CN101785774A - Compound niacin simvastatin bilayer sustained-release tablet - Google Patents
Compound niacin simvastatin bilayer sustained-release tablet Download PDFInfo
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- CN101785774A CN101785774A CN200910232861A CN200910232861A CN101785774A CN 101785774 A CN101785774 A CN 101785774A CN 200910232861 A CN200910232861 A CN 200910232861A CN 200910232861 A CN200910232861 A CN 200910232861A CN 101785774 A CN101785774 A CN 101785774A
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Abstract
The invention relates to a compound niacin simvastatin bilayer sustained-release tablet and a preparation method thereof. The invention mainly provides a simple and convenient technology which adopts a compressed bilayer sustained-release tablet, solves the problem of uneven content of simvastatin probably generated during coating, prepares the simvastatin into a rapid-release tablet layer and compresses the rapid-release tablet layer and a niacin sustained-release tablet layer into a bilayer sustained-release tablet. The invention takes HPMC(hydroxypropyl methyl cellulose), compritol 888 ATO, ethocel, octadecanol, sodium carboxymethylcellulose, sodium alginate, and the like as sustained-release materials, prepares the niacin into the sustained-release layer and prepares the simvastatin into the rapid-release tablet layer by rapid-release auxiliary materials accepted in the technology of pharmaceutics so as to prepare the bilayer tablet by using the two layers; and by simultaneously using the two layers, the invention has a more obvious use effect than using the niacin or the simvastatin singly, has anti-hyperlipidemia function with a good cure effect and is beneficial to reducing side effects.
Description
Technical field: the present invention relates to compound niacin simvastatin double-layer sustained release tablets and preparation method thereof.
Background technology: primary hypercholesterolemia is a kind of common clinical, frequently-occurring disease with mixing dyslipidemia, between the order of severity of cardiovascular disease such as serum cholesterol concentration and atherosclerosis, coronary heart disease significant correlation is arranged.When serum cholesterol concentration raise, atherosclerotic generation probability also increased substantially.The treatment of the cardiovascular disease difficult problem that become international, its M ﹠ M is the first place, and the annual life that seizes 1,200 ten thousand people in the whole world is near 1/4 of the total death toll of world population.
Hyperlipidemia is the one of the main reasons that causes coronary heart disease and apoplexy, and cardiovascular and cerebrovascular diseases such as coronary heart disease, apoplexy are the underlying cause of deaths of global population.Along with the change of China's aged tendency of population and growth in the living standard, particularly diet, the hyperlipidemia patient is also increasing.
Lipid regulating agent commonly used clinically at present mainly is divided into two classes, one class is the Statins based on cholesterol reducing, another kind of is fibric acid based on triglyceride reducing, though they all have drug effect preferably, but curative effect is single, and have some untoward reaction, study new lipid lowering agent thus and be significant.
Nicotinic acid is Nicotinicum Acidum again, belongs to vitamin B group, compares with above-mentioned two class medicines, and cheap, blood lipid regulation is sure, is a unique medicine that can make all lipid compositions towards the positive direction development and change.Its maximum effect is to increase high density lipoprotein (HDL), main triglyceride reducing (TMG), and (TC) also has the reduction effect to cholesterol.Clinical showing, nicotinic acid can reduce the sickness rate and the general mortality rate of cardiovascular disease.But the nicotinic acid untoward reaction is many, has limited its clinical practice.The half-life of nicotinic acid is extremely short, only 25-45 minute, large dose oral administration nicotinic acid, side effect such as flushing and liver toxicity often occur, for this reason, U.S.'s specification of just having gone on the market the eighties is that slow releasing capsule and the specification of 150～500mg is the slow releasing tablet of 250～400mg, sooner or later each 1 time, though this dosage regimen reduces obviously flushing, because liver all will be subjected to the invasion of nicotinic acid 24 hours every days, the liver side effect is still more serious.In view of the influence of 24 hours rhythm and pace of moving things variations to lipid composition in the body, be that triglyceride (TMG) is finished with interior synthetic mainly the concentrating on of the body of cholesterol (TC) night, and the pharmacokinetic property of nicotinic acid, Kos company has developed the niacin slow-release tablet of administration in 1 day 1 time, this product went on the market in the U.S. in July, 1997, and commodity are called Niaspan.
