CN107137371B - Double-layer adhesive patch for treating dental ulcer - Google Patents
Double-layer adhesive patch for treating dental ulcer Download PDFInfo
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- CN107137371B CN107137371B CN201710499159.6A CN201710499159A CN107137371B CN 107137371 B CN107137371 B CN 107137371B CN 201710499159 A CN201710499159 A CN 201710499159A CN 107137371 B CN107137371 B CN 107137371B
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/18—Iodine; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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Abstract
The invention relates to a sticking type tablet for treating oral ulcer. The adhesive patch comprises an adhesive layer and a protective layer, wherein the adhesive layer is prepared from an iodine inclusion compound, a disintegrating agent, an adhesive and a flow aid; the protective layer is made of a hydrophobic material. The adhesive sheet for treating the dental ulcer is prepared by combining the components according to a certain component proportion, and can fully play the synergistic effect of the components, thereby shortening the treatment period of the dental ulcer, relieving the treatment pain of patients suffering from the dental ulcer and quickly and effectively treating the symptoms of the dental ulcer of the patients.
Description
Technical Field
The invention relates to an iodine-containing adhesive tablet for treating dental ulcer, belongs to the technical field of medicines, and particularly belongs to the technical field of medicinal preparations in medical technology.
Background
Canker sores, commonly known as aphthae, are a common disease of the oral mucosa. Recurrent oral ulcer refers to a kind of ulcer which has a self-healing, arc or oval shape and repeated attacks with unknown reasons. Also known as recurrent aphtha or recurrent aphtha. Clinically, the ulcer can be divided into three types according to the size, depth and number of the ulcer: recurrent light ulceration of the mouth, recurrent aphthous ulceration and recurrent necrotic periglandular inflammation of the mucosa.
Recurrent oral ulceration is one of the most common diseases in oral mucosal diseases. In the life of a human, oral ulcer hardly occurs, and only occasionally occurs, and frequently occurs; about 20% of all people suffer from oral ulcers to varying degrees. Children, young and old people and the elderly can develop diseases, and the diseases are not obviously related to seasons. The oral ulcer can occur at any part of oral mucosa, mucosa is congested, reddened and edematous at the early stage of lesion, red small points with the size of a needle appear, local burning discomfort is caused, and severe spontaneous pain is caused; cold, heat, sour, sweet, and other stimuli all aggravate pain and can cause recurrent attacks. Although the ulcer is an oral disease and can be self-healed, the disease condition is gradually aggravated due to frequent occurrence of the ulcer, and the ulcer brings invariance to the work and life of people.
The etiology of recurrent oral ulceration is complex and remains unclear to date. Modern medicine considers: viral infection, bacterial infection, digestive system diseases and disorders, endocrine changes, neuro-psychiatric factors, genetic factors, immune function changes, and other factors such as deficiency of trace elements such as zinc, iron, folic acid, vitamin B2Vitamin B6Vitamin B12Etc. can cause the onset of oral ulcers.
In the existing external medicines for treating oral ulcer, the traditional Chinese medicines are tin powder, Bingpeng powder, Zhuhuangxiansu powder and other powder which mainly comprise borneol, natural indigo and the like, and the medicines are convenient to use in treating oral ulcer (patent No. CN101524368, a gel Bingpeng powder film agent). However, the powder formulation is inconvenient to use, and the powder formulation is quickly lost along with saliva after being applied to the ulcer part, so that the effective components can not exert the curative effect for a long time, which is an obvious defect. The western medicine products comprise gargle, ointment, pellicle, etc., and the main active ingredients are mainly glucocorticoid mainly comprising dexamethasone and dexamethasone acetate, antibiotic containing metronidazole, vitamin supplement mainly comprising B vitamins supplement, and local anesthetic represented by lidocaine hydrochloride and tetracaine hydrochloride (patent number: CN 104352485A). Among them, Huasu tablets (patent No. CN101411691) have a large market occupation. In addition, the patch (chinese patent CN00132507.3 a dexamethasone acetate patch and its preparation method) also has a large market, and the patch is composed of a drug-containing adhesive layer and a water-impermeable protective layer. Dexamethasone acetate has anti-inflammatory effect, and can promote contraction of ulcer surface and promote ulcer healing.
