CN104352466A - Fenofibrate composition and preparation thereof - Google Patents
Fenofibrate composition and preparation thereof Download PDFInfo
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- CN104352466A CN104352466A CN201410657373.6A CN201410657373A CN104352466A CN 104352466 A CN104352466 A CN 104352466A CN 201410657373 A CN201410657373 A CN 201410657373A CN 104352466 A CN104352466 A CN 104352466A
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Abstract
The invention belongs to the technical field of medicine preparation, and particularly relates to a fenofibrate composition and a preparation thereof. The fenofibrate composition comprises the following components in parts by weight: 100 parts of fenofibrate, 80-100 parts of a filler, 0.5-1.5 parts of an adhesive, 5-15 parts of a disintegrating agent, 0.5-3 parts of a lubricating agent and 0.5-3 parts of a surfactant, wherein the mean particle size of the fenofibrate is controlled between 10 microns and 20 microns. Compared with the prior art, according to the fenofibrate composition disclosed by the invention, the raw materials are subjected to micronization treatment; the particle sizes are controlled to be between 10 microns and 20 microns; and after the preparation is prepared, the dissolution rate of the fenofibrate can be increased, thus the bioavailability of the preparation is improved; and the stability of the preparation is also improved.
Description
Technical field
The invention belongs to field of medicine preparing technology, specifically, relate to a kind of Fenofibrate composition and preparation thereof.
Background technology
Fenofibrate is phenoxy acetic acid class hypolipidemic, can effectively suppress HMGCoA reductase, reduces the synthesis of intracellular cholesteryl, increases lipoprotein lipase active, promotes the decomposition of low density lipoprotein, LDL, reduces the concentration of triglyceride in blood.In addition, fenofibrate, by suppressing the esterification of cholesterol, reduces the effect of hematoblastic gathering and the generation of platelet production factor, slows down or delay the process of atheromatous.The peculiar good curative effect of FENOBRATE, but owing to not dissolving in water, dissolution is not enough, causes oral artifact availability low.At digestive tract, its absorbed following oral administration only has an appointment 60%.Its bioavailability is incomplete, and varies with each individual, and individual variation is larger.Generally require to use to improve bioavailability together with food.
If improve the dissolution characteristic of fibrate, just bioavailability can be improved.In order to improve bioavailability, fenofibrate class medicine is often made together with pharmaceutically acceptable adjuvant filler, binding agent, disintegrating agent, lubricant, surfactant.Such as, Chinese patent (200910116291.X) discloses so a kind of compositions, it comprises fenofibrate 6-42 part, polyethylene glycol 6000 or poloxamer188 60-80 part, Glyceryl Behenate or palmitic acid stearic acid ester of glycerol 6-42 part, Polyethylene Glycol glyceryl laurate ester or ethylene glycol monomethyl ether 2-12 part, polyoxyethylene hydrogenated Oleum Ricini or polyoxyethylene castor oil 2-12 part.But said composition is mainly used as slow releasing agent, fenofibrate rate of release is comparatively slow and quality is unstable.
Summary of the invention
For solving the problems of the technologies described above, the invention provides the high Fenofibrate composition of a kind of steady quality, dissolution and preparation thereof.
A kind of Fenofibrate composition of the present invention, described compositions calculates by mass parts, and its component comprises fenofibrate, the filler of 80-100 part, the binding agent of 0.5-1.5 part, 5-15 part disintegrating agent, the lubricant of 0.5-3 part, the surfactant of 0.5-3 part of 100 parts; The mean diameter of described fenofibrate controls between 10-20 μm.
A kind of Fenofibrate composition of the present invention, described filler is made up of one or more in lactose, mannitol, microcrystalline Cellulose, pregelatinized Starch, starch, dextrin, Icing Sugar, calcium hydrogen phosphate, calcium carbonate.
A kind of Fenofibrate composition of the present invention, one or more during described disintegrating agent is fixed by sodium carboxymethyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, mountain chinaberry form.
A kind of Fenofibrate composition of the present invention, described binding agent is made up of one or more in starch, hypromellose, hyprolose, PVPK30, dextrin.
A kind of Fenofibrate composition of the present invention, described lubricant is made up of one or more in magnesium stearate, Pulvis Talci, silicon dioxide, stearic acid, behenic acid glyceride.
