CN110354087A - A kind of fenofibrate dispersible tablet and preparation method thereof - Google Patents
A kind of fenofibrate dispersible tablet and preparation method thereof Download PDFInfo
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- CN110354087A CN110354087A CN201910787607.1A CN201910787607A CN110354087A CN 110354087 A CN110354087 A CN 110354087A CN 201910787607 A CN201910787607 A CN 201910787607A CN 110354087 A CN110354087 A CN 110354087A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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Abstract
The present invention provides a kind of fenofibrate dispersible tablets, according to parts by weight, including 80~140 parts of fenofibrates, 80~200 parts of diluent, 10~50 parts of low-substituted hydroxypropyl cellulose, 20~80 parts of disintegrating agent, 0.5~10 part of Magnesium Laurylsulfate, 10~40 parts of surfactant, wherein, the partial size of fenofibrate is 12 μm~25 μm, and disintegrating agent includes the mixture of crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium.Fenofibrate dispersible tablet of the invention under the action of Magnesium Laurylsulfate, so that disintegration time shortens, improves the dissolution rate of fenofibrate, improves its bioavilability using crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium.The present invention also provides a kind of preparation methods of above-mentioned fenofibrate dispersible tablet.
Description
Technical field
The present invention relates to fenofibrate technical fields more particularly to a kind of fenofibrate dispersible tablet and preparation method thereof.
Background technique
With our people's living-pattern preservation, crowd's average serum TC level is just stepped up, thus blood drops in China
The dilatation year by year of the market scale of rouge medicine, 2002-2011, China's hypolipidemic charges for drug compound growth rate is up to 19.1%.By
This is as it can be seen that hypolipidemic has become the principal item of China's policlinic.For many years, the mankind to the seeking of lipid lowering agent, visit
Suo Congwei termination, causes the attention of height in many countries, and domestic and international many pharmacy corporations also determine the product structure of company
Positioned at this cardiovascular field, the road of professional development is walked, to push cardiovascular and lipid lowering agent quick hair
Exhibition.
Traditional therapeutic modality mainly includes: control ideal body weight, increase motion exercise, give up smoking, keep on a diet and
Drug therapy.Drug is traditionally mostly used to carry out the mode that auxiliary other modes are treated, at present clinical alternative tune
Rouge drug mainly have Statins, fibrates, niacin class, resinae, cholesterol absorption inhibitor and other.It is solid to reduce the total gallbladder of serum
There are Statins and resinae based on pure and mild LDL cholesterol；Reducing the drug based on serum triacylglycerol has fibrates and niacin
Class；The Representative Cultivars of fibrates are fenofibrates, and fenofibrate is white or off-white color crystalline powder, odorless, tasteless, mainly
For reduce risk of cardiovascular diseases patient cholesterol levels；As other fibrates, fenofibrate is reduced
Low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) are horizontal, and can increasing high density lipoprotein (HDL) it is horizontal and
It is horizontal to reduce triglycerides (TG).Fenofibrate, which can be used alone, can also treat high cholesterol with statins combination
Mass formed by blood stasis and hypertriglyceridemia.Fenofibrate just began to use from 1975, was one of most common fibrate, and
And there are good effect and tolerance.Wide market.
The fenofibrate product traditionally made is formed into the mode of tablet, this kind of production method, the poor controllability of process,
And since fenofibrate is practically insoluble in water, the product disintegration rate of this type structure made in a conventional manner is slow,
Time is longer, generally more than 15 minutes, causes bioavilability low, influences the performance of its clinical efficacy to a certain extent, suppression
Therapeutic effect is made.
In view of the above fact, it is necessary to develop a kind of fenofibrate dispersible tablet and preparation method thereof to solve disadvantages described above.
Summary of the invention
An object of the present invention is to provide a kind of fenofibrate dispersible tablet, has disintegration time short, fenofibrate molten
The advantage that out-degree is high and bioavilability is high.
The second object of the present invention is to provide a kind of preparation method of above-mentioned fenofibrate dispersible tablet.
