CN101648002A - 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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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 fighting bacterium, diminishing inflammation, removing putrefaction and promoting tissue regeneration such as angelica, Szechuan lovage rhizome, salvia root and the like which are prepared into a plurality of dosage forms by matching the prior art. The technology overcomes the defects that the prior preparations for the trauma department have extremely slow response, longer treatment course, adhesion with the skin, influence on scab cicatrization and the like, and 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.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that is used for the treatment of various skin injury ulcer class diseases, form, belong to the field of Chinese medicines by collagen protein and anti-inflammation putrefaction-removing granulation-promoting class Chinese medicine.
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, it is the refractory disease that the doctor generally acknowledges, still there is not comparatively ideal therapeutic scheme at present, mostly be hemostasis and (or) anti-inflammation, putrefaction-removing granulation-promoting medicine and Western medicine antimicrobial drug (as gentamycin, chloromycetin etc.) use in conjunction, poor effect.
External treatment of Chinese medicine is emphasized " controlling of surgery focuses on external treatment ", and " wanting of external treatment focuses on ' putrefaction-removing granulation-promoting ' " should reach anti-inflammation, put forward the effect that pus is removed in corruption, can promote damaged and the histiocytic regeneration of ulcer wound surface, i.e. " granulation promoting " again.Present clinical Chinese medicine for external application commonly used such as powder, lotion, plaster, patch, ointment, ointment etc., mostly be merely putrefaction-removing granulation-promoting or anti-inflammation, all be to rely on medicine " putrefaction removing " with " granulation promoting ", effect is not satisfactory, onset is slow, the course of disease is long, patient's pain unbearably, clinical expansion and use restricted greatly.
Collagen protein is to form animal connective tissue's important protein matter, connective tissue is except containing 60～70% moisture, collagen protein has accounted for about 20～30%, it is the extracellular matrix components that body weight for humans is wanted, have good fibre-forming performance, anthemorrhagic performance, cell-cell interaction performance, promote 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.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition, a kind of especially pharmaceutical composition that is used for the treatment of various skin injury ulcer class diseases and preparation method thereof.
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 anti-inflammation putrefaction-removing granulation-promoting class Chinese medicine: Olibanum, Myrrha, Borneolum Syntheticum, Camphora, catechu, artificial Moschus, Sanguis Draxonis, Sanguis Draxonis, Gypsum Fibrosum Preparatum, the Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Erodii, Calamina, Margarita and Radix Sanguisorbae.
In addition, 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, 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, preferred weight proportion is 1: 1～1: 20, wherein middle pharmaceutically active ingredient mean above-mentioned anti-inflammation putrefaction-removing granulation-promoting class 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.
And collagen protein described in the gained pharmaceutical composition of the present invention can be that collagen protein or collagen feed intake separately, can also be the mixed material feeding of collagen protein and collagen, mainly is the two similar performance, 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, the general single enzyme enzymolysis such as pepsin, papain or ficoin that adopt during enzymolysis, how at low temperatures (below 10 ℃) carry out, prevent albuminous degeneration, do not destroy unique right-handed helix main structure body, only excise non-collagen tail peptide position, its relative molecular weight is 250～300kD, has complete triple-helix structure; The further hydrolysis of collagen gets gelatin, and its relative molecular weight is 100～200kD, and triple-helix structure is destroyed; Collagen protein is the further enzymatic hydrolysate of gelatin, and its relative molecular weight is below 100kD, and wherein the overwhelming majority exists with the form of collagen oligopeptide, and relative molecular weight is below 40kD.Collagen protein can also be directly from raw materials such as gelatin, Colla Corii Asini, new Colla Corii Asini enzymolysis obtain.The relative molecular weight of collagen and gelatin 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 contained collagen oligopeptide is more, 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, gelatin, collagen protein all can be brought into play effects such as promoting wound healing and tissue repair in Chinese medicine for external application.
The used collagen protein of the present invention is to be made through enzymatic isolation method 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, and its relative molecular weight is not higher than 100kD.
The used collagen protein main preparation methods of the present invention is: get the collagen raw material, clear water or saline solution are cleaned, and remove impurity such as fat, residual meat, add acid or alkali and regulate proper pH value, low temperature (0～10 ℃) enzymolysis 24～72 hours, centrifugal, get supernatant, regulate proper pH value, add the desirable proteins enzyme and carry out abundant enzymolysis, get supernatant, adding neutral salt saltouts, the dialysis remove impurity is further purified, promptly.
