CN104667335B - The recombination human source collagen product and preparation method of skin barrier function or hemorrhoid - Google Patents

The recombination human source collagen product and preparation method of skin barrier function or hemorrhoid Download PDF

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CN104667335B
CN104667335B CN201510038620.9A CN201510038620A CN104667335B CN 104667335 B CN104667335 B CN 104667335B CN 201510038620 A CN201510038620 A CN 201510038620A CN 104667335 B CN104667335 B CN 104667335B
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collagen
human source
skin
recombination human
dressing
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CN104667335A (en
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杨霞
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Shanxi Jin Bo Biomedics Inc
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Abstract

The present invention relates to the recombination human source collagen series of products for skin barrier function damage or hemorrhoid, and in particular to medical restructuring human-like collagen functional dressings(Aerosol type), the dressing of medical skin collagen repair function, it is medical restructuring human-like collagen functional dressings(Gel-type), collagen wound hemostatic material(Hemorrhoid type).Skin barrier function is damaged the product of the application or hemorrhoid have the effect of obvious, has application value.

Description

The recombination human source collagen product and preparation method of skin barrier function or hemorrhoid
Technical field
The present invention relates to the recombination human source collagen series of products for skin barrier function damage or hemorrhoid, specifically relate to And medical restructuring human-like collagen functional dressings(Aerosol type), the dressing of medical skin collagen repair function, medical recombination human source Collagen functional dressings(Gel-type), collagen wound hemostatic material(Hemorrhoid type).
Background technology
First, skin barrier function
The major infrastructure of skin barrier function is cuticula, epidermis lipid and NMF etc..The skin of narrow sense Skin barrier refers mainly to physical barrier, is made up of cuticula, structural lipid and skin adipose membrane, and wherein the above two are formed similar Brick wall structure is the important composition of skin barrier, and skin adipose membrane is then the outermost layer defence line of skin barrier.
Skin barrier function prevents loss of moist from being attacked with external environment, by skin physiology, pathological change and external environment Deng multifactor impact, when barrier function damage, some disease of skin are such as(Dermatitis, eczema, pruritus, psoriasis, pigment sink , acne etc.)Incidence of disease increase, original dermatological conditions aggravate.Some, which treat dermopathic invasive treatment, can not only cause skin The destruction of skin barrier function, such as(The treatment methods such as laser therapy, surgery excision)If surface of a wound protracted course of disease can cause the surface of a wound Cutaneous pigmentation or cicatrization.
Studies have found that, the impaired patient's cumulative year after year of skin barrier function be present in recent years.First, sebum secretion mistake It is more, sebum component to change the integrality that have impact on epidermis lipid;In addition, patient's external used medicine, cosmetics or inappropriate shield The materials such as skin product also can further destroy skin barrier function.Skin barrier function is impaired to cause the scytitis extent of reaction to increase Add, skin-tolerant decline, then cause patient to be unsatisfied with curative effect, compliance decline, finally influence clinical therapeutic efficacy.Cause This helps skin lesion patient to recover barrier function, not only has certain help to alleviating inflammatory reaction, can also improve patient to controlling The compliance for the treatment of, finally improves clinical therapeutic efficacy, reduces all kinds of skin disease recurrence rates.
Dermatitis, eczema are the more typical inflammatory dermatoses of dept. of dermatology, show as hydroderma, erythema, papule, furfur Being showed Deng, pathologic, physiologic mainly due to intercellular edema of epidermis so that space between cells increases, and skin brick wall structure is unstable, The original skin barrier of ring is broken, is increased through skin water loss;Inflammatory cell infiltration, it have impact on skin and be normally metabolized so that Lipid, NMF and anti-inflammatory factors are reduced, and skin becomes dry, furfur, is more easy to sensitivity;Because skin barrier is damaged, Skin resists the decline of environmental stimuli ability, can induce and aggravate eczema, be also easy to scabies secondary infection.Researcher proposes eczema table Skin lipid synthesis is reduced, and water content of stratum corneum declines, and skin barrier function is destroyed, and exogenous antigen is readily penetrated through skin Into internal, cause allergy after being presented by antigen presenting cell.Therefore, skin barrier function destruction is the weight of eczema morbidity Want pathogenic factor.
However, clinically, repair skin barrier function product and be still short of, existing cosmetics refer to skin barrier function Reparation, but its raw material is rested essentially within the level of fine chemistry industry, usually occurs the uncomfortable even allergy of skin after patient's use Phenomena such as, the damage of skin barrier has sometimes been aggravated on the contrary.
2nd, hemorrhoid
Hemorrhoid(Hemorrhoids)It is a kind of common disease, frequently-occurring disease.The mankind are to the understanding of hemorrhoid, treatment is long-standing.Very long Research process, the mankind propose various theories to the origin cause of formation of hemorrhoid, and corresponding treatment means are also that layer goes out not Thoroughly.
1975, the new ideas on hemorrhoid that Thomon is proposed established the theoretical foundation of the Modern Concepts of hemorrhoid.He thinks Hemorrhoid are the wart or anus pad of the lip-like of lower rectum, are anthropotomical normal configurations.Loder in 1994 etc. is it is further proposed that interior Hemorrhoid occur anal cushions down theory, i.e., its be due to fixed anus pad suspensorium Treitz fleshes and Park ligaments damage Or fracture, cause the prolapsus of anus pad and move down to cause.The characteristics of combining China again based on above-mentioned theory, for preferably specification hemorrhoid Diagnosis and treatment, surgery branch of Chinese Medical Association anorectal surgical group are formulated in April, 2000 in Chengdu《Hemorrhoid diagnosis and treatment tentative standard》, i.e.,: (1)The definition of hemorrhoid:Hemorrhoid are the agglomerates that anus pad pathologic hypertrophy, displacement and crissum veins beneath the skin clump blood stream stasis are formed.(2)Hemorrhoid Classification:Internal piles, external piles and mixed hemorrhoid.(3)The clinical manifestation of hemorrhoid and the indexing of internal piles:I degree:Band blood when just, no internal piles abjection, just After can voluntarily stop.II degree:Band blood when just, internal piles abjection, after an action of the bowels can voluntarily Hui Na.III degree:When just band blood, internal piles abjection or Internal piles is also deviate from when station, cough, fatigue, heavy burden long, need to use hand Hui Na.IV degree:Internal piles is deviate from, it is impossible to Hui Na, can be embedding with strangulation .The clinical manifestation of external piles:Anus is uncomfortable, moist unclean, and can occur together thrombosis and subcutaneous hematoma.The clinical table of mixed hemorrhoid It is existing:The symptom of internal piles and external piles exists simultaneously.
