CN105748432A - Fenofibrate soft capsule and preparation method thereof - Google Patents
Fenofibrate soft capsule and preparation method thereof Download PDFInfo
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- CN105748432A CN105748432A CN201410776744.2A CN201410776744A CN105748432A CN 105748432 A CN105748432 A CN 105748432A CN 201410776744 A CN201410776744 A CN 201410776744A CN 105748432 A CN105748432 A CN 105748432A
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Abstract
The invention relates to a fenofibrate soft capsule. The fenofibrate soft capsule comprises a capsule shell and a content, the capsule shell comprises 10 parts of gelatin, 3.8-4.6 parts of glycerin, 9 parts of water and 1.2-3.6 parts of an antiseptic, and the content comprises 20-50 parts of a fenofibrate solid dispersion, 30-60 parts of a diluent, 1-6 parts of a suspending aid, 0-3 parts of an antioxidant and 0-3 parts of the antiseptic, wherein the fenofibrate solid dispersion, comprises 1 part of fenofibrate, 2 parts of a solid dispersion carrier and 1 part of aerosil. The fenofibrate soft capsule has the advantages of good fenofibrate release property and small irritation to bodies, and is a good blood pressure lowering and blood fat lowering medicine.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of soft capsule containing fenofibrate and preparation method thereof.
Background technology
Fenofibrate, by the exploitation of Foumier company of France, in France's Initial Public Offering, successively lists for 1981 in moral, Belgium, Switzerland, Greece.Within 1992, registering in China, it is notable that fenofibrate tool reduces serum cholesterol and triglyceride effect, few side effects and light.In recent years, along with the generally raising of national life level, the intake of high protein, hypercholesterolemia and high sugar food is increased by people gradually, under all many-sided impacts such as family's gene, hyperlipemia colony sharply increases, therefore the rising year by year in lipid lowerers market.Fenofibrate is as third generation benzene oxygen aromatic acid derivatives class lipid regulating agent, a large amount of clinical data have proven to it and adjust fat determined curative effect comprehensively both at home and abroad, simultaneously because drug effect is steady, decrease medicining times, thus improve the effectiveness of medicine, safety and adaptability, it is beneficial to patient's long-term prescription, there is obvious clinical advantage, wide market.The fibrates of current China accounts for and regulates the 14%～16% of blood fat drug market share, and wherein import drugs about account for half, therefore, develops domestic fenofibrate slow releasing capsule extremely urgent.
Fenofibrate is soluble in acetone or ether, is slightly soluble in ethanol, is practically insoluble in water.Therefore stripping property is the key affecting fenofibrate drug effect.For improving stripping property and the bioavailability of fenofibrate, often fenofibrate is made solid dispersion.Know clearly disclosed in patent publication No. CN1509711A file the preparation method of a kind of Fenfibrate masticatory, using Polyethylene Glycol as solid dispersion carrier, utilize fusion method to prepare solid dispersion.The Fenfibrate masticatory this solid dispersion and other components being mixed with, can improve the dissolution rate of fenofibrate, but stomach is had certain zest by chewable tablet.If being prepared into capsule, then can weaken the stimulation to stomach, but the dissolution tool of Fenofibrate can be had a certain impact by conventional capsule.
Summary of the invention
For the feature that existing fenofibrate micronized capsules dissolution rate is low, the present invention provides a kind of fenofibrate soft capsule.
Specifically, soft capsule of the present invention includes softgel shell and content, and by weight, its raw material includes following component:
Softgel shell: 10 parts of gelatin, glycerol 3.8-4.6 part, 9 parts of water, preservative A1.2-3.6 part；
Content: fenofibrate solid dispersion 20-50 part, diluent 30-60 part, suspending agent 1-6 part, antioxidant 0-3 part, preservative B0-3 part；
The raw material of described fenofibrate solid dispersion consists of: fenofibrate 1 part, solid dispersion carrier 2 parts, micropowder silica gel 1 part；
The weight ratio of described softgel shell and content is 2:5.
In the present invention, described diluent includes one or both of polyethylene glycols or vegetable oil, wherein polyethylene glycols is selected from PEG400, Macrogol 2000, and vegetable oil is selected from Semen Maydis oil, soybean oil, Oleum Arachidis hypogaeae semen, Oleum Sesami, olive oil, Oleum Helianthi, salad oil, Oleum Gossypii semen or Oleum Brassicae campestris.Described diluent is preferably PEG400, Macrogol 2000.Content is accurately and the stability of preparation to adopt this diluent to advantageously ensure that, so that it is guaranteed that the safety and effectiveness of medicine.
