CN103637997A - Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof - Google Patents
Duloxetine hydrochloride medicament composition, enteric sustained release preparation and preparation method thereof Download PDFInfo
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Abstract
The invention provides a duloxetine hydrochloride medicament composition, an enteric sustained release preparation and a preparation method thereof. The enteric sustained release preparation comprises the following components in parts by weight: 5-40 parts of duloxetine hydrochloride, 35-65 parts of sodium alginate, 5-20 parts of calcium salt, 15-35 parts of filler and 0.5-20 parts of lubricant. The medicament composition and the enteric sustained release preparation provided by the invention are hardly released under the gastric acid condition, so that a main medicine is prevented from being damaged in a stomach, no functional sustained release coating is needed to control medicine release, no enteric sustained release material is needed, only high-velocity sodium alginate and other medical auxiliaries are used, the enteric effect is achieved by adjusting the ratio, meanwhile the sustained release function is achieved, the medicine is effectively prevented from being damaged by the gastric acid environment, and the stability of the medicament inside a body in the absorption process is maintained.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of pharmaceutical composition and enteric-coated sustained-release preparation and preparation method of duloxetine hydrochloride.
Technical background
Duloxetine hydrochloride is the medicine that is used for the treatment of severe depression, generalized anxiety disorder, women's stress urinary incontinence disease, diabetes-alleviating peripheral nervous characteristic of disease pain and these 5 kinds of neurological's relevant diseases of fibromyalgia of Lilly Co., Eli.'s exploitation, goes on the market first with 2004 in the U.S..Its chemical name is (S)-(+)-N-methyl-3-(1-naphthoxy)-3-(2-thiophene)-propylamin hydrochloride, and its chemical constitution is as follows:
Because duloxetine hydrochloride is unstable in acid gastric juice environment, easily degrade, so duloxetine hydrochloride is prepared into enteric coatel tablets or enteric coated capsule is a reasonable selection.Medicine is not discharged in gastric acid environment, and avoiding it that degraded occurs affects drug effect, discharges, absorbs, performance drug effect in the intestinal environment of medicine arrival neutrality or meta-alkalescence.But owing to containing secondary amino group in duloxetine hydrochloride structure, react with many enteric materials that contain carboxyl and form to dissolve slow or insoluble coating at all, affect the release of medicine.For fear of this problem, there is technical literature to propose to select selectively enteric material, the Chinese patent < < LY-248686 enteric coated pill of Ru Lilai company, adopts HPMC-AS-AS to prepare duloxetine hydrochloride enteric coated pill as enteric material in ZL95108414.3 > >; Or between enteric layer and medicine, add and contain migration and the interaction that glucide and talcous sealing coat alleviate enteric coating material and duloxetine, for example the Chinese patent < < duloxetine hydrochloride delayed release formulations CN101448493A > > of Teva Pharmaceutical Industries Ltd discloses the methacrylic acid copolymer enteric coating scheme that comprises sealing coat that adopts.
In addition, because the using method of duloxetine hydrochloride is 40mg/ day (20mg mono-twice-daily) to 60mg/ day (once-a-day or 30mg mono-twice-daily), in order to make patient's blood drug level maintain a state stably, reduce adverse effect simultaneously, improve patient's medication compliance, existing researcher is prepared into slow releasing preparation by this medicine.But due to the stability problem of mentioning before, in the development process of medicine, need to be prepared into enteric-coated sustained-release preparation.The patent < < duloxetine hydrochloride sustained release medicine of the holy magnificent sunlight Pharmaceutical in Chongqing for example, CN100525760C > > discloses the preparation method of the enteric-coated sustained-release preparation of duloxetine hydrochloride, it adopts common slow-release material that medicine is prepared into gel skeleton slow releasing tablet, then carries out the mode of enteric coating.The patent < < Duloxetine hydrochloride drug composition of the high sharp medical sci-tech in Tianjin, CN102579403B > > discloses a kind of preparation method of duloxetine hydrochloride sustained release capsule, previously prepared celphere, at celphere, carry out duloxetine hydrochloride medicine carrying outward, containing pill core outer cladding enteric slow release clothing layer.Still have the preparation method of mentioning in other published patent applications all to adopt the above technique of two steps to prepare enteric-coated sustained-release preparation, but disclosed above-mentioned preparation method step is complicated, operation inconvenience.
Summary of the invention
For above-mentioned problems of the prior art, the invention provides a kind of Duloxetine hydrochloride drug composition and enteric-coated sustained-release preparation and preparation method, the full-bodied sodium alginate of concrete use is framework material, regulate calcium ion addition, the object of the expection that can reach by simple preparation technology.In whole preparation process, only need to carry out pelletizing press sheet, without adopting enteric coating technique of the prior art, preparation section is few, and method is simple.