Although glucocorticoid therapy works well, even when applied topically, patient acceptance is low due to its hormonal class of drugs. Therefore, the hormone products are not used as first-line medicines in clinic. The adult patients have more reports of neuritis, endocrine dyscrasia, thyroid diseases and the like caused by using hormone products, which limits the application of the products to a certain extent. Especially when infants use the hormone product, the hormone product is not generally recommended to infants in consideration of the risk of side effects which are clinically unknown to the infants, so that the oral ulcer treatment product which is clinically used by the infant patients is basically not used, and the embarrassment that the medicine is not available exists in the infant medicine. The invention aims at the requirement that a novel oral paste product which is low in toxicity, safe and widely applicable to people appears in urgent clinical needs.
The active ingredient of the invention is iodine molecule, which belongs to human endogenous ingredients. The medicine has wide applicable population, greatly improves the compliance of the patient in taking medicine, and has far higher medicine taking safety than other products. The product of the invention has convenient use and stable property, can directly halogenate mycoprotein by iodine molecules which are adhered to the surface of ulcer and rapidly released under the action of saliva, and can kill various microorganisms without selectivity.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: provides an oral paste medicinal preparation product which can relieve physiological pain of patients while treating oral ulcer, has no hormone and antibiotic components, and realizes the purposes of safe, efficient and low-toxicity treatment of oral ulcer.
At present, commercially available oral ulcer treatment medicines contain components such as anti-inflammatory analgesic, hormone and antibiotic, and are relatively harmful after long-term application. Antibiotic drugs also cause a series of problems such as drug resistance. The clinical dosage of these drugs is severely limited due to safety problems, and the treatment of canker sores is a frequent process requiring long-term treatment regimens, and these drugs are not suitable. Especially for some sensitive people such as: a pediatric patient. Strict compliance with medical advice is required when in use.
The invention aims to avoid the defects of the medicines and develop a medicine which not only improves the treatment effect of the medicines and improves the use compliance so as to ensure that patients use the medicine more conveniently, but also can be used by various groups and has no medicine resistance and long-term toxicity.
The invention is realized by the following technical scheme.
A double-layer adhesive patch for treating oral ulcer comprises an adhesive layer and a protective layer, wherein the adhesive layer is prepared from main drug iodine inclusion compound, disintegrant, adhesive and lubricant; the protective layer is prepared from a hydrophobic material and lemon yellow pigment.
The double-layer adhesive patch for treating the dental ulcer is prepared by including a main medicine iodine inclusion compound with cydiodine through cyclodextrin, wherein the main medicine iodine inclusion compound is prepared by (1) dissolving 1.2kg of potassium iodide in water, adding 1.8kg of iodine, and carrying out ultrasonic treatment to prepare an iodine solution, (2) dissolving β -cyclodextrin 7.5kg of the iodine solution, carrying out magnetic stirring at a temperature of 65 ℃ and a rotating speed of 300-400 r/min, stirring till the iodine solution is completely dissolved to obtain β -cyclodextrin solution, (3) slowly dripping the iodine solution into β -cyclodextrin solution, continuously stirring for 4 hours at a temperature of about 65 ℃, standing at a room temperature, carrying out suction filtration, carrying out drip washing with water to obtain a coffee solid, drying at a temperature of 60-70 ℃ for 2 hours after suction drying, grinding the coffee solid by using a mortar, and sieving by using a 100-target quasi-nylon sieve to obtain the iodine inclusion compound.
