CN103961325A - Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet - Google Patents
Pramipexole tablet preparation method, tablet prepared therethrough, and application of tablet Download PDFInfo
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- CN103961325A CN103961325A CN201310043307.5A CN201310043307A CN103961325A CN 103961325 A CN103961325 A CN 103961325A CN 201310043307 A CN201310043307 A CN 201310043307A CN 103961325 A CN103961325 A CN 103961325A
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Abstract
The invention provides a pramipexole tablet preparation method. The method comprises the following steps: suspending starch in a solvent, fully swelling, dispersing and stirring, filtering, and drying; sieving pramipexole, starch, mannitol, silica and magnesium stearate, fully mixing pramipexole with starch according to an equivalent progressive maximum process; and sequentially adding mannitol and an ethanol solution of polyvinylpyrrolidone, granulating, drying, and adding magnesium stearate and silica. The invention also provides a pramipexole tablet prepared through the preparation method, and an application of the pramipexole tablet in the preparation of medicines for treating the Parkinson's disease and restless legs syndrome. The content of related substances in the pramipexole tablet is less than 0.5%. The pramipexole tablet prepared through the method contains few types of the related substances, and has an obviously reduced content of total impurities.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, the pramipexole tablet that be specifically related to a kind of preparation method of new pramipexole tablet, obtains by method of the present invention and the purposes of pramipexole tablet of the present invention.
Background technology
Body of Pramipexole dihydrochloride is the d2 dopamine receptor agonist being gone on the market by U.S. FDA approval in 1997, is used for the treatment of parkinson and restless legs syndrome etc.At present, listing dosage form has ordinary tablet and slow releasing tablet, and wherein ordinary tablet listing specification has multiple specifications such as 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg.
The chemical name of pramipexole is S-(-)-2-amino-6-n-propylamine base-4,5,6,7-tetrahydro benzothiazol, and molecular formula is C
10h
17n
3s, relative molecular mass is 211.33.Listing form is pramipexoledihydrochloride monohydrae, and its chemical constitution is as follows:
CN201110119071 discloses a kind of method of preparing body of Pramipexole dihydrochloride sheet, specifically comprises following steps: (1) is dissolved in maltodextrin in purified water; (2) pramipexole is added and prepare in the aqueous solution obtaining; (3) interior granulation material is mixed in granulator, and pramipexole maltodextrin solution is added in granulator, granulate; (4) wet grain drying to loss on drying for being less than 2.0%; (5) cross after 20 mesh sieves, add the material of Extra Section, mix; (6) by mixture compacting in flakes.The method of describing according to this patent application, finds when pilot sample, the pramipexole sheet related substance kind obtaining is many, and total impurities content is larger.
Meanwhile, the mensuration of the pramipexole sheet of the present inventor at present commercially available different size also finds, the related substance of these pramipexole sheets is more, the problem that total impurities content is larger.
Therefore, need at present a kind of preparation method of new pramipexole tablet, in the pramipexole tablet that makes to obtain, related substance greatly reduces, and total impurities content obviously reduces.
Summary of the invention
One object of the present invention is to provide a kind of preparation method of new pramipexole tablet.Another object of the present invention is to provide the pramipexole of being prepared by method of the present invention tablet.An also object of the present invention is to provide the purposes of pramipexole tablet of the present invention in the medicine for the preparation for the treatment of parkinson and restless legs syndrome.
For foregoing invention object, the invention provides following technical scheme:
On the one hand, the invention provides the preparation method of pramipexole tablet, comprise the following steps:
1) 1 weight portion starch is slowly suspended in 1-9 parts by weight solvent, fully swelling, disperse, stir after filtration drying;
2) repeating step 1) 1-6 time;
3) by pramipexole, step 2) gained starch, mannitol, silicon dioxide and magnesium stearate sieving for standby respectively;
4) take the pramipexole of aequum and the starch of step 3), with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of the step 3) of recipe quantity, join in above-mentioned mixed powder, fully mix homogeneously;
6) take the polyvinylpyrrolidone of recipe quantity, add 50%(weight) dissolve with ethanol solution, make after the polyvinylpyrrolidone alcoholic solution of 5%-10% weight, add in the mixed powder of step 5) gained, granulate;
7) dry, make granule moisture control in 2%(weight) in and granulate;
8) add magnesium stearate and the silicon dioxide of the step 3) of recipe quantity, fully mix;
9) tabletting.
