CN101690720A - Carteolol orally disintegrating tablets and preparation method thereof - Google Patents
Carteolol orally disintegrating tablets and preparation method thereof Download PDFInfo
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- CN101690720A CN101690720A CN200910191131A CN200910191131A CN101690720A CN 101690720 A CN101690720 A CN 101690720A CN 200910191131 A CN200910191131 A CN 200910191131A CN 200910191131 A CN200910191131 A CN 200910191131A CN 101690720 A CN101690720 A CN 101690720A
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Abstract
The invention discloses carteolol orally disintegrating tablets and a preparation method thereof. The orally disintegrating tablets comprise the following compositions in percentage by mass: 0.1 to 10 percent of carteolol, 50 to 90 percent of filler, 5 to 40 percent of disintegrating agent, 0.1 to 5 percent of lubricant and 0.1 to 5 percent of flavoring agent. The orally disintegrating tablets can be quickly disintegrated in oral cavity, has quick absorption, quick response, small first-pass effect of the liver, high biological utilization rate and small irritation on gastrointestinal tract, is convenient for taking, has excellent taste and is particularly suitable for old people, children and patients with swallow difficulty or drinking inconvenience. The orally disintegrating tablets are prepared by adopting a wet granulation and tableting method or a direct powder tableting method, have simple manufacture process, low cost, easily controlled quality, stable preparation, safety and efficiency, are applicable to large-scale industrial production and have wide market prospect.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly a kind of Carteolol orally disintegrating tablets also relates to the preparation method of this oral cavity disintegration tablet.
Background technology
Tablet is a kind of traditional pharmaceutical dosage form, because of its have steady quality, dosage accurately, take with advantage such as easy to carry, that mechanization degree is high, production cost is low and become one of at present the most frequently used pharmaceutical dosage form, but simultaneously, disintegrate is slow, bioavailability is lower, part patient swallows than problems such as difficulties because of it exists, and is subjected to restriction to a certain degree on using.For this reason, the oral administration solid quick releasing formulation becomes one of focus of new drug development in recent years, and oral cavity disintegration tablet, dispersible tablet and Sublingual tablet etc. continue to bring out.Oral cavity disintegration tablet is a kind of water disintegrate or dissolved tablet fast of not needing in the oral cavity, have fast, rapid-action, the advantages such as liver first-pass effect is little, bioavailability is high, GI irritation is little, taking convenience of absorption, be particularly suitable for the patient of old man, child, dysphagia or drinking-water inconvenience.
Carteolol hydrochloride (Carteolol Hydrochloride, structural formula is as follows) have only eye drop to go on the market at present at home, be used for the treatment of glaucoma, but it is as a kind of B-adrenergic receptor blocker with intrinsic sympathomimetic acitivity and membrane stabilizing action, listings such as existing tablet, granule and capsule abroad, be used for the treatment of diseases such as hypertension, heart neurosis, arrhythmia, angina pectoris and children's's tetralogy of Fallot, have good efficacy.But the research of the relevant Carteolol orally disintegrating tablets of Shang Weijian report up to now.
Carteolol hydrochloride
Summary of the invention
In view of this, one of purpose of the present invention is to provide a kind of Carteolol orally disintegrating tablets, and two of purpose is to provide the preparation method of described Carteolol orally disintegrating tablets.
For achieving the above object, the present invention adopts following technical scheme:
1, Carteolol orally disintegrating tablets comprises following component by mass percentage: carteolol hydrochloride 0.1%～10%, filler 50%～90%, disintegrating agent 5%～40%, lubricant 0.1%～5% and correctives 0.1%～5%.
Further, described oral cavity disintegration tablet comprises following component by mass percentage: carteolol hydrochloride 0.1%～5%, filler 67%～89%, disintegrating agent 10%～25%, lubricant 0.1%～1% and correctives 0.4%～2.5%;
Further, described filler is one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; Described disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant, and described gas-producing disintegrant is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate; Described lubricant is one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel; Described correctives is one or more in saccharin sodium, aspartame, steviosin and the Mentholum;
Further, described filler is one or more in lactose, mannitol and the microcrystalline Cellulose; Described disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant, and described gas-producing disintegrant is made up of tartaric acid and sodium bicarbonate or citric acid and sodium bicarbonate; Described lubricant is a magnesium stearate; Described correctives is saccharin sodium and Mentholum or aspartame and Mentholum.
