CN1771915A - Oral disintegrated Anfenmame tablet for treating children's cold and its prepn - Google Patents
Oral disintegrated Anfenmame tablet for treating children's cold and its prepn Download PDFInfo
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- CN1771915A CN1771915A CN 200510057322 CN200510057322A CN1771915A CN 1771915 A CN1771915 A CN 1771915A CN 200510057322 CN200510057322 CN 200510057322 CN 200510057322 A CN200510057322 A CN 200510057322A CN 1771915 A CN1771915 A CN 1771915A
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Abstract
The oral disintegrated Anfenmame tablet includes active components paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide as well as stuffing, disintegrating agent, corrective, lubricant, flow assistant and other supplementary material. The oral disintegrated Anfenmame tablet has main medicine materials coated to mask bad taste, can disintegrate in oral cavity and is especially suitable for children to take for treating cold.
Description
Technical field
The present invention relates to a kind of acetaminophen, hydrochloric acid of containing is the compound recipe coldrex that ephedrine, dextromethorphan hydrobromide are formed, can be in the oral cavity disintegrating oral novel form and preparation method rapidly.
Background technology
The common sympton of flu is headache, heating, nasal obstruction, watery nasal discharge, systemic pain etc.It is generally acknowledged that common cold has rhinovirus to cause, owing to still do not have specific drug for virus at present, so the main symptomatic treatment that adopts.It is wide in variety to be used for the anti-compound preparation that cures cold now on the market, from contained main component, medicine commonly used is mainly antiallergic agent, alleviate nasal mucosa congestion and edema medicine, the antipyretic analgesic three major types contains antitussive medicine in the some of them compound recipe coldrex, antiallergic agent is often selected chlorphenamine (chlorphenamine), the medicine that alleviates nasal mucosa hyperemia often selects pseudoephedrine, and antipyretic analgesic is often selected acetaminophen, aspirin for use, and cough medicine is generally selected the central antitussive dextromethorphan hydrobromide for use.
The child since the immunity of health a little less than, very easily catch a cold at the change of season, if untimely treatment, can concurrent bronchitis, pneumonia and even concurrent otitis media, myocarditis etc.In the children's who catches a cold, particularly premature infant, low birthweight infant or congenital heart disease, malnutrition, anemia, child suffering from rickets are arranged because weak, in case pneumonia, often state of an illness threat to life or protracted course of disease.Therefore, need carry out Drug therapy timely.For this special medication colony of child, be very important for it provides suitable specification and dosage form, yet opposite with its market demand be, specialize in flu medication that the child uses and few at present on the market.Authoritative department is spot-check the virgin medication prescription of 1600 shares, kind surplus the medicine that uses reaches 320, children special-purpose medicine less than 1/3rd; In more than the 3000 kind of medicine that circulates on market, be used for child's less than 2%, most medicines are that the child is shared with the adult.When the child used, the prompting of usage, consumption was unclear, mostly is " child is cut down according to the circumstance ", how to subtract, and what subtract, and said and failed to understand.So often cause the infant inappropriate medication, delay treatment is even malpractice influences the infant physical and mental health.Chinese children accounts for 1/3rd of national population, and development child medicine is that society is required.
Oral cavity disintegration tablet is meant not to be needed water or only need use low amounts of water, need not to chew, and tablet places lingual surface, after rapid dissolving of chance saliva or the disintegrate, borrows swallowing act, and medicine can be gone into the tablet of stomach onset.The development of oral cavity disintegration tablet is that new approach has been opened up in emergent treatment, also provide a new method simultaneously for the oral absorption that solves insoluble drug, be applicable to old people and child's oral medication, especially for swallowing inconvenient patient, have more suitable use advantage, thereby found a kind of way of solution for the quality of life of improving patient; Medical treatment for special circumstances such as the geologist of field work drinking-water inconvenience and desert area people provides convenience in addition, and new thinking also is provided for disintegration of tablet degree before solving is bad.Wideling popularize of oral cavity disintegration tablet except that the reform that will promote preparation tablets, also can be made and clinical application generation significant impact pharmaceutical technology, adjuvant, creates bigger economic and social benefit.It is good to the invention provides a kind of preparation mouthfeel, and taste is fragrant and sweet, and dosage is accurate, and the portable coldrex method that is applicable to the child is for the clinical application of children's cold brings a new selection.