In preferred embodiments, the solvent described in the inventive method is selected from the mixed solvent of water and alcohol; More preferably, the solvent described in the inventive method is selected from the mixed solvent of second alcohol and water; Further, the solvent described in the inventive method is selected from the ethanol-water mixture of 10 % by weight-60 % by weight; Most preferably, the solvent described in the inventive method is selected from the ethanol-water mixture of 40 % by weight-50 % by weight.In a further preferred embodiment, the method according to this invention, is suspended in 1 weight portion starch in the ethanol-water mixture of 4 weight portion 50 % by weight.
Cleaning mixture or filtrate that the inventive method produces can adopt rectifying column recycle and reuse.
On the other hand, the invention provides a kind of new pramipexole tablet, it is prepared by following methods:
1) 1 weight portion starch is slowly suspended in 1-9 parts by weight solvent, fully swelling, disperse, stir after filtration drying;
2) repeating step 1) 1-6 time;
3) by pramipexole, step 2) gained starch, mannitol, silicon dioxide and magnesium stearate sieving for standby respectively;
4) take the pramipexole of recipe quantity and the starch of step 3), with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of the step 3) of recipe quantity, join in above-mentioned mixed powder, fully mix homogeneously;
6) take the polyvinylpyrrolidone of recipe quantity, add 50%(weight) dissolve with ethanol solution, make after the polyvinylpyrrolidone alcoholic solution of 5%-10% weight, add in the mixed powder of step 5) gained, granulate;
7) dry, make granule moisture control in 2%(weight) in and granulate;
8) add magnesium stearate and the silicon dioxide of the step 3) of recipe quantity, fully mix;
9) tabletting;
In the method, described solvent is preferably the mixed solvent of water and alcohol, the more preferably mixed solvent of second alcohol and water, is especially selected from the solvent of the ethanol-water mixture of 10 % by weight-60 % by weight, is most preferably selected from the solvent of the ethanol-water mixture of 40 % by weight-50 % by weight;
Wherein, in the pramipexole tablet obtaining, the content of related substance is less than 0.5%(by weight).
Preferably, according to pramipexole tablet of the present invention, it is prepared by said method of the present invention, has following composition:
Wherein, in described pramipexole tablet, the content of related substance is less than 0.5% with the weighing scale of described tablet.
In a preferred embodiment, in pramipexole tablet of the present invention, the content of related substance is less than 0.3% with the weighing scale of described tablet.
In another preferred embodiment, in pramipexole tablet of the present invention, the content of related substance is less than 0.2% with the weighing scale of described tablet.
In another preferred embodiment, in pramipexole tablet of the present invention, the content of related substance is less than 0.15% with the weighing scale of described tablet.
Again on the one hand, the invention provides the purposes of pramipexole tablet of the present invention in the medicine for the preparation for the treatment of parkinson and relevant disease and the purposes in the medicine for the preparation for the treatment of restless legs syndrome.
It should be noted that, term used herein " pramipexole " comprises pramipexole and pramipexole officinal salt, as pramipexole hydrochlorate, pramipexole dihydrochloride, with and acceptable solvent compound, particularly comprise pramipexole dihydrochloride monohydrate.
Unless otherwise defined, all technology used herein or scientific terminology have the identical meanings that those of ordinary skill in the art understand conventionally.
Preparation method advantages of simple provided by the invention, cost is lower, and the pramipexole sheet its related substances obtaining significantly reduces.
Brief description of the drawings
Fig. 1 is the HPLC figure of the pramipexole sheet of commercially available (import).
Fig. 2 is the HPLC figure according to the pramipexole sheet of the embodiment of the present invention 1 gained.
Fig. 3 is the HPLC figure according to the pramipexole sheet of comparative example 1 (CN201110119071) gained.
Detailed description of the invention
Following examples are used for explaining the present invention, and unrestricted the present invention.
In following examples and comparative example, alleged body of Pramipexole dihydrochloride is pramipexoledihydrochloride monohydrae.The various materials that use in embodiment are the pharmaceutical grade product of commercially available acquisition.
Embodiment 1 body of Pramipexole dihydrochloride sheet (0.125g)
Prescription, every 1000 contain following component:
| Pramipexole two hydrochloride monohydrates | 125mg |
| Starch | 43g |
| Mannitol | 43g |
| Magnesium stearate | 0.45g |
| Silicon dioxide | 0.45g |
| Polyvinylpyrrolidone | 1.5g |
The preparation method of the body of Pramipexole dihydrochloride sheet described in the present embodiment, comprises the following steps:
1) medical starch 100g is suspended in to 10%(weight) ethanol-water solution 100g in, fully swelling, disperse, stir after 20min, filter, dry.
