CN102058544A - Method for preparing enteric slow release pellet containing fenofibric acid choline salt - Google Patents
Method for preparing enteric slow release pellet containing fenofibric acid choline salt Download PDFInfo
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- CN102058544A CN102058544A CN2010105821660A CN201010582166A CN102058544A CN 102058544 A CN102058544 A CN 102058544A CN 2010105821660 A CN2010105821660 A CN 2010105821660A CN 201010582166 A CN201010582166 A CN 201010582166A CN 102058544 A CN102058544 A CN 102058544A
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Abstract
The invention relates to an enteric slow release pellet containing an active pharmaceutical ingredient of fenofibric acid choline salt, which is characterized by comprising a pill core, an isolation coat layer and a film coat layer for controlling medicament release; and the purpose of medicament enteric slow release can be achieved without additional enteric coat layers. The pill core is prepared by mainly utilizing an extrusion-spheronization method, the coating is carried out by utilizing a fluidized bed.
Description
Technical field:
The invention belongs to the technical field of chemicals sustained-release preparation, exactly relate to a kind of preparation method that contains active component fenofibrate acid choline salt enteric sustained-release pellet.
Technical background:
Fenofibrate acid choline salt chemical name is 2-(4-(4-chlorobenzoyl) phenoxy group)-2 Methylpropionic acid choline salt, and structural formula is seen formula 1:
Formula 1
Studies show that fenofibrate acid comes the blood lipid regulation metabolism by peroxide activator enzyme paraphyte activator receptor α (PPAR α) and PPAR γ.
On December 15th, 2008, drugs approved by FDA the fenofibrate acid choline salt enteric-soluble controlled-release capsule (Trilipix) of Abbott, be used for blood fat reducing disease patient's triglyceride (TG) and low density lipoprotein, LDL (LDL), high density lipoprotein increasing (HDL).To some hyperlipemic patients, the clinical treatment criterion recommends to adopt fibrate and statins drug combination further to improve blood fat.Trilipix is first and unique so far special quasi drugs of shellfish of getting permission to unite with statins use.
Drugs approved by FDA Trilipix listing is based on estimates fenofibrate acid and various statins drug combination curative effects and the maximum so far clinical research data of safety.This product and 3 kinds of statinses (rosuvastatin, atorvastatin and simvastatin) of the most generally writing out a prescription have carried out the curative effect and the safety III phase clinical research of multicenter double blind control at random of 3 12 weeks to 2698 routine mixed dyslipidemia patients.Patient LDL＞130mg/dL that research is included in, triglyceride＞150mg/dL, and HDL male＜40mg/dL, women＜50mg/dL.1911 routine patients have finished the clinical research in 12 weeks altogether, then enter the long-term open further research of 52 weeks.This III phase clinical research result all meets its main therapeutic goal.The drug combination treatment uses statins significantly to improve HDL and triglyceride levels more separately, has significantly improved LDL than the independent medication of this product.All drug combinations and statins all have the clinical effect that reduces LDL.It is better than single drug that the statins drug combination of this product and recipe quantity maximum improves the effect of 3 kinds of lipids.
Fenofibrate acid all has good absorption at whole gastrointestinal tract, Trilipix absolute bioavailability 81%.Under fasted conditions, single oral dose Trilipix, blood drug level reached the peak in 4～5 hours.
The indication that Trilipix ratifies is as follows: 1. be used for Combination dyslipidemia patient and select statins treatment coronary heart disease for use or coronary heart disease risk is arranged to obtain the patient of target LDL-C, unite TG and the increase HDL-C of use to reduce these patients with statins; 2. be used for serious hypertriglyceridemia patient separately; 3. be used for the constitutional hyperlipidemia separately and mix the dyslipidemia patient, with LDL-C, T-CHOL, triglyceride and the apolipoprotein B of reduction patient rising, and increase patient's HDL-C.
Patent documentation CN101217944A explanation Trilipix is a kind of enteric slow release small pieces capsule, its content is enteric-coated a plurality of small pieces, the about 3mm of the diameter of small pieces, its preparation method is: wet granulation → drying → granulate → adding adds the packing of mixing of materials → tabletting → enteric-coating layer → after the assay was approved.Whole prescription design of this explanation Trilipix and preparation method are all more loaded down with trivial details, at first will use multiple controlled slowly releasing adjuncts to prepare slow releasing tablet, and then enteric coated.
