CN104739775A - Novel venlafaxine hydrochloride sustained release pill and preparation method thereof - Google Patents
Novel venlafaxine hydrochloride sustained release pill and preparation method thereof Download PDFInfo
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- CN104739775A CN104739775A CN201310739897.5A CN201310739897A CN104739775A CN 104739775 A CN104739775 A CN 104739775A CN 201310739897 A CN201310739897 A CN 201310739897A CN 104739775 A CN104739775 A CN 104739775A
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Abstract
The invention provides a novel venlafaxine hydrochloride sustained release pill and a preparation method thereof. The novel venlafaxine hydrochloride sustained release pellet is prepared from 1-50wt% of venlafaxine hydrochloride, 5-70wt% of a filler, 0.1-5wt% of a binder, 0.1-2wt% of an anti-adhering agent, 10-50wt% of a lipid material and the balance a wetting agent. The preparation method comprises preparing a venlafaxine hydrochloride-containing pill core by an extrusion-spheronization method and preparing the novel venlafaxine hydrochloride sustained release pill from the venlafaxine hydrochloride-containing pill core by a hot melting coating technology. The used coating material does not contain solvent, process time is short, a coating material utilization rate is high and a production cost is reduced. The hot melting coating technology effectively reduces toxic or side effects of venlafaxine hydrochloride, reduces a drug release rate, improves bioavailability, has a short production period and satisfies large scale production requirements.
Description
Technical field
The present invention relates to a kind of new venlafaxine hydrochloride sustained-release piller and preparation method thereof, belong to pharmaceutical technology sectors.
Background technology
VENLAFAXINE HCL (VenlafaxineHydrochloride), chemistry (R/S)-1-[2-(dimethylamino)-1-(4-anisyl) ethyl]-cyclohexanol hydrochloridumi by name, its molecular formula is C17H27N02.HCl, and molecular weight is 313.87; White or off-white color crystalline powder, odorless, taste is slightly bitter; It is soluble in water, dilute hydrochloric acid; Dissolve in ethanol, chloroform, almost insoluble in ether; Fusing point is 215 ~ 217 DEG C.The pKa of venlafaxine is 9.4, and Determination of oil-water partition coefficient is 0.43.
VENLAFAXINE HCL is as third generation antidepressants, main pharmacological mechanism is for suppressing nerve synapse cephacoria to the re uptake of 5-HT and NA, make them have enough concentration at synaptic space, thus strengthen the function of maincenter 5-TH and NA neurotransmitter, play antidepressant effect.At present, VENLAFAXINE HCL is widely used in treatment all kinds depression clinically, to be also applied to after clinical treatment obsession, schizophrenia, social phobia, wound the diseases such as stress disorders simultaneously.Compared with antidepressants before, venlafaxine is rapid-action, and untoward reaction is few, and tolerance dose scope is larger; Higher clinical cure rate is had, lower treatment cost to major depression patient; And have obvious dose-effect relationship, the antidepressants that illustration may be compared to for single neurotransmitter in the antidepressants of dual neurotransmitter have better curative effect.
Piller is commonly called as micropill, is to be mixed and made into spherical or class spherical port formulation with medicine and adjuvant, and particle diameter is grade, is generally 0.25 ~ 2.5mm.Because piller is multiple unit type form of administration, compared with other dosage forms, there is many advantages.(1) be orally evenly distributed in gastrointestinal tract, improve medicine and gastrointestinal contact area, raising bioavailability; (2) piller can applying different rate of releasing drug combines, thus obtains good rate of releasing drug, reaches blood drug level, extends action time, and reduces GI irritation; (3) particle diameter little when gastrointestinal transit unable to take food thing and gastric emptying affect, absorb favorable reproducibility; (4) different pharmaceutical can be used to make piller compound preparation, increase the stability of medicine; (5) making some physical property that piller can change medicine, improving as become mobility after ball, non-friable etc., like this can as the basis of preparing tablet, capsule etc.; (6) can piller be incapsulated in shell, cover adverse drug abnormal smells from the patient.(7) adopt different prescriptions, drug can also carry out coating and make rapid release, slow release or controlled release piller.Therefore slow controlled release piller thinks one of comparatively ideal controlled release agent type at present, is the direction of current sustained-release preparation development.
At present, the method preparing piller has a lot, as extrusion-spheronization, centrifugal-fluid bed make ball method, coating pan pill method, ebullated bed or fluid bed pill method, melting pill method, vibration spraying pill method etc.Wherein extrusion-spheronization is most widely used because with this method gained pellet size evenly, narrow particle size distribution, medicament contg be even.Required device is simple, easy to operate.Use extruder to be extruded into by wet stock cylindrical, extrudate is rolled onto spherical by spheronizator again.Extrude difficulty because piller likely has in preparation process, cannot the situation such as round as a ball molding occur, therefore the preparation prescription of piller is similar to ordinary preparation, needs to add suitable excipient, as filler, binding agent, lubricant, wetting agent etc.
