CN108014096A - A kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof - Google Patents
A kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof Download PDFInfo
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- CN108014096A CN108014096A CN201611271553.6A CN201611271553A CN108014096A CN 108014096 A CN108014096 A CN 108014096A CN 201611271553 A CN201611271553 A CN 201611271553A CN 108014096 A CN108014096 A CN 108014096A
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- release agent
- release
- sustained
- venlafaxine hydrochloride
- slow
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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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
-
- 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
Abstract
The present invention provides a kind of venlafaxine hydrochloride sustained-release preparation for being resistant to alcohol and preparation method thereof, the sustained release preparation includes：VENLAFAXINE HCL, slow-release material and filler, wherein slow-release material are xanthans and the mixture of hypromellose；The preparation method includes：Using one kind in extrusion spheronization method, wet granulation, above-mentioned VENLAFAXINE HCL, slow-release material and filler are prepared into particle, are filled in capsule, or direct tablet compressing piece agent；The tolerance alcohol refers to, avoids venlafaxine hydrochloride sustained-release preparation and is discharged rapidly in containing spirituous dissolution medium.
Description
Technical field
The present invention relates to field of medicaments, specifically, is related to a kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof.
Background technology
VENLAFAXINE HCL is a kind of effective antidepressants, and chemical name is (R/S) -1- [2- (dimethylamine) -1- (4-
Anisyl) ethyl] cyclohexanol HCI, molecular formula C17H27NO2HCl, molecular weight 313.87, structural formula are：
The unclear antidepressant clear and definite mechanism of Venlafaxine, it is considered that with suppressing central nervous system hydroxytryptamine and going
Methylepinephrine reuptake is related.Non-clinical study shows that Venlafaxine and its active metabolite ODV are 5-HT, NE reuptake
Potent inhibitor, be dopamine weak inhibitor.
Venlafaxine hydrochloride slow-release capsule is that Irish Wyeth produces, trade name Efexor XR.
Correlation technique prepared by existing venlafaxine hydrochloride slow-release capsule, is coating of pellets technology, that is, prepares a certain size
Pellet as capsule core, then it is coated.Difference is：First, whether capsule core contains medicine hydrochloric acid text daraf(reciprocal of farad)
Pungent, i.e., capsule core is pellet core or blank capsule core；Second, the number of plies of coating, i.e., including in medicated layer, separation layer or slow release layer
It is one or more of；Third, the preparation of medicine micropellets is different, such as extrusion spheronization method, powder lamination centrifugal granulation or suspension are used
Medicine-feeding method；Fourth, the slow-release material selected is different, such as ethyl cellulose, acrylic resin, cellulose acetate, vinyl acetic acid
The difference of the slow-release materials such as vinegar；Fifth, coating solution solvent when preparing coating is different, such as organic solvent, aqueous solvent.
As patent 97109594.9 claims in the technical solution mentioned, wherein Sustained release coating materials are fine for ethyl
Dimension element, hydroxypropyl methylcellulose is pore-foaming agent, and used coating solvent is dichloromethane and absolute methanol.
The correlation technique of existing venlafaxine hydrochloride sustained-release tablet agent, is osmotic pumps technology, such as patent
Technical solution described in ZL200610140521.2, wherein infiltration controlled release tablet contains soluble drug label, coating membrane and position
In the composition of the film-coating layer containing main ingredient outside coating membrane.When preparing said preparation, drug containing label is prepared first, is then carried out twice
Coating.
Using these technical solutions, although the preparation of good slow release characteristic can be prepared, preparation process is complex；
Also, poisonous and inflammable and explosive dangerous toxic solvent, such as dichloromethane in some versions, are used.
In addition, preparation prepared by these methods, easily the quick release in alcoholic medium, causes dosage burst release；Such as
Have during patient medication and drink, or containing spirituous beverage or things, easily cause blood concentration excessive, increase adverse reaction
Danger.It should avoid drinking although pointing out in the specification of the medicine, during drug administration, still there is patient this feelings occur
Condition, concurrently gives birth to overdose, and excessive symptom includes：Tachycardia, the different degrees of loss of consciousness (from drowsiness to stupor), sleep hole
Dissipate big, insane pain breaking-out and vomiting.Also report ECG Change (for example, QT asks that the phase extends, bundle branch passes to retardance and QRS prolongs
It is long), Ventricular Tachycardia, bradycardia, low blood pressure, dizziness and death.
