CN105326837A - Memantine hydrochloride sustained release-donepezil quick release compound capsule - Google Patents
Memantine hydrochloride sustained release-donepezil quick release compound capsule Download PDFInfo
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- CN105326837A CN105326837A CN201510647592.0A CN201510647592A CN105326837A CN 105326837 A CN105326837 A CN 105326837A CN 201510647592 A CN201510647592 A CN 201510647592A CN 105326837 A CN105326837 A CN 105326837A
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- release
- donepezil
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Abstract
The invention provides a memantine hydrochloride sustained release-donepezil quick release compound capsule and a preparation method thereof. The memantine hydrochloride sustained release-donepezil quick release compound capsule is characterized in that a preparation consists of memantine hydrochloride sustained release pellets and donepezil quick release granules; each sustained release pellet sequentially comprises an empty pellet core, a medicated layer and a sustained release coating layer from inside to outside; and the donepezil quick release granules are prepared from main drugs, other fillers, a disintegrating agent, adhesive and the like. Compared with other dosage forms, the preparation has the features that two drugs are combined so that a complementary synergy effect is achieved, the number of tablets can be reduced, everyday medicine taking load is reduced, and obedience and compliance of a patient can also be improved.
Description
Technical field
The invention discloses and a kind ofly treat the pharmaceutical composition of moderate to severe senile dementia disease.Be specifically related to a kind of memantine slow release-donepezil rapid release compound capsule and preparation method thereof, belong to technical field of medicine.
Background technology
Alzheimer (AD) be with
memorypower goes down, cognitive dysfunction, mental act are extremely
clinicala kind of chronic progressive external mental deterioration disease of feature.
researchdisplay, along with the increase at age, the sickness rate of this disease is in rising trend, and within more than 80 years old, old people's sickness rate reaches 20%.In the U.S., nearly 5,200,000 people suffer from senile dementia at present, and the dead age is substantially at over-65s.China's AD sickness rate is about about 1%, and estimate that in current China more than 60 years old old people, AD patient can up to 5,000,000 people, over-65s sickness rate 3% ~ 5%, and is cumulative year after year trend.Due to primary disease prevalence and disability rate high, to patient home and society bring huge burden, along with the acceleration of social senilization's process, this disease develops into serious public health problem gradually.
Memantine and donepezil all belong to a line kind in global Alzheimer type senile dementia treatment.The coupling of memantine and donepezil is the selection to severe senile Alzheimer type dementia disease of the treatment moderate that has been confirmed, is a set of effective therapeutic scheme.N-methyl-D-aspartate (NMDA) receptor stimulating agent and acetylcholinesteraseinhibitors inhibitors unite two into one by this treatment, two kinds of mechanism of action complementations, increase curative effect.The curative effect of two kinds of Drug combinations exceedes and is used alone acetylcholinesteraseinhibitors inhibitors, obviously can improve the cognitive function of patient, emotion and activity of daily living, more alone donepezil hydrochloride better effects if.
The dosage form that memantine goes on the market at present is mainly tablet, oral administration solution, slow releasing capsule.The dosage form of the domestic listing of donepezil is mainly tablet, capsule, oral cavity disintegration tablet.The dosage form of two kinds of drug regimens is not had to go on the market temporarily at present.Compound capsule of the present invention, it is simultaneously containing slow release and immediate release section, immediate release section makes medicine reach therapeutic plasma concentrations fast, slow-released part can pass through slow releasing, medicine is made to maintain certain blood level, reduce the blood drug level peak valley phenomenon that general formulation presents, reduce and take number of times.
Summary of the invention
The present invention is intended to openly a kind of drug release and stablizes, is suitable for memantine slow release-donepezil rapid release compound capsule that Alzheimer type patient takes.
Memantine slow release-donepezil rapid release compound capsule can reduce the peak valley phenomenon of the blood drug level that general formulation presents, and reduces and takes number of times.
The structure of memantine slow-release micro-pill of the present invention is followed successively by celphere, medicated layer, sustained-release coating layer from inside to outside, wherein each several part percentage by weight is respectively: celphere 20% ~ 60%, medicated layer 10% ~ 80%, sustained-release coating layer 1% ~ 50%.