Simvastatin is the 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor, efficient blood lipid-lowering medicine.This medicine effect is strong, the curative effect height, and side effect is slight, because of its safety, characteristics efficient, low toxicity have become the most frequently used class blood lipid-lowering medicine in the present whole world, be mainly used in the treatment hypercholesterolemia at present clinically, blood fat reducing improves blood flow, antithrombotic etc., common dose is 20mg, and the FDA maximum permissible dose is 80mg, and it absorbs good, side effect is little, and the half-life is longer.Simvastatin after oral 2 hours blood drug level reach peak value, the intravital plasma protein binding rate of simvastatin and metabolite thereof and people all higher (95%).
Studies show that, the curative effect of the alleviation high-cholesterol disease of taking nicotinic acid and statins simultaneously and being produced is than only clothes are wherein any more obvious, nicotinic acid adds that lovastatin or simvastatin not only can reduce low density lipoprotein, LDL, and can adjust the level of triglyceride and raising high density lipoprotein.Abroad, such preparation existing procucts listing, as the niacin slow-release tablet of U.S. Kos company development and the compound preparation (commodity are called Advicor) of lovastatin, the niacin slow-release tablet of Abbott company development and the compound preparation (commodity are called SIMCOR) of simvastatin, niacin slow-release tablet outsourcing film-coat wherein, lovastatin and simvastatin are added in the film-coat.
Summary of the invention: it is simple to the invention provides a kind of preparation technology, the reliable compound antihyperglycemic medicine of curative effect, it is made up of two-layer, one deck contains the nicotinic acid of clinical effective, it is pressed into slow release layer, and another layer contains the simvastatin of clinical effective, is made into release layer, nicotinic acid in two-layer does not mix mutually with simvastatin, is beneficial to the performance of stability of drug and drug effect.The niacin slow-release tablet of Abbott company development and the compound preparation (commodity are called SIMCOR) of simvastatin, niacin slow-release tablet outsourcing film-coat wherein, simvastatin is added in the film-coat.Because every content 20mg of simvastatin,, and be insoluble drug, dissolubility is very low; therefore, when niacin slow-release tablet carried out the simvastatin coating outward, technology was comparatively complicated; otherwise regular meeting causes coating inhomogeneous, and medicament contg is inhomogeneous, influences the performance of curative effect of medication.The invention provides a kind of technology simply and easily, adopt the compacting double-layer sustained release tablets, solve the uneven difficult problem of simvastatin content, simvastatin is made the rapid release lamella, be pressed into double-layer sustained release tablets with niacin slow-release tablet, solve coating and may produce the uneven difficult problem of content.The present invention makes slow release layer as slow-release material with nicotinic acid with hydroxypropyl emthylcellulose (HPMC), Rikemal B 200 (Comprital 888ATO), ethyl cellulose, octadecanol, sodium carboxymethyl cellulose, sodium alginate etc., with acceptable rapid release adjuvant on the galenic pharmacy simvastatin is made release layer, thereby be made into double-layer tablet, both are used simultaneously, result of use than single nicotinic acid or simvastatin is more obvious, can produce the good effect for reducing fat of curative effect simultaneously, and help to reduce side effect.
The niacin sustained release layer, nicotinic acid: the ratio of hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, Rikemal B 200, acrylic resin is 1: 0.15～3.
The niacin sustained release layer can add methylcellulose, polyvinylpyrrolidone, lactose, microcrystalline Cellulose, starch, Icing Sugar, and adds binding agent, wetting agent routinely.
The preparation method of niacin sustained release layer, with nicotinic acid: after a kind of in hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, Rikemal B 200, the acrylic resin or wherein make up arbitrarily mixes with 1: 0.15～3, adopt pelletizing press sheet, perhaps adopt full pressed powder.
The simvastatin release layer can add acceptable rapid release adjuvant on the galenic pharmacies such as carboxymethyl starch sodium, low viscosity replacement hydroxypropyl cellulose, lactose, microcrystalline Cellulose, and add binding agent, wetting agent routinely.
