CN101648014A - Medicinal composition for treating skin injury and ulcer and application thereof - Google Patents
Medicinal composition for treating skin injury and ulcer and application thereof Download PDFInfo
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- CN101648014A CN101648014A CN200810118307A CN200810118307A CN101648014A CN 101648014 A CN101648014 A CN 101648014A CN 200810118307 A CN200810118307 A CN 200810118307A CN 200810118307 A CN200810118307 A CN 200810118307A CN 101648014 A CN101648014 A CN 101648014A
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Abstract
The invention discloses a medicinal composition for treating skin injury and ulcer diseases, and belongs to the field of Chinese medicament. The medicinal composition consists of collagen and Chinesemedicaments for clearing heat and releasing toxin such as coptis root, golden cypress bark, rhubarb, giant knotweed rhizome, honeysuckle flower, forsythia fruit and the like which are prepared into aplurality of dosage forms by matching the prior art. The technology overcomes the defects that the prior common preparations for the trauma department have extremely slow response, longer treatment course, adhesion with the skin, influence on scab cicatrization and the like, has quick and remarkable treatment effect on various skin diabrosis diseases such as mechanical wound, burn/scald, bedsore,chronic leg ulcer, diabetic foot or cancerous ulcer and the like, and can greatly shorten the required time for wound healing and tissue repair.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and application thereof that is used for the treatment of various skin injury ulcer class diseases, said composition is made up of collagen protein and antipyretic and antidotal type Chinese medicine, belongs to the field of Chinese medicines.
Background technology
With skin injury or ulcer is that all kinds of diseases of sign mainly contain various types of mechanical injurys, burn and scald, decubital ulcer, control ulcer, diabetic foot, cancer ulcer etc. under chronic, because such disease causes that skin surface is damaged more, cause and reach skin corium or darker skin lesion deeply, often touching difficulty more, the course of disease is longer, be the refractory disease that the doctor generally acknowledges, still do not have comparatively ideal therapeutic scheme at present.
External treatment of Chinese medicine is emphasized " controlling of surgery focuses on external treatment ", and " external treatment want, focus on ' putrefaction-removing granulation-promoting ' " should reach the effect of anti-inflammation, blood circulation promoting and blood stasis dispelling, can promote damaged and the histiocytic regeneration of ulcer wound surface again.Mostly clinical Chinese medicine for external application commonly used such as powder, lotion, plaster, patch, ointment, ointment etc. are merely anti-inflammation at present, though certain curative effect is arranged, onset is extremely slow, and the course of disease is longer, has limited its clinical expansion and application.
Collagen protein has good fibre-forming performance, anthemorrhagic performance, cell-cell interaction performance, promotes good biological characteristicses such as wound healing and tissue repair, pair cell, tissue and even organ exercise normal function and reparation has significant impact to wound, the bootable epithelial cell defective region of moving into, lubricate when cell migration; The synthetic substrate of utilizing of regenerative cell has the AC effect simultaneously, strengthens the regenerative cell adhesive attraction; Collagen between the filling regenerative cell can reduce the auxocyte contact inhibition.As ideal organizational project biomaterial, collagen protein is applied in cosmetics and the hemostasis class medical apparatus and instruments always.
Based on collagen protein above biological characteristics is arranged, collagen protein and antipyretic and antidotal type kind are organically combined,, provide a valid approach for more effectively treating skin injury or ulcer all kinds of diseases for characterizing.
Summary of the invention
One of purpose of the present invention provides a kind of pharmaceutical composition, a kind of especially pharmaceutical composition that is used for the treatment of various skin injury ulcer class diseases.
Second purpose of the present invention provides the application of this pharmaceutical composition in the various skin injury ulcer class diseases of treatment.
In conjunction with existing result of study, the present invention seeks to be achieved through the following technical solutions:
At first, the invention provides a kind of pharmaceutical composition that is used for the treatment of skin injury ulcer class disease, this pharmaceutical composition raw materials of effective components medicine is any or the combination more than two kinds in collagen protein and the following antipyretic and antidotal type Chinese medicine: Rhizoma Coptidis, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Polygoni Cuspidati, Flos Lonicerae, Fructus Forsythiae, Radix Sanguisorbae, Herba Andrographis, Folium Isatidis, Radix Isatidis, Indigo Naturalis, Rhizoma Osmundae, Herba Taraxaci, Herba Violae, Flos Chrysanthemi Indici, Rhizoma Paridis, Rhizoma Bistortae, Radix Rhapontici, Rhizoma Smilacis Glabrae, Caulis Sargentodoxae, Herba Patriniae, Lasiosphaera Seu Calvatia, Herba Euphorbiae Humifusae, Herba Lobeliae Chinensis, Herba Hedyotidis Diffusae, Radix Ampelopsis, the Radix Angelicae Dahuricae, Herba Achilleae.
