CN101204378B - Memantine hydrochloride oral medicine compound and its preparation method - Google Patents
Memantine hydrochloride oral medicine compound and its preparation method Download PDFInfo
- Publication number
- CN101204378B CN101204378B CN 200610165399 CN200610165399A CN101204378B CN 101204378 B CN101204378 B CN 101204378B CN 200610165399 CN200610165399 CN 200610165399 CN 200610165399 A CN200610165399 A CN 200610165399A CN 101204378 B CN101204378 B CN 101204378B
- Authority
- CN
- China
- Prior art keywords
- memantine
- preparation
- memantine hydrochloride
- medicine compound
- tablet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Abstract
The invention discloses a medicine combination containing memantine hydrochloride and a manufacturing method thereof. The combination contains the solid dispersoid of memantine hydrochloride prepared by rotary evaporating process and sponging drying process, which effectively disguises the adverse smell of memantine hydrochloride. The medicine combination is used for curing the senile dementia resulted from Alzheimer's disease.
Description
Technical field
The invention discloses a kind of pharmaceutical composition that is used for the treatment of senile dementia, particularly relate to a kind of drug port cavity disintegrating tablet composition and method of making the same that contains memantine.
Background technology
Senile dementia (Alzheimer's disease) is one of common complaint among the elderly, shows as mainly that memory weakens and identification ability obstacle etc., is a kind of gradual function of nervous system's degenerative imbalance.A large amount of research data both domestic and external shows that per ten old peoples just have a dementia symptom that manifests in various degree, are having a strong impact on people's Health and Living quality.Along with the arrival of world's aging society, the control of senile memory dysfunctions such as senile hypomnesis, alzheimer disease seems and becomes more and more important.Memantine is a kind of novel anti-senile dementia new drug, mainly acts on the glutamine system in the brain, works by the release that delays the excitatory neurotransmitter glutamate, Glu, thereby reaches the purpose of treatment.
CN1709229A discloses prescription of a kind of memantine oral cavity disintegration tablet and preparation method thereof, and CN1709230A discloses prescription of a kind of memantine hydrochloride dispersable table and preparation method thereof.The applicant finds, according to the oral cavity disintegration tablet and the dispersible tablet of above two pieces of preparation methoies that patent provided preparation, can not well cover the taste of memantine, still has bitterness residual.The applicant finds by a large amount of tests, adopt rotary evaporation technology or drying process with atomizing, memantine and correctives are prepared into solid dispersion, can reach good taste masking effect, prepared oral cavity disintegration tablet, dispersible tablet and chewable tablet are distinguished the flavor of sweet refrigerant, and do not have grittiness.Suitably adjusted simultaneously the type and the consumption of other adjuvant, reached disintegrate rapidly, be uniformly dispersed, good mouthfeel, flavor be sweet refrigerant, and do not have the effect of grittiness.
Summary of the invention
The invention provides a kind of pharmaceutical composition, be specifically related to a kind of solid dispersion that memantine and its acceptable accessories prepare that contains, said composition is mainly used in the senile dementia that treatment is caused by Alzheimer's disease.
The invention provides a kind of pharmaceutical composition that contains the memantine active component, wherein contain the solid dispersion that memantine and acceptable accessories prepare.
Pharmaceutical composition provided by the present invention, described solid dispersion adopt rotary evaporation technology or drying process with atomizing preparation.
Pharmaceutical composition provided by the present invention, described acceptable accessories are acrylic resin.
Pharmaceutical composition provided by the present invention, described acrylic resin are Eudragit E 100 or Eudragit E 30.
Pharmaceutical composition provided by the present invention, the percentage by weight of described acrylic resin are 7%～8%.
Preparation of drug combination method provided by the present invention, the temperature of rotary evaporation are 45～55 ℃;
Preparation of drug combination method provided by the present invention is characterized in that spray-dired temperature is 105～115 ℃.
The existence form of pharmaceutical composition provided by the present invention can be oral cavity disintegration tablet, dispersible tablet or chewable tablet, and this preparation method has effectively been covered the disagreeable taste of memantine, and gained oral cavity disintegration tablet, dispersible tablet or chewable tablet are distinguished the flavor of sweet refrigerant, no grittiness, good mouthfeel.
The specific embodiment
The present invention is described in further detail below in conjunction with embodiment, but be not limited to following embodiment.Wherein " % " is meant " weight % ".
Embodiment 1
The existence form of this embodiment is an oral cavity disintegration tablet.
Preparation technology: take by weighing memantine by recipe quantity, behind dissolve with ethanol, add Eudragit E 100 and stir and make it dissolving, put in the Rotary Evaporators 50 ℃ and be spin-dried for, pulverized 120 mesh sieves; Take by weighing recipe quantity memantine clathrate, mannitol, ethyl cellulose RT-N-10, low-substituted hydroxypropyl methylcellulose, acesulfame potassium and starch and adopt equivalent to progressively increase behind the method mix homogeneously, it is an amount of to add 10% starch slurry, the system soft material, and drying is measured moisture; The magnesium stearate, low-substituted hydroxypropyl methylcellulose and the Mentholum that add the prescription ratio, mixing, tabletting.