The preparation method of simvastatin release layer with after acceptable rapid release adjuvant on the galenic pharmacy mixes, adopts pelletizing press sheet with simvastatin, perhaps adopts full pressed powder.
The preparation method of compound niacin simvastatin double-layer sustained release tablets, with nicotinic acid: after a kind of in hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, the Rikemal B 200 or wherein make up arbitrarily mixes with 1: 0.15～3, adopt pelletizing press sheet, perhaps adopt full pressed powder; Simvastatin with after acceptable rapid release adjuvant on the galenic pharmacy mixes, is adopted pelletizing press sheet, perhaps adopt full pressed powder, suppress double-layer tablet then.
Description of drawings:
Fig. 1 is the release profiles of embodiment 1,2 niacin slow-release tablet
Fig. 2 is the release profiles of embodiment 3,4 niacin slow-release tablets
Fig. 3 is the release profiles of embodiment 5,6 niacin slow-release tablets
Fig. 4 is the release profiles of embodiment 7,8 niacin slow-release tablets
Fig. 5 is the release profiles of embodiment 9,10 niacin slow-release tablets
Fig. 6 is the release profiles of embodiment 11,12 niacin slow-release tablets
Fig. 7 is the release profiles of embodiment 13,14 niacin slow-release tablets
Fig. 8 is the release profiles of embodiment 15,16 niacin slow-release tablets
Fig. 9 is the release profiles of embodiment 17,18 niacin slow-release tablets
Figure 10 is the release profiles of embodiment 19,20 niacin slow-release tablets
Figure 11 is the release profiles of embodiment 21,22 niacin slow-release tablets
Figure 12 is the release profiles of embodiment 23,24 niacin slow-release tablets
The specific embodiment:
The preparation of embodiment 1 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K4M) 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K4M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, drying, granulate adds stearic acid and mixes, and gets the niacin sustained release granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, the simvastatin immediate-release granules.The compacting double-layer tablet.
Nicotinic acid release and simvastatin dissolution determination method among the embodiment 1～24:
Simvastatin stripping assay method:
By " 2000 editions two appendix XD first methods of Chinese Pharmacopoeia adopt the device of dissolution method (appendix XC first method), with reference to the USP25 version, adopt the sodium dihydrogen phosphate of 0.5% sodium lauryl sulphate (to get sodium dihydrogen phosphate 1.36g, sodium lauryl sulphate 5g, add water 900mL jolting and make dissolving, transfer pH to 7.00 ± 0.05 with phosphoric acid or sodium hydroxide solution, be diluted with water to 1000mL) be dissolution medium, rotating speed is 100r/min, respectively at 15,30, got solution 5ml in 45 minutes, add uniform temp simultaneously, the dissolution medium of equal volume, institute's sample thief filters immediately, gets subsequent filtrate and adopts high effective liquid chromatography for measuring.The result shows that simvastatin stripping in 15 minutes is complete.
The assay method of nicotinic acid release:
By " 2005 editions two appendix XD first methods of Chinese pharmacopoeia adopt the device of dissolution method (appendix XC first method), sodium dihydrogen phosphate (pH7.0) 1000mL with 0.5% sodium lauryl sulphate is a release medium, changing release medium after 1 hour is 1000mL water, rotating speed is that per minute 100 changes, respectively at 1,2,4,8, get solution 10ml in 12,24 hours, add the dissolution medium of uniform temp, equal volume simultaneously, institute's sample thief filters immediately, gets the subsequent filtrate determined by ultraviolet spectrophotometry.
The release of embodiment 1 nicotinic acid the results are shown in accompanying drawing 1, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 0.37 has tangible slow release characteristic, and the release of medicine can be kept 24 hours.
The preparation of embodiment 2 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K4M) 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K4M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepares soft material, the granulation of sieving, granulate behind the particle drying, add stearic acid and mix, get simvastatin layer granule, the compacting double-layer tablet.
The release of embodiment 2 nicotinic acid the results are shown in accompanying drawing 1, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 0.37 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 3 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K15M) 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K15M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, simvastatin layer mixture of powders.The compacting double-layer tablet.