The double-layer adhesive tablet for treating the oral ulcer is characterized in that the disintegrant is dextrin; the adhesive is a mixture of carbomer and hydroxypropyl methyl cellulose; wherein the hydroxypropyl methylcellulose has types of K100M, K10M, and K4M, preferably K100M.
The lubricant is magnesium stearate; the hydrophobic material is polyvinyl alcohol.
In the double-layer adhesive patch for treating the dental ulcer, 10 ten thousand tablets are taken as a batch, and the adhesive layer contains 20-50 g (about 3.8-9.5 g of iodine) of main medicine iodine inclusion; contains 3000-6000 g of dextrin; 40-50 g of hydroxypropyl methyl cellulose; contains 1000-3000 g carbomer. 30-100 g of magnesium stearate; the protective layer contains 100-200 g of polyvinyl alcohol; 1-2 g of lemon yellow pigment; the solvent is distilled water, the using amount is about 4000-5000 ml, and the hydrophobic material accounts for 3% -4% of the dry weight of the protective layer.
The double-layer adhesive patch for treating the dental ulcer is prepared from the following components in parts by weight:
the preparation process comprises the following steps:
(1) weighing iodine inclusion compound, dextrin and hydroxypropyl methyl cellulose according to the prescription amount, and sieving the mixture by a 80-mesh standard sieve for later use;
(2) uniformly mixing the iodine inclusion compound and dextrin to obtain mixed powder 1;
(3) adding 2000ml of distilled water into the mixed powder 1 to prepare a soft material, granulating by using a 18-mesh standard sieve, and completely drying wet granules at 60 ℃ to obtain an intermediate 1;
(4) granulating the intermediate 1 by using a 24-mesh nylon sieve, adding carbomer and magnesium stearate according to the prescription amount, and uniformly mixing to obtain mixed powder 2;
(5) tabletting the mixed powder 2 of the medicine-containing layer by using a 5mm round shallow concave punch to obtain a double-layer adhesive sheet layer;
(6) taking polyvinyl alcohol with the amount of the prescription, adding distilled water, stirring for 2 hours at the temperature of 75-85 ℃, adding lemon yellow pigment with the amount of the prescription after the polyvinyl alcohol is completely dissolved, and removing bubbles by ultrasonic waves to obtain a uniform protective layer;
(7) and (5) spraying the protective layer on the surface of the adhesive sheet layer obtained in the step (5) to obtain the double-layer adhesive sheet for treating the dental ulcer.
The double-layer adhesive tablet for treating the oral ulcer is a novel medicament for treating the oral ulcer, which is formed by iodine inclusion compound, dextrin, magnesium stearate, hydroxypropyl methyl cellulose, carbomer, polyvinyl alcohol and lemon yellow pigment. In the treatment process, the double-layer adhesive patch for treating the dental ulcer takes 4 days as a treatment course, compared with the use limit of the current marketed product, namely huasu patch, the dosage of the huasu patch per day is not more than 5, and the product can be administered for multiple times a day.
The specific dosage level of the double stick for treating oral ulcers according to the present invention for a particular patient will depend on a variety of factors including the weight, sex, age, general health, diet, time of administration and severity of oral ulcers of the patient receiving the treatment.
Experiments prove that compared with the common iodine inclusion compound tablet, the double-layer adhesive tablet for treating the dental ulcer provided by the invention has the advantage that the pain of the ulcer surface of a patient is greatly reduced. The patient does not influence the eating during the administration, and the time for treating the oral ulcer of the double-layer adhesive patch of the invention is reduced by 3 days compared with the traditional average treatment healing time, thereby producing satisfactory treatment effect.
