CN103919740A - Donepezil hydrochloride oral tablet - Google Patents
Donepezil hydrochloride oral tablet Download PDFInfo
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- CN103919740A CN103919740A CN201410110014.9A CN201410110014A CN103919740A CN 103919740 A CN103919740 A CN 103919740A CN 201410110014 A CN201410110014 A CN 201410110014A CN 103919740 A CN103919740 A CN 103919740A
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- Prior art keywords
- donepezil hydrochloride
- sheet according
- hydrochloride sheet
- agent
- acidifier
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Abstract
The invention provides a donepezil hydrochloride oral tablet, which comprises the following raw materials by weight: 10-50% of donepezil hydrochloride, 0.01-0.03% of anti-oxidant, 0.3-1.0% of acidifier, 70-90% of filler, 5-10% of disintegrating agent, 0.5-2.5% of adhesive, 0.5-1.0% of lubricant, and 0.5-1.0% of flow aid. The invention also comprises a method for preparing the tablet, by strictly controlling the moisture of the final product, amount of the anti-oxidant and the acidifier in the component is obviously reduced, the product stability is better and the security is higher.
Description
Invention field
The present invention relates to chemical pharmacy field, be specifically related to senile disease field, be i.e. a kind of medicine that is used for the treatment of senile dementia, particularly a kind of donepezil hydrochloride sheet for the treatment of slight or moderate Alzheimer 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.
CN101756917 discloses a kind of oral cavity disintegration tablet of donepezil hydrochloride.This oral cavity disintegration tablet or adopted the technique of powder coating, preparation process complexity, or do not solve the contradiction between easy hygroscopicity and the quality of oral cavity disintegration tablet.Donepezil hydrochloride hygroscopicity is strong, easily moisture absorption and go bad under normality, and finished product water content should not be too high.
As the common recognition of pharmaceutical industry, the height of preparation finished product water content is larger to the stability influence of medicine, and particularly degradation pathway is taking hydrolysis as main medicine, and moisture increase stability significantly declines.Therefore the moisture of controlling preparation finished product can improve the stability of donepezil hydrochloride.
Summary of the invention
What the present invention aimed to provide a kind of stable performance contains oral tablet of donepezil hydrochloride and preparation method thereof.
Although solve the problem of donepezil hydrochloride stability, can be by adding a large amount of antioxidants and Acidifier to solve, such as in humidity
temperature
under condition, dry moisture no longer reduces, and adds
acidifier,
antioxidant just can play good antioxidant effect, still, as the medicine of a long-term taking, the used in amounts of antioxidant and Acidifier will reduce to reduce possible carcinogenic risk.
For realizing the technical scheme that the object of the invention adopts be: controlling under the condition of moisture, the collaborative film property material that adopts is as binding agent, obtain better stablizing effect, and greatly reduced the consumption of antioxidant, Acidifier, guaranteed the safety of product.
On the one hand, the invention provides a kind of donepezil hydrochloride sheet, it is composed of the following components by weight percentage:
Donepezil hydrochloride 1-5%
Antioxidant
Acidifier
Filler
Disintegrating agent
Binding agent
Lubricant
Fluidizer 0.5～1.0%.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described antioxidant is BHA or tert-butyl group methylphenol.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described Acidifier is tartaric acid or citric acid.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described filler is selected from one or more in microcrystalline Cellulose, pregelatinized Starch, lactose, mannitol and starch.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described lubricant is
Magnesium stearate.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described fluidizer is
Silicon dioxide.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, described binding agent is No. IV, polyacrylic resin or hydroxypropyl emthylcellulose.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, wherein, ethanol in binding agent
With the volume ratio of water be 75%.
Some embodiments therein, donepezil hydrochloride sheet of the present invention, it is made up of following component:
Donepezil hydrochloride 5g
BHA 0.01g
Tartaric acid 1g
Lactose 50g
Mannitol 50g
Low-substituted hydroxypropyl cellulose 2g
Polyacrylic resin IV 1g
Magnesium stearate 0.5g
Silicon dioxide 0.5g
Make 1000.
