A kind of spray-filming agent and preparation method thereof for superficial burns
Technical field
The present invention relates to medicine, in particular to a kind of spray-filming agent.
Background technique
Burn is a kind of relatively common injury, is typically occurred in daily life, and contingency, experiment can also be betided
And in war.Burn refers generally to heating power, including hydrothermal solution, steam, high-temperature gas, flame, red-hot metal liquid or solid etc. and is drawn
The histologic lesion risen, refers mainly to skin and/or mucous membrane, and serious person can also injure subcutaneous or/and sub-mucosal tissues, as muscle, bone,
Joint even internal organ.To the severity of burn, three degree of quarterings is mostly used to be judged at present:
I degree (erythematous): only injuring epidermis shallow-layer-- cuticula, hyaline layer, stratum granulosum or injure stratum aculeatum, but occur
Layer is alive.Local redness, micro- swollen, cusalgia, without blister.It fully recovers in 3-5 days, de- fines, stay scar.
II degree (vesiculovirus): being divided into Superficial bums and deepⅱdegreeburn.Superficial bums: there are larger bubble, oedema companion
Severe pain, dermal sensation allergy.Although Superficial bums injure most skin basal layer, but do not injure the nipple knot of skin corium
Structure.Just because of Superficial bums, there is also the basal layers of part health, and basal layer is the most intensive portion of skin progenitor cell
Position, so the intrinsic stem cell of basal layer can constantly divide, be proliferated after skin Superficial bums.Eventually complete damage skin
Regeneration and Repair, realize Scarless wound healing, generally need 1~2 week.Deepⅱdegreeburn in addition to epidermis, whole papillary layer of corium are burnt,
The involvement of reticular layer of corium part, the hair follicle and sweat gland positioned at corium deep layer are still vibrant.It generally needs fully recover within 3~4 weeks, has after healing
Scar.
III degree (eschar): ochrodermia or sallow charing, dry, hide-like, dermal sensation is blunt, and pain is unobvious.
Wound healing is slower, and majority needs to make skin graft, and there are scar or/and deformities after healing.
Superficial burns refer generally to the burn of surface of a wound self-heal in 21 days after wound, including I degree of burn and light degree Ⅱ and portion
Divide shallower deepⅱdegreeburn.
Burn, which is often brought, compares bitter sorrow experience, and especially facial burn can bring the heavy heart to patient
Reason burden.Therefore it provides and a kind of can reduce patient body pain and the Burn medicine that is beneficial to rehabilitation has very real meaning
Justice.
Summary of the invention
In view of the above technical problems, the present invention provides a kind of spray-filming agent and preparation method thereof for superficial burns.This hair
The bright spray-filming agent for superficial burns consists of the following components in percentage by weight: flamazine 0.1~5%, antibacterial agent
0.1~3%, epidermal growth factor 0.01~0.1%, local anesthetic 0.05~1%, borneol 0.1~1%, shikonin extract 0.5~
5%, root of Dahurain angelica extracting solution 1~8%, cortex phellodendri extract 1~8%, polygonum cuspidate extracting solution 2~10%, film forming agent 0.1~5%, glycerol 1
~10%, water surplus.
Further, it consists of the following components in percentage by weight: flamazine 0.5~3%, antibacterial agent 0.5~
2%, epidermal growth factor 0.03~0.08%, local anesthetic 0.1~0.5%, borneol 0.3~0.8%, shikonin extract 3~
5%, root of Dahurain angelica extracting solution 3~5%, cortex phellodendri extract 3~5%, polygonum cuspidate extracting solution 4~8%, film forming agent 0.5~3%, glycerol 2~
8%, water surplus.
Specifically, it consists of the following components in percentage by weight: flamazine 2%, antibacterial agent 1%, epidermal growth factor
Sub 0.05%, local anesthetic 0.3%, borneol 0.5%, shikonin extract 2%, root of Dahurain angelica extracting solution 4%, cortex phellodendri extract 4%, polygonum cuspidate
Extracting solution 6%, film forming agent 1%, glycerol 6%, water surplus.
Specifically, the film forming agent is the carboxymethyl chitosan that deacetylation is greater than 85%.
Specifically, the antibacterial agent is selected from chlorhexidine acetate, chlorhexidine gluconate, benzalkonium bromide, polyhexamethylene guanide
In any one.It is wherein preferably chlorhexidine gluconate.
Specifically, the local anesthetic is selected from one of procaine, lidocaine or totokaine.
