CN100394917C - Bilobanoate oral-cavity disintegrating tablet and preparation method - Google Patents
Bilobanoate oral-cavity disintegrating tablet and preparation method Download PDFInfo
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- CN100394917C CN100394917C CNB2005100572849A CN200510057284A CN100394917C CN 100394917 C CN100394917 C CN 100394917C CN B2005100572849 A CNB2005100572849 A CN B2005100572849A CN 200510057284 A CN200510057284 A CN 200510057284A CN 100394917 C CN100394917 C CN 100394917C
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Abstract
The present invention relates to a bilobanoate oral disintegrating tablet and a preparation method thereof. The tablet is mainly prepared from components of the following shares by weight: 2 to 40 shares of bilobanoate, 1 to 20 shares of disintegrating agent and 2 to 100 shares of bulking agent. The preparation method which is disclosed by the present invention is simple. Prepared bilobanoate oral disintegrating tablet can be dissolved in a small quantity of water, and disintegrated in short time. The tablet has good mouth feel. The compliance of patients who need taking medicines for a long time is largely improved, so therapeutic effect is guaranteed.
Description
Technical field
The present invention relates to a kind of ginkgo flavone and lactone tablet and preparation method thereof, be specifically related to a kind of blood circulation promoting and blood stasis dispelling function that has, dizzy and the coronary heart disease that the treatment blood stasis type thoracic obstruction and the slight cerebral arteriosclerosis of blood stasis type cause, anginal Bilobanoate oral-cavity disintegrating tablet and preparation method thereof.
Background technology
Ginkgo flavone and lactone is extraction from Folium Ginkgo, the refining two class new Chinese medicines through the formal production of National Drug Administration's approval that form, and it contains flavone, flavonol glycosides, obedient class lactone etc.Have the degree of myocardial ischemia of improving the coronary ligation dog, dwindle the myocardial ischemia scope, suppress ADP, the accumulative effect of collagen hyperamization platelet.
Ginkgo flavone and lactone is the effective site in the domestic Folium Ginkgo of at first developing, and drugs approved by FDA enters the U.S. and carries out clinical research.The present domestic a kind of dosage form of granule of having only.Need use water-solubleization of eliminating cold for resuscitation when granule is taken, take inconvenient; Especially for the patient of water intaking difficulty, usually be difficult to take medicine on request; And every bag of 1g of granule, volume is bigger, carries inconvenience; This medicine treatment simultaneously is longer the course of treatment, need take for a long time.Above factor all may cause patient's compliance poor, thereby can't guarantee therapeutic effect.
Summary of the invention
Purpose of the present invention just is a kind of taking convenience is provided, and is mainly used in dizzy and coronary heart disease, anginal Bilobanoate oral-cavity disintegrating tablet that the treatment blood stasis type thoracic obstruction and the slight cerebral arteriosclerosis of blood stasis type cause.
Another object of the present invention provides the preparation method of this oral cavity disintegration tablet.
The object of the present invention is achieved like this: a kind of Bilobanoate oral-cavity disintegrating tablet is characterized in that it is mainly made by following components in part by weight: 2～40 parts of ginkgo flavone and lactone, 1～20 part of disintegrating agent, 2～100 parts of filleies.
Above-mentioned disintegrating agent is selected one or more in the following raw material for use: the tween 80 in microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, citric acid, sodium bicarbonate, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, the surfactant, sodium lauryl sulphate.
Above-mentioned filler is selected one or more in the following raw material for use: microcrystalline Cellulose, microcrystalline Cellulose-micropowder silica gel, lactose, starch, modified starch-1500, mannitol, sorbitol, xylitol, erythrose, pregelatinized Starch, Icing Sugar, glucose, dextrin.
In wet granulation, the present invention has also increased binding agent, and its amount adds wherein by 2～40 weight portions; The selected binding agent of the present invention is selected one or more in the following raw material for use: starch slurry, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, carbomer, dextrin, gelatine size, mucialga of arabic gummy, water, ethanol, sodium alginate, syrup.
In order to improve mouthfeel, can increase correctives, its amount adds wherein by 1～40 weight portion; The selected correctives of the present invention is selected one or more in the following raw material for use: sucrose, glucose, steviosin, stevioside, glycyrrhizin, mannitol, sorbitol, xylitol, citric acid, aspartame, cyclamate, Suo Matian, glucide, Mentholum, flavoring orange essence, strawberry essence, chocolate essence.
In order to increase particulate flowability, the present invention has also increased lubricant, and its amount adds wherein by 0.2～6 weight portion; The selected lubricant of the present invention is selected one or more in the following raw material for use: stearic acid, magnesium stearate, calcium stearate, micropowder silica gel, Pulvis Talci, hydrogenated vegetable oil, polyethylene glycol 6000, Macrogol 4000, fumaric acid sodium stearate.
