CN111617058A - Oral wound treatment plaster - Google Patents
Oral wound treatment plaster Download PDFInfo
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- CN111617058A CN111617058A CN202010605289.5A CN202010605289A CN111617058A CN 111617058 A CN111617058 A CN 111617058A CN 202010605289 A CN202010605289 A CN 202010605289A CN 111617058 A CN111617058 A CN 111617058A
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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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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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
- A61K47/34—Macromolecular 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
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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
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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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
Abstract
The invention provides an oral wound treatment patch. The oral wound treatment patch comprises an ointment and a film agent, wherein the ointment comprises the following components in parts by weight: 20-70 parts of hydrophilic high molecular compound, 1-25 parts of first filling agent, 0-10 parts of first medicine, 1-10 parts of first surfactant, 1-15 parts of first plasticizer and 1-20 parts of first solvent, wherein the film agent comprises: 40-90 parts of hydrophobic high molecular compound, 2-25 parts of second filling agent, 1-30 parts of second plasticizer and 1-20 parts of second solvent. The ointment has the effects of sealing wound surface, stopping bleeding rapidly, releasing medicine and preventing infection, wherein the hydrophilic high molecular compound absorbs saliva, blood and the like on the surface of the wound surface to generate hydration, so that stronger adhesive force is generated on mucous membrane, and the retention time of the ointment in the mouth is prolonged; the hydrophobic component of the film agent can effectively prevent liquid and bacteria-carrying components from the outside of the wound surface from permeating into the wound surface, and can effectively control the release of the medicine.
Description
Technical Field
The invention relates to the technical field of oral medical products, in particular to an oral wound treatment patch.
Background
Oral trauma is a common case in oral medicine, and generally refers to lesions of the oral mucosa caused by mechanical, physical and chemical stimuli. In the process of trauma, oral trauma is caused by the fact that foreign bodies puncture, tooth bites or punctures adjacent oral mucosa or sharp edges of stumps, stumps or brackets and the like and poor prostheses scrape the oral mucosa. In addition, a wound surface is also generated during surgical treatment such as tooth extraction and tooth implantation, and general treatment such as chemotherapy. Therefore, the wound surface is irregular, uneven in edge and even has tissue defects, so that the treatment is troublesome. Because the dressing can not be coated outside, the oral cavity has a bacterial environment, the oral cavity has the functions of language, food intake and the like, and the wound surface is not allowed to contact with the medicine for a long time, the wound is easy to turn into ulcer, so that the wound is not healed, the state of an illness is prolonged, and the pain of a patient is increased. Therefore, the treatment of oral wounds is always a problem to be solved clinically.
At present, the commonly used techniques mainly include physical isolation, pharmaceutical action and the like. When the medicine is directly used, the dosage of the medicine is not easy to control, and the medicine can quickly lose effect under the washing of saliva and the like in the oral cavity. The treatment of oral wounds by using preparations such as liquid, powder, paste, film and the like which do not contain or contain medicines becomes a trend and a conventional means.
The liquid, powder and paste are convenient to use, particularly the fine parts between teeth are easy to use, but the liquid and the paste are easy to wash away by saliva and the like in the oral cavity, the action time is short, and particularly the dosage of the medicine is difficult to control. The film agent can be made into multilayer composite form, such as the most classical three-layer structure, wherein the inner part is an adhesion layer, the middle part is a medicine layer, and the outer part is a water-insoluble protective layer. The action time of the film agent is easy to control, and the concentration and the release process of the medicine are also easy to control. However, the film agent is difficult to be applied to fine parts, and the range of application is limited. In addition, the oral actions of food, drink, etc. all pose substantial difficulties in the long-term retention and long-lasting release of the drug in the affected area.
Disclosure of Invention
The invention mainly aims to provide an oral wound treatment patch, which solves the problem of poor adhesion of an oral wound treatment membrane in the prior art.
