WO2017206758A1 - 皮肤多种损伤创面治疗的外用药物组合物及其制备方法 - Google Patents

皮肤多种损伤创面治疗的外用药物组合物及其制备方法 Download PDF

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WO2017206758A1
WO2017206758A1 PCT/CN2017/085443 CN2017085443W WO2017206758A1 WO 2017206758 A1 WO2017206758 A1 WO 2017206758A1 CN 2017085443 W CN2017085443 W CN 2017085443W WO 2017206758 A1 WO2017206758 A1 WO 2017206758A1
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pharmaceutical composition
wound
wounds
skin
water
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PCT/CN2017/085443
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English (en)
French (fr)
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傅远桥
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傅远桥
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Priority to JP2018563615A priority Critical patent/JP6681482B2/ja
Priority to EP17805703.0A priority patent/EP3466447B1/en
Publication of WO2017206758A1 publication Critical patent/WO2017206758A1/zh
Priority to US16/204,352 priority patent/US10864240B2/en
Priority to US17/102,529 priority patent/US11571452B2/en

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    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
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Definitions

  • the present invention relates to a liquid external pharmaceutical composition for use in the treatment of various wound wounds in human skin.
  • the invention belongs to the field of combined Chinese and Western medicine surgery.
  • a large amount of dressing is used to wrap the wound, and after the moisture in the medicine is dried, the dressing often adheres to the wound surface, and tears are removed when the dressing is changed.
  • the new tissue of the injured wound causes bleeding, the patient's pain is unbearable, and the dressing time is long, and the medical staff has a large workload.
  • the ointment is used, the ointment is incompatible with the wound exudate. In the case of more exudate in the wound surface, the ointment is easy to flow, which may also cause the dressing to adhere to the wound surface, which makes it difficult to replace the dressing.
  • the film-forming spray although better sealing the wound surface, does not well solve the absorption of the wound surface, and is prone to under-film empyema.
  • Chinese medicine believes that "the river sprouts and protects the grass, and the blood germination protects the skin.” Just like grass and wood can not be separated from water and soil, the repair of skin damage wounds should be adequately supported by human blood. Chinese medicine Astragalus, Angelica, Salvia, Radix Paeoniae Alba, Qi and activating blood, swelling and pain, blood and blood are born.
  • Huanglian, Astragalus, Phellodendron, and Radix are the ancient famous Fanglian Huangdu Jiedu Decoction, from the Eastern Jin Gehong “Elbow Reserve Emergency” and the Tang Dynasty Wang Shuo "Outside Taiwan Secrets", the later medical doctors used to treat various sores Oral. In modern medical journals, it is common to use scutellaria, scutellaria, and cypress in the treatment of burn wounds.
  • White sputum clearing heat and detoxification, Sijiqing is both clearing away heat and detoxifying, and collecting sore and sore, but also cooling blood to stop bleeding, white sputum to collect wet sores, licorice to reconcile various drugs, detoxification and anti-inflammatory, together with jaundice, angelica, salvia, and red peony Tissue living cells have a nutritional effect.
  • the frankincense is partial to the qi and sputum
  • the myrrh is partial to the blood and phlegm
  • the frankincense, the myrrh and the fragrant scent are scattered, which is the medicine for expelling qi stagnation and blood stasis. Big sores can rely on qi and blood to eliminate swelling and promote the repair of local damage.
  • the role of frankincense and myrrh-relieving muscles is difficult to replace with general drugs.
  • Blood is the main medicine for dilated blood, new blood, the main blood, the treatment of gold sores, pain, single use can also be immediately seen, combined with frankincense, myrrh, is a strong combination, blood circulation and phlegm Big. Blood does not leave sputum, blood circulation can relieve pain, so these three herbs are blood three Musketeers, where there is blood stasis, they are pointed by the Jianfeng, all blood and pain. In addition to the antibacterial astringent effect, catechu has a deodorizing effect.
  • the ideal wound medicine should have analgesia, quickly seal the wound, absorb the wound exudate, reduce exudation, facilitate drainage, protect the wound, promote the growth of the epidermal cells, have a broad antibacterial spectrum and have a strong effect, no or little It produces resistant strains, has no toxicity, has fewer side effects, and has fewer scars after wound healing. Therefore, the object to be solved by the present invention is to find a liquid external pharmaceutical composition for treating various wound wounds of the skin conveniently and efficiently, wherein an important raw material medicine and a combination of Chinese and Western techniques are used, and different methods are used to prepare a specific method. The pharmaceutical composition tries to satisfy the conditions that the ideal wound medicine should have.
  • an important component of the pharmaceutical composition of the present invention consists of glycerol, 1,2 propanediol, water-soluble azone or mercaptomethyl sulfoxide and water in a specific ratio.
  • This important component can effectively seal the wound surface, absorb the wound exudate, form a transparent thin sputum, resist the invasion of external bacteria, and combine it with the selected drug group in the treatment of various skin damage wounds on the skin. Can present many ideal therapeutic effects! This important component and its specific ratio are the greatest features of the present invention.
  • the human body is an organism that is covered by the skin all over the skin. Through the exchange of blood circulation and body fluids, the smallest unit that constitutes the body, that is, each living cell, exchanges substances with the outside world in a completely closed and relatively constant environment to achieve metabolism and maintain life. The operation. If the skin is damaged by various reasons, the tissue cells of the damaged part protected by the skin will be exposed, and the damage will appear as a “disaster”. The body will mobilize a limited force to reach the wounded area for “rescue and disaster relief”, and the wound will appear. A series of pathophysiological evolution, the body can mobilize the defensive power is limited, the wound is large, and has to rely on foreign aid - drugs.
  • the wound As a doctor, in the face of multiple wounds on the skin, the wound is quickly restored to a completely closed state, isolated from the surrounding air, thereby reversing the pathological changes of the wound, such as hemostasis, bleeding, swelling, sterilization, and promoting the physiological repair of the wound.
  • a variety of damaged skin wounds can successfully survive the "disaster” and return to normal.
  • the first priority of a variety of wound treatments is to quickly and completely seal the wound. This discussion is not emphasized in the existing literature, and the inventor is thoroughly observing and thinking about this discussion before seriously practicing it.
  • the invention can realize the function of the four substances constituting the basic medicine array, and the wound skin of the skin can not be coated with the obviously stimulating drug, thereby causing the wound tissue tissue cells to be damaged again.
  • the basic medicine array selected by the invention not only satisfies the above Requirements, but also extract the medicinal active ingredients of Chinese medicinal materials, to achieve water absorption, anti-permeation, promote penetration, thin sputum, live qi and blood, Tong col network, for nutrition, and promote new life. These are wounds healed as soon as possible, reducing A favorable measure of scarring.
  • the invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein important components of the pharmaceutical composition include glycerin, 1,2 propanediol, water-soluble azone or mercaptomethyl sulfoxide And water is composed of a specific ratio, wherein the glycerol is present in an amount of from 80 to 90% by volume of the composition.
  • the 1,2 propylene glycol is present in an amount of from 6 to 15% by volume of the composition; and the water-soluble azone is present in an amount of from 0.2 to 2% by volume, preferably from 0.6 to 1% by volume. More preferably, the content is from 0.2 to 0.5% by volume; the mercaptomethyl sulfoxide is present in the composition in an amount of from 1 to 4% by volume, preferably from 1 to 3% by volume, more preferably from 1 to 1.5% by volume; The water is present in an amount of from 3 to 8 % by volume of the composition, preferably from 3 to 5% by volume, more preferably from 3 to 4 % by volume.
  • One embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin and an important component thereof, wherein an important component of the pharmaceutical composition is from 80 to 90% by volume based on the final volume ratio of the composition.
  • Glycerol 6-15% by volume of 1,2 propanediol, 0.2-2% by volume of water-soluble azone, or 1-4% by volume of mercaptomethyl sulfoxide, 3-8 vol% of water.
  • One embodiment of the present invention discloses an important component of a pharmaceutical composition for treating multiple wounds of the skin, treating a sterile wound wound alone, wherein the pharmaceutical composition is
  • the important component consisted of glycerol, 10% by volume of 1,2 propanediol, 0.5% by volume of water-soluble azone, and 6% by volume of water in a final volume ratio of the composition of 83.5% by volume.
  • the important component of the pharmaceutical composition for treating multiple wound wounds of the present invention is preferably glycerol by medical analysis of pure glycerol (Glycerol, glycerin, density 1.236 g/ml, 500ml weighs 628g, molecular formula C 3 H 8 O 3 , molecular weight 92.09, purity ⁇ 99%), 1,2 propanediol (1,2-Propanediol, molecular formula C 3 H 8 O 2 , molecular weight 76.09, purity ⁇ 99%), water soluble Sexual azone and water are composed according to the specific proportion, calculated according to the final volume percentage, wherein glycerol accounts for 80%-90%, and 1,2 propanediol accounts for 6-15%, which is to make full use of these two components.
  • the liquid form and moisture absorbing properties absorb the exudate of the wound while not causing the wound to be too dry.
  • composition for treating various wound wounds of the skin of the present invention contains Laurocapram (molecular formula C 18 H 35 NO, molecular weight 281.48, analytical purity >98%, relative density (20 ° C) 0.906-0.926, The acidity and alkalinity), wherein the oil-soluble azone is modified into a water-soluble azone, which is a complex of mercaptomethyl sulfoxide and pyrrolidone, a colorless transparent viscous liquid.
  • Laurocapram molecular weight 281.48, analytical purity >98%, relative density (20 ° C) 0.906-0.926, The acidity and alkalinity
  • the water-soluble azone can effectively increase the osmotic absorption effect of the drug contained in the composition, thereby achieving not only inhibiting the surface layer which kills the wound surface but also inhibiting the pathogenic bacteria which kill the deep layer of the wound surface, fully exerting the therapeutic effect of the drug and reducing the drug. Dosage.
  • the water soluble azone has a preferred content of 2-20 mL/L, more preferably 6-10 mL/L, and 2-5 mL/L is optimal.
  • the water soluble azone is preferably a pharmaceutical grade water soluble azone.
  • the azone can also be replaced with mercaptomethyl sulfoxide, which preferably has a content of 10-40 mL/L, more preferably 10-30 mL/L, 10- 15 The mL/L is optimal.
  • the mercaptomethyl sulfoxide is preferably a pharmaceutical grade mercaptomethyl sulfoxide.
  • water is a natural good solvent, and the effect of containing water is that a certain proportion of a mixture of propylene glycol and water can delay some Hydrolysis of the drug increases its stability, thereby extending the shelf life of the composition.
  • glycerol is highly hygroscopic, a small amount of water can be added to balance its strong hygroscopicity.
  • Glycerol combined with water can enhance the solubility of the medicinal active ingredients of Chinese medicinal materials under high temperature and high pressure conditions.
  • the preferred content of water is from 30 to 80 mL/L, more preferably from 30 to 50 mL/L, and most preferably from 30 to 40 mL/L.
  • a pharmaceutical composition consisting of an important component of the pharmaceutical composition of the specific ratio and a medicinal active ingredient of the selected formula Chinese herbal medicine can be applied to the wound to quickly close the wound.
  • the wound surface is covered with a transparent enamel, which can effectively prevent and treat wound infection, eliminate wound edema, stop the exudation of the wound surface, reduce the body's physical consumption, and can resist the free radicals, the wound cells that can protect the wound and the nutritious wound.
  • the hair is repaired to repair the wound, so that the wound heals faster under the armpit. Generally, there is little scar left in the second degree burn wound.
  • the pharmaceutical composition of the present invention contains a traditional Chinese medicine raw material medicine:
  • the pharmaceutical composition of the present invention further comprises at least one of astragalus, angelica, salvia, and red peony, and the medicinal active ingredient of at least one of the scutellaria, angelica, salvia, and red peony is used under high temperature and high pressure conditions. Glycerol is combined with water for extraction.
  • Astragalus membranaceus contains a variety of chemical active ingredients, mainly including saponins, flavonoids, polysaccharides, amino acids and trace elements. It has the effects of tonifying qi, promoting blood, stimulating pus, and soothing sores.
  • the preferred content of xanthine in the composition is from 10 to 30 g/L, more preferably from 10 to 20 g/L, and most preferably from 10 to 15 g/L.
  • Angelica contains volatile oil, angelica lactone, ferulic acid, nicotinic acid, succinic acid, ⁇ -sitosterol, carotenoid, monosaccharide, polysaccharide, phospholipid, various amino acids and inorganic elements, etc., with blood and activating blood circulation, regulating menstruation and relieving pain, detoxification It can reduce swelling, make up the phlegm, nourish yin and nourish blood, and moisturize the skin.
  • the preferred content of Angelica is 5-20 g/L, more preferably 5-10 g/L, and most preferably 6-8 g/L.