The fenofibrate acid choline salt enteric sustained-release pellet of the present invention's preparation is compared with above-mentioned fenofibrate acid choline salt enteric slow release small pieces has following advantage: though 1. small pieces also belong to multiple-unit release dosage form, several small pieces but each capsule can only be packed into, micropill then can pack into dozens of even hundreds of micropills, so micropill is compared with small pieces, the release site is more, stimulate littler to gastrointestinal, release curve and plasma concentration curve are more stable, bigger at the gastrointestinal tract distribution area, bioavailability is higher; 2. the release unit is more little, is subjected to the influence of gastric emptying more little, so micropill is not influenced by gastric emptying substantially, the interior infiltration rate of the body of medicine is more even and bioavailability among individuals difference is littler; 3. the flowability of micropill is better than small pieces, and size is more even, easier coating and divided dose; 4. from preparation technology, the preparation of micropill is especially extruded spheronization and is prepared the wet-granulation process that micropill only is equivalent to small pieces, and convection drying is just passable then, has saved sheeting process.And the coating of the enteric slow release film-coat of fenofibrate of the present invention acid choline salt enteric sustained-release pellet takes into account enteric and slow release simultaneously, do not need independent enteric-coating layer, and technology is simpler; 5. on the slave unit, the punch diameter of compressed minitablets is about 3mm, and the sheeting equipment that use in present domestic pharmaceutical factory generally can only use the drift of diameter greater than 5mm, so small pieces can't carry out extensive Industry Promotion at home, and in contrast be, along with domestic understanding to this good dosage form of micropill is goed deep into gradually, the micropill production line of oneself has been set up in increasing domestic pharmaceutical factory, wherein centrifugal granulation has been with to extrude the commercial processes that spheronization prepares micropill very ripe, just lacking the production of reaching the standard grade of pellet preparations project at present.
Summary of the invention:
An object of the present invention is to overcome the shortcoming and defect of above-mentioned prior art, provide a kind of prescription and preparation technology more reasonable easier, be more suitable for industrialization, clinically the choline salt of fenofibrate acid safely and effectively enteric sustained-release pellet preparation.
Another object of the present invention provides a kind of preparation method of fenofibrate acid choline salt enteric sustained-release pellet, mainly be that the hypotonicity film-coat material of application pH value independent form and the mixing coating solution of pH value dependent form enteric film coat material carry out coating, wherein pH value dependent form enteric film coat material is as the enteric porogen, because this class material does not dissolve under one's belt, make micropill not discharge medicine under one's belt substantially so can keep the hypotonicity of micropill film-coat layer, and this class material is easily molten in the intestinal, the permeability of film-coat layer is increased greatly, medicine just slowly releases, and has so just accomplished the purpose that slowly discharges in intestinal.
Fenofibrate acid choline salt enteric sustained-release pellet of the present invention is made up of the film-coat layer that contains pill core and control drug release, and does not need the extra packet enteric coating layer can reach the purpose of medicament enteric-coated slow release.
The prescription of fenofibrate acid choline salt enteric sustained-release pellet of the present invention is formed:
(1) contains pill core composition consumption (g/g)
Fenofibrate acid choline salt 20%～60%
Diluent 40%～80%
Wetting agent is an amount of
(2) contagion gown layer composition consumption (g/g)
Contagion gown layer material (dry polymeric) 5%～12%
Antiplastering aid 78%～95%
(3) enteric slow release film-coat layer composition consumption (g/g)
Film-coat material (dry polymeric) 40%～75%
Antiplastering aid 20%～50%
The preparation method and the step of fenofibrate acid choline salt enteric sustained-release pellet of the present invention:
(1) microsphere and its preparation is selected for use and is extruded spheronization or centrifugal granulation, forms and can make fenofibrate acid choline salt and contain pill core according to the above-mentioned pill core prescription of containing.Wherein extruding spheronization prepares fenofibrate acid choline salt micropill to contain the pill core concrete steps as follows: 1. get the raw materials ready and batch mixing: crude drug was pulverized 100 mesh sieves, with the abundant mixing of microcrystalline Cellulose; 2. make soft material: add wetting agent and make soft material; 3. soft material is extruded: soft material is extruded into bar through extruder, is smooth brachyplast shape; 4. round as a ball: as the rapid gradation of extrudate to be added in the spheronizator round as a ball, to take out behind the certain hour and promptly make micropill; 5. dry: the micropill that makes is got product in 50 ℃ of oven dry contains pill core.