The pathogenic factor of hemorrhoid is a lot of, and sitting, station, fatigue long etc. make human body be in a kind of fixation postures for a long time, so as to shadow Blood circulation is rung, makes in pelvic cavity that internal organs are congested in slow blood flow and abdomen, causes haemorrhoidal vein over filling, varicose, protuberance, wall of vein Tension force declines and causes hemorrhoid.If lack of exercise, enterocinesia slows down, and excrement is descending slow or because of habitual constipation, so as to oppress Vein, make contrafluxion and blood backflow obstacle, cause haemorrhoidal vein internal pressure to raise, wall of vein resistance reduces, and may also lead to hemorrhoid The sore incidence of disease increases.
The treatment of hemorrhoid is generally divided into two kinds of non-operative treatment and operative treatment.Non-operative treatment is generally acknowledged that asymptomatic hemorrhoid It need not treat, emphasis, which should be placed on, to be eliminated in symptom, be common are oral drug therapy, external medication, injection and set bundle and is treated Method etc..Operative treatment is primarily adapted for use in III, IV phase internal piles and the patient that can not alleviate through non-operative treatment treatment symptom, including Peeling outside and ligation inside, haemorrhoidal ring shape resection, the lower hemorrhoid artery ligation art of Doppler's guiding, Hemorrhoidectomy With Anastomat etc..
Undoubtedly, explore the low method of a kind of reliable curative effect, easy to operate, few intercurrent disease, recurrence rate be still it is current and The research direction of hemorrhoid will be treated from now on.
The content of the invention
The present invention in order to solve the problems, such as skin barrier function damage or internal piles in terms of product lack, there is provided it is a series of heavy Group human-like collagen product --- medical skin collagen repair function dressing, medical restructuring human-like collagen functional dressings (Gel-type), it is medical restructuring human-like collagen functional dressings(Aerosol type), collagen wound hemostatic material(Hemorrhoid type), the present invention Additionally provide the preparation method of this series of products.
The present invention adopts the following technical scheme that realization:
1st, recombination human source collagen product --- the medical skin collagen reparative regeneration for skin barrier function damage Functional dressings, include each component of following mass concentration:
Recombination human source collagen 0.05~1%;
Humectants and emollientses:Sodium Hyaluronate 0.05~1%,
Glycerine 0.3~6%,
Vaseline 0.2~4%,
Hydrolecithin 0.15~3%,
Dimethyl silicone polymer 0.2~4%,
Xanthan gum 0.1~1%,
Butanediol 0.2~4%,
White Mineral Oil 0.8~10%,
DPG 0.3~6%,
Sunflower oil 0.6~10%,
Vitamin E 0.1~1%,
Vitamin C 0.1~1%;
Cosolvent:Stearic acid 0.2~4%,
18 alcohol 0.3~6%;
Bacteriostatic preservative:Phenoxyethanol 0.1~1%,
Soluble metyl hydroxybenzoate 0.05~3%,
Soluble propylhydroxybenzoate 0.01~2%;
Water surplus.
Recombination human source collagen product --- medical skin collagen reparative regeneration work(for skin barrier function damage The preparation method of energy dressing, comprises the following steps:
First humectants and emollientses and cosolvent are dissolved into pure water, stirred, then add the membrane filtration with 0.22 μm The recombination human source collagen crossed, continues to stir, obtains homogeneous system, adds bacteriostatic preservative, then with pure water by surplus Supply, stir, finally by between obtained dressing regulation pH value to 5.5 to 7.5, get product.
2nd, recombination human source collagen product --- the medical restructuring human-like collagen for skin barrier function damage Functional dressings(Gel-type), include each component of following mass concentration:
Recombination human source collagen 0.05~1%;
Sodium Hyaluronate 0.05~1%;
Glycerine 0.1~2%;
Bacteriostatic preservative:Phenoxyethanol 0.1~1%,
Soluble metyl hydroxybenzoate 0.05~3%,
Soluble propylhydroxybenzoate 0.01~2%;
Water surplus.
Recombination human source collagen product for skin barrier function damage --- medical restructuring human-like collagen work( Can dressing(Gel-type)Preparation method, comprise the following steps:
First Sodium Hyaluronate, glycerine are dissolved into pure water, stirred, then adds what is crossed with 0.22 μm of membrane filtration Recombination human source collagen, continue to stir, obtain homogeneous system, add bacteriostatic preservative, then supplied surplus with pure water, Stir, finally by between obtained dressing regulation pH value to 5.5 to 7.5, get product.
3rd, recombination human source collagen product --- the medical restructuring human-like collagen for skin barrier function damage Functional dressings(Aerosol type), include each component of following mass concentration:
Recombination human source collagen 0.05~1%;
PBS:Sodium dihydrogen phosphate 0.1~2%,
Sodium chloride 0.5~3%;
Bacteriostatic preservative:Phenoxyethanol 0.1~1%,
Soluble metyl hydroxybenzoate 0.05~3%,
Soluble propylhydroxybenzoate 0.01~2%;
Water surplus.
Recombination human source collagen product for skin barrier function damage --- medical restructuring human-like collagen work( Can dressing(Aerosol type)Preparation method, comprise the following steps:
First soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate are dissolved into pure water, stirred, adds PBS, Then the recombination human source collagen crossed with 0.22 μm of membrane filtration is added, continues to stir, obtains homogeneous system, add benzene oxygen Ethanol, then surplus is supplied with pure water, stirred, obtained dressing is finally adjusted into pH value between 5.5 to 7.5, i.e., Obtain finished product.
4th, the recombination human source collagen product for internal piles --- collagen wound hemostatic material(Hemorrhoid type), including it is following The each component of mass concentration:
Recombination human source collagen 0.05~1%;
Poloxamer188 10~30%;
PLURONICS F87 0.5~6%;
Glycerine 1~4%;
Bacteriostatic preservative:Phenoxyethanol 0.1~1%,
Soluble metyl hydroxybenzoate 0.05~3%,
Soluble propylhydroxybenzoate 0.01~2%,
Chlorhexidine 0.1~1%;
Water surplus.