In order to achieve the above object, according to one aspect of the present invention, there is provided an oral wound treatment patch, including an ointment and a film agent, the ointment including, in parts by weight: 20-70 parts of hydrophilic high molecular compound, 1-25 parts of first filling agent, 0-10 parts of first medicine, 1-10 parts of first surfactant, 1-15 parts of first plasticizer and 1-20 parts of first solvent, wherein the film agent comprises: 40-90 parts of hydrophobic high molecular compound, 2-25 parts of second filling agent, 1-30 parts of second plasticizer and 1-20 parts of second solvent.
Further, the above paste comprises: 40-60 parts of a first hydrophilic polymer compound, 5-15 parts of a first filling agent, 0.1-10 parts of a first drug, 3-8 parts of a first surfactant, 2-10 parts of a first plasticizer and 5-10 parts of a first solvent
Further, the hydrophilic polymer compound in the paste comprises a natural polymer compound, a linear polymer compound and a cross-linked polymer compound, and preferably, the hydrophilic polymer compound in the paste comprises, by weight, 5-30 parts of the natural polymer compound, 10-40 parts of the linear polymer compound and 1-10 parts of the cross-linked polymer compound.
Further, the natural polymer compound is selected from one or more of carboxymethyl cellulose, hydroxyethyl cellulose, carboxypropyl cellulose, hydroxypropyl ethyl cellulose, xanthan gum, carrageenan, arabic gum and sodium alginate, preferably the linear polymer compound is one or more of polyvinylpyrrolidone, polyvinylpyrrolidone iodine, polyethylene glycol and poloxamer, and preferably the cross-linked polymer compound is polyacrylate.
Further, the first filling agent is selected from one or more of starch, cyclodextrin, glycerol and sorbitol, preferably, the first surfactant is selected from one or more of oleate, glycerate, tween 80 and span 80, preferably, the first solvent is one or more of water, ethanol, isopropanol, propylene glycol, carbonate, ethyl acetate and pyrrolidone, preferably, the first plasticizer is selected from one or more of citrate, dibutyl adipate, dibutyl sebacate, acetyl citrate and glyceryl acetate, preferably, the first medicament is one or more of dexamethasone acetate, vitamin E and minocycline hydrochloride.
Further, the paste also comprises 0.01-5 parts by weight of a flavoring agent, wherein the flavoring agent is selected from one or more of peppermint oil, borneol, aspartame, stevioside and xylitol.
Further, the film agent comprises the following components in parts by weight: 40-90 parts of hydrophobic high molecular compound, 2-20 parts of second filling agent, 5-30 parts of second plasticizer, 1-20 parts of second solvent and 0-5 parts of second medicine.
The hydrophobic polymer compound may include cellulose-based polymers and synthetic polymers, and preferably includes 25 to 80 parts by weight of cellulose-based polymers and/or 15 to 70 parts by weight of synthetic polymers.
Further, the cellulose-based polymer is alkyl cellulose or cellulose acetate, and preferably, the synthetic polymer is one or more selected from polyvinyl acetate, polyacrylate, polylactic acid, and polycaprolactone.
Further, the second filling agent is selected from any one or more of starch, cyclodextrin, polyethylene glycol and sorbitol, preferably, the second plasticizer is selected from any one or more of citrate, dibutyl adipate, dibutyl sebacate, acetyl citrate, glycerol acetate, cellulose acetate, ethyl cellulose, polyvinyl acetate, polyethylene and polylactic acid, the second solvent is selected from any one or more of ethanol, acetone and ethyl acetate, and the second medicament is selected from any one or more of chlorhexidine hydrochloride, vitamin E and ibuprofen.
Further, the thickness of the film agent is 20-500 μm, one or more film holes are formed in the film agent, the aperture of each film hole is preferably 0.1-2 mm, and the hole center distance of each film hole is preferably 1-5 mm.
Further, the thickness of the film agent is 50 to 300 μm, preferably 100 to 200 μm, and the pore diameter of the film pores is preferably 0.5 to 1.5mm, preferably 0.5 to 1.0 mm.
