CN106619514A - Pramipexole dihydrochloride self-microemulsion preparation and preparing method thereof - Google Patents
Pramipexole dihydrochloride self-microemulsion preparation and preparing method thereof Download PDFInfo
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Abstract
The invention discloses a pramipexole dihydrochloride self-microemulsion preparation and a preparing method thereof. A liquid self-microemulsion preparation is prepared from pramipexole dihydrochloride, an oil phase, an emulsifier and a co-emulsifier, or the obtained liquid self-microemulsion preparation is further used for generating a solid self-microemulsion preparation together with an excipient. The pharmaceutical composition for treating Parkinson's disease has a reasonable ratio, drug release can be achieved quickly, and a good treatment effect can be realized for the disease.
Description
Technical field
The invention belongs to pharmaceutical technology field, and in particular to a kind of hydrochloric acid pula gram self-micro emulsion formulation and preparation method thereof.
Background technology
Parkinson's (ParkinsonSdisease) are a kind of nerves of the common slow progress for betiding the elderly
System degenerative disease, clinic is with static tremor, myotonia and dyskinesia as principal character.With entering for population aging
Journey, its illness rate increases year by year, it has also become be only second to the nervous system common disease of cerebrovascular disease.For a long time, with levodopa
Based on medicine replacement therapy be treatment of Parkinson disease preferred option, but existing remedy measures can not effectively prevent be
To the progress for slowing down disease.Over treatment Early Parkinson's disease is nearly 30 years, levodopa is always treated Parkinsonian mainly to be had
Imitate medicine but Long-Time Service occurs that the fluctuation to reacting includes " agent end phenomenon " and " on-off phenomenon " and motor complication, such as
Dyskinesia, myodystony a new generation non-ergot class dopamine-receptor stimulant Pramipexole appear as Parkinsonian
Bring hope.Pramipexole can be applied individually to any Parkinsonian treatment, reduce dyskinetic caused by levodopa treatment
Incidence, with levodopa combination, can reduce dosage and the bad reaction of levodopa.Early application Pramipexole makes more in early days
Can delay the appearance of these symptoms with levodopa, and the life quality of patient can be improved.
【Product advantage】New non-ergot class dopamine-receptor stimulant Pramipexole shows it in treatment Parkinson's
Unique advantage, it is specific as follows：（1）Early application Pramipexole being capable of delayed motion disease compared with early application levodopa treatment
The appearance of shape, and can improve the life quality of patient compared with levodopa；（2）Treatment advanced Parkinson disease is shared with levodopa
The dosage of levodopa can be reduced and improve the UPDRS scorings of patient；（3）With other ergot class dopamine-receptor stimulants
Compare and do not result in cardiac valve lesion.（4）There are the series of advantages such as antidepressant effect, Small side effects.Domestic and international upper market condition
Condition：The product, by the Yin lattice writing brush exploitation of Berlin, Germany lattice, are FDA in May, 1997 in U.S.'s Initial Public Offering, trade name Mirapex
Ratified the medicine for Parkinson first in past 6 years.Import preparation 07 year is formal in Discussion on Chinese Listed, at present in addition to the U.S.
In more than 20 country's listings such as China, European Union, Japan and Canada.
Patent and administrative protection：The product are protected at home without compound, the product administrative protection（Grant number B-
DE03091203）To expire in December, 2010.It is imitated to have listed product and the indication for approved is not encroached right.Other systems
Preparation Method patent can get around and can apply our own preparation method patent.Market Prospect Forecast：China comes into
Astogeny society, with the continuous growth of elderly population, the preventing and treating to the diseases of middle -and old -aged person becomes social problem.Exploitation is high
Effect, safety, the anti-Parkinson medicine of low toxicity side effect had both met huge market demand, were also the needs of society.Therefore, the medicine
From indication and Clinical analysis, possess very much the value of developmental research, once listing at home, significant society will be produced
Benefit and economic benefit.
The content of the invention
It is an object of the invention to provide a kind of hydrochloric acid pula gram self-micro emulsion formulation and preparation method thereof, it is remarkably improved
Hydrochloric acid pula gram dissolution in vitro and vivo biodistribution utilization rate, and raw material is easy to get, preparation process is simple is feasible, and yield is high, cost
It is low, it is possible to achieve industrialization large-scale production, with significant economic benefit.
For achieving the above object, the present invention is adopted the following technical scheme that：
A kind of hydrochloric acid pula gram self-micro emulsion formulation, it is specially a kind of liquid self-micro emulsion formulation or a kind of Solid Self-microemulsion preparation.