Summary of the invention
The present invention is directed to the deficiencies in the prior art part, a kind of child's of being specially adapted for coldrex oral disintegrated Anfenmame tablet is provided, its active component comprises acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and adjuvant comprises IV acrylic resin, Pulvis Talci, disintegrating agent, filler, lubricant, fluidizer, correctives etc.Every contains acetaminophen 80mg, pseudoephedrine hydrochloride 7.5mg, dextromethorphan hydrobromide 2.5mg.Its disintegrating agent can be selected polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, crosslinked carboxymethyl fecula sodium, microcrystalline Cellulose, citric acid/sodium bicarbonate, citric acid/sodium carbonate for use, filler is selected from lactose, starch, mannitol, correctives is selected from aspartame, edible essence, sodium chloride etc., lubricant is selected from magnesium stearate, Pulvis Talci, and fluidizer is micropowder silica gel.
The present invention has adopted powder coating technology that principal agent acetyl aminophenol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide are carried out the coating taste masking, here said powder coating is meant every kind of principal agent is carried out coating respectively, also can be to behind three kinds of principal agent mix homogeneously, carry out coating again, adding correctives then corrects residual bitterness, make oral disintegrated Anfenmame tablet have good mouthfeel, coating material mainly is made up of IV acrylic resin, Pulvis Talci and ethanol, and its percentage by weight is respectively 10%, 1%, 89%.Make oral cavity disintegration tablet have good disintegrating property because of adding the method that disintegrating agent combines in adopting, can disintegrate rapidly in the oral cavity, preferably be less than or equal to 1 minute less than 2 minutes its disintegration.
The prescription weight ratio of oral disintegrated Anfenmame tablet:
| No. four acrylic resin disintegrants of filler paracetamol dextromethorphan hydrobromide pseudoephedrine hydrochloride flavouring lubricants glidants | 1-80％ 1-40％ 1-5％ 1-15％ 0-10％ 0-1％ 0-1％ 0.1-10％ 0.1-15％ |
Preferred formulation weight ratio:
| Lactose starch acetaminophen dextromethorphan hydrobromide pseudoephedrine hydrochloride | 1-50％ 1-50％ 1-40％ 1-5％ 1-15％ |
| No. four acrylic resin PVPPs of Aspartame dolomol superfine silica gel powder essence sodium chloride | 0-3％ 0.1-1％ 0.1-1％ 0-5％ 0-1％ 0.5-10％ 0.5-6％ |
The present invention also provides a kind of method for preparing oral cavity disintegration tablet: acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide are carried out powder coating, cross 80 mesh sieves respectively, the recipe quantity lactose and the starch that add by 100 mesh sieves mix again, and it is an amount of to add entry, cross 20 mesh sieves and granulate, 60 ℃ of dryings, 30 mesh sieve granulate add other adjuvant, measure semi-finished product content behind the mix homogeneously, tabletting after meeting the requirements promptly gets oral disintegrated Anfenmame tablet.