The double-layer adhesive patch for treating the oral ulcer can be produced according to the conventional preparation process. Research shows that the healing time is about 5 to 6 days, which is equivalent to the self-healing time when a single oral ulcer treatment medicament, such as borneol, yin-nourishing and tissue regeneration-promoting powder, watermelon frost, compound sarcandra glabra and the like, is used. When the double-layer adhesive patch for treating the dental ulcer is used for treating the dental ulcer, the pain is obviously relieved, the healing period is obviously shortened, and the convenience of medication is obviously improved. The double-layer adhesive patch for treating dental ulcer, which is prepared from specific raw and auxiliary materials and a specific proportion, is used for 2-3 days, and the ulcer is basically cured. During medication, the adhesive patch is adhered to the mucosa of the oral ulcer through the adhesive effect of an adhesive mixture consisting of carbomer and hydroxypropyl methylcellulose in a specific ratio, and the main drug iodine is slowly released in the oral environment. The effective components directly reach the affected part, and the double-layer tablet is adhered in the oral cavity under the protection of hydrophobic material polyvinyl alcohol to slowly erode, so that the medicinal components can be kept to lose powder for a long time. Therefore, the double-layer adhesive patch for treating the dental ulcer can exert long-acting treatment efficacy.
The double-layer adhesive patch for treating the dental ulcer is characterized in that:
① the buccal patch is designed to release the medicine effectively on the surface of oral ulcer, thereby improving the utilization rate of the medicine, and allowing the medicine to exert great curative effect even in small dose, compared with common iodine-containing medicine such as cydiodine buccal tablet (specification 1.5 mg/tablet), the iodine-containing inclusion compound is only 0.5 mg/tablet, which is reduced by nearly 70%, and can be administered for multiple times in the day, with good safety, and is especially suitable for children and other special groups.
② the double-layer tablet is convenient to use, and the physiological functions of patients such as drinking water and eating during treatment are not affected.
③ the main medicine of the medicine is an iodine inclusion compound, the active ingredient is human endogenous substance-iodine, the toxic and side effect is small, compared with other medicines with larger side effect such as dexamethasone acetate adhesive plaster, the product has high safety factor, wide applicable population and good patient experience, and is an ideal medicine for treating oral local ulcer.
Detailed Description
The present invention is further illustrated by the following detailed description, but is not to be construed as being limited thereto.
Example 1
Prescription (10 ten thousand tablets):
the preparation process comprises the following steps:
weighing 50g of iodine inclusion compound, weighing 5000g of dextrin and 40g of hydroxypropyl methyl cellulose, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; then 2000g of carbomer is added, a 100-mesh sieve is used for mixing with magnesium stearate with the total particle weight of 50g, and the mixture is used as powder containing a medicine layer; tabletting by using a 5mm round shallow concave punch; the weight of the tablet is about 0.071g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-mouth bottle, adding 5000ml of distilled water, stirring for 2h at 75-85 ℃, adding 1g of lemon yellow pigment after PVA is completely dissolved, removing bubbles by ultrasound to obtain uniform yellow liquid, and spraying the uniform yellow liquid on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 2
Prescription (10 ten thousand tablets):
the preparation process comprises the following steps:
weighing 50g of iodine inclusion compound, weighing 5000g of dextrin and 50g of hydroxypropyl methyl cellulose, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; then 2000g of carbomer is added, a 100-mesh sieve is used for mixing with magnesium stearate with the total particle weight of 50g, and the mixture is used as powder containing a medicine layer; tabletting by using a 5mm round shallow concave punch; the weight of the tablet is about 0.071g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-mouth bottle, adding 4000ml of distilled water, stirring for 2h at 75-85 ℃, adding 1g of lemon yellow pigment after PVA is completely dissolved, removing bubbles by ultrasonic waves to obtain uniform yellow liquid, and spraying the uniform yellow liquid on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 3
