CN103877046A - Donepezil hydrochloride dispersible tablet and preparation method thereof - Google Patents
Donepezil hydrochloride dispersible tablet and preparation method thereof Download PDFInfo
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- CN103877046A CN103877046A CN201410109709.5A CN201410109709A CN103877046A CN 103877046 A CN103877046 A CN 103877046A CN 201410109709 A CN201410109709 A CN 201410109709A CN 103877046 A CN103877046 A CN 103877046A
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- donepezil hydrochloride
- dispersible tablet
- hydrochloride dispersible
- disintegrating agent
- sodium
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Abstract
The invention relates to a donepezil hydrochloride dispersible tablet and a preparation method thereof, and belongs to the technical field of medicines. The donepezil hydrochloride dispersible tablet comprises the following components in percentage by weight: 1-5 percent of donepezil hydrochloride, 40-90 percent of disintegrating agent, 1-15 percent of lubricant and glidant and 1-15 percent of adhesive. The preparation method comprises the following steps: screening the components; uniformly mixing the donepezil hydrochloride and the disintegrating agent; adding the adhesive to prepare a soft material; granulating, baking and straightening granulating; adding the disintegrating agent, the lubricant and the glidant, and uniformly mixing; determining tablet weight, and tabletting to obtain the oxycodone hydrochloride dispersible tablet. The medicine is mainly used for treating senile dementia, especially mild or moderate alzheimer disease in clinical application, has stable quality, is beneficial to drug dissolution and absorption, is quick in response and convenient to take, can be taken orally after being dispersed with water, and also can be sucked in the mouth or swallowed.
Description
Invention field
The present invention relates to chemical pharmacy field, be specifically related to senile disease field, relate to a kind of donepezil hydrochloride dispersible tablet and preparation method thereof, described donepezil hydrochloride dispersible tablet can be used for treatment slightly or moderate Alzheimer's disease.
Background of invention
Aging trend allows patients with Alzheimer disease quantity increase, and China will enter aging society, and the sickness rate of a very important problem-AD of simultaneous is increasing year by year.Investigation is found: northern China suffer from mean age of AD be 75,76 years old, the ratio of suffering from AD in over-65s crowd reaches more than 15%.AD patient's activity of daily living declines, and they are not familiar with spouse, children, wears the clothes, has a meal, defecation all can not take care of oneself, the inconvenience of particularly taking medicine; The auditory hallucination hallucination in addition having, brings endless misery and worried to people own and around.Patient's AD mean survival time (MST) is 5.5 years, and AD disease, after cardiovascular diseases, cerebrovascular and cancer, has become " the fourth-largest killer " of aged health.
Donepezil hydrochloride (Donepezil Hydrochloride) is the cholinesterase inhibitor (AChEI) of second filial generation treatment Alzheimer, strong to neuron acetylcholinesterase selectivity, it increases animal brain acetyl choline content by suppressing acetylcholine esterase, acetyl choline content in making to participate in directly between the synapse of neurotransmission increases, produce therapeutic effect, can improve learning disorder. the acetylcholinesterase of heart and intestinal is not almost had to inhibitory action, therefore selectivity is strong, long action time, side effect is little, without features such as hepatotoxicities. be the comparatively desirable medicine for the treatment of senilism type dementia.
Through clinical verification for many years, donepezil hydrochloride is mainly used in treating senile dementia disease, and effect is remarkable.As capsule and the tablet of oral formulations, because it is taken and carry for convenience of more welcome by consumers in general.But the oral formulations of listing is that the ability disintegrate in 40 minutes of donepezil hydrochloride conventional tablet is complete at present, is unfavorable for that drug-eluting absorbs.
The invention provides a kind of new donepezil hydrochloride dispersible tablet, stable and controllable for quality, disintegration rate is fast, and bioavailability is high, rapid-action, and production technology is simple.
