion of amino acid into collagen, participate in the synthesis of collagen, accelerate cell proliferation, and promote healing of wound healing.
  • the agent can also dissociate the hydroxyl group in the redox reaction, and provide an oxygen-rich environment to the oxygen-deficient wound during the oxidation process to meet the respiratory needs of the cell and promote wound repair.
  • the invention also provides a preparation method of the above antibacterial anti-inflammatory medicament, which comprises:
  • the sodium tetraborate and propylene glycol are first mixed to facilitate the sufficient dispersion between the two, and then mixed with pure water having a temperature of 80 to 100 ° C to effectively avoid the emulsification phenomenon.
  • the step of mixing the sodium tetraborate with propylene glycol comprises: mixing sodium tetraborate with a skin penetration enhancer, stirring for 15 to 25 minutes, mixing with propylene glycol, and continuing to stir for 15 to 25 minutes.
  • a skin penetration enhancer Through the addition of the skin penetration enhancer, the penetration property of the agent is further improved, and the deep tissue of the damaged wound can be quickly penetrated, and interacts with the bacteria to interfere with the metabolism of the bacteria, thereby achieving better sterilization effect. Stir for 15 to 25 minutes to make the solution mix more evenly.
  • the skin penetration enhancer is selected from the group consisting of dimethyl sulfoxide, propoxyethanol, methyl salicylate and hyaluronic acid, and the skin penetration enhancer is 5 to 10 parts by weight.
  • the obtained antibacterial liquid has a pH of 5.0 to 7.0 and is weakly acidic.
  • the obtained antibacterial liquid has a density of 1 to 1.5 g/cm 3 , and the antibacterial liquid in the density range can be compared on the basis of ensuring the efficacy thereof. stable.
  • the molar ratio of sodium tetraborate to ascorbic acid is 1:1, which is more convenient for the proton exchange reaction of sodium tetraborate and ascorbic acid.
  • the obtained agent is a suspension, and it is necessary to add slowly when adding glycerin and ascorbic acid respectively.
  • the glycerin is added at a rate of 10 to 30 mL/min.
  • the addition rate of the ascorbic acid solution (10 mmol/mL) was 20 to 30 mL/min.
  • the step of slowly adding the ascorbic acid and before the step of filtering the antibacterial liquid further comprising mixing the antibacterial liquid with the arctiin and the atractyl alcohol step.
  • the weight fraction of arctiin is 0.5 to 1 part
  • the weight part of atractyrone is 1 to 2 parts.
  • the step of mixing the antibacterial solution with the prophylactic agent after the step of slowly adding ascorbic acid and before the step of filtering further comprises the step of dandelion slurry and/or borneol.
  • the antibacterial liquid is mixed with the prophylactic agent, and the pro-healing agent can enhance the repairing function of the agent, promote the amino acid conversion of collagen, participate in the synthesis of collagen, accelerate the proliferation of the cell proliferation, promote the healing of the wound repair, and It is enough to make the wound repair performance of the medicament stronger.
  • the step of mixing the antibacterial liquid with the pro-healing agent comprises: first mixing the antibacterial liquid with the powder of 100-120 mesh borneol and heating at 40-50 ° C for 5-10 min, until the borneol is completely After dissolving, it is mixed with the dandelion slurry. Mixing and heating the antibacterial liquid with the borneol firstly improves the dissolution efficiency of the borneol. The heating temperature is maintained at 40 to 50 ° C for 5 to 10 minutes, which can avoid the volatilization loss caused by the excessive temperature of the volatile oil component in the borneol and the excessive heating time.
  • the method for preparing the antibacterial anti-inflammatory agent has mild process conditions and is easy to realize, and by controlling the mixing order of the components in the raw materials, the dispersibility between the components is good, which is favorable for the acid-base ionization exchange reaction to be fully carried out, and
  • the clarification of the transparent antibacterial anti-inflammatory agent is beneficial to obtain an antibacterial and anti-inflammatory agent which is more effective and more stable.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were uniformly mixed in parts by weight, and then mixed with pure water at a temperature of 100 ° C; then, glycerin was added at a rate of 12 mL/min to be uniformly mixed, and then the temperature was lowered to 70 ° C and then 20 mL / The addition rate of min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid, which was filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 80 ° C; then glycerin was added at a rate of 10 mL / min to be evenly mixed, and then the temperature was lowered to 60 ° C.
  • the addition rate of 25 mL/min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid, which was filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, glycerin was added at a rate of 15 mL/min to be uniformly mixed, and then the temperature was lowered to 65 ° C and then 25 mL / The addition rate of min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid, which was filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, glycerin was added at a rate of 18 mL/min to be uniformly mixed, and then the temperature was lowered to 65 ° C and then 25 mL / The addition rate of min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid. The antibacterial liquid was mixed with arctiin and atractyl ketone, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with dimethyl sulfoxide in parts by weight, stirred for 25 min, mixed with propylene glycol, stirring was continued for 25 min, and then mixed with pure water at a temperature of 90 ° C; then glycerol was added at an addition rate of 22 mL/min. After mixing evenly, when the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol/mL) is added at an addition rate of 25 mL/min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, and then the antibacterial liquid is combined with arctiin and atractylodes The ketone is mixed and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with propoxyethanol in parts by weight, stirred for 15 min, mixed with propylene glycol, stirring was continued for 25 min, and then mixed with pure water at a temperature of 90 ° C; then glycerin was added at a rate of 20 mL/min. After that, when the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol/mL) is added at an addition rate of 22 mL/min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, and then the antibacterial liquid is mixed with arctiin and atractyl alcohol. , filtration, that is, the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with methyl salicylate in parts by weight, stirred for 20 min, mixed with propylene glycol, stirring was continued for 15 min, and then mixed with pure water at a temperature of 90 ° C; then glycerol was added at an addition rate of 30 mL/min.