Recombination human source collagen product --- collagen wound hemostatic material for skin barrier function damage(Hemorrhoid Type)Preparation method, comprise the following steps:
First by poloxamer(407 and 188), glycerine be dissolved into pure water, stir, then add with 0.22 μm of film Filtered recombination human source collagen, continues to stir, obtains homogeneous system, adds bacteriostatic preservative, then will with pure water Surplus is supplied, and is stirred, and finally by between obtained dressing regulation pH value to 4.5 to 7.8, is got product.
In mentioned component:
1st, recombination human source collagen:The predominantly type of recombination human source collagen II and III type, on recombination human source collagen The preparation method of albumen, the applicant have applied for national inventing patent, and patented certificate, patent name:A kind of recombined human Source collagen and its production method, the patent No.:ZL201210482543.2.Recombination human source collagen its amino acid composition with Natural collagen protein amino acid sequence appropriate section 100% is identical.Immunological rejection, allergic reaction probability are not produced applied to human body It is extremely low, detected through biological activity, there is the biological activity for meeting or exceeding human body natural collagen protein, be to report at present Optimization collagen design, the function of natural collagen protein can be exercised in human body.
It is very suitable with very strongly hydrophilic because recombination human source collagen is rich in abundant hydrophilic amino-acid residue The adhesion and growth of condensating fiber cell.And cell surface has the glycoprotein of similar fibronectin, to the given zone of collagen surface There is high affinity in domain.Therefore, collagen is advantageous to the survival and growth of cell.Meanwhile its taxis guiding function may be guided Epithelial cell rapidly enters damaged part, effectively improves skin regeneration speed, shortens the wound healing time, so as to recover skin screen Hinder function.
Skin injury and local inflammatory reaction can cause sulfydryl in skin to reduce, tyrosinase activity enhancing, many The hyperplasia of inflammatory mediator and cell factor energy stimulation melanin cell, accelerate B16 cell, cause pigmentation.Collagen Tyrosine residue and skin in tyrosine competition, combined with the activated centre of tyrosinase, urged so as to suppress tyrosinase Change tyrosine and be converted into DOPA quinone, so as to effectively prevent melanin from producing to a certain extent, reduce pigmentation.
CO2Scar can be formed after laser and after operative treatment.Scar be formed as body inflammatory reaction, skin by Damage the random growth of tissue;III collagen type is reduced or missing causesThe Collagen Type VI of type-III is out of proportion etc..It is main in the product Want composition with recombination human source collagen based on III type, can effectively connect the glue of the dermis of skin fault rupture caused by wound and infection Fibrillation, the missing of local III collagen type of the supplement surface of a wound, so as to improve cytoactive, promote cytothesis function, deeply Impaired skin corium, accelerate that the growth into fiber stem cell of human body self collagen can be secreted, fill up the space of cytoplasm, enhancing Intercellular supporting construction, desalinate and fill up scar.
2nd, Sodium Hyaluronate:Sodium Hyaluronate is also the important component of extracellular matrix, is existed with collagen collective effect Extracellular environment can be improved, necessary nutritional support and conditions warrant are provided for cells survival, so as to promote neonatal cell to generate And promote cell metabolism, accelerate wound healing.And study and show, keloid is compared with other tissues in corium break Weary hyaluronic acid, this product application Sodium Hyaluronate can reach the effect of prevention of scar formation with collagen collective effect.
3rd, PBS:PBS, have the function that to adjust pH, necessary guarantor is provided to restructuring human-like collagen Dis environment, its activity is not suffered a loss, promote absorption of the collagen in skin surface.Carried simultaneously for skin damage cell repair For necessary ionic environment.
4th, humectants and emollientses and cosolvent:A kind of emulsifying agent with anti-inflammatory effect can be formed after the mixing of these compositions, To caused by external cause keratinocyte damage have protective effect, can by reduce Skin Flake and recover pliability come strengthen dry or The appearance of damaged skin.Also there is the effect nourished and adjust skin simultaneously, have splendid skin sense, easily absorb.It is especially suitable For drying, weathering, old age and the skin for having damage.
5th, poloxamer:Poloxamer is a preferable sustained-release and controlled release material, after poloxamer contacts surface of a wound body temperature, energy Enough nature plastics, make its even dispersion in the surface of a wound, and layer protecting film is formed on the surface of a wound, and can make recombination human source collagen egg Give full play to its bioavilability in vain, can the durable contact surface of a wound, reach wound repair, haemostatic effect.
6th, Chlorhexidine:For conventional skin, mucosal disinfectant, its biocidal property can be effectively played in the hemorrhoid surface of a wound, reduced scorching The secretion of property material, there is the antibacterial effect that relieves the pain.
7th, bacteriostatic preservative:Parabens and Phenoxyethanol are conventional bacteriostatic preservative, broad-spectrum antiseptic, stability By force, under acid and alkaline case can antibacterial, there is good biocompatibility with human body.
The effect of in order to further prove herein described product, applicant have also carried out following clinical test and divided respectively Analysis:
(One)Medical skin collagen repair function dressing
1. method and data
This experiment is two centers, random, contrast clinical trial research, and selected patient is that Dermatology Outpatient Department is diagnosed as skin The scorching, patient of eczema.Two centers enter 80 dermatitis and eczema patients of group, per each 40 of center altogether.Experiment 37 is completed at center 1 altogether, Come off 3, center 2 completes 40 altogether.
2. result of the test
2.1 1 course for the treatment of cure rates compare
From table 1, the Chi-square Test of table 2, FAS, PPS set analysis result are consistent, after two groups of patients treatment 12 days, 15 days Cure rate has significant difference, and 12 days cure rates of test group are 39.5%, 5.1% higher than control group;Cure rate is within 15 days 63.2%th, higher than the 12.8% of control group;Medical skin collagen repair function dressing treatment one course for the treatment of cure rate of dermatitis and eczema is more right According to high by 50.4%.