Summary of the invention
The invention provides a kind of new donepezil hydrochloride dispersible tablet and preparation method thereof, be mainly used in treating senile dementia, particularly slight or moderate Alzheimer disease, processing technology is simple, and the quality of the pharmaceutical preparations is reliable and stable.
On the one hand, the invention provides a kind of donepezil hydrochloride dispersible tablet, the component that it comprises following percentage by weight:
Donepezil hydrochloride 1～5%
Disintegrating agent 40～90%
Lubricant and fluidizer 1～15%
Binding agent 1～15%.
Some embodiments therein, donepezil hydrochloride dispersible tablet of the present invention, wherein, described disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, silica sol.
Some embodiments therein, donepezil hydrochloride dispersible tablet of the present invention, wherein, described lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, hydrated sodium aluminosilicate.
Some embodiments therein, donepezil hydrochloride dispersible tablet of the present invention, wherein, described binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, mucialga of arabic gummy.
Some embodiments therein, donepezil hydrochloride dispersible tablet of the present invention, the component that it comprises following percentage by weight:
On the other hand, the present invention relates to a kind of preparation method of donepezil hydrochloride dispersible tablet of the present invention, it comprises following steps:
(1) donepezil hydrochloride, adjuvant are crossed respectively to 100 mesh sieves, for subsequent use;
(2) take disintegrating agent by recipe quantity, add the donepezil hydrochloride of recipe quantity, mix homogeneously;
(3) add binding agent to be mixed and made into soft material, granulate with 18-24 mesh sieve, granule is dried under 50-80 DEG C of condition;
(4) after granule is dried, 20 mesh sieve granulate;
(5) add disintegrating agent, lubricant and fluidizer to mix;
(6) sample examination, in mensuration granule, the content of donepezil hydrochloride, determines sheet weight, tabletting, obtains donepezil hydrochloride dispersible tablet.
Excipient of the present invention comprises, but be not limited to, ion-exchanger, aluminum, aluminium stearate, lecithin, serum albumin, as human albumin, buffer substance is as phosphate, glycine, sorbic acid, potassium sorbate, the partial glycerol ester admixture of saturated vegetable fatty acid, water, salt or electrolyte, as protamine sulfate, sodium hydrogen phosphate, potassium hydrogen phosphate, sodium chloride, zinc salt, colloid silicon, magnesium trisilicate, polyvinylpyrrolidone, polyacrylate, wax, polyethylene-polyoxypropylene-blocking-up polymer, lanoline, sugar, as lactose, dextrose plus saccharose, starch is as corn starch and potato starch, the derivant of cellulose and it is as sodium carboxymethyl cellulose, ethyl cellulose and cellulose acetate, natural gum powder, Fructus Hordei Germinatus, gelatin, Pulvis Talci, adjuvant is as cocoa butter and suppository wax, oily as Oleum Arachidis hypogaeae semen, Oleum Gossypii semen, safflower oil, Oleum Sesami, olive oil, Semen Maydis oil and Oleum Glycines, glycols compound, as propylene glycol and Polyethylene Glycol, esters is as ethyl oleate and ethyl laurate, agar, buffer agent is as magnesium hydroxide and aluminium hydroxide, alginic acid, pyrogen-free water, Deng oozing salt, Lin Ge (family name) solution, ethanol, phosphate buffer solution, and other nontoxic proper lubrication agent are as sodium laurylsulfate and magnesium stearate, coloring agent, releasing agent, coating dress material, sweeting agent, flavoring agent and spice, antiseptic and antioxidant.
Pharmaceutical composition of the present invention can also optionally contain one or more diluent.The example of diluent comprises mannitol, sorbitol, biphosphate calcium dihydrate, microcrystalline Cellulose and efflorescence cellulose.Preferred diluent is microcrystalline Cellulose.Microcrystalline Cellulose can be obtained from several suppliers, comprises Avicel PH101, Avicel PH102, Avicel PH103, Avicel PH105 and Avicel PH200 that FMCCorporation manufactures.