Embodiment 2
The existence form of this embodiment is a dispersible tablet.
Preparation technology: take by weighing memantine by recipe quantity, behind dissolve with ethanol, add Eudragit E 30 and stirring and make it to dissolve, put 110 ℃ of spray dryinges in the spray dryer, pulverized 120 mesh sieves; Take by weighing recipe quantity memantine clathrate, mannitol, ethyl cellulose RT-N-10, microcrystalline Cellulose, acesulfame potassium and lactose and adopt equivalent to progressively increase behind the method mix homogeneously, it is an amount of to add 10% starch slurry, the system soft material, and drying is measured moisture; The silicon dioxide, acesulfame potassium and the Mentholum that add the prescription ratio, mixing, tabletting.
Embodiment 3
The existence form of this embodiment is a chewable tablet.
Preparation technology: take by weighing memantine by recipe quantity, behind dissolve with ethanol, add Eudragit E 30 and stirring and make it to dissolve, put 110 ℃ of spray dryinges in the spray dryer, pulverized 120 mesh sieves; Take by weighing recipe quantity memantine clathrate, sucrose, ethyl cellulose RT-N-10, carboxymethyl starch sodium, acesulfame potassium and lactose and adopt equivalent to progressively increase behind the method mix homogeneously, it is an amount of to add 10% starch slurry, the system soft material, and drying is measured moisture; The Pulvis Talci, acesulfame potassium and the Mentholum that add the prescription ratio, mixing, tabletting.
Embodiment 4
Embodiment 1 prepared oral cavity disintegration tablet is carried out the mensuration of disintegration in the body.
Assay method: select different experimenters, put into sheet on the tongue and pick up counting, the slight friction of last Hubei Province and tongue last slice is taken away the sheet surface by the part of saliva dissolves, stops timing in mouth when no solid or grittiness.The results are shown in following table:
| 1 | 2 | 3 | 4 | 5 | 6 | On average | |
| Disintegration (s) | 27 | 28 | 26 | 30 | 28 | 29 | 28 |
The disintegrate of this oral cavity disintegration tablet is rapid, and has effectively covered the disagreeable taste of memantine, and it is sweet refrigerant to distinguish the flavor of, no grittiness, good mouthfeel.
Claims (1)
1. pharmaceutical composition that contains the memantine active component, it is characterized in that containing the solid dispersion that memantine and acceptable accessories prepare, described solid dispersion adopts 45～55 ℃ of rotary evaporation technologies or 105～115 ℃ of drying process with atomizing preparations, be weight percentage 7%～8% acrylic resin of described acceptable accessories, wherein acrylic resin is selected from Eudragit E 100 or Eudragit E 30.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610165399 CN101204378B (en) | 2006-12-19 | 2006-12-19 | Memantine hydrochloride oral medicine compound and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610165399 CN101204378B (en) | 2006-12-19 | 2006-12-19 | Memantine hydrochloride oral medicine compound and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101204378A CN101204378A (en) | 2008-06-25 |
| CN101204378B true CN101204378B (en) | 2010-09-01 |
Family
ID=39565008
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610165399 Active CN101204378B (en) | 2006-12-19 | 2006-12-19 | Memantine hydrochloride oral medicine compound and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101204378B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108066297B (en) * | 2016-11-16 | 2022-09-16 | 深圳万和制药有限公司 | Positioning release memantine orally disintegrating tablet composition for treating senile dementia |
| CN110613691A (en) * | 2018-06-19 | 2019-12-27 | 北京万全德众医药生物技术有限公司 | Orally disintegrating tablet containing PEG-DSPE-memantine hydrochloride compound |
| CN111437260A (en) * | 2019-01-17 | 2020-07-24 | 北京万全德众医药生物技术有限公司 | Method for preparing memantine hydrochloride solid pharmaceutical composition |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709229A (en) * | 2005-06-10 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride orally disintegrating tablet and its preparing method |
| CN1709230A (en) * | 2005-07-05 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride dispersable table and its preparing method |
| CN1742711A (en) * | 2005-09-23 | 2006-03-08 | 北京阜康仁生物制药科技有限公司 | Menantine hydrochloride effervescent tablet and preparing method thereof |
| CN1742712A (en) * | 2005-09-23 | 2006-03-08 | 北京阜康仁生物制药科技有限公司 | Menantine hydrochloride soft capsule and preparing method |
-
2006
- 2006-12-19 CN CN 200610165399 patent/CN101204378B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1709229A (en) * | 2005-06-10 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride orally disintegrating tablet and its preparing method |
| CN1709230A (en) * | 2005-07-05 | 2005-12-21 | 北京阜康仁生物制药科技有限公司 | Memantine hydrochloride dispersable table and its preparing method |