For achieving the above object, the present invention is achieved by the following technical solutions:
A Duloxetine hydrochloride drug composition, it comprises duloxetine hydrochloride and high viscosity sodium alginate, in weight portion, duloxetine hydrochloride 5-40 part, high viscosity sodium alginate 35-65 part.
Further improvement to technique scheme: the viscosity of described high viscosity sodium alginate is 400-500mPas.
Further improvement to technique scheme: described pharmaceutical composition also contains the calcium salt of 5-20 part.
The present invention also provides the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition, it comprises following component: in weight portion, and duloxetine hydrochloride 5-40 part, sodium alginate 35-65 part, calcium salt 5-20 part, filler 15-35 part, lubricant 0.5-2 part.
Further improvement to technique scheme: described calcium salt is one or more in calcium citrate, Citric acid calcium, calcium gluconate, calcium hydrogen phosphate.
Further improvement to technique scheme: described filler is selected from one or more in microcrystalline Cellulose, lactose, starch or mannitol.
Further improvement to technique scheme: described lubricant is selected from one or more in magnesium stearate, Pulvis Talci or micropowder silica gel.
Further improvement to technique scheme: described enteric-coated sustained-release preparation also contains binding agent, binding agent is selected from a kind of in polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, uses ethanol water to prepare as solvent.
The preparation method of described duloxetine hydrochloride enteric-coated sustained-release preparation, it is standby by wet granule compression tablet legal system, specifically comprises the following steps:
(1) duloxetine hydrochloride is mixed homogeneously with sodium alginate, calcium salt, filler, be prepared into mixture A;
(2) binding agent is dissolved in suitable solvent, joins uniformly in mixture A, stir, by granulator, make wet granular, be dried to obtain mixture B;
(3) by mixture B granulate in pelletizing machine, join in mixer, add lubricant to mix simultaneously and make mixture C;
(4) by mixture C according to suitable sheet weight sheet, obtain duloxetine hydrochloride enteric-coated sustained-release tablet.
Further improvement to technique scheme: described duloxetine hydrochloride enteric-coated sustained-release tablet also comprises the coating of non-functional.
Duloxetine hydrochloride enteric-coated sustained-release tablet of the present invention and preparation method thereof has following characteristics:
1, with respect to existing duloxetine hydrochloride ordinary preparation, adjuvant used in the present invention is less, do not need enteric coating operation, by sodium alginate nature, control the release of medicine in acid, can effectively avoid the destruction of gastric acid environment to medicine, keep the stability of medicine absorption process in vivo.
2, with respect to existing duloxetine hydrochloride, product of the present invention can only need to take medicine once every day, taking convenience, guarantee to discharge lastingly, lentamente medicine, make the blood drug level product time maintain treatment level, reach better curative effect, especially, for patients with depression, more easily improve patient's Compliance.
3, with respect to existing enteric slow release tablet, wet granulation technology of the present invention is mature and stable, and preparation technology is simple, and operation sequence is few, and favorable reproducibility is cost-saving, is beneficial to industrial amplification production, remarkable in economical benefits.
Accompanying drawing explanation
Fig. 1 is embodiment 1 and the stripping curve of the 40mg specification duloxetine hydrochloride enteric-coated sustained-release tablet of embodiment 2 preparations in pH6.8 phosphate buffer.
Fig. 2 is embodiment 3 and the stripping curve of the 60mg specification duloxetine hydrochloride enteric-coated sustained-release tablet of embodiment 4 preparations in pH6.8 phosphate buffer.
The specific embodiment
Below in conjunction with drawings and Examples, further illustrate the present invention, can make those skilled in the art more fully understand the present invention, but not limit the present invention in any way.The content of the duloxetine hydrochloride of mentioning in embodiment can be adjusted, and not limited by the content of mentioning in embodiment.
The release inspection method of mentioning in embodiment is: according to 2010 editions two appendix XD drug release determination method first methods of Chinese Pharmacopoeia, rotating speed is 100 revs/min, probe temperature is 37 ℃ ± 0.5 ℃, first hydrochloric acid solution (simulated gastric fluid) 1000ml of pH1.0 of take is medium, 2h sampling and measuring, investigates the stability of duloxetine hydrochloride enteric-coated sustained-release tablet in acid; The pH6.8 phosphate buffer 1 000ml of usining again investigates its later stage slow release effect as dissolution medium, sample point is respectively 1,2,4,8h, according to the drug release determination method of Duloxetine Delayed-Release Capsules in American Pharmacopeia USP35 version, use high performance liquid chromatography to measure.