The release of embodiment 3 nicotinic acid the results are shown in accompanying drawing 2, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K15M)=preparation in 1: 0.37 is slow release effectively, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 4 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K15M) 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K15M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, simvastatin layer powder, the compacting double-layer tablet.
The release of embodiment 4 nicotinic acid the results are shown in accompanying drawing 2, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K15M)=preparation in 1: 0.37 is slow release effectively, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 5 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 375g
Hydroxypropyl emthylcellulose (K100M) 140g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 10g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K100M, polyvinylpyrrolidone K90, stearic acid by equivalent incremental method mixing, are got the niacin sustained release mixture of powders.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, behind the particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 5 nicotinic acid the results are shown in accompanying drawing 3, show nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K100M)=preparation in 1: 0.37 has tangible slow release characteristic, the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 6 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 375g
Hydroxypropyl emthylcellulose (K100M) 140g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 10g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K100M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, simvastatin layer powder, the compacting double-layer tablet.
The release of embodiment 6 nicotinic acid the results are shown in accompanying drawing 3, show nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K100M)=preparation in 1: 0.37 has tangible slow release characteristic, the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 7 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K100M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K100M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid, gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, simvastatin layer powder, the compacting double-layer tablet.
The release of embodiment 7 nicotinic acid the results are shown in accompanying drawing 4, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K100M)=preparation in 1: 0.4 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 8 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K100M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K100M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepares soft material, the granulation of sieving, drying, granulate adds stearic acid and mixes, get simvastatin layer granule, the compacting double-layer tablet.
The release of embodiment 8 nicotinic acid the results are shown in accompanying drawing 4, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K100M)=preparation in 1: 0.4 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 9 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K15M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K15M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying adds stearic acid and mixes, and granulate gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying adds stearic acid and mixes, the granulate that sieves, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 9 nicotinic acid the results are shown in accompanying drawing 5, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 0.4 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 10 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K15M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K15M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying adds stearic acid and mixes, and granulate gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepare soft material, granulations of sieving, particle drying, granulate adds the stearic acid mixing, must simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 10 nicotinic acid the results are shown in accompanying drawing 5, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K15M)=preparation in 1: 0.4 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 11 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K4M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K4M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 11 nicotinic acid the results are shown in accompanying drawing 6, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 0.4 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 12 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Hydroxypropyl emthylcellulose (K4M) 200g
Polyvinylpyrrolidone (K90) 20g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, hydroxypropyl emthylcellulose K4M, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepare soft material, granulations of sieving, particle drying, granulate adds the stearic acid mixing, must simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 12 nicotinic acid the results are shown in accompanying drawing 6, shows nicotinic acid: the niacin slow-release tablet of hydroxypropyl emthylcellulose (K4M)=preparation in 1: 0.37 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 13 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Ethyl cellulose 700g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 10g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, ethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule; Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 13 nicotinic acid the results are shown in accompanying drawing 7, shows nicotinic acid: the niacin slow-release tablet of ethyl cellulose=preparation in 1: 2.8 has tangible slow release effect, and medicine can discharge in 24 hours fully, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 14 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Ethyl cellulose 700g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 10g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, ethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepare soft material, granulations of sieving, particle drying, granulate adds the stearic acid mixing, must simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 14 nicotinic acid the results are shown in accompanying drawing 7, shows nicotinic acid: the niacin slow-release tablet of ethyl cellulose=preparation in 1: 2.8 has tangible slow release effect, and medicine discharged in 24 hours fully, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 15 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Ethyl cellulose 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, ethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 15 nicotinic acid the results are shown in accompanying drawing 