  • Salvia miltiorrhiza contains active ingredients such as tanshinone, salvian phenol, and baicalin. It has anti-oxidation, anti-bacterial, blood-activating, phlegm, blood and pain relief, excretion and pain relief, long meat and muscle, and promote wound healing.
  • the preferred content of Salvia miltiorrhiza is 5-20 g/L, more preferably 5-15 g/L, and most preferably 8-10 g/L.
  • Red peony contains paeoniflorin, paeoniflorin, paeoniflorin, catechin extract, ethyl gallate, volatile oil, etc. It has anti-myocardial ischemia, improves blood microcirculation, inhibits platelet aggregation and antithrombotic formation, and has analgesic and antispasmodic Liver, anti-inflammatory and antibacterial effects, inhibition of Staphylococcus aureus and Pseudomonas aeruginosa, fungi, herpes virus, enterovirus.
  • the preferred content of red peony is 5-20 g/L, more preferably 5-15 g/L, and most preferably 8-10 g/L.
  • the pharmaceutical composition of the present invention may further comprise at least one of Coptidis Rhizoma, Astragalus, Cork, and Hazelnut, and the medicinal active ingredient of at least one of the coptis, scutellaria, cork, and medlar is at a high temperature.
  • the high pressure conditions were extracted with glycerin combined with water.
  • Coptis contains a variety of isoquinoline alkaloids and berberine. It can remove endotoxin, anti-S. aureus, Escherichia coli, and has the functions of clearing heat and dampness, purging fire and detoxification. For burns, berberine decoction for external use, not only can resist infection, but also reduce exudation and promote scarring.
  • the preferred content of Coptidis Rhizoma is 5-20 g/L, more preferably 5-10 g/L, and most preferably 6-8 g/L.
  • Astragalus mainly contains flavonoids, such as baicalein, wogonin, baicalin, and sugars containing volatile oils and amino acids.
  • Astragalus membranaceus has strong antibacterial activity and has obvious inhibitory effects on Staphylococcus aureus, hemolytic streptococcus, Escherichia coli and Pseudomonas aeruginosa, and also has anti-inflammatory and anti-oxidative effects.
  • the preferred content of astragalus is 5-20 g/L, more preferably 5-10 g/L, and most preferably 6-8 g/L.
  • Cork mainly contains berberine, corkaline, corkone, and paeoli lactone.
  • Chinese medicine said that the hot poisonous sore, Huang Bailiang, has a significant inhibitory effect on Staphylococcus aureus, hemolytic streptococcus, Escherichia coli, and Pseudomonas aeruginosa.
  • the preferred content of cork is 5-20 g/L, more preferably 5-10 g/L, and most preferably 6-8 g/L.
  • Gardenia mainly contains flavonoids such as iridoid glycosides, crocin, rutin, etc., which can eliminate irritability, clearing heat and dampness, cooling blood and detoxification, topical swelling and pain relief, Staphylococcus aureus and hemolytic chain. Cocci have a strong antibacterial effect.
  • the hazelnuts are preferably present in an amount of from 5 to 20 g/L, more preferably from 5 to 10 g/L, most preferably from 6 to 8 g/L.
  • the pharmaceutical composition according to the present invention further includes at least one of white peony, mycelium, white peony, and licorice, and the medicinal active ingredient of at least one of the medicinal materials of white peony, white peony, green holly, and licorice is
  • the high temperature and high pressure conditions were extracted with glycerin combined with water.
  • the main components of white peony are gallic acid, tartaric acid, sitosterol, chrysophanol, mucus, which have the functions of clearing away heat and detoxifying and reducing swelling and muscle growth.
  • This product has bitter cold and clear sputum, Xin San swelling, sore muscles and pain relief, and has obvious inhibitory effect on Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli.
  • the folklore of the white pheasant is commonly known as “seeing swollen sputum”, and the application of single-flavor medicine has a strong anti-infective effect.
  • the preferred content of chalk is 5-20 g/L, more preferably 6-15 g/L, and most preferably 8-10 g/L.
  • Sijiqing The main ingredients of Sijiqing are protocatechuic acid, protocatechuic aldehyde, condensed tannic acid, flavonoids and volatile oil. It has the functions of clearing away heat and detoxifying, cooling blood to stop bleeding and soreing. Sijiqing has antibacterial and anti-inflammatory properties, increases coronary blood flow, resists myocardial ischemia, forms a protective aponeurosis on burn wounds, can prevent infection, prevents exudation, has adsorption capacity, and has certain permeability. Does not increase the depth of the wound and so on.
  • the preferred content of Silymarin is 5-20 g/L, more preferably 5-15 g/L, and most preferably 8-10 g/L.
  • the main components of the white peony are bibenzyl, phenanthrene and its derivatives, and a small amount of volatile oil mucus. It has the effect of astringent hemostasis and swelling of the muscles. It is used to treat skin cleft palate, water and fire burns, absorb wound exudate, protect wounds and promote wound healing.
  • the preferred content of chalk is 5-20 g/L, more preferably 6-15 g/L, and most preferably 8-10 g/L.
  • Licorice contains more than 100 kinds of flavonoids, more than 60 kinds of triterpenoids, 18 kinds of amino acids and various alkaloids. It has an adrenal glucocorticoid-like effect, has anti-inflammatory, anti-oxidation, immune regulation and detoxification effects, and also has anti-viral and anti-bacterial, spleen and qi, clearing heat and detoxification, relieving pain, and reconciling various drugs.
  • the preferred content of licorice is 5-15 g/L, more preferably 6-12 g/L, and most preferably 8-10 g/L.
  • the pharmaceutical composition according to the present invention further comprises at least one of boswellia, myrrh, blood, and catechu, and the medicinal active ingredient of at least one of the boswell, myrrh, blood, and catechin It is extracted by immersion with 1,2 propylene glycol.
  • the frankincense contains mainly resin, gum and volatile oil. It can relieve pain and relieve inflammation, and has the effect of activating blood circulation, relieving pain and reducing swelling and muscle growth. It is an important drug for treating sore and scorpion venom.
  • the preferred content of mastic is from 3 to 10 g/L, more preferably from 5 to 8 g/L, and most preferably from 5 to 6 g/L.
  • Myrrh contains mainly volatile oil, resin, and gum.
  • the water infusion agent has an inhibitory effect on the fungus, and is often paired with the frankincense to play a role in promoting blood circulation, relieving pain, swelling the muscles, and strengthening the sputum. Chinese medicine believes that blood stasis does not go, and new blood does not.
  • the preferred content of myrrh is 3-10 g/L, more preferably 5-8 g/L, and most preferably 5-6 g/L.
  • the blood contains hemoglobin, hemoglobin, resin acid and the like. It can stop bleeding and promote blood circulation, anti-inflammatory and analgesic, and has the effect of promoting blood circulation, relieving sore muscles.
  • the preferred content of blood is 3-10 g/L, more preferably 5-8 g/L, and most preferably 4-5 g/L.
  • the catechin contains catechol, which is resistant to oxidation and antibacterial (inhibiting Gram-positive and negative bacteria, inhibiting Staphylococcus aureus, Enterococcus, Escherichia coli, and anti-influenza virus). It has activating blood to heal, stop bleeding and build muscle, and collect moisture. The role of sores.
  • the preferred content of catechu is from 3 to 10 g/L, more preferably from 5 to 8 g/L, and most preferably from 4 to 5 g/L.
  • composition of the present invention wherein the pharmaceutical composition may further comprise a miscible antibiotic.
  • the antibiotics of the present invention include gentamicin and chloramphenicol.
  • the composition of the present invention can temporarily add a group of antibiotics to each 100 ml of the composition according to the pathogenic diagnosis of the wound infection according to the pathogenic diagnosis of the wound infection, such as: 80,000 units of gentamicin and 0.25 grams of chloramphenicol (but not limited to the above two, can also choose other suitable group of antibiotics), fully shaken and applied to the wound surface.
  • a group of antibiotics such as: 80,000 units of gentamicin and 0.25 grams of chloramphenicol (but not limited to the above two, can also choose other suitable group of antibiotics), fully shaken and applied to the wound surface.
  • One embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein the pharmaceutical composition is substantially 10-30 g/L of the raw material medicinal scutellariae of the following final mass to volume ratio, Angelica sinensis 5- 20g/L, Salvia miltiorrhiza 5-20g/L, Radix Paeoniae 5-20g/L, Coptis 5-20g/L, Astragalus 5-20g/L, Phellodendron 5-20g/L, Gardenia 5-20g/L, White peony 5-20g/L, Sijiqing 5-20g/L, White peony 5-20g/L, Licorice 5-15g/ L, frankincense 3-10g / L, myrrh 3-10g / L, blood 3-10g / L, catechu 3-10g / L and final volume percentage of glycerol 80-90%, 1, 2 It is made up of 6-15% of propylene glycol, 0.2-2% of water-soluble azone, or
  • One embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein the final mass-to-volume ratio of the drug substance is 10-20 g/L of Astragalus, 5-10 g/L of Angelica sinensis, and 5-10 g of Salvia miltiorrhiza.
  • One embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein the final mass-to-volume ratio of the drug substance is 10-15 g/L of Astragalus, 6-8 g/L of Angelica sinensis, and 8-g 10g/L, red peony 8-10g/L, berberine 6-8g/L, jaundice 6-8g/L, yellow peony 8-10g/L, medlar 6-8g/L, white peony 8-10g/L, four seasons Qing 8-10g / L, white peony 8-10g / L, licorice 8-10g / L, frankincense 5-6g / L, myrrh 5-6g / L, blood 4-5g / L, catechu 4-5g / L and final volume percentage of glycerol 80-90%, 1,2 propylene glycol 6-15%, water-soluble azone, 0.2-0.5% or mercaptomethyl sulfoxide 1-1.5%,
  • a specific embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein the final mass-to-volume ratio of the drug substance is 20 g/L of Astragalus, 15 g/L of Angelica sinensis, 15 g/L of Salvia miltiorrhiza, and Radix Paeoniae Alba.
  • a specific embodiment of the present invention discloses a drug group for treating various wound wounds of the skin
  • the final mass-to-volume ratio of the drug substance is 20 g/L of Salvia miltiorrhiza, 20 g/L of Phellodendron chinense, 20 g/L of Sijiqing, 15 g/L of Radix Paeoniae, 15 g/L of licorice, 8 g/L of licorice, 8 g/L of catechu tea and a final volume of 100
  • the content of glycerin is 88.4%
  • 1,2 propanediol is 8%
  • water-soluble azone is 0.6%
  • water is 3%.
  • a specific embodiment of the present invention discloses a pharmaceutical composition for treating various wound wounds of the skin, wherein the final mass-to-volume ratio of the drug substance is 10 g/L of Astragalus, 8 g/L of Angelica sinensis, 8 g/L of Salvia miltiorrhiza, and Radix Paeoniae Alba.
  • Another aspect of the present invention discloses a method for preparing the pharmaceutical composition, wherein the preparation method comprises the following methods: selecting and weighing an appropriate amount of astragalus, angelica, salvia, red peony, berberine, astragalus, cork, and alfalfa At least three kinds of seeds, white peony, four seasons, white peony and licorice are put into the corresponding amount of glycerol mixed with distilled water. Under the environment of water vapor of 0.02 MPa and 105 ° C, the compartment is heated to contain the raw material medicine.
  • the preparation method comprises the following methods: selecting at least one of appropriate amount of astragalus, angelica, salvia, and red peony; at least one of berberine, scutellaria, cork, and scorpion; white At least one of ⁇ , Sijiqing, white peony, and licorice, at least three kinds, and the corresponding amount of glycerol is mixed with the corresponding amount of distilled water, and the partition layer is heated under the environment of water vapor of 0.02 MPa and 105 ° C.
  • the glycerin of the drug is combined with water for 10 minutes, and after cooling, the dregs are filtered off, and the consumed glycerin is added to make up the amount; at least one of the appropriate amount of frankincense, myrrh, blood, and catechu is selected and put into In the corresponding amount of 1,2 propylene glycol, after soaking for 24 hours, the drug residue is filtered off, and the loss of 1,2 propylene glycol is added; the glycerol containing the active ingredient of the drug substance is added.
  • the 1,2 propanediol containing the active ingredient of the raw material drug is mixed with a corresponding amount of water-soluble azone or mercaptomethyl sulfoxide, thoroughly stirred, and sterilized by filling.
  • the medicinal active ingredient of the Chinese medicinal material contained in the composition of the present invention is extracted by using glycerin or 1,2 propylene glycol as a solvent.
  • the medicinal active ingredient of Chinese medicinal materials has low solubility in glycerol and is slow to precipitate.
  • the Applicant has found that a small amount of water is added to glycerol, and the medicinal active ingredient of the Chinese medicinal material has good solubility with a suitable pressure and temperature for a certain period of time.
