CN103599086B - Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method - Google Patents
Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method Download PDFInfo
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Abstract
The invention belongs to medical art, relate to Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method, described double-layer osmotic pump controlled-release tablet is made up of medicated layer, boosting layer and coating membrane three part.Described medicated layer weight percent consists of: Folium Ginkgo total flavones 40% ~ 90%, suspending agent 5% ~ 35%, osmotic pressure active substance 5% ~ 25%, lubricant 0% ~ 5%; Boosting layer weight percent consists of: macromolecule sweller 45% ~ 90%, osmotic pressure active substance 10% ~ 50%, lubricant 0% ~ 5%; Coating membrane coating solution w/v consists of: semipermeable polymer material: 2% ~ 4%; Porogen: 0.001% ~ 0.09%; Solvent is acetone: the mixed solution of water=1000:3 ~ 19; Coating weight gain is 3% ~ 20% of label weight.Said preparation has medicine constant release, blood levels easy to control, reduces toxic and side effects.Can administration number of times be reduced, improve the compliance of patient.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method thereof.
Background technology
Folium Ginkgo total flavones is Folium Ginkgo extract, and content is more than 20%, main containing some flavone and flavonoid glycoside composition, comprises the compositions such as Quercetin, isorhamnetin, kaempferide class.Study of pharmacy shows, Folium Ginkgo total flavones can increase cerebrovascular flow, improves Cerebrovascular disorders function, protection brain cell, and coronary artery dilator, prevents angina pectoris and myocardial infarction, prevent thrombosis, improves body immunity.Very useful per capita to coronary heart diseases and angina pectoris, cerebral arteriosclerosis, alzheimer disease, hypertension.
Existing in the market take Folium Ginkgo total flavones as the Chinese patent medicine preparation of crude drug, comprises tablet, capsule, injection, drop, oral liquid, pill and ointment etc., is ordinary preparation.As conventional tablet, every sheet Folium Ginkgo total flavones 9.6mg, oral 1
~2 pieces/times, three times on the one.Compliance is poor, and blood concentration fluctuation is large, and long term administration easily causes untoward reaction.
For solving the problem, existing researcher have developed Folium Ginkgo extract controlled release tablet, and described patent is CN1177603C, and this sheet is compaction of pellet coating again, utilizes packaging technique to delay medicine in the gastrointestinal holdup time, drug slow is discharged lastingly, 2
~within 12 hours, present Zero order release.But this sheet processing technology is loaded down with trivial details, improves production cost, brings difficulty to industrialization.Therefore, how to improve curative effect of medication, maintain blood drug level, reduce toxic and side effects, reduce patient medication number of times, become the free-revving engine of Folium Ginkgo total flavones preparation research.
Summary of the invention
The object of the invention is the deficiency overcoming Folium Ginkgo total flavones ordinary preparation, Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet and preparation method thereof is provided.It has zero-order release kinetics feature, with a certain amount of medicine of constant rate of speed sustained release, effectively can control blood drug level, and effective persistent period is long.Its rate of releasing drug and extraneous factor, pharmaceutical properties have nothing to do, not by the impact of the variable factors such as gastrointestinal tract.Therefore can avoid the excessive untoward reaction caused of blood concentration fluctuation, reduce toxic and side effects.Every day only need take medicine once, sustainable 24 hours of drug effect, reduces patient consumes's number of times, greatly improves the safety of Drug therapy, effectiveness and compliance.
Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet provided by the invention utilizes the release principle of osmotic pressure, and hydrone enters label by semipermeable membrane, makes boosting floor height molecular species dissolves and expansion, produces hyperosmosis.Coating membrane is relative rigid structure, enters with moisture, forms higher hydrostatic pressing in label, forces drug solution from small delivery aperture with constant speed sustained release.
Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet provided by the invention is made up of medicated layer, boosting layer, coatings three part, and medicated layer a side perforating and obtain.