Or rather, the primary raw material of the used collagen protein of the present invention derives from gelatin, Colla Corii Asini, new Colla Corii Asini, Corii Sus domestica, Corii Bovis seu Bubali, Os Sus domestica, Os Bovis seu Bubali, during pig heel string or cattle are followed any one or a few, make through thorough enzymolysis, its relative molecular weight is preferably below the 40kD, described enzyme solution can be a pepsin, trypsin, pancreatin, neutral protease, alkaline protease, bromelain, any one single enzyme enzymolysis in ficin or the papain, it also can be pepsin, trypsin, pancreatin, neutral protease, alkaline protease, bromelain, the combination enzymolysis of any several enzymes in ficin or the papain, can also be that the bionic enzymatic method of copying the human consumption absorption process fully (promptly at first adopts the pepsin enzymatic isolation method of simulation human stomach's digestion process and physical and chemical parameter, simulate human body intestinal canal then and digest and assimilate the pancreas of process and physical and chemical parameter (albumen) enzyme enzymatic isolation method, thereby obtain to supply the directly low molecule oligopeptide material of absorption of human body).
The used collagen of the present invention is to be made through enzymolysis 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.
The used collagen of the present invention mainly adopts the method for being prepared as follows to make:
Get the collagen raw material, clear water or saline solution are cleaned, and remove impurity such as fat, residual meat, and add acid or alkali and regulate proper pH value, low temperature (0～10 ℃) enzymolysis 24～72 hours, centrifugal, get supernatant, add neutral salt to saltout, the dialysis remove impurity is further purified, promptly.
More properly say, the primary raw material of the used collagen of the present invention derives from Corii Sus domestica, Corii Bovis seu Bubali, Os Sus domestica, Os Bovis seu Bubali, in pig heel string or the cattle heel string any one or a few, make through suitable enzymatic isolation method, its relative molecular weight is 250～300kD, described enzyme solution can be a pepsin, trypsin, pancreatin, neutral protease, alkaline protease, bromelain, any one single enzyme enzymolysis in ficin or the papain also can be a pepsin, trypsin, pancreatin, neutral protease, alkaline protease, bromelain, the combination enzymolysis of any several enzymes in ficin or the papain.
Among the preparation technology of above-mentioned collagen protein or collagen, used acid is any one or a few in tartaric acid, malic acid, acetic acid, citric acid, glycine or the hydrochloric acid, and used alkali is any one or a few in ammonia, sodium hydroxide, potassium hydroxide, sodium carbonate or the sodium bicarbonate.
Among the preparation technology of above-mentioned collagen protein or collagen, the used salt of saltouing can be any one or a few in ammonium sulfate, magnesium sulfate, sodium sulfate, sodium chloride or the sodium phosphate.
Pharmaceutical composition of the present invention mainly adopts the method for being prepared as follows to make:
A, get anti-inflammation putrefaction-removing granulation-promoting class Chinese crude drug, pulverize, adopt suitable method to extract, refining purification, part resin and mineral substance medical material can all or part ofly stay powder, make drug extract;
B, get the collagen protein that makes and (or) collagen, 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 and collagen protein are wanted as body weight for humans (being the raw material of granulation promoting) has good biological characteristics and physiology characteristic:
Physiology characteristic: a, ion and macromole binding ability: under naturalness and physiological condition, tropocollagen molecule has 60 free carboxyl groups approximately, and these groups have in conjunction with cationic ability, and under there was situation in lyotropic salt, the ions binding degree improved; B, fibre-forming performance: collagen fabric natural in tissue gets up with specific sequential organization, and the reorganization by collagen protein can obtain the polymorphic collagen protein; C, in conjunction with the multiple factor: collagen protein can be in conjunction with the multiple factor, and induces, regulates the cell growth.
Biological characteristics: a, excellent biological compatibility and reduced immunogenicity function: new organization support or be absorbed into cell, collagen and substrate show good harmony; Collagen protein surface some zone and human cell surface glycoprotein particular combination, the wild phase capacitive; To macrophage, somatomedin etc. play chemotaxis, for cell adhesion, move, propagation provides support; B, promote wound healing, the characteristic of tissue repair: the guiding 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; C, degradability; D, hemostatic function: coagulation platelet; The mechanical pressure hemostasis; E, strongly hydrophilic: spiral network structure; Rich in amino acid; The hydroxyl of hydroxyproline; Molecular asymmetry.