Pharmaceutical composition of the present invention can also optionally contain disintegrating agent.Disintegrating agent can be the one in several modified starches, modified cellulose polymer or polycarboxylic acids, such as crosslinked Carboxymethyl cellulose sodium, Explotab, polacrilin potassium and calcium carboxymethylcellulose (CMCCalcium).In one embodiment, disintegrating agent is croscarmellose sodium.Croscarmellose sodium NF type A obtains with trade name " Ac-di-sol " on market.
Pharmaceutical composition of the present invention can also optionally contain one or more surfactants or wetting agent.Surfactant can be anion, cation or neutral surface active agent.Anion surfactant comprises sodium lauryl sulfate, dodecyl sodium sulfate, oleyl sodium sulfate and the sodium laurate mixing with stearate and Talcum.Cationic surfactant comprises benzalkonium chloride and alkyl trimethyl ammonium bromide.Neutral surface active agent comprises glycerol list olein, polyoxyethylene sorbitan fatty acid ester, polyvinyl alcohol and anhydro sorbitol fat.The embodiment of wetting agent comprises poloxamer, polyoxyethylene alkyl ether, castor oil derivatives and polyoxyethylene 8 stearate fat.
The present invention can also optionally join antioxidant in preparation, thereby gives its chemical stability.Antioxidant is selected from the extract of a-tocopherol, Y-tocopherol, S-tocopherol, tocopherol enrichment natural origin, sodium or calcium salt, the Vitamin C acyl cetylate of L-AA and it, amass wealth by heavy taxation propyl propionate, amass wealth by heavy taxation misery ester, amass wealth by heavy taxation sour dodecyl ester, Yoshinox BHT (BHT) and butylated hydroxyanisol (BHA).In one embodiment, antioxidant is BHT or BHA.
The preferred dosage form of drug composition of the present invention is the tablet of preparing by compression method.Described tablet can carry out film with the mixture such as hydroxypropyl cellulose and hydroxypropyl emthylcellulose, contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian in this mixture; The mixture of polyvinyl alcohol (PVA) and Polyethylene Glycol (PEG), contains titanium dioxide and/or other coloring agent, such as ferrum oxide, dyestuff and Se Dian; Or any other suitable instant-free coating agent.Coating provides taste masked and other stability to final tablet.What commercially available film provided for Colorcon is preparation mixture of powders
.
The present invention can also add sweeting agent and/or fumet.
Compared with prior art, excellent results of the present invention is as follows:
(1) donepezil hydrochloride dispersible tablet is made up of medicine and disintegrating agent and good excipient, therefore its in 2 minutes rapidly disintegrate be uniformly dispersed, oral after promptly disintegrate become homodisperse fine particle, be conducive to drug-eluting and absorb.
(2) taking convenience, donepezil hydrochloride dispersible tablet can add aqueous dispersion deutostoma clothes, also can be contained in mouth and suck and take or swallow, and takes more convenient.
(3) donepezil hydrochloride dispersible tablet has improved the stability of medicine, has ensured the quality of medicine, has extended the storage period of medicine.Sample keeps sample 6 months through accelerated test 6 months and room temperature, and significant change does not all occur for its character, dispersing uniformity, content and microorganism project, meets quality standard regulation.This product shows through the accelerated test investigation result of 6 months: indices is all stable.
The donepezil hydrochloride dispersible tablet being made by said method all complies with relevant regulations in inspection aspect content, weight differential, stripping, disintegration, dispersing uniformity.This product can add aqueous dispersion deutostoma clothes, also can be contained in mouth and suck and take or swallow.Can be used for treating senile dementia disease.