On the other hand, the present invention relates to a kind of preparation method of donepezil hydrochloride sheet of the present invention, concrete step is as follows: (1) pulverized and sieved 80 orders after donepezil hydrochloride is mixed with filler, disintegrating agent; (2) binding agent of preparation recipe quantity, adds antioxidant and Acidifier in bonding agent and dissolves simultaneously; (3) add the bonding agent having prepared in the material being pulverized and mixed, granulate with 30 order nylon screens, adopt ebullated bed to be dried, control air intake humidity
inlet temperature
be controlled at 45 minutes drying time, adopt Infrared Heating fast tester for water content to measure, control pellet moisture and exist
in scope; (4) by 20 order nylon screen granulate for above-mentioned steps (3) dried particles, then add the lubricant of recipe quantity, additional disintegrating agent, fluidizer, mix equal Uniform, according to granule content tabletting and get final product.
Compared with prior art, the present invention has following advantage:
Preparation method provided by the present invention, adopts simple wet granulation technology, simple to operate, is convenient to large production operation, and product of the present invention is due to good stability, has saved coating operation sequence, has saved the cost of coating.
The present invention controls by air intake humidity dry, and drying time is short, can reduce to greatest extent the tire loss of donepezil hydrochloride in technique preparation process.
Adjuvant of the present invention is very stable, they are in storage period moisture absorption hardly, can ensure that product is in storage period moisture stabilization, reduce moisture and change the impact on donepezil hydrochloride, simultaneously No. IV, polyacrylic resin of the present invention is as binding agent, due to polyacrylic resin hydrophobicity, can well completely cut off the impact of moisture on medicine, therefore stability is better with respect to like product.
Preparation technology provided by the present invention, reduced the use amount of Acidifier and antioxidant in prescription, when having ensured donepezil hydrochloride stability, improved patient and take the compliance of this product, and safety is higher.
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 FMC Corporation 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.
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 5g
BHA 0.01g
Tartaric acid 1g
Lactose 50g
Mannitol 50g
Low-substituted hydroxypropyl cellulose 2g
Polyacrylic resin IV 1g
Magnesium stearate 0.5g
Silicon dioxide 0.5g
Make 1000.
Preparation method:
(1) after being mixed with filler, disintegrating agent, donepezil hydrochloride pulverized and sieved 80 orders;
(2) binding agent of preparation recipe quantity, adds antioxidant and Acidifier in bonding agent and dissolves simultaneously;
(3) add the bonding agent having prepared in the material being pulverized and mixed, granulate with 30 order nylon screens, adopt ebullated bed to be dried, control air intake humidity
inlet temperature
be controlled at 45 minutes drying time, adopt Infrared Heating fast tester for water content to measure, control pellet moisture and exist
in scope;
(4) by 20 order nylon screen granulate for above-mentioned steps (3) dried particles, then add the lubricant of recipe quantity, additional disintegrating agent, fluidizer, mix equal Uniform, according to granule content tabletting and get final product.
Make donepezil hydrochloride sheet moisture Control 1.0～1.35%.
Embodiment 2
Donepezil hydrochloride 5g
Tert-butyl group methylphenol 0.01g
Tartaric acid 1g
Lactose 60g
Mannitol 45g
Low-substituted hydroxypropyl cellulose 2g
Polyacrylic resin IV 1g
Magnesium stearate 0.75g
Silicon dioxide 0.25g
Make 1000.
Preparation method:
(1) after being mixed with filler, disintegrating agent, donepezil hydrochloride pulverized and sieved 80 orders;
(2) binding agent of preparation recipe quantity, adds antioxidant and Acidifier in bonding agent and dissolves simultaneously;
(3) add the bonding agent having prepared in the material being pulverized and mixed, granulate with 30 order nylon screens, adopt ebullated bed to be dried, control air intake humidity
inlet temperature
be controlled at 45 minutes drying time, adopt Infrared Heating fast tester for water content to measure, control pellet moisture and exist
in scope;
(4) by 20 order nylon screen granulate for above-mentioned steps (3) dried particles, then add the lubricant of recipe quantity, additional disintegrating agent, fluidizer, mix equal Uniform, according to granule content tabletting and get final product.