To achieve the above object, a kind of fenofibrate dispersible tablet provided by the invention, according to parts by weight, comprising:
Wherein, the partial size of fenofibrate is 12 μm~25 μm, and disintegrating agent includes that crosslinked polyvinylpyrrolidone and carboxylic first are formed sediment
The mixture of powder sodium.
Fenofibrate dispersible tablet of the invention mainly includes fenofibrate, diluent, low-substituted hydroxypropyl cellulose, disintegration
Agent, Magnesium Laurylsulfate, surfactant, the addition of low-substituted hydroxypropyl cellulose improve the hardness of the fenofibrate dispersible tablet and steady
It is qualitative.Disintegrating agent can expand rapidly hundred times after meeting water, have the function that fenofibrate dispersible tablet is made to burst apart, disintegration of the invention
Agent includes the mixture of crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium, utilizes crosslinked polyvinylpyrrolidone and carboxymethylstarch
Sodium is under the action of Magnesium Laurylsulfate, so that disintegration time shortens, improves the dissolution rate of fenofibrate, improves bioavilability.
Wherein, fenofibrate can be selected as 80 parts, 90 parts, 100 parts, 110 parts, 120 parts, 130 parts, 140 parts.Fenofibrate
Partial size be 12 μm, 15 μm, 18 μm, 21 μm, 23 μm, 25 μm.
Wherein, diluent can be selected as 80 parts, 100 parts, 120 parts, 140 parts, 160 parts, 180 parts, 200 parts.
Preferably, diluent is selected as at least one of microcrystalline cellulose, pregelatinized starch, mannitol, lactose or dextrin.
Wherein, low-substituted hydroxypropyl cellulose can be selected as 10 parts, 20 parts, 30 parts, 40 parts, 50 parts.
Wherein, disintegrating agent can be selected as 20 parts, 30 parts, 40 parts, 50 parts, 60 parts, 70 parts, 80 parts.Disintegrating agent includes crosslinking
The mixture of polyvinylpyrrolidone and carboxyrnethyl starch sodium, for example, crosslinked polyvinylpyrrolidone is selected as 20 parts and carboxymethylstarch
Sodium is selected as 20 parts；Crosslinked polyvinylpyrrolidone is selected as 20 parts and carboxyrnethyl starch sodium is selected as 40 parts.
Wherein, Magnesium Laurylsulfate can be selected as 0.5 part, 1 part, 3 parts, 5 parts, 7 parts, 9 parts, 10 parts.
Wherein, surfactant can be selected as 10 parts, 20 parts, 30 parts, 40 parts.
Preferably, surfactant is selected as lauryl sodium sulfate, poly- sorb rouge 80, polyoxyethylene fatty acid ester, octane
At least one of base sodium sulphate or poloxamer.
Correspondingly, the present invention also provides a kind of preparation methods of fenofibrate dispersible tablet, comprising steps of
(1) micronization technology processing is carried out to fenofibrate, the partial size for controlling fenofibrate is 12 μm~25 μm；
(2) by the fenofibrate of formula ratio, diluent, low-substituted hydroxypropyl cellulose, disintegrating agent, Magnesium Laurylsulfate, surface
Activating agent is uniformly mixed in mixed-hopper, and disintegrating agent includes the mixture of crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium；
(3) ethanol solution is added in mixed-hopper and carries out wet granulation；
(4) particle obtained by step (3) is dried and whole grain, then carries out tabletting, obtains fenofibrate dispersible tablet.
Preferably, the preparation method of fenofibrate dispersible tablet further includes the step (5) after step (4): to step (4)
Obtained fenofibrate dispersible tablet carries out aluminum-plastic packaged.
Further, at 105-125 DEG C, heat-sealing temperature is controlled at 200-220 DEG C for the aluminum-plastic packaged forming temperature control.
Further, the ethanol solution in step (3) is the ethyl alcohol that into medicinal alcohol plus purified water compound concentration is 40%
Solution.
Specific embodiment
The technical scheme of the invention is further explained by means of specific implementation, but does not constitute and appoint to of the invention
What is limited.
Embodiment 1
The fenofibrate dispersible tablet of the present embodiment, comprising:
Wherein, the partial size of fenofibrate is 12 μm.
