CN1742711A - Menantine hydrochloride effervescent tablet and preparing method thereof - Google Patents
Menantine hydrochloride effervescent tablet and preparing method thereof Download PDFInfo
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- CN1742711A CN1742711A CN 200510105342 CN200510105342A CN1742711A CN 1742711 A CN1742711 A CN 1742711A CN 200510105342 CN200510105342 CN 200510105342 CN 200510105342 A CN200510105342 A CN 200510105342A CN 1742711 A CN1742711 A CN 1742711A
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Abstract
The present invention relates to a memantine hydrochloride effervescent tablet for curing senile dementia and its preparation method. It is made up by using memantine hydrochloride as raw material and adding a certain auxiliary material according to conventional process.
Description
Technical field
The present invention relates to a kind of new medicinal preparation, particularly relate to Menantine hydrochloride effervescent tablet that is used for the treatment of the senile dementia disease and preparation method thereof.
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.The U.S. is used for the relevant research expenditure of senile dementia and is only second to AIDS and ranks second.It is reported that the sickness rate of U.S.'s degenerative brain disorder accounts for 10% in the old people of one's mid-60s, in the old people more than 85 years old, account for 47%, become No. four killer after heart disease, tumor and apoplexy.The cause of disease of primary disease is thrown a flood of light on as yet at present, is a thorny problem in the treatment always, brings white elephant for society, family and patient, brings great misery to the patient.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, is the nmda antagonist that a unique exploitation is used for Alzheimer.
The advantage of the existing granule of effervescent tablet has the characteristics of tablet again, be to be a kind of tablet that disintegrating agent is made with the effervescent material, in water, can produce a large amount of bubbles, and can dissolve in the short period of time, have that drug effect is rapid, bioavailability is high, convenient carrying, the patient who is specially adapted to child, old man and can not swallows solid preparation, so effervescent tablet has the dosage form novelty, the characteristics that market prospect is wide.
Memantine hydrochloride has conventional tablet and capsule, oral liquid by German Merz company's research and development and in Germany's listing.This product is just carried out the III phase in the U.S. and is clinically gone on the market in the U.S. in the hope of obtaining.Also do not have the dosage form listing of memantine at present on the domestic market, but mechanisms such as a lot of pharmaceutical factory, government department, scientific research institutions are carrying out the research work of this medicine.The Menantine hydrochloride effervescent tablet that the present invention relates to provides a kind of new instructions of taking, makes things convenient for patient to take.
Adopt the technology of the present invention that memantine is prepared into effervescent tablet, not only expanded the dosage form range of application of memantine, particularly through selection to the present invention's prescription, it is good to have obtained the sense of taste, disintegrate rapidly, absorb fast, taking convenience, can improve bioavailability of medicament and blood drug level, improve the novel formulation of drug effect, and preparation method is simple, is fit to large-scale production.
Summary of the invention
Menantine hydrochloride effervescent tablet provided by the invention contains memantine active ingredient and the excipient substance that is fit to make effervescent tablet, and wherein the percentage by weight of memantine is 0.2-20%, and the percentage by weight of adjuvant is 80-99.8%.Every of described Menantine hydrochloride effervescent tablet preferably contains memantine 2.5-25mg.
The present invention is through selecting, found the excipient substance of suitable Menantine hydrochloride effervescent tablet, described adjuvant comprises soda acid effervescent, disintegrating agent, filler, binding agent, coloring agent, lubricant, wherein the percentage by weight of soda acid effervescent is 15-97.5%, the percentage by weight of filler is 0-80%, the percentage by weight of disintegrating agent is 0-20%, the percentage by weight of binding agent is that the percentage by weight of 1-10%, correctives is 0.5-10%, the percentage by weight of coloring agent is 0.5-10%, and the percentage by weight of lubricant is 0.1-5%.
Acid source is selected from citric acid, tartaric acid, four mixture of one or more in acid, lysine, the arginine in the effervescent, and alkali source is selected from one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate; The molar ratio of acid source and alkali source is 3 in the soda acid effervescent: 1-1: 3.
Disintegrating agent is selected from one or more in carboxymethyl starch sodium, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, the sodium carboxymethyl cellulose;
Filler is selected from one or more of lactose, microcrystalline Cellulose, sucrose, sorbitol, mannitol, xylitol, erythritol, pregelatinized Starch, starch.