Described medicated layer weight percent consists of:
Folium Ginkgo total flavones 40% ~ 90%
Suspending agent 5% ~ 35%
Osmotic pressure active substance 5% ~ 25%
Lubricant 0% ~ 5%
Boosting layer weight percent consists of:
Macromolecule sweller 45% ~ 90%
Osmotic pressure active substance 10% ~ 50%
Lubricant 0% ~ 5%
Coating membrane coating solution w/v consists of:
Coating material: 2% ~ 4%;
Porogen: 0.001% ~ 0.09%
Solvent: acetone: water=1000:3 ~ 19;
Coating weight gain is 3% ~ 20% of label weight
And at the side machine drilling of label medicated layer or laser boring 0.5 ~ 1.0mm.
Suspending agent preferably 8% ~ 30% in described medicated layer, osmotic pressure active substance preferably 5% ~ 20%.In boosting layer, macromolecule sweller preferably 55% ~ 85%, osmotic pressure active substance preferably 10% ~ 45%.
Medicament composing prescription percentage ratio of the present invention is preferably as follows:
Medicated layer:
Folium Ginkgo total flavones 50% ~ 85%
Suspending agent 8% ~ 30%
Osmotic pressure active substance 5% ~ 20%
Lubricant 0.2% ~ 2%
Boosting layer:
Macromolecule sweller 55% ~ 85%
Osmotic pressure active substance 10% ~ 45%
Lubricant 0.2% ~ 3%
Coating membrane coating solution bulking value is preferably than consisting of:
Coating material: 2%
~3.5%;
Porogen: 0.001% ~ 0.05%;
Solvent: acetone: water=1000:5 ~ 15.
Coating weight gain is preferably 3% of label weight
~15%
At the side machine drilling of label medicated layer or laser boring 0.5 ~ 1.0mm.
In the present invention, it is 100 that the suspending agent of Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet medicated layer is selected from molecular weight, 000 ~ 600, one or more combination in the polyoxyethylene of 000, hydroxypropyl methylcellulose, polyvinylpyrrolidone, arabic gum, sodium alginate, preferred molecular weight is 100, the polyoxyethylene of 000 ~ 600,000.Adding of suspending agent can make medicine form suspension, contributes to medicine and discharges from drug release hole.
In the present invention, the osmotic pressure active substance of Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is selected from one or more in sodium chloride, potassium sulfate, magnesium sulfate, magnesium chloride, potassium chloride, tartaric acid, sorbitol, sucrose, mannitol, preferred sodium chloride; Adding of osmotic pressure active substance, enough osmotic pressuries can be produced to maintain the rate of release of medicine relative constancy.
In the present invention, the lubricant of Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is selected from the one or more combination in magnesium stearate, Pulvis Talci, magnesium laurylsulfate, micropowder silica gel, hydrogenated vegetable oil, Polyethylene Glycol.
In the present invention, in the boosting layer of Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet, macromolecule sweller is selected from molecular weight is 1,000, one or more combination in the polyoxyethylene of 000 ~ 7,000,000, hydroxypropyl methylcellulose, polyvinylpyrrolidone, arabic gum, sodium alginate, preferred molecular weight is 1,000,000 ~ 7, the polyoxyethylene of 000,000, is selected from PEON12K, PEON60K, one or more combination in WSR301, WSR303, WSRCoagulant.Macromolecule sweller after absorbing water volume constantly increases, and the material suspension promoting medicated layer discharges through release aperture, to maintain zero order release rate.
Semipermeable membrane macromolecular material in invention formulation coatings is selected from ethyl cellulose, cellulose acetate, cellulose diacetate, preferred cellulose acetate;
The solvent of invention formulation coatings is the mixture of different proportion acetone and water;
Water soluble pore formers in invention formulation coatings is selected from the combination of one or more in polyethylene glycol 1500, Macrogol 2000, Macrogol 4000, polyethylene glycol 6000, hydroxypropyl methylcellulose; Preferred ethylene glycol 1500, Macrogol 2000, Macrogol 4000.