The preparation method of spray-filming agent for superficial burns of the invention the following steps are included:
(1) presses formula ratio, and after glycerol and the water of same volume are mixed, local anesthetic, borneol and epidermal growth factor are dissolved
In wherein;
(2) presses formula ratio, and flamazine, antibacterial agent and film forming agent are dissolved in a small amount of water;
(3) shikonin extract, root of Dahurain angelica extracting solution, Cortex Phellodendri are added after mixes solution obtained by step (1) and (2) to mention
It takes liquid, polygonum cuspidate extracting solution and excess water, is uniformly mixed to obtain the final product.
Specifically, the shikonin extract, root of Dahurain angelica extracting solution, cortex phellodendri extract and polygonum cuspidate extracting solution the preparation method comprises the following steps:
Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate are cleaned after crushing respectively, the ratio of 5g water is added in 1g Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri or polygonum cuspidate, point
Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate are not boiled to the water for evaporating 2/3 volume, filter off residue, acquired solution is Asian puccoon, white
The root of Dahurian angelica, Cortex Phellodendri and polygonum cuspidate extracting solution.
Carboxymethyl chitosan has preferable water solubility, can inhibit the growth and breeding of some fungies, bacterium and virus.?
Have the function of promoting blood clotting, can be used as hemostat.It can also be used in Wound filling substance, has sterilizing, promotes wound
It heals, absorbs Wound exudate, is not easy the effects of syneresis.
Asian puccoon (latin name: Arnebiae radix), bitter cold in nature enters percardium, Liver Channel.With clearing heat and cooling blood, promoting blood circulation
The effect of removing toxic substances, promoting eruption ecchymose removing.It burns for blood-heat and toxin exuberance, atropurpureus macula, measles without adequate eruption, sore, eczema and extreme misery.Modern medicine
Pharmacological research surface, Asian puccoon have inhibiting effect to virus and bacterium in vitro, and can accelerate epithelial growth and treatment burn, part
Using can promote wound healing.
The root of Dahurain angelica (latin name: Angelicae dahuricae radix): acrid flavour, warm-natured, return lung, spleen, stomach meridian.With solution
The effect of table cold dispelling, wind-expelling pain-stopping, clearing the nasal passage, eliminating dampness stops band, detumescence and apocenosis, dispelling wind and arresting itching.It is recorded in Compendium of Material Medica: the root of Dahurain angelica
For the bright main ingredient of sun, therefore blood disease, tire disease can be controlled again, and apocenosis myogenic pain relieving.
Cortex Phellodendri (latin name: Phellodendri chinensis cortex): bitter, it is cold in nature, return kidney, bladder meridian.Have
There is the effect of heat-clearing and damp-drying drug, purging intense heat, except steaming, detoxification sore treatment.
Polygonum cuspidate (latin name: Polygoni cuspidate rhizome et radix): mildly bitter flavor, cold nature, return liver,
Gallbladder, lung channel.For jaundice with damp-heat pathogen, stranguria with turbid discharge, leukorrhagia, rheumatic arthralgia, carbuncle sore tumefacting virus, scald, menostasis, abdominal mass, instep plays damage,
Cough with lung heat.
Spray-filming agent for superficial burns of the invention, which is sprayed on burn site surface, can quickly form layer protecting film;It can be fast
Short stopping pain;Chitosan inherently has antibacterial activity, compound flamazine and cationic surfactant, so that the present invention couple
Wound has very strong sterilizing effect;Being aided with Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate etc. has in therapeutic effect burn
Medicine;Epidermal growth factor can be such that burn site restores faster.Compared to more traditional ointment, spray-filming agent user of the invention
Just, it is suitable for superficial burns.
In order to better understand and implement, the following detailed description of the present invention.
Specific embodiment
Prepare embodiment
The preparation method of spray-filming agent for superficial burns of the invention the following steps are included:
(1) after Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate are cleaned crushing respectively by, add 5g by 1g Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri or polygonum cuspidate
Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate are boiled to the water for evaporating 2/3 volume respectively, filter off residue, acquired solution by the ratio of water
As Asian puccoon, the root of Dahurain angelica, Cortex Phellodendri and polygonum cuspidate extracting solution.
(2) presses 1 formula ratio of table, after glycerol and the water of same volume are mixed, by local anesthetic, borneol and epidermal growth factor
It is dissolved in wherein;
(3) presses 1 formula ratio of table, and flamazine, antibacterial agent and film forming agent are dissolved in a small amount of water;
(4) shikonin extract, the root of Dahurain angelica made from step (1) are added after mixes solution obtained by step (2) and (3)
Extracting solution, cortex phellodendri extract, polygonum cuspidate extracting solution and excess water are uniformly mixed to obtain the final product.