Binding agent is selected from a kind of or wherein several mixture in ethanol, water, ethanol-water solution, syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution;
Coloring agent is selected from a kind of or wherein several mixture in carotene, sunset yellow, carmine, the chlorophyll;
Correctives is selected from one or more the mixture in flavoring orange essence, Herba Menthae essence, grape essence, cherry essence, flavoring banana essence, flavoring pineapple essence, vanilla, Fructus Citri Limoniae essence, aspartame, saccharin sodium, the steviol glycosides.
Lubricant is selected from one or more the mixture among micropowder silica gel, magnesium stearate, calcium stearate, stearic acid, Pulvis Talci, silicon dioxide, sodium chloride, Stepanol MG, PEG4000, the PEG6000;
The invention provides the effervescent tablet of memantine, can adopt the mixed once pelletizing press sheet, method is: medicine and various adjuvant are pulverized, after crossing the 80-100 mesh sieve, mix homogeneously is with the water-ethanol system soft material that contains binding agent, granulate with the 12-24 mesh sieve, 40-80 ℃ dry 0.5-3 hour, 18-20 mesh sieve granulate, add other adjuvant mix homogeneously after tabletting get final product; Also can adopt soda acid to separate granulating tabletting process, method is: medicine and partial supplementary material (containing acid source) are pulverized, excessively behind the 80-100 mesh sieve; mix homogeneously; add adhesive system soft material, with the granulation of 12-24 mesh sieve, 40-80 ℃ dry 2-5 hour; 18-20 mesh sieve granulate; after containing the granule of alkali source with method preparation, two kinds of granule mix homogeneously, add other adjuvants after; regulate pressure, tabletting.
More than various operations be that those skilled in the art are in common knowledge and familiar.
The most preferred prescription composition of the present invention is listed among the embodiment.
The specific embodiment
Come Menantine hydrochloride effervescent tablet of the present invention done further specifying by following example, but be not limited in following example.
Embodiment 1:
Prescription:
Memantine 10g
Mannitol 25g
Citric acid 150g
Sodium bicarbonate 100g
Aspartame 2.5g
Sunset yellow 2.5g
Starch slurry 7g (with amylometer)
PEG6000 3g
Make 1000 altogether
Preparation method:
Earlier above-mentioned each material pulverize separately is crossed 100 mesh sieves, behind memantine, mannitol, the abundant mix homogeneously of citric acid, adding is mixed with an amount of starch slurry of coloring agent sunset yellow and makes soft material, 16 mesh sieves are granulated, 60 ℃ after dry 3-4 hour, 16 mesh sieve granulate, standby; Other gets sodium bicarbonate, adds surplus and is mixed with an amount of starch slurry of coloring agent sunset yellow and makes soft material, and 16 mesh sieves are granulated, 60 ℃ after dry 3-4 hour, 16 mesh sieve granulate, two kinds of granules mix, add other adjuvant mix homogeneously after, be pressed into Menantine hydrochloride effervescent tablet.
Embodiment 2:
Prescription:
Memantine 10g
Tartaric acid 320g
Sodium bicarbonate 220g
Crosslinked carboxymethyl fecula sodium 8g
Aspartame 10g
Fructus Citri Limoniae essence 8g
Carmine 7g
Pulvis Talci 7g
5%PVP-K30 anhydrous alcohol solution 6g (in PVP-K30)
Make 1000 altogether
Preparation method:
Earlier above-mentioned each material pulverize separately is crossed 100 mesh sieves, behind memantine, tartaric acid, sodium bicarbonate, the abundant mix homogeneously of crosslinked carboxymethyl fecula sodium, add an amount of 5%PVP-K30 anhydrous alcohol solution that contains the coloring agent carmine and make soft material, 16 mesh sieves are granulated, and 80 ℃ of dryings are after 1.5 hours, 16 mesh sieve granulate, outer correctives aspartame, the Fructus Citri Limoniae essence of adding, the lubricant Pulvis Talci behind the mixing, is pressed into Menantine hydrochloride effervescent tablet.