(2) coating method is selected fluidized bed coating for use, will contain pill core and carry out coating according to above-mentioned contagion gown layer composition and enteric slow release film-coat layer prescription composition, can make fenofibrate acid choline salt enteric sustained-release pellet.To contain pill core and add in the fluidising chamber, and regulate air quantity most of micropill is blown afloat in fluidising chamber, regulate atomization gas pressure and constant flow pump flow velocity, and make the coating solution atomizing effect good, and carry out coating then and get final product.
The adjuvant that fenofibrate acid choline salt enteric sustained-release pellet of the present invention contains pill core is as follows:
(1) diluent that contains pill core comprises one or more mixing wherein such as microcrystalline Cellulose, lactose, sucrose, starch, Pulvis Talci;
(2) binding agent that contains pill core comprises one or more mixing wherein such as hypromellose, polyvidone, carboxymethyl cellulose, is made into aqueous solution or water/alcoholic solution during use;
(3) contain pill core wetting agent comprise that water or concentration are for the ethanol of≤95% (v/v) etc.
The used coating material of fenofibrate of the present invention acid choline salt enteric sustained-release pellet is as follows:
(1) thin film coating material of contagion gown layer comprises hypromellose (HPMC) or its serial commodity such as Opadry etc., or methylcellulose (MC) or polyvidone (PVP) or polyvinyl alcohol (PVA) or hydroxyethyl-cellulose (HEC) or hydroxypropyl cellulose (HPC).
(2) thin film coating material of control drug release comprises polyvinyl acetate, for example its aqueous dispersion product K ollicoat SR 30D; Or EUDRAGIT NE 30 D EUDRAGIT NE 30D, for example its aqueous dispersion Kollicoat EMM 30D or Eudragit NE 30D; Or ethyl acrylate-methyl methacrylate-methacrylic acid chlorination trimethylamine groups ethyl ester copolymer, for example its aqueous dispersion Eudragit RS 30D and EudragitRL 30D; Or ethyl cellulose, for example its aqueous dispersion Aquacoat or Surelease or Yi Shida.
(3) the enteric porogen comprises methacrylic acid and ethyl acrylate copolymer, for example Eudragit L100-55 or Eudragit L 30D-55 or Kollicoat MAE 100P or Kollicoat MAE 30DP; Or methacrylic acid and methylmethacrylate copolymer, for example Eudragit L100 or polyacrylic resin II and Eudragit S100 or polyacrylic resin III; Or cellulose and derivant thereof, cellulose acetate phthalate (cellulose acetate peptide acid esters for example, CAP) or 1,2,4-benzenetricarboxylic acid cellulose acetate (cellulose acetate benzenetricarboxylic acid ester, CAT) or Hydroxypropyl Methylcellulose Phathalate (hypromellose peptide acid esters, HPMCP) or 1,2,4-benzenetricarboxylic acid hydroxypropyl emthylcellulose (HPMCr) or succinic acid cellulose acetate (CAS) or succinic acid acetic acid hydroxypropyl emthylcellulose (HPMCAS) or enteric solubility Opadry (Opadry) etc.
The adjunct ingredient of fenofibrate acid choline salt enteric sustained-release pellet film-coat layer of the present invention is as follows:
The plasticizer that cooperates coating material to use comprises one or more mixing in triethyl citrate, propylene glycol, triacetin, acetyl list monoglyceride, phthalic acid ester, the Semen Ricini wet goods plasticizer;
Antiplastering aid comprises one or more mixing of materials such as Pulvis Talci, glyceryl monostearate and micropowder silica gel.
