CN106727446A - Film-forming composition, diaphragm and application - Google Patents

Film-forming composition, diaphragm and application Download PDF

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Publication number
CN106727446A
CN106727446A CN201611218476.8A CN201611218476A CN106727446A CN 106727446 A CN106727446 A CN 106727446A CN 201611218476 A CN201611218476 A CN 201611218476A CN 106727446 A CN106727446 A CN 106727446A
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film
parts
forming composition
canker sore
diaphragm
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CN106727446B (en
Inventor
陈伟才
张利萍
刘都树
黄亮
罗勇
易丹
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Guangzhou Liby Enterprise Group Co Ltd
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Guangzhou Liby Enterprise Group Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7015Drug-containing film-forming compositions, e.g. spray-on
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a kind of canker sore protection film composition.A kind of canker sore protection film composition according to the mass fraction, including 2 parts~40 parts of main film forming agent, 1 part~20 parts of furtherance film and 45 parts~90 parts of organic solvent;The main film forming agent is selected from least one in shellac, ethyl cellulose and aliphatic acid;The furtherance film is selected from least one in polyvinyl butyral resin, polyvinyl alcohol and polyvinyl acetate.When above-mentioned main film forming agent is used cooperatively with furtherance film; the canker sore diaphragm of formation has more excellent integrality; canker sore diaphragm can be resistant to the immersion of saliva and wash away, so that canker sore protects extended residence time of the film composition at canker sore.

Description

Film-forming composition, diaphragm and application
Technical field
The present invention relates to technical field of medicine preparation, more particularly to a kind of film-forming composition, diaphragm and application.
Background technology
In daily life and work, people can usually occur all kinds of somatic damages.As occurred on human body skin top layer The skin injuries such as scratch, cut wound, scald and the mucous membrane of mouth limitation ulcerative lesions etc. for occurring in human oral cavity.Such body Bulk damage typically has self-healing, but the healing rate of wound or canker sore is generally slower, when wound or canker sore Can also be aggravated the pain sense during by environmental stimuli, and influence its healing, and the live and work for giving people is made troubles.
At present, process the conventional method of such somatic damage be at wound or canker sore application preparation with anti-inflammatory, drop Low pain, prevent scabies secondary infection, promote healing.But these preparations are easily eliminated at wound or canker sore, and cannot prevent Only wound or canker sore are subject to environmental stimuli.Forming diaphragm in wound or canker sore surface using filmogen can solve Certainly above mentioned problem.However, the diaphragm that the filmogen for using at present is formed is mostly easily rupturable so that the diaphragm for being formed Fragile and the residence time is not enough at wound or canker sore, the protecting effect to wound or canker sore is not good.
The content of the invention
Based on this, it is necessary to provide film-forming composition, diaphragm and the application being not easily broken after a kind of film forming.
A kind of film-forming composition, according to the mass fraction, including 2 parts~40 parts of main film forming agent, 1 part~20 parts of furtherance film Agent and 45 parts~90 parts of organic solvent;
The main film forming agent is selected from least one in shellac, ethyl cellulose and aliphatic acid;
The furtherance film is selected from least one in polyvinyl butyral resin, polyvinyl alcohol and polyvinyl acetate.
Wherein in an implementation method, the aliphatic acid is aliphatic acid that carbon number is 12~18.
Wherein in an implementation method, the aliphatic acid is selected from laurate, tridecanoic acid, myristic acid, pentadecanoic acid, palm At least one in acid, heptadecanoic acid and stearic acid.
Wherein in an implementation method, the organic solvent is ethanol.
Wherein in an implementation method, also including 3~25 parts of water.
Wherein in an implementation method, also including 0.05 part~1 part of thickener.
Wherein in an implementation method, the thickener is selected from hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl first At least one in base cellulose and vinyl pyrrolidone.
Wherein in an implementation method, also including 0.1 part~2 parts of function additive;The function additive be selected from essence, At least one in menthol, borneol, sodium azulenesulfonate and pearl powder.
A kind of diaphragm, is prepared by above-mentioned film-forming composition.
Application of the above-mentioned film-forming composition in canker sore diaphragm and Wound protection film is prepared.