Embodiment 3:
Prescription:
Memantine 20g
Sucrose 56.5g
Citric acid 150g
Sodium bicarbonate 90g
Sodium carbonate 10g
Steviol glycosides 5g
Cherry essence 5g
Stepanol MG 5g
Sunset yellow 2.5g
5%PVP-K30 anhydrous alcohol solution 6g (in PVP-K30)
Make 1000 altogether
Preparation method:
Earlier above-mentioned each material pulverize separately is crossed 100 mesh sieves, behind memantine, sucrose, tartaric acid, sodium bicarbonate, the abundant mix homogeneously of sodium carbonate, add an amount of 5%PVP-K30 anhydrous alcohol solution that contains the coloring agent sunset yellow and make soft material, 16 mesh sieves are granulated, and 80 ℃ of dryings are after 1.5 hours, 16 mesh sieve granulate, outer correctives steviol glycosides, the cherry essence of adding, the lubricant Stepanol MG behind the mixing, is pressed into Menantine hydrochloride effervescent tablet.
Embodiment 4:
Prescription:
Memantine 10g
Lactose 95g
Citric acid 60g
Sodium bicarbonate 40g
Polyethylene glycol 6000 40g
Sodium chloride 5g
Fructus Citri Limoniae essence 5g
Aspartame 5g
Carotene 6g
5%PVP-K30 anhydrous alcohol solution 4g
Make 1000 altogether
Preparation method:
With after the polyethylene glycol 6000 water-bath fusion, add the sodium bicarbonate mix homogeneously earlier, drying under reduced pressure is pulverized, and crosses 100 mesh sieves, and is standby; Again all the other each material pulverize separately are crossed 100 mesh sieves, behind memantine, lactose, citric acid, the abundant mix homogeneously of above-mentioned polyethylene glycol 6000 sodium bicarbonate clathrate, add the 5%PVP-K30 anhydrous alcohol solution and make soft material, 24 mesh sieves are granulated, and 60 ℃ after dry 1-2 hour, 20 mesh sieve granulate, outer coloring agent carotene, correctives Fructus Citri Limoniae essence, aspartame, the lubricant sodium chloride of adding, behind the mixing, be pressed into Menantine hydrochloride effervescent tablet.
Embodiment 5
Prescription:
Memantine 10g
Tartaric acid 60g
Sodium bicarbonate 40g
Fructus Citri Limoniae essence 5g
Sunset yellow 2.5g
PEG6000 2.5g
Dehydrated alcohol is an amount of
Make 1000 altogether
Preparation method:
Earlier above-mentioned each material pulverize separately is crossed 100 mesh sieves, behind memantine, tartaric acid, sodium bicarbonate, the abundant mix homogeneously of Fructus Citri Limoniae essence, add the ethanol solution system soft material that contains sunset yellow, 24 mesh sieves are granulated, 60 ℃ of dryings are after 1.5 hours, and 20 mesh sieve granulate add PEG6000, regulate pressure, be pressed into Menantine hydrochloride effervescent tablet.
Claims (10)
1. a Menantine hydrochloride effervescent tablet is characterized in that, contains active ingredient memantine and the excipient substance that is fit to make effervescent tablet.
2. the effervescent tablet of claim 1 is characterized in that, wherein the percentage by weight of memantine is 0.2-20%, and the percentage by weight of adjuvant is 80-99.8%.Every of described Menantine hydrochloride effervescent tablet preferably contains memantine 2.5-25mg.
3. the effervescent tablet of claim 2, it is characterized in that, wherein said adjuvant is selected from soda acid effervescent, disintegrating agent, filler, binding agent, correctives, coloring agent, lubricant, wherein the percentage by weight of soda acid effervescent is 15-97.5%, the percentage by weight of filler is 0-80%, the percentage by weight of disintegrating agent is 0-20%, the percentage by weight of binding agent is that the percentage by weight of 1-10%, correctives is 0.5-10%, the percentage by weight of coloring agent is 0.5-10%, and the percentage by weight of lubricant is 0.1-5%.
