CN106619579A - Eugenol oral ulcer film, and preparation method thereof - Google Patents
Eugenol oral ulcer film, and preparation method thereof Download PDFInfo
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- CN106619579A CN106619579A CN201610955134.8A CN201610955134A CN106619579A CN 106619579 A CN106619579 A CN 106619579A CN 201610955134 A CN201610955134 A CN 201610955134A CN 106619579 A CN106619579 A CN 106619579A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/075—Ethers or acetals
- A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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Abstract
The invention discloses an eugenol oral ulcer film. The eugenol oral ulcer film is prepared from, by weight, 0.2 to 0.6 part of eugenol, 0.2 to 5.5 parts of polyvinyl alcohol, 0.01 to 3.5 parts of sodium carboxymethylcellulose, 0 to 1 part of glycerin, and 10 to 100 parts of distilled water. The invention also discloses a preparation method of the eugenol oral ulcer film. The eugenol oral ulcer film is capable of protecting oral ulcer wound for a long term, preventing secondary infection, preventing bacteria and diminishing inflammation, narcotizing and easing pain, and promoting heal; and effect is achieved quickly at lesion locations.
Description
Technical field
The present invention relates to a kind of medical instruments field, more particularly to a kind of eugenol stomatocace film；The invention further relates to
A kind of preparation method of eugenol stomatocace film.
Background technology
Canker sore is oral cavity class disease common in a kind of life, is mostly occurred at mucous membrane of mouth, with mucous membrane of mouth office
It is the form of expression that portion is damaged.Because meeting recurrent exerbation is clinically also known as recurrent oral ulceration after its healing, among the people
It is called aphtha.This disease all may occur in all ages and classes layer, not agnate, different regions people, and illness rate is general
20% is may be up in crowd, is clinically modal oral keritonocytes.For the first time the ill duration is long, hereafter sends out every time
Make the course of disease time and slowly shorten, the cavity interior stimulation pain sense oral cavity such as largely affect patient chew, swallow when ill
Activity brings various pains and inconvenience to patient.Especially considerable influence is produced to the patients ' life quality of frequent outbreak.Clinically
According to the size of ulcer performance, the depth and number difference are divided into light-duty canker sore, stomatitis type ulcer and gangrenosum acne mucous membrane week again
Enclose inflammation.Its principle of reatment is to eliminate paathogenic factor, improves eating habit, improves resistance etc. and alleviates local symptom, promotes ulcer.
The chemical name of eugenol is 4- pi-allyl 2- metoxyphenols, is organic acid phenols, is widely present in cloves
In the aromatic oil such as oil, basyleaves, skin oil, camphorated oil.Eugenol has extensive pharmacological action, mainly there is anti-inflammation, antipyretic
Analgesic acts on.But eugenol belongs to volatile oil, it is extremely difficult to be dissolved in water, stability is poor, it is easy to conventional formulation production and
Scatter and disappear in storage, affect drug effect.It is used to using eugenol alleviate the product of canker sore as active ingredient in prior art
Mainly have：
The A of Chinese patent CN 104800261 disclose a kind of cloves compound mouthwash, comprising Tea Polyphenols, eugenol and three
Seven extracts, the present invention combines Multiple components, in addition to the function in the cleaning oral cavity with different mouthwashes, also has
The mouth disease such as treatment or pre- preventing parodontitis, carious tooth, halitosis and canker sore, brightens, is good for tooth, clearing heat for detumescence, the work(of pre- anti-cancer
Effect.
In addition, a kind of prescription of the fourth roc GARG of anti-inflammatory analgetics of Chinese patent CN1820737A and preparation method prepare one
It is main fourth roc GARG to plant with basil oil (main component is as eugenol), borax, can be widely used for acute and chronic dental pulp
Inflammation, periodontitis, gum pyorrhea, redness, cavity is scorching, there is good analgesic effect.
Although however, above-mentioned utilization eugenol has mouthwash obtained in inhibitory action or GARG to malignant bacteria and fungi
Antiinflammation, pain of alleviation can be played, but mouthwash or these products of GARG are short with the time of contact in oral cavity, onset time compared with
Slowly, needing a kind of new product of offer badly can solve the eugenol poor technical problem of stability in the formulation, while can long-acting guarantor
Retaining chamber ulcer wound surface, acts on rapidly in lesions position.