According to the release Mechanisms of piller different available different coating material, coating is carried out to piller, have rolling coating, pressed coated, buried tube type coating, fluidized bed coating according to the different packaging technique of equipment.Because VENLAFAXINE HCL is water soluble drug, the water in coating solution can be surperficial to piller by the drug migration of coating in piller, and loses slow release effect, and non-solvent coating can avoid the generation of this problem, and activity time is short, coating material utilization rate is high, thus reduces production cost.Non-solvent coating method comprises: hot melt coating, dry powder coating, coating electrostatic, pressed coated, light ripening coating etc.Hot melt packaging technique be coating material with the state coverage of melting in medical surfaces, this technology is compared with other packaging technique, hot melt packaging technique has incomparable advantage: without the need to using any solvent, activity time is short, exempt from the but evaporation of solvent and the program of disposal, be suitable for some facile hydrolysis, should not adopt the medicine of aqueous coatings system, coating material utilization rate is high, reducing production cost etc., is a kind of environmental protection, energy-conservation, efficient novel packaging technique.The venlafaxine hydrochloride sustained-release piller application hot melt packaging technique reported herein is prepared from, and at present, not yet has the relevant report adopting hot melt packaging technique to prepare venlafaxine hydrochloride sustained-release piller.
Summary of the invention
The object of the invention is the defect filling up prior art, the novel venlafaxine hydrochloride sustained-release piller that a kind of toxic and side effects is little, slow releasing medicine, bioavailability are high is provided.
Another object of the present invention is to provide the preparation method of above-mentioned venlafaxine hydrochloride sustained-release piller.
Venlafaxine hydrochloride sustained-release piller described in the present invention comprises the slow-release pill made containing pill core and sustained-release coating layer, it is characterized in that slow-release pill is composed as follows:
(1) containing pill core, the component containing, for example lower mass percentage:
VENLAFAXINE HCL 1 ~ 50%
Filler 5% ~ 70%
Binding agent 0.1% ~ 5%
Wetting agent 10% ~ 60%
Antiplastering aid 0.1% ~ 2%
(2) sustained-release coating layer, the component containing, for example lower mass percentage:
Matrix material 10% ~ 50%
Porogen 0% ~ 5%
Lipid-coated mixture percentage composition is to contain pill core Weight computation.
Venlafaxine hydrochloride sustained-release piller described in the present invention, the particle size distribution wherein containing pill core is 0.3 ~ 1.5mm, preferably 0.6 ~ 1.0mm.
Venlafaxine hydrochloride sustained-release piller described in the present invention, wherein the excipient contained in pill core is any one or multiple inactive material that pharmaceutics allows.
Venlafaxine hydrochloride sustained-release piller described in the present invention, is wherein selected from starch, lactose, dextrin, amylum pregelatinisatum, cellulose, sucrose, any one of mannitol or two or more mixture containing the filler in pill core.
Venlafaxine hydrochloride sustained-release piller described in the present invention, is wherein selected from starch, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose and sodium salt thereof, polyvinylpyrrolidone, any one of gelatin or two or more mixture containing the binding agent in pill core.
Venlafaxine hydrochloride sustained-release piller described in the present invention, is wherein selected from water, ethanol, propylene glycol, glycerol, PEG400, Tweens, spans, any one of gathering propanol or two or more mixture containing the wetting agent in pill core.
Venlafaxine hydrochloride sustained-release piller described in the present invention, is wherein selected from magnesium stearate, micropowder silica gel, Pulvis Talci, titanium dioxide, silicon dioxide, polyethylene glycols, magnesium laurylsulfate, stearic acid, any one of sodium stearyl fumarate or two or more mixture containing the antiplastering aid in pill core.
Venlafaxine hydrochloride sustained-release piller described in the present invention, is wherein selected from glyceryl monostearate, glycerol distearate, glyceryl tristearate, Glyceryl Behenate, tripalmitin, palmitic acid stearic acid ester of glycerol, trilaurin, myristin, new certain herbaceous plants with big flowers acid glyceride, stearic acid, Palmic acid, capric acid, oleic acid, any one of Cera Flava or two or more mixture containing the matrix material in pill core.
Described in the present invention venlafaxine hydrochloride sustained-release piller, it is characterized in that described porogen is selected from methylcellulose, Polyethylene Glycol, polyvinylpyrrolidone, copolyvidone, sucrose, hypromellose, polymethacrylate, the cellulose phthalate element any one of class or two or more mixture.
