CN106474137B - A kind of film for treating oral ulcer containing chlorophyll and preparation method thereof - Google Patents
A kind of film for treating oral ulcer containing chlorophyll and preparation method thereof Download PDFInfo
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- CN106474137B CN106474137B CN201610782100.3A CN201610782100A CN106474137B CN 106474137 B CN106474137 B CN 106474137B CN 201610782100 A CN201610782100 A CN 201610782100A CN 106474137 B CN106474137 B CN 106474137B
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/409—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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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
-
- 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
-
- 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
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
Abstract
The invention belongs to pharmaceutical technology field, and in particular to a kind of film for treating oral ulcer containing chlorophyll and preparation method thereof.The film for treating oral ulcer containing chlorophyll that the present invention is provided is main by chlorophyll, daucosterol, vitamin B6, Ropivacaine, film forming agent, glucoside, ATBC and distilled water composition.The film for treating oral ulcer compatibility containing chlorophyll that the present invention is provided rationally, science, each component interaction has significant antibacterial, anti-inflammatory and analgesic effect, can effectively mitigate the state of an illness of canker sore patient, shortens healing time.And the film for treating oral ulcer containing chlorophyll that the present invention is provided has adherence force strong, dissolution velocity is fast, takes off the good advantage of film integrality, can effectively ensure the performance of drug effect, is a kind of ideal film for treating oral ulcer.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of to contain the film for treating oral ulcer of chlorophyll and its preparation side
Method.
Background technology
Canker sore is a kind of cause of disease complexity, the common oral mucous membrane disease easily recurred.In daily life, because stinging
Canker sore is relatively conventional caused by wound, scald, scratch, scuffing etc..Once forming canker sore, not only influence patient normal
Living and diet, even triggers general disease sometimes.The medicine for the treatment of canker sore mainly has at present：Immunopotentiating agent and steroids
Medicine.This kind of medicine can effectively treat that some depths are big, cureless ulcer abroad using relatively wide, and can effectively press down
Ulcer recurrence processed was up to 3-6 months.
Due to the special physiological environment in oral cavity, most drug pastes residence time in oral cavity is short, it is difficult to the characteristics of being adapted to oral cavity
Lasting active drug concentration is reached in diseased region.It is clinical based on the symptomatic treatment of local application for canker sore, face
Bed medication has the formulations such as powder, paste, film and injection, but many because intraoral action time is shorter, directly affects curative effect.Such as
The powders such as Chinese medicine Bingpeng San, must be applied to affected part when using, medicine can be lost in saliva quickly；Paste is difficult to be coated in trouble
Place；Although conventional film can be affixed on ulcer surface, it is very easy to come off, and general dissolved within a few minutes disappears, medicine
Thing osmosis is inadequate.Therefore the problem that the high treatment stomatocace medicine of new, curative effect is current urgent need to resolve is developed.
Film is by medicine and the processed film-like preparation being made of suitable filmogen, for oral or mucous membrane external application.Closely
Nian Lai, is quickly grown using the mucoadhesive agent that bioadhesion technology grows up both at home and abroad.Because film can be tightly
Adhere on mucous membrane, strengthen the compactness and continuation of medicine and mucosal contact, so as to reach the slow release effect of medicine, significantly
Improve drug effect.For the special physiological environment in oral cavity, pelliculae pro cavo oris can be attached to mucomembranous surface, and both ulcer can be played
The effect of mechanical protection, can also make medicine directly reach affected part, and positioning release can greatly improve therapeutic effect.
Chinese patent application 201410261996.1, which is disclosed, a kind of treats pad pasting of canker sore and preparation method thereof, institute
Pad pasting is stated for nano fiber non-woven fabric, the non-woven fabrics is made up of nuclear shell structure nano fiber, the nuclear shell structure nano fiber
Shell is polyethylene glycol oxide shell, and the nuclear shell structure nano fiber stratum nucleare is dexamethasone, vitamin C and vitamin B2It is mixed
Compound.The pad pasting prepared can ensure its sufficiently large drug storage amount and release area, and used polyethylene glycol oxide
Dissolution velocity in the oral cavity is more moderate, can make to be continuously maintained in effective drug concentration at ulcer, is more beneficial for oral cavity and bursts
The healing of ulcer.