  • the ascorbic acid solution (10 mmol / mL) is added at a rate of 26 mL / min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, and then the antibacterial liquid is combined with arctiin and atractylodes
  • the ketone is mixed and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with hyaluronic acid by weight, stirred for 20 min, then mixed with propylene glycol, stirring was continued for 20 min, and then mixed with pure water at a temperature of 90 ° C; then slowly added to add glycerin at an addition rate of 25 mL / min. After mixing evenly, when the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol/mL) is added at a rate of 21 mL/min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, and then the antibacterial liquid is combined with arctiin and atractylodes The ketone is mixed, filtered, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, glycerin was added at a rate of 15 mL/min to be uniformly mixed, and then the temperature was lowered to 65 ° C and then 25 mL / The addition rate of min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid. The antibacterial liquid was mixed with the dandelion slurry and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, stirred for 20 min, and then mixed with pure water at a temperature of 90 ° C; then glycerin was added at a rate of 15 mL / min, and the temperature was lowered to 65 ° C.
  • the ascorbic acid solution (10 mmol/mL) was added at a rate of 25 mL/min, and then mixed with phenoxyethanol to obtain an antibacterial liquid; the antibacterial liquid was first mixed with the powder of 100-120 mesh borneol and heated at 45 ° C for 8 min. After the borneol is completely dissolved, it is mixed with arctiin and atractyl ketone, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with hyaluronic acid by weight, stirred for 20 min, mixed with propylene glycol, stirring was continued for 20 min, and then mixed with pure water at a temperature of 90 ° C; then glycerin was added at a rate of 24 mL/min. After that, when the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol/mL) is added at a rate of 28 mL/min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, and the antibacterial liquid is mixed with the powder of 100-120 mesh borneol. And heating at 45 ° C for 8 min, filtration, that is, the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with propoxyethanol in parts by weight, stirred for 20 min, mixed with propylene glycol, stirring was continued for 20 min, and then mixed with pure water at a temperature of 90 ° C; then glycerin was added at a rate of 15 mL/min. After that, when the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol / mL) is added at an addition rate of 25 mL / min, and then mixed with phenoxyethanol to obtain an antibacterial liquid, which is then mixed with dandelion slurry, arctiin and atractylodes The ketone is mixed and filtered to obtain the antibacterial anti-inflammatory agent.
  • the embodiment provides an antibacterial anti-inflammatory agent, and the raw material of the antibacterial anti-inflammatory agent is packaged by weight include:
  • the preparation method of the medicament is:
  • Sodium tetraborate was mixed with hyaluronic acid by weight, stirred for 20 min, mixed with propylene glycol, stirring was continued for 20 min, and then mixed with pure water at a temperature of 90 ° C; then glycerin was added at a rate of 26 mL/min. After the temperature is lowered to 65 ° C, the ascorbic acid solution (10 mmol / mL) is added at a rate of 23 mL / min, and then mixed with phenoxyethanol to obtain an antibacterial liquid; the antibacterial liquid and the powder of 100 to 120 mesh borneol are firstly prepared. The mixture was heated and heated at 45 ° C for 8 min. After the borneol was completely dissolved, it was mixed with dandelion slurry, arctiin and atractyl ketone, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present comparative example provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 100 ° C; then, when the temperature was lowered to 70 ° C, the ascorbic acid solution (10 mmol/mL) was added at an addition rate of 25 mL/min. After the mixture is uniformly mixed, an antibacterial liquid is obtained, and the antibacterial anti-inflammatory agent is obtained by filtration.
  • the present comparative example provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate, ascorbic acid and pure water are mixed in parts by weight, and reacted at 72 ° C for 3.3 h, cooled to 45-46 ° C, and then cooled to room temperature after 1.5 hours, and then added with propylene glycol in parts by weight to obtain antibacterial anti-inflammatory. preparation.
  • the present comparative example provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • the antibacterial anti-inflammatory agent is obtained by mixing sodium tetraborate, propylene glycol, ascorbic acid, glycerin and phenoxyethanol in parts by weight, mixing with pure water having a temperature of 90 ° C, and filtering.
  • the present comparative example provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate is mixed with glycerin in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, propylene glycol is slowly added and mixed uniformly, and the ascorbic acid is added at a rate of 25 mL/min when the temperature is lowered to 65 ° C.
  • the solution (10 mmol/mL) was mixed with phenoxyethanol to obtain an antibacterial liquid, which was filtered to obtain the antibacterial anti-inflammatory agent.
  • the present comparative example provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate is mixed with ascorbic acid in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then slowly added propylene glycol and mixed uniformly, and then slowly added glycerin and phenoxyethanol when the temperature is lowered to 65 ° C, and mixed. After the uniformity, the antibacterial liquid is obtained and filtered to obtain the antibacterial anti-inflammatory agent.
  • the embodiment provides an antibacterial anti-inflammatory agent, and the raw material of the antibacterial anti-inflammatory agent is packaged by weight include:
  • the preparation method of the medicament is:
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • the propylene glycol was mixed with pure water at a temperature of 90 ° C in parts by weight; then, the glycerin was slowly added at a rate of 15 mL/min to be uniformly mixed, and the ascorbic acid solution was added at a rate of 25 mL/min when the temperature was lowered to 65 ° C ( 10mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid, and then the antibacterial liquid is mixed with arctiin and atractyl ketone, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol are mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then slowly added to the glycerin at a rate of 15 mL / min, and then mixed with benzene, and then the temperature is lowered to 65 ° C. After the oxyethanol is uniformly mixed, an antibacterial liquid is obtained, and the antibacterial liquid is mixed with arctiin and atractyl ketone, and filtered to obtain the antibacterial anti-inflammatory agent.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly by weight, and then mixed with pure water at a temperature of 90 ° C; when the temperature was lowered to 65 ° C, the ascorbic acid solution (10 mmol / mL) was added at an addition rate of 25 mL / min, and then After mixing with phenoxyethanol to obtain an antibacterial liquid, the antibacterial anti-inflammatory agent is obtained.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, glycerin was added at a rate of 15 mL/min to be uniformly mixed, and then the temperature was lowered to 65 ° C and then 25 mL / The ascorbic acid solution (10 mmol/mL) was added at a rate of addition of min, and the antibacterial anti-inflammatory agent was obtained by filtration.
