CN105030714A - Aniracetam sustained release tablet and preparation method thereof - Google Patents
Aniracetam sustained release tablet and preparation method thereof Download PDFInfo
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- CN105030714A CN105030714A CN201510390021.3A CN201510390021A CN105030714A CN 105030714 A CN105030714 A CN 105030714A CN 201510390021 A CN201510390021 A CN 201510390021A CN 105030714 A CN105030714 A CN 105030714A
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- releasing
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- aniracetam
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Abstract
The invention discloses an aniracetam sustained release tablet and a preparation method thereof, and belongs to the technical field of medicines. The aniracetam sustained release tablet comprises, by weight, 40-80 parts of aniracetam, 5-40 parts of a sustained release skeletal material, 0.5-5 parts of a lubricant, 1-20 parts of a pore forming agent, 1-10 parts of a flow aid and 1-10 parts of an adhesive. The aniracetam sustained release tablet stably releases, releases 25-40% in 1h, releases 55-80% in 4h, and releases above 80% in 8h. The aniracetam sustained release tablet has small side effects on stomach and intestine, and an aniracetam raw material is wrapped by a sodium alginate/attapulgitecompound, and the method effectively controls release of aniracetam and reduces irritation of medicines to the gastrointestinal tract. The method is simple to operate, is suitable for large-scale industrial production, and has large application values.
Description
Technical field
The invention belongs to technical field of pharmaceuticals, particularly a kind of slow-releasing Anixitan tablet and preparation method thereof.
Background technology
Senile dementia is a kind of chronic degenerative brain neuroblastoma systemic disease, and the memory of patient can be caused to decline, and the abilities such as study, understanding, judgement decline.There is no the process that medicine can stop senile dementia at present, but there are some medicines can improve some symptom of disease, delay advancing of disease process, thus reach the effect improved and promote quality of life, such as aniracetam, Ta Kening, donepezil, huperzine A etc.
China enters aging society, and within current more than 60 years old, population is 1.2 hundred million, accounts for more than 10% of country's total population, wherein 20% has dementia symptom in more than 80 years old crowd.Current China has dementia more than 500 ten thousand, expects 2025, and China's more than 60 years old population will account for more than 20% of total population.Along with increasing of the aged, senile dementia brings heavy society and economic pressures by us.Senile dementia, as the common mental sickness of old people, is brought huge health services pressure to government, society and patient home, is caused extensive concern.It is introduced, compared with developed countries, the difficult problem that we face is: China's large population base, imply that old dementia patients is by large contingent.China just enters aging society in underdeveloped, the still unsound situation of Social safeguard system, and old dementia patients significantly increases and just do not bring heavy burden to patient home, also can have influence on national economic development and social stability.
The cause of disease of senile dementia and control thereof are very complicated problems, and modern medicine has been deep into gene, molecular level to its research, but still can not disclose its definite cause of disease and pathogenesis.Therefore, current Therapeutic Method is only limitted to the progress by the interfering effects of drug state of an illness, and patients in remission, can not make it fundamentally be treated.Conventional medicine has calcium ion antagonist, cholinergic drug, brain blood circulation promoter, brain cell metabolic activation thing etc.
Aniracetam learns light moderate, the handicapped vascular dementia of memory and cognition and Alzheimer, post-stroke light moderate cognitive in various degree and behavior disorder, person in middle and old age's benign memory deficits have obvious therapeutical effect.At present, the commercial dosage forms of aniracetam mainly contains tablet, granule and dispersible tablet, mostly is regular dosage form, all there is the defects such as taking dose is large, the half-life is shorter, medicining times is more, brings inconvenience to the treatment of senile dementia disease and patient consumes.
Slow releasing preparation refer to oral after in regulation release medium, on request lentamente non-constant velocity release medicine, compare with corresponding ordinary preparation, administration frequency at least reduces half or reduces to some extent, and significantly can increase the compliance of patient or the preparation of curative effect.Slow releasing preparation can reduce administration frequency, facilitates patient to take, and can improve curative effect, reduces blood concentration fluctuation, reduces toxic and side effects.
At present, the domestic slow-releasing Anixitan preparation that there is no goes on the market, and its reason is mainly that the absorption of aniracetam is too rapid, and the half-life is shorter, and the preparation difficulty of its slow releasing preparation is comparatively large, and the slow releasing preparation that the applicable old dementia patients of preparation is taken is particularly difficult.
Summary of the invention
The object of the invention is to overcome the shortcoming that exists in above-mentioned prior art with not enough, a kind of slow-releasing Anixitan tablet is provided.
Another object of the present invention is to provide the preparation method of above-mentioned Ni Xitan slow releasing tablet.Described preparation method adopts wet granulation, after granule oven dry, granulate, adds moderate lubrication agent mixing, tabletting and get final product; By this preparation method, slow-releasing Anixitan tablet can apply to field of medicaments effectively.