Each two groups of cure rates for the treatment of time point of the FAS collection of table 1 compare
Note:* Fisher exact methods are represented
Cure rate between each treatment time point group of the PPS collection of table 2(%)Compare
Note:* Fisher exact methods are represented
2.2 1 course for the treatment of skin lesion symptom disappearance rate compare
Examined from table 3Fisher exact methods, after patient's one course for the treatment of of treatment between two groups 4 skin symptoms disappearance Rate has significant difference, and test group is scorching hot, the tight phenomenon of skin all disappears, itch, pain disappearance rate be respectively 86.5%, 85.7%, the tight disappearance rate of control group itch, scorching hot, pain, skin is respectively 36.8%, 60.0%, 33.3%, 33.3%, experiment Group disappearance rate is higher by 49.7%, 40.0%, 52.4%, 66.7% compared with control group respectively.
Therefore, the dressing of medical skin collagen repair function have it is antipruritic, only it is scorching hot, relieve the pain, eliminate the effect of skin is tight, Effect is better than control.
The course for the treatment of skin lesion symptomatic condition of table 3 one compares
Safety results:Any adverse events are not found during experimental observation.
(Two)Medical restructuring human-like collagen functional dressings(Gel-type)
3. method and data
This experiment is two centers, random, contrast clinical trial research, and selected patient is that Dermatology Outpatient Department is diagnosed as acne Or CO2Patient after laser therapy.Two centers enter 160 patients of group altogether, are randomly divided into 4 groups, acne test group 40, acne pair According to group 40, CO2Laser test group 40, CO2Laser control group 40.Experiment 155 is completed in this experiment altogether, is come off 5, its Middle acne group completes 77, CO2Laser group completes 78.
4. result of the test
Acne group:
4.1 1 course for the treatment of cure rates compare
From the Chi-square Test of table 4,12 days after two groups of patients treatment, the cure rate of 15 days have significant difference, fully recover from an illness within 12 days More rate is 47.8%, 8.1% higher than control group;15 days cure rates are 72.5%, 10.8% higher than control group;Medical recombination human source Collagen functional dressings(Gel-type)One course for the treatment of cure rate relatively compares height 61.7%.
The different treatment time point cure rates of table 4 compare
Note:* Fisher exact methods are represented
4.2 1 course for the treatment of skin lesion symptom disappearance rate compare
Examined from the Fisher exact methods of table 5, after patient treats a course for the treatment of, pain, skin are tight between two groups disappears Mistake rate has a significant difference, and test group pain disappearance rate is 92.2%, 45.5% higher than control, high by 46.7%;Test group skin Tight disappearance rate is 94.1%, 64.3% higher than control, high by 29.8%.After one course for the treatment of, itch, scorching hot disappearance rate are without statistics Learn difference, average out to 86.5%, 75.0%.
Therefore, medical restructuring human-like collagen functional dressings(Gel-type)With relieving the pain, mitigate the effect of skin is tight, Effect is better than control;It is antipruritic, only scorching hot effect it is close with compareing.
The course for the treatment of skin lesion symptomatic condition of table 5 one compares
CO2Laser group:
4.3 cure rates compare
From table 6, table 7, FAS, PPS collection two groups of cure rate result of the comparison of each treatment time are consistent, test groups Treatment just has patient's recovery from illness, a course for the treatment of totally 30 patient's recoveries from illness for 9 days, and control group treats only 1 patient's recovery from illness in 15 days;Treatment 12 My god, the cure rate of 15 days have a significant difference, it is 39.5% to treat 12 days test group cure rates, and 15 days cure rates are 76.3%, and Control group is respectively 0.0%, 2.6%;Medical restructuring human-like collagen functional dressings(Gel-type)(Plain edition)One course for the treatment of is fully recovered Rate relatively compares high by 73.7%.
Cure rate between each treatment time point group of the FAS collection of table 6(%)Compare
Note:* Fisher exact methods are represented
Cure rate between each treatment time point group of the PPS collection of table 7(%)Compare
Note:* Fisher exact methods are represented
Safety results:Any adverse events are not found during experimental observation.
(Three)Medical restructuring human-like collagen functional dressings(Aerosol type)
5. method and data
This experiment is two centers, random, contrast clinical trial research, and selected patient is that Dermatology Outpatient Department is diagnosed as acne Or the patient of dermatitis, eczema.Two centers enter 160 patients of group altogether, are randomly divided into 4 groups, acne test group 40, acne control group 40, dermatitis, eczema test group 40, dermatitis, eczema control group 40.Experiment 152 is completed in this experiment altogether, is come off 8, its Middle acne group completes 76, and dermatitis, eczema group complete 76.
6. result of the test
Acne group:
6.1 1 course for the treatment of cure rates compare
From the Chi-square Test of table 8,12 days after two groups of patients treatment, the cure rate of 15 days have significant difference, test group 12 days cure rates are 41.0%, 8.1% higher than control group;15 days cure rates are 69.2%, 10.8% higher than control group;Medical heavy Group human-like collagen functional dressings(Aerosol type)Treat the course for the treatment of cure rate of acne one and relatively compare height 58.4%.
Each two groups of cure rates for the treatment of time point of the FAS collection of table 8 compare
Note:* Fisher exact methods are represented
6.2 1 course for the treatment of skin lesion symptom disappearance rate compare
Examined from the Fisher exact methods of table 9, pain, skin are tight between two groups after patient's one course for the treatment of of treatment Disappearance rate has significant difference, and test group disappearance rate is respectively 92.9%, 92.3%, control group disappearance rate is respectively 45.5%, 64.3%, test group disappearance rate is higher by 47.4%, 28.0% compared with control group respectively;Two groups of itch, scorching hot no difference of science of statistics, it is averaged Disappearance rate is respectively 88.4%, 68.8%
Therefore, medical restructuring human-like collagen functional dressings(Aerosol type)Treatment acne is tight with relieving the pain, eliminating skin The effect of taut, effect are better than control, antipruritic, to stop scorching hot effect close with compareing.
The course for the treatment of skin lesion symptomatic condition of table 9 one compares
Dermatitis, eczema group:
6.3 1 course for the treatment of cure rates compare
From table 10, the Chi-square Test of table 11, FAS, PPS set analysis result are consistent, 12 days, 15 days after two groups of patient's treatments Cure rate have a significant difference, 12 days cure rates of test group are 36.1%, 5.1% higher than control group;Cure rate is within 15 days 54.1%th, higher than the 12.8% of control group;Medical restructuring human-like collagen functional dressings(Aerosol type)Treatment dermatitis and eczema one is treated Journey cure rate relatively compares height 41.3%.