  • the present embodiment provides an antibacterial anti-inflammatory agent, and the raw materials of the antibacterial anti-inflammatory agent include, by weight:
  • the preparation method of the medicament is:
  • Sodium tetraborate and propylene glycol were mixed uniformly in parts by weight, and then mixed with pure water at a temperature of 90 ° C; then, glycerin was added at a rate of 60 mL / min, and the mixture was uniformly mixed, and then the temperature was lowered to 65 ° C and then 25 mL / The addition rate of min was added to the ascorbic acid solution (10 mmol/mL), and then mixed with phenoxyethanol to obtain an antibacterial liquid, which was filtered to obtain the antibacterial anti-inflammatory agent.
  • Example 3 of the present invention The antibacterial and anti-inflammatory preparations provided in Example 3 of the present invention and Comparative Examples 1-11 are combined with clinical trials. Evaluation of the therapeutic effect of patients with second degree burns:
  • All patients in this group were patients with grade II burns, which met the inclusion and exclusion criteria, aged 7-62 years, with an average of 31.4 years. They were randomly divided into 12 groups, of which 1 group was the treatment group, and 11 groups were the control group, 30 cases in each group. There were no significant differences in the age, burn area and condition of the 12 groups of patients, which were comparable.
  • the wound was red and swollen: it was observed by the naked eye, and there was no obvious redness and swelling of the wound surface.
  • Wounding time of wound surface visual observation, the wound begins to form a dry suede as a time node;
  • Wound healing time visual observation, complete epithelialization of the wound surface, forming a pink dry wound surface as a time node.
  • Control group 7 (administering the drug in Comparative Example 7)
  • the redness and swelling time, the wound scarring time, and the wound healing time of the control group 7 were far longer than those of the experimental group, and both were significant. Difference (P ⁇ 0.01). It can be seen that if the preparation lacks the key active active ingredient sodium tetraborate and only contains ascorbic acid, the repairing ability of the preparation for promoting wounds is weak, indicating that ascorbic acid and sodium tetraborate synergistically play a significant role in the experimental group preparation. The therapeutic effect.
  • Control group 8 (administering the drug in Comparative Example 8) compared with the experimental group, the red color of the control group 8 patients
  • the swelling time, wound scarring time, and wound healing time were much longer than those in the experimental group, and all had significant differences (P ⁇ 0.01). It can be seen that if the preparation lacks the key active active ingredient ascorbic acid and only contains sodium tetraborate, the preparation has a weak ability to promote wound repair, indicating that ascorbic acid and sodium tetraborate synergistically play a significant role in the experimental group preparation. The therapeutic effect.
  • the experimental group had more redness and swelling time, wound scarring time, and wound healing time than the control group 9, which had significant differences. (P ⁇ 0.01). It can be seen that the addition of glycerin to the antibacterial anti-inflammatory agent is advantageous for promoting the repairing ability of the wound because glycerin can form a protective film of a certain thickness at the wound surface.
  • the experimental group had more redness and swelling time, wound scarring time, and wound healing time than the comparison 10, which had significant differences. (P ⁇ 0.01). It can be seen that the addition of phenoxyethanol to the antibacterial anti-inflammatory agent can enhance the antibacterial effect and promote the repairing ability of the wound.
  • test plan [0,1]
  • the antibacterial and anti-inflammatory agent provided by the present invention has excellent therapeutic effect on burn wounds, and is mainly manifested in: after the use of the medicament, the redness and swelling can be resolved within 1.6 days, the wound can be scarred within 2 days, and the wound is wound within 3 days. Can achieve healing.
  • the redness and swelling can be resolved within 1.6 days
  • the wound can be scarred within 2 days
  • the wound is wound within 3 days. Can achieve healing.
  • the wound repair was complete, and no scar was visible to the naked eye.
  • Example 4 is different from Examples 1-3 in that the addition of arctiin and atractyrone, and the results of the test of Example 4 are relatively better than those of Examples 1-3. It shows that the addition of arctiin and atractyl alcohol can improve the antibacterial ability of the antibacterial anti-inflammatory agent, and at the same time enhance the healing speed of the wound.
  • Examples 5-7 differ from Example 4 in that a skin penetration enhancer is added, It can be seen from the test results that the therapeutic effects of Examples 5-7 are relatively better than those of Example 4, indicating that the addition of the skin penetration enhancer makes the penetration property of the agent more, and can quickly penetrate into the deep tissue of the damaged wound, and Interacts with bacteria, interferes with the metabolism of the bacteria, thus achieving better bactericidal effect.
  • Example 9 is different from Examples 1-3 in that a pro-augmenting agent is added, and it can be seen from the test results that the therapeutic effect of Example 9 is remarkably superior to that of Examples 1-3, indicating that the healing is improved.
  • the agent can enhance the repair function of the medicament and promote the rapid repair of the wound to achieve a better therapeutic effect.
  • the antibacterial anti-inflammatory agent of the present invention is achieved by an acid-base ionization exchange reaction.
  • glycerin can form a certain thickness of the barrier film at the wound surface, which can effectively protect the wound surface from contact with the outside atmosphere, and also has certain antibacterial and moisturizing effects, so as to avoid the wound surface. Secondary infection damage.
  • ascorbic acid interacts with sodium tetraborate to form sodium tetraborate and sodium ascorbate. Ascorbic acid has direct bactericidal effect. Sodium tetraborate itself has antiseptic effect. After sodium hydrogen tetraborate exchanges hydrogen ions, it becomes sodium hydrogen tetraborate.
  • sodium tetraborate Due to the active nature of hydrogen atoms, sodium tetraborate has enhanced polarity after hydrogen is obtained, and the molecular activity is enhanced. It can quickly move to the wound surface in the barrier film formed by glycerin and efficiently promote wound healing.
  • phenoxyethanol has a good bactericidal effect, can enhance the bactericidal and antiseptic effect of the antibacterial anti-inflammatory agent, and can also enhance the stability of the antibacterial anti-inflammatory agent and change its odor. Phenoxyethanol is used in combination with other components, and has synergistic effect, so that the obtained antibacterial anti-inflammatory agent has a broad-spectrum and long-acting bactericidal effect.