1 each component formula ratio of<table, by weight percentage (%)>
Film-formation result embodiment
Test specimen: sample obtained by the embodiment of the present invention 1~5 and commercially available product (Jin Fusheng)
Test method: 5 subjects participate in double blind experiments, and three kinds of sprays are sprayed on skin, with mobility, drying property,
Film forming are as follows: the evaluation index of film-formation result.Wherein mobility standards of grading are as follows: 1 point-being very easy to loss, 2 points-are easier to
Flowing, 3 points-seldom flowing;Drying property standards of grading are as follows: 1 point is drying time > 6min, 2 points of drying times are 3-6min, 3 points
For drying time < 3min;Film forming standards of grading are as follows: 1 point-imperceptible obvious film, 2 points-can be formed incomplete film, 3 points-
Obvious complete film can be formed.Add up all scores, and calculates the total score of all subjects, and the score value the high, indicates film forming effect
Fruit is better.It the results are shown in Table 2:
<table 2>
The moldability of the sample of the embodiment of the present invention 1~5 in double blind experiment it can be seen from film-formation result appraisal result
Well, mobility is small, and film-formation result is better than commercially available product.
Promote wound healing assay embodiment
Test specimen: sample obtained by the embodiment of the present invention 1~5 and commercially available product (SD-Ag)
Test method: 70 rats, half male and half female, 6-8 week old are randomly divided into 7 groups, every group 10.Be divided into embodiment 1~
5 groups, commercially available product group and control group.Note 10% chloraldurate 0.7ml in abdominal cavity is pushed away using electricity and is shaved off back about 3cm × 3cm size
Hair, spray 75% ethanol disinfection after with marking pen label 3cm × 2cm region, cut off back skin of unhairing with eye scissors, do
Wound area is recorded after dry 1h, each group gives corresponding laboratory sample respectively, and medical fluid sprays (pressing is twice) from distance 5-10cm,
The applied thickness of SD-Ag is 0.2mm, is administered 3 times a day;Control group is not administered.The wound feelings of observation rat wound site daily
Condition, and 3,5,10,15,20 days dynamic observation Rat Wound Healing situations after surgery measure surface of a wound area and calculate healing rate, more
Conjunction rate=(original face area-shows surface of a wound area)/original face area, it is considered that traumatic wounds dry tack free is not suppurated, scab
Naturally it falls off, wound is considered as healing in fair and tender normal skin shape.It the results are shown in Table 3 and table 4:
3 average wound area (mm of < table2)>
#For with control group ratio, p < 0.05;It * is the p < 0.05 compared with commercially available product group.
<table 4 is averaged healing rate (%)>
#For with control group ratio, p < 0.05;It * is the p < 0.05 compared with commercially available product group.
Sterilization test embodiment
According to GB 15979-2002 " Disposable Sanitary Accessory sanitary standard " appendix C measure the embodiment of the present invention 1~
The antibacterial effect of 5 and SD-Ag.
Test organisms: bacterium: staphylococcus aureus (ATCC 6538), Escherichia coli (ATCC 25922);
Saccharomycete: Candida albicans (ATCC 10231).
Bacterium solution preparation: the nutrient agar inclined-plane fresh cultured object 18 in the 3rd~14 generation of bacterial strain~for 24 hours is taken, 5ml is used
0.03mol/L phosphate buffer (hereinafter referred to as PBS) washes lower lawn, needed for being diluted to after so that bacterium is suspended uniformly with above-mentioned PBS
Concentration.
Operating procedure:
By test organisms, slant culture is washed down with PBS for 24 hours, and bacteria suspension is made, it is desirable that concentration are as follows: with 100 μ l drops in right
On piece in the same old way, bacterial count recovered are 1 × 104~9 × 104Cfu/ piece.
It takes by coupons (2.0cm × 3.0cm) and control print each 4, is divided into 4 groups and is placed in 4 sterilizing plates.It is described
Print and sample homogeneous material, same size are compareed, but is free of anti-biotic material, and sterilized processing.