  • Glycerol has a boiling point of 290 °C.
  • the glycerol water-repellent compartment was heated to 105 ° C with high-pressure steam for 10 minutes. The temperature and time are selected to maintain the chemical stability of glycerol and to ideally dissolve the medicinal active ingredients of the Chinese herbal medicines.
  • 1,2 propylene glycol is relatively low in the proportion of the common component of the composition, but the amount thereof is sufficient as a solvent for soaking the medicinal active ingredients of the frankincense, myrrh, blood, and catechu in the extracting composition. .
  • the invention follows the rule of Chinese medicine surgery for clearing away heat and detoxifying, promoting blood circulation and swelling, phlegm and stasis, and collecting soreness and soreness.
  • Angelica Salvia, Radix Paeoniae Alba; Radix, Radix Astragali, Phellodendron, Radix, Radix Paeoniae Alba, Radix Paeoniae Alba, Radix Paeoniae Alba, Radix Glycyrrhizae; Frankincense, Myrrh, Blood, Tea, and a new variety of herbs, light dose
  • a large prescription consisting of four drug arrays, adding a basic drug matrix that absorbs moisture, moisturizes, forms a film, and acts as a solvent.
  • the first drug arrays of Astragalus, Angelica, Salvia, Radix Paeoniae Alba, qi and blood, Tory detoxification belong to Jun;
  • the third drug is white, four seasons, white peony, licorice, collecting sore and swelling, belonging to the scent;
  • the fourth drug is frankincense, myrrh, blood, catechu, qi and blood circulation, stagnation Muscle, genera.
  • the four drug arrays are four small prescriptions, and each of the four traditional Chinese medicines, according to their functional traits, in the above-mentioned order, respectively constitute the corresponding Jun, Chen, Zuo, and Zhi.
  • the invention also discloses the use of the pharmaceutical composition for the preparation of a topical medicament for treating various wound wounds of the skin.
  • the multiple wounds of the skin do not include: skin ulcers caused by tuberculosis infection or malignancy, acne due to imbalance of androgen secretion.
  • the various wound wounds of the skin of the present invention include burn wounds, burn wounds, skin bruise wounds, suture wounds after cutting, acne wounds, skin wounds, and granulation tissue wounds.
  • the beneficial effects of the present invention are disclosed in a liquid external pharmaceutical composition for treating various wound wounds of human skin.
  • the use of the pharmaceutical composition containing the medicinal active ingredient of the traditional Chinese medicine raw material can quickly and effectively seal the wound surface, eliminate the edema of the wound surface, reduce and stop the exudation of the wound surface, and combine the pharmaceutical composition with the existing exudate of the wound surface to form a transparent Thin enamel can protect the wound base and surrounding vital cells from further damage, prevent and control wound infection, promote wound healing under the wound, and minimize the formation of scars.
  • the pharmaceutical composition has the use of a topical medicament for treating various wounds of the skin.
  • Fig. 1 is a view showing the actual preparation of the pharmaceutical composition preparation 3 of the present invention.
  • the term “medical” refers to a reagent having a purity greater than 95%
  • the “medical glycerol” used in the examples of the present invention is an analytical grade grade of medical glycerin having a density of 1.236 g/mL, 500 mL weight. 628 g, molecular formula C 3 H 8 O 3 , molecular weight 92.09, purity ⁇ 99%; “medical 1,2 propylene glycol” purity ⁇ 99%.
  • the term "pharmaceutical grade” refers to the purity of a chemical that can be used in a human medicament.
  • the water-soluble azone in the present invention is pharmaceutical grade.
  • treating refers to reversing, alleviating or inhibiting the progression of a disease to which the term applies, or one or more symptoms of a disease.
  • the term also includes preventing the disease, including preventing the occurrence of the disease or any symptoms associated therewith, as well as reducing the severity of the condition or any condition prior to its occurrence.
  • the term "glycerol combined with water” refers to a solvent obtained by mixing glycerin and water in a specific ratio.
  • the "glycerol-containing water” used in the embodiment of the present invention has a volume of glycerol of 80 to 90 parts and a volume of water of 3 to 8 parts.
  • the volume ratio of glycerol to water in "glycerol water” used in the specific embodiment of the present invention is preferably 800:50 or 884:30 or 847:40 or 835:60.
  • composition 1-3 of the present invention was prepared according to the ratio of Table 1 and the following process flow.
  • the modulation process is as follows:
  • the preparation process of the preparation 4 was carried out in the same manner as above, but the Chinese herbal medicine was not weighed.
  • the composition of the present invention can temporarily add a group of antibiotics to each 100 mL of the composition according to the pathogenic diagnosis of the wound infection according to the pathogenic diagnosis of the wound infection, such as: 80,000 units of gentamicin and 0.25 grams of chloramphenicol (but not limited to the above two, can also choose other suitable group of antibiotics), fully shaken and applied to the wound surface.
  • a group of antibiotics such as: 80,000 units of gentamicin and 0.25 grams of chloramphenicol (but not limited to the above two, can also choose other suitable group of antibiotics), fully shaken and applied to the wound surface.
  • Example 2 Pharmaceutical composition preparation 4 Clinical examination of suture wound after skin cutting certificate
  • Formulation 4 in Table 1 is an important component of the pharmaceutical composition of the present invention and consists of glycerol, 1,2 propanediol, water-soluble azone, and water in a specific ratio. After the skin-cutting wound is sutured, the traditional treatment is covered with 75% alcohol gauze. The following is a clinical comparison of the treatment of the skin wound after suturing, using the pharmaceutical composition preparation 4 of the present invention and a conventional alcohol dressing.
  • a total of 50 sterile surgical cases were selected, aged from 20 to 60 years old, including 40 males and 10 females, divided into treatment group and control group.
  • the length of skin incision was more than 8 cm.
  • Treatment group After the skin incision is sutured and cleaned, the preparation 4 is applied to the sutured wound needle with a cotton ball, and after 1-2 minutes, the wound suture is covered with a sterile gauze, and the tape is fixed. On the second day, when the wound dressing was changed, the preparation 4 was applied again, and after the line was removed on the 7th-8th day, the preparation 4 was applied in time to close the needle.
  • Control group the skin incision was sutured and cleaned, and applied to the wound suture with 75% alcohol gauze, covered with sterile gauze, and fixed with tape. On the third day, the dressing at the wound was replaced. In a small number of cases, there was a sign of infection in the wound. The wound dressing was changed every day until the wound healed.
  • the therapeutic effect was evaluated according to the healing state of the wound and the inflammatory reaction of the suture needle.
  • the statistical effect of the pharmaceutical composition preparation 4 of the present invention for treating skin wound wound suture is superior to the traditional treatment method of covering suture wound with 75% alcohol gauze, because alcohol can sterilize, but it It is a volatile fungicide.
  • 75% alcohol gauze is applied to the suture wound. After a few hours, the alcohol is evaporated and the gauze is left on the wound. If the patient is not well cared for, the bacteria easily invade from the edge of the gauze to the wound of the wound, which in turn causes different degrees of wound infection.
  • the components of the pharmaceutical composition preparation 4 of the present invention are mainly glycerin and 1,2 propanediol, which are not volatile, and can quickly and completely close the wound needle after contact with the wound needle, and absorb a small amount of the wound needle.
  • the wounds formed by burns are the most serious, most complicated and most representative.
  • the inventors used burn wounds as a model to illustrate an example of treatment of a wounded skin wound by the inventive pharmaceutical composition.
  • the principle of treatment and treatment of burns should be early prevention and treatment of shock, early and short-term use of high-efficiency antibiotics, early scientific treatment of burn wounds, tight coverage of wounds, reduce wound exudation, is to reduce the body's physical energy consumption, keep the wound dry, And make the broad-spectrum antibacterial drug reach the deep part of the wound, resisting free radicals, resisting oxidation, and protecting the remaining epithelial germ cells from apoptosis. It is an important part of the treatment of burns to heal as soon as possible.
  • a pharmaceutical composition of the present invention for treating various wound wounds of the skin is designed in accordance with the above principles for the treatment of wounds.
  • the important component of the composition is also a matrix, which is mainly composed of concentrated glycerol and 1,2 propanediol. It has strong hygroscopicity and proper moisturizing property, and combines with the moisture in the wound surface and the amino acid higher than the plasma content.
  • the wound can be quickly closed, the bacteria falling into the wound after the application of the drug can not grow, the bacteria can not invade from the outside, and the proper content of azone or thiomethyl group in the ratio Sulfoxide can lead the antibacterial, antibacterial, nutrient, anti-oxidation and micro-circulation of the active ingredients in the formula to penetrate into the deep part of the wound, thereby improving the blood supply of the wound tissue and blocking the bacteria that enter the wound through the blood circulation.
  • the present inventors self-administered and used the pharmaceutical composition of the present invention to treat a large number of patients with multiple skin wounds, including general surgical dressings in outpatients and wards, treatment and treatment of emergency skin bruises, and burning.
  • skin wounds including general surgical dressings in outpatients and wards, treatment and treatment of emergency skin bruises, and burning.
  • Nearly a thousand cases of scald wounds, long-term bed rest, and other treatments have achieved significantly better results than traditional wound medicines, which not only promote wound healing, shorten wound treatment, reduce patient suffering, and save medical care.
  • the cost has also reduced the labor of medical staff.
  • the source of the components of the pharmaceutical composition of the present invention is a well-known conventional medicine described in the Chinese Pharmacopoeia, but the inventors in the practice according to the ratio of the pharmacological pharmacology of the combination of Chinese and Western medicine surgery, using a specific method to extract
  • the medicinal active ingredient which imparts a novel dosage form, enables the combination of traditional Chinese and Western medicine to treat the performance of various wounds on the skin.
  • III degree or equivalent III degree was 4 cases.
  • the skin of the wound has blisters or transparent dry phlegm, and the blister or underarm wound is red and white, and the pain is lighter.
  • the skin of the wound is translucent brown eschar, the pain of the wound disappears, or the whole skin is lost due to infection of the second degree burn wound.
  • the blister was cut off on the day after the injury, and the exudate was removed, and the pharmaceutical composition preparation 3 of the present invention was used to apply the blister on the blister skin; after 24 hours after the injury, the blister skin was removed and the burn wound was applied.
  • the pharmaceutical composition preparation 3 of the present invention was used to apply the blister on the blister skin; after 24 hours after the injury, the blister skin was removed and the burn wound was applied.
  • small area III degree burns after the granulation tissue grows to be level with the surrounding tissue, the granulation tissue is applied and exposed.
  • the developmental changes of the wound surface were observed after 3-5 days of application.
  • the observation of shallow second degree burn wounds for 8 days can be used to judge the healing tendency of wounds according to the combination of dryness and wound surface.
  • the application of deep second degree burn wounds for 20 days can judge the healing tendency of wounds according to the presence or absence of empyema under the armpits.
  • Second-degree burns or small-area III-degree burns that have been severely infected are continuously removed from the necrotic tissue, and the wound granulation tissue is flattened and applied repeatedly for 30 days. It can be judged according to the wound surface of the wound and the surrounding condition of the wound.
  • the healing trend of the wound A small number of cases in which the healing trend cannot be determined are judged by the final treatment outcome.
  • the application time is more than 5 days, and the healing time of the wound is prolonged.
  • the total effective rate is 98.3%
  • the pharmaceutical composition preparation 3 of the present invention is used.
  • the wound will form a transparent thin enamel within 4-6 hours. If there is more exudate in the wound, apply it once after 6 hours, and apply the drug up to three times on the first day.
  • the wound On the second day, if the wound is found to be clean, transparent and dry, just add a liquid to the transparent bowl. If it is found that there is necrotic tissue under the transparent sac, the transparent sputum can be moistened with a physiological saline cotton ball to remove the necrotic tissue and then the composition is applied.
  • the transparent sputum was clean, the wound was cleaned, and the wound was continuously exposed. Only the medicine was applied to the wound surface. If there is necrotic tissue under the armpit, continue to remove the re-application.
  • the burnt scald damages the entire layer of the skin and even damages the subcutaneous tissue, it is treated according to the principle of III degree burn treatment.
  • the granulation tissue grows to be level with the surrounding normal skin, if the wound surface is not large, no skin grafting is applied, and only the composition liquid is applied, the granulation tissue of the wound surface can be quickly transparent, and the edema of the wound is subsided, and the granule will gradually heal under the armpit. Since the wound surface heals quickly and the granulation tissue does not repeatedly proliferate, the scar of the granulation wound healing after the treatment of the composition liquid of the present invention is also relatively soft.
  • the blister skin was cut and the application was continued on the wound surface.
  • the wounds were all covered with transparent enamel, no oozing, no secretions.
  • the wound surface was dry, no infection, and the application of the drug was stopped.