Oral cavity disintegration tablet of the present invention at first adopts powder coating technology, and three principal agents are carried out coating cover bitterness, and then wet granulation, add correctives, lubricant, fluidizer etc.The invention provides with acetaminophen, hydrochloric acid is that ephedrine, dextromethorphan hydrobromide are that the mouth of active ingredient collapses novel form, this oral cavity disintegration tablet be particularly suitable for the taking medicine flu child patient of difficulty.Take oral disintegrated Anfenmame tablet the time, medicine is kept in the mouth, about 1-60 is fully disintegrate under the saliva of buccal cavity effect in second, no grittiness, disagreeable tastes such as no bitterness.The characteristics of above-mentioned prescription and technology are: lactose has good compressibility, make the oral cavity disintegration tablet of preparation have good friability, make that tablet has critical external compressive resistance ability preferably in transportation, the polyvinylpolypyrrolidone good fluidity, specific surface area is big, in sheet, be uniformly dispersed, have intensive capillarity, in the rapid inlet port cavity disintegrating tablet of water energy, tablet can be expanded rapidly and produce disintegration preferably, starch had both been made filler, again as in disintegrating agent, with the polyvinylpolypyrrolidone synergism that adds, make the oral cavity disintegration tablet of preparation have good disintegrating property, aspartame is a kind of sweeting agent of extensive use, and its sugariness is 200 times of sucrose, and is soluble in water, with the strawberry essence use in conjunction, in the oral cavity, produce good mouthfeel, make this product accept the magnesium stearate exquisiteness for the flu child easily, lubricity is strong, has good tack, unilateral bright and clean attractive in appearance behind the tabletting, and micropowder silica gel has good fluidizer effect, improves the flowability of material.
Oral disintegrated Anfenmame tablet with fluidized bed coating after, use conventional tablet manufacturing equipment preparation, the product mouthfeel of gained is good, remedies the few defective of coldrex kind that is fit to the child in the market, will produce considerable economic and social benefit.Anfenmame oral cavity disintegration tablet of the present invention is mainly used in the symptomatic treatment of children's cold, takes every day 3 times, each 1-2 sheet.
Description of drawings
Acetaminophen coated granule micro state (amplifying 64 times) before Fig. 1, the coating
Acetaminophen coated granule micro state behind Fig. 2, the coating (amplifying 64 times)
Dextromethorphan hydrobromide coated granule micro state (amplifying 64 times) before Fig. 3, the coating
Dextromethorphan hydrobromide coated granule micro state behind Fig. 4, the coating (amplifying 64 times)
Pseudoephedrine hydrochloride coated granule micro state (amplifying 64 times) before Fig. 5, the coating
Pseudoephedrine hydrochloride coated granule micro state behind Fig. 6, the coating (amplifying 64 times)
Specific embodiment
The particulate preparation of embodiment 1 principal agent powder coating
As solvent, add the IV acrylic resin with ethanol, as antiplastering aid, coating fluid prescription is by weight with Pulvis Talci:
| Acrylic resin IV ethanol Pulvis Talci | 10％ 89％ 1％ |
Its preparation technology is as follows: it is standby that the crude drug mechanical activation comminution is also crossed 100 mesh sieves; Get the dehydrated alcohol of an amount of (by above-mentioned weight ratio), add the IV acrylic resin while stirring, till dissolving fully; Take by weighing the Pulvis Talci of recipe quantity, be added in the IV acrylic resin alcoholic solution, keep stirring; Medicine is added in the fluidized-bed coating machine, and best inlet temperature is 30 ℃, requires medicine is carried out coating according to the equipment operation, and (weightening finish of acetaminophen coating should reach about 25% until the coating weightening finish of stipulating; The dextromethorphan hydrobromide coating should increase weight and reach about 40%; The weightening finish of pseudoephedrine hydrochloride coating should reach about 50%); Stop into coating solution, open drying, baking temperature is 30 ℃, dry 30min; Discharging is with 80 mesh sieve granulate; Measure the content of coating powder, standby.
In order further to understand the particulate state of coated drugs, used optical microscope to amplify 64 times, observe the particulate micro state of drug coating, the results are shown in accompanying drawing 1, accompanying drawing 2, accompanying drawing 3, accompanying drawing 4, accompanying drawing 5, accompanying drawing 6.