2) repeating step 1) 5 times;
3) by body of Pramipexole dihydrochloride, step 2) gained starch, mannitol, silicon dioxide crosses respectively 100 mesh sieves, magnesium stearate crossed to 60 mesh sieves for subsequent use;
4) take the starch of pramipexole two hydrochloride monohydrates and step 3) by the constituent content of 1000, with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of step 3) by the constituent content of 1000, join in above-mentioned mixed powder, fully mix homogeneously;
6) take polyvinylpyrrolidone by the constituent content of 1000, add 50%(weight) dissolve with ethanol solution, make 5%(weight) polyvinylpyrrolidone alcoholic solution after, add in the mixed powder of step 5) gained, granulate;
7) 60 DEG C dry, make granule moisture control in 2%(weight) in and granulate;
8) dried granule, after 30 eye mesh screens are granulated, adds by the magnesium stearate of the step 3) of 1000 constituent contents and silicon dioxide, fully mixes;
9) tabletting;
10) adopt the hard sheet of shading PVC and PTP aluminum-plastic blister, select qualified aluminium-plastic panel, check the projects such as content, related substance, uniformity of dosage units, dissolution.
Aforesaid operations environment is taked lucifuge measure, and the daylight lamp pad pasting between production operation, weakens light, avoids strong illumination.Embodiment 2 body of Pramipexole dihydrochloride sheets (0.25g)
Prescription, every 1000 contain following component:
| Pramipexole two hydrochloride monohydrates | 250mg |
| Starch | 50g |
| Mannitol | 50g |
| Magnesium stearate | 0.5g |
| Silicon dioxide | 0.5g |
| Polyvinylpyrrolidone | 7.6g |
1) medical starch 100g is suspended in the ethanol-water solution 400g of 50 % by weight, abundant swelling dispersion is stirred after 40min, filters, dry;
2) repeating step 1) 2 times;
3) by body of Pramipexole dihydrochloride, step 2) gained starch, mannitol, silicon dioxide crosses respectively 100 mesh sieves, magnesium stearate crossed to 60 mesh sieves for subsequent use;
4) take the starch of pramipexole two hydrochloride monohydrates and step 3) by the constituent content of 1000, with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of step 3) by the constituent content of 1000, join in above-mentioned mixed powder, fully mix homogeneously;
6) take polyvinylpyrrolidone by the constituent content of 1000, add 50%(weight) dissolve with ethanol solution, make 10%(weight) polyvinylpyrrolidone alcoholic solution after, add in the mixed powder of step 5) gained, granulate;
7) 60 DEG C dry, make granule moisture control in 2%(weight) in and granulate;
8) dried granule, after 30 eye mesh screens are granulated, adds by the magnesium stearate of the step 3) of 1000 constituent contents and silicon dioxide, fully mixes;
9) tabletting;
10) adopt the hard sheet of shading PVC and PTP aluminum-plastic blister, select qualified aluminium-plastic panel, check the projects such as content, related substance, uniformity of dosage units, dissolution.
Embodiment 3 body of Pramipexole dihydrochloride sheets (1g)
Prescription, every 1000 contain following component:
| Pramipexole two hydrochloride monohydrates | 1g |
| Starch | 100g |
| Mannitol | 100g |
| Magnesium stearate | 1.0g |
| Silicon dioxide | 1.0g |
| Polyvinylpyrrolidone | 6.3g |
1) medical starch 200g is suspended in the ethanol-water solution 600g of 20 % by weight, fully swelling, disperse, stir after 20min, filtration drying;
2) repeating step 1) 5 times;
3) by body of Pramipexole dihydrochloride, step 2) gained starch, mannitol, silicon dioxide crosses respectively 100 mesh sieves, magnesium stearate crossed to 60 mesh sieves for subsequent use;
4) take the starch of pramipexole two hydrochloride monohydrates and step 3) by the constituent content of 1000, with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of step 3) by the constituent content of 1000, join in above-mentioned mixed powder, fully mix homogeneously;
6) take polyvinylpyrrolidone by the constituent content of 1000, add 50%(weight) dissolve with ethanol solution, make 5%(weight) polyvinylpyrrolidone alcoholic solution after, add in the mixed powder of step 5) gained, granulate;
7) 60 DEG C dry, make granule moisture control in 2%(weight) in and granulate;
8) dried granule, after 30 eye mesh screens are granulated, adds by the magnesium stearate of the step 3) of 1000 constituent contents and silicon dioxide, fully mixes;
9) tabletting;
10) adopt the hard sheet of shading PVC and PTP aluminum-plastic blister, select qualified aluminium-plastic panel, check the projects such as content, related substance, uniformity of dosage units, dissolution.