In the present invention, described suspending agent includes one or more in ethyl-hydroxyethyl fiber, chitose, methylcellulose, ethyl cellulose, agar, hydroxyethylmethyl-cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, benzoic acid, Polyethylene Glycol etc., described suspending agent is preferably ethyl cellulose, hydroxypropyl methyl cellulose, adopts this suspending agent to be conducive to the viscosity increasing disperse medium to reduce the sedimentation velocity of microgranule or to increase microgranule hydrophilic.
In the present invention, described antioxidant includes one or more in sodium sulfite, sodium pyrosulfite, potassium metabisulfite, ethylenediaminetetraacetic acid, citric acid, malic acid, ascorbic acid, inositol etc., it is preferably ascorbic acid, ethylenediaminetetraacetic acid, adopting this antioxidant to desirably prevent, oxidation of drug is rotten, cyst wall is aging causes the problems such as medicine disintegration prolongation, it is also possible to play the effect of metal ion chelation agent.
In the present invention, described preservative includes one or more in sorbic acid, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate etc., the preferred methyl parahydroxybenzoate of described preservative, sorbic acid.Both preservative are broad spectrum type preservative, have the advantages that stable in properties toxicity is low.
In the present invention, also can adding cosolvent in content, described cosolvent is selected from ethanol, glycerol or propylene glycol.
Further, the preferred described soft capsule of the present invention, by weight, raw material includes following component:
Softgel shell: 10 parts of gelatin, glycerol 3.8-4.6 part, 9 parts of water, methyl parahydroxybenzoate 1.2-3.6 part；
Content: fenofibrate solid dispersion 30-40 part, diluent PEG400,40-50 part, suspending agent chitose 2-4 part, hydroxypropyl methyl cellulose 2-4 part, antioxidants Ascorbic acid 1-2 part, preservative methyl parahydroxybenzoate 1-2 part；
The raw material of described fenofibrate solid dispersion consists of: fenofibrate 1 part, acrylic resin 2 parts, micropowder silica gel 1 part；
The weight ratio of described softgel shell and content is 2:5.
The preparation method that invention also provides above-mentioned fenofibrate soft capsule, described preparation method comprises the steps:
1) preparation of capsule shell fluid: gelatin, G & W are mixed in proportion, 80-90 DEG C of heating in water bath dissolves, and adds appropriate preservative, and stirring, after evacuation is degassed, 50-70 DEG C of insulation is standby.
2) preparation of content: this solid dispersion and diluent, suspending agent, antioxidant, preservative are sufficiently mixed uniformly；
3) content and capsule shell fluid are made soft capsule.
Described step 2) in also can add cosolvent.
In the present invention, the preparation method of described solid dispersion is as follows:
1) example 1:2:1 weighs fenofibrate, solid dispersion and micropowder silica gel in mass ratio；
2) solid dispersion carrier is placed in evaporating dish, 60 DEG C～80 DEG C heating in water bath stirrings are until being molten condition, add fenofibrate, micropowder silica gel, fused mass is stirred under 1000-1400r/min 8-12min, cooling curing in ice-water bath while stirring, solidfied material puts dry 44-52h in exsiccator, pulverizes, sieve, obtain the solid dispersion of fenofibrate.
Adopt solid dispersion technology and make water-soluable gel system to improve this product dissolution have positive effect, it is possible to improve insoluble drug fenofibrate dissolution rate, extend ingredient release time, it is thus achieved that good slow release effect is more stable by drug effect.
Detailed description of the invention
Following example are used for illustrating the present invention, but are not limited to the scope of the present invention.
Embodiment 1 fenofibrate solid dispersion and preparation thereof
The preparation of solid dispersion: weigh fenofibrate 10g, polyethylene glycol 6000 20g and micropowder silica gel 10g respectively, polyethylene glycol 6000 is placed in evaporating dish, 60 DEG C of heating in water bath stirrings are until being molten condition, add fenofibrate, micropowder silica gel, molten mixture stirring when 1200r/min 10min, is immediately placed in ice-water bath cooling curing, solidfied material is put in exsiccator dry 48 hours, pulverize, sieve.