Embodiment 1
Described in the present embodiment, the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation comprises the following steps:
1, get 18 parts of duloxetine hydrochlorides, pulverized 100 mesh sieves, put into wet mixing pelletizer with 51 parts of sodium alginates, 12 parts of calcium gluconate and 17 parts of lactose and mix, be prepared into mixture A, standby;
2, binding agent PVP K30 is dissolved in 95% alcoholic solution, stirs and join in mixture A, stir, prepare soft material, wet soft material is used oscillating granulator to cross 20 mesh sieves and makes wet granular, and in fluid bed, 45 ℃ are dried, and obtaining dry granule is mixture B;
3, the mixture B making, after pelletizing machine 18 mesh sieve granulate, adds magnesium stearate lubricant mix homogeneously in Mixers with Multi-direction Movement to obtain mixture C.
4, through sampling, measure after granule content, according to assay result, calculate, tabletting, controls tabletting hardness at 40-50N, is prepared into duloxetine hydrochloride enteric-coated sustained-release tablet (40mg specification).
Described in the employing embodiment of the present invention 1, method makes sample, records the release conditions of slow releasing tablet as table 1.
The release check result of table 1: embodiment 1 slow releasing tablet
Embodiment 2
Described in the present embodiment, the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation comprises the following steps:
1, get 15 parts of duloxetine hydrochlorides, pulverized 100 mesh sieves, put into wet mixing pelletizer and mix with 48 parts of sodium alginates, 11 parts of calcium hydrogen phosphate, 8 portions of mannitol, 16 parts of microcrystalline Cellulose, be prepared into mixture A, standby;
2, binding agent HPMC E5 is joined in 50% alcoholic solution, stir and join in mixture A, stir, prepare soft material, wet soft material is used oscillating granulator to cross 20 mesh sieves and makes wet granular, and in baking oven, 50 ℃ are dried, and obtaining dry granule is mixture B;
3, the mixture B making, after pelletizing machine 18 mesh sieve granulate, adds magnesium stearate lubricant mix homogeneously in Mixers with Multi-direction Movement to obtain mixture C.
4, through sampling, measure after granule content, according to assay result, calculate, tabletting, controls tabletting hardness at 45-55N.The plain sheet of preparation is above used to high-efficiency coating pan coating, and coating material is used the coating solution of the Opadry 85F series coating powder preparation of Ka Lekang packaging technique company limited, art for coating add the dispose procedure that does not affect medicine.Be prepared into duloxetine hydrochloride enteric-coated sustained-release tablet (40mg specification).
Described in the employing embodiment of the present invention 2, method makes sample, records the release conditions of slow releasing tablet as table 2.
The release check result of slow releasing tablet described in table 2: embodiment 2
Embodiment 3
Described in the present embodiment, the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation comprises the following steps:
1, get 20 parts of duloxetine hydrochlorides, pulverized 100 mesh sieves, 54 parts of sodium alginates, 10 parts of Citric acid calciums, put into wet mixing pelletizer with 14 parts of starch and mix, be prepared into mixture A, standby;
2, binding agent PVP K90 is joined in 95% alcoholic solution, stir and join in mixture A, stir and prepare soft material, wet soft material is used oscillating granulator to cross 20 mesh sieves and makes wet granular, and in fluid bed, 45 ℃ are dried, and obtaining dry granule is mixture B;
3, the dry granule making, after pelletizing machine 18 mesh sieve granulate, adds magnesium stearate lubricant in Mixers with Multi-direction Movement, to mix homogeneously and obtain mixture C with micropowder silica gel.
4, through sampling, measure after granule content, according to assay result, calculate, tabletting, controls tabletting hardness at 50-60N, is prepared into duloxetine hydrochloride enteric-coated sustained-release tablet (60mg specification).
Described in the employing embodiment of the present invention 3, method makes sample, records the release conditions of slow releasing tablet as table 3.
The release check result of slow releasing tablet described in table 3: embodiment 3
Embodiment 4
Described in the present embodiment, the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation comprises the following steps:
1, get 23 parts of duloxetine hydrochlorides, pulverized 100 mesh sieves, 50 parts of sodium alginates, 9 parts of calcium citrates, put into wet mixing pelletizer with 16 parts of microcrystalline Cellulose and mix, be prepared into mixture A, standby;
2, binding agent PVP K30 is dissolved in 95% alcoholic solution, stirs and join in mixture A, stir and prepare soft material, wet soft material is used oscillating granulator to cross 24 mesh sieves and makes wet granular, and in fluid bed, 45 ℃ are dried, and obtaining dry granule is mixture B;
3, the dry granule making, after pelletizing machine 20 mesh sieve granulate, adds magnesium stearate lubricant mix homogeneously in Mixers with Multi-direction Movement to obtain mixture C.