The above-mentioned medical material of respectively distinguishing the flavor of is in preparation medicine process of the present invention, can be used as medicine by former powder, also can select suitable method to extract (as: decocting cooking method, ethanol extraction method, steam distillation, supercritical extraction, enzyme extraction method etc.) according to the exclusive physicochemical property of effective ingredient, refining (as: water extract-alcohol precipitation, alcohol extracting-water precipitating, by macroporous resin column etc.) obtains corresponding extract and feeds intake.
The weight proportion of pharmaceutically active ingredient and collagen protein is 1: 0.5～1: 50 in the gained pharmaceutical composition of the present invention, the weight proportion of pharmaceutically active ingredient and collagen protein is 1: 1～1: 20 in further in the preferred pharmaceutical compositions, wherein middle pharmaceutically active ingredient mean above-mentioned blood-activating stasis-removing kind Chinese crude drug after extracting resulting Chinese medicine extract and (or) the former powder of medical material, be meant the ratio of the two solid content weight in the final products with the part by weight of collagen protein.
Collagen protein described in the gained pharmaceutical composition of the present invention can replace with the mixture of collagen or collagen protein and collagen, is that mainly collagen protein is similar substantially to collagen character, and just there is some difference for molecular weight.
Collagen is meant the spirality fiber shape protein that is twisted into by three peptide chains, be to form animal connective tissue's important protein matter, its mainly from raw materials such as Corii Sus domestica, Corii Bovis seu Bubali, cattle heel string, pig heel string, Os Sus domestica, Os Bovis seu Bubali simple hydrolysis obtain, its relative molecular weight is 250～300kD; Collagen protein is the enzymatic hydrolysate of collagen, its relative molecular weight below 100kD, also can enzymolysis to relative molecular weight below 40kD.Collagen protein can also be directly from raw materials such as gelatin, Colla Corii Asini, new Colla Corii Asini, Corii Sus domestica, Corii Bovis seu Bubali, cattle heel string, pig heel string, Os Sus domestica, Os Bovis seu Bubali enzymolysis obtain.The relative molecular weight of collagen is big, poorly water-soluble, and the viscosity height, mechanical strength is big, and the ancillary drug good moldability can be sticked wound, and under the effect of collagenase, but enzymolysis becomes oligopeptide or aminoacid to participate in tissue growth; And the relative molecular weight of collagen protein is less, and water solublity is strong, is easy to be absorbed by the body, and because proline and hydroxyproline content are more, can participates in the histiocyte growth of body directly, for it is supplied raw materials.Collagen, collagen protein all can be brought into play effects such as promoting wound healing and tissue repair in Chinese medicine for external application.
Pharmaceutical composition of the present invention mainly adopts the method for being prepared as follows to make:
Get the antipyretic and antidotal type Chinese crude drug, pulverize, adopt conventional extracting method to extract, make with extra care purification, make drug extract; Get the collagen protein or collagen solution or the fine powder that make, add said medicine extract and proper pharmaceutical excipients, make required dosage form according to the pharmaceutics routine techniques, as preparations such as gel, Wet-dressing agent, ointment, obedient unguentum, liniment, lotion, liniment, aerosol or sprays.
Among the present invention, the extracellular matrix components that collagen protein is wanted as body weight for humans (being the raw material of granulation promoting) has good biological characteristics and physiology characteristic:
Collagen protein and antipyretic and antidotal type Chinese medicine composition are used, and collagen protein provides nutrition and " granulation promoting " material for diseased region on the one hand, accelerates damaged and the histiocytic regeneration of ulcer wound surface significantly, promotes wound healing and tissue repair; On the other hand, the antipyretic and antidotal type medicine promotes the wound surface revascularization, improve the local woanded surface microcirculation, having improved tissue supports, wound healing and tissue repair have been promoted greatly, because: 1. sophisticated fibroblast is if the anaerobic supply can not be made collagen, and collagen leaves cell and is gathered into fiber also is aerobic processes; 2. proline and lysine need the hydroxylase hydroxylation in the intracellular transport process, unite otherwise can not realize intersecting, and dihydroxylation process is then aerobic; 3. to be disposed to the polymerization behind the extracellular also be the dependent speed limit process of an oxygen concentration to collagen.