Fenofibrate acid choline salt enteric sustained-release pellet single dose of the present invention is 45mg or 135mg, takes every day 1 time, and its drug release rate characteristic is as follows:
Description of drawings
Fig. 1 embodiment 3 fenofibrate acid choline salt enteric sustained-release pellet cumulative release curve
Fig. 2 embodiment 4 fenofibrate acid choline salt enteric sustained-release pellet cumulative release curve
The specific embodiment
Following examples just describe, and do not limit scope of invention.
Embodiment 1 preparation contains pill core
(1) prescription:
Fenofibrate acid choline salt 400g
Microcrystalline Cellulose 600g
60% ethanol is an amount of
(2) preparation technology:
Get fenofibrate acid choline salt crude drug, pulverizing is also crossed 100 mesh sieves, with the abundant mixing of microcrystalline Cellulose; The material of mixing is added about 60% alcoholic solution of an amount of concentration make soft material; Soft material dropped into be squeezed into the strip extrudate in the extruder; The rapid gradation of extrudate is added in the spheronizator round as a ball, takes out behind the certain hour and promptly make micropill; The micropill that makes is promptly obtained dry micropill in 50 ℃ of baking 3～6h.The micropill outward appearance slyness that the result makes, roundness is good, and is all spherical in shape.
Embodiment 2 ball core bag contagion gowns
The prepared pill core (promptly not the micropill of coating) that contains of embodiment 1 is at first carried out the sealing coat coating with 3%HPMC.
(1) coating fluid prescription:
Hypromellose (HPMC) 300g
Pulvis Talci 150g
95% ethanol 7500mL
Water adds to 10000mL
(2) art for coating:
The not coated micropill (W1) of constant weight is placed in the fluid bed, regulate suitable air blast flux and atomization gas pressure and constant flow pump flow velocity, make the coating solution atomizing effect good, be unlikely to lose too many coating solution again, there is not any adhesion phenomenon between micropill yet, after coating finished, the weight that takes by weighing coated micropill was (W2), then
(viscosity is 3～5cps) 300g, adds 95% ethanol 7500mL, stirs to make it to be uniformly dispersed to take by weighing HPMC, be diluted with water to 10000mL and make it dissolving fully, add the 150g Pulvis Talci, the high speed homogenize, carry out coating according to above-mentioned art for coating then, coating weightening finish 3%～5%.
Embodiment 3 preparation fenofibrate acid choline salt enteric sustained-release pellets
Adopt following coating fluid prescription to proceed coating the embodiment 2 prepared micropills that are surrounded by contagion gown, can make fenofibrate acid choline salt enteric sustained-release pellet.
(1) coating fluid prescription:
Eudragit?RS?30D 300g
Eudragit?L?30D-55 20g
Triethyl citrate 15g
Pulvis Talci 40g
Water adds to 750g
(2) preparation technology:
With Eudragit RS 30D, Eudragit L 30D-55 and water mixing, add triethyl citrate and Pulvis Talci, the high-speed stirred homogenize promptly gets coating solution.Adopt low spray formula fluid unit, the fenofibrate acid choline salt micropill 400g that 18～24 purposes is surrounded by contagion gown adds in the fluidising chamber, regulate air blast flux, atomization gas pressure, constant flow pump flow velocity, coating temperature, make the coating solution atomizing effect good, be unlikely to lose too many coating solution again, there is not adhesion phenomenon between micropill substantially, coating weightening finish 15%～20% yet.Coating finishes baking 12h in rearmounted 40 ℃ of calorstats.Every capsules dress 135mg coated micropill (being equivalent to fenofibrate acid 45mg).
Release experiment: 1. with two appendix XC first subtraction units of Chinese Pharmacopoeia version in 2010, according to burst size in the acid of two appendix XD second method working samples of Chinese Pharmacopoeia version in 2010.Every capsules dress coated micropill 135mg (being equivalent to fenofibrate acid 45mg), with 0.1mol/L hydrochloric acid solution 900ml release medium, rotating speed is that per minute 75 changes, operation in accordance with the law, when 2h, it is an amount of to get solution, measures.Chromatographic condition is that chromatographic column is C18 post (150mm * 4.6mm, 5 μ m), and mobile phase is 0.05molL-1 potassium dihydrogen phosphate-methanol (70: 30), transfers pH2.5 with phosphoric acid, detects wavelength 286nm.Result such as Fig. 1.
