CN101797235B - Carbazochrome sodium sulfonate oral disintegrating tablets and preparation method thereof - Google Patents
Carbazochrome sodium sulfonate oral disintegrating tablets and preparation method thereof Download PDFInfo
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- CN101797235B CN101797235B CN2010101290751A CN201010129075A CN101797235B CN 101797235 B CN101797235 B CN 101797235B CN 2010101290751 A CN2010101290751 A CN 2010101290751A CN 201010129075 A CN201010129075 A CN 201010129075A CN 101797235 B CN101797235 B CN 101797235B
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- sodium sulfonate
- carbazochrome sodium
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Abstract
The invention discloses carbazochrome sodium sulfonate oral disintegrating tablets and a preparation method thereof. The carbazochrome sodium sulfonate oral disintegrating tablets are prepared from the following components in percentage by mass: 1-15% of carbazochrome sodium sulfonate, 50-90% of filler, 5-40% of disintegrant, 1-8% of adhesive, 0.1-5% of lubricant and 0.1-5% of flavoring agent. The oral disintegrating tablets have the advantages of smooth surface, attractive appearance, moderate hardness, quick absorption, quick effect taking, small liver first-pass effect, high bioavailability, little irritation to the gastrointestinal tract, favorable mouthfeel and convenient taking, can quickly disintegrate in the oral cavity without water, is particularly suitable for aged people, children, patients in bed or with dysphagia, and especially for bleeding patients inconvenient to drink water during or after operations. The oral disintegrating tablets are prepared in a wet-method pelletizing tabletting way. The preparation method has the advantages of simple production technology, stable and easily-controlled preparation quality, and low cost, and is suitable for industrial large-scale production.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, particularly a kind of carbazochrome sodium sulfonate oral disintegrating tablets also relates to the method for preparing of this oral cavity disintegration tablet.
Background technology
Tablet have steady quality, dosage accurately, take and advantage such as easy to carry, that the production mechanization degree high, production cost is low, be one of at present the most frequently used pharmaceutical dosage form.But disintegrate is slow, bioavailability is lower, part patient swallows than deficiencies such as difficulties because of it exists simultaneously, on using, receives restriction to a certain degree.In recent years, novel troches such as oral cavity disintegration tablet, dispersible tablet and Sublingual tablet continue to bring out.Oral cavity disintegration tablet is a kind of water disintegrate or dissolved tablet fast of in the oral cavity, not needing; 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, bed, dysphagia or drinking-water inconvenience.
Carbazochrome sodium sulfonate (Carbazochrome Sodium Sulfonate); Chemical name is 1-methyl-6-oxo-2,3,5; 6-tetrahydro indole-5-semicarbazone-2-sulfonate sodium trihydrate; Be the take the lead in hemorrhage of new generation of successful development of Japanese Tanabe Mitsubishi Pharmaceutical Co, have that haemostatic effect is good, onset rapidly, advantage such as persistent, toxic and side effects be little, be mainly used in urinary system, upper digestive tract, respiratory tract and department of obstetrics and gynecology hemorrhagic disease; Comparatively remarkable to the urinary system curative effect, also can be used for prevention and treatment of operative hemorrhage etc.
Carbazochrome sodium sulfonate
The preparation type that carbazochrome sodium sulfonate has gone on the market mainly contains conventional tablet, capsule, powder, granule, injection and injection powder pin etc., does not see the oral cavity disintegration tablet listing at present as yet, does not also see the correlational study report.
Summary of the invention
In view of this, one of the object of the invention is to provide a kind of carbazochrome sodium sulfonate oral disintegrating tablets, and two of purpose is to provide a kind of method for preparing of said carbazochrome sodium sulfonate oral disintegrating tablets.
For achieving the above object, the present invention adopts following technical scheme:
1, carbazochrome sodium sulfonate oral disintegrating tablets, composed of the following components by mass percentage: carbazochrome sodium sulfonate 1%～15%, filler 50%～90%, disintegrating agent 5%～40%, binding agent 1%～8%, lubricant 0.1%～5% and correctives 0.1%～5%.