According to Walden et al. (The Effect of Ethanol on the Release of Opioids from
Oral Prolonged-Release Preparations, Drug Development and Industrial Pharmacy,
33：10,1,101 1111,2007) research, alcohol tolerance refer to the amount containing alcohol and preferred alcohol between 4%~
Between 40% in the 0.1N HCl acid alcoholic medias of (such as 5%, 10%, 20% or 40%), the hydrochloric acid text daraf(reciprocal of farad) that is discharged after 2h
Pungent percentage is compared with the Percent Active Ingredient discharged in 0.1N HCl media, at most no more than 15 percentage points.In order to
The alcohol tolerance of pharmaceutical preparation is assessed, U.S. Food and Drug Administration (FDA) suggests carrying out dissolution in vitro experiment to compare
Compared with the dynamics obtained in the 0.1N HCl media (pH for representing stomach) and with 5%, 20% and 40%CV/V) ethanol take
The dynamics obtained in the same media in generation.
The content of the invention
It is an object of the present invention to provide a kind of hydrochloric acid text daraf(reciprocal of farad) sustained release agent；The hydrochloric acid text daraf(reciprocal of farad) sustained release agent containing
Burst release does not occur in the medium of alcohol；
Another object of the present invention is to provide the preparation method of the hydrochloric acid text daraf(reciprocal of farad) sustained release agent；This method is simple, work
Skill flow is short.
In order to achieve the above object, on the one hand, the present invention provides a kind of venlafaxine hydrochloride sustained-release agent, wherein, the hydrochloric acid
Effexor ER includes at least main ingredient and slow-release material, and the main ingredient is VENLAFAXINE HCL, and the slow-release material includes
The xanthans and hydroxypropyl cellulose that mass ratio is 1: 1-3: 1.
Some specific embodiments according to the present invention, wherein, xanthans and hydroxypropyl cellulose mass ratio are 1.5: 1-2:
1。
Some specific embodiments according to the present invention, wherein, using the venlafaxine hydrochloride sustained-release agent gross weight as 100%
Count, including at least the main ingredient of 15-45% and the slow-release material of 40-80% in the sustained release agent.
Some specific embodiments according to the present invention, wherein, using the venlafaxine hydrochloride sustained-release agent gross weight as 100%
Meter, the sustained release agent is including at least the main ingredient of 15-25% and the slow-release material of 65-80%.
Some specific embodiments according to the present invention, wherein, the venlafaxine hydrochloride sustained-release agent further includes filler.
Some specific embodiments according to the present invention, wherein, using the venlafaxine hydrochloride sustained-release agent gross weight as 100%
Meter, the sustained release agent include main ingredient 15-45%, slow-release material 40-80% and filler 5-20%.
Some specific embodiments according to the present invention, wherein, using the venlafaxine hydrochloride sustained-release agent gross weight as 100%
Meter, the sustained release agent include main ingredient 15~25%, slow-release material mixture 65-80% and filler 5-10%.
Some specific embodiments according to the present invention, wherein, the filler is selected from microcrystalline cellulose, sorbierite, lactose
With the one or more in starch.
Some specific embodiments according to the present invention, wherein, the filler is selected from microcrystalline cellulose and/or starch.
On the other hand, present invention also offers the preparation method of the venlafaxine hydrochloride sustained-release agent, wherein, the side
Method includes at least the step of pelletizing to obtain wet granular with water after mixing by main ingredient, slow-release material and filler.
Some specific embodiments according to the present invention, wherein, the described method includes mix main ingredient, slow-release material and filler
Pelletized to obtain wet granular with water after closing uniformly, be then prepared into pellet, obtain the venlafaxine hydrochloride sustained-release agent.