With collagen protein and the medication combined application of antipyretic and antidotal type, medicine promotes the wound surface blood circulation innovatively, and (fibroblast is made collagen needs oxygen to quicken the aerobic process; Proline and lysine need the hydroxylase hydroxylation in intracellular transport, and dihydroxylation process needs oxygen; The polymerization that collagen is disposed to behind the extracellular also is an aerobic speed limit process); Collagen protein focuses on " granulation promoting ", and the extracellular matrix components that body weight for humans is wanted is accelerated damaged and the histiocytic regeneration of ulcer wound surface, promotes wound healing and tissue repair.Pharmaceutical composition of the present invention has better therapeutic effect at various skin injury ulcer class diseases, particularly will, it mainly is suitable for the obstinate that various diseases causes even the wound of infection, controls ulcer, diabetic foot, cancer ulcer etc. as decubital ulcer, under chronic; Various types of open wounds, as: mechanical injury, knife injury, burn and scald etc.
In addition, for improving the preparation curative effect, pharmaceutical composition of the present invention can also add Chinese medicine extract or the fine drug powder except that the antipyretic and antidotal type medicine, as blood-activating stasis-removing kind: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, Radix Notoginseng, the Radix Paeoniae Alba, Radix Paeoniae Rubra, Flos Carthami, Caulis Spatholobi, Herba Leonuri, Radix Achyranthis Bidentatae, Hirudo, Eupolyphaga Seu Steleophaga, Semen Persicae, Radix Arnebiae (Radix Lithospermi), Rhizoma Curcumae, Rhizoma Corydalis, Cortex Moutan, Scorpio, Scolopendra etc.; Anti-inflammation hemostasia putrefaction-removing granulation-promoting class: Olibanum, Myrrha, Borneolum Syntheticum, Radix Sanguisorbae, Camphora, catechu, artificial Moschus, Sanguis Draxonis, Sanguis Draxonis, Gypsum Fibrosum Preparatum, the Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Erodii, Calamina, Margarita, Radix Sanguisorbae etc.
The last purpose of the present invention provides the application of gained pharmaceutical composition in the various skin injury ulcer class diseases of treatment, more properly saying, is open wound, burn and scald, decubital ulcer, the chronic application of controlling down in the various skin ulceration class diseases such as ulcer, diabetic foot, cancer ulcer due to the various types of mechanical traumas of treatment.
Beneficial effect
Gained pharmaceutical composition of the present invention is for innovatively with collagen protein and the medication combined application gained of antipyretic and antidotal type, treat various skin injury ulcer class diseases and have ideal curative effect, be particularly suitable for the obstinate that various diseases causes even the wound of infection, control ulcer, diabetic foot, cancer ulcer etc. as decubital ulcer, under chronic; Various types of open wounds, as: mechanical injury, knife injury, burn and scald etc.Under the guidance of Chinese medical theory, the present invention follows the principle of " wanting of external treatment; focus on ' putrefaction-removing granulation-promoting ' ", " putrefaction removing " and " granulation promoting " are organically combined, mutually promote, " putrefaction removing " effect of pharmaceutically active ingredient in not only giving full play to, but also can make full use of the low immunogenicity of collagen protein, and the coordination ability between host cell and the tissue is strong, haemostatic effect is good, biodegradable, advantages such as physical and mechanical properties is good, combine closely with wound, initiatively participate in the agglutination of wound surface, quicken " granulation promoting " process, shortened healing of wound mouth and tissue repair required time greatly, alleviate the patient suffering, had vast market prospect.
The specific embodiment
Below further specify the present invention by specific embodiment, but following examples only are used to the present invention is described without limits to the present invention.
Embodiment one
Get the cattle heel string of newly butchering, the soak with hydrochloric acid of the following usefulness of room temperature 2mol/L 48 hours takes out, and uses distilled water wash, 0.5mol/L sodium hydroxide solution neutralization, it was soaked in 20 ℃ of temperature, 0.1% pepsin solution 12 hours again, and took out, water cleans, be cut into 0.05～0.5cm fritter, under condition same as described above acidleach and enzymolysis once, 60 ℃～70 ℃ dryings, collagen.
