CN111000830B - Oral film and preparation method thereof - Google Patents
Oral film and preparation method thereof Download PDFInfo
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
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- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/542—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
- A61K31/545—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
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- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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Abstract
The invention discloses an oral sticking film and a preparation method thereof, wherein the oral sticking film comprises a medicine-carrying adhesive layer, an extension layer and a hydrophobic protective layer which are sequentially attached; the medicine-carrying adhesive layer is prepared from the following raw materials in parts by weight: 20 to 40 portions of adhesive, 0.5 to 5 portions of drug-loaded substance A, 0.1 to 1 portion of flavoring agent, 0.1 to 1 portion of essence, 0.5 to 3 portions of release agent and 300 to 600 portions of deionized water; the extension layer is prepared from the following raw materials in parts by weight: 10 to 40 portions of spreading agent and 0 to 5 portions of drug-loaded substance B. The oral patch can be directly applied to the ulcer affected part, has a drug slow-release effect, can relieve pain, promote wound healing and shorten the course of disease, has no side effect and strong adhesive force, can be firmly and durably applied to the oral ulcer affected part, is not easy to fall off when a patient eats and drinks water, and improves the use comfort of the patient. The preparation method of the oral film is simple, low in cost and suitable for industrial production.
Description
Technical Field
The invention relates to the technical field of medicines, in particular to an oral film and a preparation method thereof.
Background
Canker sores, commonly known as "canker sores," are the most common ulcerative lesions of the oral mucosa, most commonly found on the inner side of the lips, tongue, abdomen, buccal mucosa, vestibular sulcus, soft palate, etc., where the mucosa lacks a stratum corneum or poorly keratoses. The pain is severe when the oral ulcer is attacked, the local burning pain is obvious, and serious patients can influence diet and speaking, thereby causing great inconvenience to daily life; can be complicated with halitosis, chronic pharyngitis, constipation, headache, dizziness, nausea, debilitation, dysphoria, fever, lymphadenectasis, etc. Therefore, the oral preparation is especially important for preventing oral ulcer, and the use of the oral preparation for keeping oral hygiene is an important way for preventing the oral ulcer.
The oral preparations for treating oral ulcer on the market are mainly divided into the following types: oral cavity sticking film, oral cavity sticking film and oral cavity film glue. The existing oral sticking film is composed of hydroxypropyl methylcellulose, and the oral sticking film can be temporarily adhered to an oral ulcer part, but has water solubility, is easily dissolved by saliva, is easily influenced by oral cavity movement, and has the defects of insecure adhered part and short action time. Although the existing oral patch can be firmly adhered to an oral ulcer affected part, after the patch absorbs water and swells, foreign matters in the oral cavity bulge out and meditation, and are easily influenced by oral movement, drinking water and eating; in addition, the commercially available oral patch has a small area and cannot play an effective protection role for ulcer with a large area. Although the existing oral cavity membrane glue can effectively protect the oral cavity ulcer surface, has a large action area and can adapt to the more complicated oral cavity ulcer surface, the existing oral cavity membrane glue needs to be assisted by an ethanol solution when in use, and the ethanol solution of the oral cavity membrane glue needs to be adhered to the wound surface in the use process, so that stimulation is easily brought to the wound surface of a patient, and the adaptability of the patient is reduced.
Therefore, it is urgent to develop an oral patch, which can be firmly adhered to the affected part of the stomatocace, is not easily affected by oral cavity movement, has strong ductility, can be applied to different oral wounds, and improves the comfort of the patient.
Disclosure of Invention
The invention aims to overcome the defects, provides the oral sticking film which can be directly applied to the ulcer affected part, has a drug slow-release effect, can relieve pain, promote wound healing and shorten the course of disease, has no side effect and strong adhesive force, can be firmly and durably applied to the oral ulcer affected part, is not easy to fall off when a patient eats or drinks water, reduces the stimulation to the oral ulcer affected part when the patient eats or drinks water, and improves the use comfort of the patient; in addition, the invention also provides a preparation method of the oral film.