The result that microscopically is observed shows: be covered one deck clothing film or with the inter-adhesive one-tenth larger particles of the small crystalline particle of a plurality of medicines of drug powder behind the coating, its outer bag again by one deck, coating fluid prescription that visible employing is selected and fluidized bed coating technology can reach the purpose to the taste masking of drug target powder coating.
Embodiment 2 is a principal agent with acetaminophen coating powder, pseudoephedrine hydrochloride coating powder, dextromethorphan hydrobromide coating powder, and other compositions are that the prescription that adjuvant prepares oral disintegrated Anfenmame tablet is:
| Paracetamol dressing powder contains the hydrogeneous bromic acid dextromethorphan of the hydrochloric pseudoephedrine dextromethorphan hydrobromide of paracetamol pseudoephedrine hydrochloride dressing powder dressing powder lactose starch PVPP strawberry essence | 80g 7.5g 2.5g 150g 27g 30g is an amount of |
| The micropowder silica gel of aspartame sodium chloride magnesium stearate | 15g 6g 3g 3g |
| 1000 |
Tabletting adopts conventional tablet pharmaceutical equipment commonly used, its concrete preparation method is as follows: with acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide coating powder, cross 80 mesh sieves respectively, the recipe quantity lactose and the starch that add by 100 mesh sieves mix again, it is an amount of to add entry, cross 20 mesh sieves and granulate 60 ℃ of dryings, 30 mesh sieve granulate, add other adjuvant, measure semi-finished product content behind the mix homogeneously, the rotary tablet machine tabletting is used in the back that meets the requirements, and promptly gets oral disintegrated Anfenmame tablet.
The oral disintegrated Anfenmame tablet of gained, hardness are about 4kg, friability (Chinese Pharmacopoeia 2000 editions) 1.5%, and disintegration time is 50 seconds in the oral cavity.
Embodiment 3
| Paracetamol dressing powder contains the hydrogeneous bromic acid dextromethorphan of the hydrochloric pseudoephedrine dextromethorphan hydrobromide of paracetamol pseudoephedrine hydrochloride dressing powder dressing powder sweet mellow wine microcrystalline cellulose low-substituted hydroxypropyl cellulose essence Aspartame dolomol superfine silica gel powder | An amount of 15g 3g of 80g 7.5g 2.5g 300g 10g 50g 3g |
| 1000 |
Tabletting can adopt direct compression process, its concrete preparation method is as follows: with acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide coating powder, cross 80 mesh sieves respectively, add recipe quantity other adjuvants except that lubricant and fluidizer again, mixed 40 minutes, add lubricant and fluidizer with V-Mixer by 100 mesh sieves, mixed 5 minutes, measure semi-finished product content, the rotary tablet machine tabletting is used in the back that meets the requirements, and promptly gets oral disintegrated Anfenmame tablet.
The oral disintegrated Anfenmame tablet of gained, hardness are about 3.5kg, friability (Chinese Pharmacopoeia 2000 editions) 3%, and disintegration time is 30 seconds in the oral cavity.
Embodiment 4
| Paracetamol dressing powder contains the hydrogeneous bromic acid dextromethorphan of the hydrochloric pseudoephedrine dextromethorphan hydrobromide of paracetamol pseudoephedrine hydrochloride dressing powder dressing powder sweet mellow wine starch crosslinked carboxymethyl fecula sodium sodium acid carbonate citric acid essence Aspartame dolomol superfine silica gel powder | An amount of 15g 3g of 80g 7.5g 2.5g 250g 10g 50g 10g 7.5g 3g |
| 1000 |
Tabletting can adopt direct compression process, its concrete preparation method is as follows: with acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide coating powder, cross 80 mesh sieves respectively, add recipe quantity other adjuvants except that lubricant and fluidizer again, mixed 40 minutes, add lubricant and fluidizer with V-Mixer by 100 mesh sieves, mixed 5 minutes, measure semi-finished product content, the rotary tablet machine tabletting is used in the back that meets the requirements, and promptly gets oral disintegrated Anfenmame tablet.