Embodiment two
Get fresh porcine skin and clean unhairing, degrease, be cut into small pieces, 0.45mol/L sodium chloride-the tris-HCI buffer (pH7.5) that adds 50 times of amounts, under 4 ℃ the condition freezing 48 hours, stirred once each 5 minutes every 8 hours, centrifugalize (3000r/min) 15min, get 4 ℃ of preservations of supernatant, precipitate repeats aforesaid operations, gets 4 ℃ of preservations of supernatant.Merge the gained supernatant, under condition of stirring, add glacial acetic acid, make solution contain glacial acetic acid 0.5mol/L, pH2.5～3 add sodium chloride again under condition of stirring, make whole solution sodium chloride-containing 1mol/L, speed with 60r/min under 4 ℃ stirred 12 hours, centrifugalize, abandoning supernatant, collecting precipitation thing, the 0.5mol/L glacial acetic acid solution dissolving that adds 50 times, supernatant is collected in centrifugalize, adds the 0.5mol/L sodium hydroxide solution neutralization of amount of calculation, and adding sodium chloride makes whole solution contain the 4.4mol/L sodium chloride solution, speed with 60r/min under 4 ℃ stirred centrifugalize, collecting precipitation thing 12 hours, with 100 times distilled water immersions 12 hours, centrifugalize, 4 ℃ of dryings of gained precipitate get collagen.
Embodiment three
Get fresh porcine skin and clean unhairing, degrease, rub, add water with the concentration of 60g/L and be transferred to fermentation tank, stir, be warming up to 90 ℃, kept 5 minutes, be cooled to 37 ℃ then, added 1% pepsin enzymolysis 2 hours, be warming up to 60 ℃, added 2% trypsin digestion 12 hours, be warming up to 90 ℃, the 10kD ultrafilter membrane is crossed in deactivation 5 minutes, spray drying gets the collagen protein of molecular weight less than 40kD.
Embodiment four
Get gelatin, stir after adding 20 times of water swollens, be transferred to fermentation tank, stir, be warming up to 90 ℃, kept 5 minutes, be cooled to 37 ℃ then, add 1% papain, be warming up to 60 ℃, enzymolysis 2 hours, be warming up to 90 ℃, the 100kD ultrafilter membrane is crossed in deactivation 5 minutes, spray drying gets the collagen protein of molecular weight less than 100kD.
Embodiment five
Prescription: Rhizoma Coptidis 80g Cortex Phellodendri 50g Radix Et Rhizoma Rhei 50g collagen protein 5
Method for making: above-mentioned four flavors, Rhizoma Coptidis, Cortex Phellodendri, Radix Et Rhizoma Rhei add 5 times of amount 70% alcohol reflux 2 times, filter, and merge, and decompression recycling ethanol concentrates, and drying is pulverized, and is standby.Get carbomer 8g, added the water swollen 24 hours, add triethanolamine and transfer pH to 8, stir evenly, add above-mentioned dried cream powder and collagen protein fine powder 5g, and add water to 100g, stir evenly, remove and bubble, make gel.
Annotate: collagen protein is raw material with the Corii Sus domestica, makes through pancreatin and the abundant enzymolysis of neutral pepsin, and relative molecular weight is below 10kD.
Embodiment six
Prescription: Herba Achilleae 1000g collagen protein 38g
Method for making: above two flavors, get Herba Achilleae and add 10 times of water gagings decoctions 2 times, each 2 hours, collecting decoction filtered, concentrating under reduced pressure, drying is pulverized, and is standby.Other gets vaseline 650g, lanoline 150g and liquid Paraffin heated 1 hour in 150 ℃ in right amount, filter, put and be chilled to 50 ℃, add Rhizoma Curcumae volatile oil, stir evenly, add above-mentioned dried cream fine powder and collagen protein fine powder 38g then, with micronizing in the vibration type super micron mill 15 minutes, fully mix homogeneously is made ointment.
Annotate: collagen protein is raw material with the Corii Bovis seu Bubali, (promptly at first adopt the pepsin enzymatic isolation method of simulation human stomach's digestion process and physical and chemical parameter through the bionic enzymatic method, simulate human body intestinal canal then and digest and assimilate the pancreatin enzymatic isolation method of process and physical and chemical parameter) make, relative molecular weight is below 5kD.