The preparation method of the venlafaxine hydrochloride sustained-release piller described in the present invention comprises the following steps:
Step 1: VENLAFAXINE HCL mixed homogeneously with filler, uses binding agent and wetting agent, powder is made soft material;
Step 2: soft material is placed in extruder/spheronizator to extrude/round as a ball, can add appropriate antiplastering aid in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: to the fluidized-bed coating machine of atomization Compressed Gas heating/insulation, coating can be carried out with the heat fusing matrix material can being heated at coating process/be incubated by being placed in containing pill core, dry, obtain venlafaxine hydrochloride sustained-release piller;
Soft material described in step 1 utilizes Quick-stirring granulator powder and binding agent, wetting agent to be mixed.
Described in step 2 is adopt extrusion spheronization legal system standby containing the preparation method in pill core, and the sieve diameter that its extruder uses is 0.5mm ~ 1.5mm, preferred 0.8mm; The rotating speed of described spheronizator is 1050rpm; The described bake out temperature containing pill core is at 50 DEG C ~ 75 DEG C.
Fluidized-bed coating machine described in step 3 is the fluidized-bed coating machine with the attemperator such as vapour jacket and heating tape; Described heat fusing matrix material needs to use heater to keep its temperature, and temperature range is at 45 DEG C ~ 170 DEG C; Described containing baking temperature after pill core coating between 30 DEG C ~ 50 DEG C.
Compared with prior art, the present invention has following beneficial effect:
The invention provides venlafaxine hydrochloride sustained-release piller and there is slow release effect, can medicine stability be strengthened, improve the bioavailability of medicine, reduce dosage, effectively reduce the accumulation of medicine, reduce toxic and side effects.
Compared with existing venlafaxine hydrochloride sustained-release piller, the present invention adopts hot melt packaging technique to prepare a kind of new venlafaxine hydrochloride sustained-release piller.This technology, without the need to an organic solvent, can be prepared that medicine stability is good, bioavailability is high and have the venlafaxine hydrochloride sustained-release piller of certain slow releasing function.
The preparation method of venlafaxine hydrochloride sustained-release piller provided by the invention---hot melt packaging technique utilizes the fluidized-bed coating machine with the attemperator such as vapour jacket and heating tape that the coating material atomisation of molten condition is coated on substrate surface.This process does not need to use solvent, and effectively can solve with an organic solvent coating may cause environmental problem, or uses water to bring the problem of microbial contamination as the solvent of coating material.In addition based on the type of coating material, hot melt packaging technique also has Continuous slow release, covers bad smell, improve medicine stability, improve bioavailability, moistureproof effect.The feature of this technology is that the production cycle is very short, be well suited for the kind that coating amount is larger, the present invention prepares the release that effectively can slow down medicine in conjunction with extrusion spheronization method and technique, improve the bioavailability of medicine, medicine stability can be strengthened, effectively reduce the accumulation of medicine, reduce the venlafaxine hydrochloride sustained-release piller of toxic and side effects.
Accompanying drawing explanation
Fig. 1 is venlafaxine hydrochloride sustained-release piller release curve.
Detailed description of the invention
The present invention is further illustrated below by way of detailed description of the invention.
Embodiment 1
Percentage ratio in prescription is the percentage by weight of this component shared by whole prescription, and matrix material percentage composition is to contain pill core Weight computation, and following each embodiment is identical.
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with microcrystalline Cellulose, adds the mixed solution of hypromellose and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes glyceryl monostearate heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 92 DEG C
Leaving air temp: 65 DEG C
Coating weight gain: 25%
Chilling temperature: 25 DEG C.
Embodiment 2
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with starch, adds the mixed solution of hypromellose and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes Glyceryl Behenate heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 96 DEG C
Leaving air temp: 70 DEG C
Coating weight gain: 30%
Chilling temperature: 25 DEG C.
Embodiment 3
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with lactose, adds the mixed solution of hypromellose and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes palmitic acid stearic acid ester of glycerol heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 87 DEG C
Leaving air temp: 60 DEG C
Coating weight gain: 25%
Chilling temperature: 25 DEG C.
Embodiment 4
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with microcrystalline Cellulose, adds the mixed solution of polyvinylpyrrolidone and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes palmitic acid stearic acid ester of glycerol and hypromellose heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 87 DEG C
Leaving air temp: 60 DEG C
Coating weight gain: 25%
Chilling temperature: 25 DEG C.
Embodiment 5
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with microcrystalline Cellulose, adds the mixed solution of hypromellose and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes palmitic acid stearic acid ester of glycerol and hypromellose heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 92 DEG C
Leaving air temp: 65 DEG C
Coating weight gain: 25%
Chilling temperature: 25 DEG C.