The preparation of fenofibrate dispersible tablet is carried out using above-mentioned composition, comprising steps of
(1) micronization technology processing is carried out to fenofibrate, the partial size for controlling fenofibrate is 12 μm；
(2) by the fenofibrate of formula ratio, low-substituted hydroxypropyl cellulose, crosslinked polyvinylpyrrolidone, carboxyrnethyl starch sodium,
Magnesium Laurylsulfate, pregelatinized starch, octyl sodium sulphate are uniformly mixed in mixed-hopper；
(3) add purified water compound concentration to be 40% ethanol solution into medicinal alcohol, mixture is added in ethanol solution
Wet granulation is carried out in bucket；
(4) particle obtained by step (3) is dried and whole grain, then carries out tabletting, obtains fenofibrate dispersible tablet；
(5) aluminum-plastic packaged, aluminum-plastic packaged forming temperature control is carried out to the fenofibrate dispersible tablet that step (4) obtains to exist
105-125 DEG C, heat-sealing temperature is controlled at 200-220 DEG C.
Embodiment 2
The fenofibrate dispersible tablet of the present embodiment, comprising:
Wherein, the partial size of fenofibrate is 14 μm.
The preparation method of the fenofibrate dispersible tablet of the embodiment is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
Embodiment 3
The fenofibrate dispersible tablet of the present embodiment, comprising:
Wherein, the partial size of fenofibrate is 16 μm.
The preparation method of the fenofibrate dispersible tablet of the embodiment is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
Embodiment 4
The fenofibrate dispersible tablet of the present embodiment, comprising:
Wherein, the partial size of fenofibrate is 18 μm.
The preparation method of the fenofibrate dispersible tablet of the embodiment is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
Comparative example 1
The fenofibrate dispersible tablet of this comparative example, comprising:
Wherein, the partial size of fenofibrate is 12 μm.
The preparation method of the fenofibrate dispersible tablet of the comparative example is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
Comparative example 2
The fenofibrate dispersible tablet of this comparative example, comprising:
Wherein, the partial size of fenofibrate is 12 μm.
The preparation method of the fenofibrate dispersible tablet of the comparative example is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
Comparative example 3
The fenofibrate dispersible tablet of this comparative example, comprising:
Wherein, the partial size of fenofibrate is 12 μm.
The preparation method of the fenofibrate dispersible tablet of the comparative example is identical as the preparation method of embodiment 1, does not do herein in detail
It describes in detail bright.
The fenofibrate dispersible tablet obtained to Examples 1 to 4 and comparative example 1~3 is tested for the property, disintegrating property and molten
Out-degree the performance test results are shown in Table 1.
Disintegrating property: this product is disintegrated (dispersing uniformity) and is checked using the 4th 0921 disintegration time limited of general rule of version in 2015
The method of law regulation detects examination, can all be disintegrated in 3 minutes and pass through sieve.
Dissolution rate performance: using Chinese Pharmacopoeia the 4th 0931 dissolution rate of general rule of version in 2015 and drug release determination method second
Method (slurry processes) is tested, and using 1.0% sodium dodecyl sulfate solution 1000ml as dissolution medium, revolving speed is 75 turns per minute,
It is sampled in 10,20,30,40,50,60min.Absorbance can be measured at nm 289, calculate dissolution rate.
1 disintegrating property of table and dissolution rate the performance test results
From the disintegrating property and dissolution rate the performance test results of Examples 1 to 4 and comparative example 1~3 it is found that the skill of the application
The dissolution rate of the fenofibrate dispersible tablet obtained in art scheme is fast and disintegration time is short, and bioavilability can be improved.Comparative example
Any one lacked in crosslinked polyvinylpyrrolidone, carboxyrnethyl starch sodium or Magnesium Laurylsulfate in 1-3 is not achieved the application's
Effect.
Finally, it should be noted that the above embodiments are merely illustrative of the technical solutions of the present invention rather than protects to the present invention
The limitation of range is protected, although the present invention is described in detail referring to preferred embodiment, the invention is not limited to above
Revealed embodiment, and various modifications, equivalent combinations according to the essence of the present invention should be covered.