4. the effervescent tablet of claim 4, it is characterized in that, acid source is selected from one or more the mixture in citric acid, tartaric acid, four caproic acids, lysine, the arginine in the effervescent wherein, and alkali source is selected from one or more mixture wherein such as sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate; Disintegrating agent is selected from one or more in carboxymethyl starch sodium, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, the sodium carboxymethyl cellulose; Filler wherein is selected from one or more of lactose, microcrystalline Cellulose, sucrose, sorbitol, mannitol, xylitol, erythritol, soluble starch, starch; Binding agent wherein is selected from a kind of or wherein several mixture in ethanol, water, ethanol-water solution, syrup, starch slurry, carboxymethylcellulose sodium solution, the povidone solution; Coloring agent wherein is selected from a kind of or wherein several mixture in carotene, sunset yellow, carmine, the chlorophyll; Lubricant wherein is selected from one or more the mixture among micropowder silica gel, magnesium stearate, calcium stearate, stearic acid, Pulvis Talci, silicon dioxide, sodium chloride, Stepanol MG, PEG4000, the PEG6000; Correctives is selected from one or more the mixture in flavoring orange essence, Herba Menthae essence, grape essence, cherry essence, flavoring banana essence, flavoring pineapple essence, vanilla, Fructus Citri Limoniae essence, aspartame, saccharin sodium, the steviol glycosides.The molar ratio of acid source and alkali source is 3 in the soda acid effervescent: 1-1: 3.
5. the effervescent tablet of claim 4 is characterized in that, in order to increase the stability of this product, can be in the middle of preparation process, adopt polymer to wrap up the alkali source material, mix with unclassified stores, described polymer can be selected PEG4000, PEG6000 or its mixture.
6. the effervescent tablet of claim 4 is characterized in that, its prescription consists of (1000)
Memantine 10g
Mannitol 25g
Citric acid 150g
Sodium bicarbonate 100g
A Sipa 2.5g
Sunset yellow 2.5g
Starch slurry 7g (with amylometer)
PEG6000 3g
7. the effervescent tablet of claim 4 is characterized in that, its prescription consists of (1000)
Memantine 10g
Tartaric acid 320g
Sodium bicarbonate 220g
Crosslinked carboxymethyl fecula sodium 8g
Aspartame 10g
Fructus Citri Limoniae essence 8g
Carmine 7g
Pulvis Talci 7g
5%PVP-K30 anhydrous alcohol solution 6g (in PVP-K30)
8. the effervescent tablet of claim 4 is characterized in that, its prescription consists of (1000)
Memantine 20g
Sucrose 62.5g
Citric acid 150g
Sodium bicarbonate 90g
Sodium carbonate 10g
Steviol glycosides 5g
Cherry essence 5g
Stepanol MG 5g
Sunset yellow 2.5g
5%PVP-K30 anhydrous alcohol solution 6g (in PVP-K30)
9. the effervescent tablet of claim 4 is characterized in that, its prescription consists of (1000)
Memantine 10g
Lactose 95g
Citric acid 60g
Sodium bicarbonate 40g
Polyethylene Glycol 40g
Sodium chloride 5g
Fructus Citri Limoniae essence 5g
Aspartame 5g
Carotene 6g
5%PVP-K30 anhydrous alcohol solution 4g
10. the preparation method of the effervescent tablet of claim 4, it is characterized in that, can adopt the mixed once pelletizing press sheet, method is: medicine and various adjuvant are pulverized, excessively behind the 80-100 sieve, mix homogeneously, with the water-ethanol system soft material that contains binding agent, granulate with the 12-24 mesh sieve, 40-80 ℃ dry 0.5-3 hour, 18-20 mesh sieve granulate, add other adjuvant mix homogeneously after tabletting get final product; Also can adopt soda acid to separate granulating tabletting process, method is: medicine and partial supplementary material (containing acid source) are pulverized, excessively behind the 80-100 mesh sieve; mix homogeneously; add adhesive system soft material, with the granulation of 12-24 mesh sieve, 40-80 ℃ dry 2-5 hour; 18-20 mesh sieve