By applying the technical scheme of the invention, the ointment and the film agent can be combined together or can be separately subpackaged, namely the ointment and the film agent are respectively positioned in independent packaging containers before use and are not in direct contact with each other. The combined use of the ointment and the film agent means that the following components are sequentially used together in the treatment: firstly, paste containing medicines (including medicines) and hydrophilic components and the like is smeared on the surface of the oral wound, so that the effects of sealing the wound, quickly stopping bleeding, releasing medicines and preventing infection are achieved; and then the membrane agent with easy plasticity is covered on the paste and the wound surface, so that the membrane agent and the paste are naturally combined, the hydrophobic component of the membrane agent can effectively prevent liquid and bacteria-carrying components from the outside of the wound surface from permeating into the wound surface, the release of the medicine can be effectively controlled, and the new wound surface formed in the oral cavity is treated or prevented. Or making the ointment and the membrane into an integrated structure, and directly applying to the treatment of the oral wound. Furthermore, the hydrophilic high molecular compound is the main component of the ointment, and when contacting with the wound surface, the hydrophilic high molecular compound absorbs saliva, blood and the like on the surface of the wound surface to generate hydration, so that stronger adhesive force is generated on the mucous membrane, the retention time of the ointment in the mouth is prolonged, and the medicinal effect of the ointment is fully exerted. The hydrophobic high molecular compound is the main component of the film agent, controls the dissolution of external liquid such as saliva and the like and the dissolution of ointment, prolongs the retention time of the ointment in the mouth and effectively controls the slow release of the medicine.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:
fig. 1 shows a schematic structure of a film dosage form according to an embodiment of the present invention.
Wherein the figures include the following reference numerals:
10. a film agent; 11. and (4) film holes.
Detailed Description
It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.
As analyzed by the background of the present application, the existing oral wound treatment film has poor adhesion, which results in that the medicine cannot fully exert its effect, and in order to solve the problem, the present application provides an oral wound treatment patch, which comprises an ointment and a film agent 10, wherein the ointment comprises, in parts by weight: 20-70 parts of hydrophilic high molecular compound, 1-25 parts of first filling agent, 0.5-10 parts of first medicine, 1-10 parts of first surfactant, 1-15 parts of first plasticizer and 1-20 parts of first solvent, wherein the film agent 10 comprises: 40-100 parts of hydrophobic polymer compound, 2-25 parts of second filling agent, 1-30 parts of second plasticizer and 1-20 parts of second solvent.
The ointment and film 10 of the present invention may be combined together or may be separately dispensed, the latter being preferred. I.e., the paste and film dosage form 10 are each in separate packaging containers prior to use, without direct contact with each other. The combined use of the ointment and the film 10 means that they are used together in the treatment sequentially: firstly, paste containing medicines (including medicines) and hydrophilic components and the like is smeared on the surface of the oral wound, so that the effects of sealing the wound, quickly stopping bleeding, releasing medicines and preventing infection are achieved; and then the membrane agent 10 with easy plasticity is covered on the ointment and the wound surface, so that the membrane agent 10 is naturally combined with the ointment, and the hydrophobic component of the membrane agent 10 can effectively prevent liquid and bacteria-carrying components from the outside of the wound surface from permeating into the wound surface and can effectively control the release of the medicine. Or making the ointment and the membrane into an integrated structure, and directly applying to the treatment of the oral wound. Furthermore, the hydrophilic high molecular compound is the main component of the ointment, and when contacting with the wound surface, the hydrophilic high molecular compound absorbs saliva, blood and the like on the surface of the wound surface to generate hydration, so that stronger adhesive force is generated on the mucous membrane, the retention time of the ointment in the mouth is prolonged, and the medicinal effect of the ointment is fully exerted. The hydrophobic high molecular compound is the main component of the film agent, controls the dissolution of external liquid such as saliva and the like and the dissolution of ointment, prolongs the retention time of the ointment in the mouth and effectively controls the slow release of the medicine.