2, the preparation method of described Carteolol orally disintegrating tablets is to adopt wet granule compression tablet method or direct powder compression to make oral cavity disintegration tablet the carteolol hydrochloride of recipe quantity and filler, disintegrating agent, lubricant and correctives.
Further, described wet granule compression tablet method may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 100 orders;
B, granulation: the carteolol hydrochloride after step a pulverized, filler, in disintegrating agent and correctives mixing, add binding agent again and make soft material, 20～40 mesh sieves are granulated, 45 ℃～55 ℃ dryings, dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent and lubricant mixing, tabletting promptly gets Carteolol orally disintegrating tablets;
Further, the binding agent among the described step b is that mass fraction is 1%～10% 30 POVIDONE K 30 BP/USP 30 solution;
Further, described step b be after step a is pulverized carteolol hydrochloride, filler, in disintegrating agent and correctives mixing, add mass fraction again and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate;
Further, described direct powder compression may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 80 orders;
B, tabletting: with all components mix homogeneously after the step a pulverizing, tabletting promptly gets Carteolol orally disintegrating tablets.
Beneficial effect of the present invention is: Carteolol orally disintegrating tablets of the present invention needn't be used water delivery service, saliva can make its disintegrate or dissolving rapidly in the oral cavity, taking convenience, the patient who is suitable for old man, child, dysphagia or drinking-water inconvenience, and cool taste, sweetness, exquisiteness, the patient is easy to accept, and drug compliance is good; Medicine after the disintegrate enters the gastrointestinal tract with gulping down the drink action except that major part, there is considerable part directly to absorb through the oral cavity, rapid-action, liver first-pass effect is little, the bioavailability height, be applicable to the acute attack of hypertension, angina pectoris, children's's tetralogy of Fallot etc., can reduce danger, for medical personnel's rescue is raced against time; Entering the gastrointestinal medicine is homodisperse fine particle, is large tracts of land and distributes in gastrointestinal tract, and absorption point increases, thereby has reduced medicine to the gastrointestinal local excitation; The present invention adopts wet granule compression tablet method or direct powder compression to prepare Carteolol orally disintegrating tablets, and production technology is simple, and is with low cost, easy to control the quality, and preparation stabilization, safety, effective are fit to large-scale industrialization production, and market prospect is wide.
The present invention is " Chongqing City's veterinary drug Engineering Technical Research Centre " research project.
The specific embodiment
In order to make the purpose, technical solutions and advantages of the present invention clearer, will be described in detail the preferred embodiments of the present invention below.
Carteolol orally disintegrating tablets of the present invention comprises following component by mass percentage:
Carteolol hydrochloride: preferred 0.1%～10%, more preferably 0.1%～5%;
Filler: preferred 50%～90%, more preferably 67%～89%;
Disintegrating agent: preferred 5%～40%, more preferably 10%～25%;
Lubricant: preferred 0.1%～5%, more preferably 0.1%～1%;
Correctives: preferred 0.1%～5%, more preferably 0.4%～2.5%.
In described filler preferred starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose one or more, more preferably one or more in lactose, mannitol and the microcrystalline Cellulose.Lactose is soluble in water, stable in properties, and no hygroscopicity, the tablet of making is bright and clean attractive in appearance, and it is fast to discharge medicine, and available starches-dextrin-Icing Sugar (mass ratio is 7: 1: 1) substitutes.Mannitol is soluble in water, stable in properties, no hygroscopicity, made tablet surface smooth and beautiful appearance, the good no grittiness of distinguishing the flavor of, sugariness is equivalent to 70% of sucrose approximately, heat absorption during because of dissolving, so dissolve in the oral cavity refrigerant sense is arranged, but flowability is poor slightly, can with flowability preferably lactose be used.Microcrystalline Cellulose is water insoluble, have good flowability and compressibility, except that lubricating and disintegration as also having concurrently the filler, when uniting as disintegrating agent with in swelling behavior strong low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium and the polyvinylpolypyrrolidone one or more, can improve the porosity of tablet, strengthen capillarity, make tablet disintegrate fast in low amounts of water.