With collagen protein and (or) collagen and anti-inflammation putrefaction-removing granulation-promoting class Chinese medicine is used in combination, initiatively provide nutrition and " granulation promoting " material on the one hand for diseased region, compare with simple " the medicine putrefaction removing is with granulation promoting ", accelerate damaged and the histiocytic regeneration of ulcer wound surface significantly, promoted wound healing and tissue repair; On the other hand, anti-inflammation putrefaction-removing granulation-promoting class medicine focuses on " propose corruption and remove pus; antibiotic convergence, removing the necrotic tissue meat, tissue regeneration promoting meat ", the cleaning wound surface, improve the local woanded surface microcirculation indirectly, improve and organize oxygen supply, promoted wound healing and tissue repair 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.
Innovatively with collagen protein and (or) collagen and the medication combined application of anti-inflammation putrefaction-removing granulation-promoting class, medicine focuses on " putrefaction removing ", antibiotic convergence, the cleaning wound surface, improve the local woanded surface microcirculation indirectly, improve and organize oxygen supply, (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 or collagen focus on " granulation promoting ", as the extracellular matrix components that body weight for humans is wanted, accelerate damaged and the histiocytic regeneration of ulcer wound surface, promote 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 the Chinese medicine extract except that anti-inflammation putrefaction-removing granulation-promoting class medicine, as the clearing away heat,cooling blood and removing toxin class: 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, 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 etc.; Blood-activating stasis-removing kind: Radix Angelicae Sinensis, Rhizoma Chuanxiong, Radix Salviae Miltiorrhizae, 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.
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 anti-inflammation putrefaction-removing granulation-promoting class, treat various skin injury ulcer class diseases and all 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, " granulation promoting " process of acceleration has shortened healing of wound mouth and tissue repair required time greatly, has shortened the course of disease, alleviated the patient suffering, thereby compare with the purpose of merely using anti-inflammation or drug for invigorating blood circulation and eliminating stasis to reach " putrefaction removing is with granulation promoting ", with the obvious advantage, be subjected to patient's consistent favorable comment.
For illustrating beneficial effect of the present invention more fully, the spy is illustrated with following pharmacodynamics test.
Pharmacodynamics test: to the influence test of experimental mice wound tissue healing
1 test material
Experimental animal: Kunming mouse, male and female half and half, body weight 18～22g is available from the Shandong University animal testing center; Trial drug: the ointment that the embodiment of the invention four provides; Control drug: JINGWANHONG RUANGAO, by Tianjin Darentang Pharmaceutical Factory production.
2 test methods
Modeling: mice is at the equal normal drinking-water of experimental session, full diet, and 24h is with the mouse back 2cm * 2cm that loses hair or feathers before test.Scald mouse back skin with 80 ℃ of thermostatted waters respectively by a glass cylinder, cause II degree scalding model.Be divided into blank group, treatment group and matched group (external application JINGWANHONG RUANGAO) after the mice modeling at random, every group each 15.Give respectively treatment group and matched group every day and relative medicine 4 times, raise separately, prevent to gnaw mutually between the mice and bite medicine, continuous 7 days.
Observe the wound healing situation, record skin incrustation time and wound healing time.
3 result of the tests
Adopt variance analysis that result of the test is carried out statistical procedures, represent that with x ± s result of the test is as follows:
Table 1 is respectively organized relatively (x ± s) of mice wound tissue healing result
| Group | Dosage | ??n | The incrustation time (my god) | Healing time (my god) |
| Blank group | ??- | ??15 | ??0.94±0.18 | ??17.8±1.85 |
| The treatment group | ??45g/kg | ??15 | ??0.52±0.10**△ | ??11.6±1.22**△ |
| Matched group | ??45g/kg | ??15 | ??0.75±0.13* | ??14.2±1.38* |
Annotate: compare * P＜0.05, * * P＜0.01 with the blank group; Compare △ P＜0.05 with matched group.
Experimental result shows, gained pharmaceutical composition of the present invention can obviously reduce the time of incrustation of mouse back scalded skin and healing, and the healing degree points out this present invention gained pharmaceutical composition that the experiment mice wound tissue healing is had remarkable facilitation than matched group more obvious (P＜0.05).