In a preferred embodiment of the present application, the above paste includes: 40-60 parts of a first hydrophilic polymer compound, 5-15 parts of a first filling agent, 0.1-10 parts of a first drug, 3-8 parts of a first surfactant, 2-10 parts of a first plasticizer and 5-10 parts of a first solvent. By further controlling the dosage of the components, the ointment has more sufficient adhesive force with the oral mucosa and drug slow release time.
In order to further sufficiently exert the effect of the hydrophilic polymer compound, the hydrophilic polymer compound preferably has a hydrogen bond-forming functional group, a sufficiently long polymer chain having a certain flexibility, a relatively high density of negative charges, and an appropriate polymer molecular weight. The polymer can comprise one or more of natural polymer and modified material thereof, and synthetic polymer material. Preferably, the hydrophilic polymer compound in the paste comprises a natural polymer compound, a linear polymer compound and a cross-linked polymer compound, and in order to complement the advantages of the hydrophilic polymers, the hydrophilic polymer compound in the paste preferably comprises 5-30 parts by weight of the natural polymer compound, 10-40 parts by weight of the linear polymer compound and 1-10 parts by weight of the cross-linked polymer compound.
Further preferably, the natural polymer compound is selected from one or more of carboxymethyl cellulose, hydroxyethyl cellulose, carboxypropyl cellulose, hydroxypropyl ethyl cellulose, xanthan gum, carrageenan, acacia and sodium alginate, preferably, the linear polymer compound is one or more of polyvinylpyrrolidone, polyvinylpyrrolidone iodine, polyethylene glycol and poloxamer, and preferably, the cross-linked polymer compound is polyacrylate, such as carbomer and carbopol.
The first filler is dissolvable by saliva or blood, forming micro-channels within the paste for releasing the drug. The size and distribution of the micro-channels can be adjusted by adjusting the type and amount of the filler, and the drug release process can be adjusted, and the first filler is preferably selected from one or more of starch, cyclodextrin, glycerol and sorbitol.
The use of a solvent allows the components to be processed to form a uniform paste. The solvent needs to meet the requirements of co-dissolving with each component, no toxicity, no mucous membrane irritation and the like, and preferably the first solvent is one or more of water, ethanol, isopropanol, propylene glycol, carbonate, ethyl acetate and pyrrolidone.
The surfactant can maintain each component in a stable state in the hydrophilic solvent without causing phase separation or the like. Surfactants include, but are not limited to, anionic, cationic, nonionic, and amphoteric surfactants. Preferably, the first surfactant is selected from one or more of oleate, glycerate, tween 80 and span 80.
The paste may also contain some plasticizer to enhance the bonding with the film 10. Preferably, the first plasticizer is one or more selected from the group consisting of citric acid ester, dibutyl adipate, dibutyl sebacate, acetyl citrate and glyceryl acetate.
In addition to providing a physical barrier, the ointment may also be added with a series of drugs to enhance wound healing. The first medicament for the ointment comprises medicaments which are disclosed to be suitable for oral mucosa treatment, such as a hemostatic agent, an antibacterial agent, an anti-inflammatory agent and the like. Systemic drugs may also be included for sustained release from the oral cavity, including but not limited to hormonal drugs, hypertensive drugs, antibiotics, cardiovascular drugs, and the like. Preferably, the first medicament is one or more of dexamethasone acetate, vitamin E and minocycline hydrochloride.
In order to improve the acceptability of the oral wound treatment patch, the paste preferably further comprises 0.01-5 parts by weight of a flavoring agent, wherein the flavoring agent is one or more selected from peppermint oil, borneol, aspartame, stevioside and xylitol.
In another embodiment of the present application, the film agent 10 comprises, by weight: 40-90 parts of hydrophobic high molecular compound, 2-20 parts of second filling agent, 5-30 parts of second plasticizer, 1-20 parts of second solvent and 0-5 parts of second medicine. By further controlling the dosage of the components, the paste and the film agent 10 have more sufficient adhesion and protection time.
