CN1296042C - Acetyl salicyl sulfonone oral cavity disintegration tablet and its preparation method - Google Patents
Acetyl salicyl sulfonone oral cavity disintegration tablet and its preparation method Download PDFInfo
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- CN1296042C CN1296042C CNB2005100681032A CN200510068103A CN1296042C CN 1296042 C CN1296042 C CN 1296042C CN B2005100681032 A CNB2005100681032 A CN B2005100681032A CN 200510068103 A CN200510068103 A CN 200510068103A CN 1296042 C CN1296042 C CN 1296042C
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Abstract
A sindacon oral disintegrating tablet prepared by the technology of the present invention has the effects of obviously relieving the pathological change of an ultra-micro structure of an ischemical reperfusion injury area, obviously improving the SOD activity of a rat cardiac muscle structure, reducing MDA generation, improving ischemic myocardial blood circulation, increasing myocardial blood flowing amount, reducing myocardial oxygen consumption, eliminating oxygen free groups, increasing oxygen resistance, promoting and improving myocardial collateral circulation, lowering blood fat, preventing blood cell coagulation and lowering the permeability and the brittleness of capillary vessels. The present invention is generally used for treating cardio-cerebrovascular systemic diseases in clinic, particularly coronary diseases, angina pectoris, concurrent cardiac functional insufficiency of cardiomyopathy, ischemic heart diseases, hyperlipemia blood symptoms and high-viscosity blood symptoms. The present invention also relates to preparing methods of the sindacon oral disintegrating tablet, which comprise a direct taste correcting method, a powder coating preparing method and a mini-pill medicine-coating method.
Description
Technical field
The present invention relates to a kind of acetyl salicyl sulfonone oral cavity disintegration tablet of field of pharmaceutical preparations, it can be used for treating diseases of cardiovascular and cerebrovascular systems, especially coronary heart disease, angina pectoris, the concurrent cardiac insufficiency of myocarditis, ischemic heart desease, and hyperlipidemia mass formed by blood stasis and high blood viscosity.The invention still further relates to the preparation method of described acetyl salicyl sulfonone oral cavity disintegration tablet.
Background technology
Fructus Hippophae flavone is the flavone compound that extracts from Elaeangnaceae plant Fructus Hippophae (claiming the vinegar willow again, Hippophae rhamnoides L.), and Fructus Hippophae is the main areal area of hippophae plant in the areas such as northeast, North China, northwest and southwest of China.All contain flavone compound in Fructus Hippophae and the leaf, the total content of the flavone compound in the leaf is than high in the fruit.The chemical compound of certified flavonoid has: Quercetin, isorhamnetin, kaempferol and glycoside thereof, myricetin, chlorogenic acid, pigweed glycosides, catechol and astragaloside etc.At present, the flavone compound-Fructus Hippophae flavone that extracts from Fructus Hippophae has been widely used in clinical
[1]
1. be used for the treatment of angina pectoris
Application Fructus Hippophae flavone sheets such as Zhang Zhen is virtuous are treated 101 routine angina pectoris (blood stasis disease) patient, and clinical efficacy shows: the Fructus Hippophae flavone sheet can significantly reduce angina pectoris attacks frequency and nitroglycerin day consumption, and its total effective rate is 87.13%; Improving the electrocardiogram effective percentage is 53.85%; And can significantly reduce blood viscosity.Du Shaoxing etc. have observed the curative effect of Fructus Hippophae flavone to the patients with coronary heart disease left heart function, find that treatment back patient's clinical symptoms is improved, and obviously reduce diastolic pressure.Treat forward and backward using ultrasound kinetocardiogram the measurement result of left heart function shown, left chamber week the footpath LVFS, whenever the amount of fighting, heart output all are significantly improved in left chamber.Tian Qingyin etc. treat 36 routine patients with coronary heart disease with Fructus Hippophae flavone, to inquire into its mechanism of action.The blood plasma oxidized low density lipoprotein level behind the patient treatment of finding significantly reduces, and shows that Fructus Hippophae flavone plays an important role to the control of coronary heart disease.
2. ischemic heart desease
Flood and show etc. show that with Fructus Hippophae flavone treatment ischemic heart desease result the treatment effective percentage is up to 94%.Electrocardiogram improvement rate reaches 54.8%, and the back effective time of taking medicine is slower, but clinical symptoms and Electrocardiographic improvement are compared lasting stability, therefore infers that this medicine not exclusively is to bring into play clinical efficacy by direct blood vessel dilating.Analyzing its mechanism, may be by preventing platelet aggregation, reduces capillary permeability and fragility, increases myocardium antioxidant capacity under the situation of keeping blood capillary normal configuration and function, and promotes and improve the side Zhi Xunhuan of heart.