Chinese patent CN103142562B discloses a kind of sustained release pad pasting for treating canker sore, and the sustained release pad pasting has
Three-decker, upper strata is the controlled-release coating contacted with oral ulcer surface；Lower floor is the polyacrylic film with protective effect；In
Layer is made up of for drug-loaded layer bacteria cellulose/load medicinal substances composite membrane, and described load medicinal substances are：Borneol, calculus bovis factitius, acetic acid
Dexamethasone, vitamin B2Central one or more and glycerine, dextrin, carbomer, polyethylene glycol and sodium carboxymethylcellulose
Mixture.The sustained release pad pasting prepared has good adhesiveness, gas permeability, biocompatibility, and drugloading rate is big, local to make
Use the time long, pain can be mitigated, promote wound healing, prevent wound infection.Bitten suitable for canker sore, mucous membrane of mouth
Wound in oral cavity.
However, the key agents of the oral film used at present are the hormone medicines such as dexamethasone, dexamethasone acetate,
Long-term use can produce drug dependence, while can also produce serious side effect, greatly limit the medicine popularization and
Using.
The content of the invention
In order to solve the deficiency that film for treating oral ulcer is present in the prior art, contain it is an object of the invention to provide one kind
Film for treating oral ulcer of chlorophyll and preparation method thereof.The film for treating oral ulcer containing chlorophyll that the present invention is provided has notable
Antibacterial, anti-inflammatory and analgesic effect, while also without any hormone medicine, having the advantages that safe, side effect is low.
The invention provides a kind of film for treating oral ulcer containing chlorophyll, including following components and its parts by weight：
12-24 parts of chlorophyll, 6-10 parts of daucosterol, vitamin B62-4 parts, 4-8 parts of Ropivacaine, film forming agent 40-58
Part, 10-16 parts of glucoside, 16-26 parts of ATBC and 320-450 parts of distilled water.
Further, the film for treating oral ulcer containing chlorophyll includes following components and its parts by weight：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B63 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, glucoside 12
400 parts of part, 20 parts of ATBC and distilled water.
Further, the film forming agent is by sodium alginate, polyvinyl alcohol and citric acid 4-6 by weight:3-5:0.8-1.2
Composition.
Further, the film forming agent is by sodium alginate, polyvinyl alcohol and citric acid by weight 5:4:1 composition.
Further, the glucoside is lauryl glucosyl.
In addition, present invention also offers a kind of preparation method of the film for treating oral ulcer containing chlorophyll, including following step
Suddenly：
S1 takes the distilled water of half amount to be heated to 70-80 DEG C, and the film forming agent for adding half amount is stirred to being completely dissolved, while hot
Filtering, takes filtrate, adds ATBC into filtrate, stir, obtain rubber cement solution；
Chlorophyll, daucosterol, vitamin B6 are added after the rubber cement solution cooling that S2 obtains step S1, stirs, connects
Addition Ropivacaine, glucoside, is mixed, de-bubbled, plastic film mulch, dries, obtains containing medicine film；
Remaining distilled water is heated to 70-80 DEG C by S3, is added remaining film forming agent and is stirred to being completely dissolved, while hot mistake
Filter, takes filtrate, de-bubbled, be layered on that step S2 prepares under conditions of 45-50 DEG C containing in medicine film, obtain medicine film；
The medicine film that S4 obtains step S3 is dried, and is cut, and sterilizing is produced.
Further, it is characterised in that rubber cement solution is cooled to 40-45 DEG C in the step S2.
Further, it is characterised in that the drying temperature of the step S2 and step S4 are 65-70 DEG C, drying time is
20-30min。
Chlorophyll chlorophyll in the film for treating oral ulcer containing chlorophyll that the present invention is provided is green purchased from Haining Feng Ming leaf
Plain Co., Ltd, article No. is 65963-40-8；The molecular formula of daucosterol is C35H60O6, No. CAS is 474-58-8；Sodium alginate
No. CAS be 9005-38-3；No. CAS of polyvinyl alcohol is 9002-89-5.