Embodiment 6
Prepare venlafaxine hydrochloride sustained-release piller:
Step 1: VENLAFAXINE HCL mixed homogeneously with lactose, adds the mixed solution of hypromellose and water, is made by powder and has certain plastic moistening even soft material;
Step 2: extruded being placed in extruder by soft material, extrudate is put in spheronizator round as a ball, adds appropriate Pulvis Talci in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: will be placed in fluidized-bed coating machine containing pill core, heating makes Glyceryl Behenate and polyvinylpyrrolidone heat fusing carry out coating again, dry, obtains venlafaxine hydrochloride sustained-release piller.
Atomizing pressure: 0.254mpa
Wind speed: 6 ~ 7m/s
Inlet temperature: 95 DEG C
Leaving air temp: 70 DEG C
Coating weight gain: 30%
Chilling temperature: 25 DEG C.
The above embodiment only have expressed several embodiment of the present invention, and it describes comparatively concrete and detailed, but therefore can not be interpreted as the restriction to the scope of the claims of the present invention.It should be pointed out that for the person of ordinary skill of the art, without departing from the inventive concept of the premise, can also make some distortion and improvement, these all belong to protection scope of the present invention.Therefore, the protection domain of patent of the present invention should be as the criterion with claims.
Claims (9)
1. a venlafaxine hydrochloride sustained-release piller, is characterized in that, slow-release pill comprises the slow-release pill made containing pill core and sustained-release coating layer, and wherein sustained-release coating layer adopts hot melt packaging technique, and slow-release pill is composed as follows:
(1) containing pill core, the component containing, for example lower mass percentage:
VENLAFAXINE HCL 1 ~ 50%
Filler 5% ~ 70%
Binding agent 0.1% ~ 5%
Wetting agent 10% ~ 60%
Antiplastering aid 0.1% ~ 2%
(2) sustained-release coating layer adopts hot melt packaging technique, the component containing, for example lower mass percentage:
Matrix material 10% ~ 50%
Porogen 0% ~ 5%
Lipid-coated mixture percentage composition is to contain pill core Weight computation.
2. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, is characterized in that, described filler is selected from the mixture of any one or two or more arbitrary proportion in microcrystalline Cellulose, starch, Icing Sugar, dextrin, lactose, mannitol.
3. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, it is characterized in that, described binding agent is selected from the mixture of any one or two or more arbitrary proportion in starch, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose and sodium salt thereof, polyvinylpyrrolidone, gelatin, Polyethylene Glycol.
4. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, it is characterized in that, described antitackiness agent is selected from the mixture of any one or two or more arbitrary proportion in magnesium stearate, micropowder silica gel, Pulvis Talci, titanium dioxide, silicon dioxide, polyethylene glycols, magnesium laurylsulfate, stearic acid, sodium stearyl fumarate.
5. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, it is characterized in that, described matrix material is selected from the mixture of any one or two or more arbitrary proportion in glyceryl monostearate, glycerol distearate, glyceryl tristearate, Glyceryl Behenate, tripalmitin, palmitic acid stearic acid ester of glycerol, trilaurin, myristin, new certain herbaceous plants with big flowers acid glyceride, stearic acid, Palmic acid, capric acid, oleic acid, Cera Flava.
6. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, it is characterized in that, described wetting agent is selected from the mixture of any one or two or more arbitrary proportion in water, ethanol, propylene glycol, glycerol, PEG400, Tweens, spans, poly-propanol.
7. venlafaxine hydrochloride sustained-release piller as claimed in claim 1, it is characterized in that, described porogen is selected from methylcellulose, Polyethylene Glycol, polyvinylpyrrolidone, copolyvidone, sucrose, hypromellose, polymethacrylate, the cellulose phthalate element any one of class or two or more mixture.
8. a preparation method for venlafaxine hydrochloride sustained-release piller according to claim 1, it is characterized in that, step is as follows:
Step 1: VENLAFAXINE HCL mixed homogeneously with filler, uses binding agent and wetting agent, powder is made soft material;
Step 2: soft material is placed in extruder/spheronizator to extrude/round as a ball, can add appropriate antiplastering aid in round as a ball process, round as a ballly makes ball core, dries, obtains containing pill core;
Step 3: to the fluidized-bed coating machine of atomization Compressed Gas heating/insulation, coating can be carried out with the heat fusing matrix material can being heated at coating process/be incubated by being placed in containing pill core, dry, obtain venlafaxine hydrochloride sustained-release piller.
9. the preparation method of venlafaxine hydrochloride sustained-release piller as claimed in claim 8, is characterized in that in step 2, extruder hole sizer diameter is 0.5mm ~ 1.5mm.
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| CN107519147A (en) * | 2016-06-21 | 2017-12-29 | 广州医药研究总院有限公司 | Desmethylvenlafaxine slow-release pill and preparation method thereof |
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Application publication date: 20150701 |