The concurrent cardiac insufficiency of 3 myocarditiss
Su Qinghe etc. use Fructus Hippophae flavone and concurrent diastolic dysfunction 61 example and 52 examples of digoxin (matched group) treatment myocarditis respectively.The result shows that Fructus Hippophae flavone sheet group obvious effective rate and total effective rate are all apparently higher than the digoxin group.After 2 weeks, stroke volume, minute output, ejection fraction, left chamber weak point have remarkable increase before LVFS is all than treatment with Fructus Hippophae flavone, and the prompting Fructus Hippophae flavone truly has the good effect that improves cardiac function.Analyze its mechanism, may suppress the myocardial ATP enzyme and show the positive inotropic effect, impel blood supply of cardiac muscle to improve and peripheral vascular expansion, make factors such as cardiac afterload alleviates relevant with this medicine.
4 hyperlipemias and high blood viscosity
Big an ancient unit of weight of Xin etc. has compared Fructus Hippophae flavone and the high fat of Treated with Radix Salviae Miltiorrhizae, high blood viscosity patient's curative effect.Method is that treatment group 35 examples are used Fructus Hippophae flavone 20mg, and is oral, 1 day 3 times; Matched group Radix Salviae Miltiorrhizae 10mg, oral, 1 day 2 times, be for 6 weeks the course of treatment, found that treatment group cholesterolemia, triglyceride, apolipoprotein B100, plasma coagulation factors, blood viscosity, platelet aggregation rate and thrombosis index are all than having significantly before the treatment or extremely significantly descending.Matched group is 10s at shear rate
-1The time blood viscosity have extremely significantly before the treatment and descend, be 100s at shear rate
-1The time haemoconcentration and thrombosis index before the treatment remarkable decline is arranged.After showing the Fructus Hippophae flavone treatment, majority parameters (is removed 10s
-1The blood viscosity index is outer) descend, effect is better than Radix Salviae Miltiorrhizae.
5 pairs of hemodynamic influences
Adopt double-blind method, measure take medicine forward and backward healthy volunteer's cardiac function and Changes of hemodynamics with Admittance, STI method, the result shows
[14], oral Fructus Hippophae flavone 10mg/ time can make the ratio and the isovolumic contraction time of ratio, isovolumic contraction time and the left chamber ejection time of time and left chamber ejection time before row's blood of normal person significantly dwindle; Whenever significantly increase of the amount of fighting, minute output, cardiac index, myocardial contraction intensity index, heart are whenever fought and are made the trend that work index etc. all has increase; Total peripheral resistance significantly reduces, and blood vessel degree of complying with significantly increases.The The above results explanation, Fructus Hippophae flavone can strengthen contractile function, the pumping function of normal person's cardiac muscle, and can reduce Peripheral resistance, increases blood vessel elasticity.Wu Ying etc.
[15]Cause anesthetized open-chest dog heart failure model with pentobarbital sodium, intravenous injection Fructus Hippophae total flavones 4.8mg/kg and 9.7mg/kg all can make heart failure dog cardiac output, cardiac index, intraventricular pressure change maximum rate (+LVdP/dt
Max) and the left ventricular pressure peak value obviously raise.During injection 9.7mg/kg, the starting point that ventricle begins to shrink obviously shortens to the interval of the maximum rate of change of intraventricular pressure;-LVdP/dt
MaxObviously increase; T value, left chamber EDP obviously descend; Total peripheral vascular resistance and maximal oxygen consumption obviously reduce,, aorta mean arterial pressure and heart rate do not have obvious influence.As seen: quiet notes Fructus Hippophae total flavones can obviously strengthen heart pump function and the myocardial contractility of heart failure dog, and can obviously improve the myocardial relaxation performance, reduces peripheral vascular resistance and myocardial oxygen consumption, illustrates that Fructus Hippophae flavone has the effect of anti-heart failure.