In order to achieve the above object, a first aspect of the present invention provides an oral patch, which comprises a drug-loaded adhesive layer, an extension layer, and a hydrophobic protective layer, wherein the drug-loaded adhesive layer, the extension layer, and the hydrophobic protective layer are sequentially attached to each other, and the weight ratio of the drug-loaded adhesive layer to the hydrophobic protective layer is (50-60): (10-40): (20 to 50); the total thickness of the oral sticking film is 0.3-0.4 mm;
the drug-loaded adhesive layer is prepared from the following raw materials in parts by weight: 20 to 40 portions of adhesive, 0.5 to 5 portions of drug-loaded substance A, 0.1 to 1 portion of flavoring agent, 0.1 to 1 portion of essence, 0.5 to 3 portions of release agent and 300 to 600 portions of deionized water;
the extension layer is prepared from the following raw materials in parts by weight: 10-40 parts of a spreading agent and 0-5 parts of a drug-loaded substance B;
the hydrophobic protective layer is made of any one or combination of more of ethyl cellulose, hydroxyethyl methacrylate, methyl methacrylate copolymer and hydroxypropyl methylcellulose acetate succinate.
By adopting the technical scheme, the medicine-carrying adhesive layer has adhesion, so that the oral sticking film can be ensured to firmly act on the affected part of the oral ulcer for a long time; the hydrophobic protective layer can prevent water, so that a patient can eat normally in the administration process, the stimulation of food, water, drinks and the like to the affected part of the oral ulcer is reduced, and the use comfort of the patient is improved; the extension layer has good ductility and is suitable for different oral wound surfaces; the drug-carrying adhesive layer contains drug-carrying substances, so that the oral cavity adhesive film has a drug slow-release effect, can relieve pain, promote wound healing and shorten the course of disease, and has no side effect.
Preferably, the adhesive is selected from any one or more of hypromellose, carbomer, polycarbophil and chitosan.
Preferably, the drug-loaded substance A is selected from any one or more of antibacterial drugs, glucocorticoids and analgesic drugs.
Preferably, the flavoring agent is saccharin sodium.
Preferably, the release agent is selected from any one of magnesium stearate and hydrogenated castor oil or a combination of the two.
Preferably, the extending agent is selected from any one of or a combination of two of acacia gum and gum base.
By adopting the technical scheme, the edible gum with excellent ductility is selected as the ductility agent, and no side effect is generated on the human body.
Preferably, the drug-loaded substance B is selected from any one or more of antibacterial drugs, glucocorticoids and analgesic drugs.
The second invention provides a preparation method of the oral film, which comprises the following steps:
s1, weighing raw materials according to a ratio;
s2, dissolving an adhesive in deionized water, sequentially adding a drug-loaded substance A, a release agent, essence and a flavoring agent, and uniformly stirring and mixing to obtain a solution A;
s3, sequentially adding any one or more of ethyl cellulose, hydroxyethyl methacrylate, methyl methacrylate copolymer and hydroxypropyl methylcellulose acetate succinate into a volatile organic solvent, and uniformly stirring and mixing to obtain a solution B;
s4, adding the drug-loaded substance B after the ductility agent is melted, and stirring and mixing uniformly to obtain a solution C;
s5, preparation of a drug-loaded adhesive layer: preparing a film from the solution A obtained in the step S2 through an integrated film forming machine, drying for 5min at the temperature of 60-80 ℃, drying for 5min at the temperature of 100-105 ℃, and stripping the film to obtain a drug-loaded adhesive layer;
s6, preparing an extension layer on the drug-loaded adhesive layer: uniformly coating the solution B obtained in the step S3 on the medicine-carrying adhesive layer prepared in the step S5;
and S7, uniformly spraying the solution C obtained in the step S4 on the surface of the extension layer in the film prepared in the step S6, drying, cutting, sterilizing and packaging to obtain the oral sticking film.