The content of the invention
The technical problem to be solved is, there is provided a kind of eugenol stomatocace film and preparation method thereof, can
The long-effective protection canker sore surface of a wound, prevents scabies secondary infection, acts on rapidly in lesions position, with anti-inflammation, analgesia, promotees
Enter effect of healing.
In order to solve above-mentioned technical problem, the invention provides a kind of eugenol stomatocace film, including it is following by weight
The raw material of part meter is made：
Make as the optimal technical scheme of the eugenol stomatocace film, including following raw material by weight：
Correspondingly, the present invention also provides a kind of preparation method of eugenol stomatocace film, comprises the following steps：
Step 1：0.2-0.6 part eugenols, 0.2-5.5 part polyvinyl alcohol, 0.01-3.5 part carboxylic first are weighed by weight
Base sodium cellulosate, 0-1 parts glycerine and 10-100 part distilled water, it is stand-by；
Step 2：Polyvinyl alcohol and sodium carboxymethylcellulose are mixed and added into into distilled water immersion 20-30 hours makes its abundant
It is swelling, obtain colloidal materials；
Step 3：The colloidal materials are heated under 85-95 DEG C of water bath condition 20-40 minutes and is stirred and evenly mixed, be incubated quiet
Put 30 minutes；
Step 4：Glycerine and eugenol are added in the colloidal materials in insulation, and are slowly stirred mixing, stood, obtained
Mixed solution；
Step 5：Mixed solution is paved on glass container, horizontal positioned, hermetically drying, demoulding, institute is obtained final product after punching
State eugenol stomatocace film.
As the optimal technical scheme of the preparation method of the eugenol stomatocace film, in the step 3, glue during standing
Body material is incubated 30 minutes at 30-35 DEG C.
As the optimal technical scheme of the preparation method of the eugenol stomatocace film, in the step 5, after plastic film mulch
Glass container is placed in an oven, is dried under the conditions of temperature is for 35-45 DEG C, and drying time is 2.5-4 hours.
As the optimal technical scheme of the preparation method of the eugenol stomatocace film, in the step 5, after plastic film mulch
In room temperature, wind speed is to be dried under conditions of 5-15m/s to glass container, and drying time is 12-18 hours.
As the optimal technical scheme of the preparation method of the eugenol stomatocace film, the eugenol stomatocace film
Thickness be 0.5 ± 0.02mm.
As the optimal technical scheme of the preparation method of the eugenol stomatocace film, the eugenol stomatocace film
It is punched into the size of 1.5cm × 1.5cm.
Implement the embodiment of the present invention, have the advantages that：
Eugenol is made into film by the present invention with reference to polyvinyl alcohol and sodium carboxymethylcellulose, with good film-forming property, table
Face is smooth, and thickness, color are uniform, and the good advantage of flexibility is affixed on the canker sore surface of a wound, and skin tracing ability is good, and application uses easypro
It is suitable, it is difficult for drop-off.Meanwhile, the active ingredients eugenol in film can rapidly act on focus, and pain of alleviation, antiphlogistic antibacterial promotes
Granulation tissue generation and the healing in ulcer sore face, and the film is in preparation and storage, and eugenol can be retained stably
Be not in that significantly volatilization is scattered and disappeared in film, the stability of product effect is guaranteed；Polyvinyl alcohol, carboxymethyl are fine
The plain sodium of dimension, glycerine and distilled water are all pharmaceutical grade auxiliary material, and with splendid biocompatibility and degradability, product safety can
Lean on.
Description of the drawings
Fig. 1 is the canonical plotting of cloves phenol solution of the present invention.
Specific embodiment
To make the object, technical solutions and advantages of the present invention clearer, will make further detailed to the present invention below
Description.
The present invention provides a kind of eugenol stomatocace film, including following raw material by weight is made：
Eugenol (Eugenol) chemical name is 4- pi-allyl 2- metoxyphenols, is organic acid phenols, is widely present
In the aromatic oil such as caryophyllus oil, basyleaves, skin oil, camphorated oil.Because containing aromatic rings in its structure, the polar group on aromatic rings
Phenolic hydroxyl group, can be combined with the active group of some enzymes of bacterium, destroy the normal metabolic function of bacterium to affect the normal of bacterium
Growth.So eugenol has the effect such as sterilization, anti-inflammatory, can substantially suppress staphylococcus, Candida albicans, streptococcus, mould
And Escherichia coli etc..With the development of modern medicine, research finds that eugenol also has the mediator transmission of blocking surface of a wound nerve endings,
To alleviate pain at disease damage rapidly, the shape that local anesthetic action also can suppress peroxidase activity and reduce inflammatory mediator simultaneously is being produced
Into, so as to eliminate the congested swelling symptom at ulcer rapidly, reach promote granulation tissue generate and ulcer sore face healing.More than
Pharmacology and physiology new discovery cause application of the eugenol in dentistry more and more extensive.