Further, composed of the following components by mass percentage: carbazochrome sodium sulfonate 1%～10%, filler 65%～85%, disintegrating agent 5%～20%, binding agent 2%～6%, lubricant 0.1%～1% and correctives 0.4%～1.5%;
Further, composed of the following components by mass percentage: carbazochrome sodium sulfonate 8%～9%, filler 74%～80%, disintegrating agent 6%～12%, binding agent 3%～5%, lubricant 0.4%～0.5% and correctives 0.4%～1.0%;
Further, said filler is one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; Said 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 gas-producing disintegrant is made up of tartaric acid, citric acid or fumaric acid and sodium bicarbonate or sodium carbonate; Said binding agent is one or more in starch, methylcellulose, ethyl cellulose and the hydroxypropyl methylcellulose; Said lubricant is one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel; Said correctives is one or more in saccharin sodium, aspartame, steviosin and the Mentholum;
Further, said filler is one or more in starch, mannitol and the microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone and/or gas-producing disintegrant; Said binding agent is a hydroxypropyl methylcellulose; Said lubricant is a magnesium stearate; Said correctives is Mentholum and/or aspartame;
Further, said filler is starch, mannitol and microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant, and gas-producing disintegrant is made up of citric acid and sodium bicarbonate; Said correctives is Mentholum or Mentholum and aspartame.
2, the method for preparing of said carbazochrome sodium sulfonate oral disintegrating tablets adopts the wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
Further, the wetting agent among the said step b is that volume fraction is 60% ethanol water;
Further, adopt 24 mesh sieves to granulate among the said step b, dried granule is crossed 24 mesh sieve granulate.
Beneficial effect of the present invention is: carbazochrome sodium sulfonate oral disintegrating tablets any surface finish of the present invention, attractive in appearance, and hardness is suitable; Needn't use water delivery service, saliva can make its rapidly disintegrate in the oral cavity, and taking convenience is particularly suitable for the patient of old man, child, bed or dysphagia, especially in the operation or postoperative hemorrhage and the patient of the inconvenience of drinking water; Cool taste, sweetness, exquisiteness, the patient is easy to accept, and drug compliance is good; Medicine after the disintegrate has the direct trans-oral of considerable part to absorb except that part gets into the gastrointestinal tract with swallowing act, and rapid-action, liver first-pass effect is little, and bioavailability is high; Getting into the gastrointestinal medicine is homodisperse fine particle, in gastrointestinal tract, is large tracts of land and distributes, and absorption point increases, and local excitation reduces to gastrointestinal; The present invention adopts the wet granule compression tablet legal system to be equipped with carbazochrome sodium sulfonate oral disintegrating tablets, and production technology is simple, and stable being prone to of the quality of the pharmaceutical preparations controlled, and be with low cost, is fit to large-scale industrialization production.
The present invention is " Chongqing City's veterinary drug Engineering Technical Research Centre " research project.
The specific embodiment
In order to make the object of the invention, technical scheme and advantage clearer, will carry out detailed description to the preferred embodiments of the present invention below.
Carbazochrome sodium sulfonate oral disintegrating tablets of the present invention, composed of the following components by mass percentage:
Carbazochrome sodium sulfonate: 1%～15%, preferred 1%～10%, more preferably 8%～9%;
Filler: 50%～90%, preferred 65%～85%, more preferably 74%～80%;
Disintegrating agent: 5%～40%, preferred 5%～20%, more preferably 6%～12%;
Binding agent: 1%～8%, preferred 2%～6%, more preferably 3%～5%;
Lubricant: 0.1%～5%, preferred 0.1%～1%, more preferably 0.4%～0.5%;
Correctives: 0.1%～5%, preferred 0.4%～1.5%, more preferably 0.4%～1.0%.
Said filler is selected from one or more in starch, pregelatinized Starch, dextrin, Icing Sugar, lactose, mannitol, xylitol, erythritol and the microcrystalline Cellulose; In preferred starch, mannitol and the microcrystalline Cellulose one or more, more preferably mannitol, starch and microcrystalline Cellulose.Starch property is highly stable, low price, and hygroscopicity is little, and water absorption is strong and certain dilatancy is arranged, and is applicable to water-insoluble or microsolubility medicine.Mannitol is soluble in water, stable in properties, and no hygroscopicity, sugariness is equivalent to 70% of sucrose approximately, and heat absorption during because of dissolving has refrigerant sense when dissolving in the oral cavity.Microcrystalline Cellulose is water insoluble; Have good flowability and compressibility; Except that as also having concurrently lubricated the filler and disintegration, during with the strong low-substituted hydroxypropyl cellulose of swelling behavior, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone Combined application, can improve the porosity of tablet; Strengthen capillarity, make tablet disintegrate fast in low amounts of water.
Said disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, polyvinylpolypyrrolidone and the gas-producing disintegrant; Preferred polyvinylpolypyrrolidone and/or gas-producing disintegrant, more preferably polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant.Polyvinylpolypyrrolidone has very high capillary activity and hydratability, can rapidly water be absorbed in the tablet, and when internal pressure is the intensity that swelling power surpasses tablet, disintegrate promptly takes place 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, said 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 citric acid and sodium bicarbonate.