By adopting the technical scheme, the method has the advantages that,
preferably, the volatile organic solvent in step S3 is selected from any one of ethanol and acetone or a combination of two of the two.
Compared with the prior art, the invention has the beneficial effects that:
1. the oral sticking film can be directly applied to the ulcer affected part, has a drug slow-release effect, can relieve pain, promote wound healing and shorten the course of disease, has no side effect and strong adhesive force, can be firmly and durably applied to the oral ulcer affected part, is not easy to fall off when a patient eats or drinks water, reduces the stimulation to the oral ulcer affected part when the patient eats or drinks water, and improves the use comfort of the patient.
2. The preparation method of the oral film is simple, low in cost and suitable for industrial production.
Drawings
Fig. 1 is a schematic structural view of the oral patch of the present invention.
The correspondence between each mark and the part name is as follows:
hydrophobic protective layer 1, extension layer 2, medicine carrying adhesion layer 3.
Detailed Description
In order to make the technical means, the characteristics, the purposes and the functions of the invention easy to understand, the invention is further described with reference to the specific drawings.
Example 1
Referring to fig. 1, an oral film in this embodiment includes a drug-loaded adhesive layer 3, an extension layer 2, and a hydrophobic protective layer 1, which are sequentially attached to each other.
Wherein, the weight ratio of the medicine-carrying adhesive layer 3, the extension layer 2 and the hydrophobic protective layer 1 is 37.5:38:24.5; the total thickness of the oral sticking film is 0.3mm;
the medicine-carrying adhesive layer 3 in the oral film of the embodiment is prepared from the following raw materials by weight: 3.5kg of adhesive, 100g of drug-loaded substance A, 20g of flavoring agent, 30g of essence, 100g of release agent and 40.25kg of deionized water.
The extension layer 2 in the oral film of the embodiment is made of the following raw materials by weight: 3.8kg of extending agent.
The hydrophobic protective layer 1 in the oral film of this embodiment is made of 2.45kg of ethyl cellulose.
In this embodiment, the adhesive in the oral film is carbomer.
The drug-loaded substance A is selected from any one or combination of more of antibacterial drugs, glucocorticoids and analgesic drugs, wherein the antibacterial drugs are any one or combination of two of metronidazole and cephalosporin.
Preferably, the drug-carrying substance a in the oral film of the present embodiment is metronidazole.
In the embodiment, the flavoring agent in the oral film is saccharin sodium.
In this example, the release agent in the oral film is magnesium stearate.
The extending agent in the oral film of the embodiment is a gum base.
The essence in the oral cavity film of the embodiment is cherry flavor essence.
The preparation method of the oral film in the embodiment comprises the following steps:
s1, weighing raw materials according to a ratio;
s2, dissolving 3.5kg of carbomer in 40.25kg of deionized water, sequentially adding 100g of metronidazole, 100g of magnesium stearate, 30g of cherry flavor and 20g of saccharin sodium, and uniformly stirring and mixing to obtain a solution A;
s3, adding 2.45kg of ethyl cellulose into 28.18kg of volatile organic solvent, and uniformly stirring and mixing to obtain a solution B;
wherein the volatile organic solvent is ethanol.
S4, melting 3.8kg of gum base to obtain a solution C;
s5, preparing a medicine-carrying adhesive layer 3: pouring the solution A obtained in the step S2 into a storage tank, enabling a crawler of the integrated film forming machine to pass through a material liquid surface in the storage tank, controlling the thickness of the film to be 0.1mm through a material scraper, then sending the crawler loaded with the material liquid into a tunnel oven, drying for 5min at 60 ℃, drying for 5min at 80 ℃, and then stripping the film to obtain a drug-loaded adhesive layer 3; wherein the water content of the drug-loaded adhesive layer 3 obtained in the step S5 is 7-15%;
s6, preparing an extension layer 2 on the drug-loaded adhesive layer 3: scraping the medicine-carrying adhesive layer 3 obtained in the step S5 by a scraper, then uniformly coating the solution B obtained in the step S3 on the medicine-carrying adhesive layer 3 scraped by the scraper, and adjusting the thickness of the film coated on the medicine-carrying adhesive layer 3 by the scraper to enable the thickness of the obtained film to be 0.2mm;
and S7, uniformly spraying the solution C obtained in the step S4 on the surface of the extension layer 2 in the film prepared in the step S6 by a spraying method, wherein the spraying temperature is 45-55 ℃, the thickness of the obtained film is 0.3mm by adjusting the spraying feeding rate, finally drying at 50-60 ℃, cutting into small blocks of 1cm multiplied by 2.5cm, sterilizing and packaging to obtain the oral film product.