Embodiment seven
Prescription: Rhizoma Coptidis 50g Cortex Phellodendri 10g Radix Et Rhizoma Rhei 20g Rhizoma Polygoni Cuspidati 10g
Flos Lonicerae 15g Fructus Forsythiae 10g Herba Andrographis 10g Folium Isatidis 10g
Radix Isatidis 10g Indigo Naturalis 1g Rhizoma Osmundae 10g Herba Taraxaci 20g
Herba Violae 10g Flos Chrysanthemi Indici 10g Rhizoma Paridis 10g Rhizoma Bistortae 10g
Radix Rhapontici 10g Rhizoma Smilacis Glabrae 10g Caulis Sargentodoxae 10g Herba Patriniae 20g
Lasiosphaera Seu Calvatia 10g Herba Euphorbiae Humifusae 10g Herba Lobeliae Chinensis 10g Herba Hedyotidis Diffusae 20g
Radix Ampelopsis 10g Radix Angelicae Dahuricae 10g Herba Achilleae 20g Radix Sanguisorbae 20g
Collagen protein 15g
Method for making: above-mentioned 28 flavors, get Indigo Naturalis, collagen protein is standby; Get Rhizoma Coptidis, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Polygoni Cuspidati and add 5 times of amount 50% alcohol reflux 3 times, merge, filter, decompression recycling ethanol concentrates, and is standby; Flos Lonicerae, Herba Taraxaci, Flos Chrysanthemi Indici, the Radix Angelicae Dahuricae add the water vapor distillation and extract volatile oil, and 18 flavors such as medicinal residues and Folium Isatidis add 10 times of water gagings and decoct 2 times, and each 1 hour, collecting decoction, filter, concentrating under reduced pressure mixes with above-mentioned alcohol-extracted extract, drying under reduced pressure is pulverized, and is standby.Other gets sodium carboxymethyl cellulose 60g, adds the abundant swollen of suitable quantity of water, stirs evenly, and adds above-mentioned dried cream fine powder, Indigo Naturalis and collagen protein aqueous solution, and adds water to 1000g, mixes 20 minutes in the vibration type super micron mill, makes gel.
Annotate: collagen protein is a raw material with Corii Sus domestica and heel string, makes through trypsin and the abundant enzymolysis of papain, and relative molecular weight is below 20kD.
Embodiment eight
Prescription: Radix Isatidis 100g Folium Isatidis 50g Rhizoma Osmundae 50g Herba Taraxaci 50g
Herba Euphorbiae Humifusae 50g Herba Lobeliae Chinensis 50g collagen protein 50g collagen 20g
Method for making: above-mentioned eight flavors, Radix Isatidis, Folium Isatidis, Rhizoma Osmundae, Herba Taraxaci, Herba Euphorbiae Humifusae, Herba Lobeliae Chinensis add 10 times of water gagings and decoct 3 times, and each 1 hour, collecting decoction filtered, and was evaporated to relative density and is about 1.20 clear paste, and is standby; Other gets methylcellulose 15g, adds the abundant swollen of low amounts of water, stirs evenly, and adds above-mentioned clear paste, collagen protein and collagenic aqueous solution, and adds water to 1000g, stirs, and removes bubble, makes gel.
Annotate: collagen protein is raw material with the gelatin, makes through the abundant enzymolysis of ficoin, and relative molecular weight is below 30kD.Collagen is raw material with the Corii Bovis seu Bubali, adopts acetic acid solution to extract, and makes through the pepsin enzymolysis, and relative molecular weight is at 250～285kD.
Embodiment nine
Prescription: Radix Rhapontici 100g Rhizoma Smilacis Glabrae 100g Caulis Sargentodoxae 50g Herba Patriniae 100g
Rhizoma Chuanxiong 90g Radix Angelicae Sinensis 90g collagen 20g collagen protein 30g
Method for making: above-mentioned eight flavors, Rhizoma Chuanxiong, Radix Angelicae Sinensis add 5 times of amount 70% alcohol reflux 3 times, and collecting decoction filters, and decompression recycling ethanol is to there not being the alcohol flavor, and is standby; The gained medicinal residues add 10 times of water gagings with Radix Rhapontici, Rhizoma Smilacis Glabrae, Caulis Sargentodoxae, Herba Patriniae and decoct 2 times, each 1 hour, collecting decoction filters, and is concentrated into an amount of, add above-mentioned recovery ethanol liquid, collagen protein and collagen solution, stir evenly, add water to 1000ml, placement is spent the night, get the supernatant packing, promptly get lotion.
