CN100512800C - Orally disintegrating tablet for treating cerebral apoplexy and preparation process thereof - Google Patents
Orally disintegrating tablet for treating cerebral apoplexy and preparation process thereof Download PDFInfo
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- CN100512800C CN100512800C CNB2005100486472A CN200510048647A CN100512800C CN 100512800 C CN100512800 C CN 100512800C CN B2005100486472 A CNB2005100486472 A CN B2005100486472A CN 200510048647 A CN200510048647 A CN 200510048647A CN 100512800 C CN100512800 C CN 100512800C
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Abstract
The invention discloses an oral disintegration pill and making method for cerebral apoplexy, which comprises the following parts: 30-80g Paramecium flavone, 30-100g filler, 20-60g disintegration agent, 2-6g auxiliary flow agent and 3-15g corrigent.
Description
Technical field
The present invention relates to a kind of by oral cavity disintegration tablet that is applicable to treatment apoplexy disease that extracts in the natural plant crude drugs and preparation method thereof.
Background technology
Along with the raising of living standards of the people, people to diseases prevention, cure the disease, the requirement of recovery and healthy also improves thereupon.Cerebrovascular disease is one of human three big causes of the death, and the survivor half leaves sequela, is directly threatening the health of middle-aged and elderly people, and the cerebrovascular disease patient also has the trend of increase in person between twenty and fifty now.The body-building of the prevention of cerebrovascular disease and treatment, middle-aged and elderly people is at present prolonged life, the protection of between twenty and fifty people's cerebral ischemia has become the important topic of society and medical circle extensive concern, and country also is placed on critical positions to the development of treatment Chinese Traditional Medicines new product, novel form.
The Radix seu Caulis Embeliae Parviflorae total flavones is the extractive of general flavone of Primulaceae Radix seu Caulis Embeliae Parviflorae Lysimachia barystachys Bung. or short peach Lysimachia clethroides Duby.In D.C., general flavone content is 20%-90%, hyperin content is 1%-10%, and diseases such as treatment the apoplexy hemiplegia, numb limbs and tense tendons, facial hemiparalysis, the speech that cause be unfavorable are had curative effect preferably.Preliminary pharmacodynamic study shows; this extractive of general flavone has significant diastole effect to the Medulla Bovis seu Bubali tremulous pulse bar that exsomatizes; significantly increase rabbit carotid artery and cerebral blood flow, acute pulmonary embolism, respiratory distress and death due to the arachidonic acid antithrombotic are had obvious protective effect.
Because dosage form needs a large amount of water to send down when most oral formulations is taken, this makes and many old peoples and apoplexy patient or dysphagia is difficult to take when perhaps water intaking is inconvenient.Injection often is easy to generate anaphylaxis and untoward reaction again, and it is big that the while injection also exists operation easier, and patient's misery is also big, makes and medical treatment cost high the shortcoming that patient economy burden is heavy.Therefore be necessary to prepare and take convenient dosage form to satisfy the multiple needs that clinical treatment and family use.
Summary of the invention
Purpose of the present invention is intended to overcome the shortcoming of prior art, provide that a kind of absorption is fast, bioavailability is high, toxic and side effects is low, avoid liver first-pass effect, and needn't drink water, only need tens seconds to get final product rapid disintegrate in the oral cavity, can finish the oral cavity disintegration tablet of the treatment apoplexy disease of taking medicine with saliva hypopharynx.
Another object of the present invention is to provide the preparation method of this oral cavity disintegration tablet.
The oral cavity disintegration tablet of treatment apoplexy disease of the present invention is made up of following compositions in portion by weight: Radix seu Caulis Embeliae Parviflorae total flavones 30-80, filler 30-100, disintegrating agent 20-60, fluidizer 2-6, correctives 3-15.
Described oral cavity disintegration tablet can also distinguish or add jointly lubricant 1-5, the binding agent 1-5 of parts by weight on the basis of mentioned component.