Each two groups of cure rates for the treatment of time point of the FAS collection of table 10 compare
Note:* Fisher exact methods are represented
Cure rate between each treatment time point group of the PPS collection of table 11(%)Compare
Note:* Fisher exact methods are represented
6.4 1 course for the treatment of skin lesion symptom disappearance rate compare
Examined from the Fisher exact methods of table 12, after patient treats a course for the treatment of, between tight two groups of itch, skin Disappearance rate has significant difference, and test group itch disappearance rate is 72.2%, 36.8% higher than control, is higher by 35.4%;Test group skin The tight disappearance rate of skin is 83.3%, 33.3% higher than control, is higher by 50.0%.
Scorching hot, pain disappearance rate no difference of science of statistics, average out to 75.0%, 50.0%.Due to pain patients number before treatment It is less, only make reference.
Therefore, medical restructuring human-like collagen functional dressings(Aerosol type)With it is antipruritic, eliminate skin it is tight the effect of, Effect is better than control, and only scorching hot, value analgesic effect and control group are close.
The course for the treatment of skin lesion symptomatic condition of table 12 1 compares
Safety results:Any adverse events are not found during experimental observation.
(Four)Collagen wound hemostatic material(Hemorrhoid type)
7. method and data
This experiment is two centers, random, contrast clinical trial research, and selected patient is that department of general surgery's patient diagnosis is internal piles Patient.Two centers enter 80 patients of group altogether, are randomly divided into 2 groups, test group 40, control group 40.Examination is completed in this experiment altogether 77 are tested, is come off 3.
8. result of the test
8.1 hemostasis, the improvement degree of rectal tenesmus sense and pain, antipruritic effect compare
From the Chi-square Test of table 13, test group after treatment(=130.167、P<0.001), control group(=63.401、P< 0.001)Amount of bleeding is reduced, and illustrates that two groups of treatments are effective;Two groups of amounts of bleeding are formed after treatment(P<0.001), gross hemostasis rate(= 26.277、P<0.001)There is significant difference, test group gross hemostasis rate is 92.1%, 35.9% higher than control group(It is shown in Table 14), Test group haemostatic effect is good compared with control group.
The pretherapy and post-treatment amount of bleeding situation of change of 13 two groups of patients of table
Note:* it is Fisher exact methods
Gross hemostasis rate after 14 two groups of patient's treatments of table(%)Compare
Safety results:Any adverse events are not found during experimental observation.
Clinical test conclusion:
(1), medical skin collagen repair function dressing:Reconstruction skin barrier function, controlled suitable for dermatitis, eczema Treat, for local skin itch caused by dermatitis, eczema, scorching hot, skin is tight, pain etc..Skin barrier function can be repaired, is used In skin barrier function it is impaired caused by dry skin furfur, erythema, papule, red blood silk and the thinning reparation of atrophoderma.Can Prevention of scar is formed and pigmentation.
(2), it is medical restructuring human-like collagen functional dressings(Gel-type):Treatment for face acnes.For acne Caused erythema, papule, warts, blackhead, Whiteheads, red blood silk and the polymorphy skin lesion diseases such as atrophoderma is thinning Shape.Local skin symptom can be improved, such as:Itch, scorching hot, skin is tight, pain.Can be by increasing moisture content of skin, regulation skin Skin pH value and grease rebuild skin barrier function.For dry skin furfur and other skins caused by skin barrier function damage The reparation of damage.Prevention of scar is formed and pigmentation.Skin barrier function is rebuild, improves local desiccation, pain, itch etc. certainly Feel symptom.Laser wounds are repaired, there is covering, hemostasis, wound healing.Surface of a wound pigmentation and scar can be suppressed Formed.
(3), it is medical restructuring human-like collagen functional dressings(Aerosol type):By increasing moisture content of skin, reduce through table The severe edema due to hypofunction of the spleen shunts vector(TEWL), skin ph and fat secretion are adjusted, for repairing skin barrier function, suitable for skin barrier The auxiliary treatment of disease of skin caused by function is impaired.1st, dermatitis, eczema are treated, can quickly improve dermatitis, skin caused by eczema Skin itch, scorching hot, tight, pain and erythema, papule, dry furfur, thinning of skin atrophy, telangiectasis;For face The treatment of acne.2nd, for erythema, papule, warts, blackhead, Whiteheads caused by acne, prevention of scar is formed and color It is plain calm.
(4), collagen wound hemostatic material(Hemorrhoid type):The product is applied to the treatment of internal piles.Available for caused by hemorrhoid Bleeding, local crissum falling inflation and pain, perianal pruritus etc..
Specific embodiment
Below in conjunction with specific embodiment, the present invention will be further described.
Embodiment 1
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.05%;Humectants and emollientses:Thoroughly Bright matter acid sodium 0.8%, glycerine 0.3%, vaseline 0.2%, hydrolecithin 0.15%, dimethyl silicone polymer 0.8%, xanthan gum 0.5%th, butanediol 0.2%, White Mineral Oil 0.8%, DPG 0.3%, sunflower oil 3.5%, vitamin E 0.1%, vitamin C 0.5%; Cosolvent:Stearic acid 0.2%, 18 alcohol 0.3%;Bacteriostatic preservative:Phenoxyethanol 0.8%, soluble metyl hydroxybenzoate 0.05%, nipalgin third Ester sodium 1%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.05%, i.e., is recombinated in every 1kg dressing containing 0.5g Human-like collagen, other compositions are also calculated with this.Specific preparation method is first to be dissolved into humectants and emollientses and cosolvent In 850g pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain To homogeneous system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram Dressing adjusts pH value to 5.5, gets product.
Embodiment 2
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.1%;Humectants and emollientses:It is transparent Matter acid sodium 0.1%, glycerine 3%, vaseline 2%, hydrolecithin 1.5%, dimethyl silicone polymer 1.5%, xanthan gum 0.25%, fourth two Alcohol 2%, White Mineral Oil 5%, DPG 3%, sunflower oil 6%, vitamin E 0.75%, vitamin C 0.35%;Cosolvent:Stearic acid 2%th, 18 alcohol 1.5%;Bacteriostatic preservative:Phenoxyethanol 0.1%, soluble metyl hydroxybenzoate 0.12%, soluble propylhydroxybenzoate 0.08%;Surplus Water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.1%, i.e., recombined human containing 1g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that humectants and emollientses and cosolvent first are dissolved into 880g In pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain Even system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram of dressing PH value is adjusted to 6.0, is got product.