Found through experiment, chlorophyll, daucosterol and vitamin B that the present invention is provided6It is used in mixed way with significant suppression
Bacterium, anti-inflammatory and analgesic effect.Film for treating oral ulcer containing chlorophyll prepared by the present invention is to beta hemolytic streptococcus
Bacteriostatic diameter is more than 27.0mm, is more than 36.3mm to the bacteriostatic diameter of staphylococcus aureus, staphylococcic antibacterial to white
Diameter is more than 35.9mm, is more than 33.5mm to the bacteriostatic diameter of Pseudomonas aeruginosa, to beta hemolytic streptococcus, Staphylococcus aureus
Bacterium, staphylococcus albus and Pseudomonas aeruginosa have significant inhibitory action, illustrate the present invention provide chlorophyll, daucosterol and
Vitamin B6Mutually having cooperateed with strengthens antibacterial effect.
Further, found through anti-inflammation test, compared with control group, the canker sore containing chlorophyll prepared by the present invention
Pad pasting can significantly decrease the ear method of double differences of mouse, with preferable anti-inflammatory effects, and its anti-inflammatory effects fills in rice with compound
The anti-inflammatory effects of loose emulsifiable paste are approached, and illustrate chlorophyll, daucosterol and vitamin B that the present invention is provided6Mutually cooperate with enhancing anti-
Scorching effect.Meanwhile, found through analgesic test, compared with model group, the patch of the canker sore containing chlorophyll prepared by the present invention
What film can significantly extend mouse licks the sufficient time, and with preferable analgesic activity, and its analgesic effect fills in rice than compound
The analgesic effect of loose emulsifiable paste is good, illustrates chlorophyll, daucosterol and vitamin B that the present invention is provided6Enhancing has mutually been cooperateed with to ease pain
Effect.
The film forming agent being made up of sodium alginate, polyvinyl alcohol and citric acid by certain weight ratio that the present invention is provided has modeling
Property it is good, paste property it is strong, it is easy in the advantage of oral cavity pasting.Meanwhile, citric acid also solves sodium alginate and is easy to grow microorganism
Defect, not in addition addition preservative in the case of can effectively extend the shelf-life of patch.Found through experiment：This hair
The stickup time of the film for treating oral ulcer containing chlorophyll of bright preparation is more than 82min, and dissolution velocity is more than 28min/g, takes off film
Integrality is more than 99%, illustrate it is of the invention provide be made up of sodium alginate, polyvinyl alcohol and citric acid by certain weight ratio
Film forming agent can effectively improve the adherence force of the film for treating oral ulcer containing chlorophyll, dissolution velocity and take off film integrality, greatly
The quality of big raising film for treating oral ulcer.
Further, the film for treating oral ulcer containing chlorophyll that the present invention is provided is 25 ± 2 DEG C, relative humidity in temperature
To preserve 6 months under conditions of 60% ± 10%, its outward appearance, weight differential, microbial limit meet regulation, with higher
Stability.
Further, the Ropivacaine that the present invention is provided can further promote the contraction of local vascular, can subtract
The amount of bleeding of few wound, accelerates wound detumescence healing.ATBC and glucoside can increase the lubricity of film forming agent,
Friction is reduced, increases the surface gloss and aesthetic appearance of film, while the elasticity and pliability of pad pasting can also be improved, dissolving is improved
Speed, makes pad pasting overall performance more preferable.
Further, the present invention can not only cover the bad mouthfeel produced when monofilm is used using composite membrane technology, and
And can solve due to the saliva in oral cavity and mouth motion, the problem of causing drug wastage and influence the adhesiveness of film, make
Affected part drug accumulation, so as to improve curative effect.
Compared with prior art, the film for treating oral ulcer containing chlorophyll that the present invention is provided has the advantage that：
(1) film for treating oral ulcer containing chlorophyll that the present invention is provided has significant antibacterial, anti-inflammatory and analgesic effect,
The pain of canker sore patient can effectively be mitigated, shorten the healing time of canker sore, can effectively prevent canker sore
Recurrence；
(2) film for treating oral ulcer containing chlorophyll that the present invention is provided has adherence force strong, and dissolution velocity is fast, takes off film complete
The good advantage of whole property, can effectively ensure drug effect, be more beneficial for the rehabilitation of canker sore patient.
