CN103315953A - Fenofibrate self-microemulsifying preparation and preparation method thereof - Google Patents
Fenofibrate self-microemulsifying preparation and preparation method thereof Download PDFInfo
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- CN103315953A CN103315953A CN2012100892705A CN201210089270A CN103315953A CN 103315953 A CN103315953 A CN 103315953A CN 2012100892705 A CN2012100892705 A CN 2012100892705A CN 201210089270 A CN201210089270 A CN 201210089270A CN 103315953 A CN103315953 A CN 103315953A
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Abstract
The invention belongs to the field of medical technology, and discloses a fenofibrate self-microemulsifying preparation and a preparation method thereof. Raw materials of the fenofibrate self-microemulsifying preparation comprise following ingredients, by weight: 10 to 25% of fenofibrate, 50 to 70% of polyoxyethylene hydrogenated castor oil, 20 to 30% of caprylic/capric triglyceride, 20 to 30% of propylene glycol and 10 to 15% of ethanol. The fenofibrate solid self-microemulsifying preparation is further prepared in a liquid phase by applications of spherical crystallization techniques, and the preparation comprises following ingredients, by weight: 1.0 to 2.5g of fenofibrate, 5.0g of polyoxyethylene hydrogenated castor oil, 2.0g of caprylic/capric triglyceride, 2.0g of propylene glycol, 1.0ml of ethanol, 2.0 ml of acetone, 4.0ml of dichloromethane, 5.0 to 11.0 g of ethyl cellulose (10 to 40 cp) (or Eudragit RS100, RL100), 0.5g of PEG4000, and 3.0 g of micropowder silicagel.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of preparation method of pharmaceutical preparation, exactly it is a kind of fenofibrate solid self-microemulsion microgranule and preparation method thereof.Specifically a kind of in liquid phase a step make fenofibrate solid self-microemulsion microgranule.
Background technology
Atherosclerosis is the important risk factor of cardiovascular disease, and it is atherosclerotic main inducing that blood fat increases.Hyperlipemia can be passed through arterial intima, changes macrophage function, promotes links such as platelet aggregation lipidosis and foam cell formation to promote atherosclerosis.Blood fat reducing is for the generation of prevention coronary heart disease, and the mortality rate that reduces cardiovascular and cerebrovascular disease has very important meaning.The special class of shellfish has clear and definite reduction serum cholesterol and triglyceride effect, is a desirable fat-reducing medicament, and fenofibrate can be used as the first line fat-reducing medicament and promotes the use of clinically.
Fenofibrate is by the exploitation of French Fournier company, and 1981 in French Initial Public Offering, successively in moral, Belgium, Switzerland, Greece's listing.1992 in China registration, this product reduce serum cholesterol and the triglyceride effect remarkable, few side effects and light.
The existing dosage form of fenofibrate has sheet, capsule, slow releasing capsule, slow-release pill, chewable tablet, dispersible tablet, granule, also have fenofibrate micropowder tablet, fenofibrate solid dispersion sheet in addition, abroad dosage forms such as existing fenofibrate solid dispersion, clathrate, liposome nanoparticle.Fenofibrate is water-soluble hardly, belongs to insoluble drug, and the tablet, capsule, granule and the powder that therefore prepare them should solve the low problem of its preparation stripping.
Micronization at present commonly used and solid dispersion technology solve the low problem of dissolution.As make fenofibrate micropowder tablet, fenofibrate solid dispersion sheet etc.The raw material that adopts micronization to be made generally in is assembled easily, and the preparation oral formulations needs to granulate, some steps such as the encapsulated or back tabletting of granulating with other adjuvant.Adopt solid dispersion technology to prepare the following steps of the general needs of oral formulations: the solid dispersion that at first adopts suitable method (fusion method, solvent method, fusion-solvent method, surperficial dispersion method etc.) preparation medicine, pulverize then, sieve, granulate, encapsulated or with other adjuvant back tabletting of granulating, also need further coating etc. if want to prepare controlled slow-release preparation.Because preparation section is many, often need strictness to control each link well, can guarantee that just preparation has good repeatability, so develop a kind of comparatively simple preparation technology, be the effective means that guarantees the insoluble drug quality of the pharmaceutical preparations.