Above-mentioned film-forming composition, after being coated at wound or canker sore, organic solvent volatilization, main film forming agent and furtherance film Agent cooperatively forms diaphragm, and the diaphragm of formation has more excellent integrality, and can be resistant to immersion and wash away, so that protecting Extended residence time of the cuticula composition at wound or canker sore, to the protecting effect of wound or canker sore more preferably.On State film-forming composition to can be used for preparing canker sore diaphragm and Wound protection film, so as to at canker sore or wound is carried out Protection.
Specific embodiment
Film-forming composition, diaphragm and application are described in further detail below in conjunction with specific embodiment.
The film-forming composition of one implementation method, according to the mass fraction, including 2 parts~40 parts of main film forming agent, 1 part~20 parts Furtherance film, 0.05 part~1 part of thickener, 0.1 part~2 parts of function additive, 45 parts~90 parts of organic solvent and 3 parts ~25 parts of water.
Film-forming composition is liquid or gel.Wherein in an implementation method, thickener is not contained in film-forming composition, Now film-forming composition is liquid.In other embodiments, amount of thickener is higher in film-forming composition, and film-forming composition is Gel.
Film-forming composition can be used at canker sore or wound, used as canker sore diaphragm film-forming composition or wound Mouth diaphragm film-forming composition, makes canker sore or wound be isolated from the outside.Certainly, in situation about not reacted with other drugs Under, it is also possible to film-forming composition is applied to other ointment surfaces of skin surface, for ointment to be isolated from the outside.Hereinafter lead Will using film-forming composition as canker sore diaphragm film-forming composition as a example by illustrate, when film-forming composition as other use During way, its action principle is essentially identical with as canker sore diaphragm, and only applied environment is different, and therefore not to repeat here.
Film forming agent is volatilized by solvent or runs into saliva, can form the insoluble film of uniform sheet.One wherein In implementation method, main film forming agent is selected from least one in shellac, ethyl cellulose and aliphatic acid.Preferably, main film forming agent is Shellac.Shellac, also known as lac or red glue, is that lac insect draws the purple natural resin secreted out of after host tree resin.Wherein one In individual implementation method, after removing the impurity such as branch, crushing, screening, add water shellac stirring and rinsing in cask washing, and the later stage is again A small amount of builder is added, centrifugal dehydration after cleaning, then obtained with drying machine drying.
Wherein in an implementation method, aliphatic acid is aliphatic acid that carbon number is 12~18.Specifically, aliphatic acid is selected At least one from laurate, tridecanoic acid, myristic acid, pentadecanoic acid, palmitic acid, heptadecanoic acid and stearic acid.
Wherein in an implementation method, furtherance film is selected from polyvinyl butyral resin, polyvinyl alcohol and polyvinyl acetate At least one in ester.Preferably, furtherance film is polyvinyl butyral resin.Wherein in an implementation method, polyvinyl alcohol The viscosity of butyral is 5.5MPaS.The acetalizing degree of polyvinyl butyral resin is 68%~88%.Adding furtherance film can improve The integrality of canker sore diaphragm, the canker sore diaphragm of formation is not susceptible to fracture and breakage.
Wherein in an implementation method, organic solvent is ethanol.The mass concentration of ethanol is 99.0%~99.9%.
Wherein in an implementation method, it is fine that thickener is selected from hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl At least one in dimension element and vinyl pyrrolidone.Vinyl pyrrolidone includes vinylpyrrolidone copolymer and ethene At least one in base pyrrolidones homopolymers.The addition of thickener can substantially increase the glutinous of canker sore protection film composition Degree.
Wherein in an implementation method, function additive is selected from essence, menthol, borneol, sodium azulenesulfonate and pearl powder At least one.
Wherein in an implementation method, essence selects food-grade essence.Essence can be flavoring apple essence, honey peach perfume Essence, or any other taste essence.
Wherein in an implementation method, after adding menthol, canker sore protection film composition has peppermint fragrance, and And with refrigerant effect.The addition of borneol can play clearing heat and detoxicating effect.Sodium azulenesulfonate is the letter of Kessazulen sodium sulfonate Claim, its chemical entitled Isosorbide-5-Nitrae-dimethyl -7- isopropyl Azulene -3- sodium sulfonates.Sodium azulenesulfonate has anti-inflammatory, promotes the work of granulation regeneration With.
Above-mentioned film-forming composition, after being coated at wound or canker sore, organic solvent volatilization, main film forming agent and furtherance film Agent cooperatively forms diaphragm, and the diaphragm of formation has more excellent integrality, and diaphragm can be resistant to immersion and wash away, so that Extended residence time of the film composition at wound or canker sore must be protected, to the protecting effect of wound or canker sore more It is good.