Embodiment 2 fenofibrate solid dispersion and preparation thereof
The preparation of solid dispersion: weigh fenofibrate 10g, acrylic resin 20g, micropowder silica gel 10g respectively, acrylic resin is placed in evaporating dish, 60 DEG C of heating in water bath stirrings are until being molten condition, add fenofibrate, micropowder silica gel, molten mixture stirring when 1200r/min 10min, puts rapidly cooling curing in ice-water bath, solidfied material is put in exsiccator and is dried 48 hours, pulverize, sieve.
Embodiment 3 fenofibrate soft capsule
Softgel shell: gelatin 1.26g, glycerol 0.48g, water .13g, methyl parahydroxybenzoate 0.15g.
Content: the solid dispersion 4g of embodiment 2 preparation, PEG400 3g, chitose 0.25g, hydroxypropyl methyl cellulose 0.13g, ascorbic acid 0.1g, methyl parahydroxybenzoate 0.05g.
Embodiment 4, fenofibrate soft capsule
Softgel shell: gelatin 1.37g, glycerol 0.55g, water 1.23g, methyl parahydroxybenzoate 0.24g.
Content: weigh the solid dispersion 4g of embodiment 2 preparation, PEG400 4g, glycerol 0.28g, hydroxypropyl methyl cellulose 0.1g, ascorbic acid 0.14g, methyl parahydroxybenzoate 0.04g.
Embodiment 5, fenofibrate soft capsule
Softgel shell: gelatin 1.46g, glycerol 0.63g, water 1.31g, methyl parahydroxybenzoate 0.18g.
Content: weigh the solid dispersion 4g of embodiment 2 preparation, PEG400 4.5g, chitose 0.2g, hydroxypropyl methyl cellulose 0.1g, ascorbic acid 0.12g, methyl parahydroxybenzoate 0.02g.
Embodiment 6 fenofibrate soft capsule
Softgel shell: gelatin 1.26g, glycerol 0.58g, water 1.13g, methyl parahydroxybenzoate 0.45g.
Content: the solid dispersion 4g of embodiment 2 preparation, Macrogol 2000 4g, ethyl cellulose 0.24g, hydroxypropyl methyl cellulose 0.11g, ascorbic acid 0.15g, methyl parahydroxybenzoate 0.05g.
Embodiment 7 fenofibrate soft capsule
Softgel shell: gelatin 1.26g, glycerol 0.58g, water 1.13g, methyl parahydroxybenzoate 0.45g.
Content: the solid dispersion 2g of embodiment 2 preparation, Macrogol 2000 6g, ethyl cellulose 0.6g, hydroxypropyl methyl cellulose 0.11g.
Embodiment 8 fenofibrate soft capsule
Softgel shell: gelatin 1.26g, glycerol 0.58g, water 1.13g, methyl parahydroxybenzoate 0.45g.
Content: the solid dispersion 5g of embodiment 2 preparation, Macrogol 2000 3g, ethyl cellulose 0.25g, hydroxypropyl methyl cellulose 0.2g, ascorbic acid 0.3g, methyl parahydroxybenzoate 0.3g.
The preparation of embodiment 9 fenofibrate soft capsule
According to embodiment 3 formula preparation fenofibrate soft capsule, its step is as follows:
1) preparation of capsule shell fluid: by gelatin, G & W mix homogeneously, 80 DEG C of heating in water bath dissolve, and add methyl parahydroxybenzoate, and agitated, after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh fenofibrate solid dispersion, PEG400, chitose, hydroxypropyl methyl cellulose, ascorbic acid, methyl parahydroxybenzoate mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with capsule shell fluid by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
Embodiment 10, fenofibrate soft capsule preparation
Preparing fenofibrate soft capsule according to embodiment 4 formula, its step is as follows:
1) preparation of capsule shell fluid: weighing gelatin, glycerol, water, mix homogeneously, 80 DEG C of heating in water bath dissolve, and addition methyl parahydroxybenzoate is agitated, and after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh fenofibrate solid dispersion 4g, Polyethylene Glycol, glycerol, hydroxypropyl methyl cellulose, ascorbic acid, methyl parahydroxybenzoate, mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with softgel shell by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
The preparation of embodiment 11 fenofibrate soft capsule
Preparing fenofibrate soft capsule according to the formula of embodiment 5, its step is as follows:
1) preparation of capsule shell fluid: weighing gelatin, glycerol, water, 80 DEG C of heating in water bath dissolve, and add methyl parahydroxybenzoate, and agitated, after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh solid dispersion, Polyethylene Glycol, chitose, hydroxypropyl methyl cellulose, ascorbic acid, benzoic acid mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with softgel shell by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
The preparation of embodiment 12 fenofibrate soft capsule
Preparing fenofibrate soft capsule according to embodiment 6 formula, its step is as follows:
1) preparation of capsule shell fluid: weighing gelatin, glycerol, water, mix homogeneously by weight, 80 DEG C of heating in water bath dissolve, and add appropriate methyl parahydroxybenzoate, and agitated, after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh the solid dispersion of embodiment 2 preparation, Macrogol 2000, ethyl cellulose, hydroxypropyl methyl cellulose, ascorbic acid, methyl parahydroxybenzoate mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with softgel shell by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
The preparation of embodiment 13 fenofibrate soft capsule
Preparing fenofibrate soft capsule according to embodiment 7 formula, its step is as follows:
1) preparation of capsule shell fluid: weighing gelatin, glycerol, water, mix homogeneously by weight, 80 DEG C of heating in water bath dissolve, and add appropriate methyl parahydroxybenzoate, and agitated, after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh the solid dispersion of embodiment 2 preparation, Macrogol 2000, ethyl cellulose, hydroxypropyl methyl cellulose mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with softgel shell by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
The preparation of embodiment 14 fenofibrate soft capsule
Preparing fenofibrate soft capsule according to embodiment 8 formula, its step is as follows:
1) preparation of capsule shell fluid: weighing gelatin, glycerol, water, mix homogeneously by weight, 80 DEG C of heating in water bath dissolve, and add appropriate methyl parahydroxybenzoate, and agitated, after evacuation is degassed, 70 DEG C of insulations are standby.
2) preparation of softgel shell content: weigh the solid dispersion of embodiment 2 preparation, Macrogol 2000, ethyl cellulose, hydroxypropyl methyl cellulose, ascorbic acid, methyl parahydroxybenzoate mix homogeneously, standby.
3) being loaded in automatic rotation rolling capsule machine with softgel shell by above-mentioned softgel shell content, temperature controls, at 40-50 DEG C, to prepare into fenofibrate soft capsule.
Using the fenofibrate soft capsule that method provided by the invention and formula are made, dissolution rate is high, absorbs effective.
Although, above the present invention is described in detail with a general description of the specific embodiments, but on basis of the present invention, it is possible to it is made some modifications or improvements, and this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to the scope of protection of present invention.
Claims (10)
1. a fenofibrate soft capsule, described soft capsule includes softgel shell and content, and by weight, its raw material includes following component:
Softgel shell: 10 parts of gelatin, glycerol 3.8-4.6 part, 9 parts of water, preservative A1.2-3.6 part；
Content: fenofibrate solid dispersion 20-50 part, diluent 30-60 part, suspending agent 1-6 part, antioxidant 0-3 part, preservative B0-3 part；
The raw material of described fenofibrate solid dispersion consists of: fenofibrate 1 part, solid dispersion carrier 2 parts, micropowder silica gel 1 part；
The weight ratio of described softgel shell and content is 2:5.
2. fenofibrate soft capsule according to claim 1, it is characterized in that, described diluent includes one or both of polyethylene glycols or vegetable oil, described polyethylene glycols is selected from PEG400, Macrogol 2000, and vegetable oil is selected from Semen Maydis oil, soybean oil, Oleum Arachidis hypogaeae semen, Oleum Sesami, olive oil, Oleum Helianthi, salad oil, Oleum Gossypii semen or Oleum Brassicae campestris；Described diluent is preferably PEG400, Macrogol 2000.
3. fenofibrate soft capsule according to claim 1, it is characterized in that, described suspending agent includes one or more in ethylhydroxyethylcellulose, chitose, methylcellulose, ethyl cellulose, agar, hydroxyethylmethyl-cellulose, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, benzoic acid, Polyethylene Glycol, and described suspending agent is preferably ethyl cellulose, hydroxypropyl methyl cellulose.
4. fenofibrate soft capsule according to claim 1, it is characterized in that, described antioxidant includes one or more in sodium sulfite, sodium pyrosulfite, potassium metabisulfite, ethylenediaminetetraacetic acid, citric acid, malic acid, ascorbic acid, inositol, and described antioxidant is preferably ascorbic acid, ethylenediaminetetraacetic acid.