Embodiment：
Below by way of the description of embodiment, the invention will be further described, but this is not the limit to the present invention
System, those skilled in the art are according to the basic thought of the present invention, and various modifications may be made or improves, but without departing from this
The basic thought of invention, within the scope of the present invention.The component of the present invention is conventional commercial components, and is all food
Level component, has no toxic side effect to human body.
Embodiment 1, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
12 parts of chlorophyll, 6 parts of daucosterol, vitamin B62 parts, 4 parts of Ropivacaine, 40 parts of film forming agent, dodecyl grape
320 parts of 10 parts of glucosides, 16 parts of ATBC and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid
By weight 4:5:1.2 composition.
Preparation method：
S1 takes the distilled water of half amount to be heated to 70 DEG C, and the film forming agent for adding half amount is stirred to being completely dissolved, while hot mistake
Filter, takes filtrate, adds ATBC into filtrate, stir, obtain rubber cement solution；
The rubber cement solution that S2 obtains step S1 is cooled down but to 40 DEG C, adds chlorophyll, daucosterol, vitamin B6, stirring
Uniformly, Ropivacaine, glucoside are subsequently added into, is mixed, de-bubbled, plastic film mulch, is dried under conditions of temperature is 65 DEG C
30min, is obtained containing medicine film；
Remaining distilled water is heated to 70 DEG C by S3, is added remaining film forming agent and is stirred to being completely dissolved, filters, take while hot
Filtrate, de-bubbled, be layered on that step S2 prepares under conditions of 45 DEG C containing in medicine film, obtain medicine film；
The medicine film that S4 obtains step S3 dries 30min under conditions of temperature is 65 DEG C, cuts, and sterilizing is produced.
Embodiment 2, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B63 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, dodecyl grape
400 parts of 12 parts of glucosides, 20 parts of ATBC and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid
By weight 5:4:1 composition.
Preparation method：
S1 takes the distilled water of half amount to be heated to 75 DEG C, and the film forming agent for adding half amount is stirred to being completely dissolved, while hot mistake
Filter, takes filtrate, adds ATBC into filtrate, stir, obtain rubber cement solution；
The rubber cement solution that S2 obtains step S1 is cooled down but to 42 DEG C, adds chlorophyll, daucosterol, vitamin B6, stirring
Uniformly, Ropivacaine, glucoside are subsequently added into, is mixed, de-bubbled, plastic film mulch, is dried under conditions of temperature is 68 DEG C
25min, is obtained containing medicine film；
Remaining distilled water is heated to 75 DEG C by S3, is added remaining film forming agent and is stirred to being completely dissolved, filters, take while hot
Filtrate, de-bubbled, be layered on that step S2 prepares under conditions of 42 DEG C containing in medicine film, obtain medicine film；
The medicine film that S4 obtains step S3 dries 25min under conditions of temperature is 68 DEG C, cuts, and sterilizing is produced.
Embodiment 3, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
24 parts of chlorophyll, 10 parts of daucosterol, vitamin B64 parts, 8 parts of Ropivacaine, 58 parts of film forming agent, dodecyl Portugal
450 parts of 16 parts of polyglycoside, 26 parts of ATBC and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and lemon
Acid is by weight 6:3:0.8 composition.
Preparation method：
S1 takes the distilled water of half amount to be heated to 80 DEG C, and the film forming agent for adding half amount is stirred to being completely dissolved, while hot mistake
Filter, takes filtrate, adds ATBC into filtrate, stir, obtain rubber cement solution；
The rubber cement solution that S2 obtains step S1 is cooled down but to 45 DEG C, adds chlorophyll, daucosterol, vitamin B6, stirring
Uniformly, Ropivacaine, glucoside are subsequently added into, is mixed, de-bubbled, plastic film mulch, is dried under conditions of temperature is 70 DEG C
20min, is obtained containing medicine film；
Remaining distilled water is heated to 80 DEG C by S3, is added remaining film forming agent and is stirred to being completely dissolved, filters, take while hot
Filtrate, de-bubbled, be layered on that step S2 prepares under conditions of 50 DEG C containing in medicine film, obtain medicine film；
The medicine film that S4 obtains step S3 dries 20min under conditions of temperature is 70 DEG C, cuts, and sterilizing is produced.