Wherein:
The Radix seu Caulis Embeliae Parviflorae total flavones is alcohol extract or the water extract of Primulaceae Radix seu Caulis Embeliae Parviflorae Lysimachia barystachys Bung. or short peach Lysimachia clethroides Duby.In D.C..General flavone content is 20%-90%, and hyperin content is 1%-10%.
Described Radix seu Caulis Embeliae Parviflorae extractive of general flavone preparation method is made up of following steps:
One, carries out coarse pulverization after getting Radix seu Caulis Embeliae Parviflorae medical material cleaning;
Two, add the solvent thermal reflux, extract, of 4-12 times of amounts or boil and put forward, described solvent is 10-95% ethanol or water, refluxes merge extractive liquid, recovery solvent 1-3 hours;
Three, the extractum behind the recovery solvent adds the water of 1-4 times of amounts of medical material amount, is chilled to room temperature after boiling, and uses membrane filtration, and filtrate is pressed 1-4 times of last macroporous adsorptive resins of medical material amount, uses 1-20% alcoholic solution, 30-100% alcoholic solution eluting successively;
When four, eluent reclaims and to be concentrated into proportion behind the ethanol and to be 60 ℃ 1.30 or more after, 40 ℃ of-90 ℃ of vacuum dryings, pulverizing is sieved, and promptly gets the Radix seu Caulis Embeliae Parviflorae total flavones.
Binding agent: include but not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl level methylcellulose (HPMC), can use use also capable of being combined separately.
Filler: mannitol, microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin and maltodextrin, sucrose etc., can use use also capable of being combined separately.
Disintegrating agent: crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl level methylcellulose (L-HPC), cross-linked carboxymethyl cellulose (CCNa) etc., can use use also capable of being combined separately.
Correctives: mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Fluidizer: micropowder silica gel, Pulvis Talci, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant: magnesium stearate, glyceryl monostearate, Stepanol MG, Pulvis Talci etc., can use use also capable of being combined separately.
Because Radix seu Caulis Embeliae Parviflorae extractive of general flavone mildly bitter flavor, the present invention can adopt two kinds of diverse ways to carry out flavoring or taste masking: 1, adopt the direct flavoring of correctives; 2, in advance the Radix seu Caulis Embeliae Parviflorae extractive of general flavone is carried out powder coating with taste masking, concrete preparation method is as follows:
The preparation method of the oral cavity disintegration tablet of treatment apoplexy disease of the present invention is made up of following steps:
One, with correctives and Radix seu Caulis Embeliae Parviflorae extractive of general flavone mix homogeneously;
Two, take by weighing filler, disintegrating agent, fluidizer according to quantity, mix homogeneously again with step 1 gains mix homogeneously, adds binding agent, lubricant mixing;
Three, send into tablet machine, tabletting gets final product.
The preparation method of the oral cavity disintegration tablet of treatment apoplexy disease of the present invention is made up of following steps:
One, get coating material, be dissolved to weight percent concentration with solvent and be 14-20%, standby, getting the Radix seu Caulis Embeliae Parviflorae extractive of general flavone again places ebullated bed to make boiling, spray into above-mentioned solution then and carry out powder coating, get Radix seu Caulis Embeliae Parviflorae extractive of general flavone powder coating granule, dry back sieving for standby;
Two, take by weighing filler, disintegrating agent, fluidizer according to quantity, mix homogeneously again with step 1 gains mix homogeneously, adds binding agent, lubricant mixing;
Three, send into tablet machine, tabletting gets final product.
Described coating material is gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, methylcellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl level methylcellulose, acrylic resin, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), can use use also capable of being combined separately.
Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet of the present invention, its preparation method are to adopt common press device, and the manufacturer with preparation conventional tablet all can adopt.Adopt the oral cavity disintegration tablet of this method preparation to have enough hardness (intensity), can satisfy the requirement of production, packing, accumulating, have good mouthfeel and short disintegration time simultaneously again.
Tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of tablet machine-shaping, disintegrate is slow, bioavailability is low, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, and after the rapid disintegrate of chance saliva, by pharynx power, medicine can be gone into the tablet of stomach onset.Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate or dissolving, can swallow by conventional tablet, can be placed in the water again to take after the disintegrate, also can not need to take medicine with water swallow.Especially provide convenience for old man, dysphagia or the inconvenient person that fetches water take medicine,, then can improve patient's drug compliance greatly if adopt certain method to improve its mouthfeel in the preparation.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, toxic and side effects is low, avoids liver first-pass effect etc., and the Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet that reaches therefore of the present invention has remarkable advantages aspect the treatment apoplexy disease.
The pharmacodynamic study of pharmaceutical preparation of the present invention:
Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet has the obvious treatment effect to focal cerebral ischemia in rats; cerebral ischemia there is protective effect; in addition; Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet has obvious increase anesthetized dog cerebral blood flow (CBF); reduce cerebral vascular resistance (CVR); anticoagulant; suppress thrombosis; blood viscosity lowering; improve effects such as pia mater encephali microcirculation disturbance; the Medulla Bovis seu Bubali tremulous pulse bar that exsomatizes is had significant diastole effect, significantly increase rabbit carotid artery and cerebral blood flow, to acute pulmonary embolism due to the arachidonic acid antithrombotic; respiratory distress and death have obvious protective effect.The Radix seu Caulis Embeliae Parviflorae extractive of general flavone dose of pharmaceutical preparation of the present invention can be according to variations such as the type of route of administration, patient's age, body weight, the disease of being treated and the orders of severity, its day clothes dosage can be 40～200mg/ man day.
The toxicologic study of pharmaceutical preparation of the present invention:
Toxicologic study shows, the maximum tolerated dose that per os gives Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet is respectively: rat〉7.5g/kg, mice the 12.5g/kg.Beale Canis familiaris L. by 105,210, the 420mg/kg oral dose, rat by 0.35,0.70,1.40g/kg irritates stomach, continuous 6 months, hematology and biochemical indicator no abnormality seen, pathological examination is no abnormality seen also, learns check by statistics, compares there was no significant difference with the blank group.
The dissolution in vitro test shows the T of Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet
80=8 ' 24 ", T
90=12 ' 24 ", make common Radix seu Caulis Embeliae Parviflorae total flavones sheet or capsule, its T
80All more than 30 '; Disintegration test: oral cavity disintegration tablet in 2ml (19-21 ℃) water less than 50 "; and conventional tablet of making or capsule in 800ml (37 ℃) water generally all more than 10 ', so Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet has bioavailability height, rapid-action characteristics compared with common tablet or capsule.
In addition, Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablet mainly is to discharge at Orally disintegrating, and part can directly absorb by the Sublingual blood capillary, enters blood circulation, thereby avoids liver first-pass effect.
The specific embodiment
Embodiment 1 (directly flavoring method):
Get Radix seu Caulis Embeliae Parviflorae extractive of general flavone 40g, mannitol 80g, crospolyvinylpyrrolidone 60g, aspartame 5g.Above-mentioned raw materials is crossed 100 mesh sieves respectively, earlier with behind Radix seu Caulis Embeliae Parviflorae extractive of general flavone and the aspartame mixing, again with mannitol, crospolyvinylpyrrolidone mixing, with 95% ethanol wet granulation, 60 ℃ of vacuum dryings 3 hours, 30 mesh sieve granulate add ginseng essence 5g, dextrin 5g, micropowder silica gel 3g is behind the magnesium stearate 2g mixing, with 8mm drift tabletting, promptly get 1000 Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablets wanting required for the present invention, every heavy 200mg.
Embodiment 2 (directly flavoring method):
Get Radix seu Caulis Embeliae Parviflorae extractive of general flavone 80g, microcrystalline Cellulose 50g, crospolyvinylpyrrolidone 50g, aspartame 8g.Above-mentioned raw materials is crossed 100 mesh sieves respectively, earlier with behind Radix seu Caulis Embeliae Parviflorae extractive of general flavone and the aspartame mixing, again with microcrystalline Cellulose, crospolyvinylpyrrolidone mixing, with 95% ethanol wet granulation, 60 ℃ of vacuum dryings 3 hours, 30 mesh sieve granulate, add ginseng essence 3g, magnesium stearate 2g, micropowder silica gel 4g, dextrin 3g, behind the mixing, with 8mm drift tabletting, promptly get 1000 Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablets wanting required for the present invention, every heavy 200mg.