Detailed description of the invention
Further explain the present invention below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1: donepezil hydrochloride dispersible tablet, component is as follows:
Preparation method is as follows:
(1) first donepezil hydrochloride, starch, microcrystalline Cellulose are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, microcrystalline Cellulose, mix homogeneously by prescription.Add the donepezil hydrochloride of recipe quantity, mix homogeneously, adds binding agent 1% hypromellose aqueous solution soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add cross-linking sodium carboxymethyl cellulose, magnesium stearate, silicon dioxide to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 2: donepezil hydrochloride dispersible tablet, component is as follows:
Preparation method is as follows:
(1) first donepezil hydrochloride, starch, microcrystalline Cellulose are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, microcrystalline Cellulose, mix homogeneously by prescription.Add the donepezil hydrochloride of recipe quantity, mix homogeneously, adds polyvinyl pyrrolidone soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
In 37 DEG C of water, in 2 minutes, all disintegrate, also by No. 2 screen clothes, meets the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 3: donepezil hydrochloride dispersible tablet, component is as follows:
Preparation method is as follows:
(1) first donepezil hydrochloride, starch are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch by prescription, add the donepezil hydrochloride of recipe quantity, mix homogeneously, adds binding agent 5% starch slurry soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add polyvinylpolypyrrolidone, magnesium stearate to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Embodiment 4: donepezil hydrochloride dispersible tablet, component is as follows:
Preparation method is as follows:
(1) first donepezil hydrochloride, starch, carboxymethyl starch sodium are crossed respectively to 100 mesh sieves, for subsequent use.
(2) take starch, carboxymethyl starch sodium, mix homogeneously by prescription.Add the donepezil hydrochloride of recipe quantity, mix homogeneously, adds binding agent 1% hypromellose aqueous solution soft material processed, and 20 mesh sieves are granulated, and in 50-60 DEG C of oven dry, 20 mesh sieve granulate, add low-substituted hydroxypropyl cellulose and magnesium stearate to mix.
(3) sample examination granule content, according to measured granule content, calculates sheet weight, tabletting.
(4) the full review of sampling, packs to obtain finished product after qualified.
Disintegration is all disintegrates by No. 2 screen clothes in 2 minutes in 37 DEG C of water, meet the pharmacopeia annex dispersible tablet regulation of disintegration.
Biological activity test
3 batches of following three kinds of tests are embodiment 1 formulation and technology and prepare.
(1) table 1 is dissolution (%) comparative result of donepezil hydrochloride dispersible tablet and commercially available donepezil hydrochloride ordinary tablet (defending material pharmacy, 5mg/ sheet).
With reference to dissolution method (2010 editions two annex XC bis-methods of Chinese Pharmacopoeia).
Ordinary tablet cumulative percentage dissolution (%) is sold relatively in table 1 donepezil hydrochloride dispersible tablet and market
As can be seen from Table 1, the dissolution in vitro of donepezil hydrochloride dispersible tablet in 10-30min is obviously better than ordinary tablet.
(2) donepezil hydrochloride dispersible tablet assay
Measure with reference to high-efficient liquid phase technique (two annex VD of Chinese Pharmacopoeia version in 2010).
Table 2 donepezil hydrochloride dispersible tablet assay
| Batch | Donepezil hydrochloride dispersible tablet content (%) |
| Batch 1 | 100.24 |
| Batches 2 | 100.25 |
| Batches 3 | 100.30 |
As can be seen from Table 2, the content of the donepezil hydrochloride dispersible tablet requirement that conforms with the regulations.
(3) the quality stability comparison of donepezil hydrochloride dispersible tablet
Donepezil hydrochloride dispersible tablet accelerated test: the donepezil hydrochloride dispersible tablet of blister package is put under 2 DEG C of 40 DEG C of scholars of temperature, relative humidity 75% scholar's 5% condition and placed six months, outcome quality is stable, and indices is as shown in table 3.