The optimum ratio of above-mentioned Bilobanoate oral-cavity disintegrating tablet is: 2～20 parts of ginkgo flavone and lactone, 2～10 parts of disintegrating agents, 4～40 parts of filleies, 4～20 parts of binding agents, 2～20 parts of correctivess, 1～4 part of lubricant, and all in parts by weight.
The best proportioning of above-mentioned Bilobanoate oral-cavity disintegrating tablet is: ginkgo flavone and lactone 40, microcrystalline Cellulose 15, mannitol 60, crospolyvinylpyrrolidone 4, carboxymethyl starch sodium 6.5, glycyrrhizin 9, strawberry essence 8, fumaric acid sodium stearate 1, and all in parts by weight.
The best proportioning of above-mentioned Bilobanoate oral-cavity disintegrating tablet is: ginkgo flavone and lactone 20, microcrystalline Cellulose 15, mannitol 45, crospolyvinylpyrrolidone 2, carboxymethyl starch sodium 8, sodium bicarbonate 3.5, citric acid 2, glycyrrhizin 4, Aspartane 10, flavoring orange essence 8, polyethylene glycol 6000 are 1, all in parts by weight.
Above-mentioned oral cavity disintegration tablet is met the rapid disintegrate of saliva in the oral cavity, and swallows into stomach with saliva, and mainly by the gastrointestinal absorption onset, part absorbs onset by oral mucosa.Certainly the tablet of being made up of above-mentioned raw materials can also be made buccal tablet (comprising buccal tablet), Sublingual tablet, chewable tablet, mouth paster, oral cavity adhesion tablet.
The present invention adopts above elite adjuvant, particularly effective combination of disintegrating agent and correctives, make the Bilobanoate oral-cavity disintegrating tablet of making can be in the water of minute quantity 1～5ml, disintegrate in 10～60 seconds very short time, and the screen cloth by the following aperture of 710 μ m; Place people's oral cavity to test, can be at 20-60 disintegrate dispersion in second, no grittiness, good mouthfeel.Be particularly suitable for the patient of dysphagia such as old man, and the patient of water intaking difficulty takes in the special environment (as go out, tourism etc.).Every the state of an illness is heavier generally in the heavy scope of 0.1～0.3g sheet, when needing taking dose big, may reach the heavy maximum 0.5g of sheet.Because the present invention takes and easy to carry, good mouthfeel, the patient for need are taken medicine has for a long time improved patient's compliance greatly, thus the assurance therapeutic effect.
Another object of the present invention is achieved in that the preparation method of above-mentioned Bilobanoate oral-cavity disintegrating tablet, and its key is: with the pretreatment of drying, pulverize, sieve of above-mentioned other components except that binding agent; Will binding agent be made soft material, is granulated, drying through adding with the disintegrating agent mixing in pretreated principal agent, filler, correctives and the part; Always again remaining extraneous component is carried out mixing, tabletting gets finished product again.
The concrete preparation method of above-mentioned Bilobanoate oral-cavity disintegrating tablet is: with the pretreatment of drying, pulverize, sieve of above-mentioned principal agent, filler, disintegrating agent, correctives, lubricant; Will through in pretreated principal agent, filler, correctives and the part with the disintegrating agent mixing; Make binding agent with alcoholic solution or starch slurry, binding agent is added in the above-mentioned material of mixing, make soft material; Granulate with 10～60 mesh sieves; Granule is in 40～80 ℃ of oven dry, and during near doing, granulate continues to be dried to and meets the requirements; With remaining disintegrating agent and the lubricant of adding, always mix with granule, tabletting gets finished product more again.
In the preparation method of above-mentioned Bilobanoate oral-cavity disintegrating tablet, in be 50～90% of disintegrating agent total amount with the amount of disintegrating agent.
Preparation method of the present invention can also be that above-mentioned each component is dried, pulverizes, sieved after the pretreatment, directly adopts freeze-drying or directly adopts powder pressing method to make oral cavity disintegration tablet; Or earlier ginkgo flavone and lactone being prepared into solid dispersion or clathrate or coating, refabrication becomes oral cavity disintegration tablet.
Certainly, the preparation method of above-mentioned Bilobanoate oral-cavity disintegrating tablet can also be conventional pretreatment that the ginkgo flavone and lactone in the said components, disintegrating agent, filler are dried, pulverize, sieved, and direct compression gets finished product behind the mixing.
To the Bilobanoate oral-cavity disintegrating tablet for preparing according to the present invention, adopt following three kinds of methods to carry out disintegration time mensuration, its result is as follows.
1, test tube method
Adopt static disintegrate, the method for dynamically sieving is measured.
