CN108014082A - A kind of dronedarone hydrochloride sustained release tablets and preparation method thereof - Google Patents
A kind of dronedarone hydrochloride sustained release tablets and preparation method thereof Download PDFInfo
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- CN108014082A CN108014082A CN201711378902.9A CN201711378902A CN108014082A CN 108014082 A CN108014082 A CN 108014082A CN 201711378902 A CN201711378902 A CN 201711378902A CN 108014082 A CN108014082 A CN 108014082A
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- Prior art keywords
- sustained release
- release tablets
- dronedarone hydrochloride
- wax
- framework material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K9/205—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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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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- Chemical & Material Sciences (AREA)
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- Medicinal Preparation (AREA)
Abstract
The invention belongs to field of pharmaceutical preparations, and the invention discloses sustained release tablets of dronedarone hydrochloride and preparation method thereof.The sustained release tablets of the present invention include dronedarone hydrochloride, hydrophobic framework material, adhesive and lubricant；Wherein, according to mass percent meter, dronedarone hydrochloride 10%~35%, hydrophobic framework material 50% ~ 90%, adhesive 1% ~ 5%, lubricant 0.5% ~ 5%；The sustained release tablets of the present invention include hydrophobic framework material etc., can be very good the release of regulating medicine, technique is simple, is conducive to expanding production.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation and preparation method thereof, more particularly to a kind of dronedarone hydrochloride sustained release tablets and its
Preparation method.
Background technology
Dronedarone（Dronedarone）It is a kind of new antiarrhythmic drug, it is by French mono- An Wante of Sai Nuofei
Company develops, and is registered in USA and EU, China is approved clinic in July, 2006.Arrhythmia cordis often perplex many patients and
The clinical practice of doctor, particularly amiodarone, because its control to many Premature Ventricular Beats, auricular fibrillation or auricular flutter
Make and receive the effect of fine, but long-term larger amount of application, make its side effect cause blemish in an otherwise perfect thing, particularly it causes
Liver, lung, thyroid gland and cornea etc..The medical instrument has and amiodarone（amiodarone）Similar electro physiology effect, is the latter's
More novel drugs are substituted, because it is free of iodine.Therefore it will not cause and the relevant adverse reaction of iodine.Multaq is a kind of anti-arrhythmia cordis
Medicine, which is used to reduce, occurs the sudden risk being in hospital with permanent atrial vibration with atrial flutter patients by cardiovascular disease, these
Patient occurred auricular fibrillation or auricular flutter and had cardiovascular risk factors in the recent period.Research data shows that dronedarone exists
Control atrial fibrillation room is flutterred in terms of breaking-out like very promising, keeps it to have to arrhythmia cordis because it improves the side effect of amiodarone
There is a new product of good therapeutic effect.Separately there is document report：Dronedarone reduces atrial fibrillation patients cardiovascular event or death
The incidence that source property is in hospital.
Dronedarone can reduce patient's cardiovascular disease for first proof and be in hospital the auricular fibrillation medicine of risk, and auricular flutter can develop
For auricular fibrillation.
Sustained release tablets refer to it is oral after slowly non-constant velocity release medicine in a long time, its main feature is that medicine temporally changes
Few lasting non-constant velocity release after first more.As soon as it will not be as ordinary tablet to release completely in vivo, such sustained release tablets are not
Larger stimulation can be produced to intestines and stomach, mainly shielded, more so used in the larger medicine of local excitation.Make medicine blood medicine
Toxicity is minimized caused by fluctuation of concentration, it is possible to reduce medicining times, so as to improve the compliance of patient.