Prescription (10 ten thousand tablets):
the process comprises the following steps:
taking 50g of iodine inclusion compound, weighing 6000g of dextrin and 40g of hydroxypropyl methyl cellulose, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 6min, and grading with 24 mesh nylon sieve; then 2000g of carbomer is added, a 100-mesh sieve is used for mixing magnesium stearate with the total particle weight of 60g, and the magnesium stearate is used as powder containing a medicine layer; tabletting by using a 5mm round shallow concave punch. The weight of the patch is about 0.070g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2 hours at the temperature of 75-85 ℃; after PVA is completely dissolved, 2g of lemon yellow pigment is added, bubbles are removed by ultrasonic waves, and uniform yellow liquid is obtained; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 4
Prescription (10 ten thousand tablets):
the preparation process comprises the following steps:
mixing 50g of iodine inclusion compound, 5000g of dextrin and 40g of hydroxypropyl methyl cellulose in a V-shaped mixer for 15min, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; then 1600g carob bean gum is added, a 100-mesh sieve is mixed with magnesium stearate with the total particle weight of 40g, and the magnesium stearate is used as powder of a medicine-containing layer; tabletting by using a 5mm round shallow concave punch. The weight of the patch is about 0.070g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2.5 hours at the temperature of 75-85 ℃; after PVA is completely dissolved, 2g of lemon yellow pigment is added, bubbles are removed by ultrasonic waves, and uniform yellow liquid is obtained; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet
Example 5
Prescription: (10) ten thousand tablets
The process comprises the following steps:
taking 30g of iodine inclusion compound, weighing 4500g of dextrin, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; adding 1500g carob bean gum, sieving with 100 mesh sieve, mixing with magnesium stearate 40g of total granule weight to obtain powder containing medicinal layer; tabletting by using a 5mm round shallow concave punch, wherein the weight of the tablet is about 0.070g, and obtaining an adhesive layer; adding 200g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2 hours at the temperature of 75-85 ℃ until PVA is completely dissolved; then adding 1g of lemon yellow pigment, and removing bubbles by ultrasonic waves to obtain uniform yellow liquid; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 6
Prescription: (10 ten thousand tablets)
The process comprises the following steps:
weighing 20g of iodine inclusion compound, weighing 4800g of dextrin and 40g of hydroxypropyl methyl cellulose, mixing by a V-shaped mixer for 15min, adding 20000ml of distilled water to moisten powder, preparing a soft material, granulating by a 18-mesh nylon sieve, drying by a fluidized bed at 110 ℃ for 7min, finishing granules by a 24-mesh nylon sieve, adding 2000g of carob bean gum, mixing 25g of sodium dodecyl sulfate by a 100-mesh sieve to obtain medicine-containing layer powder, tabletting by using a 5mm round shallow concave punch, and obtaining about 0.071g of tablet weight to obtain a sticking layer; adding 5000ml of 95% ethanol into 300g of polyvinyl alcohol, and then adding 1g of lemon yellow pigment to obtain uniform yellow liquid; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 7
Prescription: (10 ten thousand tablets)
The process comprises the following steps:
weighing 4800g of dextrin from 45g of iodine inclusion compound, mixing with a V-shaped mixer for 15min, adding 2000ml of distilled water to wet the powder, and making into soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 6min, and grading with 24 mesh nylon sieve; then 2800g carob bean gum is added, a 100-mesh sieve is mixed with magnesium stearate with the total weight of 30g granules to be used as powder of a medicine-containing layer; tabletting by using a 5mm round shallow concave punch; the weight of the tablet is about 0.071g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2 hours at the temperature of 75-85 ℃; after PVA is completely dissolved, 1g of lemon yellow pigment is added, bubbles are removed by ultrasonic waves, and uniform yellow liquid is obtained; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 8
Prescription (10 ten thousand tablets)
The process comprises the following steps:
taking 10 g of iodine inclusion compound, weighing 4000 g of starch, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; adding 1500g carob bean gum, sieving with 100 mesh sieve, mixing with 30g magnesium stearate as medicinal layer powder; tabletting by using a 5mm round shallow concave punch; the weight of the tablet is about 0.060g, so as to obtain a sticking layer; adding 300g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2 hours at the temperature of 75-85 ℃; after PVA is completely dissolved, 1g of lemon yellow pigment is added; removing bubbles by ultrasonic waves to obtain uniform yellow liquid; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 9
Prescription (10 ten thousand tablets):
the preparation process comprises the following steps:
weighing 50g of iodine inclusion compound, weighing 5000g of dextrin, mixing for 15min by a V-shaped mixer, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, fluidized bed drying at 110 deg.C for 7min, and grading with 24 mesh nylon sieve; then 2000g of carbomer is added, a 100-mesh sieve is used for mixing with magnesium stearate with the total particle weight of 50g, and the mixture is used as powder containing a medicine layer; tabletting by using a 5mm round shallow concave punch; the weight of the tablet is about 0.071g, and a sticking layer is obtained; adding 300g of polyvinyl alcohol into a three-necked bottle, adding 5000ml of distilled water, and stirring for 2 hours at the temperature of 75-85 ℃; after PVA is completely dissolved, 1g of lemon yellow pigment is added, bubbles are removed by ultrasonic waves, and uniform yellow liquid is obtained; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
Example 10
Prescription (10 ten thousand tablets):
the preparation process comprises the following steps:
weighing 50g of iodine inclusion compound, weighing 5000g of dextrin and 20g of hydroxypropyl methyl cellulose, mixing in a V-shaped mixer for 15min, adding 2000ml of distilled water to wet the powder, and preparing a soft material; granulating with 18 mesh nylon sieve, drying at 65 deg.C for 40min, and grading with 24 mesh nylon sieve; then adding 800g of Arabic gum, and mixing with 100-mesh sieve to obtain magnesium stearate with the weight of 50g of total granules as powder containing a medicine layer; tabletting by using a 5mm round shallow concave punch. The weight of the tablet is about 0.065g, and a sticking layer is obtained; taking 300g of acrylic resin, adding 5000ml of 95% ethanol, and then adding 1g of lemon yellow pigment to obtain uniform yellow liquid; spraying the mixture on the surface of the adhesive layer to obtain the double-layer adhesive sheet.
The best auxiliary materials and the dosage thereof are determined by measuring the adhesive force, the expansion rate, the friability and the like of each embodiment of the invention and the cydiodine buccal tablets, and the best prescription and process are obtained by comparison. The experimental methods and results are as follows.
1. Adhesion determination
The external adhesion force of the oral adhesive sheet is measured based on the force balance principle, and the peeling force is directly used as the adhesion force. Selecting processed egg shell with proper size, moistening the inner membrane surface of the egg shell with fresh artificial saliva, adhering the medicine-carrying part of the iodine inclusion oral cavity sticking sheet with the moistened inner membrane of the egg shell, pressing with fingers for 30s, suspending the weight bag with water injection port at the lower part of the iodine inclusion oral cavity sticking sheet, removing external force, and slowly adding water into the weight bag. When the adhesive sheet falls off from the eggshell membrane, the total weight W (g) of the weight bag is weighed, and the release area S (mm) can be obtained according to the diameter of the adhesive sheet-2) The adhesion force is expressed as F ═ W/s.
2. Friability measurement
Taking 20 adhesive sheets without protective layer as test pieces, removing powder on the surface of the adhesive sheets with a blower, precisely weighing with an electronic balance, placing the treated test pieces in a cylinder, and rotating 100 times. The test article was taken out and the powder was removed with a blower. And (4) precisely weighing, wherein the weight loss is not more than 1%, and broken, cracked and cracked pieces cannot be detected, otherwise, the weighing is not qualified. The experiment is generally carried out once, if the weight loss amount exceeds 1 percent, the repeated inspection can be carried out for 2 times, the average weight loss amount of 3 times does not exceed 1 percent, and broken pieces with fracture, cracking and breakage can not be detected. The results of the examples are as follows:
compared with the single iodine inclusion compound tablet, the self-made tablet is superior to the self-made iodine inclusion compound tablet in friability.