Comparative example 1, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
21 parts of chlorophyll, 8 parts of daucosterol, 6 parts of Ropivacaine, 50 parts of film forming agent, 12 parts of lauryl glucosyl, lemon
400 parts of 20 parts of lemon acid tributyl and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid by weight 5:4:
1 composition.
Preparation method is similar to Example 2.
Difference with embodiment 2 is, does not add vitamin B6, increase the parts by weight of chlorophyll.
Comparative example 2, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B23 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, dodecyl grape
400 parts of 12 parts of glucosides, 20 parts of ATBC and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid
By weight 5:4:1 composition.
Preparation method is similar to Example 2.
Difference with embodiment 2 is, by vitamin B6Replace with vitamin B2。
Comparative example 3, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is made up of following components and its parts by weight：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B63 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, dodecyl grape
400 parts of 12 parts of glucosides, 20 parts of ATBC and distilled water；The film forming agent by sodium alginate and polyvinyl alcohol by weight
1:1 composition.
Preparation method is similar to Example 2.
Difference with embodiment 2 is that the film forming agent is by sodium alginate and polyvinyl alcohol by weight 1:1 composition.
Comparative example 4, a kind of film for treating oral ulcer containing chlorophyll
The film for treating oral ulcer containing chlorophyll is by following components and its parts by weight：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B63 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, dodecyl grape
400 parts of 12 parts of glucosides, 20 parts of ATBC and distilled water；The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid
By weight 1:1:1 composition.
Preparation method is similar to Example 2.
Difference with embodiment 2 is that the film forming agent is by sodium alginate, polyvinyl alcohol and citric acid by weight 1:1:
1 composition.
The bacteriostatic test of test example one, the film for treating oral ulcer containing chlorophyll
1st, test material：Embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2 prepare containing chlorophyll
Film for treating oral ulcer.
2nd, for the preparation of examination bacterium
Respectively by beta hemolytic streptococcus, staphylococcus aureus, staphylococcus albus and green in sterile room
Purulence bacillus is seeded in beef extract nutrient solution, and cellar culture is carried out under the conditions of 28-30 DEG C.
3rd, test method：
Diffusion method is punched using agar, sterile petri dish is divided into 5 groups, every group 4, by the beef extract nutrient solution after sterilizing
Pour into sterile petri dish, per 15~20mL of ware, 0.1mL hemolytic hammers are drawn with Sterile pipette after it solidifies
Bacterium, staphylococcus aureus, staphylococcus albus and Pseudomonas aeruginosa are added on culture dish for examination bacterium, and coating is uniform, and every group each
Culture dish adds different strains.
After coating is finished, 5 equidistant holes are then made a call on culture medium with external diameter 4mm sterilizing stainless steel card punch.
Film for treating oral ulcer nothing containing chlorophyll prepared by embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2
Bacterium water is completely dissolved, and distinguishing extraction embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2 with micro sample adding appliance contains
The μ l of film for treating oral ulcer solution 30 of chlorophyll, middle hole addition normal saline does control group, carries out mark.By bacterium
It is placed at 37 DEG C and cultivates 24h, measures antibacterial circle diameter (bacteriostatic diameter mm meters), experiment is repeated 5 times, using 5 average values to be antibacterial
Loop diameter.
4th, result of the test
Result of the test is as shown in table 1.
The bacteriostatic test data of film for treating oral ulcer of the table 1 containing chlorophyll
As shown in Table 1, suppression of the film for treating oral ulcer containing chlorophyll that prepared by the present invention to beta hemolytic streptococcus
Bacterium diameter is more than 27.0mm, is more than 36.3mm to the bacteriostatic diameter of staphylococcus aureus, staphylococcic to white antibacterial straight
Footpath is more than 35.9mm, is more than 33.5mm to the bacteriostatic diameter of Pseudomonas aeruginosa, to beta hemolytic streptococcus, Staphylococcus aureus
Bacterium, staphylococcus albus and Pseudomonas aeruginosa have a significant inhibitory action, and the fungistatic effect ratio sheet of comparative example 1 and comparative example 2
The effect of film for treating oral ulcer containing chlorophyll prepared by inventive embodiments 1-3 is poor, illustrates chlorophyll, Hu that the present invention is provided
Glucoraphenin and vitamin B6Mutually having cooperateed with strengthens antibacterial effect.