Annotate: collagen protein is raw material with the gelatinum oxhide, makes through bromelain and the abundant enzymolysis of papain, and relative molecular weight is below 15kD; Collagen is raw material with the Os Bovis seu Bubali, adopts citric acid solution to extract, and makes through papain enzymolysis, and relative molecular weight is at 260～290kD.
Embodiment ten
Prescription: Flos Lonicerae 55g Fructus Forsythiae 20g Herba Andrographis 50g Folium Isatidis 50g
Radix Isatidis 50g Indigo Naturalis 5g Rhizoma Osmundae 10g Herba Taraxaci 20g
Radix Paeoniae Alba 50g collagen protein 25g collagen 15g
Method for making: above-mentioned ten simply, Flos Lonicerae adopts steam distillation to make volatile oil, gained medicinal residues and Fructus Forsythiae, Herba Andrographis, the Radix Paeoniae Alba, Radix Isatidis, Rhizoma Osmundae and Herba Taraxaci add 10 times of water gagings together and decoct 3 times, each 1 hour, collecting decoction filtered, be evaporated to relative density and be about 1.10 clear paste, add Indigo Naturalis, mixing, the mixed solution and the formalin 5ml of adding collagen protein and collagen, pour in the frothing machine simultaneously, 10～the 20min that gets blisters makes abundant foaming, treat the foam uniform and smooth after, be sub-packed in the can rapidly, in-20 ℃ of lyophilizations 24 hours, the sterilization packing promptly got sponginum.
Annotate: collagen protein is raw material with the gelatin, makes through pepsin and the abundant enzymolysis of papain, and relative molecular weight is at 5～10kD.Collagen is raw material with Corii Sus domestica, Corii Bovis seu Bubali, pig heel string and cattle heel string, adopts acetic acid solution to extract, and makes through papain enzymolysis, and relative molecular weight is at 250～280kD.
Embodiment 11
Prescription: Radix Et Rhizoma Rhei 80g Rhizoma Polygoni Cuspidati 50g Flos Lonicerae 25g Fructus Forsythiae 60g
Herba Andrographis 100g Folium Isatidis 100g Herba Hedyotidis Diffusae 50g collagen 50g
Method for making: above-mentioned eight flavors, Radix Et Rhizoma Rhei, Rhizoma Polygoni Cuspidati add 5 times of amount 70% alcohol reflux 3 times, and merge extractive liquid, filters, and decompression recycling ethanol is to there not being the alcohol flavor, and is standby; The gained medicinal residues add 10 times of water gagings with Flos Lonicerae, Fructus Forsythiae, Herba Andrographis, Folium Isatidis, Herba Hedyotidis Diffusae and decoct 3 times, and each 1 hour, collecting decoction, filter, be concentrated in right amount, add collagen solution and formalin 5ml, pour in the frothing machine simultaneously, 10～the 20min that gets blisters makes abundant foaming, treat the foam uniform and smooth after, be sub-packed in the can rapidly, in-20 ℃ of lyophilizations 24 hours, the sterilization packing promptly got sponginum.
Annotate: collagen is raw material with Corii Sus domestica and pig heel string, adopts tartaric acid solution to extract, and makes through papain enzymolysis, and relative molecular weight is at 250～300kD.
Embodiment 12
Get the obtained gel agent treatment of embodiment eight chronic skin skin infection cases totally 122 examples, male's 56 examples wherein, women's 66 examples are divided into treatment group 80 example and matched group 42 examples at random; 5～68 years old age, average 40.1 years old; Course of disease January～22 months, general 2～March; Ulcer area 5～80cm
2Upper limb ulcer 23 examples wherein, other position 6 examples; Wound or traumatic infection form ulcer 38 examples, traumatic infection 52 examples that burn causes.Disinfect the bedsore wound surrounding skin during use earlier in alcohol, the reuse normal saline cleans clean, coats gel after waiting to do, the local ultra violet lamp 30min that adopts, and every day 2 times, and keep local cleaning, drying, tracing observation therapeutic effect.Criterion of therapeutical effect: 1. cure: skin is formed a scab fully or cicatrix generates; 2. effective: wound surface oozes out minimizing, has the part granulation tissue to generate; 3. invalid: wound surface does not have significant change or accompanying infection; Observed result: after controlling 70 days, 57 example healings in 80 examples are organized in treatment, account for 71.25%; 13 examples are effective, and it is invalid to account for 16.25%, 10 example, accounts for 12.5%; 18 examples are cured in matched group 42 examples, account for 42.86%; 8 examples effectively account for 19.05%; 16 examples are invalid, account for 38.10%.Learn by statistics and handle, two groups are all having significant difference (P＜0.05) aspect cure rate and the effective percentage.