But eugenol belongs to volatile oil, it is extremely difficult to be dissolved in water, stability is poor, it is easy to the production and storage in conventional formulation
During scatter and disappear, affect drug effect.Existing patent utilization eugenol has mouthwash obtained in inhibitory action to malignant bacteria and fungi
Although or GARG can play the time of contact in antiinflammation, pain of alleviation, mouthwash or these products of GARG and oral cavity
Short, onset time is slower.
For this purpose, eugenol is made into film by the present invention with reference to polyvinyl alcohol and sodium carboxymethylcellulose, with film forming
Good, surface is smooth, and thickness, color are uniform, and the good advantage of flexibility is affixed on the canker sore surface of a wound, and skin tracing ability is good, and application makes
It is difficult for drop-off with comfortable.It should be noted that polyvinyl alcohol and sodium carboxymethylcellulose both of which are filmogens, it is tool
There is a high degradable high polymer material of adhesiveness, biological safety, polyvinyl alcohol and sodium carboxymethylcellulose cooperate and use,
Be conducive to improving the filming performance and adhesion property of film.Meanwhile, the active ingredients eugenol in film can rapidly act on focus,
Pain of alleviation, antiphlogistic antibacterial promotes granulation tissue generation and the healing in ulcer sore face, and the film preparing and storing
Cheng Zhong, eugenol can be remained in stably in film, be not in that significantly volatilization is scattered and disappeared, and the stability of product effect is protected
Card；Polyvinyl alcohol, sodium carboxymethylcellulose, glycerine and distilled water are all pharmaceutical grade auxiliary material, with splendid biocompatibility and
Degradability, product safety reliability.
Preferably, a kind of eugenol stomatocace film of the invention, including following raw material by weight is made：
It should be noted that eugenol stomatocace film of the present invention, the by weight proportioning of eugenol may be selected
Number be 0.2,0.3,0.4,0.5 or 0.6, but not limited to this；The selectable number of proportioning of polyvinyl alcohol be 1.5,2.1,
2.7th, 3.5 or 5.0, but not limited to this；The selectable number of proportioning of sodium carboxymethylcellulose be 0.3,0.9,1.5,2.0 or
3.2, but not limited to this；The selectable number of proportioning of glycerine is 0,0.5 or 1.0, but not limited to this；The proportioning of distilled water is optional
The number selected is 20,30,40,46,52 or 70, but not limited to this.
Correspondingly, the present invention also provides a kind of preparation method of eugenol stomatocace film, comprises the following steps：
Step 1：0.2-0.6 part eugenols, 0.2-5.5 part polyvinyl alcohol, 0.01-3.5 part carboxylic first are weighed by weight
Base sodium cellulosate, 0-1 parts glycerine and 10-100 part distilled water, it is stand-by.
Step 2：Polyvinyl alcohol and sodium carboxymethylcellulose are mixed and added into into distilled water immersion 20-30 hours makes its abundant
It is swelling, obtain colloidal materials.
Because environment temperature has large effect for swellbility in swelling process, under cryogenic conditions, if according to room temperature 20
The proportioning of polyvinyl alcohol and sodium carboxymethylcellulose at DEG C and distilled water, polyvinyl alcohol and sodium carboxymethylcellulose it is swelling not complete
Entirely, plastic film mulch is difficult.Currently preferred technical scheme is the polyvinyl alcohol and sodium carboxymethylcellulose that will be immersed in distilled water
Be placed at 20-25 DEG C of constant temperature carry out it is swelling；Another feasible technical scheme of the present invention is the change according to room temperature, and with room temperature 25
DEG C it is reference temperature(TR), the appropriate addition for increasing distilled water.Specifically, room temperature often reduces by 5 DEG C, the addition of distilled water in formula
Increase 1-3ml.
Step 3：The colloidal materials are heated under 85-95 DEG C of water bath condition 20-40 minutes and is stirred and evenly mixed, be incubated quiet
Put 30 minutes.