  • the method for preparing the antibacterial anti-inflammatory agent has mild process conditions and is easy to realize, and by controlling the mixing order of the components in the raw materials, the dispersibility between the components is good, which is favorable for the acid-base ionization exchange reaction to be fully carried out, and
  • the transparent antibacterial anti-inflammatory agent is clarified, and the antibacterial anti-inflammatory agent is more effective and more stable in nature.

Abstract

本发明提供了一种抗菌消炎药剂及其制备方法，属于创面修复制剂领域。这种抗菌消炎药剂的原料包括：抗坏血酸、四硼酸钠、丙二醇、苯氧乙醇、甘油、及纯水。该制备方法为：将四硼酸钠与丙二醇混合均匀后，再与温度为80～100℃的纯水混合；随后缓慢加入甘油混合均匀后，待温度降至60～70℃时再缓慢加入抗坏血酸，再与苯氧乙醇混合均匀后得到抗菌液，过滤。

Description

一种抗菌消炎药剂及其制备方法
相关申请的交叉引用
本申请要求于2017年4月11日提交中国国家知识产权局的申请号为2017102324333、名称为“一种抗菌消炎药剂及其制备方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本发明涉及创面修复制剂领域，具体而言，涉及一种抗菌消炎药剂及其制备方法。
背景技术
炎症，是人体内十分常见且非常重要的病理过程，主要是指具有血管系统的活体组织对由细菌、病毒等组成的损伤因子的防御性反应。体表的外伤感染和各大器官的大部分常见病和多发病都属于炎症性疾病。
血管反应是炎症过程的中心环节。炎症，就是平时人们所述的“发炎”，是机体对于刺激的一种防御反应，表现为红、肿、热、痛和功能性障碍。在炎症过程中，一方面损伤因子直接或间接的造成组织和细胞破坏，另一方面通过炎症充血和渗血反应，以稀释、杀伤和包围损伤因子。同时，通过实质和间质细胞的再生使受损的组织得以修复和愈合。
然而目前在治疗炎症时，多采用抗生素。这种抗生素类抗菌剂易出现依赖性和抗药性，且不易使创伤组织快速愈合。
发明内容
本发明的第一目的在于提供一种抗菌消炎药剂，这种抗菌消炎药剂具有广谱长效的杀菌功能，且能够高效地促进创面修复愈合，使得创伤组织快速愈合且消除疤痕。
本发明的第二目的在于提供一种上述抗菌消炎药剂的制备方法，该方法工艺条件温和、易于实现，且通过控制原料的混合顺序，能够得到分散度良好、且澄清透明的抗菌消炎药剂。
为了实现本发明的上述目的，特采用以下技术方案：
一种抗菌消炎药剂，抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸10～20份、四硼酸钠10～20份、丙二醇10～20份、甘油10～20份、苯氧乙醇1～2份、及纯水50～60份。
一种上述抗菌消炎药剂的制备方法，其包括：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为80～100℃的纯水混合；随后缓慢加入甘油混合均匀后，待温度降至60～70℃时再缓慢加入抗坏血酸，再与苯氧乙醇混合均匀后得到抗菌液，过滤。
与现有技术相比，本发明的有益效果为：
本发明的这种抗菌消炎药剂，是基于酸碱电离交换反应来实现的。在这种药剂中，甘油能够在创面处形成一定厚度的隔离膜，能够有效的将创面保护起来，使其不与外界大气接触，同时也具有一定的抑菌和保湿作用，避免创面处受到二次感染损伤。在甘油的隔离膜内部，抗坏血酸与四硼酸钠相互作用，形成四硼酸氢钠和抗坏血酸钠。抗坏血酸具有直接杀菌作用，四硼酸钠本身具有防腐作用，在四硼酸钠交换氢离子后成为四硼酸氢钠，由于氢原子的性质活泼，四硼酸钠得到氢后极性增强，分子的运动活性增强，能够在甘油形成的隔离膜内快速运动至创面并高效地促进创面修复愈合。此外，苯氧乙醇具有较好的杀菌作用，能够增强该抗菌消炎药剂的杀菌防腐的功效，同时也能增强该抗菌消炎药剂的稳定性、以及改变其气味。苯氧乙醇与其他组分共同配伍使用，具有协同增效的作用，使得到的抗菌消炎药剂具有广谱长效的杀菌功效。
制备该抗菌消炎药剂的方法，工艺条件温和、易于实现，且通过控制原料中各组分的混合顺序，使各组分之间的分散性良好，有利于酸碱电离交换反应充分进行，并得到澄清透明的抗菌消炎药剂，且这种抗菌消炎药剂的药效更佳、性质更稳定。
具体实施方式
下面将结合实施例对本发明的实施方案进行详细描述，但是本领域技术人员将会理解，下列实施例仅用于说明本发明，而不应视为限制本发明的范围。实施例中未注明具体条件者，按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者，均为可以通过市售购买获得的常规产品。
本实施方式提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计 包括：
抗坏血酸10～20份、四硼酸钠10～20份、丙二醇10～20份、甘油10～20份、苯氧乙醇1～2份、及纯水50～60份。
在这种抗菌消炎剂中，甘油能够在创面处形成一定厚度的隔离膜，能够有效的将创面保护起来，使其不与外界大气直接接触，同时也具有一定的抑菌和保湿作用，避免创面处受到二次感染损伤。在甘油的隔离膜所覆盖的创面处，抗坏血酸具有直接杀菌作用；抗坏血酸与四硼酸钠相互作用，形成四硼酸氢钠和抗坏血酸钠。四硼酸钠具有防腐去污、清洁创面的功能，通过质子交换成为四硼酸氢钠更增强了其防腐去污、清洁创面的功能。同时，由于氢原子的性质活泼，四硼酸钠得到氢后极性增强，分子的运动活性增强，使得该抗菌消炎剂具有很好的渗透性，可使创面快速清洁、促进愈合。
苯氧乙醇具有较好的杀菌作用，能够增强该抗菌消炎药剂的杀菌防腐的功效，同时也能增强其稳定性、以及改变其气味。苯氧乙醇与其他组分共同配伍使用，具有协同增效的作用，使得到的抗菌消炎药剂具有广谱长效的杀菌功效。
在本发明较佳的实施例中，原料按重量份数计还包括：牛蒡子苷0.5～1份、苍术酮1～2份。发明人在多年创造性劳动和研究的基础上发现，在上述抗菌消炎剂中，加入这两种化合物，能够显著提高该抗菌消炎剂的抑菌能力，同时也能增强伤口的愈合速度。
牛蒡子苷，分子式为C27H34O11，属于木脂素类化合物，其结构如式(Ⅰ)所示：
Figure PCTCN2017090998-appb-000001
苍术酮，分子式为C15H20O，其如式(Ⅱ)所示：
Figure PCTCN2017090998-appb-000002
在本发明较佳的实施例中，原料还包括皮肤促透剂，皮肤促透剂按重量份数计为5～10份。通过皮肤促透剂的添加，使得该药剂的渗透性能更加，能够快速的渗透进入受损创面的深层组织，并与细菌相互作用，干扰菌体的新陈代谢，从而起到更佳的杀菌效果。