6 pairs of hemorheological influences
People find in the influence of research Fructus Hippophae flavone sheet to hemorheology and blood fat, the measured value of patient's whole blood contrast viscosity, plasma viscosity, plasma fibrinogen, packed cell volume all reduces than having extremely significantly before measuring after taking medicine, prompting Fructus Hippophae flavone sheet can increase the negative charge of erythrocyte surface, increase intercellular repulsive force, impel the erythrocyte depolymerization, make hemodilution.Illustrate that this medicine has the effect of tangible reduction plasma fibrinogen, thereby reduce the function of plasma viscosity.Wang Bingwen etc. give rat oral gavage with Fructus Hippophae total flavones 4mg/ (kgd) and 20mg/ (kgd), and 16d can significantly reduce the high shear rate (200s of normal rat continuously
-1) under whole blood viscosity; To erythrocyte electrophoretic time, hematid specific volume, reduced viscosity and erythrocyte sedimentation rate there are no significant the influence; At shear rate is 100s
-1And 200s
-1The time, Fructus Hippophae total flavones 20mg/ (kgd) can significantly improve plasma viscosity, is 100s at shear rate
-1The time, Fructus Hippophae total flavones 20mg/ (kgd) can significantly reduce whole blood contrast viscosity.
The protective effect of 7 pairs of rat heart muscle reperfusions injury
The influence of the ultrastructure when Wu Ying etc. have observed Fructus Hippophae total flavones to the rat heart muscle reperfusion injury and active malonaldehyde (MDA) content in to cardiac muscular tissue's superoxide dismutase (SOD).Method is made the myocardial ischemia-reperfusion model for behind the intramuscular injection Fructus Hippophae total flavones 6d in advance with the SD rat.Ischemia 40min as a result; Fructus Hippophae total flavones can obviously alleviate the Ultrastructural pathological change in ischemical reperfusion injury district after pouring into 30min again; it is active and reduce the generation of MDA to significantly improve rat heart muscle tissue SOD, this protective effect may with improve the active of free radical scavenging enzyme and suppress lipid peroxidation relevant.
The influence of 8 pairs of vascular smooth muscles
Yu Xiaohong etc. adopt isolated rabbit thoracic aorta bar specimen, observe Fructus Hippophae flavone to KCl, CaCl
2The influence that the vascular smooth muscle that brings out with norepinephrine shrinks
[19], find that Fructus Hippophae total flavones can obviously resist KCl, CaCl
2With the contractile response of norepinephrine, amount effect curve is moved to right to the myocardium vessel smooth muscle; Also can obviously suppress tame rabbit aorta strip Ca
2+Interior stream dependency shrinks.The above results shows that the vasorelaxation action of Fructus Hippophae flavone may be relevant with the retardance calcium channel.
In sum, Fructus Hippophae flavone can improve the blood circulation of ischemic myocardial as a kind of pure Chinese medicine extract, increases the blood flow of cardiac muscle, reduces the oxygen consumption of cardiac muscle, eliminates oxygen-derived free radicals, improves oxygen-resistant ability, and can promote and improve the side Zhi Xunhuan of cardiac muscle; The energy blood fat reducing prevents the hemocyte cohesion simultaneously, reduces the permeability and the fragility of blood capillary.To treating and prevent all safety, effective of multiple cardiovascular disease, no obvious toxicity.
Beneficial effect
When taking medicine, the Fructus Hippophae flavone conventional tablet need water to take, for coronary heart disease, angina pectoris and hyperpietic, take too much water and must increase the patient's heart load, therefore be unfavorable for patient's treatment, for the heavier patient of disease, may have influence on patient's safety, therefore Fructus Hippophae flavone is made the oral cavity disintegration tablet that does not need water to take helps rehabilitation of patients and treatment, helps improving the safety of treatment.In addition, owing to reasons such as technologies of preparing, exist that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor after most of common oral preparation are taken and problem such as bioavailability is lower, thereby influence the performance of drug effect, also directly affect the effect of treatment.Therefore, be necessary to prepare and take convenient dosage form to satisfy the multiple needs that clinical treatment and family use.
The shortcoming of the present invention by providing a kind of acetyl salicyl sulfonone oral cavity disintegration tablet to overcome ordinary preparation satisfied the demand of clinical application.
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 chance saliva is collapsed broken rapidly, and reflexive enters in the body with swallowing act.Be characterized in that absorption is fast, bioavailability is high, intestinal is residual few, taking convenience.Oral cavity disintegration tablet needn't be used water delivery service, and saliva can make its disintegrate.The disintegration time of oral cavity disintegration tablet of the present invention is short, and is generally can disintegrate in 60 seconds complete, helps medicine stripping and absorption, onset is rapid, the more important thing is owing to need not take water, reduced the load of patient's heart, effectively improving the safety for the treatment of in the treatment patient disease.