The venlafaxine hydrochloride sustained-release preparation of this technique productions, can be easier to that slow releasing pellet is made.
The present invention can take this area conventional method to prepare pellet, can for example pass through extrusion spheronization or centrifugal granulating system
It is standby into pellet.
Some specific embodiments according to the present invention, wherein, the method can specifically include：
(1) extrusion spheronization plasmid method prepares capsule：Weigh VENLAFAXINE HCL, microcrystalline cellulose and slow-release material mixing
After uniformly, appropriate purified water softwood is added, using extrusion spheronization method, extrudes unit frequency 45rpm, selects 0.8mm sieve plates, it is round as a ball
Unit frequency 1300rpm, round as a ball time 1min, venlafaxine hydrochloride sustained-release of the Sieving and casing between 20~40 mesh is micro- after drying
Ball, fills capsule.
(2) wet granulation process prepares capsule：It is equal to weigh VENLAFAXINE HCL, microcrystalline cellulose and slow-release material mixing
Even, as 50~70rpm of female rotating speed in centrifugal granulator, is played, parent nucleus amplification 25~35rpm of rotating speed, the particle made is placed in
Dry about 18h in 55 ± 5 DEG C of air dry ovens, controls water content≤3%, and hydrochloric acid text of the Sieving and casing between 20~40 mesh is drawn
The pungent sustained release pellet of method, fills capsule.
Some specific embodiments according to the present invention, wherein, the preparation method bag of the venlafaxine hydrochloride sustained-release agent
Include and pelletize main ingredient, slow-release material and filler with water after mixing to obtain wet granular, carry out tabletting, obtain the sustained release
Preparation.
Some specific embodiments according to the present invention, wherein, the method can specifically include：
Tablet：Weigh VENLAFAXINE HCL, microcrystalline cellulose and slow-release material after mixing, add appropriate purified water system
Softwood, crosses the granulation of 30 mesh sieves, after dry, tabletting (the direct 9mm of punch die) after 20 mesh sieve net whole grains.
In conclusion the present invention provides a kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof.The hydrochloric acid of the present invention
Effexor ER has the following advantages that：
(1) in containing spirituous medium burst release does not occur for venlafaxine hydrochloride sustained-release agent of the invention；
(2) venlafaxine hydrochloride sustained-release agent of the invention is pelletized using pure water, avoids using dichloromethane and absolute methanol,
Improve production security；
(3) the more existing preparation method of the method for the present invention is relatively easy compared to the equipment of pill, and speed of production is very fast, technique weight
Existing property is good, continuous production, yield and efficient and not high to the technical requirements of worker；Report that technique uses film control more at present
Release, the requirement to production equipment is high, high to the skill requirement of skilled worker, and the reappearance between batch is poor, and with controlled release
The aging of mould, stability are bad.
Brief description of the drawings
Fig. 1 is release of the different prescriptions of embodiment 1 in 0.1M hydrochloric acid；
Fig. 2 compares for 1 prescription 1 of embodiment and EFFEXOR the ER release profiles in different ethanol；
Fig. 3 compares for different prescription and EFFEXOR the ER release profiles in different ethanol of embodiment 3.
Embodiment
Below by way of the specific embodiment implementation process that the present invention will be described in detail and the beneficial effect produced, it is intended to which help is read
Reader more fully understand the present invention essence and feature, not as to this case can practical range restriction.
The preparation of 1 venlafaxine hydrochloride slow-release capsule of embodiment
1 venlafaxine hydrochloride slow-release capsule of table (1) prescription
| Component | Prescription 1 (mg) | Prescription 2 (mg) | Prescription 3 (mg) |
| VENLAFAXINE HCL | 84.85 | 84.85 | 84.85 |
| Hydroxypropyl cellulose | 130.18 | 100.11 | 34.14 |
| Xanthans | 234.32 | 180.19 | 61.46 |
| Microcrystalline cellulose | 33.8 | 40.6 | 31.9 |
The prescription in table 1 is pressed respectively, is weighed VENLAFAXINE HCL, microcrystalline cellulose and slow-release material after mixing, is added
Enter appropriate purified water softwood, using extrusion spheronization method, extrude unit frequency 45rpm, select 0.8mm sieve plates, round as a ball unit frequency
1300rpm, round as a ball time 1min, venlafaxine hydrochloride sustained-release pellet of the Sieving and casing between 20~40 mesh after drying, filling
Capsule.