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
Prescription: Gypsum Fibrosum Preparatum 60g Sanguis Draxonis 25g Borneolum Syntheticum 25g artificial Moschus 5g
Radix Arnebiae (Radix Lithospermi) 60g catechu 50g collagen protein 20g
Method for making: above-mentioned seven flavors, Radix Arnebiae (Radix Lithospermi) add 4 times of amount 70% alcohol reflux 2 times, filter, and merge, and decompression recycling ethanol concentrates, and drying is pulverized, and is standby; 20 mesh standard sieves are crossed in four flavor coarse pulverizations such as Gypsum Fibrosum Preparatum, and micronizing is 25 minutes in the vibration type super micron mill, gets micropowders, and is standby.Other gets vaseline 600g and lanoline 150g in 150 ℃ of heating 1 hour, filters, and puts and is chilled to 50 ℃, adds the dried cream fine powder of above-mentioned Radix Arnebiae (Radix Lithospermi), micropowders and collagen protein fine powder 20g, mixing, and ointment is made in packing.
Annotate: collagen protein is raw material with the donkey skin, (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 40kD.
Embodiment two
Prescription: Sanguis Draxonis 90g Borneolum Syntheticum 50g collagen protein 10g collagen 5g
Method for making: above-mentioned four flavors, 20 mesh standard sieves are crossed in Sanguis Draxonis and Borneolum Syntheticum coarse pulverization, and micronizing is 20 minutes in the vibration type super micron mill, gets micropowders, and is standby.Other gets vaseline 640g, lanoline 80g and liquid paraffin in right amount in 150 ℃ of heating 1 hour, filters, and puts and is chilled to 50 ℃, add above-mentioned micropowders and collagen protein and collagen fine powder 15g altogether, in the vibration type super micron mill, mixed 10 minutes discharging, ointment is made in packing.
Annotate: collagen protein is raw material with the gelatin, makes through papain and the abundant enzymolysis of trypsin, and relative molecular weight is below 20kD.Collagen is raw material with Corii Sus domestica and Corii Bovis seu Bubali, and adopting acetic acid to regulate pH is 7.0, makes through the ficoin enzymolysis, and relative molecular weight is at 255～280kD.
Embodiment three
Prescription: Rhizoma Chuanxiong 90g Olibanum 50g Myrrha 50g exhausts 30g
Pseudobulbus Bletillae (Rhizoma Bletillae) 125g Herba Erodii 125g collagen protein 30g
Method for making: above-mentioned seven flavors, Rhizoma Chuanxiong, the Pseudobulbus Bletillae (Rhizoma Bletillae) and Herba Erodii decoct with water 2 times, and each 2 hours, collecting decoction filtered, and concentrated, and drying is pulverized, and is standby; Olibanum, Myrrha and Sanguis Draxonis are pulverized, and cross 200 orders, and be standby.Get carbomer 10g, added the water swollen 24 hours, add triethanolamine and transfer pH to 8.0, stir evenly, add impalpable powder and collagen protein fine powder 30g such as above-mentioned dried cream powder, Olibanum, and add water to 1000g, stir evenly, remove 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 four
Prescription: Flos Carthami 160g Sanguis Draxonis 40g Radix Angelicae Sinensis 80g Radix Arnebiae (Radix Lithospermi) 40g
Radix Sanguisorbae 45g Pseudobulbus Bletillae (Rhizoma Bletillae) 30g Borneolum Syntheticum 10g collagen protein 45g
Method for making: above-mentioned eight flavors, Flos Carthami, Radix Angelicae Sinensis, Radix Arnebiae (Radix Lithospermi) and Sanguis Draxonis add 4 times of amount 80% alcohol reflux 2 times, filter, and merge, and decompression recycling ethanol concentrates, and drying is pulverized, and is standby; The gained medicinal residues add 10 times of water gagings with the Radix Sanguisorbae and the Pseudobulbus Bletillae (Rhizoma Bletillae) and decoct 2 times, and each 2 hours, collecting decoction filtered, concentrating under reduced pressure, and drying is pulverized, and is standby.Other gets vaseline 680g, lanoline 70g and liquid Paraffin in right amount in 150 ℃ of heating 1 hour, filters, and puts and is chilled to 50 ℃, add above-mentioned dried cream fine powder and collagen protein fine powder 45g, mixed discharging 15 minutes with pulverizing in the vibration type super micron mill, ointment is made in packing.