Embodiment 3 (powder coating taste masking method):
Get Radix seu Caulis Embeliae Parviflorae extractive of general flavone 40g, gelatin 40g, microcrystalline Cellulose 60g, micropowder silica gel 2g, crospolyvinylpyrrolidone 50g, aspartame 5g.Getting the Radix seu Caulis Embeliae Parviflorae extractive of general flavone places ebullated bed to seethe with excitement, gelatin is carried out Radix seu Caulis Embeliae Parviflorae extractive of general flavone powder coating with spraying into by certain speed after aspartame water dissolved dilution becomes 18% concentration, 50 mesh sieves are crossed in dry back, promptly get Radix seu Caulis Embeliae Parviflorae extractive of general flavone powder coating granule.With microcrystalline Cellulose, micropowder silica gel, crospolyvinylpyrrolidone, aspartame, behind the mixing again with sieve after the granule mixing, add magnesium stearate 3g at last, mixing; The intermediate content detection, determine that sheet is heavy after, send into tablet machine, with 8mm drift tabletting, promptly get 1000 Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablets wanting required for the present invention, every heavily about 200mg.
Embodiment 4 (powder coating taste masking method):
Get Radix seu Caulis Embeliae Parviflorae extractive of general flavone 60g, gelatin 40g, mannitol 40g, micropowder silica gel 2g, crospolyvinylpyrrolidone 48g, aspartame 5g, ethyl cellulose 2g.Getting the Radix seu Caulis Embeliae Parviflorae extractive of general flavone places ebullated bed to seethe with excitement, gelatin is carried out Radix seu Caulis Embeliae Parviflorae extractive of general flavone powder coating with spraying into by certain speed after aspartame water dissolved dilution becomes 18% concentration, 50 mesh sieves are crossed in dry back, promptly get Radix seu Caulis Embeliae Parviflorae extractive of general flavone powder coating granule.With mannitol, micropowder silica gel, crospolyvinylpyrrolidone, aspartame, ethyl cellulose, behind the mixing again with sieve after the granule mixing, add magnesium stearate 3g at last, mixing; The intermediate content detection, determine that sheet is heavy after, send into tablet machine, with 8mm drift tabletting, promptly get 1000 Radix seu Caulis Embeliae Parviflorae total-flavone mouth disintegrating tablets wanting required for the present invention, every heavily about 200mg.
Disintegration of the foregoing description and slice, thin piece hardness measurement numerical value are as follows:
Claims (7)
1, a kind of oral cavity disintegration tablet for the treatment of the apoplexy disease is characterized in that being made up of following compositions in portion by weight: Radix seu Caulis Embeliae Parviflorae total flavones 30-80, filler 30-100, disintegrating agent 20-60, fluidizer 2-6, correctives 3-15; Described filler is one or more the combination in mannitol, microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin, maltodextrin, the sucrose; Described disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl level methylcellulose, the cross-linked carboxymethyl cellulose; Described fluidizer is one or more the combination in micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate; Described correctives is one or more the combination in mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, the citric acid.
2, a kind of oral cavity disintegration tablet for the treatment of the apoplexy disease, it is characterized in that forming: Radix seu Caulis Embeliae Parviflorae total flavones 30-80, filler 30-100, disintegrating agent 20-60, fluidizer 2-6, correctives 3-15, lubricant 1-5 by following compositions in portion by weight; Described filler is one or more the combination in mannitol, microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin, maltodextrin, the sucrose; Described disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl level methylcellulose, the cross-linked carboxymethyl cellulose; Described fluidizer is one or more the combination in micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate; Described correctives is one or more the combination in mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, the citric acid; Described lubricant is one or more the combination in magnesium stearate, glyceryl monostearate, Stepanol MG, the Pulvis Talci.