5. fenofibrate soft capsule according to claim 1, it is characterized in that, described preservative A, B all include one or more in sorbic acid, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, the preferred methyl parahydroxybenzoate of described preservative, sorbic acid.
6. fenofibrate soft capsule according to claim 1, it is characterised in that be also added into cosolvent in described content, described latent solvent is selected from ethanol, glycerol or propylene glycol, and the addition of described cosolvent is 1-6 part by weight.
7. fenofibrate soft capsule according to claim 1, it is characterised in that described solid dispersion carrier includes polyethylene glycol 6000, acrylic resin.
8. the fenofibrate soft capsule according to any one of claim 1-7, it is characterised in that by weight, its raw material includes following component:
Softgel shell: 10 parts of gelatin, glycerol 3.8-4.6 part, 9 parts of water, methyl parahydroxybenzoate 1.2-3.6 part；
Content: fenofibrate solid dispersion 30-40 part, diluent PEG400 40-50 part, suspending agent chitose 2-4 part, hydroxypropyl methyl cellulose 2-4 part, antioxidants Ascorbic acid 1-2 part, preservative methyl parahydroxybenzoate 1-2 part；
The raw material of described fenofibrate solid dispersion consists of: fenofibrate 1 part, acrylic resin 2 parts, micropowder silica gel 1 part；
The weight ratio of described softgel shell and content is 2:5.
9. the preparation method of fenofibrate soft capsule described in any one of claim 1-8, comprises the steps:
1) preparation of softgel shell: by gelatin, G & W mix homogeneously, 80-90 DEG C of heating in water bath dissolves, and adds preservative A, and stirring, after evacuation is degassed, 50-70 DEG C of insulation is standby；
2) preparation of content: described fenofibrate solid dispersion is sufficiently mixed uniformly with diluent, suspending agent, antioxidant, preservative B；
3) described content and described softgel shell are made soft capsule.
10. preparation method according to claim 9, it is characterised in that: the preparation method of described fenofibrate solid dispersion is as follows:
1) example 1:2:1 weighs fenofibrate, solid dispersion carrier and micropowder silica gel in mass ratio；
2) solid dispersion carrier is placed in evaporating dish, 60 DEG C～80 DEG C heating in water bath stirrings are until being molten condition, add fenofibrate, micropowder silica gel, fused mass is stirred under 1000-1400r/min 8-12min, cooling curing in ice-water bath while stirring, solidifies dry 44-52h in rearmounted exsiccator, pulverizes, sieve, obtain the solid dispersion of fenofibrate.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106265590A (en) * | 2016-09-14 | 2017-01-04 | 佛山市弘泰药物研发有限公司 | A kind of roflumilast soft capsule and preparation method thereof |
| CN106580914A (en) * | 2017-02-27 | 2017-04-26 | 佛山市弘泰药物研发有限公司 | Vilazodone hydrochloride softgel and preparation method thereof |
| CN106667957A (en) * | 2017-02-22 | 2017-05-17 | 佛山市弘泰药物研发有限公司 | Safinamide soft capsules and preparation method thereof |
| CN106822029A (en) * | 2017-02-21 | 2017-06-13 | 佛山市弘泰药物研发有限公司 | A kind of pyrrole Lun Panai soft capsules and preparation method thereof |
| CN110946830A (en) * | 2019-12-31 | 2020-04-03 | 辰欣药业股份有限公司 | Fenofibrate solid dispersion preparation capable of being rapidly dissolved and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265590A (en) * | 2016-09-14 | 2017-01-04 | 佛山市弘泰药物研发有限公司 | A kind of roflumilast soft capsule and preparation method thereof |
| CN106822029A (en) * | 2017-02-21 | 2017-06-13 | 佛山市弘泰药物研发有限公司 | A kind of pyrrole Lun Panai soft capsules and preparation method thereof |
| CN106667957A (en) * | 2017-02-22 | 2017-05-17 | 佛山市弘泰药物研发有限公司 | Safinamide soft capsules and preparation method thereof |
| CN106580914A (en) * | 2017-02-27 | 2017-04-26 | 佛山市弘泰药物研发有限公司 | Vilazodone hydrochloride softgel and preparation method thereof |
| CN110946830A (en) * | 2019-12-31 | 2020-04-03 | 辰欣药业股份有限公司 | Fenofibrate solid dispersion preparation capable of being rapidly dissolved and preparation method thereof |
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Application publication date: 20160713 |