Test example two, the film for treating oral ulcer anti-inflammation test containing chlorophyll
1st, subjects：70 Kunming mouses are chosen, male and female half and half, body weight is 25-30g, it is real by Yunnan University of Traditional Chinese Medicine
Center offer is provided.
2nd, test material：Embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2 prepare containing chlorophyll
Film for treating oral ulcer；Compound Dexamethasone Cream, is purchased from Beijing Shuan Ji pharmaceutical Co. Ltds, Chinese medicines quasi-word H11021754.
3rd, test method：
70 mouse are randomly divided into 7 groups, respectively control group, Dexamethasone group, 1 group of embodiment, 2 groups of embodiment, reality
2 groups of 3 groups of example, 1 group of comparative example and comparative example are applied, it is every group 10, uniform on the auris dextra of every group of mouse to apply the μ l of dimethylbenzene 50, left ear
Compare, cause after inflammation after 2h, the auris dextra to the mouse of each group coats following medicine, apply dose as follows：
Control group：Smear physiological saline；
Dexamethasone group：Smear Compound Dexamethasone Cream；
1 group of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 1；
2 groups of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 2；
3 groups of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 3；
1 group of comparative example：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml comparative examples 1；
2 groups of comparative example：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml comparative examples 2；
Smear and vertebra execution is taken off after medicine 12h, two ears are cut along auricle, with 8mm card punch respectively at the same position of left and right ear
Round auricle is laid, is weighed, the ear method of double differences, the ear method of double differences=auris dextra circle auricle weight-left ear circle auricle weight is calculated.
4th, result of the test：
Result of the test is as shown in table 2.
The influence that film for treating oral ulcer of the table 2 containing chlorophyll swells to mouse auricular concha caused by dimethylbenzene xylene
| Group | The ear method of double differences (mg) |
| Control group | 8.20±1.32 |
| Dexamethasone group | 4.16±0.44** |
| 1 group of embodiment | 5.20±0.64** |
| 2 groups of embodiment | 4.76±0.56** |
| 3 groups of embodiment | 5.32±0.67** |
| 1 group of comparative example | 7.94±1.10 |
| 2 groups of comparative example | 7.20±1.02 |
Note：Compared with control group**P ＜ 0.01.
As shown in Table 2, compared with control group, 3 groups of 1 group of embodiment, 2 groups of embodiment and embodiment can significantly decrease small
The ear method of double differences of mouse, with preferable antiinflammation, and its anti-inflammatory effects is approached with Compound Dexamethasone Cream, and comparative example 1
The ear method of double differences of 2 groups of group and comparative example is not statistically significant compared with control group, illustrates chlorophyll, daucosterol that the present invention is provided
And vitamin B6Mutually collaboration plays a part of to strengthen anti-inflammatory.
Test example three, the film for treating oral ulcer analgesic test containing chlorophyll
1st, test material：100 female KM kind mouse are chosen, body weight is 25-30g, in Yunnan University of Traditional Chinese Medicine tests
The heart is provided.
2nd, test material：Embodiment 1, embodiment 2, embodiment 3, comparative example 1 and comparative example 2 prepare containing chlorophyll
Film for treating oral ulcer；Compound Dexamethasone Cream, is purchased from Beijing Shuan Ji pharmaceutical Co. Ltds, Chinese medicines quasi-word H11021754.
3rd, mouse hot-plate pain model is set up：
100 mouse are placed on hot plate pain threshold detector, the metapedes time will be licked<5s or>30s is thrown aside, to prevent foot from scalding,
If deadline is 60s, incubation period of metapedes reaction is licked as pain indicator using mouse, screening licks the metapedes time and is>5s,<30s's
Mouse.
4th, test method：Choose 70 qualified mouse, be randomly divided into 7 groups, every group 10, respectively model group, fill in rice
2 groups of loose group, 1 group of embodiment, 2 groups of embodiment, 3 groups of embodiment, 1 group of comparative example and comparative example.Auris dextra to the mouse of each group is applied
Upper following medicine, applies dose as follows：
Control group：Smear physiological saline；
Dexamethasone group：Smear Compound Dexamethasone Cream；
1 group of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 1；
2 groups of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 2；
3 groups of embodiment：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml embodiments 3；
1 group of comparative example：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml comparative examples 1；
2 groups of comparative example：Smear the film for treating oral ulcer containing chlorophyll prepared by 1g/ml comparative examples 2；
Determine the time that 60min, 120min after last medicine lick foot reaction.