Summary of the invention
One, prescription
The present invention provides a kind of acetyl salicyl sulfonone oral cavity disintegration tablet in one aspect, and its prescription is a raw material with the Fructus Hippophae flavone, is adjuvant with filler, disintegrating agent, correctives, fluidizer, lubricant etc., and randomly uses coating material.
Fructus Hippophae flavone among the present invention is a kind of raw material of using prior art for preparing, and domestic have manufacturer to produce, and raw material standard is WS-10001-(HD-1311)-2003
[2]
Comprise following compositions (by weight percentage) in the oral cavity disintegration tablet of the present invention:
1. Fructus Hippophae flavone 2%～20%
2. filler 50%～90%
3. coating material 0～10%
4. disintegrating agent 10%～35%
5. correctives 0.2%～10%
6. fluidizer 0.2%～5%
7. lubricant 0.1%～3%
Count by weight percentage, the preferable amount of the Fructus Hippophae flavone in this prescription is 3%～15%.
In the present invention, coating material is a kind of optional member.The coating material coating material that can be used among the present invention is selected from acrylic resin, ethyl cellulose, methylcellulose, hydroxypropyl emthylcellulose, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester.Can use separately, also can be used.In oral cavity disintegration tablet of the present invention, the content of coating material is preferably 0～8%, and more preferably 0～6%.
In the present invention, filler can be selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, xylitol, sorbitol, erythrose, glucose, polymerization sugar, SMCC or pregelatinized Starch etc., perhaps their combination in any.In oral cavity disintegration tablet of the present invention, the content of filler is preferably 35%～80%, and more preferably 40%～80%.
In the present invention, disintegrating agent can be selected from crospolyvinylpyrrolidone (PPVP), carboxymethyl starch sodium (CMS-Na), low-substituted hydroxypropyl cellulose (L-HPC), cross-linking sodium carboxymethyl cellulose etc., perhaps their combination in any.In oral cavity disintegration tablet of the present invention, the content of disintegrating agent is preferably 12%～35%, and more preferably 15%～35%.
In the present invention, correctives can be selected from mannitol, lactose, stevioside, gelatin, Aspartane, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid or citric acid etc., perhaps their combination in any, but be not limited thereto.In oral cavity disintegration tablet of the present invention, the content of correctives is preferably 0.5%～8%, and more preferably 0.5%～5%.
Two, preparation method
The invention still further relates to the preparation method of acetyl salicyl sulfonone oral cavity disintegration tablet, a kind of preparation method wherein is as follows.
The first step is got Fructus Hippophae flavone and partially filled dose and is put into mixer granulator, stirs.Add binding agent and make granule with mixer granulator, granule was dried 30 mesh sieve granulate;
Second step will make granule takes by weighing also mix homogeneously according to quantity with other filler, disintegrating agent, correctives, fluidizer, it is standby to add the lubricant mixing at last;
The 3rd step gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
The another kind of preparation method of oral cavity disintegration tablet of the present invention is as follows.
The first step is got selected coating material, with for example dissolvings such as ethanol, acetone or alcohol aqueous solution or aqueous acetone solution of solvent that adapt with it, and is diluted to debita spissitudo, preferred 2%-12% (w/v), and more preferably 3%-8% (w/v) makes coating solution.
Second step got Fructus Hippophae flavone and mixes with micropowder silica gel and place fluid bed to make boiling, spray into coating solution with suitable speed then and carry out powder coating, coated granule, drying is sieving for standby afterwards.
The 3rd step will make coated granule takes by weighing according to quantity and mix homogeneously with filler, disintegrating agent, correctives, fluidizer, add the lubricant mixing at last, the gained material detects through intermediate, determine the sheet weight after, tabletting is promptly.
Another preparation method of oral cavity disintegration tablet of the present invention is as follows.
The grain that the first step is taken prior art production places coating pan or fluid bed or centrifugal coating granulator through the celphere between 200 microns to 500 microns, the Fructus Hippophae flavone powder is dissolved in the surface that is sprayed on the ball core in the ethanol, medicated powder is sticked on the ball core, make the pastille micropill; Second step was got the coating material for example dissolvings such as ethanol, acetone or alcohol aqueous solution or aqueous acetone solution of solvent that adapt with it, and was diluted to debita spissitudo, and preferred 3%-8% (w/v) makes coating solution.