Aforesaid operations environment is taked lucifuge measure, and the daylight lamp pad pasting between production operation, weakens light, avoids strong illumination.
Embodiment 4 body of Pramipexole dihydrochloride sheets (0.125g)
Prescription, every 1000 contain following component:
| Pramipexole two hydrochloride monohydrates | 125mg |
| Starch | 43g |
| Mannitol | 43g |
| Magnesium stearate | 0.45g |
| Silicon dioxide | 0.45g |
| Polyvinylpyrrolidone | 4.58g |
1) medical starch 100g is suspended in the ethanol-water solution 900g of 60 % by weight, fully swelling, disperse, stir after 40min, filter, dry;
2) repeating step 1) 1 time;
3) by body of Pramipexole dihydrochloride, step 2) gained starch, mannitol, silicon dioxide crosses respectively 100 mesh sieves, magnesium stearate crossed to 60 mesh sieves for subsequent use;
4) take the starch of pramipexole two hydrochloride monohydrates and step 3) by the constituent content of 1000, with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of step 3) by the constituent content of 1000, join in above-mentioned mixed powder, fully mix homogeneously;
6) take polyvinylpyrrolidone by the constituent content of 1000, add 50%(weight) dissolve with ethanol solution, make 8%(weight) polyvinylpyrrolidone alcoholic solution after, add in the mixed powder of step 5) gained, granulate;
7) 60 DEG C dry, make granule moisture control in 2%(weight) in and granulate;
8) dried granule, after 30 eye mesh screen granulate, adds by the magnesium stearate of the step 3) of 1000 constituent contents and silicon dioxide, fully mixes;
9) tabletting;
10) adopt the hard sheet of shading PVC and PTP aluminum-plastic blister, select qualified aluminium-plastic panel, check the projects such as content, related substance, uniformity of dosage units, dissolution.
Aforesaid operations environment is taked lucifuge measure, and the daylight lamp pad pasting between production operation, weakens light, avoids strong illumination.
Comparative example 1 body of Pramipexole dihydrochloride sheet---prepare with reference to patent application CN201110119071 method
Prescription:
1) take 5g maltodextrin and be added in stainless steel cask, add purified water 25g, stirring and dissolving;
2) the pramipexole two hydrochloride monohydrate 250mg that take batch consumption add in the aqueous solution of the maltodextrin preparing, and stir to obtain clear and bright solution;
3) successively mannitol, pregelatinized Starch and the microcrystalline Cellulose of batch consumption are poured in high speed wet granulator and mixed;
4) add the maltodextrin solution of hydrochloric pramipexole to granulate;
5) dry, control loss on drying and be less than 2.0%;
6) dry granule is crossed 20 mesh sieve granulate, then adds silicon dioxide and the magnesium stearate of Extra Section, mixes;
7) tabletting;
8) adopt the hard sheet of shading PVC and PTP aluminum-plastic blister, select qualified aluminium-plastic panel, check the projects such as content, related substance, uniformity of dosage units, dissolution.
The assay method of embodiment 5 pramipexole sheet related substances
Measure according to high performance liquid chromatography (two annex V D of Chinese Pharmacopoeia version in 2010).
Adopt C18 (125mm; 4.6mm) chromatographic column; mobile phase A is phosphate buffered solution (900mL water; 9.1g potassium dihydrogen phosphate, 0.5g perfluoroetane sulfonic acid sodium hydrate, phosphoric acid,diluted is adjusted pH to 3.0; be diluted with water to 1000ml); Mobile phase B is the mixed solvent of acetonitrile and buffer solution (acetonitrile: buffer solution 200:800), adopts gradient elution (0.01min, 20%B; 15.0min, 80%B), flow velocity 1.5mL/min, detects wavelength 264nm, 40 DEG C of column temperatures, sample size 100 μ l.
Embodiment 6 related substances are investigated
The related substance of the pramipexole sheet that the whole bag of tricks is made detects, and the results are shown in Table 1
Table 1 pramipexole sheet related substance detects
"/" represents not survey, and " commercially available " is purchased from Boehringer Ingelheim company.Every kind of sample test 3 times above.
Result demonstration, body of Pramipexole dihydrochloride sheet related substance of the present invention significantly reduces, and dissolution and uniformity of dosage units all meet the requirements.Although specific embodiment of the invention scheme is described, those skilled in the art will appreciate that under the prerequisite that does not depart from scope of the present invention or spirit and can carry out multiple change and modification to the present invention.Thereby, this invention is intended to contain all these changes and modification of dropping within the scope of claims and coordinate thereof.