It should be noted that in above-mentioned film-forming composition, thickener, function additive and water can be omitted according to circumstances.
The preparation method of above-mentioned film-forming composition, comprises the following steps:
S110,2 parts~40 parts of main film forming agent and 1 part~20 parts of furtherance film are added to 45 parts~90 parts organic Stirred in solvent to well mixed.
Wherein in an implementation method, stirring is carried out in homogenizer, and the rotating speed of mixer is 1000r/min ~3000r/min, the time of stirring is 10 minutes~30 minutes.
In other embodiments, stirring can also be carried out in other agitators, or be stirred manually.
S120, add 3 parts~25 parts of water and continue to stir to well mixed.
Wherein in an implementation method, stirring is carried out in homogenizer, and the rotating speed of mixer is 1000r/min ~3000r/min, the time of stirring is 10 minutes~30 minutes.
In other embodiments, stirring can also be carried out in other agitators, or be stirred manually.
It should be noted that in other embodiments, step S120 can also be omitted.In other embodiments, exist In step S110, while adding function additive and thickener to be mixed.
The preparation method of above-mentioned film-forming composition is simple, easy to operate, low for equipment requirements, easily realizes industrialized production.
The diaphragm of one implementation method, is prepared by above-mentioned film-forming composition.
Specifically, solvent volatilizees in above-mentioned film-forming composition, other components cooperatively form diaphragm.
Diaphragm can be as the diaphragm of canker sore diaphragm, Wound protection film or other purposes.
Said protection film has more excellent integrality, when being played a protective role at wound or canker sore, more resistant to Soak and wash away, so as to residence time at wound or canker sore is longer, to the protecting effect of wound or canker sore more It is good.
Here is the explanation of specific embodiment.
Embodiment 1
20 parts of shellac and 20 parts of polyvinyl butyral resin are added to during 65 parts of mass concentrations are 99.8% ethanol, Stirred in homogenizer again 30 minutes and obtain liquid film-forming composition to well mixed.The rotating speed of mixer is 3000r/min。
Embodiment 2
By 10 parts of shellac, 10 parts of C18 stearic acid, 1 part of polyvinyl butyral resin, 0.1 part of thickener ethoxy Cellulose, 0.1 part of menthol are added to during 70 parts of mass concentrations are 99.0% ethanol, and 10 points are stirred in homogenizer Clock is to well mixed, then is added thereto to 3 parts of water, continues to stir and obtains gelatinous film-forming composition in 10 minutes.Mixer Rotating speed be 1000r/min.
Embodiment 3
By 10 parts of laurate, 5 parts of ethyl cellulose, 5 parts of polyvinyl butyral resin, 0.1 part of thickener hydroxypropyl It is 99.5% that base cellulose, 0.5 part of menthol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate are added to 75 parts of mass concentrations Ethanol in, 10 minutes are stirred in homogenizer to well mixed, then be added thereto to 4 parts of water, continue to stir 10 points Clock obtains gelatinous film-forming composition.The rotating speed of mixer is 2000r/min.
Embodiment 4
By 15 parts of palmitic acid, 5 parts of polyvinyl acetate, 0.5 part of thickener hydroxypropyl methyl cellulose, 1 part Menthol, 0.8 part of borneol and 0.2 part of sodium azulenesulfonate are added to during 75 parts of mass concentrations are 99.8% ethanol, at a high speed 10 minutes are stirred in mixer to well mixed, then are added thereto to 4 parts of water, continue to stir obtain within 10 minutes it is gelatinous into Film composition.The rotating speed of mixer is 1000r/min.
Embodiment 5
By 20 parts of ethyl cellulose, 5 parts of polyvinyl butyral resin, 5 parts of polyvinyl alcohol, 0.5 part of thickener second Alkenyl pyrrolones, 0.5 part of menthol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate are added to 65 parts of mass concentrations In 99.8% ethanol, 20 minutes are stirred in homogenizer to well mixed, then be added thereto to 3.5 parts of water, continued Stirring obtains gelatinous film-forming composition in 10 minutes.The rotating speed of mixer is 1000r/min.