The hydrophobic polymer is the main component of the film 10 and serves to protect the film 10 from damage by the tongue, saliva, food, etc. in the oral cavity. In order to enhance the protective effect, the hydrophobic polymer compound preferably includes a cellulose-based polymer and a synthetic polymer. In order to provide the cellulose-based polymer and the synthetic polymer with synergistic effects, the hydrophobic polymer compound preferably comprises, by weight, 25 to 80 parts of the cellulose-based polymer and 15 to 70 parts of the synthetic polymer. Preferably, the cellulose polymer is alkyl cellulose or cellulose acetate, and the synthetic polymer is selected from one or more of polyvinyl acetate, polyacrylate, polylactic acid, and polycaprolactone.
The filler can be dissolved by saliva or blood to form micro-channels on the membrane, so as to create conditions for dissolving and falling off of the medicine in the ointment, and control the release speed of the medicine, and preferably, the second filler is one or more selected from starch, cyclodextrin, polyethylene glycol and sorbitol.
The film 10 may also contain some plasticizers to enhance the bonding with the paste. The second plasticizer is selected from one or more of citrate, dibutyl adipate, dibutyl sebacate, acetyl citrate, acetin, cellulose acetate, ethyl cellulose, polyvinyl acetate, polyethylene and polylactic acid.
The use of a solvent allows the components to be processed to form a uniform paste. The solvent needs to meet the requirements of co-dissolving with each component, no toxicity, no mucous membrane irritation and the like, and preferably the second solvent is any one or more of ethanol, acetone and ethyl acetate.
In addition to providing a physical barrier, the film 10 may also include a series of drugs to enhance wound healing. The second medicament for film 10 includes the disclosed medicaments suitable for oral mucosal treatment, such as hemostatic, antibacterial, anti-inflammatory, and the like. Systemic drugs may also be included for sustained release from the oral cavity, including but not limited to hormonal drugs, hypertensive drugs, antibiotics, cardiovascular drugs, and the like. Preferably, the second medicament is selected from one or more of chlorhexidine hydrochloride, vitamin E and ibuprofen.
In order to further enhance the binding force between the film agent 10 and the paste, the thickness of the film agent 10 is preferably 20-500 μm, as shown in fig. 1, one or more film holes 11 are formed in the film agent 10, the aperture of each film hole 11 is preferably 0.1-2 mm, and the hole center distance of each film hole 11 is preferably 1-5 mm. The film agent 10 contains film holes 11 which are regularly arranged and used for enhancing the bonding force with the ointment, effectively controlling the release of the medicine and treating or preventing the formation of new wound surfaces in the oral cavity.
The preparation method of the film agent 10 includes, but is not limited to, one or more of wet film forming, dry film forming, hot-pressing film forming, and freeze-drying film forming.
A series of film holes 11 with a certain regular arrangement are prepared on the film agent 10 by a mechanical method. Mechanical methods include, but are not limited to, perforation, pore size and arrangement to ensure both film strength, handling, and control the drug release and dissolution process of the ointment. Preferably, the thickness of the film agent 10 is 50 to 300 μm, preferably 100 to 200 μm, and the pore diameter of the film pores 11 is preferably 0.5 to 1.5mm, preferably 0.5 to 1.0 mm.
The advantageous effects of the present application will be further described below with reference to examples and comparative examples.
Example 1
Pastes and films were prepared using a number of ingredients identified in tables 1 and 2 below. The paste is prepared by mixing the above components and stirring. The film agent is prepared into solution, smeared, dried and formed. A control test was carried out with the commercial paste Reso-pac (HergeKajia, Germany) as comparative example 3.
Table 1: the main components of the ointment (weight portion unit: gram)
Taking paste example 3 as an example, the preparation process of the paste is as follows: 100g of water, 20g of absolute ethyl alcohol, 10 g of acetyl tributyl citrate, 4 g of Tween 80 and 4 g of span 80 are mechanically stirred to obtain uniform liquid. Then, under stirring, adding 8 g of minocycline hydrochloride, 5g of glycerol, 10 g of sorbitol, 4 g of carbopol, 5g of carboxymethyl cellulose and 40 g of polyvinylpyrrolidone step by step, transferring to a strong mixer with high-speed dispersion, mixing uniformly, and heating under vacuum to remove part of water and ethanol to obtain the ointment.