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 8kD.
Embodiment five
Prescription: Margarita 30g catechu 125g Radix Angelicae Sinensis 75g Rhizoma Chuanxiong 75g
Pseudobulbus Bletillae (Rhizoma Bletillae) 125g Radix Arnebiae (Radix Lithospermi) 60g Gypsum Fibrosum Preparatum 30g collagen protein 80g
Method for making: above-mentioned eight flavors, Rhizoma Chuanxiong, Radix Angelicae Sinensis, the Pseudobulbus Bletillae (Rhizoma Bletillae) and Radix Arnebiae (Radix Lithospermi) add 5 times of amount 60% alcohol reflux 3 times, merge, and filter, and decompression recycling ethanol concentrates, and drying is pulverized, and is standby; 20 orders are crossed in Margarita, catechu and Gypsum Fibrosum Preparatum coarse pulverization, micronizing 30min in the vibration type super micron mill, and discharging, standby.Other gets sodium carboxymethyl cellulose 60g, adds the abundant swollen of suitable quantity of water, stirs evenly, and adds micropowders and collagen solutions such as above-mentioned dried cream fine powder, Margarita, mixing, and add water to 1000g, make gel.
Annotate: collagen protein is a raw material with Corii Sus domestica and pig heel string, makes through trypsin and the abundant enzymolysis of papain, and relative molecular weight is below 10kD.
Embodiment six
Prescription: Radix Sanguisorbae 40g Margarita 20g Olibanum 35g Myrrha 35g Herba Erodii 60g Sanguis Draxonis 20g
Borneolum Syntheticum 15g Camphora 15g catechu 20g Calamina 45g Pseudobulbus Bletillae (Rhizoma Bletillae) 60g Gypsum Fibrosum Preparatum 45g
Artificial Moschus 10g collagen protein 20g collagen 35g
Method for making: above-mentioned ten five tastes, Radix Sanguisorbae, Herba Erodii, Gypsum Fibrosum Preparatum and the Pseudobulbus Bletillae (Rhizoma Bletillae) add 10 times of water gagings and decoct 3 times, and each 1.5 hours, collecting decoction filtered, and are evaporated to relative density and are about 1.10 clear paste, and are standby; 20 mesh sieves are crossed in nine flavor flushing coarse pulverizations such as other Margarita, pulverize 30min in the vibration type super micron mill, and discharging is standby; Other gets methylcellulose 15g, adds the abundant swollen of low amounts of water, stirs evenly, and adds micropowders and collagen protein and collagen solutions such as above-mentioned clear paste, Margarita, 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 5kD.Collagen is raw material with Corii Sus domestica and Corii Bovis seu Bubali, and adopting the Fructus Citri Limoniae acid for adjusting pH is 2.0 ± 0.2, makes through the pepsin enzymolysis, and relative molecular weight is at 250～300kD.
Embodiment seven
Prescription: Radix Notoginseng 30g Radix Paeoniae Rubra 35g Flos Carthami 30g Herba Leonuri 55g Hirudo 30g Eupolyphaga Seu Steleophaga 30g
Semen Persicae 85g Radix Arnebiae (Radix Lithospermi) 30g Rhizoma Curcumae 60g Rhizoma Corydalis 45g Cortex Moutan 30g Rhizoma Chuanxiong 90g
Radix Angelicae Sinensis 90g Radix Sanguisorbae 30g Radix Angelicae Dahuricae 30g collagen 25g collagen protein 55g
Method for making: above-mentioned 17 flavors, Hirudo and Eupolyphaga Seu Steleophaga micronizing add suitable quantity of water homogenate, the pepsin that adds 120U/g (substrate) then, regulate pH to 2.0 ± 0.2,40 ℃ insulation enzymolysis 3 hours, add diluted sodium hydroxide solution then and regulate pH to 8.0 ± 0.2, add 2.0% pancreatin, 50 ℃ are incubated enzymolysis 3 hours, 85 ℃ of insulation 30min, ultrafiltration, intercept the little peptide solution of relative molecular weight below 5kD, standby; The Radix Angelicae Dahuricae, Radix Notoginseng, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Cortex Moutan, Radix Arnebiae (Radix Lithospermi) and Rhizoma Corydalis 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 Sanguisorbae, Radix Paeoniae Rubra, Flos Carthami, Herba Leonuri and Semen Persicae and decoct 2 times, each 2 hours, collecting decoction filtered, merge with decocting liquids such as little peptide solution of above-mentioned Hirudo Eupolyphaga Seu Steleophaga and Radix Notoginseng, be concentrated in right amount, add collagen protein and collagen solution, stir evenly, add water to 1000ml, placement is spent the night, and gets the supernatant packing, promptly gets lotion.