Embodiment 13
Get embodiment seven gained gels treatment patients with bedsore 52 examples, wherein male 22 examples, women 30 examples; The oldest 80 years old, minimum 31 years old, average 52 years old; Paralytic patient 25 examples wherein, cerebrovascular accident person's 27 examples; II degree decubital ulcer 28 examples, III degree decubital ulcer 24 examples; Wound surface area reckling 1cm * 3cm, the maximum 7cm * 14cm.Therapeutic scheme: disinfect the bedsore wound surrounding skin during use earlier in alcohol, the reuse normal saline cleans clean, coats this gel after waiting to do, and is local with roasting light irradiation 30min, every day 2 times, and keep local cleaning, drying.As a result in 52 examples, except that 3 examples because of the therapy discontinued of leaving hospital automatically, all the other 40 routine wound surface all heal, and account for 81.63%, 9 routine wound surface and heal substantially, account for 18.37%.The course of treatment is the shortest 14 days, and is the longest 60 days, and The average healing is 38 days.
Claims (9)
1, a kind of pharmaceutical composition that is used for the treatment of skin injury ulcer class disease is characterized in that this pharmaceutical composition raw materials of effective components medicine is any or the combination more than two kinds in collagen protein and the following antipyretic and antidotal type Chinese medicine: Rhizoma Coptidis, Cortex Phellodendri, Radix Et Rhizoma Rhei, Rhizoma Polygoni Cuspidati, Flos Lonicerae, Fructus Forsythiae, Herba Andrographis, Folium Isatidis, Radix Isatidis, Indigo Naturalis, Rhizoma Osmundae, Herba Taraxaci, Herba Violae, Flos Chrysanthemi Indici, Rhizoma Paridis, Rhizoma Bistortae, Radix Rhapontici, Radix Sanguisorbae, Rhizoma Smilacis Glabrae, Caulis Sargentodoxae, Herba Patriniae, Lasiosphaera Seu Calvatia, Herba Euphorbiae Humifusae, Herba Lobeliae Chinensis, Herba Hedyotidis Diffusae, Radix Ampelopsis, the Radix Angelicae Dahuricae, Herba Achilleae.
2, pharmaceutical composition according to claim 1 is characterized in that the ratio of collagen protein and Chinese medicine ingredients is 1: 0.5～1: 50 in this pharmaceutical composition effective ingredient.
3, pharmaceutical composition according to claim 2 is characterized in that the ratio of collagen protein and Chinese medicine ingredients is 1: 1～1: 20 in this pharmaceutical composition effective ingredient.
4,, it is characterized in that collagen protein wherein replaces with collagen, or replace with the mixture of collagen and collagen protein according to claim 1,2 or 3 described pharmaceutical compositions.
5, according to claim 1,2 or 3 described pharmaceutical compositions, it is characterized in that used collagen protein is to be made through enzymolysis by gelatin, Colla Corii Asini, new Colla Corii Asini, Corii Sus domestica, Corii Bovis seu Bubali, Os Sus domestica, Os Bovis seu Bubali, pig heel string or cattle heel string, its relative molecular weight is not higher than 100kD.
6, pharmaceutical composition according to claim 5 is characterized in that the relative molecular weight of used collagen protein is not higher than 40kD.
7, pharmaceutical composition according to claim 4 is characterized in that used collagen is to be made by Corii Sus domestica, Corii Bovis seu Bubali, Os Sus domestica, Os Bovis seu Bubali, pig heel string or cattle heel string, and its relative molecular weight is 250～300kD.
8, each described pharmaceutical composition is used for the treatment of application in the medicine of skin injury ulcer class disease in preparation in the claim 1 to 7.
9, as the purposes of pharmaceutical composition as described in the claim 8, it is characterized in that described skin injury ulcer class disease comprises mechanical injury, burn and scald, decubital ulcer, chronic ulcer of the lower limb, diabetic foot or cancer ulcer.
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