The preparation of 2 venlafaxine hydrochloride slow-release capsule of embodiment
According to prescription 1 in embodiment 1, VENLAFAXINE HCL, microcrystalline cellulose and slow-release material are weighed after mixing, extremely
In centrifugal granulator, 50~70rpm of female rotating speed is played, parent nucleus amplification 25~35rpm of rotating speed, 55 ± 5 are placed in by the particle made
Dry about 18h, controls water content≤3%, VENLAFAXINE HCL of the Sieving and casing between 20~40 mesh in DEG C air dry oven
Sustained release pellet, fills capsule.
The preparation of 3 venlafaxine hydrochloride slow-release capsule of embodiment
2 venlafaxine hydrochloride slow-release capsule of table (2) prescription
The prescription in table 2 is pressed respectively, is weighed VENLAFAXINE HCL, microcrystalline cellulose and slow-release material after mixing, is added
Enter appropriate purified water softwood, using extrusion spheronization method, extrude unit frequency 45rpm, select 0.8mm sieve plates, roll because of unit frequency
1300rpm, is rolled because of time 1min, venlafaxine hydrochloride sustained-release pellet of the Sieving and casing between 20~40 mesh after drying, filling
Capsule.
The preparation of 4 venlafaxine hydrochloride sustained-release tablet of embodiment
According to prescription 1 in embodiment 1, weigh VENLAFAXINE HCL, microcrystalline cellulose and slow-release material after mixing, add
Enter appropriate purified water softwood, cross the granulation of 30 mesh sieves, after dry, tabletting (the direct 9mm of punch die) after 20 mesh sieve net whole grains.
5 drug release determination of embodiment
Implementation column 2 of the present invention is measured according to drug release determination method (four general rules of Chinese Pharmacopoeia 2015 edition, 0,931 first method)
The venlafaxine hydrochloride slow-release capsule of preparation, respectively with 0.1N HCl, 0.1N HCl: ethanol (95: 5, V/V), 0.1N HCl: second
Alcohol (80: 20, V/V) and 0.1N HCl: ethanol (60: 40, V/V) 900ml are dissolution medium, and rotating speed is 100 turns per minute, in accordance with the law
Operation, through 2 it is small when, 3 it is small when, 4 it is small when, 6 it is small when, 8 it is small when, 12 it is small when, 16 it is small when, 20 it is small when, 24 it is small when take solution respectively
10ml, filtration, and mutually synthermal, same volume dissolution medium 10ml is supplemented immediately, as test solution, directly with efficient
Liquid chromatography detects.Commercially available spansule (EFFEXOR ER) is separately taken, is measured in the same method.The VENLAFAXINE HCL of embodiment 1 delays
Release capsule release profiles and see Fig. 1 and Fig. 2.The venlafaxine hydrochloride slow-release capsule release profiles of embodiment 3 are shown in Fig. 3.Embodiment 4
Venlafaxine hydrochloride sustained-release tablet is in 0.1N HCl media and 0.1N HCl: is released in ethanol (95: 5, V/V) medium with the accumulative of time
Degree of putting such as table 3.
Table 3
Claims (8)
1. a kind of venlafaxine hydrochloride sustained-release agent, it includes at least main ingredient and slow-release material, and the main ingredient is VENLAFAXINE HCL,
The slow-release material includes the xanthans and hydroxypropyl cellulose that mass ratio is 1: 1-3: 1；It is preferred that xanthans and hydroxy propyl cellulose
Plain mass ratio is 1.5: 1-2: 1.Wherein, sustained release preparation is containing the dissolution medium that volumetric concentration is 5%, 20% and 40% ethanol
In, the medicine of 2 interior releases when small is less than about 40%.