Colloidal materials are carried out into heating water bath and there are during stirring a large amount of bubbles to produce, reduce the smooth of film
Property.Preparation method of the present invention stands the mixing macromolecular material after heating water bath in 30-35 DEG C of constant water bath box
30 minutes, bubble was both eliminated, turn avoid the too fast problem for being difficult plastic film mulch of mixing material cooling.
Step 4：Glycerine and eugenol are added in the colloidal materials in insulation, and are slowly stirred mixing, stood, obtained
Mixed solution.
Eugenol is heated volatile, therefore in order to avoid eugenol is heated volatilization in preparation process, is adding fourth first
To ensure that mixing filmogen temperature is unsuitable too high during fragrant phenol, suitable holding temperature is 30-35 DEG C, be slowly stirred and avoid producing
A large amount of bubbles, and stand 30 minutes exclusion bubbles.
Step 5：Mixed solution is paved on glass container, horizontal positioned, hermetically drying, demoulding, institute is obtained final product after punching
State eugenol stomatocace film.
Mixed solution after de-soak is poured on glass container, because the mixed solution was through the insulation of 30 minutes, its stream
Dynamic property preferably, is easily paved in glass container, and film forming thickness is uniform.
It should be noted that preparation method of the present invention reduces drug content to avoid being directly exposed in air,
Should be dried in a sealed meter environment, wherein preferably technical scheme be by after plastic film mulch glass container place in an oven,
To be dried under the conditions of 35-45 DEG C, drying time is 2.5-4 hours to temperature；More preferably technical scheme is the glass after plastic film mulch
In room temperature, wind speed is to be dried under conditions of 5-15m/s to container, and drying time is 12-18 hours.
Thickness after film forming is 0.5 ± 0.02mm, and is punched into appropriate size as needed, it is preferable that the present invention will
The eugenol stomatocace film is punched into the size of 1.5cm × 1.5cm.
Quality evaluation is carried out to the eugenol stomatocace film below by several experiments：
1st, laboratory sample：
Formula：Eugenol 0.5g, polyvinyl alcohol 2.1g, sodium carboxymethylcellulose 0.9g, glycerine 0.5g, add distilled water
46ml。
Preparation method：
Step 1：0.2-0.6 part eugenols, 0.2-5.5 part polyvinyl alcohol, 0.01-3.5 part carboxylic first are weighed by weight
Base sodium cellulosate, 0-1 parts glycerine and 10-100 part distilled water, it is stand-by；
Step 2：Polyvinyl alcohol and sodium carboxymethylcellulose are mixed and added into into distilled water immersion 20-30 hours makes its abundant
It is swelling, obtain colloidal materials；
Step 3：The colloidal materials are heated under 85-95 DEG C of water bath condition 20-40 minutes and is stirred and evenly mixed, 30-35
Insulation at DEG C stands 30 minutes；
Step 4：Glycerine and eugenol are added in the colloidal materials in insulation, and are slowly stirred mixing, stood, obtained
Mixed solution；
Step 5：Mixed solution is paved on glass container, horizontal positioned, sealed under conditions of wind speed is 5-15m/s
It is dried, demoulding obtains eugenol stomatocace film, as laboratory sample after punching.
2nd, experimental technique
2.1 weight differential degree are determined
Laboratory sample eugenol stomatocace film 20 is taken, accurately weighed 20 film gross weights are obtained per the average of piece
Weight.Distinguish accurately weighed per sheet weight again, seek weight differential degree.
Formula is as follows：Weight differential degree=(monolithic weight-average weight)/average weight × 100%.
2.2 dissolution times are determined
Laboratory sample eugenol stomatocace film 6 is taken, is uniformly affixed on and is filled 200ml distilled water (37 DEG C) 500ml beakers
Apart from water surface 3cm on wall.The time being completely dissolved is write down, and obtains adherent average dissolution time.
Separately take eugenol stomatocace film 6 to be placed under same experiment condition, and simulation enteron aisle is slowly stirred with glass bar
Wriggle and chewing situation is swallowed in oral cavity, then write down its time being completely dissolved, and obtain average dissolution time under stirring condition.