A kind of Fenofibrate composition of the present invention, described surfactant is made up of one or more in sodium lauryl sulphate, Tween 80, poloxamer.
The preparation that a kind of Fenofibrate composition of the present invention is made, described preparation is tablet or capsule.
The preparation method of the preparation that a kind of Fenofibrate composition of the present invention is made, described preparation method concrete steps are: 1) by fenofibrate micronization processes, control particle diameter between 10 μm-20 μm; 2) by the fenofibrate of recipe quantity, filler, disintegrating agent mix homogeneously; 3) add the solution of the binding agent of the surfactant of recipe quantity, the solvent of described solution is that water is or/and ethanol; 4) granulate after making soft material, dry, then add the lubricant granulate of recipe quantity, obtain granule; 5) by granulation or filling capsule.
Compared with prior art, Fenofibrate composition of the present invention, by raw material micronization processes, controls particle diameter between 10-20 μm, after making preparation, can improve the dissolution of fenofibrate, thus improve the bioavailability of preparation, and the stability of preparation also increases.
Detailed description of the invention
Below in conjunction with specific embodiment, Fenofibrate composition of the present invention and preparation thereof are described further, but protection scope of the present invention is not limited to this.
Embodiment 1
Composition: fenofibrate 100g, microcrystalline Cellulose 54g, lactose 36g, cross-linking sodium carboxymethyl cellulose 8g, make 1000 containing the 50% alcoholic solution 20ml of 5% (wt%) PVPK30, sodium lauryl sulphate 1.5g, magnesium stearate 1g.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, microcrystalline Cellulose, lactose, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) add 50% alcoholic solution containing 5%PVPK30 being dissolved with sodium lauryl sulphate in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 2
Composition: fenofibrate 100g, pregelatinized Starch 42g, microcrystalline Cellulose 56g, cross-linking sodium carboxymethyl cellulose 8g, make 1000 containing the 50% alcoholic solution 25ml of 5% (wt%) PVPK30, sodium lauryl sulphate 2g, magnesium stearate 1g.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, pregelatinized Starch, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) add 50% alcoholic solution containing 5%PVPK30 being dissolved with sodium lauryl sulphate in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 3
Composition: fenofibrate 100g, microcrystalline Cellulose 56g, pregelatinized Starch 40g, cross-linking sodium carboxymethyl cellulose 8g, the 50% alcoholic solution 24ml containing 5% (wt%) PVPK30, sodium lauryl sulphate 2g, magnesium stearate 1g, mountain chinaberry are determined 0.2g, make 1000.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) fenofibrate, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose, mountain chinaberry fixation mix homogeneously in high-speed granulator is taken; 3) add 50% alcoholic solution containing 5%PVPK30 being dissolved with sodium lauryl sulphate in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 4
Composition: fenofibrate 100g, microcrystalline Cellulose 56g, pregelatinized Starch 40g, cross-linking sodium carboxymethyl cellulose 8g, make 1000 containing the 50% alcoholic solution 24ml of 5% (wt%) PVPK30, sodium lauryl sulphate 2g, magnesium stearate 1g.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) add 50% alcoholic solution containing 5%PVPK30 being dissolved with sodium lauryl sulphate in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 5
Composition: the aqueous solution 24ml of fenofibrate 100g, calcium carbonate 40g, pregelatinized Starch 40g, sodium carboxymethyl cellulose 10g, starch-containing 1g, poloxamer 0.5g, Pulvis Talci 2g, silica 1 g make 1000.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, calcium carbonate, pregelatinized Starch, starch, sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) aqueous solution adding the starch-containing 1g being dissolved with poloxamer makes dry wet uniform soft material in above-mentioned powder, and crosses 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, silicon dioxide, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 6
Composition: fenofibrate 100g, dextrin 56g, mannitol 40g, cross-linking sodium carboxymethyl cellulose 10g, 50% alcoholic solution 20ml, sodium lauryl sulphate 2g containing hypromellose 0.3g, Tween 80 1g, magnesium stearate 1g, behenic acid glyceride 1g make 1000.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, dextrin, mannitol, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) add be dissolved with sodium lauryl sulphate, Tween 80 in above-mentioned powder, make dry wet uniform soft material containing 50% alcoholic solution of hypromellose 0.3g, and cross 20 mesh sieves and granulate; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, behenic acid glyceride, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 7
Composition: fenofibrate 100g, dextrin 56g, mannitol 40g, cross-linking sodium carboxymethyl cellulose 10g, 50% alcoholic solution 20ml, sodium lauryl sulphate 2g containing hypromellose 0.3g, Tween 80 1g, mountain chinaberry determines 1g, behenic acid glyceride 1g makes 1000.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) fenofibrate, dextrin, mannitol, cross-linking sodium carboxymethyl cellulose, mountain chinaberry fixation mix homogeneously in high-speed granulator is taken; 3) add be dissolved with sodium lauryl sulphate, Tween 80 in above-mentioned powder, make dry wet uniform soft material containing 50% alcoholic solution of hypromellose 0.3g, and cross 20 mesh sieves and granulate; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the behenic acid glyceride of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Embodiment 8
Composition: fenofibrate 100g, lactose 56g, calcium hydrogen phosphate 40g, cross-linking sodium carboxymethyl cellulose 8g, the 50% alcoholic solution 25ml containing hyprolose 1g, poloxamer 2g, magnesium stearate 1g, silica 1 g make 1000.