Example 2
Referring to fig. 1, an oral film in this embodiment includes a drug-loaded adhesive layer 3, an extension layer 2, and a hydrophobic protective layer 1, which are sequentially attached to each other.
Wherein, the weight ratio of the medicine-carrying adhesive layer 3, the extension layer 2 and the hydrophobic protective layer 1 is 50:13:48; the total thickness of the oral sticking film is 0.3mm;
the medicine-carrying adhesive layer 3 in the oral film of the embodiment is prepared from the following raw materials by weight: 3.8kg of adhesive, 500g of drug-loaded substance A, 100g of flavoring agent, 30g of essence, 500g of release agent and 38kg of deionized water.
The extension layer 2 in the oral film of the embodiment is made of the following raw materials by weight: 1.2kg of spreading agent and 0.1kg of drug-loaded substance B.
The hydrophobic protective layer 1 in the oral film of this example is made of ethyl cellulose 4.8 kg.
The adhesive in the oral film of the embodiment is carbomer.
The drug-loaded substance A is selected from any one or combination of a plurality of antibacterial drugs, glucocorticoids and analgesic drugs, wherein the antibacterial drugs are any one or combination of metronidazole and cephalosporin.
Preferably, the drug-loaded substance a in the oral patch of this embodiment is metronidazole.
The drug-loaded substance B is selected from any one or combination of a plurality of antibacterial drugs, glucocorticoids and analgesic drugs, wherein the antibacterial drugs are any one or combination of metronidazole and cephalosporin.
Preferably, the drug-loaded substance a in the oral film of this embodiment is a cephalosporin.
In this embodiment, the flavoring agent in the oral film is saccharin sodium.
In this example, the release agent in the oral film is magnesium stearate.
The extending agent in the oral film of the embodiment is a gum base.
The essence in the oral cavity film of the embodiment is cherry flavor essence.
The preparation method of the oral film in the embodiment comprises the following steps:
s1, weighing raw materials according to a ratio;
s2, dissolving 3.8kg of carbomer in 38kg of deionized water, sequentially adding 500g of metronidazole, 100g of magnesium stearate, 100g of cherry flavor essence and 30g of saccharin sodium, and uniformly stirring and mixing to obtain a solution A;
s3, adding 4.8kg of ethyl cellulose into 51kg of volatile organic solvent, and uniformly stirring and mixing to obtain a solution B;
wherein the volatile organic solvent is ethanol.
S4, adding 0.1kg of drug-loaded substance B into 1.2kg of gum base, and melting to obtain solution C;
s5, preparing a medicine-carrying adhesive layer 3: pouring the solution A obtained in the step S2 into a storage tank, enabling a crawler of the integrated film forming machine to pass through a material liquid surface in the storage tank, controlling the thickness of the film to be 0.1mm through a material scraper, then sending the crawler loaded with the material liquid into a tunnel oven, drying for 5min at 60 ℃, drying for 5min at 80 ℃, and then stripping the film to obtain a drug-loaded adhesive layer 3; wherein the water content of the medicine-carrying adhesive layer 3 obtained in the step S5 is 7-15%;
s6, preparing an extension layer 2 on the drug-loaded adhesive layer 3: scraping the drug-loaded adhesive layer 3 obtained in the step S5 by a scraper, uniformly coating the solution B obtained in the step S3 on the drug-loaded adhesive layer 3 scraped by the scraper, and adjusting the thickness of a film coated on the drug-loaded adhesive layer 3 by the scraper to enable the thickness of the obtained film to be 0.2mm;
and S7, uniformly spraying the solution C obtained in the step S4 on the surface of the extension layer 2 in the film prepared in the step S6 by a spraying method, wherein the spraying temperature is 45-55 ℃, the thickness of the obtained film is 0.3mm by adjusting the spraying feeding rate, finally drying at 50-60 ℃, cutting into small blocks of 1cm multiplied by 2.5cm, sterilizing and packaging to obtain the oral sticking film product.