Claims (10)
1. a method of preparing pramipexole tablet, the method includes the steps of:
1) 1 weight portion starch is slowly suspended in 1-9 parts by weight solvent, fully swelling, disperse, stir after filtration drying;
2) repeating step 1) 1-6 time;
3) by pramipexole, step 2) gained starch, mannitol, silicon dioxide and magnesium stearate sieving for standby respectively;
4) take the pramipexole of step 3) and the starch of step 3) of aequum, with the abundant mix homogeneously of equivalent incremental method, make mixed powder;
5) take the mannitol of the step 3) of aequum, join in above-mentioned mixed powder, fully mix homogeneously;
6) take the polyvinylpyrrolidone of aequum, add 50 % by weight dissolve with ethanol solutions, make after the polyvinylpyrrolidone alcoholic solution of 5%-10% weight, add in the mixed powder of step 5) gained, granulate;
7) dry, make pellet moisture be controlled at 2 % by weight with interior and granulate;
8) add magnesium stearate and the silicon dioxide of the step 3) of aequum, fully mix;
9) tabletting.
2. according to the process of claim 1 wherein that the solvent described in step 1) is selected from the mixture of water and alcohol, is preferably the mixture of water and ethanol.
3. according to the process of claim 1 wherein that the solvent described in step 1) is the ethanol-water mixture of 10 % by weight-60 % by weight, is preferably the ethanol-water mixture of 40 % by weight-50 % by weight.
4. according to the method for any one of claim 1-3, wherein step 3)-step 8) completes in lucifuge environment.
5. a pramipexole tablet, its method by claim 1-4 makes, and is less than 0.5% with weight of formulation in respect of the content of related substance in described preparation.
6. according to the pramipexole tablet of claim 5, this tablet is composed of the following components:
7. according to the pramipexole tablet of claim 5 or 6, wherein the content of related substance is less than 0.3%.
8. according to the pramipexole tablet of claim 7, wherein the content of related substance is less than 0.2%.
According to the pramipexole tablet of any one of claim 5-8 in the application in parkinsonian medicine for the preparation for the treatment of.
10. the application in the medicine for the preparation for the treatment of restless legs syndrome according to the pramipexole tablet of any one of claim 5-8.
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| CN201310043307.5A CN103961325B (en) | 2013-02-03 | 2013-02-03 | The preparation method of Pramipexole tablet and thus obtained tablet and its application |
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| CN201310043307.5A CN103961325B (en) | 2013-02-03 | 2013-02-03 | The preparation method of Pramipexole tablet and thus obtained tablet and its application |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030036548A1 (en) * | 2001-08-10 | 2003-02-20 | Boehringer Ingelheim Pharma Kg | Method for treating anhedonia using dopamine agonists |
| CN101125128A (en) * | 2002-07-25 | 2008-02-20 | 法玛西雅公司 | Sustained-release tablet composition of pramipexole |
| EP2295040A1 (en) * | 2009-09-11 | 2011-03-16 | Sanovel Ilac Sanayi ve Ticaret A.S. | Pharmaceutical compositions of pramipexole |
| KR20110104374A (en) * | 2010-03-16 | 2011-09-22 | 성균관대학교산학협력단 | Preparation method of pramipexole formulation with excellent storage stability |
-
2013
- 2013-02-03 CN CN201310043307.5A patent/CN103961325B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030036548A1 (en) * | 2001-08-10 | 2003-02-20 | Boehringer Ingelheim Pharma Kg | Method for treating anhedonia using dopamine agonists |
| CN101125128A (en) * | 2002-07-25 | 2008-02-20 | 法玛西雅公司 | Sustained-release tablet composition of pramipexole |
| EP2295040A1 (en) * | 2009-09-11 | 2011-03-16 | Sanovel Ilac Sanayi ve Ticaret A.S. | Pharmaceutical compositions of pramipexole |
| KR20110104374A (en) * | 2010-03-16 | 2011-09-22 | 성균관대학교산학협력단 | Preparation method of pramipexole formulation with excellent storage stability |
Non-Patent Citations (2)
| Title |
|---|
| 孟胜男主编: "《药剂学》", 31 January 2012 * |
| 金征宇，等编著: "《碳水化合物化学——原理与应用》", 31 January 2008 * |
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Effective date of registration: 20200401 Address after: No.99 Yunliang Hexi Road, Qilin science and Technology Innovation Park, Jiangning District, Nanjing City, Jiangsu Province Patentee after: Nanjing Shenghe pharmaceutical research and Development Co., Ltd Address before: 210038 No. 9 Zhong Hui Road, Nanjing economic and Technological Development Zone, Jiangsu Patentee before: NANJING SANHOME PHARMACEUTICAL Co.,Ltd. |