The 3rd step got the micropill that contains Fructus Hippophae flavone and places coating pan or fluid bed or centrifugal coating granulator, sprayed into coating solution with suitable speed then and carried out the micropill coating, got coated micropill, dry back sieving for standby.
The 4th step will make coated micropill takes by weighing according to quantity and mix homogeneously with filler, disintegrating agent, correctives, fluidizer, add the lubricant mixing at last, the gained material detects through intermediate, determine the sheet weight after, tabletting is promptly.
Oral cavity disintegration tablet of the present invention can adopt common press device and technology to be prepared, and the manufacturer with preparation conventional tablet all can implement.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.
The specific embodiment
For better explanation the present invention, as follows in conjunction with preparation technology's illustrative example, these embodiment just are used for further setting forth the present invention, and the content that does not limit the present invention in any way.
Embodiment 1
One, prescription
1. raw material---Fructus Hippophae flavone 100.0g;
2. filler---microcrystalline Cellulose 140.0g;
Mannitol 860.0g;
3. disintegrating agent---crospolyvinylpyrrolidone 120.0g;
Low-substituted hydroxypropyl cellulose 180.0g;
4. correctives---Aspartane 20.0g;
5. lubricant---magnesium stearate 13.0g;
Make 10000 altogether
Two, preparation method
The first step is got Fructus Hippophae flavone and microcrystalline Cellulose 140g and is put into mixer granulator and stir, and is binding agent with 5% polyvidone ethanol liquid, makes granule with mixer granulator, and granule was dried 30 mesh sieve granulate;
Second step will make granule with mannitol, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Aspartane, take by weighing also mix homogeneously according to quantity, it is standby to add the lubricant mixing at last;
The 3rd step gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
Embodiment 2
One, prescription
1. raw material---Fructus Hippophae flavone 100.0g;
2. filler---microcrystalline Cellulose 260.0g;
Mannitol 1240.0g;
3. disintegrating agent---crospolyvinylpyrrolidone 200.0g;
Low-substituted hydroxypropyl cellulose 250.0g;
4. correctives---Aspartane 15.0g;
5. lubricant---magnesium stearate 15.0g;
Make 20000 altogether
Two, preparation method
The technical process of embodiment 2 is identical with embodiment's 1.
Embodiment 3
One, prescription
1. raw material---Fructus Hippophae flavone 100.0g;
2 filleies---mannitol 1100.0g;
Microcrystalline Cellulose 240.0g
3. coating material---Eudragit
E100 20.0g;
Eudragit
NE-30D 3.0g
4. fluidizer---micropowder silica gel 10.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 140.0g.
Low-substituted hydroxypropyl cellulose 160.0g
6. correctives---Aspartane 15.0g;
7. lubricant---magnesium stearate 10.0g;
Make 20000 or 10000 altogether
Two, preparation method
The first step is got Eudragit
The E100 dissolve with ethanol adds Eudragit
NE-30D stirs, and with ethanol dilution to 6%, standby as coating solution.
Second step got Fructus Hippophae flavone and micropowder silica gel mixes, and places fluid bed to make boiling, sprays into coating solution with suitable speed then and carry out powder coating, gets coated granule, dry back sieving for standby.
The 3rd step will make coated granule and mannitol, microcrystalline Cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Aspartane, take by weighing also mix homogeneously according to quantity, add the magnesium stearate mixing at last, the gained material detects through intermediate, determine that sheet is heavy after, tabletting is promptly.
Embodiment 4
One, prescription
1. raw material---Fructus Hippophae flavone 100.0g;
2 filleies---mannitol 900.0g;
Microcrystalline Cellulose 240.0g;
Celphere 200.0g;
Starch 100.0g;
3. coating material---Eudragit
E100 20.0g;
4. fluidizer---micropowder silica gel 10.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 120.0g;
Low-substituted hydroxypropyl cellulose 160.0g
6. correctives---Aspartane 15.0g;
7. lubricant---magnesium stearate 10.0g;
Make 20000 or 10000 altogether
Preparation method
The first step is got grain through being that 200 microns celphere is put in the coating pan; Fructus Hippophae flavone is dissolved in 1200 milliliters of ethanol liquid that contain 2% polyvidone, is sprayed on the surface of ball core, make the pastille micropill;
Second step was got coating material with dissolve with ethanol and be diluted to 6% concentration, made coating solution;
The 3rd step got the micropill that contains Fructus Hippophae flavone and places centrifugal coating granulator, sprayed into coating solution with suitable speed then and carried out coating, got coated micropill;
The 4th step will make coated micropill takes by weighing according to quantity and mix homogeneously with filler, disintegrating agent, correctives, fluidizer, add the lubricant mixing at last, the gained material detects through intermediate, determine the sheet weight after, tabletting is promptly.