The oral disintegrated Anfenmame tablet of gained, hardness are about 3.5, friability (Chinese Pharmacopoeia 2000 editions) 3.5%, and disintegration time is 25 seconds in the oral cavity.
Claims (9)
1. oral disintegrated Anfenmame tablet is characterized in that: mainly acetyl aminophenol, the hydrochloric acid by effective therapeutic dose is that ephedrine, dextromethorphan hydrobromide and pharmaceutic adjuvant are formed, and disintegration time was less than 2 minutes in the oral cavity.
2. oral disintegrated Anfenmame tablet according to claim 1 is characterized in that: every contains acetaminophen 80mg, pseudoephedrine hydrochloride 7.5mg, dextromethorphan hydrobromide 2.5mg.
3. oral disintegrated Anfenmame tablet according to claim 1 is characterized in that: the adjuvant that oral cavity disintegration tablet adopts comprises filler, disintegrating agent, lubricant.
4. oral disintegrated Anfenmame tablet according to claim 3 is characterized in that: filler is selected from least a in lactose, mannitol, starch, the microcrystalline Cellulose.
5. oral disintegrated Anfenmame tablet according to claim 3 is characterized in that: disintegrating agent is selected from least a in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, crosslinked carboxymethyl fecula sodium, sodium carbonate/citric acid, the sodium bicarbonate/citric acid.
6. 1 described oral disintegrated Anfenmame tablet as requested is characterized in that: the symptomatic treatment that is used for children's cold.
7. oral disintegrated Anfenmame tablet according to claim 1, it is characterized in that: adopt the powder coating technology that the bitterness of principal agent is covered, the coating material of selecting for use is a kind of can not the dissolving rapidly in the oral cavity and can rapid dissolved acrylic resin at gastric.
8. according to each described oral disintegrated Anfenmame tablet of claim 1-7, it is characterized in that: the prescription that weight share is determined:
Lactose 1-50%
Starch 1-50%
Acetaminophen 1-40%
Dextromethorphan hydrobromide 1-5%
Pseudoephedrine hydrochloride 1-15%
Aspartame 0-3%
Magnesium stearate 0.1-1%
Micropowder silica gel 0.1-1%
Essence 0-5%
Sodium chloride 0-1%
No. four acrylic resin 0.5-10%
Polyvinylpolypyrrolidone 0.5-6%
9. preparation method of oral cavity disintegration tablet according to claim 1, it is characterized in that: acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide are carried out powder coating, cross 80 mesh sieves respectively, the recipe quantity lactose and the starch that add by 100 mesh sieves mix again, and it is an amount of to add entry, crossing 20 mesh sieves granulates, 60 ℃ of dryings, 30 mesh sieve granulate add other adjuvant, tabletting behind the mix homogeneously promptly gets oral disintegrated Anfenmame tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100573220A CN100448431C (en) | 2005-10-17 | 2005-10-17 | Oral disintegrated Anfenmame tablet for treating children's cold and its prepn |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100573220A CN100448431C (en) | 2005-10-17 | 2005-10-17 | Oral disintegrated Anfenmame tablet for treating children's cold and its prepn |
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| Publication Number | Publication Date |
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| CN1771915A true CN1771915A (en) | 2006-05-17 |
| CN100448431C CN100448431C (en) | 2009-01-07 |