Annotate: collagen protein is a raw material with gelatinum oxhide and new Colla Corii Asini, makes through bromelain and the abundant enzymolysis of papain, and relative molecular weight is below 7kD; Collagen is raw material with Os Sus domestica and Os Bovis seu Bubali, and adopting hydrochloric acid to regulate pH is 2.0 ± 0.2, makes through the pepsin enzymolysis, and relative molecular weight is at 265～290kD.
Embodiment eight
Prescription: Herba Achilleae 75g Herba Erodii 30g Radix Arnebiae (Radix Lithospermi) 125g Borneolum Syntheticum 15g Scorpio 50g
Scolopendra 50g Radix Glycyrrhizae 55g collagen protein 60g
Method for making: above-mentioned eight flavors, Scorpio and Scolopendra micronizing, add suitable quantity of water homogenate, add diluted sodium hydroxide solution then and regulate pH to 8.0 ± 0.2, add 4.0% pancreatin and the trypsin of 3000U/g (substrate), 50 ℃ of insulation enzymolysis 4 hours, 85 ℃ of insulation 30min, ultrafiltration intercepts the little peptide solution of relative molecular weight below 10kD, and is standby; Borneolum Syntheticum is with few alcoholic solution of trying one's best, and is standby; Herba Achilleae, Herba Erodii, Radix Arnebiae (Radix Lithospermi) and Radix Glycyrrhizae add 10 times of water gagings together and decoct 3 times, and each 1 hour, collecting decoction, filter, merge with decocting liquids such as little peptide solution of above-mentioned Scorpio Scolopendra and Radix Notoginseng, be concentrated in right amount, add collagen solution and Borneolum Syntheticum solution, stir evenly, add water to 1000ml, placed 24 hours, filter, get supernatant and be sub-packed in the aerosol apparatus, promptly get spray.
Annotate: collagen protein is a raw material with cattle heel string and pig heel string, makes through the abundant enzymolysis of trypsin, and relative molecular weight is below 3kD.
Embodiment nine
Prescription: Camphora 25g Herba Hedyotidis Diffusae 120g Sanguis Draxonis 55g Herba Achilleae 160g Radix Angelicae Dahuricae 80g
Collagen 10g collagen protein 45g
Method for making: above-mentioned seven flavors, Herba Hedyotidis Diffusae, Herba Achilleae and the Radix Angelicae Dahuricae add 10 times of water gagings together and decoct 3 times, and each 1 hour, collecting decoction, filter, add collagen protein and collagen solution, stir evenly, be concentrated into an amount of, suitably dressing adsorbs medicinal liquid, and evenly sprinkling the micropowders of Sanguis Draxonis and Camphora, packing promptly gets Wet-dressing agent.
Annotate: collagen protein is raw material with the gelatin, makes through the abundant enzymolysis of pepsin, and relative molecular weight is below 30kD.Collagen is raw material with Corii Sus domestica and pig heel string, and adopting the winestone acid for adjusting pH is 6.5 ± 0.2, makes through papain enzymolysis, and relative molecular weight is at 260～300kD.
Embodiment ten
Prescription: Herba Leonuri 60g Radix Salviae Miltiorrhizae 80g Hirudo 50g Sanguis Draxonis 20g Borneolum Syntheticum 20g Radix Arnebiae (Radix Lithospermi) 120g
Collagen protein 20g
Method for making: above-mentioned seven flavors, Herba Leonuri, Radix Salviae Miltiorrhizae, Hirudo and Radix Arnebiae (Radix Lithospermi) add 9 times of water gagings together and decoct 2 times, and each 1.5 hours, filter, collecting decoction, concentrating under reduced pressure, drying is pulverized, and is standby.Get above-mentioned dried cream fine powder and add ethyl acetate-ethanol-acetone mixed solution dissolving, other adds Borneolum Syntheticum, Sanguis Draxonis and collagen protein fine powder, and adding pressure sensitive adhesive 250g, mix homogeneously and mixed mix homogeneously 30 minutes in the vibration type super micron mill, leave standstill, film on coating machine, drying is made the paster agent.