8, shows nicotinic acid: the niacin slow-release tablet of ethyl cellulose=preparation in 1: 0.37 has the good slow release effect, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 16 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Ethyl cellulose 185g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 7.0g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, ethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepare soft material, granulations of sieving, particle drying, granulate adds the stearic acid mixing, must simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 16 nicotinic acid the results are shown in accompanying drawing 8, shows nicotinic acid: the niacin slow-release tablet of ethyl cellulose=preparation in 1: 0.37 has the good slow release effect, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 17 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Glyceryl Behenate 320g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 8g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, Glyceryl Behenate, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 17 nicotinic acid the results are shown in accompanying drawing 9, shows nicotinic acid: the niacin slow-release tablet of Glyceryl Behenate=preparation in 1: 0.64 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 18 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Glyceryl Behenate 320g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 8g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, Glyceryl Behenate, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepares soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 18 nicotinic acid the results are shown in accompanying drawing 9, shows nicotinic acid: the niacin slow-release tablet of Glyceryl Behenate=preparation in 1: 0.64 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 19 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Octadecanol 90g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 6g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, octadecanol, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 19 nicotinic acid the results are shown in accompanying drawing 10, shows nicotinic acid: the niacin slow-release tablet of octadecanol=preparation in 1: 0.18 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 20 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 500g
Octadecanol 90g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 6g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, octadecanol, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepares soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 20 nicotinic acid the results are shown in accompanying drawing 10, shows nicotinic acid: the niacin slow-release tablet of octadecanol=1: 0.18 preparation has tangible slow release characteristic, but the release of medicine can keep 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 21 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Sodium alginate 750g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 1.0g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, sodium alginate, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 21 nicotinic acid the results are shown in accompanying drawing 11, shows nicotinic acid: the niacin slow-release tablet of sodium alginate=preparation in 1: 3 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 22 compound niacin simvastatin double-layer sustained release tablets sheets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Sodium alginate 750g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 20g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, sodium alginate, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepare soft material, granulations of sieving, particle drying, granulate adds the stearic acid mixing, must simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 22 nicotinic acid the results are shown in accompanying drawing 11, shows nicotinic acid: the niacin slow-release tablet of sodium alginate=preparation in 1: 3 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 23 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Sodium carboxymethyl cellulose 750g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 1.0g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 10g
Lactose 75g
Carboxymethyl starch sodium 3g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, sodium carboxymethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, carboxymethyl starch sodium by the equivalent method mix homogeneously that progressively increases, add an amount of binding agent and prepare soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 21 nicotinic acid the results are shown in accompanying drawing 12, shows nicotinic acid: the niacin slow-release tablet of sodium carboxymethyl cellulose=preparation in 1: 3 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
The preparation of embodiment 24 compound niacin simvastatin double-layer sustained release tablets (1000 amounts)
Nicotinic acid layer prescription
Nicotinic acid 250g
Sodium carboxymethyl cellulose 750g
Polyvinylpyrrolidone (K90) 17.2g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Simvastatin layer prescription
Simvastatin 10g
Microcrystalline Cellulose 25g
Low viscosity replaces hydroxypropyl cellulose 5g
Lactose 50g
Stearic acid 1g
Binding agent: the 5%PVP80% alcoholic solution is an amount of
Preparation technology:
Nicotinic acid, sodium carboxymethyl cellulose, polyvinylpyrrolidone K90 by equivalent incremental method mixing, are added suitable amount of adhesive and prepare soft material, the granulation of sieving, particle drying, granulate adds stearic acid and mixes, and gets nicotinic acid layer granule.Other gets simvastatin, lactose, microcrystalline Cellulose, low viscosity and replaces hydroxypropyl cellulose by the equivalent method mix homogeneously that progressively increases, and adds an amount of binding agent and prepares soft material, the granulation of sieving, particle drying, the granulate that sieves adds stearic acid and mixes, simvastatin layer granule.The compacting double-layer tablet.
The release of embodiment 22 nicotinic acid the results are shown in accompanying drawing 12, shows nicotinic acid: the niacin slow-release tablet of sodium carboxymethyl cellulose=preparation in 1: 3 has tangible slow release characteristic, and the release of medicine can be kept 24 hours, and simvastatin is stripping fully in 15 minutes.
Claims (7)
1. the slow releasing preparation of compound niacin simvastatin, it is characterized in that: slow releasing tablet is made up of two-layer, and one deck contains the nicotinic acid of clinical effective, is made into slow releasing preparation; Another layer contains the simvastatin of clinical effective, is made into quick releasing formulation, and nicotinic acid in two-layer and simvastatin do not mix mutually.