The liquid self-micro emulsion formulation is made up of hydrochloric acid pula gram, oil phase, emulsifying agent, assistant for emulsifying agent；Its each raw material used
Percentage is：Hydrochloric acid pula gram 0.1% ~ 5%, oil phase 5% ~ 80%, emulsifying agent 5% ~ 60%, assistant for emulsifying agent 5% ~ 60%, respectively
Raw material weight percentage sum is 100%；
Wherein, the oil phase is Sunsoft 8090, oleic acid LABRAFIL M 1944CS, ethyl oleate, caprylic capric triglycerin
One or more in ester, oleic acid；
The emulsifying agent is Labraso, Tween-80, Solutol HS15, polyoxy second
One or more in the castor oil of alkene 35, the rilanit special of polyethylene glycol -40；
The assistant for emulsifying agent is one or more in TC, propane diols, PEG400, glycerine.
The preparation method of the liquid self-micro emulsion formulation is that hydrochloric acid pula gram is added into oil phase, emulsifying agent or assistant for emulsifying agent
After middle dissolving, add other raw materials and be well mixed, obtain final product in soft capsule using conventional method is filling.
The Solid Self-microemulsion preparation is the liquid that will be made up of hydrochloric acid pula gram, oil phase, emulsifying agent, assistant for emulsifying agent from micro-
Emulsion formulation is further made with excipient；Liquid self-micro emulsion formulation used is 1 with the weight ratio of excipient:1~1:60；
Wherein, the excipient is the one kind or several in microcrystalline cellulose, lactose, PVP K30, silica
Kind.
The preparation method of the Solid Self-microemulsion preparation is that hydrochloric acid pula gram is added into oil phase, emulsifying agent or assistant for emulsifying agent
After middle dissolving, addition prepares other raw materials needed for liquid self-micro emulsion formulation and is well mixed, then by obtained liquid from micro emulsion system
Agent is well mixed with excipient, and using direct powder compression piece agent is prepared；Or using dry granulation or wet granulation technology,
It is mixed with other auxiliary materials, compressing tablet prepares piece agent；Or micropill is prepared into by extrusion spheronization method, centrifugal granulation, load
In hard shell capsules；
Described other auxiliary materials include disintegrant, adhesive, lubricant.
The present invention remarkable advantage be：Self-micro emulsifying medicament delivery system can be such that hydrochloric acid pula gram protects in preparation and intestinal fluid
Hold the micro emulsion drop formed after dissolved state, and self-emulsifying and there is minimum particle diameter, it is ensured that larger decentralization, can significantly carry
Solubility and dissolution rate of the high hydrochloric acid pula gram in gastro-intestinal Fluid；Lipid excipient in prescription can promote chylomicron to secrete,
And then promotion hydrochloric acid pula gram Jing lymphatic transports.
Hydrochloric acid pula gram is prepared into self-micro emulsion formulation and can reach raising dissolution in vitro and vivo biodistribution utilization by the present invention
The effect of rate, and preparation needed raw material is easy to get, preparation process is simple is feasible, and yield is high, low cost, it is possible to achieve the big rule of industrialization
Mould is produced, with significant economic benefit.
Specific embodiment
In order that content of the present invention easily facilitates understanding, with reference to specific embodiment to of the present invention
Technical scheme is described further, but the present invention is not limited only to this.
Embodiment 1：The preparation of hydrochloric acid pula gram self-microemulsion soft capsules
| Hydrochloric acid pula gram | 0.2g |
| Sunsoft 8090 | 100g |
| Labraso | 50g |
| TC | 50g |
Preparation technology：
Add stirring in Sunsoft 8090 to dissolve it hydrochloric acid pula gram, sequentially add caprylic capric polyethylene glycol sweet
Grease, TC, it is filling to obtain final product in soft capsule after stirring is well mixed it.
Embodiment 2：The preparation of hydrochloric acid pula gram self-microemulsion soft capsules
| Hydrochloric acid pula gram | 0.2g |
| Oleic acid LABRAFIL M 1944CS | 100g |
| Ethyl oleate | 50g |
| Tween-80 | 25g |
| Propane diols | 25g |
Preparation technology：
By hydrochloric acid pula gram add oleic acid LABRAFIL M 1944CS in stirring dissolve it, sequentially add ethyl oleate, tween-
80th, propane diols, it is filling to obtain final product in soft capsule after stirring is well mixed it.
Embodiment 3：The preparation of hydrochloric acid pula gram self-microemulsion soft capsules
| Hydrochloric acid pula gram | 0.2g |
| Solutol HS15 | 75g |
| Sad certain herbaceous plants with big flowers acid glyceryl ester | 50g |
| Oleic acid | 25g |
| Emulsifier EL-35 | 25g |
| PEG400 | 25g |
Preparation technology：
Add stirring in Solutol HS15 to dissolve it hydrochloric acid pula gram, sequentially add sad certain herbaceous plants with big flowers acid
Glyceryl ester, oleic acid, Emulsifier EL-35, PEG400, it is filling in soft capsule after stirring is well mixed it
Obtain final product.