Matrix tablet is the important set component of sustained-release preparation, refers to medicine and leads to one or more inert solid framework materials
Tablet made of compressing technology is crossed, medicine is dispersed in porous or non-porous material, discharges medicine by various mechanism,
Medicine is set slowly to discharge.During intestines and stomach release, medicine and gastrointestinal mucosa exposure concentration are small, advantageously reduce medicine
Toxic side effect.There is hydrophilic gel matrix material applied to the framework material in sustained-release matrix tablets, erodible framework material is insoluble
Framework material, several classes of mixed matrix material.Wherein hydrogel matrix kind is most, occupies first of sustained-release and controlled release preparation.It releases the drug
Mechanism is mainly that dissolution principle, diffusion principle and corrosion are combined action principle with diffusion, dissolution.Hydrophilic gel matrix material
Four classes 1. cellulose derivative can be divided（Methylcellulose, hydroxyethyl cellulose, hydroxyethylmethylcellulose, hydroxypropyl cellulose,
Hydroxypropyl methyl cellulose, hydroxymethyl cellulose and sodium cellulose glycolate etc.）2. non-cellulosic polysaccharide（As glucose, shell are more
Sugar and galactolipin etc.）3. natural gum（Pectin, sodium alginate, potassium alginate, agar, pawl ear natural gum and tragacanth etc.）4. ethene
Based polyalcohol or acrylate copolymer etc.（Such as polyvinyl alcohol and poly- hydroxyalkyl vinyl 934）.Mixing material matrix sustained release tablet is by medicine
Thing is manufactured after being mutually mixed with insoluble wax more than above two and organophilic gel framework material.Common insoluble bone
Frame material has：Ethyl cellulose, polyethylene, polypropylene, glycerolipid, polysiloxanes and polyoxyethylene etc..
Fatty acid glycerine esters include glycerin monostearate, glyceryl palmitostearate, be by long chain fatty acids or
Person's grease and glycerine reaction and be made.It is a kind of non-ionic surfactant.Wherein glycerin monostearate is as bonding
Agent, makes Mechanism of Drug Release more reasonable.In sustained release tablets framework material, there is not yet on glycerin monostearate and stearic acid palm fibre
The report of palmitic acid acid glyceride.
Cera alba English name:Bees wax, are the esters formed by the fatty alcohol containing 26 ~ 34 carbon atoms and palmitic acid.
It is common in suppository, the one kind of beeswax as oil phase.
Brazil wax quality is very rigid, has high gloss, easily emulsifies, there is good Oil keeping.Wax
Palm wax as carrier auxiliary material, condensation spraying granulation prepares the safe ten thousand rhzomorph granular preparations of tartaric acid.
The content of the invention
The object of the present invention is to provide a kind of dronedarone hydrochloride sustained release tablets, not only delay releasing for medicine dronedarone hydrochloride
Speed is put, the release of medicine is more stablized, improves drug effect, while there is good internal in vitro correlation.
To achieve the above object of the invention, the technical scheme is that：A kind of dronedarone hydrochloride sustained release tablets, including：Salt
Sour dronedarone, hydrophobic framework material, adhesive and lubricant；Wherein, according to mass percent meter, dronedarone hydrochloride 10%
~35%, hydrophobic framework material 50% ~ 90%, adhesive 1% ~ 5%, lubricant 0.5% ~ 5%；
The hydrophobic framework material is the mixture of microcrystalline cellulose, glyceride, wax and fusogen；The glyceride is single hard
One or both of glycerol or glyceryl palmitostearate；The wax is one kind in cera alba or palm wax
Or two kinds.
Preferable hydrophobic framework material melts for glyceryl palmitostearate, microcrystalline cellulose, cera alba, palm wax and rush
The mixture of agent.
The hydrophobic framework material, according to mass percent meter, the content of each component is：Microcrystalline cellulose 5% ~ 50%,
Glyceride 10% ~ 80%, wax 10% ~ 30%, fusogen 5% ~ 10%.
The preferred component content of the hydrophobic framework material is：Wax and fusogen:Microcrystalline cellulose and glyceride mixture
Mass ratio be 1:3.
The fusogen is PEG6000 or PEG2000.In above-mentioned technical proposal, the adhesive is polyethylene pyrrole
The ethanol solution of pyrrolidone K-30.
In above-mentioned technical proposal, the lubricant is one or both of magnesium stearate or silica.