Said binding agent is selected from one or more in starch, methylcellulose, ethyl cellulose and the hydroxypropyl methylcellulose, preferred hydroxypropyl methylcellulose.
Said lubricant is selected from one or more in magnesium stearate, Pulvis Talci and the micropowder silica gel, preferred 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 the oral cavity disintegration tablet of the present invention, said correctives is selected from one or more in saccharin sodium, aspartame, steviosin and the Mentholum, preferred aspartame and/or Mentholum, more preferably Mentholum or aspartame and Mentholum.
Carbazochrome sodium sulfonate oral disintegrating tablets of the present invention adopts the preparation of wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
When wet granule compression tablet, should note following some: (1) is prone to when pulverizing separately stick on the machine because the water content of principal agent carbazochrome sodium sulfonate is about 15%, and a small amount of adhesion becomes strip and block, is difficult for sieving; Simultaneously, the water content of filler starch also higher (being generally 10%～15%) is mixed difficulty of pulverizing with principal agent, be difficult for sieving; Therefore, among the present invention starch with before should 100～105 ℃ in advance dry, make water content below 8%; Simultaneously,, pulverize, sieve, mix with other adjuvant again carbazochrome sodium sulfonate elder generation and dry starch mixing.(2) method that is routinely added to 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 through single factor experiment,, more help the quick disintegrate of oral cavity disintegration tablet when disintegrating agent adds fashionablely by inside and outside addition.Therefore, the present invention adopts inside and outside addition to add disintegrating agent.Wherein, the adding method of gas-producing disintegrant is: with granulating behind the wherein a kind of of bronsted lowry acids and bases bronsted lowry and other composition mix homogeneously, another kind is added in the dried granule behind the granulate, thereby avoids the living reaction of soda acid chance waterishlogging when wet granulation.(3) because correctives such as Mentholum etc. have effumability; The present invention adds volatile correctives before being chosen in and granulating, and reduces its volatilization loss as far as possible, remains not volatile correctives and then after granulation, adds; Make made tablet outer sweet, on mouthfeel, more be prone to accepted by the patient.
Discover, adopt the carbazochrome sodium sulfonate oral disintegrating tablets of above-mentioned supplementary material and method preparation, any surface finish, attractive in appearance, hardness is suitable, and disintegrate and pass through 30 mesh sieves fully in 30 seconds meets the requirement of oral cavity disintegration tablet in 37 ± 1 ℃ of water.
Embodiment 1
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate and the dry starch mixing of recipe quantity, pulverize, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The magnesium stearate that in dried granule, adds residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 22～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 24 seconds in 37 ± 1 ℃ of water; Taste and sweet mouthfeel, refrigerant, fine and smooth, no grittiness.
Embodiment 2
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate and the dry starch mixing of recipe quantity, pulverize, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate and the magnesium stearate that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 21～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 23 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 3
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 22～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 25 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 4
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 17～27 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 28 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 5
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 23～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 30 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
Embodiment 6
Prescription
All components pulverize separately during method for making will be write out a prescription except that carbazochrome sodium sulfonate becomes the fine powder of fineness more than 100 orders; 100～105 ℃ of dryings, make water content starch below 8%; With the carbazochrome sodium sulfonate of recipe quantity and dry starch mixing, pulverizing, cross 80 mesh sieves; Mix with mannitol, microcrystalline Cellulose, citric acid, hydroxypropyl methylcellulose and the Mentholum of recipe quantity and the polyvinylpolypyrrolidone of 1/2 recipe quantity again, cross 80 mesh sieves; Add volume fraction again and be 60% ethanol water and make soft material in right amount, 24 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 24 mesh sieve granulate; The sodium bicarbonate, magnesium stearate and the aspartame that in dried granule, add residue polyvinylpolypyrrolidone and recipe quantity again, mixing, tabletting is processed 1000 of carbazochrome sodium sulfonate oral disintegrating tablets altogether, and every contains carbazochrome sodium sulfonate 10mg.
Quality gained oral cavity disintegration tablet any surface finish, attractive in appearance; Hardness is 25～28 Ns and pauses; 30 mesh sieves are also passed through in complete disintegrate in 28 seconds in 37 ± 1 ℃ of water; Cool taste, sweetness, exquisiteness, no grittiness.