Object of the present invention is achieved through the following technical solutions: a kind of slow-releasing Anixitan tablet, comprises the component of following ratio of weight and number:
Described sustained-release matrix material is that one or both in the mixed matrix of sodium alginate/attapulgite clay complex, HPMC-K15M, hydroxypropyl cellulose, sodium alginate 420, ethyl cellulose M7, polyvinyl acetate/polyvinylpyrrolidone mixture, stearic acid, hydrogenated castor, HPMC and compritol 888, HP-β-CD (HPC) and Polyethylene Glycol (PEG) mixed matrix are used in combination.
Described lubricant is one or more in magnesium stearate, Pulvis Talci, micropowder silica gel.
Described porogen is microcrystalline Cellulose or carboxymethyl chitosan quaternary ammonium salt.
Described fluidizer is one or more in Pulvis Talci, micropowder silica gel.
Described binding agent is one or more in 10% starch-85% alcoholic solution, 2%HPMC-85% alcoholic solution, 75% alcoholic solution, 85% alcoholic solution, 95% alcoholic solution.
Above-mentioned slow-releasing Anixitan tablet, preferred component formula is:
Above-mentioned slow-releasing Anixitan tablet, another kind of preferred component formula is:
The preparation method of above-mentioned slow-releasing Anixitan tablet, comprises the following steps:
(1) aniracetam, sustained-release matrix material, lubricant, porogen, fluidizer are crossed respectively 40-100 mesh sieve for subsequent use;
(2) dry granule A is prepared: by aniracetam, after binding agent mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, spray granulation is carried out with fountain solution, after spraying terminates, discharging after being cooled to room temperature 20-30 DEG C, material is crossed 16-24 mesh sieve (preferred 18-20 mesh sieve), obtain dry granule A; Described fountain solution is the ethanol water of 30 ~ 99%;
(3) dry granule B is prepared: by porogen, after fluidizer mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, spray granulation is carried out with fountain solution, after spraying terminates, discharging after being cooled to room temperature 20-30 DEG C, material is crossed 16-24 mesh sieve (preferred 18-20 mesh sieve), obtain dry granule B; Described fountain solution is the ethanol water of 30 ~ 99%;
(4) prepare aniracetam always mixed thing: lubricant is crossed 40-100 mesh sieve (preferred 50-80 mesh sieve), mix homogeneously in a mixer with obtained dry granule A and obtained dry granule B, obtain aniracetam always mixed thing;
(5) slow-releasing Anixitan tablet agent is prepared: obtained aniracetam is always mixed thing and carry out tabletting, obtain slow-releasing Anixitan tablet agent.
Technology path provided by the invention comprises following process:
1. technique is preferred
With the vitro release of aniracetam for index, the prescription of the preferred slow-releasing Anixitan tablet of orthogonal design is adopted (to comprise composition, the kind of adjuvant and consumption) and method for making, with to the composite request of finished product sheet different time (majority is 3 time points) vitro release for inspection target, set up release aggregative indicator equation, again according to the dosage of slow-releasing Anixitan tablet design, drug release time and rate of releasing drug etc., between the release deviation area drawing slow-releasing Anixitan tablet, select prescription and the method for making of equation score the highest (best slow release effect), as the preparation technology of slow-releasing Anixitan tablet.、
2. the determination of optimised process
By the external slow-releasing Anixitan tablet preparation technology preferably drawn, need to carry out human bioavailability and bioequivalence Journal of Sex Research further, build the in vitro-in vivo correlation of slow-releasing Anixitan tablet.Preparation technology's (prescription and method for making) of adjustment slow-releasing Anixitan tablet, make preparation meet requirement (requirement of bioavailability and bioequivalence) to aspects such as drug release time, concentration and speed when drug delivery system builds in vivo, determine the best preparation technology of slow-releasing Anixitan tablet.
3. the reasonability of optimised process confirms
When carrying out above-mentioned technique and preferably confirming experiment with optimised process, reply experiment show that the reasonability of optimised process is investigated.On the basis meeting bioavailability and bioequivalence requirement, prioritizing selection processing ease degree, the preparation technology that preparation cost is low, to ensure the reasonability of preparation technology, be convenient to carry out suitability for industrialized production from now on.
Compared with prior art, the slow-releasing Anixitan tablet that the present invention relates to has technique effect useful as follows:
1) release steadily.Limit is 1 hour release 25-40%, 4 hours release 55-80%, release more than 80% in 8 hours.
2) gastrointestinal side-effect is little, and the present invention's sodium alginate/attapulgite clay complex parcel aniracetam raw material, the method effectively can control the release of aniracetam, and reducing medicine stimulates gastrointestinal.