Embodiment 3
Medical skin collagen repair function dressing, composition include recombination human source collagen 1%;Humectants and emollientses:Hyalomitome Sour sodium 1%, glycerine 0.6%, vaseline 4%, hydrolecithin 1%, dimethyl silicone polymer 4%, xanthan gum 1%, butanediol 4%, Bai Kuang Oil 10%, DPG 6%, sunflower oil 1.5%, vitamin e1 %, vitamin C 1%;Cosolvent:Stearic acid 1%, 18 alcohol 6%;It is antibacterial Preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 2.2%, soluble propylhydroxybenzoate 2%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 1%, i.e., recombination human source containing 10g in every 1kg dressing Collagen, other compositions are also calculated with this.Specific preparation method is that humectants and emollientses and cosolvent first are dissolved into 900g is pure In water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain uniformly System, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally adjust obtain one kilogram of dressing PH value is saved to 7.5, is got product.
Embodiment 4
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.07%;Humectants and emollientses:Thoroughly Bright matter acid sodium 0.5%, glycerine 2%, vaseline 0.7%, hydrolecithin 2%, dimethyl silicone polymer 0.2%, xanthan gum 0.1%, fourth Glycol 0.75%, White Mineral Oil 1%, DPG 4%, sunflower oil 0.6%, vitamin E 0.28%, vitamin C 0.65%;Cosolvent: Stearic acid 1.2%, 18 alcohol 3%;Bacteriostatic preservative:Phenoxyethanol 0.78%, soluble metyl hydroxybenzoate 1.5%, soluble propylhydroxybenzoate 0.7%; Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.07%, i.e., is recombinated in every 1kg dressing containing 0.7g Human-like collagen, other compositions are also calculated with this.Specific preparation method is first to be dissolved into humectants and emollientses and cosolvent In 800g pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain To homogeneous system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram Dressing adjusts pH value to 5.8, gets product.
Embodiment 5
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.2%;Humectants and emollientses:It is transparent Matter acid sodium 0.3%, glycerine 4%, vaseline 3%, hydrolecithin 0.5%, dimethyl silicone polymer 2%, xanthan gum 0.65%, butanediol 3%th, White Mineral Oil 3%, DPG 5.5%, sunflower oil 5%, vitamin E 0.5%, vitamin C 1%;Cosolvent:Stearic acid 4%, 18 Alcohol 4%;Bacteriostatic preservative:Phenoxyethanol 0.43%, soluble metyl hydroxybenzoate 3%, soluble propylhydroxybenzoate 0.5%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.2%, i.e., recombined human containing 2g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that humectants and emollientses and cosolvent first are dissolved into 820g In pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain Even system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram of dressing PH value is adjusted to 6.5, is got product.
Embodiment 6
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.5%;Humectants and emollientses:It is transparent Matter acid sodium 0.08%, glycerine 6%, vaseline 1%, hydrolecithin 0.75%, dimethyl silicone polymer 3%, xanthan gum 1%, butanediol 1.5%th, White Mineral Oil 8%, DPG 0.7%, sunflower oil 7%, vitamin e1 %, vitamin C 0.75%;Cosolvent:Stearic acid 0.5%th, 18 alcohol 5%;Bacteriostatic preservative:Phenoxyethanol 0.57%, soluble metyl hydroxybenzoate 1%, soluble propylhydroxybenzoate 1.3%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.5%, i.e., recombined human containing 5g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that humectants and emollientses and cosolvent first are dissolved into 800g In pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain Even system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram of dressing PH value is adjusted to 7.0, is got product.
Embodiment 7
Medical skin collagen repair function dressing, composition include recombination human source collagen 0.7%;Humectants and emollientses:It is transparent Matter acid sodium 0.05%, glycerine 1%, vaseline 2.5%, hydrolecithin 3%, dimethyl silicone polymer 1%, xanthan gum 0.85%, fourth two Alcohol 1%, White Mineral Oil 6.5%, DPG 1.5%, sunflower oil 10%, vitamin E 0.9%, vitamin C 0.9%;Cosolvent:It is stearic Sour 3%, 18 alcohol 1%;Bacteriostatic preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 2%, soluble propylhydroxybenzoate 0.01%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.7%, i.e., recombined human containing 7g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that humectants and emollientses and cosolvent first are dissolved into 800g In pure water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain Even system, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally by obtain one kilogram of dressing PH value is adjusted to 7.2, is got product.
Embodiment 8
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.05%, thoroughly Bright matter acid sodium 0.5%, glycerine 0.1%, bacteriostatic preservative:Phenoxyethanol 0.1%, soluble metyl hydroxybenzoate 0.8%, soluble propylhydroxybenzoate 0.01%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.05%, i.e., is recombinated in every 1kg dressing containing 0.5g Human-like collagen, other compositions are also calculated with this.Specific preparation method be first by Sodium Hyaluronate, that glycerine is dissolved into 800g is pure In water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain uniformly System, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally adjust obtain one kilogram of dressing PH value is saved to 7.5, is got product.
Embodiment 9
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.5%, thoroughly Bright matter acid sodium 0.9%, glycerine 1%, bacteriostatic preservative:Phenoxyethanol 0.55%, soluble metyl hydroxybenzoate 0.1%, soluble propylhydroxybenzoate 0.08%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.5%, i.e., recombined human containing 5g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that Sodium Hyaluronate, glycerine first are dissolved into 900g pure water In, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous body System, adds bacteriostatic preservative, then supplies surplus with pure water, stir, and finally adjusts obtain one kilogram of dressing PH value is got product to 6.5.
Embodiment 10
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.1%, thoroughly Bright matter acid sodium 1%, glycerine 1.2%, bacteriostatic preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 1.2%, soluble propylhydroxybenzoate 2%;It is remaining Measure water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.1%, i.e., recombined human containing 1g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that Sodium Hyaluronate, glycerine first are dissolved into 850g pure water In, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous body System, adds bacteriostatic preservative, then supplies surplus with pure water, stir, and finally adjusts obtain one kilogram of dressing PH value is got product between 7.5.