The preparation method of above-mentioned dronedarone hydrochloride sustained release tablets comprises the following steps：
（1）After batch weighing, dronedarone hydrochloride, glyceride, microcrystalline cellulose mix, sieving；
（2）Wax and fusogen are mixed, heating melting；
（3）Molten liquid is added into step（1）In obtained mixture, add adhesive that softwood is made；
（4）Above-mentioned softwood is sieved and is pelletized, it is dry, with sieve whole grain, lubricant is added, is uniformly mixed, tabletting, obtains the hydrochloric acid
Dronedarone sustained release tablets.
Wherein, step（1）The sieving was 80 mesh sieves；Step（4）The sieving was 30 mesh sieves.
Wherein, step（2）The melting is in 85 DEG C of meltings.
Compared to the prior art, the prior art of the invention has the following advantages：
1. the method for existing sustained release tablets reaches sustained release purpose using pore-foaming agent more, but your release has pyrrole
PH sensitiveness, dissolution rate is high in acid condition, and dissolution rate is relatively low in water.It cannot reach pyrrole that using pore-foaming agent
Slow release effect.The technical solution adopted in the present invention, without using pore-foaming agent, using tristerin and stearic acid palmitic acid
Glyceride is engaged with microcrystalline cellulose, can be good at solving the problems, such as the sustained release of dronedarone hydrochloride.
2. glyceryl palmitostearate, which is used alone, to pelletize, exclusive use microcrystalline cellulose insoluble drug release is too fast,
It is unable to reach slow release effect.Being used in mixed way for glyceryl palmitostearate and microcrystalline cellulose, can be very good
The release of medicine.
3. in the prior art, wax is through the film coating frequently as polishing sugar coated tablet or as sustained release tablets.Skill of the present invention
Art makes it, with glycerolipid pelletizing press sheet after melting, can regulate and control pyrrole that release well as hydrophobic framework material
Degree.
4. sustained release tablets of the present invention are overcome single using the mixed matrix material of medicine and hydrophobic framework material
A kind of material is difficult to regulate and control, and tests release in vitro, shows preferable slow release effect.Meanwhile sustained release tablets work of the invention
Skill is simple, is conducive to expanding production.
Embodiment
Below will be by the way that the invention will be further described, these descriptions are not that present invention is made further
Limit.It should be understood by those skilled in the art that the equivalent substitution made to present invention, or be correspondingly improved, still fall within this
Within the protection domain of invention.
Embodiment 1：The preparation of dronedarone hydrochloride sustained release tablets
1g dronedarone hydrochlorides are weighed, 2.5g glyceryl palmitostearates, 5g microcrystalline celluloses, are mixed according to equivalent gradually-increased
80 mesh sieves, the wax-like molten liquid of 2.5g are crossed after closing uniformly（0.5g cera albas, 1g palm waxs and 1gPEG6000 add ethanol at 85 DEG C
It is dry after melting to remove ethanol）Add in the mixture of main ingredient and microcrystalline cellulose and glyceryl palmitostearate, with
The ethanol solution of PVPK30（Concentration is 5%wt.）As adhesive（Solution usage 10g）Softwood processed, the granulation of 30 mesh sieves, 60 DEG C dry
Dry 1h, after 30 mesh sieve whole grains, adds 0.2g magnesium stearates and 0.3g silica, mixes, tabletting.
Embodiment 2：The preparation of dronedarone hydrochloride sustained release tablets
Weigh 1.2g dronedarone hydrochlorides, 5g glyceryl palmitostearates, 2.5g microcrystalline celluloses, according to equivalent gradually-increased
80 mesh sieves, the wax-like molten liquid of 2.5g are crossed after mixing（0.5g cera albas, 1g palm waxs and 1gPEG6000 add ethanol 85
It is dry after DEG C melting to remove ethanol）Add in the mixture of main ingredient and microcrystalline cellulose and glyceryl palmitostearate, with
The ethanol solution of PVPK30（Concentration is 5%wt.）As adhesive（Solution usage 10g）Softwood processed, the granulation of 30 mesh sieves, 60 DEG C dry
Dry 1h, after 30 mesh sieve whole grains, adds 0.2g magnesium stearates and 0.3g silica, mixes, tabletting.