The main composition of the film agent is shown in Table 2
Table 2: main composition of film agent (weight portion unit: gram)
Taking film agent example 2 as an example, the preparation process of the film agent is as follows: 200 g of absolute ethyl alcohol, 5g of acetyl tributyl citrate and 5g of glycerol oleate, and mechanically stirring to obtain a uniform liquid. Then 4 g of starch, 1 g of cyclodextrin and 80 g of ethyl cellulose are added step by step under stirring and mixed evenly. And (5) coating the outside and drying to obtain the film. Dividing the obtained film into three groups, wherein one group is not perforated to obtain a non-porous film agent 10 (A); feeding into a mechanical punching machine to prepare a series of circular film holes 11 with the diameter of 0.5mm and the hole center spacing of 2mm to obtain a film agent 10(B) with holes; the other group was sent to a mechanical punch to prepare a series of circular film holes 11 with a diameter of 1.0mm and a hole center spacing of 5mm to obtain a film with holes 10 (C).
The preparation method of the paste-film combined product comprises the following steps:
preparing paste, coating on a supporting base film such as PET (polyethylene terephthalate) film, and oven drying; coating film agent solution on the surface, and drying again.
And (3) performance testing:
experiment 1: adhesion Performance test
The adhesive properties of the paste were determined with reference to the test method in the pharmaceutical industry Standard YY/T1280-2015 "dental denture adhesive". The adhesive strength of the pastes of examples 1 to 7 of the present invention and the control group were each greater than 5KPa, and the adhesive strength is shown in Table 3.
TABLE 3
The paste of paste example 1 was combined with the films of film examples 1 to 7 and film comparative examples 1 to 2, respectively, and the adhesion strength of both were tested by reference to the method in pharmaceutical industry standard YY/T1280-.
TABLE 4
Experiment 2: water absorption Performance test
The water absorption test of the ointment is utilized to evaluate the capability of the ointment in absorbing and permeating blood or liquid on the oral wound surface. Collecting 5g paste, placing into a watch glass with diameter of 90mm, pressing into 5cm sheet, and adding W0Soaking 20g of normal saline for 4h, pouring unadsorbed normal saline into a beaker, and testing the quality W1The results are shown in Table 5.
A＝(W0-W1)/W0×100
A: absorption rate, W0: physiological saline mass before absorption, W1: physiological saline quality after absorption
Table 5: water absorption property of the paste
Experiment 3: sustained drug release properties
Paste example 3 and film example 2 were combined, and control film example 2 was non-porous film (a), porous film (B), and porous film (C). The prepared sample was applied to the bottom of a cup, 30ml of PBS was added, the cup was left at 37 ℃ and 10ml of PBS was sampled every 12 hours and supplemented with new 10ml of PBS. The liquid chromatography test of the sustained release performance of the drug shows the results in table 6;
TABLE 6 sustained Release Properties of drugs
Experiment 4: wound healing evaluation
1. Tooth extraction animal model
1) Animal model preparation SD rats with body weight of 180-220 g and 10% chloral hydrate (0.4ml/100g) were anesthetized. Fixing the head, disinfecting the oral cavity and extracting the first molar of the left upper jaw and the right upper jaw to form an extracted tooth wound animal model;
2) grouping and administration of groups the extracted rats were 50, half each, randomly divided into 5 groups of 10. Group a (blank): after tooth extraction, the treatment is carried out according to the conventional method; group B (control group): reso-pac (Hergkaijia, Germany); group C: paste example 3; group D: paste example 3+ film agent the apertured film agent of example 2 (B); group E: reso-pac (Hergkaijia, Germany) + film agent the apertured film agent of example 2 (B). After the tooth extraction, the groups B to E were placed on the wound of the tooth extraction after the conventional treatment. The healing area of the wound surface of the extracted tooth was observed every day, and after one week, each group of rats was sacrificed to observe the healing condition, and the results are shown in table 7.