进一步的，皮肤促透剂选自由二甲基亚砜、丙氧乙醇、水杨酸甲酯和透明质酸组成的组。二甲基亚砜，具有极强的吸湿性，且能引起细胞膜中的蛋白质结构发生可逆的构型变化，可以置换皮肤角质层中的结合水并形成一种疏松结构，从而增加药物的穿透能力。此外，丙氧乙醇，能够增强药剂的穿透能力，从而增强该药剂的抑菌能力，同时也可以充当矫味剂，使得该药剂的气味相对比较宜人。透明质酸的加入，可使创伤组织中细胞间质胶状黏着物增高，使得该药剂的粘性增大，有利于促进纤维细胞形成网状结构，缓解炎症侵害，避免疤痕的形成。水杨酸甲酯具有消肿、消炎和镇痛作用，同时也能作为溶剂，促进原料中各组分之间的相互作用。
在本发明较佳的实施例中，原料还包括促愈剂，促愈剂按重量份数计为10～20份。促愈剂选自由蒲公英浆液和/冰片组成的组。蒲公英浆液为蒲公英的新鲜乳汁，其为白色，具有抗炎解毒的功效，且其中含有丰富的有机酸、胆碱以及挥发油等有效活性成分，有利于促进创面的愈合。冰片，其为龙脑香的树脂和挥发油加工品提取获得的结晶体，其具有抑菌、抗炎的功效，同时又能敛疮生肌，能够使得该药剂的修复功能得到进一步的增强。促愈剂能够增强该药剂的修复功能，促进氨基酸转化胶原蛋白，参与胶原蛋白的合成，加速细胞增生，促进创面修复愈合。此外，也能使该药剂在氧化还原反应中使羟基解离，在氧化过程中给缺氧创面提供富氧环境，以满足细胞呼吸需要，促进创面修复。
本发明还提供一种上述抗菌消炎药剂的制备方法，其包括：
S1:按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为80～100℃的纯水混合；
先将四硼酸钠与丙二醇混合，有利于二者之间充分分散，再与温度为80～100℃的纯水混合后，能够有效避免乳化现象。
在本发明较佳的实施例中，上述四硼酸钠与丙二醇的混合步骤包括：将四硼酸钠与皮肤促透剂混合，搅拌15～25min后，再与丙二醇混合，继续搅拌15～25min。通过皮肤促透剂的添加，使得该药剂的渗透性能更加，能够快速的渗透进入受损创面的深层组织，并与细菌相互作用，干扰菌体的新陈代谢，从而起到更佳的杀菌效果。搅拌15～25min，使得溶液混合更加均匀。进一步的，皮肤促透剂选自由二甲基亚砜、丙氧乙醇、水杨酸甲酯和透明质酸组成的组，皮肤促透剂按重量份数计为5～10份。
S2:缓慢加入甘油混合均匀后，待温度降至60～70℃时再缓慢加入抗坏血酸，再与苯氧乙醇混合均匀后得到抗菌液，过滤。
在缓慢加入甘油后，混合液体逐渐由浑浊变得澄清，继续搅拌5-10分钟，等温度降到60～70℃时再缓缓倒入抗坏血酸，这时的混合液逐渐变得更加澄清透明，最后呈现淡黄色透明液体。
通过该制备方法，所得到的抗菌液的pH值为5.0～7.0，呈弱酸性。同时，通过控制各成分的之间的配比，所得到的抗菌液的密度为1～1.5g/cm3，这种密度范围内的抗菌液在能够保证其药效的基础上，性质相对比较稳定。优选的，四硼酸钠与抗坏血酸的摩尔比为1：1，有利于四硼酸钠与抗坏血酸的质子交换反应进行的更加充分。此外，为了避免该药剂在制备过程中出现乳化现象而导致所得到的药剂为混悬液，在分别加入甘油和抗坏血酸时都需要缓慢加入，优选的，甘油的添加速度为10～30mL/min，抗坏血酸溶液(10mmol/mL)的添加速度为20～30mL/min。
在本发明较佳的实施例中，在缓慢加入所述抗坏血酸的步骤之后以及在过滤所述抗菌液的步骤之前，还包括将所述抗菌液与所述牛蒡子苷和所述苍术酮混合的步骤。其中，牛蒡子苷的重量份为0.5～1份、苍术酮的重量份为1～2份。牛蒡子苷和苍术酮的加入，使得抗菌液的药效作用更强，能够进一步的增强该抗菌消炎剂的伤口愈合能力。
在本发明较佳的实施例中，上述在缓慢加入抗坏血酸的步骤之后以及在过滤步骤之前，还包括将抗菌液与促愈剂混合的步骤，促愈剂为蒲公英浆液和/或冰片。将抗菌液与促愈剂混合，促愈剂能够增强该药剂的修复功能，促进氨基酸转化胶原蛋白，参与胶原蛋白的合成，加速细胞增生滚坡爬行，促进创面修复愈合，能 够使得该药剂创面修复性能更强。
当促愈剂为蒲公英浆液和冰片时，抗菌液与促愈剂混合的步骤包括：先将抗菌液与100～120目的冰片的粉末混合并于40～50℃下加热5～10min，待冰片完全溶解后，再将其与蒲公英浆液混合。先将抗菌液与冰片混合并加热，有利于提高冰片的溶解效率。加热的温度保持在40～50℃下加热5～10min，能够避免冰片中的挥发油成分因温度过高、受热时间过长而造成的挥发损失。
制备该抗菌消炎药剂的方法，工艺条件温和、易于实现，且通过控制原料中各组分的混合顺序，使各组分之间的分散性良好，有利于酸碱电离交换反应充分进行，并得到澄清透明的抗菌消炎药剂，有利于得到药效更佳且性质更稳定的抗菌消炎药剂。
以下结合实施例对本发明的特征和性能作进一步的详细描述：
实施例1
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸20份、四硼酸钠20份、丙二醇10份、甘油20份、苯氧乙醇1份、及纯水60份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为100℃的纯水混合；随后以12mL/min的添加速度加入甘油混合均匀后，待温度降至70℃时再以20mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
实施例2
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸10份、四硼酸钠10份、丙二醇20份、甘油10份、苯氧乙醇2份、及纯水50份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为80℃的纯水混合；随后以10mL/min的添加速度加入甘油混合均匀后，待温度降至60℃时再以 25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
实施例3
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
实施例4
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、牛蒡子苷0.7份、苍术酮1.5份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后以18mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例5
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、二甲基亚砜5份、牛蒡子苷0.5份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与二甲基亚砜混合，搅拌25min后，再与丙二醇混合，继续搅拌25min，随后与温度为90℃的纯水混合；随后以22mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例6
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、透明质酸5份、牛蒡子苷1份、苍术酮1份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙氧乙醇混合，搅拌15min后，再与丙二醇混合，继续搅拌25min，随后与温度为90℃的纯水混合；随后以20mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以22mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例7