3. In vitro Release assay
Referring to pharmacopeia and literature, an intelligent drug dissolution instrument is adopted, and the measurement is carried out by using a modified slurry method test device, namely, a round flat plate is arranged at the bottom of a dissolution cup, a glass rod is used for dipping a small amount of dissolution medium to wet one surface of an adhesive sheet protective layer and then adhere the adhesive sheet protective layer to the flat plate, and the results of each embodiment of the drug release surface (the dissolution medium is newly prepared artificial saliva) are as follows:
4. contrast of patient's therapeutic effect (3 days of medication)
Test protocol: 260 patients with moderate and severe oral ulcer are recruited respectively, the patients with moderate oral ulcer are randomly divided into 13 groups, and the patients with severe oral ulcer are randomly divided into 13 groups. Cydiodine buccal tablet 1 tablet once and 3 times a day, compound sarcandra glabra buccal tablet 1 tablet once (large tablet) once, once every 2 hours and 6 times a day, watermelon frost buccal tablet 2 tablets once and 5 times a day, and the double-layer adhesive tablet for treating dental ulcer prepared in examples 1 to 10 is used 3 tablets daily. The above test was carried out for a total of 4 days. Finally, the curative effect can be judged through diagnosis and the self-experience of the patient. The results are as follows:
treatment of patients with moderate oral ulcer
Treatment of patients with severe oral ulcer
From the experimental results, the double-layered adhesive patch for treating oral ulcer according to embodiments 1 to 10 of the present invention has good therapeutic effect with a small dosage. The double-layer adhesive patch for treating the dental ulcer is calculated according to three tablets per day, and the daily dosage of iodine is 0.076-0.095 mg/3, namely 0.228-0.285 mg. While the daily dosage of cydiodine buccal tablet iodine is 1.5mg x 3, namely 4.5 mg. Therefore, the double-layer adhesive patch for treating the dental ulcer has a remarkable technical effect by selecting and proportioning the specific raw materials and auxiliary materials.
The above-described embodiments are intended to illustrate the technical idea and advantages of the invention, and the invention may also be subject to other variants, as known to the skilled person, which serve merely as illustrations of the scope of protection of the invention described above, and to the skilled person in the art who is within the scope of protection of the invention defined by the present invention there are many conventional variants and other embodiments, which are all within the scope of protection of the invention covered by the present invention.
Claims (3)
1. The double-layer adhesive patch for treating the dental ulcer is characterized in that every 10 ten thousand patches of the adhesive patch are prepared from the following components:
type of auxiliary Material and amount of auxiliary Material
Adhesive layer iodine inclusion 50 g-equivalent to iodine 9.5g
Dextrin 5000g
Magnesium stearate 50g
Carbomer 2000g
Hydroxypropyl methylcellulose K100M 40 g;
protective layer polyvinyl alcohol 300g
Lemon yellow pigment 1g
5000mL of distilled water;
the iodine inclusion compound is prepared by including cydiodine with cyclodextrin, and the preparation method comprises the following steps of (1) dissolving 1.2kg of potassium iodide in water, adding 1.8kg of iodine, and carrying out ultrasonic treatment to prepare an iodine solution, (2) stirring β -cyclodextrin 7.5kg of potassium iodide with magnetic stirring at a rotating speed of 300-400 r/min at 65 ℃ until the potassium iodide is completely dissolved to obtain a β -cyclodextrin solution, (3) slowly dripping the iodine solution into β -cyclodextrin solution, continuously stirring for 4 hours at 65 ℃, standing at room temperature, carrying out suction filtration, rinsing with water to obtain a coffee solid, drying at 60-70 ℃ for 2 hours after suction drying, grinding the coffee solid with a mortar, and sieving with a 100-target standard nylon sieve to obtain the iodine inclusion compound.