The invention provides the preparation method of Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet, preparation method is as follows:
(1) in Folium Ginkgo total flavones and each layer, all adjuvants grind respectively;
(2) medicated layer is prepared: get the Folium Ginkgo total flavones after pulverizing and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively, claim above material by recipe quantity, and mix homogeneously, for subsequent use;
(3) boosting layer is prepared: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
(4) medicated layer is compressing gently, then add boosting and be laminated into double-layer tablet;
(5) at label outsourcing semipermeable membrane clothing, coating weight gain is 3% of label weight
~ 20%, 30 ~ 70 DEG C of dryings 5 ~ 20 hours;
(6) in medicated layer one side machinery or laser boring, release aperture is 0.5 ~ 1.0mm.
In described step 5, lamella outsourcing is semipermeable membrane macromolecular material, porogen are dissolved in respectively in the solvent of acetone and water with semipermeable membrane coating, and mix homogeneously obtains coating solution.Put by label in coating pan and carry out coating, coating weight gain is preferably 3% of label weight
~20%.Coating membrane thickness produces Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet rate of release to be affected comparatively significantly.In described step 6, break into 0.5 by machine drilling method on label medicated layer surface
~the aperture of 1.0mm, to obtain final product.
Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet of the present invention beneficial effect compared with commercially available ordinary tablet is: 1, discharge medicine with zero-order, and the valid density time remains permanent, reduces in a few days times for spraying.2, rate of releasing drug and extraneous factor have nothing to do, and do not affect by factors such as gastrointestinal tract.3, make the basic held stationary of blood drug level, decrease the side effect that Wave crest and wave trough change produces.
Accompanying drawing explanation
The drug release profiles figure of Fig. 1 Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet embodiment.
Detailed description of the invention
Understand the present invention further by the following specific embodiments.But they are not limitations of the present invention
Embodiment 1
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 200
Sodium chloride 30
PEO-N1030
Magnesium stearate 2
Boosting layer forms: content (mg/ sheet)
PEO-303100
Sodium chloride 30
Magnesium stearate 2
Coating solution forms: (1000ml coating solution)
Composition weight
Cellulose acetate 30g
PEG40002g
Water 5ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add boosting and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity cellulose acetate, PEG4000 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 12%, dry 12h at 40 DEG C, then breaks into the aperture of 0.6mm, to obtain final product on medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.9981.
Embodiment 2:
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 220
Sucrose 15
PEO-N75022
Magnesium stearate 5
Boosting layer forms: content (mg/ sheet)
PEON60K100
Sucrose 30
Magnesium stearate 2
Coating solution forms: (1000ml coating solution)
Composition weight
Ethyl cellulose 28g
PEG40001g
Water 5ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add boosting and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity ethyl cellulose, PEG4000 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 7%, dry 12h at 40 DEG C, then breaks into the aperture of 0.6mm, to obtain final product on tablet medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.9845.
Embodiment 3:
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 200
Mannitol 30
Polyvinylpyrrolidone 20
Micropowder silica gel 2
Boosting layer forms: content (mg/ sheet)
PEO-303112
Sodium chloride 26
Micropowder silica gel 4
Coating solution forms: (1000ml coating solution)
Composition weight
Cellulose acetate 30g
PEG40001g
Water 5ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add boosting and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity cellulose acetate, PEG4000 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 6%, dry 12h at 40 DEG C, then breaks into the aperture of 0.7mm, to obtain final product on tablet medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.9982, but release is too slow.
Embodiment 4:
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 132
Sodium chloride 51
Arabic gum 77
Magnesium stearate 2
Boosting layer forms: content (mg/ sheet)
PEON12K72
Sodium chloride 58
Magnesium stearate 2
Coating solution forms: (1000ml coating solution)
Composition weight
Ethyl cellulose 35g
PEG20002g
Water 6ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add another and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity ethyl cellulose, PEG2000 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 9%, dry 12h at 40 DEG C, then breaks into the aperture of 0.9mm, to obtain final product on tablet medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the coefficient R recording release profiles is 0.9945, and release in vitro is slower.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.989, discharges slower.