Get 1 of product of the present invention, place in the 10ml tool plug scale test tube (diameter 10mm, height 100mm) of the axial 2ml of filling water (35～37 ℃).After 20～30 seconds, compress the test tube plug with forefinger, test tube is revolved turn 90 degrees to level, repeat once, tablet is answered disintegrate or is dispersed in the water, and it is left not have accumulative granule.Remove the test tube plug then, internal diameter is the stainless steel mesh of 575 μ m (30 order) on the test tube muzzle, test tube is inverted again, and all liq in the test tube or suspended matter should be able to all pass through screen cloth.
Measure 6 of products of the present invention as stated above, each sheet all should be up to specification.
2, syringe method
Adopt static disintegrate, the method for dynamically sieving is measured.
10ml tool plug scale test tube is cut from the bottom, cutting the place, make and to carry out the test tube sieve (internal diameter 9mm, external diameter 13mm, high 118mm) that granularity is checked along 26 orders on the outer wall cover (aperture 663 ± 13 μ m) stainless steel mesh.Needle sleeve under the 10ml glass needle tube bottom is sawed flat blended rubber sealing.Test tube is sieved the 1ml scale place that places the above 10ml syringe of handling of the warp that fills 3ml water (37 ℃) (diameter 15mm, height 95mm), and the water in the syringe sieves through test tube and enters in vitro.Get 1 of product of the present invention, place in the test tube sieve.Leave standstill, observe tablet and answer disintegrate, molten loosing, and have the microgranule after the disintegrate to pass through screen cloth, in the time of 30 seconds, upwards promote test tube and be sieved to the 6ml place, then the test tube sieve is got back to the syringe bottom downwards, place 1ml scale place again; In the time of 40 seconds, repeat this operation 1 time; In the time of 50 seconds, repeat this operation 5 times, the microgranule after the disintegrate should the overwhelming majority sieve by test tube, enters in the graduated cylinder, and is left if any the blocky-shaped particle greater than mesh size, must not be more than more than 5.
Measure 6 of products of the present invention as stated above, each sheet all should be up to specification.
3, algoscopy in the human oral cavity
6 volunteers place product of the present invention on the tongue as test pieces, write down its complete required time of disintegrate in the oral cavity.Every volunteer measures 3 of products of the present invention, to measure meansigma methods as measurement result.
Measurement result: adopt oral cavity disintegration tablet of the present invention, measure by above-mentioned three kinds of methods, wherein the disintegration time in test tube method and the syringe method is 10～60 seconds, and the disintegration time of measuring in the human oral cavity is 20～60 seconds.
To the Bilobanoate oral-cavity disintegrating tablet for preparing according to the method for the invention, the inventor has also carried out the animal local application irritation test of rabbit oral mucosa.Test method is as follows:
The dosage that gives the animal Bilobanoate oral-cavity disintegrating tablet is 1 slice/time (40～160mg/ sheet), 1 time/day, and successive administration 7 days.During test animal is divided into 1 administration group, promptly gives Bilobanoate oral-cavity disintegrating tablet 40～160mg of the present invention; 1 vehicle group promptly gives the excipient sheet; And 1 normal control group; Every group of 3 rabbits.During test the rabbit mouth is broken into two with one's hands, will be subjected to reagent or excipient sheet to place mucosa place on the tongue in rabbit oral cavity, and immediately with hands fixedly the rabbit mouth make medicine containing fully about 5 minutes, in order to avoid it is chewed, swallows or spues.At least fasting after the administration, taboo water 4 hours make to be subjected to reagent fully to contact absorption with mucosa.Put to death animal in the last administration after 24 hours, take out the local mucous membrane tissue, observation has or not phenomenons such as hyperemia, redness, and carries out histopathologic examination.
Result such as following table:
Administration group, vehicle group, the local oral mucosa of normal control group administration all do not have stimulation phenomenons such as hyperemia, edema, necrosis.The pathologic finding tissue slice shows that administration group, vehicle group and normal control group mucosal tissue structure are all normal, does not see phenomenons such as cell infiltration and degeneration, edema, necrosis.
Conclusion: the Bilobanoate oral-cavity disintegrating tablet 40～160mg among the present invention, the clinical application amount does not have the obvious stimulation reaction to oral mucosa.
Because the present invention does not change the route of administration of ginkgo flavone and lactone granule and takes dosage, therefore, clinical effectiveness is consistent with the ginkgo flavone and lactone granule.
The specific embodiment
The present invention will be further described below in conjunction with embodiment, but the present invention is not limited to these embodiment.
Embodiment 1:
A kind of Bilobanoate oral-cavity disintegrating tablet, it is made by ginkgo flavone and lactone 40, microcrystalline Cellulose 15, mannitol 60, crospolyvinylpyrrolidone 4, carboxymethyl starch sodium 6.5, all in parts by weight.