In the preferred low-substituted hydroxypropyl cellulose of described disintegrating agent, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant one or more.Low-substituted hydroxypropyl cellulose has bigger specific surface area and porosity, strong absorptive and swellability are arranged, in addition, between its mao dryness accumulated in the stomach and intestine structure and medicated powder and other granule bigger tessellation is arranged, tablet adhesion strength and hardness are increased, can produce bonding and disintegrate dual function.Crosslinked carboxymethyl fecula sodium, cross-linking sodium carboxymethyl cellulose and polyvinylpolypyrrolidone have very high capillary activity and hydratability, can rapidly water be absorbed in the tablet, when internal pressure is the intensity that swelling power surpasses tablet, disintegrate promptly takes place in tablet, is efficient tablet disintegrant.Gas-producing disintegrant is made up of organic acid and weak base, and carbon dioxide makes the quick disintegrate of tablet thereby soda acid is met water reaction generation.In the present invention, described gas-producing disintegrant preferably is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate, more preferably is made up of tartaric acid and sodium bicarbonate or citric acid and sodium bicarbonate.
In the preferred magnesium stearate of described lubricant, Pulvis Talci and the micropowder silica gel one or more, more preferably magnesium stearate.
Because oral cavity disintegration tablet is disintegrate or dissolving in the oral cavity, so when the preparation oral cavity disintegration tablet, should be specifically noted that sensory issues.Added correctives in oral cavity disintegration tablet of the present invention, described correctives comprises sweeting agent and aromatic, one or more in the preferred saccharin sodium of sweeting agent, aspartame and the steviosin, more preferably saccharin sodium or aspartame; The preferred Mentholum of aromatic.
Carteolol orally disintegrating tablets of the present invention can adopt the preparation of wet granule compression tablet method, also can adopt the direct powder compression preparation.
Described wet granule compression tablet method may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 100 orders;
B, granulation: the carteolol hydrochloride after step a pulverized, filler, in disintegrating agent and correctives mixing, add binding agent again and make soft material, 20～40 mesh sieves are granulated, 45 ℃～55 ℃ dryings, dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent and lubricant mixing, tabletting promptly gets Carteolol orally disintegrating tablets.
When wet granule compression tablet, (1) binding agent preferred mass mark is 1%～10% 30 POVIDONE K 30 BP/USP 30 solution, and more preferably mass fraction is 4% 30 POVIDONE K 30 BP/USP 30 solution; (2) the adding method of disintegrating agent has three kinds: addition 1.: granulate behind disintegrating agent and other composition mix homogeneously, thereby make disintegrating agent be present in granule interior, though disintegrate is slower, once just beading of disintegrate, help stripping; 2. outer addition: disintegrating agent is added in the dried granule behind the granulate, thereby makes disintegrating agent be present in outside the granule and between each granule, after moisture content penetrated, disintegrate was rapid, but because of there not being disintegrating agent in the granule, easy disintegrating beading not, and stripping is poor slightly; 3. inside and outside addition: disintegrating agent is divided into two parts, and a by interior addition adding, another part adds by outer addition.Discover by single factor experiment,, more help the quick disintegrate of oral cavity disintegration tablet when disintegrating agent adds fashionablely by inside and outside addition; (3) the adding method of gas-producing disintegrant is: will the wherein a kind of of bronsted lowry acids and bases bronsted lowry with other composition mix homogeneously after granulate, another kind is added in the dried granule behind the granulate, avoids that soda acid reacts when wet granulation.
Described direct powder compression may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 80 orders;
B, tabletting: with all components mix homogeneously after the step a pulverizing, tabletting promptly gets Carteolol orally disintegrating tablets.
According to the Carteolol orally disintegrating tablets of method for preparing, disintegrate and by 30 mesh sieves fully in 40 seconds in 37 ± 1 ℃ of water, and hardness meets the requirement of oral cavity disintegration tablet between 25～50 newton.
Embodiment 1
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, lactose 45g, microcrystalline Cellulose 21.5g, low-substituted hydroxypropyl cellulose 3.5g, citric acid 3g, saccharin sodium 0.02g and Mentholum 0.5g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 21.5g, low-substituted hydroxypropyl cellulose 3.5g, sodium bicarbonate 1g and magnesium stearate 0.5g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 26 seconds in 37 ± 1 ℃ of water; Hardness is 28～37 Ns and pauses; Taste and sweet mouthfeel, refrigerant, fine and smooth, no grittiness.