2.3 assay
2.3.1 calibration curve is prepared
Precision weighs 0.9988g eugenols standard sample in the small beaker of clean dried, plus 80% (V/V) dilution after, move
In entering 100ml volumetric flasks, then (V/V) ethanol is diluted to groove Jia 80%, shakes up and makes 1. number solution.Draw 1. number solution 10ml
In 100ml volumetric flasks, then groove is diluted to 80% (V/V) ethanol.Shake up the eugenol for making that concentration is 0.9838mg/ml
Reference substance storing solution.Precision absorption eugenol reference substance stock solution 1.5,2.0,2.5,3.0,3.5,4.0ml is put respectively to 100ml
(V/V) ethanol is diluted to scale in volumetric flask, plus 80%, makes into concentration and is respectively 14.76,19.68,24.60,29.51,
The control series product solution of 34.43,39.35 μ g/ml, with 80% (V/V) ethanol as blank, surveys at 281.0nm wavelength
Determine absorbance (A).With concentration (C) as abscissa, with absorbance (A) as ordinate, draw calibration curve, obtain regression equation with
Coefficient correlation.
2.3.2 Precision Experiment
The reference substance solution for taking 14.76,29.51,39.35 tri- concentration of μ g/ml is each 5 parts, with 80% (V/V) ethanol as empty
In vain, UV absorption wavelength is determined at 281.0nm, in a few days RSD values are sought.
2.3.3 sample solution stability experiment
To take be placed in beaker after eugenol stomatocace film 1 prepared by optimum prescription is shredded and Jia 80% (V/V) ethanol is stirred
Mix to film and be completely dissolved, then solution is moved in 50ml volumetric flasks, (V/V) ethanol is settled to scale and shakes up plus 80%, filter,
And just filtrate is discarded, and subsequent filtrate 10ml is then pipetted in 25ml volumetric flasks, scale is settled to, shake up and make sample liquid, sample
5 parts of product liquid, mensuration absorbance when interval time being 0,2,4,8,12h.
2.3.4 repeated experiment and assay.
Eugenol stomatocace film 6 prepared by optimum prescription is taken, is shredded after accurately weighed every sheet weight, and respectively will be each
Piece is placed in beaker Jia 80% (V/V) ethanol is stirred to film and is completely dissolved, then solution is moved in 50ml volumetric flasks, plus 80%
(V/V) ethanol is settled to scale and shakes up, and makes 6 parts of solution.Filter, and discard just filtrate, then pipette subsequent filtrate 10ml in
In 25ml volumetric flasks, scale is settled to, shakes up and make sample liquid.With 80% (V/V) ethanol as blank, in wavelength
The absorbance of determination sample liquid at 281.0nm, and regression equation is substituted into, calculate averagely containing for eugenol canker sore film
Amount and RSD values.
2.3.5 average recovery experiment
The sample liquid of the known content prepared to 4.3.4 methods, adds the eugenol reference substance storing solution of known content
0.5ml, and assay is carried out by ultraviolet specrophotometer, according to the formula rate of recovery (%)=(actual measurement content-sample contains
Amount)/add standard items content × 100%.Calculate the rate of recovery and relative RSD values.
3rd, measurement result
3.1 weight differential degree measurement results
The weight differential degree measurement result of eugenol stomatocace film is shown in Table 1, as a result shows that eugenol stomatocace film is every
Sheet weight diversity factor meets Chinese Pharmacopoeia (version in 2010) about the requirement of film within ± 10%.
The eugenol stomatocace film weight differential degree measurement result of table 1
3.2 dissolution time measurement results
The dissolution time of eugenol stomatocace film is shown in Table 2, as a result shows the average adherent molten of eugenol stomatocace film
The solution time is 68.2min, and stirring average dissolution time is 139.7s.
The eugenol stomatocace film dissolution time measurement result record sheet of table 2
The dissolution time experiment of fragrant phenol stomatocace film can find that the adherent dissolution time of eugenol stomatocace film is one
Individual hour or so, meets the medication demand of oral administration.And the dissolution time of stirring eugenol stomatocace film is shorter, fourth is pointed out
Fragrant phenol stomatocace film is that patient's words that should save your breath avoid chewing or swallowing act as far as possible when using, and in addition the eugenol oral cavity is burst
The unsuitable Oral Gastrointestinal Tract administration of ulcer film.
3.3 standard curve determination results
Cloves phenol solution determines the calibration curve for making and sees Fig. 1 by ultraviolet specrophotometer, and calculates recurrence side
Journey：A=0.018C-0.1448, correlation coefficient r=0.9991, as seen from the figure the calibration curve equation of cloves phenol solution is 14.76
Linear relationship is good in the range of～39.35 μ g/ml.