Summary of the invention
The objective of the invention is the deficiency at existing preparation, fenofibrate is made the solid self-micro emulsion formulation can make medicine steadily discharge slowly, the back blood drug level of avoiding taking medicine is too high and cause serious Liver and kidney toxicity, also can avoid liquid alcohol to the influence of soft capsule shell, improve oral administration biaavailability, improve curative effect, solidify self-microemulsion and conveniently store and carry.
The objective of the invention is to realize according to following scheme
The preparation of fenofibrate solid self-microemulsion utilizes the spherocrystal granulating technique, with the macromolecule blocker, porogen is dissolved in the even suspension solution that forms macromolecular material in the solvent, under stirring condition, add and contain in right amount in the aqueous solutions such as poor solvent of certain surface activating agent, stir through appropriate time, replenish suitable quantity of water, continue to stir an amount of time, good solvent and bridging agent phase counterdiffusion in water, emulsion droplet solidifies, and forms microspheres with solid, dry under the room temperature, collect, the associating dispersible carrier is cured the fenofibrate self-microemulsion, thereby prepares fenofibrate solid self-microemulsion microgranule.
Fenofibrate solid self-microemulsion wherein, it is characterized in that: utilize the spherocrystal granulating technique, the fenofibrate self-microemulsion is joined macromolecular material, dispersible carrier, porogen be dissolved in the even suspension solution that forms macromolecular material in the solvent, join in the poor solvent that contains surfactant, a step makes fenofibrate solid self-microemulsion microgranule in liquid phase.
Preparation fenofibrate solid self-microemulsion microgranule needs three solvent systems and surfactant to form.
Bridging agent: dichloromethane, chloroform;
Good solvent: independent or mixed solvent such as ethanol, acetone;
Poor solvent: water and aqueous medium thereof.
Surfactant: sodium lauryl sulphate, polyvinyl alcohol, poloxamer, tween 80 etc.
Macromolecular material selection cellulose derivative class is selected from one or more in hypromellose titanate esters, Hydroxypropyl Methyl Cellulose Phthalate, hypromellose, hydroxypropyl cellulose phthalate, the ethyl cellulose (10-40cp), preferred, ethyl (10-40cp) in the fenofibrate solid self-microemulsion; Crylic acid resin or cellulose derivative class, wherein crylic acid resin is selected from one or more among acrylic resin, Eudragit RL, Eudragit RS, Eudragit E, Eudragit L, the Eudragit S, preferred acrylic resins Eudragit E100, Eudragit RS100, Eudragit RL100; Porogen selects for use PEG4000, polyethylene than in pyrrolidone, HPMC K4M, lactose, the mannitol powder one or more; Dispersible carrier is selected one or more of micropowder silica gel, Pulvis Talci, calcium carbonate, calcium phosphate, magnesium stearate for use.
Fenofibrate solid self-microemulsion, it is characterized in that: the weight ratio that said composition contains fenofibrate self-microemulsion raw material is: fenofibrate: 10%～20%, polyoxyethylene hydrogenated Oleum Ricini: 50%～70%, sad capric acid triglyceride: 20%～30%, propylene glycol: 20%～30%, ethanol: 10%～15%.
Fenofibrate solid self-microemulsion is characterized in that its weight consists of: fenofibrate: 1.0～2.5, polyoxyethylene hydrogenated Oleum Ricini: 5.0, sad capric acid triglyceride: 2.0, propylene glycol: 2.0, ethanol: 1.0, acetone 2.0ml, dichloromethane 4.0, ethyl cellulose (10-40cp) (or Eudragit RS100, RS100) 5.0～11.0g, PEG40000.5, micropowder silica gel 3.0.
Fenofibrate solid self-microemulsion, it is characterized in that: the weight of fenofibrate solid self-microemulsion raw material consists of: fenofibrate: 1.0, polyoxyethylene hydrogenated Oleum Ricini: 5.0, sad capric acid triglyceride: 2.0, propylene glycol: 2.0, ethanol: 1.0, acetone 2.0ml, dichloromethane 4.0, ethyl cellulose (10cp) 5.0g, PEG40000.5g, micropowder silica gel 3.0g.
The spherocrystal granulating technique prepares fenofibrate solid self-microemulsion, and its solidification temperature is 25 ℃～50 ℃, and rotating speed is 400～600rpm.The mass fraction of fenofibrate in self-microemulsion is 0.09～0.25.The mass fraction of fenofibrate in the solid self-microemulsion is 0.05～0.25.