3, a kind of oral cavity disintegration tablet for the treatment of the apoplexy disease, it is characterized in that forming: Radix seu Caulis Embeliae Parviflorae total flavones 30-80, filler 30-100, disintegrating agent 20-60, fluidizer 2-6, correctives 3-15, binding agent 1-5 by following compositions in portion by weight; Described filler is one or more the combination in mannitol, microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin, maltodextrin, the sucrose; Described disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl level methylcellulose, the cross-linked carboxymethyl cellulose; Described fluidizer is one or more the combination in micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate; Described correctives is one or more the combination in mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, the citric acid; Described binding agent is one or more the combination in starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, alginic acid, alginate, xanthan gum or the hydroxypropyl emthylcellulose.
4, a kind of oral cavity disintegration tablet for the treatment of the apoplexy disease, it is characterized in that forming: Radix seu Caulis Embeliae Parviflorae total flavones 30-80, filler 30-100, disintegrating agent 20-60, fluidizer 2-6, correctives 3-15 by following compositions in portion by weight, lubricant 1-5, binding agent 1-5; Described filler is one or more the combination in mannitol, microcrystalline Cellulose, lactose, starch, pregelatinized Starch, dextrin, maltodextrin, the sucrose; Described disintegrating agent is one or more the combination in crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl level methylcellulose, the cross-linked carboxymethyl cellulose; Described fluidizer is one or more the combination in micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate; Described correctives is one or more the combination in mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, the citric acid; Described lubricant is one or more the combination in magnesium stearate, glyceryl monostearate, Stepanol MG, the Pulvis Talci; Described binding agent is one or more the combination in starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone, alginic acid, alginate, xanthan gum or the hydroxypropyl emthylcellulose.
5, the oral cavity disintegration tablet of treatment apoplexy disease as claimed in claim 4 is characterized in that being made up of following compositions in portion by weight: Radix seu Caulis Embeliae Parviflorae total flavones 60, gelatin 40, mannitol 40, micropowder silica gel 2, crospolyvinylpyrrolidone 48, aspartame 5, ethyl cellulose 2 and magnesium stearate 3.
6, the oral cavity disintegration tablet of treatment apoplexy disease as claimed in claim 2 is characterized in that being made up of following compositions in portion by weight: Radix seu Caulis Embeliae Parviflorae total flavones 40, gelatin 40, microcrystalline Cellulose 60, micropowder silica gel 2, crospolyvinylpyrrolidone 50, aspartame 5 and magnesium stearate 3.
7, the preparation method of the oral cavity disintegration tablet of treatment apoplexy disease as claimed in claim 4 is characterized in that being made up of following steps:
One, with correctives and Radix seu Caulis Embeliae Parviflorae total flavones mix homogeneously;
Two, take by weighing filler, disintegrating agent, fluidizer, mix homogeneously again with step 1 gains mix homogeneously, adds binding agent, lubricant mixing;
Three, send into tablet machine, tabletting gets final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100486472A CN100512800C (en) | 2005-11-24 | 2005-11-24 | Orally disintegrating tablet for treating cerebral apoplexy and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100486472A CN100512800C (en) | 2005-11-24 | 2005-11-24 | Orally disintegrating tablet for treating cerebral apoplexy and preparation process thereof |
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| Publication Number | Publication Date |
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| CN1969893A CN1969893A (en) | 2007-05-30 |
| CN100512800C true CN100512800C (en) | 2009-07-15 |
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| CNB2005100486472A Expired - Fee Related CN100512800C (en) | 2005-11-24 | 2005-11-24 | Orally disintegrating tablet for treating cerebral apoplexy and preparation process thereof |
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| CN102988318A (en) * | 2008-11-25 | 2013-03-27 | 田边三菱制药株式会社 | Orally rapidly disintegrating tablet and process for producing same |
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