5th, result of the test：
Result of the test is as shown in table 3.
The mouse of table 3 licks sufficient response latency timetable
| Group | Sufficient time (s) is licked after 60min | Sufficient time (s) is licked after 120min |
| Model group | 19.4±3.8 | 22.0±4.0 |
| Dexamethasone group | 26.9±4.2 | 28.1±4.2 |
| 1 group of embodiment | 28.6±4.4* | 31.8±4.6* |
| 2 groups of embodiment | 30.2±4.5* | 33.7±4.8* |
| 3 groups of embodiment | 28.4±4.3* | 31.4±4.4* |
| 1 group of comparative example | 22.2±3.8 | 24.6±4.2 |
| 2 groups of comparative example | 24.4±3.7 | 26.2±4.4 |
Note：Compared with model group,*P ＜ 0.05.
As shown in Table 3, compared with model group, the film for treating oral ulcer containing chlorophyll prepared by the present invention can be significant
Extend licking the sufficient time for mouse, and its analgesic effect is better than the analgesic effect of Compound Dexamethasone Cream, illustrates that the present invention is carried
Chlorophyll, daucosterol and the vitamin B of confession6The effect of enhancing analgesic is mutually cooperateed with.
The performance measurement experiment of test example four, the film for treating oral ulcer containing chlorophyll
1st, test material：Embodiment 1, embodiment 2, embodiment 3, comparative example 3 and comparative example 4 prepare containing chlorophyll
Film for treating oral ulcer.
2nd, test method：Determine the green containing leaf of embodiment 1, embodiment 2, embodiment 3, comparative example 3 and the preparation of comparative example 4
The adherence force of film for treating oral ulcer of element, dissolution velocity and take off film integrality.
2.1st, the measure of adherence force：Adherence force is weighed with the length of the time of pasting, take certain size film it is viscous with
Human mouth both sides cheek mucous membrane, it is the stickup time to be played from adhesion the time required to coming off.
2.2nd, the measure of dissolution velocity：The film for weighing 1g is put into 60 DEG C, in 100ml water, quickly stirs into solution without broken
Untill piece, the time needed for record dissolved units quality films, to represent dissolution velocity (min/g).
2.3rd, film integrality (FI) measure is taken off：Represented with film percentage of head rice, refer to and take off most complete that block film weight and institute after film
There is the ratio of film weight, be calculated as follows：FI=m1/(m1=m2In) × 100%, formula, FI is film percentage of head rice (%), m1To be most complete
Whole that block film weight, m2For fritter film weight.
3rd, result of the test：
Result of the test is as shown in table 4.
The performance measurement experiment of film for treating oral ulcer of the table 4 containing chlorophyll
| Group | Adherence force (min) | Dissolution velocity (min/g) | Take off film integrality (%) |
| Embodiment 1 | 83 | 28 | 99.3 |
| Embodiment 2 | 86 | 30 | 99.7 |
| Embodiment 3 | 82 | 28 | 99.1 |
| Comparative example 3 | 38 | 16 | 77.8 |
| Comparative example 4 | 51 | 19 | 83.6 |
As shown in Table 4, the stickup time of the film for treating oral ulcer containing chlorophyll prepared by the present invention is more than 82min, molten
Solve speed and be more than 28min/g, take off film integrality more than 99%, and the stickup time of comparative example 3 and comparative example 4, dissolution velocity and
Take off film integrality poorer than the film for treating oral ulcer effect containing chlorophyll prepared by embodiment of the present invention 1-3, illustrate the present invention
The film forming agent being made up of chlorophyll, daucosterol and citric acid by certain weight ratio provided can effectively improve the viscous of pad pasting
Paste power, dissolution velocity and take off film integrality, can effectively improve the quality of the film for treating oral ulcer containing chlorophyll.
The stability test of test example five, the film for treating oral ulcer containing chlorophyll
1st, test material：Film for treating oral ulcer containing chlorophyll prepared by embodiment 1, embodiment 2 and embodiment 3.