  • the left face and left ear gradually became swollen, and the cotton swab touched it without pain.
  • the wound protection part began to fall off, indicating that the burn wound was healed in the first stage.
  • the skin on both sides of the ear is covered with a layer of cartilage, and the surface is not flat. After the burn, the medicine is not well wrapped, and it is easy to be infected. It is difficult to treat after infection.
  • the composition of the present invention is applied to the ear of the second degree burned scald, so that the wound wound on the ear can be completely covered by the medicine, and the protective sputum can be quickly formed without being wrapped, and the infection is effectively prevented and the healing is fast. If the face is burnt by a second degree burn, it may become a III degree burn, and it will form different degrees of scar after healing, resulting in damage.
  • the second-degree burn of the face and neck is as long as it is treated correctly with the liquid of the composition of the present invention in the early stage after the injury, and no infection occurs and no scar is formed.
  • the blister skin was cut and the liquid was applied to the blister skin and applied three times a day.
  • the blister skin was removed and the liquid was applied to the wound surface and applied three times a day.
  • the wound surface was covered with transparent protective sputum. Some of the red capillaries were visible under the armpit, and no necrotic tissue was found under the armpit. The drug was applied once on the sputum.
  • the wound surface was dry, and there was no secretion in the cotton swab. There was no obvious pain, the wound stopped using the medicine, and the nutrition was strengthened.
  • the topical dry cotton swab was used to lightly wipe the oil stain, and the composition liquid of the present invention was applied to the injured site on the first day, and was applied three times a day.
  • a layer of blister skin was removed as much as possible, and the composition liquid of the present invention was applied to the wound surface, and applied three times a day.
  • the third day most of the wounds were covered and protected by dryness. Only a small number of small blisters in the hairline and auricle did not eliminate the unabsorbed, and the composition liquid was continued after debridement.
  • the 5th day there was no fluid in the entire wound, and the swelling subsided.
  • the cotton swab composition was used to administer the wound to the child for 1 time.
  • the father of the child took the above composition liquid and cotton swab and applied it, and applied it twice a day to expose the wound.
  • the granulation tissue of the original edema contracted, and the surrounding tissue was flat.
  • the wound surface was covered with a layer of dry sputum, and there was no liquefied material under the armpit. Wound area.
  • the wound was covered by cognac and the wound was further improved. After 2 weeks, the suede on the wound surface gradually fell off, and the soft wound was healed under the armpit.
  • necrotic tissue There are many yellow-green purulent necrotic tissue on the wound surface, which is not easy to be wiped off.
  • the diagnosis is II degree burn and infection.
  • Treatment After the wound necrotic tissue is eliminated as much as possible, the pharmaceutical composition of the present invention containing gentamicin or chloramphenicol is applied to the wound surface. Apply once every 6 hours on the first day, 2 times on the 2nd day, 2 times on the 3rd day, and return to the 4th day. The patient told the wound that the local pain was significantly relieved. The wound was mostly dry and there was still a small amount of sputum.
  • the skin wound after suturing of the surgical incision, after cleaning the dry wound, the composition liquid of the composition of the present invention is applied. Skin wounds with bruises are exposed after application, generally without dressing. If a thin layer of sterile gauze is used, it is only to separate the wound from the clothing.
  • the wound of the composition of the present invention can be prevented from invading the wound by external bacteria.
  • Treatment Continue to observe whether the internal organs and bones are injured, inject tetanus antitoxin, and after cleaning the skin wound, apply the composition liquid of the present invention on the wound surface. Apply 3 times on the first day. On the second day, the wounds were all scarred, the pain was relieved, and the sputum was applied twice. On the third day, the pain at the wound site was significantly relieved, the wound was dry, and the light touch was not painful. The application of the drug was stopped, and after 10 days of rest, the wounds all healed.
  • a saline cotton ball For skin infectious diseases, such as impetigo, yellow water sores, lower extremity ulcers, and granulation tissue wounds after smashing, use a saline cotton ball to wash and dry the sore or granulation tissue wounds, and apply the combination of the present invention.
  • the drug solution, the wound infection of the wound can be quickly controlled and healed.
  • the medicine was taken home. Apply 3 times on the first day. Apply 2 times on the 2nd day. On the third day of follow-up, the head and face pustulosis wounds were all scarred, no yellow water re-flow, the infection was controlled, and after the two drugs were continued, the drug could be stopped. After another 3 days of follow-up, the wound surface of the sore wound was well covered, and there was no inflammatory swelling around the basement, and the exploration was not painful. The sore wound gradually healed completely.