Embodiment 6
By 40 parts of shellac, 10 parts of polyvinyl butyral resin, 1 part of thickener vinyl pyrrole ketone, 0.5 part of peppermint Alcohol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate are added to during 65 parts of mass concentrations are 99.8% ethanol, in high-speed stirred 20 minutes are stirred in machine to well mixed, then is added thereto to 3.4 parts of water, continued to stir and obtain gelatinous film forming in 10 minutes Composition.The rotating speed of mixer is 1000r/min.
Embodiment 7
5 parts of shellac, 2 parts of polyvinyl butyral resin, 5 parts of polyvinyl alcohol, 0.05 part of thickener ethoxy is fine Dimension element, 0.5 part of menthol, 0.5 part of borneol and 0.2 part of pearl powder are added to the ethanol that 90 parts of mass concentrations are 99.8% In, 10 minutes are stirred in homogenizer to well mixed, then 4.5 parts of water is added thereto to, continue to stir 10 minutes To gelatinous film-forming composition.The rotating speed of mixer is 1000r/min.
Embodiment 8
By 20 parts of shellac, 10 parts of polyvinyl butyral resin, 0.5 part of thickener hydroxypropyl cellulose, 0.5 part thin Lotus alcohol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate are added to during 45 parts of mass concentrations are 99.8% ethanol, in high-speed stirring Stirring 20 minutes is mixed in machine to well mixed, then is added thereto to 25 parts of water, continue to stir obtain within 10 minutes it is gelatinous into Film composition.The rotating speed of mixer is 2000r/min.
Embodiment 9
By 10 parts of shitosan, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate is added to during 22.2 parts of mass concentrations are 99.8% ethanol, is stirred 10 minutes in homogenizer To well mixed, then 66 parts of water is added thereto to, continues to stir and obtain gelatinous film-forming composition in 10 minutes.Mixer Rotating speed is 1000r/min.
Embodiment 10
By 10 parts of polyvinyl alcohol, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part of borneol Sodium azulenesulfonate with 0.2 part is added to during 29.6 parts of mass concentrations are 99.8% ethanol, and 10 points are stirred in homogenizer Clock is to well mixed, then is added thereto to 59 parts of water, continues to stir and obtains gelatinous film-forming composition in 10 minutes.Mixer Rotating speed be 1000r/min.
Embodiment 11
By 10 parts of polyvinyl butyral resin, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part Borneol and 0.2 part of sodium azulenesulfonate be added to during 45 parts of mass concentrations are 99.8% ethanol, stirred in homogenizer To well mixed, then 45 parts of water is added thereto within 10 minutes, continue to stir and obtain gelatinous film-forming composition in 10 minutes.Stir The rotating speed for mixing machine is 1000r/min.
Embodiment 12
5 parts of shitosan, 5 parts of polyvinyl alcohol, 5 parts of polyvinyl butyral resin, 0.1 part of thickener hydroxypropyl is fine Dimension element, 0.5 part of menthol, 0.5 part of borneol and 0.2 part of sodium azulenesulfonate are added to the second that 21 parts of mass concentrations are 99.8% In alcohol, 10 minutes are stirred in homogenizer to well mixed, then be added thereto to 65 parts of water, continue to stir 10 minutes To gelatinous film-forming composition.The rotating speed of mixer is 1000r/min.
Embodiment 13
By 15 parts of shellac, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part of borneol and 0.2 Part sodium azulenesulfonate be added to during 41 parts of mass concentrations are 99.8% ethanol, 10 minutes are stirred in homogenizer to mixing Uniformly, then 41 parts of water is added thereto to, continues to stir and obtain gelatinous film-forming composition in 10 minutes.The rotating speed of mixer is 1500r/min。
Embodiment 14
By 10 parts of polyvinyl butyral resin, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part Borneol and 0.2 part of sodium azulenesulfonate be added to during 66 parts of mass concentrations are 99.8% ethanol, stirred in homogenizer To well mixed, then 22 parts of water is added thereto within 10 minutes, continue to stir and obtain gelatinous film-forming composition in 10 minutes.Stir The rotating speed for mixing machine is 1000r/min.
Embodiment 15
By 10 parts of shellac, 0.1 part of thickener hydroxypropyl cellulose, 0.5 part of menthol, 0.5 part of borneol and 0.2 Part sodium azulenesulfonate be added to during 66 parts of mass concentrations are 99.8% ethanol, 10 minutes are stirred in homogenizer to mixing Uniformly, then 22 parts of water is added thereto to, continues to stir and obtain gelatinous film-forming composition in 10 minutes.The rotating speed of mixer is 1000r/min。
Film-forming composition prepared by embodiment 1~15 is tested its performance as canker sore diaphragm.