granulate; after containing the granule of alkali source with method preparation, two kinds of granule mix homogeneously, add other adjuvants after; regulate pressure, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510105342 CN1742711A (en) | 2005-09-23 | 2005-09-23 | Menantine hydrochloride effervescent tablet and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510105342 CN1742711A (en) | 2005-09-23 | 2005-09-23 | Menantine hydrochloride effervescent tablet and preparing method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1742711A true CN1742711A (en) | 2006-03-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200510105342 Pending CN1742711A (en) | 2005-09-23 | 2005-09-23 | Menantine hydrochloride effervescent tablet and preparing method thereof |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204378B (en) * | 2006-12-19 | 2010-09-01 | 北京德众万全药物技术开发有限公司 | Memantine hydrochloride oral medicine compound and its preparation method |
| CN102058480A (en) * | 2009-11-17 | 2011-05-18 | 天津天士力制药股份有限公司 | Oral effervescent tablet and preparation method thereof |
| CN101427756B (en) * | 2008-12-02 | 2013-05-08 | 宜昌一致魔芋生物科技有限公司 | Konjak dietary fiber effervescent tablet and method of producing the same |
| CN103347506A (en) * | 2010-10-12 | 2013-10-09 | 约翰.霍普金斯大学 | Antitussive composition comprising memantine |
| CN103356493A (en) * | 2012-04-10 | 2013-10-23 | 上海信谊百路达药业有限公司 | Preparation method of amlodipine besylate tablets |
| WO2014007775A1 (en) * | 2012-07-02 | 2014-01-09 | Mahmut Bilgic | A novel formulation having fast dissolution |
| CN106723029A (en) * | 2016-12-09 | 2017-05-31 | 宁夏五行科技有限公司 | A kind of health food and its preparation technology with auxiliary hyperglycemic function |
| CN106890155A (en) * | 2015-12-17 | 2017-06-27 | 重庆润泽医药有限公司 | It is a kind of（S）Oxo-1-pyrrolidine ethanamide effervescent tablet of -4- hydroxyls -2 and preparation method thereof |
| CN107319243A (en) * | 2017-07-26 | 2017-11-07 | 西华大学 | A kind of compound natural kudzu root flavone antihypertensive health care effervescent tablet and preparation method thereof |
-
2005
- 2005-09-23 CN CN 200510105342 patent/CN1742711A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101204378B (en) * | 2006-12-19 | 2010-09-01 | 北京德众万全药物技术开发有限公司 | Memantine hydrochloride oral medicine compound and its preparation method |
| CN101427756B (en) * | 2008-12-02 | 2013-05-08 | 宜昌一致魔芋生物科技有限公司 | Konjak dietary fiber effervescent tablet and method of producing the same |
| CN102058480A (en) * | 2009-11-17 | 2011-05-18 | 天津天士力制药股份有限公司 | Oral effervescent tablet and preparation method thereof |
| CN102058480B (en) * | 2009-11-17 | 2014-07-23 | 天士力制药集团股份有限公司 | Oral effervescent tablet and preparation method thereof |
| CN103347506A (en) * | 2010-10-12 | 2013-10-09 | 约翰.霍普金斯大学 | Antitussive composition comprising memantine |
| CN103356493A (en) * | 2012-04-10 | 2013-10-23 | 上海信谊百路达药业有限公司 | Preparation method of amlodipine besylate tablets |
| CN103356493B (en) * | 2012-04-10 | 2014-12-03 | 上海信谊百路达药业有限公司 | Preparation method of amlodipine besylate tablets |
| WO2014007775A1 (en) * | 2012-07-02 | 2014-01-09 | Mahmut Bilgic | A novel formulation having fast dissolution |
| CN106890155A (en) * | 2015-12-17 | 2017-06-27 | 重庆润泽医药有限公司 | It is a kind of（S）Oxo-1-pyrrolidine ethanamide effervescent tablet of -4- hydroxyls -2 and preparation method thereof |
| CN106890155B (en) * | 2015-12-17 | 2020-07-07 | 重庆润泽医药有限公司 | (S) -4-hydroxy-2 oxo-1-pyrrolidine acetamide effervescent tablet and preparation method thereof |
| CN106723029A (en) * | 2016-12-09 | 2017-05-31 | 宁夏五行科技有限公司 | A kind of health food and its preparation technology with auxiliary hyperglycemic function |
| CN107319243A (en) * | 2017-07-26 | 2017-11-07 | 西华大学 | A kind of compound natural kudzu root flavone antihypertensive health care effervescent tablet and preparation method thereof |
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Open date: 20060308 |