Make donepezil hydrochloride sheet moisture Control 1.3～1.6%.
Embodiment 3
Donepezil hydrochloride 5g
Tert-butyl group methylphenol 0.01g
Citric acid 1g
Lactose 50g
Mannitol 45g
Low-substituted hydroxypropyl cellulose 2.5g
Hydroxypropyl emthylcellulose 2g
Magnesium stearate 0.5g
Silicon dioxide 0.5g
Make 1000.
Preparation method, with embodiment 1, makes donepezil hydrochloride sheet moisture Control 1.25～1.4%.
Embodiment 4
Donepezil hydrochloride 5g
BHA 0.02g
Citric acid 1g
Lactose 50g
Mannitol 50g
Low-substituted hydroxypropyl cellulose 2.5g
Hydroxypropyl emthylcellulose 2g
Magnesium stearate 0.35g
Silicon dioxide 0.5g
Make 1000.
Preparation method, with embodiment 1, makes donepezil hydrochloride sheet moisture Control 1.2～1.4%.
Embodiment 5
Donepezil hydrochloride 5g
BHA 0.01g
Citric acid 1g
Lactose 50g
Mannitol 50g
Low-substituted hydroxypropyl cellulose 2.5g
Sodium Hydroxymethyl Stalcs 1.5g
Hydroxypropyl emthylcellulose 1g
Magnesium stearate 0.5g
Silicon dioxide 0.5g
Make 1000.
Preparation method, with embodiment 1, makes donepezil hydrochloride sheet moisture Control 1.0～1.35%.
Embodiment 6
Donepezil hydrochloride 5g
BHA 0.01g
Malic acid 1g
Lactose 60g
Mannitol 45g
Low-substituted hydroxypropyl cellulose 1.5g
Polyacrylic resin IV 1g
Magnesium stearate 0.5g
Silicon dioxide 0.65g
Make 1000.
Preparation method:
(1) after being mixed with filler, disintegrating agent, donepezil hydrochloride pulverized and sieved 80 orders;
(2) binding agent of preparation recipe quantity, adds antioxidant and Acidifier in bonding agent and dissolves simultaneously;
(3) add the bonding agent having prepared in the material being pulverized and mixed, granulate with 30 order nylon screens, adopt ebullated bed to be dried, control air intake humidity
inlet temperature
be controlled at 45 minutes drying time, adopt Infrared Heating fast tester for water content to measure, control pellet moisture and exist
in scope;
(4) by 20 order nylon screen granulate for above-mentioned steps (3) dried particles, then add the lubricant of recipe quantity, additional disintegrating agent, fluidizer, mix equal Uniform, according to granule content tabletting and get final product.
Make donepezil hydrochloride sheet moisture Control 1.2～1.5%.
Biological test
The embodiment of the present invention
sample, with existing listing sample, i.e. reference reagent (aricept, defend material pharmacy, specification: 5mg) carry out contrast experiment, put into 40 DEG C, 75% humidity accelerated test case, respectively at 0 month, January, February, March, sampling in June, adopt 2010 editions standards of pharmacopoeia detection level, result is as follows:
Six months accelerated test testing results (content, %) of table 1 donepezil hydrochloride sheet
| Embodiment | 0 month | January | February | March | June |
| Embodiment 1 | 100.68 | 100.47 | 100.36 | 100.12 | 100.01 |
| Embodiment 2 | 101.22 | 101.13 | 101.01 | 100.78 | 100.24 |
| Embodiment 3 | 100.76 | 100.53 | 100.42 | 100.20 | 100.00 |
| Embodiment 4 | 100.49 | 100.36 | 100.25 | 100.08 | 99.99 |
| Embodiment 5 | 101.12 | 101.95 | 100.87 | 100.65 | 100.20 |
| Embodiment 6 | 101.15 | 101.10 | 100.87 | 100.58 | 100.13 |
| Reference reagent | 101.18 | 100.06 | 98.86 | 96.45 | 93.40 |
As can be seen from the results, the product that the present invention develops in the accelerated test of 6 months content without obvious decline, conformance with standard, listing product decline obviously, the product stability that therefore the present invention develops is better.