The size controlling scope of slow-release micro-pill of the present invention and granule is 30 order ~ 100 orders, is preferably 40 order ~ 80 orders, and in described compound capsule, the part by weight of slow-release micro-pill and granule is 1:1 ~ 3:1.
Memantine slow-release micro-pill of the present invention molding celphere used be selected from microcrystalline Cellulose ball core, starch ball core, pre-paying starch ball core, dextrin ball core, sucrose ball core one or more, be preferably microcrystalline Cellulose ball core.
Memantine slow-release micro-pill of the present invention, is characterized in that the percentage by weight of described medicated layer memantine is 50% ~ 90%, preferably 40% ~ 70%.
Memantine slow-release micro-pill of the present invention, its medicated layer except effective ingredient memantine, also comprises ethanol, water, hypromellose, polyvidone, silicon dioxide, Pulvis Talci wherein one or more.
Memantine slow-release micro-pill of the present invention, the Sustained release coating materials of its sustained-release coating layer comprises ethyl cellulose, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, cellulose acetate, hydroxyethyl-cellulose, glyceryl monostearate, polyacrylic resin wherein one or more.Be preferably, ethyl cellulose, hypromellose, glyceryl monostearate.
Memantine slow-release micro-pill of the present invention, its plasticizer is selected from glycerol, Polyethylene Glycol, TG acid wherein one or more.Be preferably, Polyethylene Glycol or glycerol.
Donepezil granule of the present invention, except effective ingredient donepezil, also comprises filler, disintegrating agent, binding agent.Filler is selected from lactose, mannitol, microcrystalline Cellulose, corn starch, pre-paying starch wherein one or more, is preferably, lactose and microcrystalline Cellulose; Described binding agent is selected from polyvidone, hydroxypropyl cellulose, hypromellose wherein one or more, is preferably, hypromellose; Described disintegrating agent is selected from carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose wherein one or more, is preferably, low-substituted hydroxypropyl cellulose.
Memantine slow release of the present invention-donepezil hydrochloride rapid release compound capsule, also comprises lubricant, and its lubricant is selected from Pulvis Talci, magnesium stearate, silicon dioxide, castor oil hydrogenated wherein one or more, is preferably, magnesium stearate.
The invention provides the preparation method of a kind of memantine slow release-donepezil rapid release compound capsule, described method is specific as follows:
The preparation of step one memantine slow-release micro-pill
1) memantine that medicated layer preparation takes recipe quantity is dissolved in suitable solvent, is mixed with containing medicinal liquid.
2) take celphere as core, by step 1) prepare be wrapped on celphere containing medicine liquid spray, make pastille piller;
| Memantine | 3%~15% |
| PVP K30 or HPMC | 5%~15% |
| 30% ethanol or water | 10%~50% |
| Silicon dioxide or Pulvis Talci | 5%~15% |
The uniformity of medicated layer medicinal liquid and mobility can affect the drug loading of celphere, are first dissolved in by memantine in 30% ethanol or water, medicine dissolution, add HPMC or PVPK30 again, be mixed with containing medicinal liquid, add silicon dioxide or Pulvis Talci, increase the mobility of medicinal liquid.In medicine-feeding process, celphere medicine carrying is even, and coating process is smooth.
3) by Sustained release coating materials, plasticizer dissolves in water or ethanol or other solvents, be mixed with sustained release coating liquid;
4) spraying of sustained release coating liquid is wrapped in step 3) obtained by pastille piller outer, obtained Memantine hydrochloride slow-release micro-pill
Prepared by step 2 donepezil granule
Fully mixed with filler by donepezil, then mix homogeneously with disintegrating agent, in said mixture, add certain density binding agent, 20 order ~ 80 orders are granulated, and 50 DEG C ~ 60 DEG C dryings, 20 order ~ 80 order granulate, obtain donepezil granule.
specific embodiment
Step 3 by above-mentioned two parts medicament mixed, then adds lubricant, mix homogeneously, filled capsules.