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Abstract

一种治疗皮肤多种损伤创面的液态外用药物组合物，该组合物包括丙三醇、1,2丙二醇、水溶性月桂氮酮或癸基甲基亚砜、以及水，还可以包括黄芪、当归、丹参、赤芍中的至少一种和黄连、黄芩等中药，可用于治疗烧伤、皮肤擦挫伤、割裂伤、感染性皮肤疮疡创面的暴露治疗。

Description

皮肤多种损伤创面治疗的外用药物组合物及其制备方法
相关申请的交叉引用
本发明要求2016年5月30日提交的中国专利申请号201610369784.4的优先权，其全部内容通过引用并入本文。
技术领域
本发明涉及一种用于人类皮肤多种损伤创面治疗的液态外用药物组合物。本发明属于中西医结合外科领域。
背景技术
人类皮肤各种损伤创面的修复愈合，是复杂的病理生理过程，轻微细小的损伤创面，经历伤后创面出血或渗出、干燥结痂、痂下愈合。大多数比较大或特殊皮损(如烧伤)创面，在损伤后创面要经历渗出、感染、坏死组织清除、感染得到控制、创面渗出减少、结痂或创面被生物材料覆盖、创面逐渐瘢痕愈合。
在皮肤损伤创面复杂的愈合过程中，除全身性治疗用药外，创面处理的一个重要环节就是创面用药的选择。目前，用于皮肤损伤创面治疗的药物制剂繁多，大致可分为水粉剂、油膏剂、消毒剂、成膜剂。本领域的技术人员都能体会到，在临床皮肤损伤创面的治疗中，以上这几类创面用药虽然都有疗效，但也都存在某些局限性。
如上所述，在治疗皮肤损伤创面目前可选用的药物制剂中，如用水粉剂，要用大量的敷料包扎创面，药剂中的水分干燥后，敷料往往与创面发生粘连，在更换敷料时，会撕伤创面的新生组织导致出血，病人疼痛难忍，且更换敷料时间长，医务人员工作量大。如用油膏剂，油膏与创面渗液不相溶，在创面渗液较多的情况下，油膏易流淌，也会造成敷料与创面粘连的现象，给更换敷料造成困难。成膜喷雾剂，虽较好地封闭创面，但没有很好地解决吸纳创面渗液，容易产生膜下积脓。
中医认为，“河流萌护草木，气血萌护肌肤”。就像草木离不开水土一样，肌肤损伤创面的修复要有人体气血的充足供养。中药黄芪、当归、丹参、赤芍益气活血，消肿止痛，气血行则肌肤生。
黄连、黄芩、黄柏、栀子系古代名方黄连解毒汤，出自东晋葛洪《肘后备急方》和唐代王焘《外台秘要方》，后世医家用于治疗各种疮疡火毒内服。近现代医籍杂志中屡见将黄连、黄芩、黄柏用麻油煎或调后涂治烧烫伤创面。诸痛痒疮皆属于心，黄芩泻上焦肺火，黄连泻上中焦心胃之火，黄柏泻下焦相火，《药品化义》中说，黄柏能降火自顶至踵，从皮肤到骨髓，无不周到，栀子通降三焦之火。这样周身之火毒能够降本流末，就不会再往外爆疮了。现代研究发现本方有抗炎抑菌作用，有降解内毒素调节免疫功能的作用，有保护脑、肝、肾、肠粘膜血管及抗细胞凋亡的作用，有抗凝血、抗血栓形成的作用。
白蔹清热解毒，四季青既清热解毒，又收湿敛疮，还凉血止血，白芨收湿敛疮，甘草调和诸药，解毒抗炎，与黄芪、当归、丹参、赤芍一起，对创面组织活细胞有营养作用。
乳香偏于行气通窍，没药偏于理血化瘀，乳香、没药辛香发散，乃驱逐气滞血瘀之要药。大疮都可以靠气通血活消除肿胀，促进局部损伤的修复。乳香、没药的消肿生肌的作用是一般药物难以取代的。
血竭除血痛，乃和血之圣药，专攻血分、力专效宏，而乳香、没药虽主血病、兼入气分。血竭为散瘀血、生新血之要药，主破积血、疗金疮、止疼痛，单用也能立竿见影，与乳香、没药联用，属强强联合、活血逐瘀之功更大。血止不留瘀、活血能止痛，所以这三味药为血家三剑客，哪里有瘀血阻滞，它们剑锋所指，无不血活痛止。儿茶除抗菌收敛的作用外，尚有去痂作用。
传统中医文献记载的疮疡科治疗用的药材有几十种，上述十六种中药材只是散在地出现在各种处方中。只用作制备汤、散(粉)、膏剂的组分。这几种剂型治疗烧伤创面的局限性已如前所述。
事实上，理想的创面用药应该具有镇痛、快速地封闭创面、吸收创面渗液、减少渗出、利于引流、能保护创面、促进创面上皮细胞生长、抗菌谱广且作用强、不产生或少产生耐药菌株、无毒性、副作用少、创面愈合后瘢痕少等特点。因此本发明所要解决的课题即寻找一种使用方便、高效的治疗皮肤多种损伤创面的液态外用药物组合物，其中使用重要原料药加之中西结合思路，以不同既往的构思，用特定的方法制备该药物组合物，尽量满足理想的创面用药应具备的条件。
发明内容
本申请书首先强调本发明药物组合物的重要组分是由丙三醇，1,2丙二醇，水溶性月桂氮酮或癸基甲基亚砜和水按特定配比组成。该重要组分在治疗皮肤多种皮肤损伤创面时，单独使用能快速封闭创面，吸收创面渗液，形成透明薄痂，抵御外部细菌的侵入，而与精选的药物组方精妙地结合，就能呈现许多理想的治疗效果！这个重要的组分及其特定的配比，是本发明的最大特征。
人体是一个外周全部被皮肤覆盖的有机体，通过血液循环和体液的交换，使构成机体的最小单位即每个活细胞在完全封闭的相对恒定的环境下与外界进行物质交换，实现新陈代谢，维持生命的运转。皮肤因多种原因造成损伤，就会造成被皮肤保护的损伤部位的组织细胞外露，损伤的局部出现“灾难”，机体就会动员有限的力量到达伤部“抢险救灾”，由此伤部出现一系列病理生理演变，机体能动员的防御力量有限，创面较大，不得不依靠外援——药物。作为医生，面对皮肤多种损伤创面，首先使创面快速地恢复完全封闭状态，与周围空气隔绝，进而逆转创面的病理变化，如止血、止渗、消肿、灭菌，促进创面生理修复，皮肤多种损伤创面才能顺利地度过“灾难”，而恢复常态。这里提出“对皮肤 多种损伤创面治疗第一要务是快速完全地封闭创面”，这一论述在现有文献中均未见强调，而本发明人正是对这一论述进行透彻的观察与思考，才认真反复实践，找到并选用丙三醇，1,2丙二醇，水溶性月桂氮酮和少量水按特定配比作为本发明药物组合物的基础药阵，配合精选的中药材组成药物组合物，淋漓尽致地挖掘发挥构成基础药阵四种物质的功能，达成本发明。皮肤多种损伤创面，不能再涂敷有明显刺激的药物而造成创面组织细胞再损伤。本发明选用的这个基础药阵不但能满足上述要求，而且还能提取中药材的药用有效成分，达到吸水湿、止渗液、促渗透、结薄痂、活气血、通脉络、供营养、促新生。这些都是创面尽快愈合，减少瘢痕的有利举措。
本发明公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述药物组合物的重要组分包括丙三醇、1,2丙二醇、水溶性月桂氮酮或癸基甲基亚砜、以及水按特定配比组成，其中所述丙三醇占组合物的含量为80-90体积％。
在一些实例中，所述1,2丙二醇占组合物的含量为6-15体积％；所述水溶性月桂氮酮占组合物的含量为0.2-2体积％，优选含量为0.6-1体积％，更优选含量为0.2-0.5体积％；所述癸基甲基亚砜占组合物的含量为1-4体积％，优选含量为1-3体积％，更优选含量为1-1.5体积％；所述水占组合物的含量为3-8体积％，优选含量为3-5体积％，更优选3-4体积％。
本发明的一个实施例公开了一种治疗皮肤多种损伤创面的药物组合物及其重要组分，其中，所述药物组合物的重要组分由占组合物终体积比为80-90体积％的丙三醇，6-15体积％的1,2丙二醇，0.2-2体积％的水溶性月桂氮酮或1-4体积％的癸基甲基亚砜，3-8体积％的水构成。
本发明的一个具体实施例公开了一种治疗皮肤多种损伤创面的药物组合物的重要组分，单独治疗无菌创口创面，其中所述药物组合物的 重要组分由占组合物终体积比为83.5体积％的丙三醇、10体积％的1,2丙二醇、0.5体积％的水溶性月桂氮酮、6体积％的水构成。
在一些具体的实例中，本发明所述的皮肤多种损伤创面治疗用的药物组合物的重要组分丙三醇优选是由医用分析纯丙三醇(Glycerol，甘油，密度1.236g/ml，500ml重628g，分子式C3H8O3，分子量92.09，纯度≥99％)、1,2丙二醇(1,2-Propanediol，分子式C3H8O2，分子量76.09，纯度≥99％)、水溶性月桂氮酮和水按特定配比组成，按终体积百分含量计算，其中丙三醇占80％-90％、1,2丙二醇占6-15％，这是充分利用这两个成分具有的液体形态和吸湿保湿的特性，吸收创面的渗液，同时又不致创面过于干燥。
本发明所述的用于皮肤多种损伤创面治疗的组合物中含有月桂氮酮(Laurocapram，分子式C18H35NO，分子量281.48，分析纯>98％，相对密度(20℃)0.906-0.926，酸碱度中性)，其中，本品系油溶性氮酮改性成为水溶性氮酮，为癸基甲基亚砜同吡咯酮的复合体，无色透明粘稠液体。对亲水性药物活性成分有明显的透皮助渗作用，使皮肤角质层与脂质相互作用，降低了有效物质向角质层间隙中脂质相转移的温度，增加了流动性，使药物或活性添加剂在角质层中的扩散阻力减小，起到很强的促渗作用。
水溶性月桂氮酮能有效地增加组合物中所含药物的渗透吸收效果，从而达到不仅抑制杀灭创面表层而且能抑制杀灭创面深层的致病细菌，充分地发挥药物的疗效、减少药物的用量。在一些实施例中，所述水溶性月桂氮酮的优选含量为2-20mL/L，6-10mL/L更优，2-5mL/L最优。在一些具体实施例中，所述水溶性月桂氮酮优选为医药级的水溶性月桂氮酮。
在一些实施例中，因功效相似，也可用癸基甲基亚砜替换月桂氮酮，所述癸基甲基亚砜优选含量为10-40mL/L，10-30mL/L更优，10-15 mL/L最优。在一些具体实施例中，所述癸基甲基亚砜优选为医药级的癸基甲基亚砜。
本发明所述的用于皮肤多种损伤创面处置治疗的药物组合物的重要组分中，水是天然的良好溶剂，含有水的作用是：一定比例的丙二醇和水的混合液能延缓某些药物的水解，增加其稳定性，从而延长组合物的有效期。此外，由于高浓度的丙三醇吸湿性很强，加入少量的水，能平衡一下其很强的吸湿性。丙三醇合水，在高温高压条件下能增强中药材的药用有效成分的溶解性。水的优选含量为30-80mL/L，更优选含量为30-50mL/L，最优选含量为30-40mL/L。
在具体使用中，本申请人发现，这种特定配比构成的药物组合物的重要组分与精选的配方中药材的药用有效成分组成的药物组合物涂在创面能很快地封闭创面并使创面结一层透明的痂，能有效地预防和治疗创面感染，消除创面水肿，使创面停止渗出，减轻患者的体质消耗，能抗自由基、能保护创面、能营养创面的生发细胞生发修复创面，使创面在痂下较快地愈合，一般如II度烧伤创面都很少留下瘢痕。
本发明药物组合物中，含有中药原料药：
本发明所述药物组合物还包括黄芪、当归、丹参、赤芍中的至少一种，所述黄芪、当归、丹参、赤芍中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
黄芪
黄芪含有多种化学有效成分，主要包括皂苷类、黄酮类、多糖类、氨基酸及微量元素等，具有补气升阳、生津养血、托毒排脓、敛疮生肌的功效。黄芪在组合物中的优选含量为10-30g/L，更优选含量为10-20g/L，最优选含量为10-15g/L。
当归
当归含有挥发油、当归内酯、阿魏酸、烟酸、琥珀酸、β-谷甾醇、胡萝卜苷、单糖、多糖、磷脂、多种氨基酸及无机元素等，具有补血活血、调经止痛、脱毒消肿、补虚化瘀、滋阴养血、润泽皮毛的作用。当归的优选含量为5-20g/L，更优选含量为5-10g/L，最优选含量为6-8g/L。
丹参
丹参含有丹参酮、丹参酚、黄芩苷等有效成分，具有抗氧化、抗菌、活血通经、祛瘀、凉血消痛、排脓止痛、长肉生肌、促进创面愈合的作用。丹参的优选含量为5-20g/L，更优选含量为5-15g/L，最优选含量为8-10g/L。
赤芍
赤芍含芍药苷、芍药碱、芍药醇、儿茶精、没食子酸乙酯、挥发油等，有抗心肌缺血、改善血液微循环、抑制血小板聚集抗血栓形成，并有镇痛解痉、护肝、抗炎抗菌作用，对金黄色葡萄球菌及铜绿假单胞菌、真菌、疱疹病毒、肠道病毒均有抑制作用。赤芍的优选含量为5-20g/L，更优选含量为5-15g/L，最优选含量为8-10g/L。
本发明中所述的药物组合物还可以包括黄连、黄芩、黄柏、栀子中的至少一种，所述黄连、黄芩、黄柏、栀子中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
黄连
黄连含有多种异喹啉生物碱、小檗碱。能清除内毒素、抗金黄色葡萄球菌、大肠杆菌、具有清热燥湿、泻火解毒的作用。对于烧伤、黄连煎剂外用，不仅能抗感染，还能减少渗出、促进结痂。黄连的优选含量为5-20g/L，更优选含量为5-10g/L，最优选含量为6-8g/L。
黄芩