Table 7: evaluation of wound healing after tooth extraction
| Grouping | A | B | C | D | E |
| Wound healing score | 1.5 | 3.0 | 3.5 | 3.8 | 3.5 |
Wound healing is evaluated according to 4 points, wherein 1: the evaluation is the same as the conventional evaluation; 2, slightly curing; 3, curing; 4 normal level.
2. Mucosal ulcer animal model
1) Animal model preparation SD rats with body weight of 180-220 g and 10% chloral hydrate (0.4ml/100g) were anesthetized. 50ul of 10% glacial acetic acid solution is injected under buccal mucosa of a rat, and ulcer (off-white, round or oval ulcer on the surface, with the diameter of 4.5-5.5 mm) is formed after 24 hours, namely the film formation is successful.
2) Grouping and administration of groups 50 rats with successful membrane removal, half male and half female, were randomly grouped into 65 groups of 10 rats each. Group a (blank): flushing with normal saline; group B (control group): reso-pac (Hergkaijia, Germany); group C: paste example 2; group D: paste example 2+ film agent the apertured film agent of example 3 (B); group E: reso-pac (Hergkaijia, Germany) + film agent the apertured film agent of example 3 (B). The rats in each group were sacrificed one week after daily observation and the healing was observed and the results are shown in table 8.
Table 8: evaluation of mucosal wound healing
| Grouping | A | B | C | D | E |
| Wound healing score | 2 | 3.3 | 3.7 | 4 | 3.7 |
4-point evaluation criterion 1: same as the previous 2: slight cure 3: cure 4: normal level
From the above description, it can be seen that the above-described embodiments of the present invention achieve the following technical effects:
the ointment and the film agent can be combined together or independently packaged, so that the wound surface is protected from external stimulation, healing is accelerated, or the wound surface which is difficult to heal in the oral cavity is treated by the ointment and the film agent containing the medicines. The hydrophilic polymer compound is the main component of the ointment, and when contacting with a wound surface, the hydrophilic polymer compound absorbs saliva, blood and the like on the surface of the wound surface, generates stronger adhesive force on a mucous membrane, protects the wound surface and fully exerts the function of the contained medicine. Furthermore, the hydrophobic film agent can effectively prevent liquid such as oral saliva from the outside of the wound surface from permeating into the ointment, delay the dissolution speed of the ointment and effectively control the release of the medicine.
Different dosage forms are used according to the needs of healing the wound surface in the mouth. Particularly, the mode of combining the ointment and the film solves the problems that the acting time of the ointment is uncontrollable when the ointment is used alone, the medicine is difficult to effectively control and release, and the like. By controlling the shape and distribution of the pores on the membrane, the action time of the plaster membrane and the process of drug slow release are effectively controlled.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (12)
1. The patch for treating the oral wounds is characterized by comprising an ointment and a film agent (10), wherein the ointment comprises the following components in parts by weight: 20-70 parts of a hydrophilic high molecular compound, 1-25 parts of a first filling agent, 0-10 parts of a first medicine, 1-10 parts of a first surfactant, 1-15 parts of a first plasticizer and 1-20 parts of a first solvent, wherein the film agent (10) comprises: 40-90 parts of hydrophobic high molecular compound, 2-25 parts of second filling agent, 1-30 parts of second plasticizer and 1-20 parts of second solvent.
2. The oral wound treatment patch according to claim 1, wherein the ointment comprises: 40-60 parts of the first hydrophilic polymer compound, 5-15 parts of the first filling agent, 0.1-10 parts of the first drug, 3-8 parts of the first surfactant, 2-10 parts of the first plasticizer and 5-10 parts of the first solvent.
3. The patch for treating oral wounds according to claim 1, wherein the hydrophilic polymer compound in the ointment comprises a natural polymer compound, a linear polymer compound and a cross-linked polymer compound, and preferably the hydrophilic polymer compound in the ointment comprises 5 to 30 parts by weight of the natural polymer compound, 10 to 40 parts by weight of the linear polymer compound and 1 to 10 parts by weight of the cross-linked polymer compound.