In preferred embodiments, memantine slow release provided by the invention-donepezil rapid release compound capsule comprises following composition:
1) celphere sucrose ball core or microcrystalline Cellulose ball core 10% ~ 20%
2) liquid formula of medicated layer is as follows:
| Memantine | 3％～15％ |
| PVP K30 or HPMC | 5％～15％ |
| 30% ethanol or water | 10％～50％ |
| Silicon dioxide or Pulvis Talci | 5％～15％ |
The uniformity of medicated layer medicinal liquid and mobility can affect the drug loading of celphere, are first dissolved in by memantine in 30% ethanol or water, medicine dissolution, add HPMC or PVPK30 again, be mixed with containing medicinal liquid, add silicon dioxide or Pulvis Talci, increase the mobility of medicinal liquid.In medicine-feeding process, celphere medicine carrying is even, and coating process is smooth.
3) the coating solution formula of slow release layer is as follows
| Ethyl cellulose or hypromellose | 15％～22％ |
| Polyethylene Glycol or glycerol | 1％～8％ |
| Pulvis Talci or castor oil hydrogenated | 1％～10％ |
The coating amount of slow-release material is the principal agent factor determining slow-release micro-pill rate of releasing drug, and in actual coating operations, the coating amount of polymer is whether piller after determining coating can reach required release.The present invention is by screening the scope of coating amount, and adopt cellulose family coating, especially ethyl cellulose, hydroxypropyl cellulose, is conducive to the release of medicine.In addition, when parcel amount is 20%-40%, the release of prepared slow-release micro-pill is as follows: 10-30% (1.5 hours), 30-90% (3 hours), >=85% (8 hours).
4) formula of donepezil granule is as follows:
| Donepezil | 1％～5％ |
| Lactose | 10％～40％ |
| Microcrystalline Cellulose | 5％～20％ |
| PVP K30 or HPMC | 1％～10％ |
| Silicon dioxide or Pulvis Talci | 1％～5％ |
In wet-granulation process, need control granulometric range is 20 order ~ 80 orders, and prepared mobility of particle is good.
In sum, memantine slow release-donepezil rapid release compound capsule of the present invention is quality controllable, stable yield, and release meets the requirements, and makes medicine reach the object of clinical application.
Embodiment 1
Embodiment 2
Embodiment 1 and embodiment 2 release contrast
Dissolving-out method: basket method, the sodium chloride-hydrochloric acid buffer solution of rotating speed 100rpm, dissolution medium pH1.2, stripping volume 900ml
From the dissolved corrosion of the memantine slow release obtained by embodiment 1 and embodiment 2-donepezil rapid release compound capsule, the release behavior of donepezil meets the requirement of rapid release, and memantine release behavior meets the requirement of slow releasing pharmaceutical.Both synergism, in vivo while fast onset drug effect, can maintain stable curative effect of medication again, reduce medicining times, effectively can improve the Compliance of patient.
Claims (13)
1. memantine slow release-donepezil hydrochloride rapid release compound capsule, comprises memantine slow-release micro-pill and donepezil granule forms.
2. it is characterized in that the structure of memantine slow-release micro-pill is followed successively by celphere, medicated layer, sustained-release coating layer from inside to outside, wherein each several part percentage by weight is respectively: celphere 20% ~ 60%, medicated layer 10% ~ 80%, sustained-release coating layer 1% ~ 50%.
3. the size controlling scope of the slow-release micro-pill described in and granule is 30 order ~ 100 orders, be preferably 40 order ~ 80 orders, in described compound capsule, the part by weight of slow-release micro-pill and granule is 1:1 ~ 3:1.
4. memantine slow-release micro-pill as claimed in claim 1, it is characterized in that: its molding celphere used be selected from microcrystalline Cellulose ball core, starch ball core, pre-paying starch ball core, dextrin ball core, sucrose ball core one or more, be preferably microcrystalline Cellulose ball core.