4, through sampling, measure after granule content, according to assay result, calculate, tabletting, controls tabletting hardness at 50-60N.The plain sheet making is used to high-efficiency coating pan coating, and HPMC E5 is mixed with 8% aqueous solution (6%PEG1500 makes plasticizer) as coating solution, art for coating add the dispose procedure that does not affect medicine.Be prepared into duloxetine hydrochloride enteric-coated sustained-release tablet (60mg specification).
Described in the employing embodiment of the present invention 4, method makes sample, records the release conditions of slow releasing tablet as table 4.
The release check result of slow releasing tablet described in table 4: embodiment 4
The stripping curve of the 40mg specification duloxetine hydrochloride enteric-coated sustained-release tablet of embodiment 1 and embodiment 2 preparations in pH6.8 phosphate buffer gathers for Fig. 1.The stripping curve of the 60mg specification duloxetine hydrochloride enteric-coated sustained-release tablet of embodiment 3 and embodiment 4 preparations in pH6.8 phosphate buffer gathers for Fig. 2.From figure, release result is known, the stripping of tablet Chinese traditional medicine in sour environment can be effectively blocked in adding of q.s sodium alginate, and can reach the release behavior of adjustment medicine in pH6.8 phosphate buffer by adjusting the addition of sodium alginate and calcium salt.The tablet of preparation can effectively be avoided degrading in gastric acid environment in taking process, slow Slow release after entering intestinal.
The described high viscosity sodium alginate using is from commercially available prod, as the sodium alginate commercially available product of Qingdao Huanghai Sea Biology Pharmacy Co., Ltd.Sodium alginate is for controlling the skeleton slow-release material of drug release, and its addition has determined the formation of whole tablet gel skeleton.Sustained-release matrix material usage cross conference cause medicine not discharge completely or pharmaceutical release time long, after patient takes, just do not reach the effect for the treatment of, and sustained-release matrix material usage is crossed the heavy dose of release phenomenon of medicine that young pathbreaker causes medicine not reach slow releasing function or occur at the release initial stage.In addition, because the special nature of sodium alginate---it does not dissolve in sour environment, guaranteed that medicine does not almost discharge in sour environment, and in alkaline environment, under the effect of bivalent metal ion, formed stable gel, played slow releasing function.So sodium alginate has also played the effect of protection medicine stability in acid simultaneously.When the present invention determines duloxetine hydrochloride 5-40 part through testing, the amount ranges of sodium alginate is 35-65 weight portion.
Duloxetine hydrochloride enteric-coated sustained-release tablet of the present invention, use full-bodied sodium alginate for sustained-release matrix material, described sodium alginate is full-bodied sodium alginate, its range of viscosities is 400-500mPas, the skeleton of the tablet that viscosity is prepared lower than the sodium alginate of this scope is unstable, cannot guarantee that sustained drug slowly discharges.
In the present invention's prescription, do not contain enteric solubility clad material, only by regulating the addition of sodium alginate and other oral pharmaceutically acceptable auxiliaries, it is possessed in sour environment and discharge hardly, the feature slowly discharging in neutrality and slight alkali environment.
The enteric-coated sustained-release tablet that the present invention contains described duloxetine hydrochloride, not only contains duloxetine hydrochloride, sodium alginate, also containing being useful on the pharmaceutically useful calcium salt that regulates this slow releasing tablet rate of release, and contains filler or lubricant or other adjuvants or its mixture.In described each preparation unit of enteric-coated sustained-release preparation, containing duloxetine hydrochloride component content is 20mg-100mg.
Described calcium salt is one or both the combination in calcium citrate, Citric acid calcium, calcium gluconate, calcium hydrogen phosphate.To be that slightly soluble arrives slightly molten for the dissolubility of several calcium salts in water above, so in tablet enters body, calcium salt does not dissolve rapidly, equally also played the effect that blocking medicine discharges in gastric acid, when medicine enters in intestinal environment, calcium salt slowly dissolves, and adding of this divalent metal example can guarantee the stable of sodium alginate gel state, and medicine slowly discharges in gel.The present invention is when duloxetine hydrochloride 5-40 part, and its amount ranges of calcium salt is 5-20 weight portion.