Film forming speed test is carried out to film-forming composition prepared by embodiment 1~15, test is adopted and carried out with the following method:
(1) first canker sore affected part saliva is dried;
(2) appropriate composition sample is applied to affected part, and starts timing;
(3) frequency of about 20 times per minute, compressing gas;
(4) after forming diaphragm completely, timing terminates.
Film forming speed evaluation criterion is as shown in table 1.
Table 1
Film formation time N Film-formation result is evaluated Film-formation result scores
It is unable to film forming It is unable to film forming 1
N > 2min Can film forming 2
1min < N≤2min Very fast film forming 3
N < 1min Fast filming 4
The result for carrying out film forming speed test to film-forming composition prepared by embodiment 1~15 is as shown in table 2.
Table 2
Embodiment Film-formation result scores
Embodiment 1 4
Embodiment 2 4
Embodiment 3 4
Embodiment 4 4
Embodiment 5 4
Embodiment 6 4
Embodiment 7 4
Embodiment 8 4
Embodiment 9 1
Embodiment 10 1
Embodiment 11 3
Embodiment 12 2
Embodiment 13 3
Embodiment 14 4
Embodiment 15 4
From table 1 and table 2, embodiment 1~8 has filming performance higher, embodiment 1 compared to embodiment 9~15 ~8 can fast filming in a short time.
Attachment time test is carried out to film-forming composition prepared by embodiment 1~15, test is adopted and carried out with the following method:
(1) first the saliva in canker sore affected part is dried;
(2) appropriate amount of sample is applied to affected part, and starts timing;
(3) frequency of about 20 times per minute, compressing gas;
(4) after forming diaphragm completely, you can normal activity oral cavity;
(5) once drunk water every half an hour;
(6) after diaphragm completely falls off, timing terminates.
Attachment Time evaluation standard is as shown in table 3.
Table 3
Attachment time N Attachment Time evaluation The attachment time scores
N < 0.5h Very short time adheres to 1
0.5h≤N < 1h Short time adheres to 2
1h≤N < 2h Slightly longer time attachment 3
2h≤N < 3h Long period adheres to 4
N≥3h Adhere to for a long time 5
The integrality of the canker sore diaphragm formed to film-forming composition prepared by embodiment 1~15 is tested, and is surveyed To canker sore diaphragm, whether record protection film there is fracture, canker sore protection during completely falling off during examination The evaluation criterion of film integrality is as shown in table 4.
Table 4
Film rupture time N Film integrality effect assessment Film integrality scores
N < 1h Integrality is poor 1
1h≤N < 2h Integrality is general 2
N≥2h Integrality is good 3
Film-forming composition attachment time test result and canker sore diaphragm integrity test prepared by embodiment 1~15 Result is as shown in table 5.
Table 5
According to table 3, table 4 and in table 5, data can be seen that embodiment 1~8 with film attachment time more long, and oral cavity The integrality of ulcer diaphragm is more preferable.
To film-forming composition prepared by embodiment 1~15 mitigate the test of pain, method of testing is as follows:
(1) each embodiment is chosen 10 canker sore patients and is tested respectively;
(2) patient is allowed to be scored by the grade form of table 6 canker sore pain sense before using film-forming composition;
(3) patient is allowed to use film-forming composition to form diaphragm in canker sore affected part;
(4) patient is allowed to be scored by the grade form of table 6 canker sore pain sense after using protection composition.
Canker sore diaphragm pain standards of grading are as shown in table 6.
Table 6
Pain is evaluated Pain scores
Ache very much 1
Compare pain 2
Ache a little 3
Slightly ache a little 4
Do not ache 5
The test result for mitigate pain to film-forming composition prepared by embodiment 1~8 is as shown in table 7.
Table 7
It can be seen from data in table 6 and table 7, canker sore patient is before the film-forming composition prepared using embodiment 1~8 All it is to compare pain to the evaluation substantially of the pain of canker sore, and after using film-forming composition, the pain of patient is obvious Decline, the substantially evaluation to pain is slightly to ache a little.As can be seen here, the film-forming composition using the preparation of embodiment 1~8 is true The pain of canker sore patient can be reduced in fact.