Annotate: collagen protein is a raw material with cattle heel string and gelatinum oxhide, makes through the abundant enzymolysis of papain, and relative molecular weight is below 60kD.
Embodiment 11
Prescription: Radix Sanguisorbae 60g Margarita 30g Olibanum 40g Myrrha 40g Herba Erodii 80g Sanguis Draxonis 15g
Borneolum Syntheticum 25g Camphora 15g catechu 15g Calamina 15g Pseudobulbus Bletillae (Rhizoma Bletillae) 55g Gypsum Fibrosum Preparatum 40g
Artificial Moschus 10g collagen protein 70g collagen 10g
Method for making: above-mentioned 14 flavors, Radix Sanguisorbae, Herba Erodii, the Pseudobulbus Bletillae (Rhizoma Bletillae) and Gypsum Fibrosum Preparatum add 10 times of water gagings together and decoct 3 times, and each 1.5 hours, collecting decoction filtered, and was evaporated to relative density and is about 1.10 clear paste, and is standby; Nine flavor micronizing to 200 orders such as Margarita get ultra-fine fine drug powder, and are standby; Other gets methylcellulose 15g, adds the abundant swollen of low amounts of water, stirs evenly, and adds ultra-fine fine drug powder and collagen protein and collagen solutions such as above-mentioned clear paste, Margarita, 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 alkaline protease, and relative molecular weight is below 15kD.Collagen is raw material with Corii Sus domestica and Corii Bovis seu Bubali, and adopting acetic acid to regulate pH is 7.0～7.5, makes through papain and ficin enzymolysis, and relative molecular weight is at 250～285kD.
Embodiment 12
Prescription: Radix Sanguisorbae 20g Margarita 20g Olibanum 35g Myrrha 50g Herba Erodii 30g Sanguis Draxonis 35g
Hirudo 30g Radix Achyranthis Bidentatae 35g Radix Angelicae Sinensis 20g Rhizoma Chuanxiong 20g Radix Salviae Miltiorrhizae 35g Scolopendra 10g
Borneolum Syntheticum 45g Camphora 45g catechu 10g Calamina 15g Pseudobulbus Bletillae (Rhizoma Bletillae) 15g Gypsum Fibrosum Preparatum 10g
Artificial Moschus 10g collagen protein 50g collagen 25g
Formalin 5ml
Method for making: above-mentioned 20 simply, and Margarita, Olibanum, Myrrha, Sanguis Draxonis, Borneolum Syntheticum and Camphora one arise from micronizing 15min in the vibration type super micron mill, gets micropowders, standby; Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Radix Angelicae Sinensis and the Pseudobulbus Bletillae (Rhizoma Bletillae) add 6 times of amount 65% alcohol reflux 3 times, merge, and filter, and decompression recycling ethanol is concentrated into relative density and is about 1.10 clear paste, and is standby; The gained medicinal residues add 10 times of water gagings with Radix Sanguisorbae, Herba Erodii, Radix Achyranthis Bidentatae, Hirudo, Scolopendra, catechu and Gypsum Fibrosum Preparatum and decoct 3 times, and each 1.5 hours, collecting decoction filtered, and are evaporated to relative density and are about 1.10 clear paste, and are standby; Be concentrated into an amount of, filter, (relative molecular weight is 10～295kD) and formalin, pours into simultaneously in the frothing machine with micropowders such as Margarita, and 10～20min gets blisters to add the mixed solution of collagen protein and collagen, make abundant foaming, after treating the foam uniform and smooth, be sub-packed in rapidly in the can, in-20 ℃ of lyophilizations 24 hours, the sterilization packing promptly gets 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 10～25kD.Collagen is raw material with Corii Sus domestica, Corii Bovis seu Bubali, pig heel string and cattle heel string, and adopting diluted sodium hydroxide solution to regulate pH is 8.0 ± 0.2, makes through trypsin digestion, and relative molecular weight is at 250～295kD.