Embodiment 5:
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 200
Lactose 30
PEO-N1030
Magnesium stearate 2
Boosting layer forms: content (mg/ sheet)
WSRCoagulant100
Sodium chloride 15
Magnesium stearate 2
Coating solution forms: (1000ml coating solution)
Composition weight
Cellulose acetate 20g
PEG15005g
Water 10ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add boosting and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity cellulose acetate, PEG1500 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 10%, dry 12h at 40 DEG C, then breaks into the aperture of 0.6mm, to obtain final product on tablet medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.9814.
Embodiment 6:
Medicated layer forms:
Constituent content (mg/ sheet)
Folium Ginkgo total flavones 200
Sucrose 30
Hypromellose 30
Pulvis Talci 2
Boosting layer forms: content (mg/ sheet)
PEO-303100
Sucrose 30
Pulvis Talci 2
Coating solution forms: (1000ml coating solution)
Composition weight
Cellulose acetate 30g
PEG40003g
Water 5ml
Acetone 1000ml
The preparation method of above-mentioned Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet is as follows:
Preparation medicated layer: take Folium Ginkgo total flavones and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively by recipe quantity, and mix homogeneously, for subsequent use;
Preparation boosting layer: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
Medicated layer is gently molded, then add boosting and be laminated into double-layer tablet;
Prepare coating solution, recipe quantity cellulose acetate, PEG4000 are dissolved in respectively in the solvent of acetone and water, mix homogeneously obtains coating solution.Put in coating pan by label, until label outer coatings film increases to into label weight 10%, dry 12h at 40 DEG C, then breaks into the aperture of 1.0mm, to obtain final product on tablet medicated layer surface by machine drilling method.Carry out extracorporeal releasing experiment, the correlation coefficient r recording release profiles is 0.980.
Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet vitro release is studied
According to Chinese Pharmacopoeia version in 2010 two annex XD drug release determination first methods, with 0.5%SDS solution 900mL for medium, rotating speed is 100r/min, temperature is (37 ± 0.5) DEG C, timing sampling 5ml, filter through microporous filter membrane (0.45 μm), supplement the SDS solution of same volume synthermal 0.5% simultaneously.Ultraviolet method measures the absorbance of Folium Ginkgo total flavones, calculates Cumulative release amount.
Release profiles as shown in figure, can significantly be found out, Folium Ginkgo total flavones osmotic pump controlled release tablet all reaches Zero order release feature in the release in vitro of 0 ~ 14h, correlation coefficient r >0.98.Folium Ginkgo total flavones osmotic pump controlled release tablet has release constant speed, lasting medicine, toxic and side effects are little, and preparation technology is easy, is easy to suitability for industrialized production.
Claims (10)
1. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet, it is made up of medicated layer, boosting layer, coatings three part, it is characterized in that,
Described medicated layer weight percent consists of:
Folium Ginkgo total flavones 40% ~ 90%
Suspending agent 5% ~ 35%
Osmotic pressure active substance 5% ~ 25%
Lubricant 0% ~ 5%
Boosting layer weight percent consists of:
Macromolecule sweller 45% ~ 90%
Osmotic pressure active substance 10% ~ 50%
Lubricant 0% ~ 5%
Coating membrane coating solution w/v consists of:
Semipermeable polymer material: 2% ~ 4%;
Porogen: 0.001% ~ 0.09%;
Solvent: acetone: water=1000:3 ~ 19;
Coating weight gain is 3% ~ 20% of label weight
And at the side machine drilling of label medicated layer or laser boring 0.5 ~ 1.0mm;
It is 100,000 ~ 600 that the suspending agent of described medicated layer is selected from molecular weight, one or more combination in the polyoxyethylene of 000, hydroxypropyl methylcellulose, polyvinylpyrrolidone, arabic gum, sodium alginate;
Osmotic pressure active substance be selected from sodium chloride, potassium sulfate, magnesium sulfate, magnesium chloride, potassium chloride, tartaric acid, sorbitol, sucrose, mannitol one or more;
In described boosting layer, sweller is selected from molecular weight is 1,000, one or more combination in the polyoxyethylene of 000 ~ 7,000,000, hydroxypropyl methylcellulose, polyvinylpyrrolidone, arabic gum, sodium alginate;
Semipermeable polymer material in described coating solution is selected from ethyl cellulose, cellulose acetate, cellulose diacetate; Water soluble pore formers is selected from the combination of one or more in polyethylene glycol 1500, Macrogol 2000, Macrogol 4000, polyethylene glycol 6000, hydroxypropyl methylcellulose.
2. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, it is characterized in that, in described boosting layer, sweller is molecular weight 1,000,000 ~ 7, the polyoxyethylene of 000,000, is selected from PEON12K, PEON60K, one or more combination in WSR301, WSR303, WSRCoagulant.
3. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, is characterized in that, the suspending agent of described medicated layer is molecular weight 100, the polyoxyethylene of 000 ~ 600,000.
4. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, is further characterized in that, in described medicated layer, suspending agent is 8% ~ 30%, and osmotic pressure active substance is 5% ~ 20%.
5., according to the Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet of claim 1-4 described in any one, it is characterized in that, in described boosting layer, macromolecule sweller 55% ~ 85%, osmotic pressure active substance 10% ~ 45%.
6., according to the Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet of claim 1-4 described in any one, it is characterized in that,
Described medicated layer weight percent consists of:
Folium Ginkgo total flavones 50% ~ 85%
Suspending agent 8% ~ 30%
Osmotic pressure active substance 5% ~ 20%
Lubricant 0.2% ~ 2%
Boosting layer weight percent consists of:
Macromolecule sweller 55% ~ 85%
Osmotic pressure active substance 10% ~ 45%
Lubricant 0.2% ~ 3%
Coating membrane coating solution w/v consists of
Semipermeable polymer material: 2% ~ 3.5%;
Porogen: 0.001% ~ 0.05%;
Solvent: acetone: water=1000:5 ~ 15;
Film coating weightening finish is 3% of label weight
~15%;
And at the side machine drilling of label medicated layer or laser boring 0.5 ~ 1.0mm.
7. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, it is characterized in that, the osmotic pressure active substance of described medicated layer is sodium chloride.
8. Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, is characterized in that: described lubricant is selected from the one or more combination in magnesium stearate, Pulvis Talci, magnesium laurylsulfate, micropowder silica gel, hydrogenated vegetable oil, Polyethylene Glycol.
9., according to the Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet of claim 1-4 described in any one, it is characterized in that, the solvent in described coating solution is the mixture of different proportion acetone and water.
10. prepare a method for Folium Ginkgo total flavones double-layer osmotic pump controlled-release tablet according to claim 1, it is characterized in that comprising the steps:
(1) Folium Ginkgo total flavones and adjuvant pulverization process respectively;
(2) medicated layer is prepared: get the Folium Ginkgo total flavones after pulverizing and suspending agent, osmotic pressure active substance, lubricant mistake 80 mesh sieves respectively, claim above material by recipe quantity, and mix homogeneously, for subsequent use;
(3) boosting layer is prepared: macromolecule sweller, osmotic pressure active substance, lubricant are crossed 80 mesh sieves respectively, claims above material by recipe quantity, and mix homogeneously, for subsequent use;
(4) after medicated layer gently being pressed, then add boosting and be laminated into double-layer tablet;
(5) at label outsourcing semipermeable membrane clothing, coating weight gain is 3% of label weight
~ 20%, 30
~70 DEG C of dryings 5
~20 hours;
(6) in medicated layer one side machinery or laser boring, release aperture is 0.5
~1.0mm.
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| CN102626428A (en) * | 2012-04-15 | 2012-08-08 | 徐州医学院 | Ginkgo leaf extract osmotic pump controlled-release preparation and preparation method thereof |
| CN103142532A (en) * | 2011-12-06 | 2013-06-12 | 复旦大学 | Ginkgolide osmotic pump tablet and preparation method thereof |
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| CN103142532A (en) * | 2011-12-06 | 2013-06-12 | 复旦大学 | Ginkgolide osmotic pump tablet and preparation method thereof |
| CN102626428A (en) * | 2012-04-15 | 2012-08-08 | 徐州医学院 | Ginkgo leaf extract osmotic pump controlled-release preparation and preparation method thereof |
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