Claims (8)
1. a kind of fenofibrate dispersible tablet, which is characterized in that according to parts by weight, comprising:
Wherein, the partial size of fenofibrate is 12 μm~25 μm, and disintegrating agent includes crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium
Mixture.
2. fenofibrate dispersible tablet as described in claim 1, which is characterized in that according to parts by weight, comprising:
Wherein, the partial size of fenofibrate is 16 μm~21 μm, and disintegrating agent includes crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium
Mixture.
3. fenofibrate dispersible tablet as described in claim 1, which is characterized in that the diluent is selected as microcrystalline cellulose, pre-
At least one of gelling starch, mannitol, lactose or dextrin.
4. fenofibrate dispersible tablet as described in claim 1, which is characterized in that the surfactant is selected as dodecyl sulphur
At least one of sour sodium, poly- sorb rouge 80, polyoxyethylene fatty acid ester, octyl sodium sulphate or poloxamer.
5. a kind of preparation method of fenofibrate dispersible tablet, which is characterized in that comprising steps of
(1) micronization technology processing is carried out to fenofibrate, the partial size for controlling fenofibrate is 12 μm~25 μm；
(2) by the fenofibrate of formula ratio, diluent, low-substituted hydroxypropyl cellulose, disintegrating agent, Magnesium Laurylsulfate, surface-active
Agent is uniformly mixed in mixed-hopper, and disintegrating agent includes the mixture of crosslinked polyvinylpyrrolidone and carboxyrnethyl starch sodium；
(3) ethanol solution is added in mixed-hopper and carries out wet granulation；
(4) particle obtained by step (3) is dried and whole grain, then carries out tabletting, obtains fenofibrate dispersible tablet.
6. the preparation method of fenofibrate dispersible tablet as claimed in claim 5, which is characterized in that further include being located at step (4)
Step (5) afterwards:
The fenofibrate dispersible tablet that step (4) obtains is carried out aluminum-plastic packaged.
7. the preparation method of fenofibrate dispersible tablet as claimed in claim 6, which is characterized in that the aluminum-plastic packaged molding
At 105-125 DEG C, heat-sealing temperature is controlled at 200-220 DEG C for temperature control.
8. the preparation method of fenofibrate dispersible tablet as claimed in claim 5, which is characterized in that the ethyl alcohol in step (3) is molten
Liquid is the ethanol solution that into medicinal alcohol plus purified water compound concentration is 40%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910787607.1A CN110354087A (en) | 2019-08-23 | 2019-08-23 | A kind of fenofibrate dispersible tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910787607.1A CN110354087A (en) | 2019-08-23 | 2019-08-23 | A kind of fenofibrate dispersible tablet and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116327716A (en) * | 2023-03-23 | 2023-06-27 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1509711A (en) * | 2002-12-20 | 2004-07-07 | 四川维奥制药有限公司 | Fenfibrate masticatory and its preparation |
| CN104352466A (en) * | 2014-11-17 | 2015-02-18 | 辰欣药业股份有限公司 | Fenofibrate composition and preparation thereof |
| CN107049975A (en) * | 2017-05-09 | 2017-08-18 | 东莞市金美济药业有限公司 | The formula and its production technology of a kind of fenofibrate dispersible tablet |
-
2019
- 2019-08-23 CN CN201910787607.1A patent/CN110354087A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1509711A (en) * | 2002-12-20 | 2004-07-07 | 四川维奥制药有限公司 | Fenfibrate masticatory and its preparation |
| CN104352466A (en) * | 2014-11-17 | 2015-02-18 | 辰欣药业股份有限公司 | Fenofibrate composition and preparation thereof |
| CN107049975A (en) * | 2017-05-09 | 2017-08-18 | 东莞市金美济药业有限公司 | The formula and its production technology of a kind of fenofibrate dispersible tablet |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116327716A (en) * | 2023-03-23 | 2023-06-27 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
| CN116327716B (en) * | 2023-03-23 | 2023-12-01 | 东莞市金美济药业有限公司 | Fenofibrate dispersible tablet and preparation method thereof |
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Application publication date: 20191022 |