Claims (10)
1. a donepezil hydrochloride sheet, it is composed of the following components by weight percentage:
Donepezil hydrochloride 1-5%
Antioxidant
Acidifier
Filler
Disintegrating agent
Binding agent
Lubricant
Fluidizer 0.5～1.0%.
2. donepezil hydrochloride sheet according to claim 1, wherein, described antioxidant is BHA or tert-butyl group methylphenol.
3. donepezil hydrochloride sheet according to claim 1, wherein, described Acidifier is tartaric acid, citric acid or malic acid.
4. donepezil hydrochloride sheet according to claim 1, wherein, described filler is selected from one or more in microcrystalline Cellulose, pregelatinized Starch, lactose, mannitol and starch.
5. donepezil hydrochloride sheet according to claim 1, wherein, described disintegrating agent is selected from one or more in low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium.
6. donepezil hydrochloride sheet according to claim 1, wherein, described lubricant is magnesium stearate.
7. donepezil hydrochloride sheet according to claim 1, wherein, described fluidizer is silicon dioxide.
8. donepezil hydrochloride sheet according to claim 1, wherein, described binding agent is No. IV, polyacrylic resin or hydroxypropyl emthylcellulose.
9. donepezil hydrochloride sheet according to claim 8, wherein, in binding agent, the volume ratio of ethanol and water is 75%.
10. according to the donepezil hydrochloride sheet described in claim 1-8 any one, it is made up of following component:
Donepezil hydrochloride 5g
BHA 0.01g
Tartaric acid 1g
Lactose 50g
Mannitol 50g
Low-substituted hydroxypropyl cellulose 2g
Polyacrylic resin IV 1g
Magnesium stearate 0.5g
Silicon dioxide 0.5g
Make 1000.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410110014.9A CN103919740A (en) | 2014-03-24 | 2014-03-24 | Donepezil hydrochloride oral tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410110014.9A CN103919740A (en) | 2014-03-24 | 2014-03-24 | Donepezil hydrochloride oral tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103919740A true CN103919740A (en) | 2014-07-16 |
Family
ID=51138291
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410110014.9A Pending CN103919740A (en) | 2014-03-24 | 2014-03-24 | Donepezil hydrochloride oral tablet |
Country Status (1)
| Country | Link |
|---|---|
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Cited By (1)
| 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 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480378A (en) * | 2008-01-09 | 2009-07-15 | 浙江华海药业股份有限公司 | Solid preparation of Donepezil hydrochloride and technique for preparing the same |
| CN102091050A (en) * | 2011-01-31 | 2011-06-15 | 重庆科瑞制药有限责任公司 | Stable simvastatin oral tablet and preparation method thereof |
| US20110218216A1 (en) * | 2010-01-29 | 2011-09-08 | Kumaravel Vivek | Extended release pharmaceutical composition of donepezil |
-
2014
- 2014-03-24 CN CN201410110014.9A patent/CN103919740A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101480378A (en) * | 2008-01-09 | 2009-07-15 | 浙江华海药业股份有限公司 | Solid preparation of Donepezil hydrochloride and technique for preparing the same |
| US20110218216A1 (en) * | 2010-01-29 | 2011-09-08 | Kumaravel Vivek | Extended release pharmaceutical composition of donepezil |
| CN102091050A (en) * | 2011-01-31 | 2011-06-15 | 重庆科瑞制药有限责任公司 | Stable simvastatin oral tablet and preparation method thereof |
Cited By (1)
| 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 |
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Application publication date: 20140716 |