Method for making: 1) by fenofibrate micronization processes, controls particle diameter between 10-20 μm; 2) take fenofibrate, lactose, calcium hydrogen phosphate, hyprolose, dextrin, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 3) add 50% alcoholic solution containing hyprolose 1g being dissolved with poloxamer in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 4) above granule is dried at 55 ~ 65 DEG C; 5) take the magnesium stearate of recipe quantity, silicon dioxide, add in granule, granule is through 18 mesh sieve granulate; 6) granule after granulate is put into mixer, mixing, discharging; 7) by granule filling in No. 2 capsules.
Prior art
Composition: fenofibrate 100g, microcrystalline Cellulose 56g, pregelatinized Starch 40g, cross-linking sodium carboxymethyl cellulose 10g, make 1000 containing the 50% alcoholic solution 24ml of 5%PVPK30, sodium lauryl sulphate 2g, magnesium stearate 1g.
Method for making: 1) take fenofibrate, microcrystalline Cellulose, pregelatinized Starch, cross-linking sodium carboxymethyl cellulose be placed in high-speed granulator mix homogeneously; 2) add 50% alcoholic solution containing 5%PVPK30 being dissolved with sodium lauryl sulphate in above-mentioned powder, make dry wet uniform soft material, and cross 20 mesh sieves granulations; 3) above granule is dried at 55 ~ 65 DEG C; 4) take the magnesium stearate of recipe quantity, add in granule, granule is through 18 mesh sieve granulate; 5) granule after granulate is put into mixer, mixing, discharging; 6) by granule filling in No. 2 capsules.
For comparing with prior art, according to dissolution method (Chinese Pharmacopoeia 2010 editions annex XC second methods), with 1.0% sodium dodecyl sulfate solution 1000ml for dissolution medium, rotating speed is 120 turns per minute, operate in accordance with the law, 5,10,20,35,45,60min time sample.Absorbance can be measured in nm place 289, calculate the dissolution of each embodiment.Experimental result is in table 1.
Table 1 embodiment Dissolution experiments compares
| 5min | 10min | 20min | 35min | 45min | 60.min | |
| Embodiment 1 | 84.52％ | 97.64％ | 98.35％ | 98.84％ | 99.01％ | 99.12％ |
| Embodiment 2 | 83.15％ | 98.07％ | 98.47％ | 98.71％ | 98.81％ | 99.05％ |
| Embodiment 3 | 94.17％ | 99.40％ | 99.44％ | 99.44％ | 99.46％ | 99.47％ |
| Embodiment 4 | 85.16％ | 98.09％ | 98.54％ | 98.86％ | 99.11％ | 99.23％ |
| Embodiment 5 | 83.27％ | 97.21％ | 98.24％ | 98.45％ | 98.91％ | 99.03％ |
| Embodiment 6 | 83.65％ | 97.89％ | 98.24％ | 98.66％ | 99.01％ | 99.07％ |
| Embodiment 7 | 93.12％ | 99.09％ | 99.37％ | 99.43％ | 99.47％ | 99.51％ |
| Embodiment 8 | 84.12％ | 98.00％ | 98.37％ | 98.73％ | 99.07％ | 99.10％ |
| Prior art | 76.65％ | 81.97％ | 86.42％ | 92.15％ | 92.92％ | 93.36％ |
Seen by the stripping result of embodiment 1-8, due to by fenofibrate raw material micronization processes, when 5min, in all embodiments, fenofibrate dissolution rate reaches more than 83%, complete in the basic stripping of 10min, adding chemistry (2Z by name, 6E, 10E)-12,14,15-trihydroxies-3,7, the mountain chinaberry of 11,15-tetramethyl hiragonic acid methyl ester is had made to order as after disintegrating agent, and result of extraction is more obvious, prove that the dissolution rate of the Fenofibrate composition preparation prepared by the present invention is fast, the bioavailability of preparation can be improved.Compared with prior art, Fenofibrate composition of the present invention, by raw material micronization processes, controls particle diameter between 10-20 μm, after making preparation, can improve the dissolution of fenofibrate, thus improve the bioavailability of preparation, and the stability of preparation also increases.