3.4 Precision Experiment results
Precision Experiment the results are shown in Table 3, and in a few days RSD is respectively：0.04%th, 0.07%, 0.09% (n=5), precision is good
It is good.
The Precision test result of table 3
3.5 sample solution stability experiment measurement results
Eugenol stomatocace film sample solution Stability Determination the results are shown in Table 4, as a result show the absorbance of sample solution
It was basically unchanged in 8 hours.
The measurement result record sheet of the eugenol stomatocace film sample solution stability of table 4
3.6 repeated experiments and assay result
The repeated experiment of eugenol stomatocace film the results are shown in Table 5 with assay, as a result show, eugenol oral cavity is burst
Eugenol average content is 98.02mg/g, RSD=4.4% in ulcer film, and repeatability is good.
The reperformance test of table 5 and assay result
3.7 rate of recovery experimental results
The determination of recovery rates of eugenol stomatocace film the results are shown in Table 6, as a result show, average recovery rate is 98.8%, RSD
=0.914%, the eugenol canker sore film rate of recovery is good.
The rate of recovery experimental result of table 6
From above-mentioned experiment, the eugenol stomatocace film surface obtained using preparation method of the present invention is smooth,
Thickness, color uniformity, flexibility is good.Shown by film quality evaluation result of the test, the eugenol oral cavity prepared is burst
Ulcer film is evaluated in weight differential degree, Mouthsimulator dissolution time, and drug content, product stability, the rate of recovery are relatively managed in film
Think.
It is below eugenol stomatocace film Preliminay clinical trials of the present invention
(1) subjects
With 50 volunteers with canker sore as the object of observation, wherein, the male sex 28, women 22, the age is 15
Between～45 years old, the course of disease 1～30 day.
(2) using method
Again eugenol stomatocace film is affixed on into ulcer wound surface after gargling using warm water, daily 1～3.
(3) efficacy determination
It is effective：Pain and red and swollen substantially regression or disappearance after application, ulcer healed in 2 days, and healing time is more conventional
Substantially shorten；
Effectively：The pain Jing after treatment, redness reaction mitigation, but intake irritable food appoints sense uncomfortable, and ulcer healed in 4 days
Close；
It is invalid：Pain relief after medication, ulcer disunion in 5 days.
(4) treatment results
50 by clinic application, effective 26, obvious effective rate 52%, effective 21, efficient 42.0%, invalid 3, always have
Efficiency 94%.
It is last to should be noted that above example only to illustrate technical scheme rather than protect to the present invention
The restriction of shield scope, although being explained in detail to the present invention with reference to preferred embodiment, one of ordinary skill in the art should
Understand, technical scheme can be modified or equivalent, without deviating from the essence of technical solution of the present invention
And scope.
Claims (8)
1. a kind of eugenol stomatocace film, it is characterised in that make including following raw material by weight：
2. eugenol stomatocace film as claimed in claim 1, it is characterised in that including following raw material system by weight
Into：
3. a kind of preparation method of eugenol stomatocace film, it is characterised in that comprise the following steps：
Step 1：It is fine that 0.2-0.6 part eugenols, 0.2-5.5 part polyvinyl alcohol, 0.01-3.5 parts carboxymethyl are weighed by weight
The plain sodium of dimension, 0-1 parts glycerine and 10-100 part distilled water, it is stand-by；
Step 2：Polyvinyl alcohol and sodium carboxymethylcellulose are mixed and added into into distilled water immersion 20-30 hours makes it fully molten
It is swollen, obtain colloidal materials；
Step 3：The colloidal materials are heated under 85-95 DEG C of water bath condition 20-40 minutes and is stirred and evenly mixed, insulation stands 30
Minute；
Step 4：Glycerine and eugenol are added in the colloidal materials in insulation, and are slowly stirred mixing, stood, mixed
Solution；
Step 5：Mixed solution is paved on glass container, horizontal positioned, hermetically drying, demoulding, the fourth is obtained final product after punching
Fragrant phenol stomatocace film.
4. the preparation method of eugenol stomatocace film as claimed in claim 3, it is characterised in that in the step 3, during standing
Colloidal materials are incubated 30 minutes at 30-35 DEG C.
5. the preparation method of eugenol stomatocace film as claimed in claim 3, it is characterised in that in the step 5, after plastic film mulch
Glass container place in an oven, temperature be 35-45 DEG C under the conditions of be dried, drying time be 2.5-4 hours.