5. memantine slow-release micro-pill as claimed in claim 1, is characterized in that: the percentage by weight of described medicated layer memantine is 50% ~ 90%, is preferably 40% ~ 70%.
6. as claimed in claim 1 memantine slow-release micro-pill, is characterized in that: described medicated layer, except effective ingredient memantine, also comprises ethanol, water, hypromellose, polyvidone, silicon dioxide, Pulvis Talci wherein one or more.
7. memantine slow-release micro-pill as claimed in claim 1, it is characterized in that: the Sustained release coating materials of described sustained-release coating layer comprises ethyl cellulose, hypromellose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, cellulose acetate, hydroxyethyl-cellulose, glyceryl monostearate, polyacrylic resin wherein one or more, be preferably, ethyl cellulose, hypromellose, glyceryl monostearate.
8. memantine slow-release micro-pill as claimed in claim 1, it is characterized in that: described sustained-release coating layer also comprises plasticizer, described plasticizer be selected from glycerol, Polyethylene Glycol, TG acid one or more, be preferably, Polyethylene Glycol or glycerol.
9. donepezil immediate-release granules as claimed in claim 1, is characterized in that: described granule, except effective ingredient donepezil, also comprises filler, disintegrating agent, binding agent.
10. the filler described in is selected from lactose, mannitol, microcrystalline Cellulose, corn starch, pre-paying starch wherein one or more, is preferably, lactose and microcrystalline Cellulose; Described binding agent is selected from polyvidone, hydroxypropyl cellulose, hypromellose wherein one or more, is preferably, hypromellose; Described disintegrating agent is selected from carboxymethylstach sodium, low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose wherein one or more, is preferably, low-substituted hydroxypropyl cellulose.
11. memantine z slow release-donepezil hydrochloride rapid release compound capsules as claimed in claim 1, it is characterized in that: in capsule, also comprise lubricant, described lubricant is selected from Pulvis Talci, magnesium stearate, silicon dioxide, castor oil hydrogenated wherein one or more, be preferably, magnesium stearate.
12. memantine slow release as claimed in claim 1-donepezil rapid release compound capsules, its preparation method is:
The preparation of step one memantine slow-release micro-pill
1) memantine that medicated layer preparation takes recipe quantity is dissolved in suitable solvent, is mixed with containing medicinal liquid;
2) take celphere as core, that step 1) is prepared is wrapped on celphere containing medicine liquid spray, makes pastille piller;
3) by Sustained release coating materials, plasticizer dissolves in water or ethanol or other solvents, be mixed with sustained release coating liquid;
4) the pastille piller spraying of sustained release coating liquid be wrapped in obtained by step 3) is outer, obtained memantine slow-release micro-pill
Prepared by step 2 donepezil immediate-release granules
Mixed homogeneously with filler by donepezil, then mix homogeneously with disintegrating agent, in said mixture, add certain density binding agent, 20 order ~ 80 orders are granulated, and 50 DEG C ~ 60 DEG C dryings, 20 order ~ 80 order granulate, obtain donepezil granule.