Embodiment 4：The preparation of hydrochloric acid pula gram Solid Self-microemulsion piece
| Hydrochloric acid pula gram | 0.5g |
| TC | 75g |
| Sunsoft 8090 | 10g |
| Sad certain herbaceous plants with big flowers acid polyethylene glycol glyceride | 15g |
| Microcrystalline cellulose | 85g |
| Sodium carboxymethyl starch | 15g |
Preparation technology：
By hydrochloric acid pula gram add TC in stirring dissolve it, sequentially add Sunsoft 8090,
Sad certain herbaceous plants with big flowers acid polyethylene glycol glyceride, after stirring is well mixed it, adds microcrystalline cellulose, sodium carboxymethyl starch, wet method system
Grain compressing tablet, obtains final product.
Embodiment 5：The preparation of hydrochloric acid pula gram Solid Self-microemulsion piece
| Hydrochloric acid pula gram | 0.10g |
| Oleic acid LABRAFIL M 1944CS | 35g |
| Ethyl oleate | 10g |
| Tween-80 | 15g |
| Propane diols | 15g |
| Lactose | 95g |
| PVPP | 15g |
| Magnesium stearate | 5g |
Preparation technology：
After oleic acid LABRAFIL M 1944CS, ethyl oleate are mixed, hydrochloric acid pula gram is added thereto into stirring dissolves it, then successively
After adding Tween-80, propane diols, stirring to be well mixed it, lactose, PVPP are added, after dry granulation,
Magnesium stearate compressing tablet is added, is obtained final product.
Embodiment 6：The preparation of hydrochloric acid pula gram Solid Self-microemulsion piece
| Hydrochloric acid pula gram | 0.5g |
| Caprylic capric glyceryl ester | 35g |
| Oleic acid | 10g |
| Solutol HS15 | 15g |
| The rilanit special of polyethylene glycol -40 | 15g |
| Lactose | 95g |
| PVPP | 15g |
| Silica | 5g |
Preparation technology：
After caprylic capric glyceryl ester, oleic acid are mixed, hydrochloric acid pula gram is added thereto into stirring dissolves it, sequentially adds poly-
Ethylene glycol 15- hydroxy stearic acid esters, the rilanit special of polyethylene glycol -40, after stirring is well mixed it, add lactose, crosslinking
Polyvinylpyrrolidone, silica, direct powder compression is obtained final product.
Embodiment 7：The preparation of hydrochloric acid pula gram Solid Self-microemulsion micro pill capsule
| Hydrochloric acid pula gram | 1g |
| TC | 70g |
| Sunsoft 8090 | 5g |
| Labraso | 5g |
| Microcrystalline cellulose | 75g |
| Lactose | 25g |
| Sodium carboxymethyl starch | 10g |
Preparation technology：
By hydrochloric acid pula gram add TC in stirring dissolve it, sequentially add Sunsoft 8090,
Labraso, after stirring is well mixed it, adds microcrystalline cellulose, lactose, sodium carboxymethyl starch, mixes
Even, extrusion spheronization method is prepared into micropill, encapsulated to obtain final product.
Embodiment 8：The preparation of hydrochloric acid pula gram Solid Self-microemulsion micro pill capsule
| Hydrochloric acid pula gram | 0.5g |
| Oleic acid LABRAFIL M 1944CS | 50g |
| Ethyl oleate | 25g |
| Tween-80 | 5g |
| Propane diols | 5g |
| Microcrystalline cellulose | 95g |
| Sodium carboxymethyl starch | 10g |
Preparation technology：
After oleic acid LABRAFIL M 1944CS, ethyl oleate are mixed, hydrochloric acid pula gram is added thereto into stirring dissolves it, then successively
After adding Tween-80, propane diols, stirring to be well mixed it, microcrystalline cellulose, sodium carboxymethyl starch are added, mixed, be with water
Adhesive prepares micropill using centrifugal granulation, encapsulated to obtain final product.
Embodiment 9：The preparation of hydrochloric acid pula gram Solid Self-microemulsion micro pill capsule
| Hydrochloric acid pula gram | 1g |
| TC | 70g |
| Caprylic capric glyceryl ester | 5g |
| Solutol HS15 | 5g |
| Emulsifier EL-35 | 5g |
| Microcrystalline cellulose | 95g |
| Sodium carboxymethyl starch | 10g |
Preparation technology：
Add stirring in TC to dissolve it hydrochloric acid pula gram, sequentially add caprylic capric triglycerin
Ester, Solutol HS15, Emulsifier EL-35, after stirring is well mixed it, add microcrystalline cellulose
Element, sodium carboxymethyl starch, mix, and extrusion spheronization method prepares micropill, encapsulated to obtain final product.