Example 3
Referring to fig. 1, an oral film in this embodiment includes a drug-loaded adhesive layer 3, an extension layer 2, and a hydrophobic protective layer 1, which are sequentially attached to each other.
Wherein, the weight ratio of the medicine-carrying adhesive layer 3, the extension layer 2 and the hydrophobic protective layer 1 is 37.5:38:24.5; the total thickness of the oral sticking film is 0.3mm;
the medicine-carrying adhesive layer 3 in the oral film of the embodiment is prepared from the following raw materials by weight: 2.1kg of adhesive, 50g of drug-loaded substance A, 10g of flavoring agent, 10g of essence, 50g of release agent and 21.2kg of deionized water.
The extension layer 2 in the oral film of the embodiment is made of the following raw materials by weight: and 1.7kg of a ductility agent.
The hydrophobic protective layer 1 in the oral film of this embodiment is made of ethyl cellulose 1.9 kg.
In this embodiment, the adhesive in the oral film is carbomer.
The drug-loaded substance A is selected from any one or combination of a plurality of antibacterial drugs, glucocorticoids and analgesic drugs, wherein the antibacterial drugs are any one or combination of metronidazole and cephalosporin.
Preferably, the drug-carrying substance a in the oral film of the present embodiment is metronidazole.
In this embodiment, the flavoring agent in the oral film is saccharin sodium.
In this example, the release agent in the oral film is magnesium stearate.
The extending agent in the oral film of the embodiment is a gum base.
The essence in the oral cavity film of the embodiment is cherry flavor essence.
The preparation method of the oral film in the embodiment comprises the following steps:
s1, weighing raw materials according to a ratio;
s2, dissolving 2.1kg of carbomer in 21.2kg of deionized water, sequentially adding 50g of metronidazole, 50g of magnesium stearate, 10g of cherry flavor essence and 10g of saccharin sodium, and uniformly stirring and mixing to obtain a solution A;
s3, adding 1.9kg of ethyl cellulose into 21.3kg of volatile organic solvent, and uniformly stirring and mixing to obtain a solution B;
wherein the volatile organic solvent is ethanol.
S4, melting 1.7kg of gum base to obtain a solution C;
s5, preparing a medicine-carrying adhesive layer 3: pouring the solution A obtained in the step S2 into a storage tank, enabling a crawler belt of the integrated film forming machine to pass through a material liquid surface in the storage tank, controlling the thickness of the film to be 0.1mm through a material scraper, then sending the crawler belt loaded with the material liquid into a tunnel oven, drying for 5min at 60 ℃, drying for 5min at 80 ℃, and then drawing the film to obtain a medicine-carrying adhesive layer 3; wherein the water content of the medicine-carrying adhesive layer 3 obtained in the step S5 is 7-15%;
s6, preparing an extension layer 2 on the drug-loaded adhesive layer 3: scraping the drug-loaded adhesive layer 3 obtained in the step S5 by a scraper, uniformly coating the solution B obtained in the step S3 on the drug-loaded adhesive layer 3 scraped by the scraper, and adjusting the thickness of a film coated on the drug-loaded adhesive layer 3 by the scraper to enable the thickness of the obtained film to be 0.2mm;
and S7, uniformly spraying the solution C obtained in the step S4 on the surface of the extension layer 2 in the film prepared in the step S6 by a spraying method, wherein the spraying temperature is 45-55 ℃, the thickness of the obtained film is 0.3mm by adjusting the spraying feeding rate, finally drying at 50-60 ℃, cutting into small blocks of 1cm multiplied by 2.5cm, sterilizing and packaging to obtain the oral film product.