黄芩主要含黄酮类化合物，如黄芩素、汉黄芩素、汉黄芩苷、并含有挥发油、氨基酸的糖类。黄芩抑菌能力强，对金黄色葡萄球菌、溶血性链球菌、大肠杆菌、铜绿假单胞菌有明显的抑制作用，还具有抗炎、抗氧化作用。黄芩的优选含量为5-20g/L，更优选含量为5-10g/L，最优选含量为6-8g/L。
黄柏
黄柏主要含小檗碱、黄柏碱、黄柏酮，黄柏内酯。中医说热毒疮黄柏良，对金黄色葡萄球菌、溶血性链球菌、大肠杆菌、铜绿假单胞菌霉菌有明显的抑制作用。黄柏的优选含量为5-20g/L，更优选含量为5-10g/L，最优选含量为6-8g/L。
栀子
栀子主要含环烯醚萜类栀子苷、藏红花素、芦丁等黄酮类，能泻火除烦、清热利湿、凉血解毒，外用消肿止痛，对金黄色葡萄球菌、溶血性链球菌有较强的抑菌作用。栀子的优选含量为5-20g/L，更优选含量为5-10g/L，最优选含量为6-8g/L。
本发明中所述的药物组合物还包括白蔹、四季青、白芨、甘草中的至少一种，所述白芨、白蔹、四季青、甘草中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
白蔹
白蔹主要成分有没食子酸、酒石酸、谷甾醇、大黄酚、粘液质，具有清热解毒、消肿生肌的作用。本品苦寒清泄、辛散消肿、敛疮生肌止痛，对金黄色葡萄球菌、铜绿假单胞菌、大肠杆菌有明显的抑制作用。白蔹民间俗称“见肿消”，单味药应用就有很强的抗感染作用。白蔹的优选含量为5-20g/L，更优选含量为6-15g/L，最优选含量为8-10g/L。
四季青
四季青主要成分原儿茶酸、原儿茶醛、缩合型鞣酸、黄酮类及挥发油。具有清热解毒、凉血止血、敛疮作用。四季青具有抗菌抗炎、增加冠状动脉血流量、抗心肌缺血、对烧伤创面有形成保护性痂膜、能预防感染、阻止渗出的功能，有吸附能力，有一定的通透性，具有不增加创面深度等优点。四季青的优选含量为5-20g/L，更优选含量为5-15g/L，最优选含量为8-10g/L。
白芨
白芨主要成分是联苄类、菲类及其衍生物、少量挥发油粘液质。具有收敛止血、消肿生肌的作用。用于治疗皮肤皲裂、水火烫伤，能吸收创面渗出物、保护创面，促进创口愈合。白芨的优选含量为5-20g/L，更优选含量为6-15g/L，最优选含量为8-10g/L。
甘草
甘草含有100多种黄酮类化合物、60多类三萜类化合物、18种氨基酸及多种生物碱等。具有肾上腺糖皮质激素样作用，具有抗炎、抗氧化、调节免疫及解毒作用，还具有抗病毒及抗菌、补脾益气、清热解毒、缓急止痛、调和诸药的功效。甘草的优选含量为5-15g/L，更优选含量为6-12g/L，最优选含量为8-10g/L。
本发明中所述的药物组合物还包括乳香、没药、血竭、儿茶中的至少一种，所述乳香、没药、血竭、儿茶中的至少一种药材的药用有效成分是用1,2丙二醇以浸泡法提取。
乳香
乳香主含树脂、树胶及挥发油。能镇痛消炎，具有活血行气止痛、消肿生肌的功效，是治疗疮疡痈疽疔毒的重要药物。乳香的优选含量为3-10g/L，更优选含量为5-8g/L，最优选含量为5-6g/L。
没药
没药主含挥发油、树脂、树胶。水浸剂对真菌有抑制作用，常与乳香配对，发挥活血止痛、消肿生肌、加强祛瘀的作用。中医认为瘀血不去、新血不生。没药的优选含量为3-10g/L，更优选含量为5-8g/L，最优选含量为5-6g/L。
血竭
血竭含有血竭素、血竭红素、树脂酸等。能止血活血、抗炎镇痛，具有活血化瘀、敛疮生肌的功效。血竭的优选含量为3-10g/L，更优选含量为5-8g/L，最优选含量为4-5g/L。
儿茶
儿茶含有儿茶酚，能抗氧化、抗菌(抑制革兰氏阳性菌和阴性菌、抑制金葡菌、肠球菌、大肠杆菌、抗流感病毒)，具有活血疗伤、止血生肌、收湿敛疮的作用。儿茶的优选含量为3-10g/L，更优选含量为5-8g/L，最优选含量为4-5g/L。
本发明所述的药物组合物，其中，所述药物组合物还可以包括混溶入抗菌素。
本发明所述抗菌素包括庆大霉素、氯霉素。
本发明组合物除上述配方成分之外，对有些创面感染严重的病例，可根据创面感染的病原学诊断，在药敏试验的指导下，临时往每100ml组合物中加入一组抗菌素，如：8万单位庆大霉素和0.25克氯霉素(但不限于上述两种，也可选择其它适合的一组抗菌素)，充分摇匀后涂用在创面上。
本发明的一个实施例公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述药物组合物是基本由下述终质量体积比的原料药黄芪10-30g/L、当归5-20g/L、丹参5-20g/L、赤芍5-20g/L、黄连5-20g/L、 黄芩5-20g/L、黄柏5-20g/L、栀子5-20g/L、白蔹5-20g/L、四季青5-20g/L、白芨5-20g/L、甘草5-15g/L、乳香3-10g/L、没药3-10g/L、血竭3-10g/L、儿茶3-10g/L和终体积百分含量的丙三醇80-90％、1,2丙二醇6-15％、水溶性月桂氮酮0.2-2％或癸基甲基亚砜1-4％、水3-8％制成。
本发明的一个实施例公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述原料药的终质量体积比为黄芪10-20g/L、当归5-10g/L、丹参5-15g/L、赤芍5-15g/L、黄连5-10g/L、黄芩5-10g/L、黄柏5-10g/L、栀子5-10g/L、白蔹6-15g/L、四季青5-15g/L、白芨6-15g/L、甘草6-12g/L、乳香5-8g/L、没药5-8g/L、血竭5-8g/L、儿茶5-8g/L和终体积百分含量的丙三醇80-90％、1,2丙二醇6-15％、水溶性月桂氮酮0.6-1％或癸基甲基亚砜1-3％、水3-5％。
本发明的一个实施例公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述原料药的终质量体积比为黄芪10-15g/L、当归6-8g/L、丹参8-10g/L、赤芍8-10g/L、黄连6-8g/L、黄芩6-8g/L、黄柏8-10g/L、栀子6-8g/L、白蔹8-10g/L、四季青8-10g/L、白芨8-10g/L、甘草8-10g/L、乳香5-6g/L、没药5-6g/L、血竭4-5g/L、儿茶4-5g/L和终体积百分含量的丙三醇80-90％、1,2丙二醇6-15％、水溶性月桂氮酮0.2-0.5％或癸基甲基亚砜1-1.5％、水3-4％。
本发明的具体实施例公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述原料药的终质量体积比为黄芪20g/L、当归15g/L、丹参15g/L、赤芍15g/L、黄连10g/L、黄芩10g/L、黄柏10g/L、栀子10g/L、白蔹15g/L、四季青15g/L、白芨15g/L、甘草12g/L、乳香8g/L、没药8g/L、血竭6g/L、儿茶6g/L和终体积百分含量的丙三醇80％、1,2丙二醇14％、水溶性月桂氮酮1％、水5％。
本发明的具体实施例公开了一种治疗皮肤多种损伤创面的药物组 合物，其中，所述原料药的终质量体积比为丹参20g/L、黄柏20g/L、四季青20g/L、白芨15g/L、甘草15g/L、儿茶8g/L和终体积百分含量的丙三醇88.4％、1,2丙二醇8％、水溶性月桂氮酮0.6％、水3％。
本发明的具体实施例公开了一种治疗皮肤多种损伤创面的药物组合物，其中，所述原料药的终质量体积比为黄芪10g/L、当归8g/L、丹参8g/L、赤芍8g/L、黄连6g/L、黄芩6g/L、黄柏6g/L、栀子6g/L、白蔹10g/L、四季青10g/L、白芨10g/L、甘草8g/L、乳香5g/L、没药5g/L、血竭4g/L、儿茶4g/L和终体积百分含量的丙三醇84.7％、1,2丙二醇12％、水溶性月桂氮酮0.3％、水4％。
本发明的另一方面公开了所述的药物组合物的制备方法，其中，所述制备方法的包括以下方法：精选称取适量黄芪、当归、丹参、赤芍、黄连、黄芩、黄柏、栀子、白蔹、四季青、白芨、甘草中至少三种，投入对应量丙三醇混合对应量的蒸馏水中，在水蒸汽0.02MPa气压和105℃温度的环境下，隔层加热含原料药的丙三醇10分钟，冷却后滤去药渣，损耗的丙三醇合水补足量；精选称取乳香、没药、血竭、儿茶的至少一种，投入到对应量的1,2丙二醇中，浸泡24小时后，滤去药渣，损耗的1,2丙二醇补足量；将含有原料药有效成分的丙三醇、含有原料药有效成分的1,2丙二醇与对应量的水溶性月桂氮酮或癸基甲基亚砜混合，充分搅匀，灌装灭菌。
在本发明的一个具体实施例中，所述制备方法包括以下方法：精选称取适量黄芪、当归、丹参、赤芍中至少一种；黄连、黄芩、黄柏、栀子中至少一种；白蔹、四季青、白芨、甘草中至少一种，共至少三种，投入对应量丙三醇混合对应量的蒸馏水中，在水蒸汽0.02MPa气压和105℃温度的环境下，隔层加热含原料药的丙三醇合水10分钟，冷却后滤去药渣，损耗的丙三醇合水补足量；精选称取适量乳香、没药、血竭、儿茶中的至少一种，投入到对应量的1,2丙二醇中，浸泡24小时后，滤去药渣，损耗的1,2丙二醇补足量；将含有原料药有效成分的丙三醇 合水、含有原料药有效成分的1,2丙二醇与对应量的水溶性月桂氮酮或癸基甲基亚砜混合，充分搅匀，灌装灭菌。
本发明组合物中所含的中药材药用有效成分是以丙三醇或1,2丙二醇作为溶媒提取的。在常温下，中药材的药用有效成分在丙三醇中的溶解度低，且析出慢。本申请人发现，在丙三醇中加入少量的水，用适当的压力、温度，经过一定的时间，丙三醇对中药材的药用有效成分溶解度良好。丙三醇的沸点290℃。在实际操作中，用高压水蒸汽把丙三醇合水隔层加热至105℃，时间维持10分钟。选定这样的温度和时间，是为了既保持丙三醇的化学稳定性，又能理想地溶出所投入的中药材药用有效成分。
1,2丙二醇在组合物的共同组分中含量比例较低，但其使用量作为浸泡溶解提取组合物中的乳香、没药、血竭、儿茶的药用有效成分的溶媒是够用的。
本发明遵循中医外科学清热解毒、活血消肿、祛腐生肌、收湿敛疮的治则，以清通相辅，以通为补，补泻平衡，通补兼施的思想，将黄芪、当归、丹参、赤芍；黄连、黄芩、黄柏、栀子；白蔹、四季青、白芨、甘草；乳香、没药、血竭、儿茶，组成了一个新的药材品种多、剂量轻的由四个药阵构成的大处方，加入一个既吸湿、保湿、成膜，又作溶媒的基础药阵。五阵协力，理法周全，方药精当，创制了一个新的制剂，本发明人在临床实践中屡用屡效。
在处方结构方面，宏观上，第一药阵黄芪、当归、丹参、赤芍，补气补血，托里排毒，属君；第二药阵黄连、黄芩、黄柏、栀子，清毒泻火，属臣；第三药阵白蔹、四季青、白芨、甘草，收湿敛疮消肿，属佐；第四药阵乳香、没药、血竭、儿茶，行气活血通络，祛腐生肌，属使。微观上，四个药阵为四个小处方，每方四味中药，依其功能性状，按上述顺序，分别构成对应的君、臣、佐、使。
本发明还公开了所述的药物组合物的在制备用于治疗皮肤多种损伤创面的外用药物中的用途。
在一些实施例中，所述皮肤多种损伤创面不包括：因结核菌感染或恶性肿瘤引起的皮肤溃疡、因雄雌激素分泌失衡而发生的痤疮。
在一些具体实施例中，本发明所述皮肤多种损伤创面包括烧伤创面、烫伤创面、皮肤擦挫伤创面、切割后的缝合创口、褥疮创面、皮肤感染创面、以及肉芽组织创面。
发明的有益效果
本发明的有益效果在于公开了一种用于人类皮肤多种损伤创面治疗的液态外用药物组合物。使用这种含有中药原药料药用有效成分的药物组合物，能快速有效地封闭创面，消除创面水肿，减少、停止创面的渗出，药物组合物与创面已有的渗出液结合形成透明薄痂，能保护创面基底及周围有生命力的细胞免受进一步的损伤，预防和控制创面感染，促进创面痂下愈合，最大限度地减少瘢痕的形成。该药物组合物有用于治疗皮肤多种损伤创面的外用药物的用途。
附图说明
图1示出的是本发明药物组合物制剂3制成品实样图。
具体实施方式
下面通过具体实施方式及实施例数据对本发明作进一步的说明。尽管为了清楚的目的，在下文中使用了专用术语，但这些术语并不意味着定义或限制本发明的范围。
如本文中所使用，术语“医用”指代纯度大于95％的试剂，在本发明中实施例中使用的“医用丙三醇”为分析纯级别的医用甘油，密度 1.236g/mL，500mL重628g，分子式C3H8O3，分子量92.09，纯度≥99％；“医用1,2丙二醇”的纯度≥99％。
如本文中所使用，术语“医药级”指代化学品的纯度能够被用于人类药物。本发明中水溶性月桂氮酮是医药级的。
如本文中所使用，术语“治疗”是指逆转、减轻或抑制该术语所应用的疾病的进展，或疾病的一种或多种症状。如本文所使用的，根据患者的状况，该术语也包括预防疾病，包括预防疾病或与其相关的任何症状的发生，以及减轻病症或其在发生前的任何病状的严重性。
如本文中所使用，术语“丙三醇合水”是指按照特定配比将丙三醇和水进行混合得到的溶剂。在本发明实施例使用的“丙三醇合水”中丙三醇的体积为80-90份，水的体积为3-8份。本发明具体实施例使用的“丙三醇合水”中丙三醇和水的体积比优选为800:50或884:30或847:40或835:60。
以下通过具体实施例对本发明做进一步的详细描述，本领域技术人员根据本发明做出各种改变，均应属于本发明所附权利要求的范围。下述实施例中的实施方法，如无特殊说明，均为常规方法。
具体实施例：