Embodiment 3：The preparation of dronedarone hydrochloride sustained release tablets
1.5g dronedarone hydrochlorides are weighed, 0.5g glycerin monostearates, 2.5g microcrystalline celluloses, mix according to equivalent gradually-increased
80 mesh sieves, the wax-like molten liquid of 2g are crossed after uniformly（1.5g cera albas and 0.5gPEG2000 add ethanol drying after 85 DEG C of meltings to remove
Remove ethanol）Add in the mixture of main ingredient and microcrystalline cellulose and glyceryl palmitostearate, with the ethanol solution of PVPK30
（Concentration is 2%wt.）As adhesive（Solution usage 10g）Softwood processed, the granulation of 30 mesh sieves, 60 DEG C of dry 1h, 30 mesh sieve whole grains
Afterwards, 0.1g magnesium stearates are added, are mixed, tabletting.
Embodiment 4：The preparation of dronedarone hydrochloride sustained release tablets
2g dronedarone hydrochlorides are weighed, 4.8g glyceryl palmitostearates, 0.3g microcrystalline celluloses, are mixed according to equivalent gradually-increased
80 mesh sieves, the wax-like molten liquid of 1.5g are crossed after closing uniformly（0.6g palm waxs and 0.3gPEG6000 add ethanol to be done after 85 DEG C of meltings
Dry removing ethanol）Add in the mixture of main ingredient and microcrystalline cellulose and glyceryl palmitostearate, with the ethanol of PVPK30
Solution（Concentration is 2%wt.）As adhesive（Solution usage 5g）Softwood processed, the granulation of 30 mesh sieves, 60 DEG C of dry 1h, 30 mesh sieves are whole
After grain, 0.05g silica is added, is mixed, tabletting.
Embodiment 5：The preparation of dronedarone hydrochloride sustained release tablets
Weigh 2.5g dronedarone hydrochlorides, 0.5g glyceryl palmitostearates, 0.5g glycerin monostearates, 2g crystallites fibre
Dimension element, 80 mesh sieves, the wax-like molten liquid of 1.75g are crossed according to equivalent gradually-increased after mixing（1g cera albas, 0.5g palm waxs and
0.5gPEG6000 adds ethanol is dry after 85 DEG C of meltings to remove ethanol）Add main ingredient and microcrystalline cellulose and stearic acid palmitic acid
In the mixture of glyceride, with the ethanol solution of PVPK30（Concentration is 5%wt.）As adhesive（Solution usage 10g）Make soft
Material, 30 mesh sieves are pelletized, 60 DEG C of dry 1h, after 30 mesh sieve whole grains, are added 0.25g magnesium stearates and 0.25g silica, are mixed,
Tabletting.
Embodiment 6：The preparation of dronedarone hydrochloride sustained release tablets
3g dronedarone hydrochlorides are weighed, 3.5g glyceryl palmitostearates, 3g microcrystalline celluloses, mix according to equivalent gradually-increased
80 mesh sieves, the wax-like molten liquid of 1.5g are crossed after uniformly（0.7g cera albas, 0.3g palm waxs and 0.5gPEG6000 add ethanol 85
It is dry after DEG C melting to remove ethanol）Add in the mixture of main ingredient and microcrystalline cellulose and glyceryl palmitostearate, with
The ethanol solution of PVPK30（Concentration is 2%wt.）As adhesive（Solution usage 25g）Softwood processed, the granulation of 30 mesh sieves, 60 DEG C dry
Dry 1h, after 30 mesh sieve whole grains, adds 0.2g magnesium stearates and 0.3g silica, mixes, tabletting.
Claims (10)
1. a kind of dronedarone hydrochloride sustained release tablets, it is characterised in that the dronedarone hydrochloride sustained release tablets include：How hydrochloric acid certainly reaches
Grand, hydrophobic framework material, adhesive and lubricant；Wherein, according to mass percent meter, dronedarone hydrochloride 10%~35%, is dredged
Water framework material 50% ~ 90%, adhesive 1% ~ 5%, lubricant 0.5% ~ 5%；
The hydrophobic framework material is the mixture of microcrystalline cellulose, glyceride, wax and fusogen；The glyceride is single hard
One or both of glycerol or glyceryl palmitostearate；The wax is one kind in cera alba or palm wax
Or two kinds.