3) present invention employs aniracetam and part pharmaceutic adjuvant and separate the method that secondary granulates, adopt fluidized bed granulation, compare with wet granulation, shorten the particle drying time.Good stability, the release of invention formulation are good, are conducive to Clinical practice.The inventive method is simple to operate, is suitable for large-scale industrial to be produced, and has larger using value.
Accompanying drawing explanation
Fig. 1 is slow-releasing Anixitan tablet preparation result figure.
Detailed description of the invention
Below in conjunction with embodiment and accompanying drawing, the present invention is described in further detail, but embodiments of the present invention are not limited thereto.
Embodiment 1
The invention provides a kind of preparation method of slow-releasing Anixitan tablet, comprise the following steps:
1. the component of slow-releasing Anixitan tablet:
Aniracetam 400mg, sodium alginate/attapulgite clay complex 150mg, starch 280mg, microcrystalline Cellulose 100mg, magnesium stearate 8mg and 60mg binding agent.
2. the preparation method of slow-releasing Anixitan tablet, comprises the following steps:
(1) aniracetam, sodium alginate/attapulgite clay complex, microcrystalline Cellulose, magnesium stearate are crossed respectively 60 mesh sieves for subsequent use, the alcoholic solution of preparation 85%;
(2) dry granule A is prepared: by aniracetam, after sodium alginate/attapulgite clay complex mix homogeneously, pour in fluid bed (FL-120D), regulate inlet temperature 35-50 DEG C, when material is warming up to 45 DEG C, carry out spray granulation with the fountain solution of preparation, after spraying terminates, be cooled to discharging after room temperature 26 DEG C, material crossed 18 mesh sieves and must do granule A;
(3) dry granule B is prepared: after starch, microcrystalline Cellulose mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, when material is warming up to 45 DEG C, spray granulation is carried out with the fountain solution fountain solution of preparation, after spraying terminates, be cooled to discharging after room temperature 26 DEG C, material crossed 18 mesh sieves and must do granule B;
(3) magnesium stearate is crossed 50 mesh sieves, mix homogeneously in a mixer with obtained dry granule A and dry granule B, obtain always mixed thing;
(4) gained is always mixed thing and carry out tabletting, obtain slow-releasing Anixitan tablet.
Embodiment 2
The invention provides a kind of preparation method of slow-releasing Anixitan tablet, comprise the following steps:
1. the component of slow-releasing Anixitan tablet:
Aniracetam 400mg, sodium alginate/attapulgite clay complex 200mg, starch 280mg, microcrystalline Cellulose 120mg, magnesium stearate 8mg and 60mg binding agent.
2. the preparation method of slow-releasing Anixitan tablet, comprises the following steps:
(1) aniracetam, sodium alginate/attapulgite clay complex, microcrystalline Cellulose, magnesium stearate are crossed respectively 60 mesh sieves for subsequent use; The alcoholic solution of preparation 85%.
(2) dry granule A is prepared: by aniracetam, after sodium alginate/attapulgite clay complex mix homogeneously, pour in fluid bed (FL-120D), regulate inlet temperature 35-50 DEG C, when material is warming up to 45 DEG C, carry out spray granulation with the fountain solution of preparation, after spraying terminates, be cooled to discharging after room temperature 26 DEG C, material crossed 18 mesh sieves and must do granule A;
(3) dry granule B is prepared: after starch, microcrystalline Cellulose mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, when material is warming up to 45 DEG C, spray granulation is carried out with the fountain solution fountain solution of preparation, after spraying terminates, be cooled to discharging after room temperature 26 DEG C, material crossed 18 mesh sieves and must do granule B;
(4) magnesium stearate is crossed 50 mesh sieves, mix homogeneously in a mixer with obtained dry granule A and dry granule B, obtain always mixed thing;
(5) gained is always mixed thing and carry out tabletting, obtain slow-releasing Anixitan tablet.
The release research of embodiment 3 slow-releasing Anixitan tablet
With reference to drug release determination method (Chinese Pharmacopoeia version in 2010 two annex XD first methods), with 0.1mol/L hydrochloric acid solution 900ml for solvent, rotating speed is 100 turns/min, temperature is set to 37 DEG C, every 1 hour, get solution 10ml, filter, and supply dissolution medium with the taking-up synthermal hydrochloric acid solution of solution same volume (9 → 1000), precision measures subsequent filtrate 5ml, is placed in 50ml volumetric flask, quantitatively scale is diluted to above-mentioned dissolution medium, shake up, as need testing solution, get 10 time points labelling respectively altogether; Separately get aniracetam reference substance 50mg, accurately weighed, add after ethanol 10ml makes dissolving, be quantitatively diluted to the solution about containing 10ug in every 1ml with above-mentioned solvent, product solution in contrast.Get above-mentioned test sample and reference substance solution, measure its absorbance at the wavelength place of 282nm respectively, calculate the accumulative release rate of every sheet.As shown in Figure 1, limit is 1 hour release 25-40%, 4 hours release 55-80%, release more than 80% in 8 hours.