The mensuration of 5 disintegrations of embodiment
For estimating medicine, carry out following experiment in intraoral disintegrate effect.
Get 6 in the beaker of 50ml, put in 37 ℃ the water-bath, respectively add water 2ml, placed 10 minutes, make hygral equilibrium, get in the foregoing description 16 of the orally disintegrating tablet preparations of preparation, every adds in the beaker timing respectively, shake beaker gently, be as the criterion with the label that can judge not disintegrate, measure the time of complete disintegrate, should disintegrate in 60 seconds.Calculate the average disintegration time of 6 tablets, be decided to be disintegration.According to similar methods, measure the disintegration of the oral cavity disintegration tablet of embodiment 2, embodiment 3 and embodiment 4 preparations, side by side in following table 1.
| Embodiment | Disintegration (second) |
| Embodiment 1 embodiment 2 embodiment 3 embodiment 3 | Average 23 seconds average 21 seconds average 16 seconds average 14 seconds |
List of references:
[1] Ge Shengrong etc. 2000 11 3 phases of volume of China Dispensary: 134～135.
[2] national drug standards are the 14th: 14-49, WS-10001-(HD-1311)-2003
Claims (7)
1. acetyl salicyl sulfonone oral cavity disintegration tablet, it is characterized in that its weight consists of Fructus Hippophae flavone 2～20%, clothing sheet material polyacrylic resin 1.28～2%, disintegrating agent polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose amount to 10～35%, filler 50-90%, correctives 0.2～10%, fluidizer 0.2～5%, lubricant 0.1～3% is formed, wherein filler is selected from mannitol, microcrystalline Cellulose, dextrin, lactose, starch, maltodextrin, in polymerization sugar and the pregelatinized Starch one or more, correctives is selected from mannitol, lactose, stevioside, gelatin, aspartame, cyclamate, glycyrrhizin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, in the citric acid one or more, fluidizer is selected from micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, in the hydrated sodium aluminosilicate one or more, lubricant is selected from magnesium stearate, glyceryl monostearate, Stepanol MG, in the Pulvis Talci, in the sodium stearyl fumarate one or more; After wherein Fructus Hippophae flavone being carried out powder coating with coating material, the gained granule is pressed into disintegrating tablet with other adjuvant.
2. a kind of acetyl salicyl sulfonone oral cavity disintegration tablet as claimed in claim 1, wherein filler is mannitol and/or microcrystalline Cellulose.
3. a kind of acetyl salicyl sulfonone oral cavity disintegration tablet as claimed in claim 1, wherein correctives is an aspartame.
4. a kind of acetyl salicyl sulfonone oral cavity disintegration tablet as claimed in claim 1, wherein lubricant is a magnesium stearate.
5. a kind of acetyl salicyl sulfonone oral cavity disintegration tablet as claimed in claim 1, wherein fluidizer is micropowder silica gel.
6. a kind of acetyl salicyl sulfonone oral cavity disintegration tablet as claimed in claim 1, it is characterized in that its weight consists of: 100 parts of Fructus Hippophae flavones, 23 parts of polyacrylic resins, 1100 parts in mannitol, 15 parts of Aspartane, 140 parts of crospolyvinylpyrrolidone, 160 parts of low-substituted hydroxypropyl celluloses, 10 parts of micropowder silica gels, 10 parts of magnesium stearate, 240 parts of microcrystalline Cellulose.
7. as the preparation method of any described acetyl salicyl sulfonone oral cavity disintegration tablet of claim 1-6, it is characterized in that forming by following steps:
The pretreatment of first step Fructus Hippophae flavone; Get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, get Fructus Hippophae flavone again and place fluid bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get Fructus Hippophae flavone powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and Fructus Hippophae flavone granule or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, added the lubricant mixing, and is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1490000A (en) * | 2003-09-15 | 2004-04-21 | 南昌弘益科技有限公司 | Hippophae rhamnoide flavone drops and preparation thereof |
| CN1586483A (en) * | 2004-07-12 | 2005-03-02 | 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 |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1490000A (en) * | 2003-09-15 | 2004-04-21 | 南昌弘益科技有限公司 | Hippophae rhamnoide flavone drops and preparation thereof |
| CN1586483A (en) * | 2004-07-12 | 2005-03-02 | 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 |
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