2. according to the dronedarone hydrochloride sustained release tablets described in claim 1, it is characterised in that preferable hydrophobic framework material is tristearin
Sour tripalmitin, microcrystalline cellulose, cera alba, the mixture of palm wax and fusogen.
3. according to the dronedarone hydrochloride sustained release tablets described in claim 1, it is characterised in that the hydrophobic framework material is according to quality
Percentages, the content of each component are：Microcrystalline cellulose 5% ~ 80%, glyceride 10% ~ 80%, wax 10% ~ 30%, fusogen 5% ~
10%。
4. according to the dronedarone hydrochloride sustained release tablets described in claim 3, it is characterised in that preferred group of the hydrophobic framework material
Part content is：Wax and fusogen:The mass ratio of microcrystalline cellulose and glyceride is 1:3.
5. dronedarone hydrochloride sustained release tablets according to claim 1, it is characterised in that the fusogen is PEG6000
Or PEG2000.
6. dronedarone hydrochloride sustained release tablets according to claim 1, it is characterised in that the adhesive is polyethylene pyrrole
The ethanol solution of pyrrolidone K-30.
7. dronedarone hydrochloride sustained release tablets according to claim 1, it is characterised in that the lubricant for magnesium stearate or
One or both of silica.
8. the preparation method of the dronedarone hydrochloride sustained release tablets described in a kind of claim 1, it is characterised in that including following step
Suddenly：
1) after batch weighing, dronedarone hydrochloride, glyceride, microcrystalline cellulose mix, sieving；
2) wax and fusogen are mixed, adds ethanol heating melting；
3) molten liquid is added into step（1）In obtained mixture, then add adhesive that softwood is made；
4) above-mentioned softwood is sieved and pelletized, it is dry, with sieve whole grain, lubricant is added, is uniformly mixed, tabletting, obtains the hydrochloric acid
Dronedarone sustained release tablets.
9. according to the method described in claim 8, it is characterized in that, step（1）The sieving was 80 mesh sieves；Step（4）
The sieving was 30 mesh sieves.
10. according to the method described in claim 8, it is characterized in that, step（2）The melting is in 85 DEG C of meltings.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711378902.9A CN108014082A (en) | 2017-12-19 | 2017-12-19 | A kind of dronedarone hydrochloride sustained release tablets and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711378902.9A CN108014082A (en) | 2017-12-19 | 2017-12-19 | A kind of dronedarone hydrochloride sustained release tablets and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102670482A (en) * | 2012-03-22 | 2012-09-19 | 盛世泰科生物医药技术(苏州)有限公司 | Sustained release preparation of dronedarone hydrochloride |
| CN102908305A (en) * | 2011-08-05 | 2013-02-06 | 北京本草天源药物研究院 | Dronedarone hydrochloride-containing oral solid medicinal composition and preparation method thereof |
| CN105997935A (en) * | 2016-05-25 | 2016-10-12 | 齐鲁工业大学 | Dronedarone hydrochloride film-controlled sustained release pellet and preparation process thereof |
| CN107095855A (en) * | 2017-06-27 | 2017-08-29 | 苏州弘森药业股份有限公司 | A kind of Piribedil sustained-release tablet and preparation method thereof |
-
2017
- 2017-12-19 CN CN201711378902.9A patent/CN108014082A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908305A (en) * | 2011-08-05 | 2013-02-06 | 北京本草天源药物研究院 | Dronedarone hydrochloride-containing oral solid medicinal composition and preparation method thereof |
| CN102670482A (en) * | 2012-03-22 | 2012-09-19 | 盛世泰科生物医药技术(苏州)有限公司 | Sustained release preparation of dronedarone hydrochloride |
| CN105997935A (en) * | 2016-05-25 | 2016-10-12 | 齐鲁工业大学 | Dronedarone hydrochloride film-controlled sustained release pellet and preparation process thereof |
| CN107095855A (en) * | 2017-06-27 | 2017-08-29 | 苏州弘森药业股份有限公司 | A kind of Piribedil sustained-release tablet and preparation method thereof |
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Application publication date: 20180511 |