Embodiment 2
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, mannitol 15g, lactose 15g, microcrystalline Cellulose 22.5g, low-substituted hydroxypropyl cellulose 5g, tartaric acid 9g, saccharin sodium 0.02g and Mentholum 2.5g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 22.5g, low-substituted hydroxypropyl cellulose 5g, sodium bicarbonate 3g and magnesium stearate 0.5g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 32 seconds in 37 ± 1 ℃ of water; Hardness is 28～45 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 3
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, mannitol 57g, lactose 16g, microcrystalline Cellulose 5.5g, low-substituted hydroxypropyl cellulose 1g, citric acid 7g, saccharin sodium 0.02g and Mentholum 2.5g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 5.5g, low-substituted hydroxypropyl cellulose 1g, sodium bicarbonate 4g and magnesium stearate 0.6g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 34 seconds in 37 ± 1 ℃ of water; Hardness is 35～43 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 4
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, mannitol 19g, lactose 15g, microcrystalline Cellulose 21.5g, cross-linking sodium carboxymethyl cellulose 4g, crosslinked carboxymethyl fecula sodium 3.5g, polyvinylpolypyrrolidone 3.5g, saccharin sodium 0.02g and Mentholum 0.48g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 21.5g, cross-linking sodium carboxymethyl cellulose 4g, crosslinked carboxymethyl fecula sodium 3.5g, polyvinylpolypyrrolidone 3.5g and magnesium stearate 0.5g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 30 seconds in 37 ± 1 ℃ of water; Hardness is 27～42 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 5
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, mannitol 45g, lactose 15g, microcrystalline Cellulose 7.5g, cross-linking sodium carboxymethyl cellulose 3.5g, crosslinked carboxymethyl fecula sodium 4g, polyvinylpolypyrrolidone 4g, saccharin sodium 0.02g and Mentholum 1.48g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 7.5g, cross-linking sodium carboxymethyl cellulose 3.5g, crosslinked carboxymethyl fecula sodium 4g, polyvinylpolypyrrolidone 4g and magnesium stearate 0.5g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 32 seconds in 37 ± 1 ℃ of water; Hardness is 37～47 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 6
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 100 orders; With carteolol hydrochloride 5g, mannitol 45g, lactose 15g, microcrystalline Cellulose 12.5g, cross-linking sodium carboxymethyl cellulose 4g, citric acid 3g, saccharin sodium 0.02g and Mentholum 2.48g mixing, add mass fraction and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate; In dried granule, add microcrystalline Cellulose 12.5g, cross-linking sodium carboxymethyl cellulose 4g, sodium bicarbonate 1g and magnesium stearate 0.5g again, mixing, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 35 seconds in 37 ± 1 ℃ of water; Hardness is 35～48 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 7
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 80 orders; Adopt equivalent to progressively increase method with carteolol hydrochloride and all the other component mix homogeneously of recipe quantity, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 5mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 34 seconds in 37 ± 1 ℃ of water; Hardness is 34～46 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 8
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 80 orders; Adopt equivalent to progressively increase method with carteolol hydrochloride and all the other component mix homogeneously of recipe quantity, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 0.1mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 36 seconds in 37 ± 1 ℃ of water; Hardness is 32～45 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 9
Prescription
Method for makingAll components pulverize separately in the prescription is become the fine powder of fineness more than 80 orders; Adopt equivalent to progressively increase method with carteolol hydrochloride and all the other component mix homogeneously of recipe quantity, tabletting is made 1000 of Carteolol orally disintegrating tablets altogether, every hydrochloric carteolol 0.1mg.
QualityGained oral cavity disintegration tablet smooth in appearance, glossy; 30 mesh sieves are also passed through in complete disintegrate in 33 seconds in 37 ± 1 ℃ of water; Hardness is 30～43 Ns and pauses; Cool taste, sweetness, exquisiteness, no grittiness.
Explanation is at last, above embodiment is only unrestricted in order to technical scheme of the present invention to be described, although by invention has been described with reference to the preferred embodiments of the present invention, but those of ordinary skill in the art is to be understood that, can make various changes to it in the form and details, and the spirit and scope of the present invention that do not depart from appended claims and limited.