Described filler is selected from one or more in microcrystalline Cellulose, lactose, starch or mannitol, according to the consumption of filler described in the Determination of quantity of prescription screening result and sustained-release matrix material, is 15-35 weight portion.
Described lubricant is selected from one or more in magnesium stearate, Pulvis Talci or micropowder silica gel, preferably magnesium stearate.According to make the mobility of granule and tabletting process whether sticking add in right amount profit and, in the present invention, the amount ranges of lubricant is 0.5-2 weight portion.
Described other adjuvants are binding agent, and binding agent is selected from a kind of in polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, use ethanol water to prepare.
Above embodiment is only in order to technical scheme of the present invention to be described, but not is limited; Although the present invention is had been described in detail with reference to previous embodiment, for the person of ordinary skill of the art, the technical scheme that still can record previous embodiment is modified, or part technical characterictic is wherein equal to replacement; And these modifications or replacement do not make the essence of appropriate technical solution depart from the spirit and scope of the present invention's technical scheme required for protection.
Claims (10)
1. a Duloxetine hydrochloride drug composition, is characterized in that it comprises duloxetine hydrochloride and high viscosity sodium alginate, in weight portion, and duloxetine hydrochloride 5-40 part, high viscosity sodium alginate 35-65 part.
2. Duloxetine hydrochloride drug composition according to claim 1, is characterized in that: the viscosity of described high viscosity sodium alginate is 400-500mPas.
3. Duloxetine hydrochloride drug composition according to claim 1 and 2, is characterized in that: described pharmaceutical composition also contains the calcium salt of 5-20 part.
4. the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition, is characterized in that it comprises following component: in weight portion, and duloxetine hydrochloride 5-40 part, sodium alginate 35-65 part, calcium salt 5-20 part, filler 15-35 part, lubricant 0.5-2 part.
5. the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition according to claim 4, is characterized in that: described calcium salt is one or more in calcium citrate, Citric acid calcium, calcium gluconate, calcium hydrogen phosphate.
6. the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition according to claim 4, is characterized in that: described filler is selected from one or more in microcrystalline Cellulose, lactose, starch or mannitol.
7. the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition according to claim 4, is characterized in that: described lubricant is selected from one or more in magnesium stearate, Pulvis Talci or micropowder silica gel.
8. the enteric-coated sustained-release preparation that contains Duloxetine hydrochloride drug composition according to claim 4, it is characterized in that: described enteric-coated sustained-release preparation also contains binding agent, binding agent is selected from a kind of in polyvidone, hydroxypropyl emthylcellulose, sodium carboxymethyl cellulose, uses ethanol water to prepare as solvent.
9. the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation according to claim 8, is characterized in that it passes through wet granule compression tablet legal system standby, specifically comprises the following steps:
(1) duloxetine hydrochloride is mixed homogeneously with sodium alginate, calcium salt, filler, be prepared into mixture A;
(2) binding agent is dissolved in suitable solvent, joins uniformly in mixture A, stir, by granulator, make wet granular, be dried to obtain mixture B;
(3) by mixture B granulate in pelletizing machine, join in mixer, add lubricant to mix simultaneously and make mixture C;
(4) by mixture C according to suitable sheet weight sheet, obtain duloxetine hydrochloride enteric-coated sustained-release tablet.
10. the preparation method of duloxetine hydrochloride enteric-coated sustained-release preparation according to claim 9, is characterized in that: described duloxetine hydrochloride enteric-coated sustained-release tablet also comprises the coating of non-functional.
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| CN201310692454.5A CN103637997B (en) | 2013-12-17 | 2013-12-17 | A kind of Duloxetine hydrochloride drug composition and enteric-coated sustained-release preparation and preparation method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108740371A (en) * | 2018-04-04 | 2018-11-06 | 广州智特奇生物科技股份有限公司 | Enteric capsulating material, using coated zinc oxide of the capsulating material and preparation method thereof |
Citations (1)
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| CN101164532A (en) * | 2006-10-17 | 2008-04-23 | 重庆圣华曦药业有限公司 | Duloxetine hydrochloride sustained release medicine |
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| CN101164532A (en) * | 2006-10-17 | 2008-04-23 | 重庆圣华曦药业有限公司 | Duloxetine hydrochloride sustained release medicine |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108740371A (en) * | 2018-04-04 | 2018-11-06 | 广州智特奇生物科技股份有限公司 | Enteric capsulating material, using coated zinc oxide of the capsulating material and preparation method thereof |
| CN108740371B (en) * | 2018-04-04 | 2021-07-30 | 广州智特奇生物科技股份有限公司 | Enteric coating material, zinc oxide coated by coating material and preparation method thereof |
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