Embodiment 11
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.35%, thoroughly Bright matter acid sodium 0.08%, glycerine 0.5%, bacteriostatic preservative:Phenoxyethanol 0.25%, soluble metyl hydroxybenzoate 0.05%, propylben Sodium 1.5%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.35%, i.e., is recombinated in every 1kg dressing containing 3.5g Human-like collagen, other compositions are also calculated with this.Specific preparation method be first by Sodium Hyaluronate, that glycerine is dissolved into 820g is pure In water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain uniformly System, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally adjust obtain one kilogram of dressing PH value is saved to 7.0, is got product.
Embodiment 12
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.78%, thoroughly Bright matter acid sodium 0.05%, glycerine 0.7%, bacteriostatic preservative:Phenoxyethanol 0.8%, soluble metyl hydroxybenzoate 3, soluble propylhydroxybenzoate 0.02;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.78%, i.e., is recombinated in every 1kg dressing containing 7.8g Human-like collagen, other compositions are also calculated with this.Specific preparation method be first by Sodium Hyaluronate, that glycerine is dissolved into 850g is pure In water, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain uniformly System, bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, finally adjust obtain one kilogram of dressing PH value is saved to 6.0, is got product.
Embodiment 13
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 1%, transparent Matter acid sodium 0.65%, glycerine 1.5%, bacteriostatic preservative:Phenoxyethanol 0.57%, soluble metyl hydroxybenzoate 2.5%, soluble propylhydroxybenzoate 1%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 1%, i.e., recombination human source containing 10g in every 1kg dressing Collagen, other compositions are also calculated with this.Specific preparation method is that Sodium Hyaluronate, glycerine first are dissolved into 900g pure water In, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous body System, adds bacteriostatic preservative, then supplies surplus with pure water, stir, and finally adjusts obtain one kilogram of dressing PH value is got product to 7.5.
Embodiment 14
Medical restructuring human-like collagen functional dressings(Gel-type), composition includes recombination human source collagen 0.9%, thoroughly Bright matter acid sodium 0.1%, glycerine 2%, bacteriostatic preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 1.5%, soluble propylhydroxybenzoate 0.5%; Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.9%, i.e., recombined human containing 9g in every 1kg dressing Source collagen, other compositions are also calculated with this.Specific preparation method is that Sodium Hyaluronate, glycerine first are dissolved into 800g pure water In, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous body System, adds bacteriostatic preservative, then supplies surplus with pure water, stir, and finally adjusts obtain one kilogram of dressing PH value is got product to 6.2.
Embodiment 15
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 0.05%, phosphorus Acid dihydride sodium 0.5%, sodium chloride 3%, bacteriostatic preservative:Phenoxyethanol 0.1%, soluble metyl hydroxybenzoate 1.5%, soluble propylhydroxybenzoate 2%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.05%, i.e., is recombinated in every 1kg dressing containing 0.5g Human-like collagen, other compositions are calculated with this.Specific preparation method is first that soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate is molten Solution stirs into 830g pure water, adds PBS, then adds the recombination human source crossed with 0.22 μm of membrane filtration Collagen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, Obtain one kilogram of dressing is finally adjusted into pH value to 7.5, got product.
Embodiment 16
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 0.3%, phosphorus Acid dihydride sodium 0.78%, sodium chloride 1.8%, bacteriostatic preservative:Phenoxyethanol 0.4%, soluble metyl hydroxybenzoate 1%, soluble propylhydroxybenzoate 0.02%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.3%, i.e., recombined human containing 3g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is first to dissolve soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate Into 890g pure water, stir, add PBS, then add the recombination human source glue crossed with 0.22 μm of membrane filtration Former albumen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, most Obtain one kilogram of dressing is adjusted into pH value to 6.5 afterwards, got product.
Embodiment 17
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 1%, phosphoric acid Sodium dihydrogen 2%, sodium chloride 1%, bacteriostatic preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 3%, soluble propylhydroxybenzoate 0.1%;Surplus Water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 1%, i.e., recombination human source containing 10g in every 1kg dressing Collagen, other compositions are calculated with this.Specific preparation method is first to be dissolved into soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate In 800g pure water, stir, add PBS, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration Albumen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, finally Obtain one kilogram of dressing is adjusted into pH value to 5.5, got product.
Embodiment 18
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 0.7%, phosphorus Acid dihydride sodium 0.1%, sodium chloride 2%, bacteriostatic preservative:Phenoxyethanol 0.57%, soluble metyl hydroxybenzoate 0.1%, soluble propylhydroxybenzoate 0.07%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.7%, i.e., recombined human containing 7g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is first to dissolve soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate Into 900g pure water, stir, add PBS, then add the recombination human source glue crossed with 0.22 μm of membrane filtration Former albumen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, most Obtain one kilogram of dressing is adjusted into pH value to 6.0 afterwards, got product.
Embodiment 19
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 0.1%, phosphorus Acid dihydride sodium 1.2%, sodium chloride 1.5%, bacteriostatic preservative:Phenoxyethanol 0.2%, soluble metyl hydroxybenzoate 0.5%, soluble propylhydroxybenzoate 0.01%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.1%, i.e., recombined human containing 1g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is first to dissolve soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate Into 800g pure water, stir, add PBS, then add the recombination human source glue crossed with 0.22 μm of membrane filtration Former albumen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, most Obtain one kilogram of dressing is adjusted into pH value to 6.5 afterwards, got product.
Embodiment 20
Medical restructuring human-like collagen functional dressings(Aerosol type), composition includes recombination human source collagen 0.07%, phosphorus Acid dihydride sodium 1.5%, sodium chloride 0.5%, bacteriostatic preservative:Phenoxyethanol 0.82%, soluble metyl hydroxybenzoate 0.05%, propylben Sodium 1%;Excess water.