实施例1 药物组合物的制备
本发明组合物制剂1-3按表1配比量及下述工艺流程调制。
调制工艺流程如下：
1)精选中药材黄芪、当归、丹参、赤芍、黄连、黄芩、黄柏、栀子、白蔹、四季青、白芨、甘草，按表1中制剂的组成分量称取，投入表1中相同制剂对应量丙三醇混合对应量的蒸馏水(丙三醇合水)中，用水蒸汽0.02MPa气压，约105℃，隔层加热含中药材的丙三醇10分钟，冷却后滤去药渣，损耗的丙三醇合水补足量。
2)精选中药材乳香、没药、血竭、儿茶，按表1中制剂对应量称取，投入到表1中相同制剂对应量的1,2丙二醇中，浸泡24小时后溶解出药用有效成分，滤去药渣，损耗的1,2丙二醇补足量。
3)将含有中药汁的丙三醇合水、1,2丙二醇，加表1中相同制剂对应量的蒸馏水和水溶性月桂氮酮混合，充分搅匀，灌装灭菌即成。
制剂4的制备工艺仿照以上步骤，但没有称取中药材。
表1：组合物制成品量以1000mL计算
成分 制剂1 制剂2 制剂3 制剂4
丙三醇 800mL 884mL 847mL 835mL
1,2丙二醇 140mL 80mL 120mL 100mL
水溶性月桂氮酮 10mL 6mL 3mL 5mL
蒸馏水 50mL 30mL 40mL 60mL
黄芪 20g - 10g -
当归 15g - 8g -
丹参 15g 20g 8g -
赤芍 15g - 8g -
黄连 10g - 6g -
黄芩 10g - 6g -
黄柏 10g 20g 6g -
栀子 10g - 6g -
白蔹 15g - 10g -
四季青 15g 20g 10g -
白芨 15g 15g 10g -
甘草 12g 15g 8g -
乳香 8g - 5g -
没药 8g - 5g -
血竭 6g - 4g -
儿茶 6g 8g 4g -
本发明组合物除上述配方成分之外，对有些创面感染严重的病例，可根据创面感染的病原学诊断，在药敏试验的指导下，临时往每100mL组合物中加入一组抗菌素，如：8万单位庆大霉素和0.25克氯霉素(但不限于上述两种，也可选择其它适合的一组抗菌素)，充分摇匀后涂用在创面上。
实施例2 药物组合物制剂4治疗皮肤切割后缝合创口的临床验 证
表1中制剂4是本发明药物组合物的重要组成部分，由丙三醇、1,2丙二醇、水溶性月桂氮酮和水按特定配比组成。皮肤切割创口缝合后，传统的治疗法是用75％酒精纱布覆盖。下面是治疗皮肤切割后缝合创口，用本发明药物组合物制剂4与用传统酒精敷料的临床对比观察。
1)一般资料：
选择无菌手术病例共50人，年龄在20岁-60岁，其中，男性40人，女性10人，平均分成治疗组和对照组，皮肤切口长度均在8公分以上。
2)治疗方法：
a.治疗组：皮肤切口缝合清理消毒完毕后，用棉球将制剂4涂在缝合的创口针口上，1-2分钟后用消毒纱布覆盖创口缝合处，胶布固定。第2天更换创口敷料时，再涂制剂4一次，第7-8天拆线后及时涂制剂4封闭针口。
b.对照组：皮肤切口缝合清理消毒完毕，用75％酒精纱布敷在创口缝合处，再用消毒纱布覆盖，胶布固定。第3天更换创口处的敷料，有少量病例出现创口有感染的迹象，往后每天更换创口敷料，直至创口愈合。
3)疗效评定标准
在创口缝合3天始至7天后拆除缝线时，根据创口的愈合状态及缝合针口的炎性反应评定疗效。
a.愈合良好：3天后创口针口均有痂，无或很少渗出物，创口处的敷料污渍少，术后7天后，创口I期愈合，针口炎性反应小。
b.愈合较好：3天后，创口针口出现少量的渗出液，创口处的敷料有明显的污渍，涂碘酒，连续3天更换创口处的敷料，渗出物渐少，创口针口渐结痂，一般术后8-9天拆线，创口基本I期愈合，针口充血红润。
c.愈合不良：术后3天更换缝合处的敷料，创口有分泌物，敷料有些潮湿，针口发红，须间隔拆去缝线，以利创口分泌物引流，天天更换敷料，创口愈合期延长。
4)治疗结果(见表2)
表2 本发明药物组合物制剂4与传统的75％酒精纱布治疗皮肤切割缝合后无菌创口治疗的临床对比观察结果统计
Figure PCTCN2017085443-appb-000001
5)讨论
从表2临床对比观察结果统计说明，本发明药物组合物制剂4治疗皮肤切割创口缝合的疗效优于传统的以75％酒精纱布覆盖缝合创口的治疗方法，这是因为酒精虽能杀菌，但它是易挥发的杀菌剂，75％酒精纱布敷在缝合创口上，几个小时后，酒精挥发完，创面就只剩下纱布了。如果病人护理不周，细菌容易从纱布的边缘侵入到创口针口，进而引发不同程度的创口感染。而本发明药物组合物制剂4中的组分主要是丙三醇和1,2丙二醇，是不易挥发的，其与创口针口接触后，能快速完全地封闭创口针口，吸收创口针口少量的渗液，与渗液中的蛋白质结合形成一层透明的薄痂，严密地保护创面免受外来细菌的侵袭，因而能使创口针口清洁干燥，达到良好的愈合。
实施例3 药物组合物治疗烧伤病人创面的临床观察
从皮肤多种损伤创面的病理生理愈合机制来看，烧伤所形成的皮肤损伤创面最严重、最复杂、最有代表性。本发明人以烧伤创面为模型说明所发明的药物组合物对皮肤损伤创面的治疗实例。
处置和治疗烧伤的原则应是早期预防和治疗休克，早期短程足量应用高效抗生素，早期科学地处置烧伤创面，使创面得到严密覆盖，减少创面渗出，就是减少病人体能消耗，保持创面干燥，并使广谱抗菌药达到创面深部，抗自由基、抗氧化、保护残存的上皮生发细胞不凋亡，促 进创面尽早愈合，是对烧伤治疗的重要环节。
本发明的一种治疗皮肤多种损伤创面的药物组合物就是根据以上对创面治疗的原则要求设计的。组合物的重要组分也是基质，选择以浓丙三醇和1,2丙二醇为主，具有很强的吸湿性和适当的保湿性，与创面渗液中的水分和高于血浆含量的氨基酸结合形成干而不硬的透明痂，使创面快速得以封闭，涂药后空气中落入创面的细菌不能生长，细菌不能从外部入侵，同时因配比中有适当含量的月桂氮酮或癸基甲基亚砜，可带领配方中的抗菌抑菌、营养、抗氧化、改善微循环的药物有效成分渗透到创面的深部，从而改善创面组织的血液供应，阻灭肠道通过血液循环到达创面的细菌，减轻创面早期的炎症再损伤，起到“内外兼修”的理想治疗效果，这是本发明者在本发明实践中的欣喜发现。相信这将为烧伤创面修复科学从分子机制和细胞学层面进行新的探索起到抛砖引玉的作用。
本发明者在长期的临床医疗实践中，自配自用本发明药物组合物治疗了大量的皮肤多种损伤创面的患者，涉及门诊和病房的一般外科换药、急诊皮肤擦挫伤的处置治疗、烧烫伤创面的用药、长期卧床的褥疮治疗等近千例，全部取得了明显优于传统的创面用药的疗效，既促进了创面的愈合、缩短了创面的疗程、减少了病人的痛苦、节省了医疗费用，又减轻了医务人员的劳动。本发明药物组合物的组成成分的来源，均是公知的记载在中国药典上的平常药品，但经本发明人在实践中依中西医结合外科的医理药理组方配比，用特定的方法提取药用有效成分，赋予新颖的剂型，使中西医结合治疗皮肤多种损伤创面的绩效大放光彩。
本发明药物组合物制剂3治疗烧伤病人创面58例临床观察
1)一般资料：
门诊治疗患者31例，为烧伤面积均小于体表面积10％的轻型烧伤患者。
住院治疗患者27例，为烧伤面积占体表面积10％-30％的患者。
按性别分，男性37例，女性21例。
按年龄分，2-14岁12例，15岁以上46例。
按烧伤深度分，浅II度43例，深II度11例，III度或相当于III度4例。
2)诊断标准：
浅II度烧伤，伤处皮肤起水疱，水疱剪开后创面鲜红，感觉剧痛。
深II度烧伤，伤处皮肤有水疱或有透明干痂，疱内或痂下创面红白相间，痛觉较轻。
III度烧伤，伤处皮肤呈半透明的褐色焦痂，创面痛觉消失，或由II度烧伤创面发生感染造成皮肤全层缺失所致。
3)治疗方法：
对于II度烧伤，伤后当日剪破水疱，排除渗液，使用本发明药物组合物制剂3，在水疱皮上涂药；伤后过24小时后，揭除水疱皮，在烧伤创面上涂药，对于小面积III度烧伤，待肉芽组织长到与周围组织相平后，在肉芽组织上涂药，均采用暴露方法。
4)疗效评定标准：
涂药时间3-5天后观察创面的发展变化。浅II度烧伤创面观察8天，可根据干痂与创面结合的状况，判断创面的愈合趋势；深II度烧伤创面涂药观察20天，可根据痂下有无积脓，判断创面的愈合趋势；已经严重感染的II度烧伤或小面积的III度烧伤，在不断清除坏死组织，创面肉芽组织长平后，多次涂药，共观察30天，可根据创面结痂和创面周边状况，判断创面的愈合趋势。少数不能确定愈合趋势的病例，则以最终治疗结果判定。
显效：浅II度烧伤在2周内创面愈合脱痂，深II度烧伤创面在4周内愈合脱痂，小面积III度烧伤的创面干燥、痂下无波动、肉芽创面感染得到有效控制。
好转：创面有少部分发生感染，涂药时间超过5天，创面愈合时间延长。
无效：达不到以上好转的标准。创面转由植皮愈合。
5)治疗效果(见表3)：
表3 本发明药物组合物制剂3对58例烧伤病人创面治疗结果的统计
Figure PCTCN2017085443-appb-000002
总有效率98.3％
实施例4 长期临床实践中皮肤多种损伤创面的治疗病案
实例一类，使用本发明药物组合物制剂3
对于浅II度或深II度烧烫伤的创面，剪去水疱，以消毒棉球浸泡组合物药液，在创面上轻轻涂擦，药液厚1毫米即可，涂药后创面暴露，不用敷料，创面会在4-6个小时内形成透明薄痂。如果创面渗出液较多，6小时后再涂药一次，第一天最多涂药三次。第二天如发现痂下创面清洁、透明痂干燥，只要在透明痂上再加涂一次药液即可。如发现透明痂下有坏死组织，可用生理盐水棉球润化透明痂，清除坏死组织，再涂组合物。第三天，透明痂干净、痂下创面清洁、继续暴露创面，只在创面上涂一次药即可。如发现痂下还有坏死组织，继续清除再涂药。
以上治疗浅II度和深II度烧烫伤，只要就诊及时，绝大多数创面不会发生感染，能如期愈合。
如果烧烫伤损坏皮肤全层，甚至伤及皮下组织，则按III度烧伤治疗原则处理。在肉芽组织长到与周边正常皮肤相平后，如创面不大，不用植皮，只涂本组合物药液，创面肉芽组织能很快结透明痂，创面水肿消退，会在痂下逐渐愈合。因创面愈合快，肉芽组织没有反复增生，所以涂治本发明组合物药液后肉芽创面愈合的瘢痕也较平软。
1)徐某，女，2岁，家住城镇，1994年5月21日就诊，诉其母从厨房端一大碗刚出锅的炖肉往餐桌边走，2岁女孩徐某绕膝叫妈，撞上其母的腿脚，高温肉汤溢出淋在女儿头上，烫伤患儿头面部，急诊就医。检查见患儿左耳、左前额、左面颊部红肿起水疱，左眼睁不开。诊断：左侧面部II度烫伤，受伤面积占体表面积约2％。治疗：剪去水疱，在水疱皮上涂本发明组合物药液，当日涂二次。第2日，剪去水疱皮，在创面上继续涂药。第3天创面全部被透明痂覆盖保护，无渗出，无分泌物。第4日创面干燥，无感染，停止涂药。第5日，左头面部及左耳渐消肿，用棉签轻触不疼痛。第10日，创面保护痂部分开始脱落，显示烫伤创面一期愈合。半年后随访，面部和左耳伤后未留瘢痕。
耳朵两层皮肤包着一层软骨，表面不平，以往烫伤后，用药不好包扎，容易感染，感染后治疗很困难。用本发明组合物涂在II度烧烫伤的耳朵上，能使耳朵上的受伤创面被药物全覆盖，不用包扎，能很快地形成保护痂，有效地抗感染、愈合快。面部II度烧烫伤一感染就可能成为III度烧烫伤，愈合后会形成不同程度的瘢痕，造成损容。面颈部II度烧烫伤，只要在伤后早期用本发明组合物药液正确地治疗，不会发生感染，不会形成瘢痕。
2)於某，男，3岁，家住城镇。1995年7月6日就诊，诉在家玩耍扳倒桌上的开水瓶，烫伤颈、胸、腹部及会阴部和双下肢的部分皮肤，伤后约2小时来院就医，伤部多处起大水疱，阴茎及阴囊也有水疱。诊断：身前部分皮肤II度烫伤，受伤面积占体表面积约10％。治疗：除全身补液等治疗外，受伤创面用本发明组合物药液涂治，涂药厚约1mm，创面全程暴露。第1日，剪破水疱皮，将药液涂在水疱皮上，日涂3次。第2日，揭去水疱皮，将药液涂在创面上，日涂3次。第3日，创面已形成透明保护痂，部分痂下可见鲜红的毛细血管，未发现痂下有坏死组织，继续在痂面上涂药1次。第4日，创面干燥，用棉签探触无分泌物，无明显疼痛，创面停止用药，嘱加强营养。第8日，患儿精神良好，饮食正常，创面带痂出院，嘱一周后来院复诊，创面痂覆盖 良好，干燥无触痛。又过一周再来复诊，见痂皮渐脱落，创面红嫩平整，外生殖器形态正常。会阴部创面难包扎，容易感染。用本发明药物组合物，暴露疗法效果好。
3)梅某某，男，38岁，农民。1996年7月25日就诊，诉昨深夜开小拖拉机在田间作业，突发机械故障熄火。就地自己维修时，柴油喷雾洒在高温的发动机气缸上，瞬间火光一闪，火焰烧伤患者的头、面、颈部。今天一早来就诊，患者头面颈部散落油污，双耳、头发、前额、面部肿胀，面目全非，检查双眼角膜及呼吸道未损伤。诊断：头面颈部II度烧伤，受伤面积占体表面积约8％。治疗：除全身输液预防感染治疗外，局部用干棉签轻拭油污后，第1日在受伤部位涂本发明组合物药液，日涂3次。第2日，尽量揭去一层水疱皮，在创面上涂本发明组合物药液，日涂3次。第3日，大部分创面被痂覆盖保护，干燥，只有发际和耳廓尚有少数小水疱未消除未吸收，继续清创后涂组合物药液。至第5日，整个创面痂下无积液，肿胀有所消退。至第8日，创面被痂下保护得好，涂药停止。至第14日，痂皮干燥，周围组织消肿，无明显触痛。又过两周，痂皮有松动，部分可剥脱，创面愈合良好。半年后随访，未发生瘢痕损容。