Claims (6)
1. a kind of hydrochloric acid pula gram self-micro emulsion formulation, it is characterised in that：The hydrochloric acid pula gram self-micro emulsion formulation is liquid from micro-
Emulsion formulation, it is made up of hydrochloric acid pula gram, oil phase, emulsifying agent, assistant for emulsifying agent.
2. a kind of hydrochloric acid pula gram self-micro emulsion formulation, it is characterised in that：The hydrochloric acid pula gram self-micro emulsion formulation is solid from micro-
Emulsion formulation, it is made up of after liquid self-micro emulsion formulation hydrochloric acid pula gram, oil phase, emulsifying agent, assistant for emulsifying agent, further with tax
Shape agent is made.
3. hydrochloric acid pula gram according to claim 1 or claim 2 self-micro emulsion formulation, it is characterised in that：Used by liquid self-micro emulsion formulation
Each raw material percentage is：Hydrochloric acid pula gram 0.1% ~ 5%, oil phase 5% ~ 80%, emulsifying agent 5% ~ 60%, assistant for emulsifying agent 5% ~
60%, each raw material weight percentage sum is 100%；
Wherein, the oil phase is Sunsoft 8090, oleic acid LABRAFIL M 1944CS, ethyl oleate, caprylic capric triglycerin
One or more in ester, oleic acid；
The emulsifying agent is Labraso, Tween-80, Solutol HS15, polyoxy second
One or more in the castor oil of alkene 35, the rilanit special of polyethylene glycol -40；
The assistant for emulsifying agent is one or more in TC, propane diols, PEG400, glycerine.
4. hydrochloric acid pula gram self-micro emulsion formulation according to claim 2, it is characterised in that：Liquid self-micro emulsion formulation and excipient
Weight ratio be 1:1~1:60；
The excipient is one or more in microcrystalline cellulose, lactose, PVP K30, silica.
5. a kind of preparation method of hydrochloric acid pula gram as claimed in claim 1 self-micro emulsion formulation, it is characterised in that：By hydrochloric acid pula
Gram be added in oil phase, emulsifying agent or assistant for emulsifying agent after dissolving, add other raw materials and be well mixed, it is filling in soft capsule i.e.
.
6. a kind of preparation method of hydrochloric acid pula gram as claimed in claim 2 self-micro emulsion formulation, it is characterised in that：By hydrochloric acid pula
Gram it is added in oil phase, emulsifying agent or assistant for emulsifying agent after dissolving, addition prepares other raw materials needed for liquid self-micro emulsion formulation and mixes
Close uniform, then obtained liquid self-micro emulsion formulation is well mixed with excipient, piece agent is prepared using direct powder compression；
Or using dry granulation or wet granulation technology, it is mixed with other auxiliary materials, compressing tablet prepare piece agent；Or by extrusion spheronization
Method, centrifugal granulation are prepared into micropill, in being fitted into hard shell capsules；
Described other auxiliary materials include disintegrant, adhesive, lubricant.
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| CN201710109450.8A CN106619514A (en) | 2017-02-27 | 2017-02-27 | Pramipexole dihydrochloride self-microemulsion preparation and preparing method thereof |
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|---|---|---|---|
| CN201710109450.8A CN106619514A (en) | 2017-02-27 | 2017-02-27 | Pramipexole dihydrochloride self-microemulsion preparation and preparing method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117771177A (en) * | 2023-08-02 | 2024-03-29 | 首都医科大学附属北京儿童医院 | Venezuela self-microemulsifying drug release system and preparation method and application thereof |
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| CN105796519A (en) * | 2014-12-30 | 2016-07-27 | 浙江京新药业股份有限公司 | Pramipexole dihydrochloride sustained-release tablet and preparation method thereof |
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| CN105147627A (en) * | 2015-08-19 | 2015-12-16 | 天津红日药业股份有限公司 | Medicine composition containing pramipexole dihydrochloride and preparation method thereof |
| CN105640886A (en) * | 2016-03-17 | 2016-06-08 | 中国人民解放军南京军区福州总医院 | Sirolimus self-microemulsion preparation and preparation method thereof |
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| CN117771177A (en) * | 2023-08-02 | 2024-03-29 | 首都医科大学附属北京儿童医院 | Venezuela self-microemulsifying drug release system and preparation method and application thereof |
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