Claims (8)
1. a Fenofibrate composition, it is characterized in that, described compositions calculates by mass parts, and its composition comprises fenofibrate, the filler of 80-100 part, the binding agent of 0.5-1.5 part, 5-15 part disintegrating agent, the lubricant of 0.5-3 part, the surfactant of 0.5-3 part of 100 parts; The mean diameter of described fenofibrate controls between 10-20 μm.
2. a kind of Fenofibrate composition according to claim 1, is characterized in that, described filler is made up of one or more in lactose, mannitol, microcrystalline Cellulose, pregelatinized Starch, starch, dextrin, Icing Sugar, calcium hydrogen phosphate, calcium carbonate.
3. a kind of Fenofibrate composition according to claim 1, is characterized in that, one or more during described disintegrating agent is fixed by sodium carboxymethyl cellulose, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, mountain chinaberry form.
4. a kind of Fenofibrate composition according to claim 1, is characterized in that, described binding agent is made up of one or more in starch, hypromellose, hyprolose, PVPK30, dextrin.
5. a kind of Fenofibrate composition according to claim 1, is characterized in that, described lubricant is made up of one or more in magnesium stearate, Pulvis Talci, silicon dioxide, stearic acid, behenic acid glyceride.
6. a kind of Fenofibrate composition according to claim 1, is characterized in that, described surfactant is made up of one or more in sodium lauryl sulphate, Tween 80, poloxamer.
7. the preparation made of a kind of Fenofibrate composition according to claim 1, it is characterized in that, described preparation is tablet or capsule.
8. the preparation method of preparation made of a kind of Fenofibrate composition according to claim 7, it is characterized in that, described preparation method concrete steps are: 1) by fenofibrate micronization processes, control particle diameter between 10 μm-20 μm; 2) by the fenofibrate of recipe quantity, filler, disintegrating agent mix homogeneously; 3) add the surfactant of recipe quantity and the solution of binding agent, the solvent of described solution is that water is or/and ethanol; 4) granulate after making soft material, dry, then add the lubricant granulate of recipe quantity, obtain granule; 5) by granulation or filling capsule.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110354087A (en) * | 2019-08-23 | 2019-10-22 | 东莞市金美济药业有限公司 | A kind of fenofibrate dispersible tablet and preparation method thereof |
| CN112121023A (en) * | 2020-09-30 | 2020-12-25 | 迪沙药业集团有限公司 | Fenofibrate tablet composition |
| CN112618511A (en) * | 2020-12-31 | 2021-04-09 | 辰欣药业股份有限公司 | Prescription composition of fenofibrate capsule and preparation process thereof |
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| US6277405B1 (en) * | 1997-01-17 | 2001-08-21 | Labaratoires Fournier, S.A. | Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110354087A (en) * | 2019-08-23 | 2019-10-22 | 东莞市金美济药业有限公司 | A kind of fenofibrate dispersible tablet and preparation method thereof |
| CN112121023A (en) * | 2020-09-30 | 2020-12-25 | 迪沙药业集团有限公司 | Fenofibrate tablet composition |
| CN112618511A (en) * | 2020-12-31 | 2021-04-09 | 辰欣药业股份有限公司 | Prescription composition of fenofibrate capsule and preparation process thereof |
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Inventor after: Cheng Ruiming Inventor after: Wang Shaotong Inventor after: Li Ruiming Inventor after: Sun Fengjing Inventor after: Sheng Zhaozhi Inventor before: Cheng Ruiming Inventor before: Wang Shaotong Inventor before: Li Ruiming Inventor before: Sun Fengjing |
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