Concrete preparation method: the pretreatment of will above-mentioned each component drying, pulverize, sieve, behind the mixing directly the employing powder pressing method make Bilobanoate oral-cavity disintegrating tablet.
Embodiment 2:
A kind of Bilobanoate oral-cavity disintegrating tablet, it is 1 to make by ginkgo flavone and lactone 20, microcrystalline Cellulose 15, mannitol 45, crospolyvinylpyrrolidone 2, carboxymethyl starch sodium 8, sodium bicarbonate 3.5, citric acid 2, glycyrrhizin 4, Aspartane 10, flavoring orange essence 8, polyethylene glycol 6000, all in parts by weight.
Concrete preparation method: above-mentioned each component is dried, pulverizes, sieved after the pretreatment, and mixing directly adopts freeze-drying to make Bilobanoate oral-cavity disintegrating tablet.
Embodiment 3: a kind of Bilobanoate oral-cavity disintegrating tablet, it is that 2g makes 1000 by ginkgo flavone and lactone 40g, microcrystalline Cellulose 30g, mannitol 90g, crospolyvinylpyrrolidone 4g, carboxymethyl starch sodium 16g, sodium bicarbonate 7g, citric acid 4g, glycyrrhizin 8g, aspartame 20g, flavoring orange essence 16g, polyethylene glycol 6000.
Concrete preparation method is as follows: with the pretreatment of drying, pulverize, sieve of above-mentioned each component; Will through pretreated principal agent, filler, correctives and in disintegrating agent crospolyvinylpyrrolidone 4g, carboxymethyl starch sodium 16g, citric acid 4g mixing; Make binding agent with 75% ethanol of 30ml the material of mixing is made soft material; Granulate with 30 mesh sieves; And under 60 ℃ temperature, dry, during near doing, granulate continues to be dried to and meets the requirements; And then with surplus add disintegrating agent sodium bicarbonate 7g and lubricant adds in the dried granule, always carry out mixing, last tabletting gets Bilobanoate oral-cavity disintegrating tablet.
Embodiment 4: a kind of Bilobanoate oral-cavity disintegrating tablet, it is that 2g makes 1000 by ginkgo flavone and lactone 120g, microcrystalline Cellulose 50g, mannitol 70g, cross-linking sodium carboxymethyl cellulose 6g, low-substituted hydroxypropyl cellulose 12g, sodium bicarbonate 9g, tartaric acid 5g, glycyrrhizin 18g, strawberry essence 16g, Macrogol 4000.
Concrete preparation method is with embodiment 3, and different is that binding agent adopts 10% starch slurry, and its addition is 30g; Granulate and adopt 10 mesh sieves, bake out temperature is 40 ℃.
Embodiment 5: a kind of Bilobanoate oral-cavity disintegrating tablet, it makes 1000 by ginkgo flavone and lactone 80g, microcrystalline Cellulose 30g, mannitol 120g, crospolyvinylpyrrolidone 8g, carboxymethyl starch sodium 13g, glycyrrhizin 8g, strawberry essence 16g, fumaric acid sodium stearate 2g.
Concrete preparation method is with embodiment 3, and different is that binding agent adopts water, and its addition is 30ml; Granulate and adopt 40 mesh sieves, bake out temperature is 70 ℃.
Embodiment 6～18: each set of dispense is than pressing table 1, and concrete preparation method is with embodiment 1 or embodiment 2 or embodiment 3.
Each component selected for use among table 1: the embodiment 6～18 and consumption (by weight)
Claims (2)
1. Bilobanoate oral-cavity disintegrating tablet, it is characterized in that: it is made by 40 parts of ginkgo flavone and lactone, 10 parts of crospolyvinylpyrrolidone, 10 parts of low-substituted hydroxypropyl celluloses, 28 parts of microcrystalline Cellulose, 71 parts in mannitol, 20 parts in water, 10 parts of ethanol, 25 parts of aspartames, 1 part of Mentholum, 10 parts and 6 parts polyethylene glycol 6000s of flavoring orange essence, all in parts by weight; It adopts following preparation method to make: with the pretreatment of drying, pulverize, sieve of described other components except that binding agent; Will binding agent be made soft material, is granulated, drying through adding with the disintegrating agent mixing in pretreated principal agent, filler, correctives and the part; Always again remaining extraneous component is carried out mixing, tabletting gets finished product again.
2. Bilobanoate oral-cavity disintegrating tablet as claimed in claim 1 is characterized in that: in described preparation method, be 50～90% of disintegrating agent total amount with the amount of disintegrating agent in described.
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| CN102138944B (en) * | 2011-03-29 | 2012-09-19 | 江苏神龙药业有限公司 | Method for preparing ginkgo biloba extract dispersible tablets |
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