Add the adding of the purpose porogen of porogen in the microsphere preparation process, make the microsphere of preparation with holes, thereby better, more adsorb the fenofibrate self-microemulsion, when guaranteeing to improve drug loading, make the microsphere that makes have vertical compression.
The sad capric acid triglyceride of oil phase in the adsorption process in the purpose fenofibrate self-microemulsion of adding micropowder silica gel and the viscosity of surfactant polyoxyethylene hydrogenation castor oil are very big, and fusion at high temperature takes place easily, adding carrier material makes medicine better be adsorbed by porous microsphere, improve solids flowability effectively, can be used for directly filling or tabletting.
The fenofibrate solid self-microemulsion of preparation can form microemulsion in 37 ℃ aqueous solution, present blue opalescence.
Advantage of the present invention be can be in liquid phase a step make fenofibrate and solidify self-microemulsion.Medicine can slowly discharge stably after said preparation entered gastrointestinal tract, reduced the serious Liver and kidney toxicity that quick releasing formulations such as oral liquid and soft capsule produce.Also avoid simultaneously in the soft capsule pure class I liquid I to the influence of softgel shell, and drug loading increase greatly, the solid self-microemulsion, better mobile because of it, can directly incapsulate or direct compression, production cost is low, favorable reproducibility, yield height.
Description of drawings
The figure laser particle size analyzer is measured fenofibrate solid self-microemulsion diameter of particle and particle size distribution
The specific embodiment
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 1.0g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing ethyl cellulose 5.0g, PEG4000 0.05g in small beaker, add acetone 2ml and dichloromethane 4ml, make it to dissolve fully or suspendible, add the fenofibrate self-microemulsion in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 0.08%SDS aqueous solution, temperature is controlled to be 25 ℃, and rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continue to stir 10min, until solidifying fully.Do not take place stickingly glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
Embodiment 2
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 1.0g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir, namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing ethyl cellulose 0.5g, PEG4000 0.05g is in small beaker, add acetone 2ml and chloroform 4ml, make it to dissolve fully or suspendible, add above-mentioned fenofibrate self-microemulsion in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 0.08%SDS aqueous solution, temperature is controlled to be 25 ℃, rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continues to stir 10min, do not take place sticking glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
Embodiment 3
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 1.0g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing the 5.0mg ethyl cellulose, 0.5gPEG4000 in small beaker, add acetone 2ml and dichloromethane 4ml, make it to dissolve fully or suspendible, add above-mentioned fenofibrate self-microemulsion 1.0g in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 1%PVA aqueous solution, temperature is controlled to be 25 ℃, rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continues to stir 10min, do not take place sticking glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
Embodiment 4
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 1.25g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir, namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing 5.0g Eudragit RS100,0.5gPEG4000 in small beaker, add acetone 2ml and dichloromethane 4ml, make it to dissolve fully or suspendible, add the fenofibrate self-microemulsion in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 0.08%SDS aqueous solution, temperature is controlled to be 25 ℃, rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continues to stir 10mi n, do not take place sticking glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 2.5g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir, namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing 11.0g Eudragit RL100,0.5g HPMC K4M is in small beaker, add acetone 2ml and dichloromethane 4ml, make it to dissolve fully or suspendible, add above-mentioned fenofibrate self-microemulsion in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 0.08%SDS aqueous solution, temperature is controlled to be 25 ℃, rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continues to stir 10min, do not take place sticking glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
Embodiment 6
[prescription]
[preparation technology]
The preparation of fenofibrate self-microemulsion: take by weighing fenofibrate 2.5g according to prescription, be dissolved in the 1.0ml ethanol, add the sad capric acid triglyceride of recipe quantity, polyethylene glycol hydrogenated castor oil and propylene glycol more successively, stir, namely.
The preparation of fenofibrate solid self-microemulsion: take by weighing 11.0g Eudragit RS100,0.5g HPMC K4M is in small beaker, add acetone 2ml and dichloromethane 4ml, make it to dissolve fully or suspendible, above-mentioned fenofibrate self-microemulsion is in small beaker, add an amount of micropowder silica gel, slowly be injected in the poor solvent that contains the 0.08%SDS aqueous solution, temperature is controlled to be 25 ℃, rotating speed is 400rpm, adds an amount of distilled water behind the continuous stirring 1h, continues to stir 10min, do not take place sticking glutinous to aggregate particle, natural drying 12h sieves and weighs on sieve, and particle diameter concentrates on 100～400 μ m.