Six months accelerated test testing results of table 3 donepezil hydrochloride dispersible tablet
| Inspection batch | Outward appearance | Disintegration/s | Dispersing uniformity | Dissolution % | Content % |
| Batch 1 | White is smooth | 37 | Conform with the regulations | 100.35 | 100.28 |
| Batches 2 | White is smooth | 38 | Conform with the regulations | 100.40 | 100.26 |
| Batches 3 | White is smooth | 38 | Conform with the regulations | 100.38 | 100.30 |
Claims (6)
1. a donepezil hydrochloride dispersible tablet, the component that it comprises following percentage by weight:
Donepezil hydrochloride 1～5%
Disintegrating agent 40～90%
Lubricant and fluidizer 1～15%
Binding agent 1～15%.
2. donepezil hydrochloride dispersible tablet according to claim 1, wherein, described disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, silica sol.
3. donepezil hydrochloride dispersible tablet according to claim 1, wherein, described lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, hydrated sodium aluminosilicate.
4. donepezil hydrochloride dispersible tablet according to claim 1, wherein, described binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, mucialga of arabic gummy.
5. according to the donepezil hydrochloride dispersible tablet described in claim 1-4 any one, the component that it comprises following percentage by weight:
6. a preparation method for donepezil hydrochloride dispersible tablet claimed in claim 1, it comprises following steps:
(1) donepezil hydrochloride, adjuvant are crossed respectively to 100 mesh sieves, for subsequent use;
(2) take disintegrating agent by recipe quantity, add the donepezil hydrochloride of recipe quantity, mix homogeneously;
(3) add binding agent to be mixed and made into soft material, granulate with 18-24 mesh sieve, granule is dried under 50-80 DEG C of condition;
(4) after granule is dried, 20 mesh sieve granulate;
(5) add disintegrating agent, lubricant and fluidizer to mix;
(6) sample examination, in mensuration granule, the content of donepezil hydrochloride, determines sheet weight, tabletting, obtains donepezil hydrochloride dispersible tablet.
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| CN201410109709.5A CN103877046A (en) | 2014-03-24 | 2014-03-24 | Donepezil hydrochloride dispersible tablet and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106727371A (en) * | 2016-12-08 | 2017-05-31 | 江苏豪森药业集团有限公司 | Doneppezil Hydrochloride pharmaceutical composition and preparation method thereof |
| CN107789328A (en) * | 2016-09-07 | 2018-03-13 | 成都康弘药业集团股份有限公司 | A kind of oral disintegrating tablet containing Doneppezil Hydrochloride and preparation method thereof |
| 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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| CN1557306A (en) * | 2004-01-15 | 2004-12-29 | 肖广常 | Flavescent sophora root essence dispersion tablet |
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2014
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1557306A (en) * | 2004-01-15 | 2004-12-29 | 肖广常 | Flavescent sophora root essence dispersion tablet |
Non-Patent Citations (1)
| Title |
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| 杨曦亮等: "盐酸多奈哌齐分散片的溶出度含量测定", 《亚太传统医药》, vol. 5, no. 2, 28 February 2009 (2009-02-28), pages 53 - 55 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107789328A (en) * | 2016-09-07 | 2018-03-13 | 成都康弘药业集团股份有限公司 | A kind of oral disintegrating tablet containing Doneppezil Hydrochloride and preparation method thereof |
| CN107789328B (en) * | 2016-09-07 | 2021-02-26 | 成都康弘药业集团股份有限公司 | Orally disintegrating tablet containing donepezil hydrochloride and preparation method thereof |
| KR20180036579A (en) * | 2016-09-30 | 2018-04-09 | 주식회사 바이오파마티스 | Composition comprising complex for prevention and treatment of dementia and cognitive impairment |
| KR101938872B1 (en) | 2016-09-30 | 2019-01-16 | 주식회사 바이오파마티스 | Composition comprising complex for prevention and treatment of dementia and cognitive impairment |
| CN106727371A (en) * | 2016-12-08 | 2017-05-31 | 江苏豪森药业集团有限公司 | Doneppezil Hydrochloride pharmaceutical composition and preparation method thereof |
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Application publication date: 20140625 |