Above-described embodiment is the present invention's preferably embodiment; but embodiments of the present invention are not restricted to the described embodiments; change, the modification done under other any does not deviate from spirit of the present invention and principle, substitute, combine, simplify; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (9)
1. a slow-releasing Anixitan tablet, is characterized in that: the component comprising following ratio of weight and number:
2. slow-releasing Anixitan tablet according to claim 1, is characterized in that: described sustained-release matrix material is that one or both in the mixed matrix of sodium alginate/attapulgite clay complex, HPMC-K15M, hydroxypropyl cellulose, sodium alginate 420, ethyl cellulose M7, polyvinyl acetate/polyvinylpyrrolidone mixture, stearic acid, hydrogenated castor, HPMC and compritol 888, HP-β-CD and Polyethylene Glycol mixed matrix are used in combination.
3. slow-releasing Anixitan tablet according to claim 1, is characterized in that: described lubricant is one or more in magnesium stearate, Pulvis Talci, micropowder silica gel.
4. slow-releasing Anixitan tablet according to claim 1, is characterized in that: described porogen is microcrystalline Cellulose or carboxymethyl chitosan quaternary ammonium salt.
5. slow-releasing Anixitan tablet according to claim 1, is characterized in that: described fluidizer is one or more in Pulvis Talci, micropowder silica gel.
6. slow-releasing Anixitan tablet according to claim 1, is characterized in that: described binding agent is one or more in 10% starch-85% alcoholic solution, 2%HPMC-85% alcoholic solution, 75% alcoholic solution, 85% alcoholic solution, 95% alcoholic solution.
7. slow-releasing Anixitan tablet according to claim 1, is characterized in that: the component formula of described slow-releasing Anixitan tablet is:
8. slow-releasing Anixitan tablet according to claim 1, is characterized in that: the component formula of described slow-releasing Anixitan tablet is:
9. the preparation method of the slow-releasing Anixitan tablet described in any one of claim 1 ~ 8, is characterized in that: comprise the following steps:
(1) aniracetam, sustained-release matrix material, lubricant, porogen, fluidizer are crossed respectively 40-100 mesh sieve for subsequent use;
(2) prepare dry granule A: by aniracetam, after binding agent mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, carry out spray granulation with fountain solution, after spraying terminates, discharging after being cooled to room temperature 20-30 DEG C, crosses 16-24 mesh sieve by material, obtain dry granule A; Described fountain solution is the ethanol water of 30 ~ 99%;
(3) prepare dry granule B: by porogen, after fluidizer mix homogeneously, pour in fluid bed, regulate inlet temperature 35-50 DEG C, carry out spray granulation with fountain solution, after spraying terminates, discharging after being cooled to room temperature 20-30 DEG C, crosses 16-24 mesh sieve by material, obtain dry granule B; Described fountain solution is the ethanol water of 30 ~ 99%;
(4) prepare aniracetam always mixed thing: lubricant is crossed 40-100 mesh sieve (preferred 50-80 mesh sieve), mix homogeneously in a mixer with obtained dry granule A and obtained dry granule B, obtain aniracetam always mixed thing;
(5) slow-releasing Anixitan tablet agent is prepared: obtained aniracetam is always mixed thing and carry out tabletting, obtain slow-releasing Anixitan tablet agent.
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| CN104042582A (en) * | 2013-03-15 | 2014-09-17 | 捷思英达医药技术（上海）有限公司 | Levetiracetam sustained-release agent composition and preparation method |
| CN104586806A (en) * | 2014-12-26 | 2015-05-06 | 东北制药集团沈阳第一制药有限公司 | Levetiracetam sustained release tablet as well as preparation method thereof |
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Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6036973A (en) * | 1994-06-27 | 2000-03-14 | Alza Corporation | Therapy for neurological diseases |
| CN1395924A (en) * | 2002-08-26 | 2003-02-12 | 鲁南制药股份有限公司 | Slow-releasing Anixidan capsule |
| CN1395925A (en) * | 2002-08-26 | 2003-02-12 | 鲁南制药股份有限公司 | Slow-releasing Anixitan tablet |
| US20100172979A1 (en) * | 2008-12-24 | 2010-07-08 | Zhongshui Yu | Controlled-release formulations |
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| WO2012070785A1 (en) * | 2010-11-23 | 2012-05-31 | Bio Pharmartis Co., Ltd. | Sustained-release pharmaceutical composition comprising levetiracetam or pharmaceutically acceptable salt thereof having improved dissolution stability and method for manufacturing the same |
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| CN104042582A (en) * | 2013-03-15 | 2014-09-17 | 捷思英达医药技术（上海）有限公司 | Levetiracetam sustained-release agent composition and preparation method |
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Application publication date: 20151111 |