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、水杨酸甲酯10份、牛蒡子苷0.7份、苍术酮1.5份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与水杨酸甲酯混合，搅拌20min后，再与丙二醇混合，继续搅拌15min，随后与温度为90℃的纯水混合；随后以30mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以26mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例8
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、丙氧乙醇10份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与透明质酸混合，搅拌20min后，再与丙二醇混合，继续搅拌20min，随后与温度为90℃的纯水混合；随后缓慢加入以25mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以21mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，过滤，即得该抗菌消炎药剂。
实施例9
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、蒲公英浆液5份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，将抗菌液与蒲公英浆液混合，过滤，即得该抗菌消炎药剂。
实施例10
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、冰片15份、牛蒡子苷1份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，搅拌20min，随后与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃ 时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液；先将抗菌液与100～120目的冰片的粉末混合并于45℃下加热8min，待冰片完全溶解后，再将其与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例11
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、透明质酸10份、冰片5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与透明质酸混合，搅拌20min后，再与丙二醇混合，继续搅拌20min，随后与温度为90℃的纯水混合；随后以24mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以28mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，将抗菌液与100～120目的冰片的粉末混合并于45℃下加热8min，过滤，即得该抗菌消炎药剂。
实施例12
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、丙氧乙醇7.5份、蒲公英浆液15份、牛蒡子苷1份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙氧乙醇混合，搅拌20min后，再与丙二醇混合，继续搅拌20min，随后与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将其与蒲公英浆液、牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
实施例13
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包 括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、透明质酸10份、冰片5份、蒲公英浆液5份、牛蒡子苷0.7份、苍术酮1.5份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与透明质酸混合，搅拌20min后，再与丙二醇混合，继续搅拌20min，随后与温度为90℃的纯水混合；随后以26mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以23mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液；先将抗菌液与100～120目的冰片的粉末混合并于45℃下加热8min，待冰片完全溶解后，再将其与蒲公英浆液、牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
对比例1
本对比例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为100℃的纯水混合；随后待温度降至70℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
对比例2
本对比例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸9.5份、四硼酸钠8.5份、丙二醇20份、及纯水62份。
该药剂的制备方法为：
按重量份数将四硼酸钠、抗坏血酸和纯水混合，并在72℃下反应3.3h，冷却至45～46℃，再在1.5小时冷却至常温后，按重量份数加入丙二醇，得到抗菌消炎制剂。
对比例3
本对比例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠、丙二醇、抗坏血酸、甘油、苯氧乙醇混合，再与温度为90℃的纯水混合、过滤，即得该抗菌消炎药剂。
对比例4
本对比例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与甘油混合均匀后，再与温度为90℃的纯水混合；随后缓慢加入丙二醇混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
对比例5
本对比例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与抗坏血酸混合均匀后，再与温度为90℃的纯水混合；随后缓慢加入丙二醇混合均匀后，待温度降至65℃时再缓慢加入甘油和苯氧乙醇，混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
对比例6
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包 括：
丙二醇15份、甘油15份、苯氧乙醇1.5份、牛蒡子苷1份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将丙二醇与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
对比例7