4. The patch for treating oral wounds according to claim 3, wherein the natural polymer compound is one or more selected from the group consisting of carboxymethyl cellulose, hydroxyethyl cellulose, carboxypropyl cellulose, hydroxypropyl ethyl cellulose, xanthan gum, carrageenan, gum arabic and sodium alginate, preferably the linear polymer compound is one or more selected from the group consisting of polyvinylpyrrolidone, povidone-iodine, polyethylene glycol and poloxamer, and preferably the cross-linked polymer compound is polyacrylate.
5. The patch according to claim 3, wherein the first filler is selected from one or more of starch, cyclodextrin, glycerin and sorbitol, preferably the first surfactant is selected from one or more of oleate, glycerate, Tween 80 and span 80, preferably the first solvent is one or more of water, ethanol, isopropanol, propylene glycol, carbonate, ethyl acetate and pyrrolidone, preferably the first plasticizer is selected from one or more of citrate, dibutyl adipate, dibutyl sebacate, acetyl citrate and glyceryl acetate, preferably the first drug is one or more of dexamethasone acetate, vitamin E and minocycline hydrochloride.
6. The patch for treating oral wounds according to any one of claims 1 to 5, further comprising 0.01 to 5 parts by weight of a flavoring agent selected from one or more of peppermint oil, borneol, aspartame, stevia and xylitol.
7. The oral wound treatment patch according to claim 1, wherein the film agent (10) comprises, in parts by weight: 40-90 parts of the hydrophobic polymer compound, 2-20 parts of the second filling agent, 5-30 parts of the second plasticizer, 1-20 parts of the second solvent and 0-5 parts of a second medicine.
8. The patch for treating oral wounds according to claim 7, wherein the hydrophobic polymer compound comprises a cellulose-based polymer and a synthetic polymer, and preferably the hydrophobic polymer compound comprises 25 to 80 parts by weight of the cellulose-based polymer and/or 15 to 70 parts by weight of the synthetic polymer.
9. The patch for treating oral wounds according to claim 8, wherein the cellulose-based polymer is alkyl cellulose or cellulose acetate, and preferably the synthetic polymer is one or more selected from polyvinyl acetate, polyacrylate, polylactic acid, and polycaprolactone.
10. The patch for treating the oral wounds according to claim 8, wherein the second filling agent is selected from any one or more of starch, cyclodextrin, polyethylene glycol and sorbitol, preferably the second plasticizer is selected from any one or more of citrate, dibutyl adipate, dibutyl sebacate, acetyl citrate, glyceryl acetate, cellulose acetate, ethyl cellulose, polyvinyl acetate, polyethylene and polylactic acid, the second solvent is selected from any one or more of ethanol, acetone and ethyl acetate, and the second medicament is selected from any one or more of chlorhexidine hydrochloride, vitamin E and ibuprofen.
11. The patch for treating the oral wounds is characterized in that the thickness of the film agent (10) is 20-500 microns, one or more film holes (11) are formed in the film agent (10), the aperture of each film hole (11) is preferably 0.1-2 mm, and the hole center distance of each film hole (11) is preferably 1-5 mm.
12. The patch for treating the oral wounds, according to claim 11, is characterized in that the thickness of the film agent (10) is 50-300 μm, preferably 100-200 μm, and the pore diameter of the film pores (11) is preferably 0.5-1.5 mm, preferably 0.5-1.0 mm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010605289.5A CN111617058A (en) | 2020-06-29 | 2020-06-29 | Oral wound treatment plaster |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010605289.5A CN111617058A (en) | 2020-06-29 | 2020-06-29 | Oral wound treatment plaster |
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| Publication Number | Publication Date |
|---|---|
| CN111617058A true CN111617058A (en) | 2020-09-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010605289.5A Pending CN111617058A (en) | 2020-06-29 | 2020-06-29 | Oral wound treatment plaster |
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| CN (1) | CN111617058A (en) |
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