2. with two appendix XC first subtraction units of Chinese Pharmacopoeia version in 2010, according to the release of two appendix XD first method working samples of Chinese Pharmacopoeia version in 2010.Release medium is phosphate buffer (pH6.8) 900ml, and other condition is the same, reclocking, and through 2h, 4h during 8h, carries out sampling and measuring.Chromatographic condition is the same.Result such as Fig. 1.
Adopt following coating fluid prescription to proceed coating the embodiment 2 prepared micropills that are surrounded by contagion gown, can make fenofibrate acid choline salt enteric sustained-release pellet.
(1) coating fluid prescription:
Eudragit?NE?30D 300g
Eudragit?L?30D-55 15g
Pulvis Talci 40g
Water adds to 750g
(2) preparation technology:
Get Eudragit NE 30D, Eudragit L 30D-55, water and Pulvis Talci by above-mentioned prescription, the high speed homogenize gets final product coating, art for coating is substantially with embodiment 3,25～28 ℃ of coating temperature, coating weightening finish 10%～15%, coating finishes baking 12h in rearmounted 40 ℃ of calorstats.Every capsules dress 130mg coated micropill (being equivalent to fenofibrate acid 45mg) is measured release, result such as Fig. 2 with the method described in the embodiment 3.
Claims (5)
1. enteric sustained-release pellet that contains active pharmaceutical ingredient fenofibrate acid choline salt, it is characterized in that forming, and do not need the extra packet enteric coating layer can reach the purpose of medicament enteric-coated slow release by the film-coat layer that contains pill core, contagion gown layer and control drug release.
2. fenofibrate acid choline salt enteric sustained-release pellet according to claim 1 is characterized in that single dose is 45mg or 135mg, takes every day 1 time, and its drug release rate characteristic is as follows:
3. the preparation method of fenofibrate acid choline salt enteric sustained-release pellet is characterized in that this preparation method comprises following prescription and step:
The I composition of writing out a prescription:
(1) contains pill core composition consumption (g/g)
Fenofibrate acid choline salt 20%～60%
Diluent 40%～80%
Binding agent 0～15%
Wetting agent is an amount of
(2) contagion gown layer composition consumption (g/g)
Contagion gown layer material (dry polymeric) 5%～12%
Antiplastering aid 78%～95%
(3) enteric slow release film-coat layer composition consumption (g/g)
Film-coat material (dry polymeric) 40%～75%
Enteric porogen 5%～40%
Plasticizer 0～20%
Antiplastering aid 20%～50%
II preparation method and step:
(1) microsphere and its preparation is selected for use and is extruded spheronization or centrifugal granulation, forms and can make fenofibrate acid choline salt and contain pill core according to the above-mentioned pill core prescription of containing;
(2) coating method is selected fluidized bed coating for use, will contain pill core and carry out coating according to above-mentioned contagion gown layer composition and enteric slow release film-coat layer prescription composition, can make fenofibrate acid choline salt enteric sustained-release pellet;
4. according to the preparation method of the described fenofibrate acid of claim 3 choline salt enteric sustained-release pellet, it is characterized in that:
(1) diluent that contains pill core comprises one or more mixing wherein such as microcrystalline Cellulose, lactose, sucrose, starch, Pulvis Talci;
(2) binding agent that contains pill core comprises one or more mixing wherein such as hypromellose, polyvidone, carboxymethyl cellulose, is made into aqueous solution or water/alcoholic solution during use;
(3) contain pill core wetting agent comprise that water or concentration are for the ethanol of≤95% (v/v) etc.