Test example 1
Oral film adsorption performance test.
The rabbit oral cavity membrane is taken, 9 small blocks are cut, the size of each small block is 3cm multiplied by 3cm, and the small blocks are fixed on a flat plate.
Three pieces of the oral patch prepared in the example were taken, each piece having a size of 1cm × 2.5cm, and was designated as sample 1.
Three commercially available oral films were taken and labeled as sample 2.
Three strips of the lost-hand oral patch were taken and labeled as sample 3.
Three groups of parallel tests are set, namely a first parallel test group, a second parallel test group and a third parallel test group, each group of parallel tests comprises three rabbit oral cavity membranes of 3cm multiplied by 3cm, and a sample 1, a sample 2 and a sample 3 are respectively adhered to the three rabbit oral cavity membranes.
Samples adhered to the oral membrane of rabbits on each plate were slowly flushed with phosphate buffer (pharmacopeia standard) at pH 6.8 and the drop time for sample 1, sample 2 and sample 3 in each set of tests was recorded. The results are shown in Table 1.
Table 1 oral film adsorptive property test results table
As can be seen from the above table, the average shedding time of sample 1 was 74min, the average shedding time of sample 2 was 84s, and the average shedding time of sample 3 was 44min in the three parallel tests. Therefore, the adhesive time of the oral film prepared in example 1 is significantly higher than that of the commercially available oral film and the commercially available oral patch, and the adhesive performance is greatly improved.
Test example 2
Oral film extension performance test.
Three pieces of the oral patch prepared in example 1 were taken and labeled as sample 3;
three commercially available oral films were taken and labeled as sample 4.
Three groups of parallel tests are set, namely a first parallel test group and a second parallel test group, and each group of parallel tests comprises a sample 3 and a sample 4.
Where the initial length of sample 3 was 2.5cm and the initial length of sample 4 was 1.9cm.
Fixing one end of the sample 3, smearing a small amount of water on the surface of the sample 3 to enable the sample to absorb water and swell for 2min, then slowly and forcefully pulling the other end of the sample until the sample 3 is broken, and recording the length of the sample 3 when the sample 3 is broken.
One end of sample 4 was fixed, a small amount of water was applied to the surface of sample 4 to allow it to absorb water and swell for 2min, then the other end of the sample was slowly pulled hard until sample 4 broke, and the length of sample 4 at break was recorded.
The test results are shown in table 2.
Table 2 oral pad pasting extensibility testing result table
As can be seen from table 2, the average length of the sample 3 is 6.5cm, the average length of the sample 4 is 2.5cm, the coefficient of extension of the sample 3 is 6.5/2.5=2.6, and the coefficient of extension of the sample 4 is 2.6/1.9=1.3. Therefore, the ductility of the oral film in example 1 is greatly superior to that of a commercially available oral film, and the oral film can meet the requirements of oral wounds of different sizes.
Test example 3
And testing the drug dissolution effect of the oral film.
Simulating the oral pH environment, and preparing a phosphate buffer solution with the pH of 6.8 as a dissolution medium according to the guiding principle of Chinese pharmacopoeia.
The dissolution conditions were: 1. the dissolution method comprises the following steps: a paddle method and a sedimentation method; 2. rotation speed, 50rpm; 3. volume of dissolution medium: 250mL.
Sampling at 10min, 20min, 30min, 60min, 120min, 240min and 360min respectively, and determining the cumulative dissolution rate of metronidazole.
Each time, 6 samples were taken in parallel.