4)伍某某，女，6岁，家住农村。1997年9月18日就诊，诉40多天前在家被绊倒，一屁股坐在刚从灶台移至地面的粥锅里，烫伤整个臀部及双大腿后侧部分皮肤，在当地卫生院治疗一天后转往武汉同济医院治疗40天，大部分创面愈合，仍剩下右侧臀部一大块创面，需天天交换敷料。患儿父亲讲，患儿这个大创面在同济医院天天交换敷料不见创面缩小，医院拟采取再次手术，家长经济耗尽，负担不起，遂要求出院回本地医院诊治。患儿来我处就诊时，面容痛苦、全身营养状况差、清瘦、轻度贫血貌，右侧臀部正中有一8×10cm的创面，创面上肉芽组织水肿略高出周围皮肤。这些症状表现，是因为患儿烫伤一个多月，皮肤存在较大的创面、渗出，天天丢失血浆蛋白和其它营养物质，对身体消耗很大。身体蛋白质偏低，创面愈合就会困难。首先要封闭创面， 避免身体继续丢失蛋白质等营养物质。给予本发明药物组合物100mL，用棉签蘸组合物给患儿创面涂药示范1次，嘱患儿父亲将上述组合物药液和棉签带回家后涂用，每日涂2次，暴露创面，连用5日；第6日来复诊，发现原来水肿的肉芽组织收缩了，与周围组织平了，创面上覆盖了一层干痂，痂下无液化物，嘱可停止涂药，避免挤压创面处。再过10天来复诊，创面还是被干痂覆盖，痂下创面进一步好转；又过2周，创面上的痂皮逐渐脱落，痂下创面形成较软的瘢痕愈合。
5)张某某，女，17岁，地区卫校学生。1998年7月12日就诊，诉半个月前在校穿短裤从学生食堂提着开水瓶回宿舍，不料瓶塞脱落，开水流出，烫伤患者右大腿外侧中部至外踝处皮肤，伤后每日到校医务室治疗。两周后放假回家，来我处就诊。检查：患者右大腿外侧中部以下至小腿外侧有一条感染创面，深达皮下组织，创面有多处黄绿色脓性坏死组织，不易拭掉，诊断为II度烫伤并感染。治疗：在尽量消除创面坏死组织后，用加入庆大霉素、氯霉素的本发明药物组合物涂在创面上。第1日每6小时涂1次，第2日涂2次，第3日涂2次，第4日来复诊，患者告诉创面局部疼痛明显减轻，检查见创面大部分干燥，仍有少量的痂下积脓，以生理盐水棉球润洗去局部有脓的干痂后，清理痂下的脓液及坏死组织，继续涂上述药液。这样又连续3天治疗后，患者的创面渐消肿，被干痂覆盖，痂下创面清洁，无痂下积脓。嘱停止涂药，避免压碰搔抓创面上的痂皮，静待结痂自行脱落。
实例二 使用本发明药物组合物制剂2
对于皮肤擦挫伤，手术切口缝合后的皮肤创口，在清洁拭干创口后，涂擦本发明组合物药液。皮肤擦挫伤的创面涂药后暴露，一般不用敷料。如果用一层薄薄的消毒纱布也只是为了将创口与衣物隔开。
皮肤擦挫伤或切割后的缝合创口，或缝合伤口拆去缝线时，经涂本发明组合物药液后，能预防外面的细菌入侵伤口感染。
1)余某某，男，34岁，教师。1998年8月26日就诊，诉骑摩托车转弯时摔在水泥路面上，擦伤右半侧身体，急诊来院。检查：患者右半身从脸、手、肘、腰腹部及大小腿外侧广泛皮肤擦伤，部分伤口血肉模糊，全身未见骨折，胸腹未见脏器损伤。诊断：右半身皮肤软组织广泛擦挫伤。治疗：继续观察全身内脏及骨骼是否有伤，注射破伤风抗毒素，清理皮肤创面后，在创面上涂本发明组合物药液。第1日涂3次。第2天创面全部结痂，疼痛有所缓解，再在痂上涂药2次。第3天，创伤处疼痛明显减轻，创面干燥，轻触摸不痛。停止涂药，静养10日后，创面全部愈合。
2)王某某，男，41岁，职员。2002年9月2日就诊，诉昨晚淋浴时，浴室钢化玻璃门突发爆裂，碎玻璃渣扎伤患者右半身鲜血直流，经当地外科急诊包扎等处理后，今天来我处就诊，拆除包扎的敷料，在伤口上涂用本发明组合物。第1日涂2次。第2次伤口完全被干痂覆盖保护，再在干痂上涂1次药。第3日轻触伤口不痛。停止用药，伤口一期愈合。
3)李某某，男，68岁，退休职员。2005年8月21日就诊，诉昨晚起夜如厕撞在塑料水桶边上，伤及右小腿前面的皮肤，今天就诊，见右小腿胫骨前皮肤掀起一块约1×1.5cm大小的皮瓣，皮瓣蜷缩发紫。治疗：预防注射TAT，常规清创后，在创面涂本发明组合物。第1天涂2次。第2、第3日每天各涂1次。第4天创面已结与周围皮肤相平的干痂，创面边缘无肿胀，轻触不痛，嘱停止用药，避免碰撞创伤处。15日后，痂皮松动，18日后痂皮脱落，创面基本长平，无瘢，留下浅灰色色素沉着。18个月后随访，创面色素消退，伤处无痕。
实例三 使用本发明药物组合物制剂1
对于皮肤感染性疾病，如脓疱疮、黄水疮、下肢溃疡、疖痈破溃后的肉芽组织创面，用生理盐水棉球对疮面或肉芽组织创面洗净拭干，涂擦本发明组合物药液，疮创面的感染能迅速得到控制而痊愈。
1)朱某某，男，5岁，家住农村。1996年9月6日就诊，诉头部长脓疱疮10天，在家用金霉素软膏涂在疮上，未能控制疮流黄水。今来我处就诊时，检查：头发已剪短，发际脓痂与短发粘混在一起，以左侧为重，右侧面额部也有脓痂，体温37.1℃，全身状态尚好。治疗：以生理盐水洗去头面部的脓痂，重新剪除稍长的头发，用消毒纱布拭干疮创面后，用本发明组合物(100ml加入氯霉素0.25克)，带药回家。第1日涂3次。第2日涂2次。第3天复诊，头面部脓疱疮创面全部结痂，没有黄水再流，感染得到控制，嘱继续涂两次药后，可停药观察。再过3天复诊，疮创面痂皮覆盖良好，基底周围无炎性肿胀，探触不痛。疮创面渐完全愈合。
2)张某某，女，83岁，城镇居民。2002年11月2日就诊，诉在家摔倒，造成左侧股骨颈骨折，经骨外科固定手术后进ICU病房，卧床一周后出现骶骨部位褥疮，经常规褥疮护理换药未能控制褥疮的感染。改用本发明药物组合物，清洗拭干褥疮创面后涂药暴露创面。第1日涂药3次。第2日褥疮创面就结痂，无分泌物。继续每日涂药2次，连用5日，褥疮创面一直保持有痂覆盖，干燥，被褥擦掉干痂后就及时补涂组合物药液，创面血运好转，面积日渐缩小。2周后创面渐趋愈合。
3)孙某某，男，56岁，农民。1998年9月11就诊，诉4日前开始，左上背部疼痛，逐日加重。起病第5日疼痛难忍，来院就医。检查：体温38.2℃，右上背部红、肿、热、硬结，中心皮下可见有黄色脓点，触痛明显，未破溃，局部无波动感。诊断：左上背部蜂窝织炎(背痈)。治疗：全身用四环素0.5，6小时1次口服，连用3天。局部在局麻下做“艹”形切开，打通脓腔，减压引流，以本发明组合物药液浸消毒纱布条放在切口内做引流条，每日换药1次。第2日，局部疼痛明显减轻，体温37.3℃。至第4日，体温36.8℃，局部不触不痛，肿胀明显消退，切口引流出分泌物量少。至第7日，切口内无脓性分泌物，无需再引流，改用压迫包扎两天后，切口长平，暴露创面，涂组合物药液， 每日2次，共涂2日，创面形成保护干痂，痂下切口创面渐愈合。
通过引用并入
本文引用的每个专利文献和科学文献的全部公开内容通过引用并入本文用于所有目的。
等效
本发明可以在不脱离其基本特征的情况下以其他具体形式实施。因此，前述实施例被认为是说明性的，而不是对本文所述的本发明的限制。本发明的范围由所附权利要求书而不是由前述说明书表示，并且意在将落入权利要求书的等同物的含义和范围内的所有改变包括在其中。

Claims (15)

  1. 一种治疗皮肤多种损伤创面的药物组合物，其中，所述药物组合物的重要组分包括丙三醇、1,2丙二醇、水溶性月桂氮酮或癸基甲基亚砜、以及水按特定配比组成，其中所述丙三醇占组合物的含量为80-90体积％。
  2. 如权利要求1所述的药物组合物，其中，所述药物组合物具有下列性质中的至少一种：
    1)所述1,2丙二醇占组合物的含量为6-15体积％；
    2)所述水溶性月桂氮酮占组合物的含量为0.2-2体积％，优选含量为0.6-1体积％，更优选含量为0.2-0.5体积％；
    3)所述癸基甲基亚砜占组合物的含量为1-4体积％，优选含量为1-3体积％，更优选含量为1-1.5体积％；
    4)所述水占组合物的含量为3-8体积％，优选含量为3-5体积％，更优选含量为3-4体积％。
  3. 如权利要求1或2所述的药物组合物，其中，所述药物组合物还包括黄芪、当归、丹参、赤芍中的至少一种，所述黄芪、当归、丹参、赤芍中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
  4. 如权利要求3所述的药物组合物，其中，所述药物组合物具有下列性质中的至少一种：
    1)所述黄芪占组合物的含量为10-30g/L，优选含量为10-20g/L，更优选含量为10-15g/L；
    2)所述当归占组合物的含量为5-20g/L，优选含量为5-10g/L，更优选含量为6-8g/L；
    3)所述丹参占组合物的含量为5-20g/L，优选含量为5-15g/L，更优选含量为8-10g/L；
    4)所述赤芍占组合物的含量为5-20g/L，优选含量5-15g/L，更优选含量为8-10g/L。
  5. 如权利要求1至4任一项所述的药物组合物，其中，所述的药物组合物还包括黄连、黄芩、黄柏、栀子中的至少一种，所述黄连、黄芩、黄柏、栀子中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
  6. 如权利要求5所述的药物组合物，其中，所述药物组合物具有下列性质中的至少一种：
    1)所述的黄连占组合物的含量为5-20g/L，优选含量为5-10g/L，更优选含量为6-8g/L；
    2)所述的黄芩占组合物的含量为5-20g/L，优选含量为5-10g/L，更优选含量为6-8g/L；
    3)所述的黄柏占组合物的含量为5-20g/L，优选含量为5-10g/L，更优选含量为6-8g/L；
    4)所述的栀子占组合物的含量为5-20g/L，优选含量为5-10g/L，更优选含量为6-8g/L。
  7. 如权利要求1至6任一项所述的药物组合物，其中，所述的药物组合物还包括白蔹、四季青、白芨、甘草中的至少一种，所述白蔹、四季青、白芨、甘草中的至少一种药材的药用有效成分是在高温高压条件用丙三醇合水进行提取。
  8. 如权利要求7所述的药物组合物，其中，所述药物组合物具有下列性质中的至少一种：
    1)所述的白蔹占组合物的含量为5-20g/L，优选含量为6-15g/L，更优选含量为8-10g/L；
    2)所述的四季青占组合物的含量为5-20g/L，优选含量为5-15g/L， 更优选含量为8-10g/L；
    3)所述的白芨占组合物的含量为5-20g/L，优选含量为6-15g/L，更优选含量为8-10g/L；
    4)所述的甘草占组合物的含量为5-15g/L，优选含量为6-12g/L，更优选含量为8-10g/L。
  9. 如权利要求1至8任一项所述的药物组合物，其中，所述的药物组合物还包括乳香、没药、血竭、儿茶中的至少一种，所述乳香、没药、血竭、儿茶中的至少一种药材的药用有效成分是用1,2丙二醇以浸泡法提取。
  10. 如权利要求9所述的药物组合物，其中，所述药物组合物具有下列性质中的至少一种：
    1)所述的乳香占组合物的含量为3-10g/L，优选含量为5-8g/L，更优选含量为5-6g/L。
    2)所述的没药占组合物的含量为3-10g/L，优选含量为5-8g/L，更优选含量为5-6g/L。
    3)所述的血竭占组合物的含量为3-10g/L，优选含量为5-8g/L，更优选含量为4-5g/L。
    4)所述的儿茶占组合物的含量为3-10g/L，优选含量为5-8g/L，更优选含量为4-5g/L。
  11. 如权利要求1至10任一项所述的药物组合物，其中，所述药物组合物还可以包括混溶入的抗菌素。
  12. 如权利要求11所述的药物组合物，其中，所述抗菌素包括庆大霉素、氯霉素。
  13. 如权利要求1至12任一项所述的药物组合物的制备方法，其中，所述制备方法包括以下方法：精选称取适量黄芪、当归、丹参、赤 芍中至少一种；黄连、黄芩、黄柏、栀子中至少一种；白蔹、四季青、白芨、甘草中至少一种，共至少三种，投入对应量丙三醇混合对应量的蒸馏水中，在水蒸汽0.02MPa气压和105℃温度的环境下，隔层加热含原料药的丙三醇合水10分钟，冷却后滤去药渣，损耗的丙三醇合水补足量；精选称取适量乳香、没药、血竭、儿茶中的至少一种，投入到对应量的1,2丙二醇中，浸泡24小时后，滤去药渣，损耗的1,2丙二醇补足量；将含有原料药有效成分的丙三醇合水、含有原料药有效成分的1,2丙二醇与对应量的水溶性月桂氮酮或癸基甲基亚砜混合，充分搅匀，灌装灭菌。
  14. 如权利要求1至12任一项所述的药物组合物的在制备用于治疗皮肤多种损伤创面的外用药物中的用途，其中，所述皮肤多种损伤创面不包括：因结核菌感染或恶性肿瘤引起的皮肤溃疡、因雄雌激素分泌失衡而发生的痤疮。
  15. 如权利要求1至12任一项所述的药物组合物的在制备用于治疗皮肤多种损伤创面的外用药物中的用途，其中，所述皮肤多种损伤创面包括烧伤创面、烫伤创面、皮肤擦挫伤创面、切割后的缝合创口、褥疮创面、皮肤感染创面、以及肉芽组织创面。
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