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、牛蒡子苷1份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将丙二醇与温度为90℃的纯水混合；随后缓慢以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
对比例8
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、牛蒡子苷1份、苍术酮2份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后缓慢以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再与苯氧乙醇混合均匀后得到抗菌液，再将抗菌液与牛蒡子苷和苍术酮混合，过滤，即得该抗菌消炎药剂。
对比例9
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、苯氧乙醇1.5份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
对比例10
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后以15mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，过滤，即得该抗菌消炎药剂。
对比例11
本实施例提供一种抗菌消炎药剂，这种抗菌消炎药剂的原料按重量份数计包括：
抗坏血酸15份、四硼酸钠15份、丙二醇15份、甘油15份、苯氧乙醇1.5份、及纯水55份。
该药剂的制备方法为：
按重量份数将四硼酸钠与丙二醇混合均匀后，再与温度为90℃的纯水混合；随后以60mL/min的添加速度加入甘油混合均匀后，待温度降至65℃时再以25mL/min的添加速度加入抗坏血酸溶液(10mmol/mL)，再与苯氧乙醇混合均匀后得到抗菌液，过滤，即得该抗菌消炎药剂。
临床试验例1
下面结合临床试验对本发明实施例3及对比例1-11中提供的抗菌消炎制剂对 II度烧伤患者的治疗效果进行评价：
一、试验方案
1.病例选择：
本组病例均为II度烧伤患者，符合纳入、排除标准，年龄7-62岁，平均31.4岁。随机分为12组，其中1组为治疗组，另外11组为对照组，每组各30例，12组患者的年龄、烧伤面积、病情等资料无显著性差异，具有可比性。
2.治疗方案：
各组患者入院后，均采用5％碘伏消毒清洗烧伤创面及周围皮肤；并抽吸创面水疱，保留水疱皮。不同之处在于，治疗组采用实施例3所制得的药剂，涂抹于创面处，每日涂抹5次，每次取绿豆大小的药剂进行涂抹。另外11组对照组分别采用对比例1～11所制得的药剂，涂抹于创面处，每日涂抹5次，每次取绿豆大小的药剂进行涂抹。
治疗期间第一周内观察患者创面的变化情况：红肿、渗出消退时间、创面结痂时间、创面愈合时间以及有无其他感染情况。
3.临床评价标准：
创面红肿、消退：肉眼观察，创面无明显红肿、渗出停止；
创面结痂时间：肉眼观察，创面开始形成干燥的痂皮为时间节点；
创面愈合时间：肉眼观察，创面完全上皮化，形成粉红色干燥创面为时间节点。
4.统计学处理：
所有数据采用SPSS17.0软件进行统计学处理。所有数据均用均数±标准差(x±s)表示，6组之间采用t检验，以P＜0.05为差异具有统计学意义。
二、试验结果：
如表1所示：
表1
Figure PCTCN2017090998-appb-000003
Figure PCTCN2017090998-appb-000004
由表1可见：
(1)实验组与对照组1(施用对比例1中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对比例1，均具有显著性差异(P<0.01)。由此可见，在该抗菌消炎药剂中加入甘油和苯氧乙醇，有利于促进创面的修复能力。
(2)实验组与对照组2(施用对比例2中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对比例2，红肿消退时间和创面愈合时间与对比例2相比具有显著性差异(P<0.01)。由此可见，该抗菌消炎药剂的治疗效果优于对比例2，促进创面愈合能力更强。
(3)实验组与对照组3-5(施用对比例3-5中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对照组3-5，均具有显著性差异(P<0.01)。由此可见，原料中各组分的添加顺序对该组合剂的药效具有决定性作用。(4)对照组6(施用对比例6中的药剂)与实验组相比，对照组6患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远远长于实验组，均具有显著性差异(P<0.01)。由此可见，如果该制剂中未加入关键的活性有效成分抗坏血酸与四硼酸钠，该制剂几乎没有显著的促进创面的修复能力。
(5)对照组7(施用对比例7中的药剂)与实验组相比，对照组7患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远远长于实验组，均具有显著性差异(P<0.01)。由此可见，如果该制剂中缺少关键的活性有效成分四硼酸钠而只含有抗坏血酸时，该制剂的促进创面的修复能力较弱，说明实验组制剂中抗坏血酸与四硼酸钠是协同起到显著的治疗效果的。
(6)对照组8(施用对比例8中的药剂)与实验组相比，对照组8患者的红 肿消退时间、创面结痂时间、以及创面愈合时间均远远长于实验组，均具有显著性差异(P<0.01)。由此可见，如果该制剂中缺少关键的活性有效成分抗坏血酸而只含有四硼酸钠时，该制剂的促进创面的修复能力较弱，说明实验组制剂中抗坏血酸与四硼酸钠是协同起到显著的治疗效果的。
(7)实验组与对照组9(施用对比例9中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对比例9，均具有显著性差异(P<0.01)。由此可见，在该抗菌消炎药剂中加入甘油，由于甘油能够在创面处形成一定厚度的其保护作用的隔离膜，有利于促进创面的修复能力。
(8)实验组与对照组10(施用对比例10中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对比例10，均具有显著性差异(P<0.01)。由此可见，在该抗菌消炎药剂中加入苯氧乙醇，可以增强抗菌功效，有利于促进创面的修复能力。
(9)实验组与对照组11(施用对比例11中的药剂)相比，实验组患者的红肿消退时间、创面结痂时间、以及创面愈合时间均远小于对比例11，均具有显著性差异(P<0.01)。由此可见，对原料中甘油添加速度的控制可以避免制备过程中乳化现象的出现，对该组合剂的药效具有决定性作用。
临床试验例2
下面结合临床试验对本发明实施例1-13中提供的抗菌消炎制剂对II度烧伤患者的治疗效果进行评价：
一、试验方案：
1.病例选择：
本组病例均为II度烧伤患者，符合纳入、排除标准，年龄10-57岁，平均29.4岁。随机分为13组，每组各20例，九组患者的年龄、烧伤面积、病情等资料无显著性差异，具有可比性。
2.治疗方案：
各组患者入院后，均采用5％碘伏消毒清洗烧伤创面及周围皮肤；并抽吸创面水疱，保留水疱皮。不同之处在于，这九组患者分别施用实施例1-13提供的抗菌消炎药剂，涂抹于创面处，每日涂抹5次，每次涂抹绿豆大小。
治疗一周内观察患者创面的变化情况：红肿、渗出消退时间、创面结痂时间、创面愈合时间以及有无其他感染情况。
3.临床评价标准：与临床试验例1一致。
4.统计学处理：与临床试验例1一致。
二、试验结果：
如表2所示：
表2.