The sampling method comprises the following steps: and (3) adding 10mL of sample into a polyethersulfone membrane, discarding the first 4mL, taking the subsequent filtrate, diluting, and measuring the metronidazole dissolution rate by using an ultraviolet method.
The results of the metronidazole cumulative dissolution test are shown in table 3.
TABLE 3 cumulative dissolution test results of metronidazole
As can be seen from table 3, the metronidazole in the oral patch in example 1 is slowly dissolved out, and the metronidazole in example 1 has a good slow-release function, so that the drug can be permanently acted on the affected part of the oral ulcer, thereby reducing the administration frequency of the patient and improving the use comfort of the patient.
In conclusion, the oral cavity patch disclosed by the invention can be directly applied to an ulcer affected part, has a drug slow-release effect, can relieve pain, promote wound healing and shorten the course of disease, has no side effect and strong adhesive force, can be firmly and durably applied to the oral cavity ulcer affected part, is not easy to fall off when a patient eats or drinks water, reduces the stimulation to the oral cavity ulcer affected part when the patient eats or drinks water, and improves the use comfort of the patient. The preparation method of the oral film is simple, low in cost and suitable for industrial production.
Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and alterations can be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (4)
1. The utility model provides an oral cavity pad pasting which characterized in that, including the medicine carrying adhesion layer, the layer that extends, the hydrophobic protective layer that laminate in proper order and set up, the medicine carrying adhesion layer extend the layer the weight ratio of hydrophobic protective layer is 50 ~ 60:10 to 40:20 to 50 percent; the total thickness of the oral sticking film is 0.3-0.4 mm;
the drug-loaded adhesive layer is prepared from the following raw materials in parts by weight: 20 to 40 portions of adhesive, 0.5 to 5 portions of drug-loaded substance A, 0.1 to 1 portion of flavoring agent, 0.1 to 1 portion of essence, 0.5 to 3 portions of release agent and 300 to 600 portions of deionized water; the drug-carrying substance A is metronidazole;
the extension layer is prepared from the following raw materials in parts by weight: 10-40 parts of a spreading agent and 0-5 parts of a drug-loaded substance B; the drug-carrying substance B is selected from any one or combination of more of antibacterial drugs, glucocorticoids and analgesic drugs; the extending agent is selected from one or a combination of two of acacia gum and gum base;
the hydrophobic protective layer is made of any one or combination of more of ethyl cellulose, hydroxyethyl methacrylate, methyl methacrylate copolymer and hydroxypropyl methylcellulose acetate succinate.
2. The oral film of claim 1, wherein said adhesive is selected from the group consisting of hypromellose, carbomer, polycarbophil, and chitosan.
3. The oral patch of claim 1, wherein said flavoring agent is saccharin sodium.
4. The oral film of claim 1, wherein said release agent is selected from the group consisting of magnesium stearate, hydrogenated castor oil, and combinations thereof.
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| CN201910887972.XA CN111000830B (en) | 2019-09-19 | 2019-09-19 | Oral film and preparation method thereof |
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| CN201910887972.XA CN111000830B (en) | 2019-09-19 | 2019-09-19 | Oral film and preparation method thereof |
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| CN111000830B true CN111000830B (en) | 2023-01-20 |
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| CN112245411B (en) * | 2020-10-16 | 2023-06-16 | 中山大学附属口腔医院 | Universal oral bandage and preparation method thereof |
| CN113616627A (en) * | 2021-09-23 | 2021-11-09 | 广东医科大学 | Double-layer film agent for treating oral ulcer and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101450053A (en) * | 2007-11-28 | 2009-06-10 | 天津太平洋制药有限公司 | Metronidazole stomatocace double-layer paster and preparation method thereof |
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2019
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101450053A (en) * | 2007-11-28 | 2009-06-10 | 天津太平洋制药有限公司 | Metronidazole stomatocace double-layer paster and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 曾芳磊.构建高载硫高性能锂硫电池正极相关材料的研究.《博士电子期刊》.2019,(第9期),第38页，尤其是第1段. * |
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