2. The double-layer adhesive patch for treating the dental ulcer is characterized in that every 10 ten thousand patches of the adhesive patch are prepared from the following components:
type of auxiliary Material and amount of auxiliary Material
Adhesive layer iodine inclusion 50 g-equivalent to iodine 9.5g
Dextrin 5000g
Magnesium stearate 50g
Carbomer 2000g
Hydroxypropyl methylcellulose K100M 50 g;
protective layer polyvinyl alcohol 300g
Lemon yellow pigment 1g
4000mL of distilled water;
the iodine inclusion compound is prepared by including cydiodine with cyclodextrin, and the preparation method comprises the following steps of (1) dissolving 1.2kg of potassium iodide in water, adding 1.8kg of iodine, and carrying out ultrasonic treatment to prepare an iodine solution, (2) stirring β -cyclodextrin 7.5kg of potassium iodide with magnetic stirring at a rotating speed of 300-400 r/min at 65 ℃ until the potassium iodide is completely dissolved to obtain a β -cyclodextrin solution, (3) slowly dripping the iodine solution into β -cyclodextrin solution, continuously stirring for 4 hours at 65 ℃, standing at room temperature, carrying out suction filtration, rinsing with water to obtain a coffee solid, drying at 60-70 ℃ for 2 hours after suction drying, grinding the coffee solid with a mortar, and sieving with a 100-target standard nylon sieve to obtain the iodine inclusion compound.
3. The method for preparing the double-layered adhesive patch for treating oral ulcer according to claim 1 or 2, comprising the steps of:
(1) weighing iodine inclusion compound, dextrin and hydroxypropyl methylcellulose K100M according to the prescription amount, and sieving with a 80-mesh standard sieve for later use;
(2) uniformly mixing the iodine inclusion compound and dextrin to obtain mixed powder 1;
(3) adding 2000ml of distilled water into the mixed powder 1 to prepare a soft material, granulating by using a 18-mesh standard sieve, and completely drying wet granules at 60 ℃ to obtain an intermediate 1;
(4) granulating the intermediate 1 by using a 24-mesh nylon sieve, adding carbomer and magnesium stearate according to the prescription amount, and uniformly mixing to obtain mixed powder 2;
(5) tabletting the mixed powder 2 of the medicine-containing layer by using a 5mm round shallow concave punch to obtain an adhesive layer;
(6) taking a prescription amount of polyvinyl alcohol, adding distilled water, stirring for 2 hours at 75-85 ℃, adding the prescription amount of lemon yellow pigment after completely dissolving, and ultrasonically removing bubbles to obtain a uniform protective layer;
(7) and (5) spraying the protective layer on the surface of the adhesive layer obtained in the step (5) to obtain the double-layer adhesive patch for treating the dental ulcer.
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| CN107582536B (en) * | 2017-09-11 | 2020-05-08 | 石家庄学院 | Bismuth potassium citrate oral cavity adhesive tablet and preparation method thereof |
| CN112007006B (en) * | 2020-08-07 | 2022-12-30 | 山东省药学科学院 | A pharmaceutical composition for treating oral ulcer, and its preparation method |
| 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 |
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| CN1634316A (en) * | 2004-10-26 | 2005-07-06 | 郑州三创释药技术有限公司 | Stomatocace paster and preparation method thereof |
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| CN1028485C (en) * | 1990-08-16 | 1995-05-24 | 中国人民解放军军事医学科学院毒物药物研究所 | Compound xidi iodine sucked tablet and its making method |
| JP2004346130A (en) * | 2003-05-20 | 2004-12-09 | Nippo Kagaku Kk | Water absorptive resin composition and sanitary material |
| CN1283259C (en) * | 2003-06-20 | 2006-11-08 | 石药集团中奇制药技术（石家庄）有限公司 | Iodine microsphere clathrate compound and its preparation method and uses |
| CN1318088C (en) * | 2005-05-25 | 2007-05-30 | 深圳市海王英特龙生物技术股份有限公司 | Oral cavity plastering sheet of interferon and its preparation method |
| 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 |
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