Figure PCTCN2017090998-appb-000005
由表2可知：
(1)本发明中提供的抗菌消炎药剂对烧伤创面的治疗效果优良，主要表现在：是在用药剂过后，能够在1.6天内使红肿消退、在2天内创面能够结痂、且在3天内创面能够达到愈合。此外，实施例1-13中药剂施用后，无过敏、毒性反应，也无二次感染症状，且在使用药剂10～12天后，创面修复完全，无肉眼可见疤痕。
(2)实施例4相对于实施例1-3而言，其不同之处在于添加了牛蒡子苷和苍术酮，由试验结果可见，实施例4的治疗效果相对优于实施例1-3，说明通过牛蒡子苷和苍术酮的添加，可以提高该抗菌消炎剂的抑菌能力，同时也能增强伤口的愈合速度。
(3)实施例5-7相对于实施例4而言，其不同之处在于添加了皮肤促透剂， 由试验结果可见，实施例5-7的治疗效果相对优于实施例4，说明通过皮肤促透剂的添加，使得该药剂的渗透性能更加，能够快速的渗透进入受损创面的深层组织，并与细菌相互作用，干扰菌体的新陈代谢，从而起到更佳的杀菌效果。
(4)实施例9相对于实施例1-3而言，其不同之处在于添加了促愈剂，由试验结果可见，实施例9的治疗效果明显优于实施例1-3，说明促愈剂能够增强该药剂的修复功能，促进创面快速修复，以达到更好的治疗效果。
尽管已用具体实施例来说明和描述了本发明，然而应意识到，在不背离本发明的精神和范围的情况下可以作出许多其它的更改和修改。因此，这意味着在所附权利要求中包括属于本发明范围内的所有这些变化和修改。
工业实用性：
本发明的这种抗菌消炎药剂，是基于酸碱电离交换反应来实现的。在这种药剂中，甘油能够在创面处形成一定厚度的隔离膜，能够有效的将创面保护起来，使其不与外界大气接触，同时也具有一定的抑菌和保湿作用，避免创面处受到二次感染损伤。在甘油的隔离膜内部，抗坏血酸与四硼酸钠相互作用，形成四硼酸氢钠和抗坏血酸钠。抗坏血酸具有直接杀菌作用，四硼酸钠本身具有防腐作用，在四硼酸钠交换氢离子后成为四硼酸氢钠，由于氢原子的性质活泼，四硼酸钠得到氢后极性增强，分子的运动活性增强，能够在甘油形成的隔离膜内快速运动至创面并高效地促进创面修复愈合。此外，苯氧乙醇具有较好的杀菌作用，能够增强该抗菌消炎药剂的杀菌防腐的功效，同时也能增强该抗菌消炎药剂的稳定性、以及改变其气味。苯氧乙醇与其他组分共同配伍使用，具有协同增效的作用，使得到的抗菌消炎药剂具有广谱长效的杀菌功效。
制备该抗菌消炎药剂的方法，工艺条件温和、易于实现，且通过控制原料中各组分的混合顺序，使各组分之间的分散性良好，有利于酸碱电离交换反应充分进行，并得到澄清透明的抗菌消炎药剂，且这种抗菌消炎药剂的药效更佳、性质更稳定。

Claims (17)

  1. 一种抗菌消炎药剂，其特征在于，所述抗菌消炎药剂的原料按重量份数计包括：
    抗坏血酸10～20份、四硼酸钠10～20份、丙二醇10～20份、甘油10～20份、苯氧乙醇1～2份、及纯水50～60份。
  2. 根据权利要求1所述的抗菌消炎药剂，其特征在于，所述原料按重量份数计还包括：牛蒡子苷0.5～1份、苍术酮1～2份。
  3. 根据权利要求1所述的抗菌消炎药剂，其特征在于，所述原料还包括皮肤促透剂。
  4. 根据权利要求3所述的抗菌消炎药剂，其特征在于，所述皮肤促透剂选自由二甲基亚砜、丙氧乙醇、水杨酸甲酯和透明质酸组成的组。
  5. 根据权利要求3或4所述的抗菌消炎药剂，其特征在于，所述皮肤促透剂按重量份数计为5～10份。
  6. 根据权利要求1所述的抗菌消炎药剂，其特征在于，所述原料还包括促愈剂。
  7. 根据权利要求6所述的抗菌消炎药剂，其特征在于，所述促愈剂选自由蒲公英浆液和冰片组成的组。
  8. 根据权利要求6或7所述的抗菌消炎药剂，其特征在于，所述促愈剂按重量份数计为10～20份。
  9. 根据权利要求7所述的抗菌消炎药剂，其特征在于，所述冰片为100～120目的冰片。
  10. 一种根据权利要求1-9中任一项所述的抗菌消炎药剂，其特征在于，所述四硼酸钠与所述抗坏血酸的摩尔比为1：1。
  11. 一种根据权利要求1-10中任一项所述的抗菌消炎药剂，其特征在于，所述抗菌消炎药剂的pH值为5.0～7.0。
  12. 一种根据权利要求1-11中任一项所述的抗菌消炎药剂的制备方法，其特征在于，其包括：
    按重量份数将所述四硼酸钠与所述丙二醇混合均匀后，再与温度为80～100℃的所述纯水混合；随后缓慢加入所述甘油混合均匀后，待温度降至 60～70℃时再缓慢加入所述抗坏血酸，再与所述苯氧乙醇混合均匀后得到抗菌液，过滤。
  13. 根据权利要求12所述的抗菌消炎药剂的制备方法，其特征在于，所述原料按重量份数计还包括：牛蒡子苷0.5～1份、苍术酮1～2份；在缓慢加入所述抗坏血酸的步骤之后以及在过滤所述抗菌液的步骤之前，还包括将所述抗菌液与所述牛蒡子苷和所述苍术酮混合的步骤。
  14. 根据权利要求12所述的抗菌消炎药剂的制备方法，其特征在于，所述四硼酸钠与所述丙二醇的混合步骤包括：将所述四硼酸钠与皮肤促透剂混合，搅拌15～25min后，再与所述丙二醇混合，继续搅拌15～25min。
  15. 根据权利要求14所述的抗菌消炎药剂的制备方法，其特征在于，所述皮肤促透剂选自由二甲基亚砜、丙氧乙醇、水杨酸甲酯和透明质酸组成的组，所述皮肤促透剂按重量份数计为5～10份。
  16. 根据权利要求12所述的抗菌消炎药剂的制备方法，其特征在于，在缓慢加入所述抗坏血酸的步骤之后以及在过滤所述抗菌液的步骤之前，还包括将所述抗菌液与促愈剂混合的步骤，所述促愈剂选自由蒲公英浆液冰片组成的组。
  17. 根据权利要求12-16中任一项所述的抗菌消炎药剂的制备方法，其特征在于，所述甘油的添加速度为10～30mL/min。
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