5. according to the preparation method of the described fenofibrate acid of claim 3 choline salt enteric sustained-release pellet, it is characterized in that:
(1) thin film coating material of contagion gown layer comprises hypromellose (HPMC) or its serial commodity such as Opadry etc., or methylcellulose (MC) or polyvidone (PVP) or polyvinyl alcohol (PVA) or hydroxyethyl-cellulose (HEC) or hydroxypropyl cellulose (HPC);
(2) thin film coating material of control drug release comprises polyvinyl acetate, for example its aqueous dispersion product K ollicoat SR 30D; Or EUDRAGIT NE 30 D EUDRAGIT NE 30D, for example its aqueous dispersion Kollicoat EMM 30D or Eudragit NE 30D; Or ethyl acrylate-methyl methacrylate-methacrylic acid chlorination trimethylamine groups ethyl ester copolymer, for example its aqueous dispersion Eudragit RS 30D and EudragitRL 30D; Or ethyl cellulose, for example its aqueous dispersion Aquacoat or Surelease or Yi Shida;
(3) the enteric porogen comprises methacrylic acid and ethyl acrylate copolymer, for example Eudragit L 100-55 or Eudragit L 30D-55 or Kollicoat MAE 100P or Kollicoat MAE 30DP; Or methacrylic acid and methylmethacrylate copolymer, for example Eudragit L100 or polyacrylic resin II and Eudragit S100 or polyacrylic resin III; Or cellulose and derivant thereof, cellulose acetate phthalate (cellulose acetate peptide acid esters for example, CAP) or 1,2,4-benzenetricarboxylic acid cellulose acetate (cellulose acetate benzenetricarboxylic acid ester, CAT) or Hydroxypropyl Methylcellulose Phathalate (hypromellose peptide acid esters, HPMCP) or 1,2,4-benzenetricarboxylic acid hydroxypropyl emthylcellulose (HPMCr) or succinic acid cellulose acetate (CAS) or succinic acid acetic acid hydroxypropyl emthylcellulose (HPMCAS) or enteric solubility Opadry (Opadry) etc.;
(4) plasticizer that cooperates coating material to use comprises one or more mixing in triethyl citrate, propylene glycol, triacetin, acetyl list monoglyceride, phthalic acid ester, the Semen Ricini wet goods plasticizer.
(5) antiplastering aid comprises one or more mixing of materials such as Pulvis Talci, glyceryl monostearate and micropowder silica gel.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102659609A (en) * | 2012-05-17 | 2012-09-12 | 安润医药科技（苏州）有限公司 | Fenofibric acid salt, and preparation method, application and medicinal composition thereof |
| CN104473909A (en) * | 2014-11-21 | 2015-04-01 | 哈尔滨圣吉药业股份有限公司 | Choline fenofibric acid sustained release pellets and preparation method thereof |
| CN104721148A (en) * | 2013-12-18 | 2015-06-24 | 江苏豪森药业股份有限公司 | Enteric-coated slow release pellet or particle solid preparation and production method thereof |
| CN104856976A (en) * | 2015-05-29 | 2015-08-26 | 河南中帅医药科技股份有限公司 | Fenofibrate sustained release capsule and preparation method thereof |
| CN105753702A (en) * | 2016-02-26 | 2016-07-13 | 西安交通大学 | 3,4-dihydroxyphenylethanol fenofibrate acid ester as well as preparation method and application thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102659609A (en) * | 2012-05-17 | 2012-09-12 | 安润医药科技（苏州）有限公司 | Fenofibric acid salt, and preparation method, application and medicinal composition thereof |
| CN104721148A (en) * | 2013-12-18 | 2015-06-24 | 江苏豪森药业股份有限公司 | Enteric-coated slow release pellet or particle solid preparation and production method thereof |
| CN104473909A (en) * | 2014-11-21 | 2015-04-01 | 哈尔滨圣吉药业股份有限公司 | Choline fenofibric acid sustained release pellets and preparation method thereof |
| CN104856976A (en) * | 2015-05-29 | 2015-08-26 | 河南中帅医药科技股份有限公司 | Fenofibrate sustained release capsule and preparation method thereof |
| CN105753702A (en) * | 2016-02-26 | 2016-07-13 | 西安交通大学 | 3,4-dihydroxyphenylethanol fenofibrate acid ester as well as preparation method and application thereof |
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| Publication number | Publication date |
|---|---|
| CN102058544B (en) | 2012-10-03 |
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