The fenofibrate solid self-microemulsion that makes is dissolved in a certain amount of 37 ℃ distilled water, after stirring a period of time, the solution clear, and tangible blue opalescence is arranged.
Claims (7)
1. claim 1 fenofibrate self-micro emulsion formulation, its feature comprises: fenofibrate self-microemulsion and utilize the spherocrystal granulating technique, the fenofibrate self-microemulsion is joined macromolecular material, dispersible carrier, porogen be dissolved in the even suspension solution that forms macromolecular material in the solvent, join in the poor solvent that contains surfactant, a step makes fenofibrate solid self-microemulsion in liquid phase.
2. fenofibrate self-microemulsion according to claim 1, it is characterized in that: the weight ratio that said composition contains fenofibrate self-microemulsion raw material is: fenofibrate: 10%～25%, polyoxyethylene hydrogenated Oleum Ricini: 50%～70%, sad capric acid triglyceride: 20%～30%, propylene glycol: 20%～30%, ethanol: 10%～15%.
3. according to claim 1,2 described a kind of fenofibrate solid self-microemulsion, it is characterized in that: macromolecular material selection cellulose derivative class is selected from one or more in hypromellose titanate esters, Hydroxypropyl Methyl Cellulose Phthalate, hypromellose, hydroxypropyl cellulose phthalate, the ethyl cellulose (10-40cp), preferred, ethyl (10-40cp); Crylic acid resin or cellulose derivative class, wherein crylic acid resin is selected from one or more among acrylic resin, Eudragit RL, Eudragit RS, Eudragit E, Eudragit L, the Eudragit S, preferred acrylic resins Eudragit E100, Eudragit RS100, Eudragit RL100; Porogen selects for use PEG4000, polyethylene than in pyrrolidone, HPMC K4M, lactose, the mannitol powder one or more; Dispersible carrier is selected one or more of micropowder silica gel, Pulvis Talci, calcium carbonate, calcium phosphate, magnesium stearate for use.
4. fenofibrate solid self-microemulsion according to claim 2, it is characterized in that: the weight of fenofibrate solid self-microemulsion raw material consists of: fenofibrate: 1.0～2.5, polyoxyethylene hydrogenated Oleum Ricini: 5.0, sad capric acid triglyceride: 2.0, propylene glycol: 2.0, ethanol: 1.0, dichloromethane 4.0, ethyl cellulose (10-40cp) (or Eudragit RS100, RS100) 5.0～11.0g, PEG40000.5, micropowder silica gel 3.0.
5. fenofibrate solid self-microemulsion according to claim 2, it is characterized in that: the weight of fenofibrate solid self-microemulsion raw material consists of: fenofibrate: 1.0, polyoxyethylene hydrogenated Oleum Ricini: 5.0, sad capric acid triglyceride: 2.0, propylene glycol: 2.0, ethanol: 1.0, dichloromethane 4.0, ethyl cellulose (10cp) 5.0g, PEG40000.5g, micropowder silica gel 3.0g.
6. preparation method according to claim 1, it is characterized in that: the mass fraction of fenofibrate in self-microemulsion is 0.09～0.25, the mass fraction of fenofibrate in the solid self-microemulsion is 0.05～0.25.
7. curing according to claim 1, it is characterized in that: the spherocrystal granulating technique prepares fenofibrate solid self-microemulsion, and its solidification temperature is 25 ℃～50 ℃, and rotating speed is 400～600rpm.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105769767A (en) * | 2016-04-12 | 2016-07-20 | 武汉理工大学 | Etofibrate self-emulsifying preparation and preparation method thereof |
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- 2012-03-20 CN CN2012100892705A patent/CN103315953A/en active Pending
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| WO2007096894A1 (en) * | 2006-02-27 | 2007-08-30 | Yissum Research Development Company Of The Hebrew University Of Jerusalem | Method for nucleating polymers |
| CN101134018A (en) * | 2006-07-18 | 2008-03-05 | 安徽省现代中药研究中心 | Fenofibrate pellet and method for preparing the same |
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| CN105769767A (en) * | 2016-04-12 | 2016-07-20 | 武汉理工大学 | Etofibrate self-emulsifying preparation and preparation method thereof |
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Application publication date: 20130925 |