Each technical characteristic of embodiment described above can be combined arbitrarily, to make description succinct, not to above-mentioned reality Apply all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited In contradiction, the scope of this specification record is all considered to be.
Embodiment described above only expresses several embodiments of the invention, and its description is more specific and detailed, but simultaneously Can not therefore be construed as limiting the scope of the patent.It should be pointed out that coming for one of ordinary skill in the art Say, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention Scope.Therefore, the protection domain of patent of the present invention should be determined by the appended claims.

Claims (10)

1. a kind of film-forming composition, it is characterised in that according to the mass fraction, including 2 parts~40 parts of main film forming agent, 1 part~20 The furtherance film and 45 parts~90 parts of organic solvent of part;
The main film forming agent is selected from least one in shellac, ethyl cellulose and aliphatic acid;
The furtherance film is selected from least one in polyvinyl butyral resin, polyvinyl alcohol and polyvinyl acetate.
2. film-forming composition according to claim 1, it is characterised in that the aliphatic acid is 12~18 for carbon number Aliphatic acid.
3. film-forming composition according to claim 2, it is characterised in that the aliphatic acid is selected from laurate, tridecanoic acid, meat At least one in myristic acid, pentadecanoic acid, palmitic acid, heptadecanoic acid and stearic acid.
4. film-forming composition according to claim 1, it is characterised in that the organic solvent is ethanol.
5. film-forming composition according to claim 1, it is characterised in that also including 3~25 parts of water.
6. film-forming composition according to claim 1, it is characterised in that also including 0.05 part~1 part of thickener.
7. film-forming composition according to claim 6, it is characterised in that the thickener is selected from hydroxyethyl cellulose, hydroxyl At least one in propyl cellulose, hydroxypropyl methyl cellulose and vinyl pyrrolidone.
8. film-forming composition according to claim 1, it is characterised in that also including 0.1 part~2 parts of function additive;Institute State at least one during function additive is selected from essence, menthol, borneol, sodium azulenesulfonate and pearl powder.
9. a kind of diaphragm, it is characterised in that the film-forming composition as described in any one of claim 1~8 is prepared.
10. the film-forming composition as described in any one of claim 1~8 is in canker sore diaphragm and Wound protection film is prepared Application.
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Cited By (3)

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Publication number Priority date Publication date Assignee Title
CN111701068A (en) * 2020-08-06 2020-09-25 苏州良辰生物医药科技有限公司 Antiviral skin dressing and preparation method thereof
CN112237592A (en) * 2020-11-30 2021-01-19 赵俊 Oral ulcer secret recipe medicine
CN114052291A (en) * 2021-10-21 2022-02-18 深圳市基克纳科技有限公司 Composition and oil leakage prevention layer thereof

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CN105030659A (en) * 2015-06-16 2015-11-11 贵州大学 Gel for body surface wound and preparation method of gel
CN105288721A (en) * 2015-10-16 2016-02-03 天津市顶硕科贸有限公司 Liquid band-aid and preparation technology thereof
CN105816908A (en) * 2016-04-29 2016-08-03 哈尔滨乾佰纳生物药业有限公司 Waterproof liquid wound protection film and preparation method thereof
CN106139239A (en) * 2016-07-12 2016-11-23 东莞市万佳医疗科技有限公司 Full-service fluid dressing and preparation method thereof
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CN102048710A (en) * 2009-11-05 2011-05-11 天津太平洋制药有限公司 Quickly dissolved film and preparation method thereof
CN105030659A (en) * 2015-06-16 2015-11-11 贵州大学 Gel for body surface wound and preparation method of gel
CN105288721A (en) * 2015-10-16 2016-02-03 天津市顶硕科贸有限公司 Liquid band-aid and preparation technology thereof
CN105816908A (en) * 2016-04-29 2016-08-03 哈尔滨乾佰纳生物药业有限公司 Waterproof liquid wound protection film and preparation method thereof
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CN111701068A (en) * 2020-08-06 2020-09-25 苏州良辰生物医药科技有限公司 Antiviral skin dressing and preparation method thereof
CN112237592A (en) * 2020-11-30 2021-01-19 赵俊 Oral ulcer secret recipe medicine
CN114052291A (en) * 2021-10-21 2022-02-18 深圳市基克纳科技有限公司 Composition and oil leakage prevention layer thereof

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