Exemplified by preparing 1kg dressing, recombination human source collagen concentration is 0.07%, i.e., is recombinated in every 1kg dressing containing 0.7g Human-like collagen, other compositions are calculated with this.Specific preparation method is first that soluble metyl hydroxybenzoate and soluble propylhydroxybenzoate is molten Solution stirs into 850g pure water, adds PBS, then adds the recombination human source crossed with 0.22 μm of membrane filtration Collagen, continue to stir, obtain homogeneous system, add Phenoxyethanol, then surplus is supplied with pure water, stirred, Obtain one kilogram of dressing is finally adjusted into pH value to 7.0, got product.
Embodiment 21
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 0.05%, poloxamer188 12%, PLURONICS F87 4%, glycerine 1%, bacteriostatic preservative:Phenoxyethanol 1%, soluble metyl hydroxybenzoate 0.05%, propylben Sodium 0.01%, Chlorhexidine 0.1%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 0.05%, i.e., is recombinated in every 1kg dressing containing 0.5g Human-like collagen, other compositions are calculated with this.Specific preparation method is that poloxamer, glycerine first are dissolved into 800g pure water In, stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous body System, adds bacteriostatic preservative, then supplies surplus with pure water, stir, and finally adjusts obtain one kilogram of material PH value is got product to 7.0.
Embodiment 22
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 0.3%, poloxamer188 15%, PLURONICS F87 2.3%, glycerine 3%, bacteriostatic preservative:Phenoxyethanol 0.57%, soluble metyl hydroxybenzoate 1%, nipalgin third Ester sodium 0.02%, Chlorhexidine 0.4%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 0.3%, i.e., recombined human containing 3g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is that first poloxamer, glycerine are dissolved into 850g pure water, Stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous system, Bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, obtain one kilogram of material is finally adjusted into pH value To 5.0, get product.
Embodiment 23
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 1%, poloxamer188 30%, PLURONICS F87 6%, glycerine 1.5%, bacteriostatic preservative:Phenoxyethanol 0.2%, soluble metyl hydroxybenzoate 3%, soluble propylhydroxybenzoate 0.1%, Chlorhexidine 1%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 1%, i.e., recombination human source containing 10g in every 1kg dressing Collagen, other compositions are calculated with this.Specific preparation method is that first poloxamer, glycerine are dissolved into 820g pure water, is stirred Mix uniformly, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous system, then Add bacteriostatic preservative, then surplus supplied with pure water, stirred, finally by obtain one kilogram of material adjust pH value to 7.8, get product.
Embodiment 24
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 0.5%, poloxamer188 25%, PLURONICS F87 1%, glycerine 4%, bacteriostatic preservative:Phenoxyethanol 0.8%, soluble metyl hydroxybenzoate 2%, soluble propylhydroxybenzoate 0.8%, Chlorhexidine 0.3%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 0.5%, i.e., recombined human containing 5g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is that first poloxamer, glycerine are dissolved into 900g pure water, Stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous system, Bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, obtain one kilogram of material is finally adjusted into pH value To 4.5, get product.
Embodiment 25
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 0.7, poloxamer188 10%, PLURONICS F87 0.5%, glycerine 2%, bacteriostatic preservative:Phenoxyethanol 0.6%, soluble metyl hydroxybenzoate 0.1%, soluble propylhydroxybenzoate 2%, Chlorhexidine 0.2%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 0.7%, i.e., recombined human containing 7g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is that first poloxamer, glycerine are dissolved into 900g pure water, Stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous system, Bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, obtain one kilogram of material is finally adjusted into pH value To 7.5, get product.
Embodiment 26
Collagen wound hemostatic material(Hemorrhoid type), composition includes recombination human source collagen 0.1%, poloxamer188 22.5%, PLURONICS F87 3%, glycerine 2.5%, bacteriostatic preservative:Phenoxyethanol 0.1%, soluble metyl hydroxybenzoate 1.5%, nipalgin Propyl ester sodium 1.5%, Chlorhexidine 0.9%;Excess water.
Exemplified by preparing 1kg materials, recombination human source collagen concentration is 0.1%, i.e., recombined human containing 1g in every 1kg dressing Source collagen, other compositions are calculated with this.Specific preparation method is that first poloxamer, glycerine are dissolved into 800g pure water, Stir, then add the recombination human source collagen crossed with 0.22 μm of membrane filtration, continue to stir, obtain homogeneous system, Bacteriostatic preservative is added, then surplus is supplied with pure water, stirred, obtain one kilogram of material is finally adjusted into pH value To 7.8, get product.

Claims (2)

  1. A kind of 1. recombination human source collagen collagen wound hemostatic material for internal piles, it is characterised in that:Including following quality The each component of concentration:
    Recombination human source collagen 0.05~1%;
    Poloxamer188 10~30%;
    PLURONICS F87 0.5~6%;
    Glycerine 1~4%;
    Bacteriostatic preservative:Phenoxyethanol 0.1~1%,
    Soluble metyl hydroxybenzoate 0.05~3%,
    Soluble propylhydroxybenzoate 0.01~2%;
    Chlorhexidine 0.1~1%;
    Water surplus;
    Wherein, the recombination human source collagen is the egg described in claim 1 in license notification number CN103122027B In vain.
  2. A kind of 2. preparation side of the recombination human source collagen collagen wound hemostatic material for internal piles described in claim 1 Method, it is characterised in that:Comprise the following steps:First poloxamer, glycerine are dissolved into pure water, stirred, then adds and uses The recombination human source collagen that 0.22 μm of membrane filtration is crossed, continues to stir, obtains homogeneous system, adds bacteriostatic preservative, so Surplus is supplied with pure water afterwards, stirred, finally by between obtained dressing regulation pH value to 4.5 to 7.8, is got product.
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CN114377186B (en) * 2022-02-24 2022-11-01 浙江天妍生物科技有限公司 Bioactive dressing for skin repair, and preparation method and product thereof
CN114796594A (en) * 2022-04-08 2022-07-29 湖南有美生物科技有限公司 Preparation method and application of yeast recombinant collagen liquid dressing
CN114917184B (en) * 2022-06-09 2023-01-10 溃克药业(哈尔滨)有限公司 Viscous medical dressing and preparation process thereof
CN115400260B (en) * 2022-08-18 2023-08-15 湘雅生物医药(湖州)有限公司 Repairing gel containing recombinant humanized collagen and preparation method thereof
CN115444969B (en) * 2022-09-21 2023-07-18 湖南达丰医疗科技有限公司 Recombinant III type collagen dressing and preparation method thereof

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