2nd, test method：Film for treating oral ulcer containing chlorophyll prepared by embodiment 1-3 uses aluminium foil bag+carton bag
Dress, is 25 ± 2 DEG C in temperature, relative humidity is 60% ± 10%, carries out 6 months greenhouses and keep sample experiment, outward appearance to sample, again
Measure difference, microbial limit and carry out investigation measure.
3rd, result of the test：
Result of the test is as shown in table 5.
The stability test of film for treating oral ulcer of the table 5 containing chlorophyll
As shown in Table 5, the film for treating oral ulcer containing chlorophyll that prepared by the present invention is 25 ± 2 DEG C in temperature, relatively wet
Spend to preserve 6 months under conditions of 60% ± 10%, its outward appearance, weight differential, microbial limit meet regulation, with higher
Stability.
Claims (6)
1. a kind of film for treating oral ulcer containing chlorophyll, it is characterised in that be made up of following components and its parts by weight：Ye Lv
Plain 12-24 parts, 6-10 parts of daucosterol, vitamin B62-4 parts, 4-8 parts of Ropivacaine, 40-58 parts of film forming agent, glucoside
320-450 parts of 10-16 parts, 16-26 parts of ATBC and distilled water；
The film forming agent is by sodium alginate, polyvinyl alcohol and citric acid by weight 4-6:3-5:0.8-1.2 is constituted；
The glucoside is lauryl glucosyl.
2. the film for treating oral ulcer as claimed in claim 1 containing chlorophyll, it is characterised in that by following components and its weight
Number is constituted：
18 parts of chlorophyll, 8 parts of daucosterol, vitamin B63 parts, 6 parts of Ropivacaine, 50 parts of film forming agent, 12 parts of glucoside, lemon
400 parts of 20 parts of lemon acid tributyl and distilled water.
3. the film for treating oral ulcer as claimed in claim 1 containing chlorophyll, it is characterised in that the film forming agent is by alginic acid
Sodium, polyvinyl alcohol and citric acid are by weight 5:4:1 composition.
4. a kind of preparation method of film for treating oral ulcer containing chlorophyll as described in claim 1-3 is any, its feature exists
In comprising the following steps：
S1 takes the distilled water of half amount to be heated to 70-80 DEG C, and the film forming agent for adding half amount is stirred to being completely dissolved, while hot mistake
Filter, takes filtrate, adds ATBC into filtrate, stir, obtain rubber cement solution；
Chlorophyll, daucosterol, vitamin B are added after the rubber cement solution cooling that S2 obtains step S16, stir, then add
Enter Ropivacaine, glucoside, mix, de-bubbled, plastic film mulch, dry, obtain containing medicine film；
Remaining distilled water is heated to 70-80 DEG C by S3, is added remaining film forming agent and is stirred to being completely dissolved, filters, take while hot
Filtrate, de-bubbled, be layered on that step S2 prepares under conditions of 45-50 DEG C containing in medicine film, obtain medicine film；
The medicine film that S4 obtains step S3 is dried, and is cut, and sterilizing is produced.
5. the preparation method of the film for treating oral ulcer as claimed in claim 4 containing chlorophyll, it is characterised in that the step
Rubber cement solution is cooled to 40-45 DEG C in S2.
6. the preparation method of the film for treating oral ulcer as claimed in claim 4 containing chlorophyll, it is characterised in that the step
S2 and step S4 drying temperature are 65-70 DEG C, and drying time is 20-30min.
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| CN109172556A (en) * | 2018-10-30 | 2019-01-11 | 何凤姣 | A kind of composition and preparation method thereof for treating canker sore |
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| CN101371824B (en) * | 2007-08-23 | 2011-08-31 | 天津药业研究院有限公司 | Oral cavity pasting tablets using Methylprednisolone and derivatives thereof as active components |
| CN101444527B (en) * | 2008-12-26 | 2011-05-25 | 昆明创邦医疗器械有限公司 | Medicament for curing oral ulcer |
| CN102319208A (en) * | 2011-09-23 | 2012-01-18 | 何雪心 | Suspension composition for treating oral mucositis caused by chemoradiotherapy |
| CN103463141A (en) * | 2013-09-22 | 2013-12-25 | 汤永强 | Chlorella spray |
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