Take above-mentioned bacteria suspension that 100 μ l are added dropwise by coupons and control sample on piece each respectively, even spread starts to count
When, 2min is acted on, print is thrown into people respectively with sterile tweezer and contains 5m1, in the test tube of corresponding neutralizer, is mixed well, is made appropriate dilute
It releases, then takes wherein 2-3 dilution, draw 0.5ml respectively, be placed in two plates, with cool to 40-45' DEG C of nutrient agar
Culture medium (bacterium) or sabouraud's agar (saccharomycete) 15m1 are poured into, and are rotated plate, are kept its full and uniform, agar solidification
After overturn plate, 35 DEG C of scholars, 2 DEG C of culture 48h (bacterium) or 72h (saccharomycete), make viable bacteria bacterium colony counting.Test is repeated 3 times, and is pressed
Following formula calculates sterilizing rate: X=(A-B)/A × 100%
In formula: X--- sterilizing rate, %;
A--- control sample average colony number;
B--- is tested sample average clump count.
Evaluation criterion: sterilizing rate >=90%, product have bactericidal effect.As a result such as table 5:
5 sterilizing rate of<table, activity 1:1>
It * is the p < 0.05 compared with SD-Ag.
Analgesic test embodiment (hot plate method in mice)
Healthy kunming mice, female, weight 20-23g are selected in experiment.It is randomly divided into control group, Fuatlin Cream group and reality
Apply a group.The threshold of pain (55 ± 0.5 DEG C of constant temperature water baths) first are surveyed before each mouse experiment, reject the threshold of pain less than 5 seconds and greater than 30
The animal of second.Embodiment group smears sample obtained by embodiment 3, and Fuatlin Cream group smears Fuatlin Cream, and control group is not
Smear drug.At toes after coating 0.5 hour, foot drug is washed away with alcohol after two by 5 middle dosage of table.To alcohol volatilize with
Afterwards, mouse is set on 55 ± 0.5 DEG C of constant temperature water bath aluminium sheets, with cloche, record is put into after mouse to be started to add certainly lid to mouse
The time of own metapedes, as the threshold of pain after administration compare each group administration front and back the threshold of pain difference, be as a result statistically analyzed rank rear in
Table 6:
<analgesic activity (X ± SD) of the spray-filming agent for superficial burns of the invention of table 6. to hot plate method in mice>
#For with control group ratio, p < 0.05;It * is the p < 0.05 compared with Fuatlin Cream group.
Clinical test embodiment
Fire victim 196 treated in 1~September in 2014, male 112, female 84, the age 3 years old to 65 years old, burn portion
Position: neck surface 54,91, upper limb, 41, lower limb, trunk 10.Depth of burn: light degree Ⅱ, burn surface area is less than 10%, nothing
Other cohesive diseases.It is randomly divided into embodiment group (100) and control group (96), two groups of patient ages, gender, burn portion
Position, depth, area, health status compare, and equal P > 0.05 is comparable.
Use drug: the spray-filming agent that embodiment group is prepared using the embodiment of the present invention 3, control group use flamazine cream
Paste (SD-Ag).
Application method: two groups of surface of a wound use 0.05% Chlorhexidine liquid debridement, remove bubble and separated epidermis, implement
The spray-filming agent of embodiment 3 is sprayed on the surface of a wound by example group, is gradually discontinued after tying dry scab, and the surface of a wound is kept to clean drying.Control group office
Portion applies SD-Ag, and disposable coating protects scab, coating again locally occurs after secretion is removed in time, two groups of equal row exposure methods.
Evaluation method: surface of a wound situation and inquiry patient perceptions are observed and recorded daily.1. recording two groups of surface of a wound pain (point nothings
Stimulation pain, minimal irritation pain, pain it is obvious, but can endure, unbearably resistance to totally 4 grades of severe pain) and secretion disappearance time.2. curing
Rate: the surface of a wound disappears (complete epithelialization) to cure after light degree Ⅱ wound.Record two groups of average cure times (the healing person containing infection).③
Whole body and local stimulation symptom after observation medication, allergic reaction and other adverse reactions.
Statistical method: measurement data is examined with t, enumeration data χ2It examines.
As a result as follows: 1. two groups of pain and secretion Disappearance Scenarios compare, and the results are shown in Table 2;2. two groups of cure rates and healing
Time compares, and the results are shown in Table 7 and table 8.
<7 two groups of pain of table and secretion extinction time>
* it indicates compared with the control group, p < 0.05
<8 two groups of cure rates of table and healing time compare>
* it indicates compared with the control group, p < 0.05
Only trauma surface infestation, incidence 1% has occurred by 1 in embodiment group, and control group has 5 generation trauma surface infestations, hair
Raw rate is 5.2%, and two groups do not find adverse reaction and allergic conditions.
The invention is not limited to above embodiment, if not departing from the present invention to various changes or deformation of the invention
Spirit and scope, if these changes and deformation belong within the scope of claim and equivalent technologies of the invention, then this hair
It is bright to be also intended to encompass these changes and deformation.