13. step 3 by above-mentioned two parts medicament mixed, then add lubricant, mix homogeneously, filled capsules.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510647592.0A CN105326837A (en) | 2015-10-09 | 2015-10-09 | Memantine hydrochloride sustained release-donepezil quick release compound capsule |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510647592.0A CN105326837A (en) | 2015-10-09 | 2015-10-09 | Memantine hydrochloride sustained release-donepezil quick release compound capsule |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106581682A (en) * | 2016-12-09 | 2017-04-26 | 河南中帅医药科技股份有限公司 | Memantine hydrochloride/donepezil slow-release resin composition and preparation method thereof |
| CN106727439A (en) * | 2016-12-21 | 2017-05-31 | 河南中帅医药科技股份有限公司 | A kind of memantine is sustained donepezil quick-release compound capsule |
| CN107412199A (en) * | 2016-05-23 | 2017-12-01 | 海南合瑞制药股份有限公司 | A kind of Memantine hydrochloride sustained-release capsule composition |
| KR20180036579A (en) * | 2016-09-30 | 2018-04-09 | 주식회사 바이오파마티스 | Composition comprising complex for prevention and treatment of dementia and cognitive impairment |
| EP3338767A1 (en) * | 2016-12-22 | 2018-06-27 | Sanovel Ilac Sanayi ve Ticaret A.S. | Capsule compositions comprising donepezil and memantine |
| CN109908097A (en) * | 2017-12-13 | 2019-06-21 | 北京万全德众医药生物技术有限公司 | Linkou County Mo Fanse collapses sustained release tablets |
| CN110613715A (en) * | 2018-06-20 | 2019-12-27 | 晟德大药厂股份有限公司 | non-pH dependent oral dosage forms for the treatment of neurodegenerative diseases |
| CN111939139A (en) * | 2020-06-30 | 2020-11-17 | 辰欣药业股份有限公司 | Memantine hydrochloride sustained-release and donepezil hydrochloride quick-release capsule and preparation method thereof |
| CN112587499A (en) * | 2020-12-29 | 2021-04-02 | 成都锦华药业有限责任公司 | Berberine hydrochloride pellet and preparation method thereof |
| WO2023128890A1 (en) * | 2021-12-28 | 2023-07-06 | Ilko Ilac Sanayi Ve Ticaret A.S. | Donepezil – memantine extended release capsule composition |
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Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107412199A (en) * | 2016-05-23 | 2017-12-01 | 海南合瑞制药股份有限公司 | A kind of Memantine hydrochloride sustained-release capsule composition |
| CN107412199B (en) * | 2016-05-23 | 2020-09-01 | 海南合瑞制药股份有限公司 | Memantine hydrochloride sustained-release capsule composition |
| KR101938872B1 (en) | 2016-09-30 | 2019-01-16 | 주식회사 바이오파마티스 | Composition comprising complex for prevention and treatment of dementia and cognitive impairment |
| KR20180036579A (en) * | 2016-09-30 | 2018-04-09 | 주식회사 바이오파마티스 | Composition comprising complex for prevention and treatment of dementia and cognitive impairment |
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| CN110573156B (en) * | 2016-09-30 | 2023-12-08 | 现代药品株式会社 | Pharmaceutical composition for preventing or treating dementia and cognitive dysfunction, containing donepezil or pharmaceutically acceptable salt thereof and memantine or pharmaceutically acceptable salt thereof, and preparation method thereof |
| CN106581682A (en) * | 2016-12-09 | 2017-04-26 | 河南中帅医药科技股份有限公司 | Memantine hydrochloride/donepezil slow-release resin composition and preparation method thereof |
| CN106727439A (en) * | 2016-12-21 | 2017-05-31 | 河南中帅医药科技股份有限公司 | A kind of memantine is sustained donepezil quick-release compound capsule |
| EP3338767A1 (en) * | 2016-12-22 | 2018-06-27 | Sanovel Ilac Sanayi ve Ticaret A.S. | Capsule compositions comprising donepezil and memantine |
| WO2018115300A1 (en) * | 2016-12-22 | 2018-06-28 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Capsule compositions comprising donepezil and memantine |
| CN109908097A (en) * | 2017-12-13 | 2019-06-21 | 北京万全德众医药生物技术有限公司 | Linkou County Mo Fanse collapses sustained release tablets |
| CN110613715A (en) * | 2018-06-20 | 2019-12-27 | 晟德大药厂股份有限公司 | non-pH dependent oral dosage forms for the treatment of neurodegenerative diseases |
| CN111939139A (en) * | 2020-06-30 | 2020-11-17 | 辰欣药业股份有限公司 | Memantine hydrochloride sustained-release and donepezil hydrochloride quick-release capsule and preparation method thereof |
| CN112587499A (en) * | 2020-12-29 | 2021-04-02 | 成都锦华药业有限责任公司 | Berberine hydrochloride pellet and preparation method thereof |
| WO2023128890A1 (en) * | 2021-12-28 | 2023-07-06 | Ilko Ilac Sanayi Ve Ticaret A.S. | Donepezil – memantine extended release capsule composition |
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Application publication date: 20160217 |