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| CNB2005100573220A Expired - Fee Related CN100448431C (en) | 2005-10-17 | 2005-10-17 | Oral disintegrated Anfenmame tablet for treating children's cold and its prepn |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101754754B (en) * | 2007-07-23 | 2013-06-19 | 株式会社太平洋 | Dispersible tablet comprising coated drug-containing particles and method for the preparation thereof |
| CN103169706A (en) * | 2011-12-26 | 2013-06-26 | 重庆医药工业研究院有限责任公司 | Compound oral disintegrating tablet containing acetaminophen and dextromethorphan |
| CN101467988B (en) * | 2007-12-27 | 2014-07-09 | 北京德众万全医药科技有限公司 | Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof |
| CN113057950A (en) * | 2020-01-02 | 2021-07-02 | 上海信谊万象药业股份有限公司 | Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1626080A (en) * | 2003-12-11 | 2005-06-15 | 江苏晨牌药业有限公司 | Paracetamol Pseudoephedrine desintegration piece and preparation method |
| CN1254246C (en) * | 2004-07-12 | 2006-05-03 | 北京科信必成医药科技发展有限公司 | Oral disintegration tablet of silaenafil and its pharmaceutically receptible salt and its preparing method |
| CN1310647C (en) * | 2004-09-21 | 2007-04-18 | 石家庄欧意药业有限公司 | Anti-cold medicine soft capsule and its preparing method |
| CN1634061A (en) * | 2004-10-11 | 2005-07-06 | 贵阳云岩西创药物科技开发有限公司 | Pharmaceutical formulation of pseudoephenrine hydrochloride and its preparing process |
-
2005
- 2005-10-17 CN CNB2005100573220A patent/CN100448431C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101754754B (en) * | 2007-07-23 | 2013-06-19 | 株式会社太平洋 | Dispersible tablet comprising coated drug-containing particles and method for the preparation thereof |
| CN101467988B (en) * | 2007-12-27 | 2014-07-09 | 北京德众万全医药科技有限公司 | Medicament composition containing paracetamol and pseudoephedrine hydrochloride and preparation method thereof |
| CN103169706A (en) * | 2011-12-26 | 2013-06-26 | 重庆医药工业研究院有限责任公司 | Compound oral disintegrating tablet containing acetaminophen and dextromethorphan |
| CN103169706B (en) * | 2011-12-26 | 2016-08-03 | 重庆医药工业研究院有限责任公司 | A kind of compound oral disintegrating tablet containing acetaminophen and dextromethorphan |
| CN113057950A (en) * | 2020-01-02 | 2021-07-02 | 上海信谊万象药业股份有限公司 | Oral pediatric paracetamol, atificial cow-bezoar and chlorphenamine maleate granule preparation and preparation process thereof |
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| Publication number | Publication date |
|---|---|
| CN100448431C (en) | 2009-01-07 |
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Address after: 400061 No. 565, Tu Shan Road, Nan'an District, Chongqing Co-patentee after: SHANGHAI FOSUN PHARMACEUTICAL(GROUP)CO., Ltd. Patentee after: CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE Co.,Ltd. Co-patentee after: HUAHONG PHARMACEUTICAL Co.,Ltd. GUANGXI ZHUANG AUTONOMOUS REGION Address before: 400061 No. 565, Tu Shan Road, Nan'an District, Chongqing Co-patentee before: SHANGHAI FOSUN PHARMACEUTICAL(GROUP)CO., Ltd. Patentee before: CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE Co.,Ltd. Co-patentee before: Guangxi Huahong Pharmaceutical Co.,Ltd. |
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Effective date of registration: 20101115 Address after: 400061 No. 565, Tu Shan Road, Nan'an District, Chongqing Co-patentee after: SHANGHAI FOSUN PHARMACEUTICAL(GROUP)CO., Ltd. Patentee after: CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE Co.,Ltd. Address before: 400061 No. 565, Tu Shan Road, Nan'an District, Chongqing Co-patentee before: SHANGHAI FOSUN PHARMACEUTICAL(GROUP)CO., Ltd. Patentee before: CHONGQING PHARMACEUTICAL RESEARCH INSTITUTE Co.,Ltd. Co-patentee before: HUAHONG PHARMACEUTICAL Co.,Ltd. GUANGXI ZHUANG AUTONOMOUS REGION |
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