The dissolution of carbazochrome sodium sulfonate oral disintegrating tablets of the present invention and commercially available carbazochrome sodium sulfonate ordinary tablet relatively
Method: getting the carbazochrome sodium sulfonate oral disintegrating tablets of various embodiments of the present invention preparation and commercially available carbazochrome sodium sulfonate ordinary tablet respectively, is dissolution medium with water 900mL, and rotating speed is that per minute 50 changes; According to two appendix XC second method operations of Chinese Pharmacopoeia version in 2005, in the time of 1,5,10,15,20,25,30,45 minute, get solution 5mL respectively; Filter; Get subsequent filtrate as need testing solution, measure trap at wavelength 363nm place, press C
10H
11N
4O
5Absorptance (the E of SNa
1%1 Cm) be 862 calculating dissolutions.The result sees the following form.Visible by table, to compare with commercially available carbazochrome sodium sulfonate ordinary tablet, carbazochrome sodium sulfonate oral disintegrating tablets of the present invention has characteristics such as disintegrate is fast, stripping is fast, dissolution height.
The dissolution of table carbazochrome sodium sulfonate oral disintegrating tablets and carbazochrome sodium sulfonate ordinary tablet relatively
Explanation is at last; Above embodiment is only unrestricted in order to technical scheme of the present invention to be described; Although through invention has been described with reference to the preferred embodiments of the present invention; But those of ordinary skill in the art should be appreciated that and can make various changes to it in form with on the details, and the spirit and scope of the present invention that do not depart from appended claims and limited.
Claims (4)
1. carbazochrome sodium sulfonate oral disintegrating tablets is characterized in that: composed of the following components by mass percentage: carbazochrome sodium sulfonate 8%～9%, filler 74%～80%, disintegrating agent 6%～12%, binding agent 3%～5%, lubricant 0.4%～0.5% and correctives 0.4%～1%; Said filler is starch, mannitol and microcrystalline Cellulose; Said disintegrating agent is polyvinylpolypyrrolidone or polyvinylpolypyrrolidone and gas-producing disintegrant, and gas-producing disintegrant is made up of citric acid and sodium bicarbonate; Said binding agent is a hydroxypropyl methylcellulose; Said lubricant is a magnesium stearate; Said correctives is Mentholum or Mentholum and aspartame.
2. the method for preparing of the described carbazochrome sodium sulfonate oral disintegrating tablets of claim 1 is characterized in that: adopt the wet granule compression tablet method, may further comprise the steps:
A, pulverizing: filler, disintegrating agent, binding agent, lubricant and correctives pulverize separately are become the fine powder of fineness more than 100 orders;
B, granulation: with carbazochrome sodium sulfonate and partially filled dose of mixing, pulverize, cross 80 mesh sieves; Again with the residue filler, in disintegrating agent, binding agent, in add the correctives mixing, cross 80 mesh sieves; Add wetting agent system soft material again, 20～40 mesh sieves are granulated, 60 ± 5 ℃ of dryings, and dried granule is crossed 20～60 mesh sieve granulate;
C, tabletting: with the dried granule behind the step b granulate with add disintegrating agent, lubricant, add the correctives mixing, tabletting promptly gets carbazochrome sodium sulfonate oral disintegrating tablets.
3. the method for preparing of carbazochrome sodium sulfonate oral disintegrating tablets according to claim 2, it is characterized in that: the wetting agent among the said step b is that volume fraction is 60% ethanol water.
4. the method for preparing of carbazochrome sodium sulfonate oral disintegrating tablets according to claim 2 is characterized in that: adopt 24 mesh sieves to granulate among the said step b, dried granule is crossed 24 mesh sieve granulate.
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| CN101797235B true CN101797235B (en) | 2012-05-09 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1985808A (en) * | 2006-12-20 | 2007-06-27 | 山东省医药工业研究所 | Carbazochrome sodium sulfonate slow-released tablet and its preparing method |
| CN101554377A (en) * | 2008-04-09 | 2009-10-14 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1985808A (en) * | 2006-12-20 | 2007-06-27 | 山东省医药工业研究所 | Carbazochrome sodium sulfonate slow-released tablet and its preparing method |
| CN101554377A (en) * | 2008-04-09 | 2009-10-14 | 鲁南制药集团股份有限公司 | Pharmaceutical composition containing prasugrel and carbazochrome sodium sulfonate |
Non-Patent Citations (1)
| Title |
|---|
| 贾伟、高文远，主编.口腔崩解片.《药物控释新剂型》.化学工业出版社、现代生物技术与医药科技出版中心,2005,(第1版),8-15. * |
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