| CN1742711A (en) * | 2005-09-23 | 2006-03-08 | 北京阜康仁生物制药科技有限公司 | Menantine hydrochloride effervescent tablet and preparing method thereof |
| CN1742712A (en) * | 2005-09-23 | 2006-03-08 | 北京阜康仁生物制药科技有限公司 | Menantine hydrochloride soft capsule and preparing method |
Non-Patent Citations (4)
| Title |
|---|
| Tatsuya ISHIKAWA ET AL..Preparation and Evaluation of Tablets Rapidly DisintegratinginSaliva Containing Bitter-Taste-Masked Granules bytheCompression Method.Chem.Pharm.Bull.47 10.1999,47(10),1451-1454. |
| Tatsuya ISHIKAWA ET AL..Preparation and Evaluation of Tablets Rapidly DisintegratinginSaliva Containing Bitter-Taste-Masked Granules bytheCompression Method.Chem.Pharm.Bull.47 10.1999,47(10),1451-1454. * |
| 张鹏威等.茶苯海明口腔崩解片的研制.中国药学杂志40 22.2005,40(22),第1720第1段、第1721第2.1和2.3部分、第1723右栏最后一段. |
| 张鹏威等.茶苯海明口腔崩解片的研制.中国药学杂志40 22.2005,40(22),第1720第1段、第1721第2.1和2.3部分、第1723右栏最后一段. * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN101204378A (en) | 2008-06-25 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP5718231B2 (en) | Erythritol tableting | |
| CN101374503B (en) | Quickly disintegrating tablet produced by direct dry-tabletting | |
| JP7335291B2 (en) | Pharmaceutical composition containing phosphate binder particles | |
| Iqubal et al. | Recent advances in direct compression technique for pharmaceutical tablet formulation | |
| CN104546747A (en) | Pharmaceutical composition containing safinamide mesylate and preparation method of pharmaceutical composition | |
| CN101778626A (en) | Medical composition containing rebamipide | |
| Chowdary et al. | Recent research on co-processed excipients for direct compression-A Review | |
| TW200812644A (en) | Orodispersible domperidone tablets | |
| CN106692090A (en) | Bilastine tablets and preparation method thereof | |
| JP5552400B2 (en) | Granules masking bitterness and unpleasant taste of herbal medicines and intraoral quick disintegrating tablets | |
| CN101204378B (en) | Memantine hydrochloride oral medicine compound and its preparation method | |
| TW201900218A (en) | Composition for disintegrating tablet containing microfibrous cellulose and active ingredient | |
| CN102631329A (en) | Oral paroxetine disintegrating tablet and preparation process thereof | |
| JP5969680B1 (en) | Chitosan powder, method for producing the same, and preparation containing chitosan | |
| JP6704351B2 (en) | Disintegrating particle composition containing ground lactose or granulated lactose | |
| JP5751677B2 (en) | Tableting of erythritol and isomalt | |
| CN102258490B (en) | Ibuprofen chewable tablet | |
| CN101269055B (en) | Ambroxol hydrochloride oral cavity disintegrating tablet and method of producing the same | |
| TWI468189B (en) | Oral internal disintegrating tablet and its manufacturing method | |
| Adriany et al. | Formulation of orodispersible tablet of luffa acutangula (L) roxb using novel co-processed via spray dried excipient | |
| CN1970085A (en) | Orally disintegrating tablet of ubenimex and preparation method thereof | |
| WO2001085134A1 (en) | Pharmaceutical solid compositions and process for the production of mouth dissolving tablets | |
| JPS59193815A (en) | Preparation of tablet | |
| TWI825159B (en) | Composition for oral ingestion that contains ingredients derived from turmeric and is chewed and/or dissolved in the oral cavity | |
| JP6839546B2 (en) | Carrot powder-containing tablets |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| EE01 | Entry into force of recordation of patent licensing contract |
Assignee: Wuxi Wanquan Medical Technology Co., Ltd. Assignor: Dezhong Wanquan Pharmaceuticals Tech. Dev. Co., Ltd., Beijing Contract record no.: 2011990000336 Denomination of invention: Memantine hydrochloride oral medicine compound and its preparation method Granted publication date: 20100901 License type: Exclusive License Open date: 20080625 Record date: 20110504 |
|
| ASS | Succession or assignment of patent right |
Owner name: JIANGSU AVENTIS PHARMA. CO., LTD. Free format text: FORMER OWNER: DEZHONG WANQUAN PHARMACEUTICALS TECH. DEV. CO., LTD., BEIJING Effective date: 20120530 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 100097 HAIDIAN, BEIJING TO: 225300 TAIZHOU, JIANGSU PROVINCE |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20120530 Address after: 225300 Taizhou City, Jiangsu Province medicine City Avenue, No. 1 Patentee after: Aventis Pharmaceutical (Jiangsu) Co., Ltd. Address before: 100097 Beijing city Haidian District Sijiqing Wanquan Zhuang 3 Building Patentee before: Dezhong Wanquan Pharmaceuticals Tech. Dev. Co., Ltd., Beijing |
|
| C56 | Change in the name or address of the patentee | ||
| CP01 | Change in the name or title of a patent holder |
Address after: 225300 Taizhou City, Jiangsu Province medicine City Avenue, No. 1 Patentee after: WANQUAN WANTE PHARMACEUTICAL JIANGSU CO., LTD. Address before: 225300 Taizhou City, Jiangsu Province medicine City Avenue, No. 1 Patentee before: Aventis Pharmaceutical (Jiangsu) Co., Ltd. |