2. venlafaxine hydrochloride sustained-release agent according to claim 1, wherein, with the venlafaxine hydrochloride sustained-release agent gross weight
Measure and counted for 100%, including at least the main ingredient of 15-45% and the slow-release material of 40-80% in the sustained release agent；It is preferred that the sustained release
Agent is including at least the main ingredient of 15-25% and the slow-release material of 65-80%.
3. venlafaxine hydrochloride sustained-release agent according to claim 1 or 2, wherein, the venlafaxine hydrochloride sustained-release agent is also
Including filler.
4. the venlafaxine hydrochloride sustained-release agent according to claims 1 to 3 any one, wherein, with the hydrochloric acid text daraf(reciprocal of farad)
Pungent sustained release agent gross weight is 100% meter, and the sustained release agent includes main ingredient 15-45%, slow-release material 40-80% and filler 5-
20%；It is preferred that the sustained release agent includes main ingredient 15~25%, slow-release material mixture 65-80% and filler 5-10%.
5. the venlafaxine hydrochloride sustained-release agent according to claim 3~4 any one, wherein, the filler is selected from micro-
One or more in crystalline cellulose, sorbierite, newborn sugar and starch, wherein it is preferred that microcrystalline cellulose.
6. the preparation method of the venlafaxine hydrochloride sustained-release agent described in Claims 1 to 5, wherein, the method is, by main ingredient,
Slow-release material and filler are pelletized as centrifugal granulator after mixing, will be obtained particles filled to capsule, are obtained described
Venlafaxine hydrochloride sustained-release agent.
7. the preparation method of the venlafaxine hydrochloride sustained-release agent described in Claims 1 to 5, wherein, the method is, by main ingredient,
Slow-release material and filler after mixing, add water to prepare softwood, using extrusion spheronization method pelletize, by it is obtained it is particles filled extremely
Capsule, obtains the venlafaxine hydrochloride sustained-release agent.
8. the preparation method of the venlafaxine hydrochloride sustained-release agent described in Claims 1 to 5, wherein, the described method includes by main ingredient,
Slow-release material and filler are pelletized to obtain wet granular after mixing with water, and tabletting, obtains the venlafaxine hydrochloride sustained-release
Agent.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611271553.6A CN108014096A (en) | 2016-12-29 | 2016-12-29 | A kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611271553.6A CN108014096A (en) | 2016-12-29 | 2016-12-29 | A kind of venlafaxine hydrochloride sustained-release agent and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101669928A (en) * | 2009-05-25 | 2010-03-17 | 北京诚创康韵医药科技有限公司 | Slow-release composition containing antidepressant |
| CN102871997A (en) * | 2011-07-12 | 2013-01-16 | 山东绿叶制药有限公司 | Controlled-release medicinal composition containing demethyl venlafaxine benzoate compounds |
| CN103919731A (en) * | 2013-11-29 | 2014-07-16 | 山东省医药工业研究所 | Preparation of alcohol tolerant venlafaxine hydrochloride sustained-release pellet |
-
2016
- 2016-12-29 CN CN201611271553.6A patent/CN108014096A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101669928A (en) * | 2009-05-25 | 2010-03-17 | 北京诚创康韵医药科技有限公司 | Slow-release composition containing antidepressant |
| CN102871997A (en) * | 2011-07-12 | 2013-01-16 | 山东绿叶制药有限公司 | Controlled-release medicinal composition containing demethyl venlafaxine benzoate compounds |
| CN103919731A (en) * | 2013-11-29 | 2014-07-16 | 山东省医药工业研究所 | Preparation of alcohol tolerant venlafaxine hydrochloride sustained-release pellet |
Non-Patent Citations (3)
| Title |
|---|
| MUKESH C. GOHEL等: "Fabrication of Triple-Layer Matrix Tablets of Venlafaxine Hydrochloride Using Xanthan Gum", 《AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS》 * |
| 绍华荣等: "黄原胶在药物制剂中的应用研究进展", 《食品与药品》 * |
| 贺周扬等: "盐酸文拉法辛凝胶骨架片的制备及体外释药特性研究", 《广东药学院学报》 * |
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