Embodiment 13
Get embodiment two obtained ointment treatment extremity skin infection patient 92 examples, wherein male 52 examples, women 40 examples.Therapeutic scheme: fully clear up wound before the medication, leak outside, coat ointment of the present invention then, every day 2 times, use uviol lamp local irradiation 30min or hair dryer hot blow 20min simultaneously until flesh tissue.Criterion of therapeutical effect: cure, wound does not promptly have clear scar or a small amount of cicatrix near primary healing, does not influence the function outward appearance; Effectively, wound is a scar healing by granulation tissue hyperplasia and wound contraction mainly, the long or most of growth of wound of healing time, but can not heal fully; Invalid, wound granulation tissue and Pi Yuan do not have growth.Among the 92 routine patients, fully recover 84 (91.30%), produce effects 4 examples (4.35%), invalid 4 examples (4.35%), total effective rate 95.65% as a result.
Embodiment 14
Get embodiment four gained ointments treatment burn and scald patient 24 examples, wherein male 16 examples, women 8 examples; The oldest 62 years old, minimum 5 years old; The course of disease is between 2h～February.Therapeutic scheme: before the use, elder generation coats this gel after wound surface is pressed the surgery of Chinese medicine conventional treatment, spreads on wound surface, every day 2 times, and combination antibiotic and fluid infusion Comprehensive Treatment.Wound pain all ends after the medication as a result, and in 24 examples, 19 routine small size burn and scald are all in 3d～7d healing; 4 routine large tracts of land II degree burn and scald 10d～15d healing do not stay cicatrix; 1 routine II+ degree burn and scald hospitalization also rapid healing after 2 months leaves a small amount of cicatrix.
Embodiment 15
Get embodiment 11 gained gels treatment patients with bedsore 45 examples, wherein male 24 examples, women 21 examples; 20～79 years old age, 48 years old mean age; The position that decubital ulcer takes place: sacrococcygeal region 23 examples, hip 6 examples, omoplate portion 5 examples, heel portion 4 examples, occipitalia 3 examples, sufficient external malleolus 4 examples; Wound surface diameter＜3cm27 example, 3～4cm18 example; Topical manifestations: epidermis is broken, and wound surface exposes subcutaneous tissue, and moist ruddy, secretions is less, can be with pain.Therapeutic scheme: earlier with 75% alcohol disinfecting surrounding skin, reuse normal saline cotton balls cleaning wound surface extracts the normal saline pressurization with syringe then and injects flushing, till the wound surface cleaning, will aspirate blister when blister is arranged.Coat this gel then, every day 2 times, and keep local cleaning, drying.The treatment standard: cure, the brown erythema disappears or festers the healing of skin ulcer face; Take a turn for the better, erythema does not disappear entirely, or the skin ulcer face slough that festers comes off, granulation, and the skin ulcer face dwindles gradually; Do not heal, the open sore part increases, and it is more than to fester.In 45 examples, cure 37 examples (82.22%) as a result, 3 examples that take a turn for the better (6.67%), invalid 5 examples (11.11%).
Embodiment 16
Get embodiment nine gained Wet-dressing agents treatments patient with diabetic feet 34 examples, male's 19 examples wherein, women's 15 examples, 45～63 years old age, 52 years old mean age; The course of disease is the longest 6 years, and is the shortest 2 years.Wherein 11 examples are and burn sample and acupuncture sample pain; The disappearance of beating of 10 routine dorsal artery of foot; 8 example trouble limb skin temperature drops are low, and dorsal artery of foot is beaten and weakened; 5 examples are suffered from limb ulcer.Therapeutic scheme: slough is removed in gradation, keeps wound and otch drain unobstructed, at first will remove the slough of ulcer surface, use the normal saline cleaning down, use then that Wet-dressing agent of the present invention+gentamycin 4U+ insulin 2U soak is in the affected part, binder is fixed, once a day.Among the 34 routine patients, 16 routine skin temperature recover normal, the skin color gain color as a result; 3 routine dorsal artery of foot are beaten and are recovered normal, 9 routine pain reliefs, and 2 routine ulcer healings, total effective rate are 88.24%.
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 anti-inflammation putrefaction-removing granulation-promoting class Chinese medicine: Olibanum, Myrrha, Borneolum Syntheticum, Camphora, catechu, artificial Moschus, Sanguis Draxonis, Sanguis Draxonis, Gypsum Fibrosum Preparatum, the Pseudobulbus Bletillae (Rhizoma Bletillae), Herba Erodii, Calamina, Margarita and Radix Sanguisorbae.
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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| CN2008101182995A CN101648002B (en) | 2008-08-13 | 2008-08-13 | Medicinal composition for treating skin injury and ulcer and application thereof |
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