Claims (9)
1. Carteolol orally disintegrating tablets is characterized in that: comprise following component by mass percentage: carteolol hydrochloride 0.1%～10%, filler 50%～90%, disintegrating agent 5%～40%, lubricant 0.1%～5% and correctives 0.1%～5%.
2. Carteolol orally disintegrating tablets according to claim 1 is characterized in that: comprise following component by mass percentage: carteolol hydrochloride 0.1%～5%, filler 67%～89%, disintegrating agent 10%～25%, lubricant 0.1%～1% and correctives 0.4%～2.5%.
3. Carteolol orally disintegrating tablets according to claim 1 and 2 is characterized in that: described filler is one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; Described disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant, and described gas-producing disintegrant is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate; Described lubricant is one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel; Described correctives is one or more in saccharin sodium, aspartame, steviosin and the Mentholum.
4. Carteolol orally disintegrating tablets according to claim 3 is characterized in that: described filler is one or more in lactose, mannitol and the microcrystalline Cellulose; Described disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant, and described gas-producing disintegrant is made up of tartaric acid and sodium bicarbonate or citric acid and sodium bicarbonate; Described lubricant is a magnesium stearate; Described correctives is saccharin sodium and Mentholum or aspartame and Mentholum.
5. the preparation method of the described Carteolol orally disintegrating tablets of claim 1 is characterized in that: adopt wet granule compression tablet method or direct powder compression to make oral cavity disintegration tablet carteolol hydrochloride and filler, disintegrating agent, lubricant and the correctives of recipe quantity.
6. the preparation method of Carteolol orally disintegrating tablets according to claim 5, it is characterized in that: described wet granule compression tablet method may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 100 orders;
B, granulation: the carteolol hydrochloride after step a pulverized, filler, in disintegrating agent and correctives mixing, add binding agent again and make soft material, 20～40 mesh sieves are granulated, 45 ℃～55 ℃ dryings, dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent and lubricant mixing, tabletting promptly gets Carteolol orally disintegrating tablets.
7. the preparation method of Carteolol orally disintegrating tablets according to claim 6, it is characterized in that: the binding agent among the described step b is that mass fraction is 1%～10% 30 POVIDONE K 30 BP/USP 30 solution.
8. the preparation method of Carteolol orally disintegrating tablets according to claim 7, it is characterized in that: described step b be after step a is pulverized carteolol hydrochloride, filler, in disintegrating agent and correctives mixing, add mass fraction again and be 4% 30 POVIDONE K 30 BP/USP 30 solution and make soft material, 24 mesh sieves are granulated, 50 ℃ of dryings, dried granule are crossed 24 mesh sieve granulate.
9. the preparation method of Carteolol orally disintegrating tablets according to claim 5, it is characterized in that: described direct powder compression may further comprise the steps:
A, pulverizing: all components pulverize separately is become the fine powder of fineness more than 80 orders;
B, tabletting: with all components mix homogeneously after the step a pulverizing, tabletting promptly gets Carteolol orally disintegrating tablets.
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- 2009-10-14 CN CN200910191131A patent/CN101690720A/en active Pending
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| CN106074414A (en) * | 2012-07-12 | 2016-11-09 | 成都康弘药业集团股份有限公司 | A kind of oral cavity disintegration tablet containing Lurasidone and preparation method thereof |
| CN106074414B (en) * | 2012-07-12 | 2019-01-18 | 成都康弘药业集团股份有限公司 | A kind of oral disnitegration tablet and preparation method thereof containing Lurasidone |
| CN103239409A (en) * | 2013-04-26 | 2013-08-14 | 北京科源创欣科技有限公司 | Stable granular composition containing carteolol or hydrochloride thereof |
| CN106561707A (en) * | 2016-10-31 | 2017-04-19 | 郑州普罗动物药业有限公司 | Povidone iodine effervescent tablet with sterilization and disinfection effects, and preparation method thereof |
| CN110251444A (en) * | 2019-07-30 | 2019-09-20 | 攀枝花学院 | The gargle tablet of easy disintegrating |
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Application publication date: 20100407 |