2. slow releasing preparation according to claim 1, it is characterized in that: the ratio of nicotinic acid and framework material is 1: 0.15～3 in the niacin sustained release layer, and wherein framework material is selected from a kind of or wherein combination arbitrarily in hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, Rikemal B 200, the acrylic resin.
3. according to claim 1,2 one of described slow releasing preparation, it is characterized in that: the niacin sustained release layer also contains polyvinylpyrrolidone and binding agent or wetting agent.
4. the slow releasing preparation one of described according to claim 1-3, wherein the preparation method of niacin sustained release layer is: with nicotinic acid: after a kind of in hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, Rikemal B 200, the acrylic resin or wherein make up arbitrarily mixes with 1: 0.15～3, adopt pelletizing press sheet, perhaps adopt full pressed powder.
5. the slow releasing preparation one of described according to claim 1, it is characterized in that the simvastatin release layer can add carboxymethyl starch sodium, low viscosity and replace hydroxypropyl cellulose, lactose, microcrystalline Cellulose and be the rapid release adjuvant, and add binding agent, wetting agent routinely.
6. according to claim 1,5 one of described slow releasing preparation, wherein the preparation method of simvastatin release layer is: simvastatin with after acceptable rapid release adjuvant on the galenic pharmacy mixes, is adopted pelletizing press sheet, perhaps adopt full pressed powder.
7. according to the preparation method of one of the described slow releasing preparation of claim 1-6, it is characterized in that, with nicotinic acid: after a kind of in hydroxypropyl emthylcellulose, ethyl cellulose, sodium carboxymethyl cellulose, sodium alginate, octadecanol, Rikemal B 200, the acrylic resin or wherein make up arbitrarily mixes with 1: 0.15～3, adopt pelletizing press sheet, perhaps adopt full pressed powder;
Simvastatin with after acceptable rapid release adjuvant on the galenic pharmacy mixes, is adopted pelletizing press sheet, perhaps adopt full pressed powder; Get two parts granule respectively and measure medicament contg, determine every layer of weight; The compacting double-layer tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910232861A CN101785774A (en) | 2009-10-20 | 2009-10-20 | Compound niacin simvastatin bilayer sustained-release tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910232861A CN101785774A (en) | 2009-10-20 | 2009-10-20 | Compound niacin simvastatin bilayer sustained-release tablet |
Publications (1)
| Publication Number | Publication Date |
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| CN101785774A true CN101785774A (en) | 2010-07-28 |
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| CN200910232861A Pending CN101785774A (en) | 2009-10-20 | 2009-10-20 | Compound niacin simvastatin bilayer sustained-release tablet |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN102921009A (en) * | 2012-11-23 | 2013-02-13 | 江苏长泰药业有限公司 | Novel niacin compound sustained release preparation for treating hyperlipidemia |
| CN103494818A (en) * | 2013-10-14 | 2014-01-08 | 南京正大天晴制药有限公司 | Nicotinic acid and simvastatin sustained release tablets and method for manufacturing same |
| CN103599081A (en) * | 2012-11-23 | 2014-02-26 | 江苏长泰药业有限公司 | Novel niacin compound slow-release preparation for treating hyperlipoidemia |
| CN105142618A (en) * | 2013-03-15 | 2015-12-09 | 韩国联合制药株式会社 | Mosapride sustained-release preparation for providing pharmacological clinical effects with once-a-day administration |
-
2009
- 2009-10-20 CN CN200910232861A patent/CN101785774A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN102921009A (en) * | 2012-11-23 | 2013-02-13 | 江苏长泰药业有限公司 | Novel niacin compound sustained release preparation for treating hyperlipidemia |
| CN103599081A (en) * | 2012-11-23 | 2014-02-26 | 江苏长泰药业有限公司 | Novel niacin compound slow-release preparation for treating hyperlipoidemia |
| CN105142618A (en) * | 2013-03-15 | 2015-12-09 | 韩国联合制药株式会社 | Mosapride sustained-release preparation for providing pharmacological clinical effects with once-a-day administration |
| CN103494818A (en) * | 2013-10-14 | 2014-01-08 | 南京正大天晴制药有限公司 | Nicotinic acid and simvastatin sustained release tablets and method for manufacturing same |
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Open date: 20100728 |