6. the preparation method of eugenol stomatocace film as claimed in claim 3, it is characterised in that the glass container after plastic film mulch exists
Room temperature, wind speed is to be dried under conditions of 5-15m/s, and drying time is 12-18 hours.
7. the preparation method of eugenol stomatocace film as claimed in claim 3, it is characterised in that the eugenol canker sore
The thickness of film is 0.5 ± 0.02mm.
8. the as claimed in claim 3 preparation method of eugenol stomatocace film, it is characterised in that the eugenol canker sore
Film is punched into the size of 1.5cm × 1.5cm.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610955134.8A CN106619579A (en) | 2016-10-27 | 2016-10-27 | Eugenol oral ulcer film, and preparation method thereof |
| PCT/CN2017/095141 WO2018076856A1 (en) | 2016-10-27 | 2017-07-31 | Eugenol oral ulcer membrane and preparation method therefor |
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| CN201610955134.8A CN106619579A (en) | 2016-10-27 | 2016-10-27 | Eugenol oral ulcer film, and preparation method thereof |
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| CN106619579A true CN106619579A (en) | 2017-05-10 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108295121A (en) * | 2018-02-13 | 2018-07-20 | 云南诺漫斯生物科技有限公司 | A kind of American cockroach film for treating oral ulcer agent and preparation method thereof |
| CN115645627A (en) * | 2022-10-24 | 2023-01-31 | 杭州师范大学 | Full-biomass-based medical antibacterial gel with high oxidation resistance and tissue repair promotion function and preparation method and application thereof |
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|---|---|---|---|---|
| GB2592863A (en) * | 2019-10-22 | 2021-09-15 | Ramesh Morjara Chetan | Topical anesthetic |
| CN113509454A (en) * | 2021-06-24 | 2021-10-19 | 西安医学院 | Novel one-way drug release oral ulcer double-layer film and preparation method thereof |
| CN113662234B (en) * | 2021-08-06 | 2022-10-04 | 浙江中创雾联生物科技有限公司 | Antibacterial atomized liquid and preparation method thereof |
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| CN102228597A (en) * | 2011-06-13 | 2011-11-02 | 武汉理工大学 | Medicament for treating oral ulcer and preparation method |
| CN102429893A (en) * | 2011-11-30 | 2012-05-02 | 四川梓橦宫药业有限公司 | Anti-inflammation and anti-allergy canker sore treating medicament and preparation method thereof |
| CN104257636A (en) * | 2014-09-26 | 2015-01-07 | 天津市聚星康华医药科技有限公司 | Lysozyme oral mucoadhesive films and preparation method thereof |
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| CN104223078A (en) * | 2014-09-26 | 2014-12-24 | 天津市聚星康华医药科技有限公司 | Tea polyphenol oral cavity instant film and preparation method thereof |
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- 2016-10-27 CN CN201610955134.8A patent/CN106619579A/en active Pending
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- 2017-07-31 WO PCT/CN2017/095141 patent/WO2018076856A1/en active Application Filing
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| CN102228597A (en) * | 2011-06-13 | 2011-11-02 | 武汉理工大学 | Medicament for treating oral ulcer and preparation method |
| CN102429893A (en) * | 2011-11-30 | 2012-05-02 | 四川梓橦宫药业有限公司 | Anti-inflammation and anti-allergy canker sore treating medicament and preparation method thereof |
| CN104257636A (en) * | 2014-09-26 | 2015-01-07 | 天津市聚星康华医药科技有限公司 | Lysozyme oral mucoadhesive films and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108295121A (en) * | 2018-02-13 | 2018-07-20 | 云南诺漫斯生物科技有限公司 | A kind of American cockroach film for treating oral ulcer agent and preparation method thereof |
| CN115645627A (en) * | 2022-10-24 | 2023-01-31 | 杭州师范大学 | Full-biomass-based medical antibacterial gel with high oxidation resistance and tissue repair promotion function and preparation method and application thereof |
| CN115645627B (en) * | 2022-10-24 | 2024-04-02 | 杭州师范大学 | All-biomass-based medical antibacterial gel with high oxidation resistance and tissue repair promotion function, and preparation method and application thereof |
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| Publication number | Publication date |
|---|---|
| WO2018076856A1 (en) | 2018-05-03 |
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Application publication date: 20170510 |