CN103271890B - Hydrochloric acid pramipexole capsule and preparation method thereof - Google Patents
Hydrochloric acid pramipexole capsule and preparation method thereof Download PDFInfo
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- CN103271890B CN103271890B CN201310258182.8A CN201310258182A CN103271890B CN 103271890 B CN103271890 B CN 103271890B CN 201310258182 A CN201310258182 A CN 201310258182A CN 103271890 B CN103271890 B CN 103271890B
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Abstract
The invention discloses a hydrochloric acid pramipexole capsule and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. Each capsule comprises 0.125-0.5mg hydrochloric acid pramipexole, 20-50mg starch, 40-70mg mannitol, 5-10mg polylactic acid, 1.5-3mg povidone K30, 0.5-2mg silicon dioxide and 0.5-2mg magnesium stearate. The preparation method comprises the following steps of uniformly mixing mannitol and the starch at an appropriate amount, adding an adhesive solution dissolved with a main drug, pelletizing, drying, granulating, adding a surplus auxiliary material, encapsulating, and obtaining the capsule.
Description
Technical field
The present invention relates to a kind of preparation of pharmaceutical preparation, particularly a kind of hydrochloric acid pramipexole capsule and preparation method thereof.
Technical background
Pramipexole is the non-Ergota class dopamine-receptor stimulant of a new generation that German Boehringer Ingelheim company develops, d2 dopamine receptor can be acted on high selectivity, be used for the treatment of parkinson disease, be disclosed in US Patent No. 4731374, US4843086 and US4886812 at first, and go on the market in July, 1997 in the U.S., commodity are called MIRAPEX
and SIFROL
.The dosage form of current listing has ordinary tablet and slow releasing tablet, and wherein the specification of ordinary tablet has: 0.125mg, 0.25mg, 0.5mg, 1.0mg, 1.5mg.The specification of slow releasing tablet has: 0.375mg, 0.75mg, 1.5mg, 3.0mg, 4.5mg.
The chemical name of pramipexole is amino-4,5,6, the 7-tetrahydrochysene-6-(propylcarbamic of S-2-)-benzothiazole, molecular formula C
10h
17n
3s, relative molecular weight 211.33.Chemical formula is as follows:
Pramipexole can be used alone treatment parkinson disease in early days, and late period can share treatment parkinson disease with dopamine.Pramipexole oral absorption is complete rapidly.Absolute bioavailability is higher than 90%, and maximal plasma concentration occurs between 1-3 hour after the tablet has been ingested.Take the degree that can not reduce pramipexole absorption together with food, but its absorption rate can be reduced.Pramipexole demonstrates linear kinetics feature, and between patient, blood plasma level difference is very little.In young and old people's body, pramipexole removes the half-life (t1/2) from 8-12 hour not etc., is the main removing approach of pramipexole with original shape from renal excretion.
In current listing preparation, normally used compound form is body of Pramipexole dihydrochloride, and body of Pramipexole dihydrochloride is the monohydrate that pramipexole contains two salt acid molecules, and chemical formula is C
10h
17n
3s.2HCl.H
2o, relative molecular weight 302.27.Body of Pramipexole dihydrochloride is white or off-white color crystalline powder, soluble in water, dissolves in methanol, indissoluble or be slightly soluble in ethanol (96%), almost insoluble in dichloromethane, highly stable time solid-state, but be in solution or when mixing mutually with other adjuvants and then there is heliosensitivity.
Preparation of body of Pramipexole dihydrochloride disclosed in currently available technology and preparation method thereof is listed below:
1, Boehringer Ingelheim Pharma KG's (publication number: CN101505734A, US2008254118A1) discloses a kind of method preparing the pramipexole dihydrochloride tablets with high storage stability.Consist of by the adjuvant preparing tablet described in patent: mannitol-D, corn starch, 30 POVIDONE K 30 BP/USP 25, colloidal silica, magnesium stearate.The domestic silica colloidal not having pharmaceutical grade, needs dependence on import at present, can increase pharmaceutical production cost.Be preferably the mixture of δ crystal modification and β crystal modification by patent requirements mannitol-D, preferred β crystal modification is between 2.5% and 10%, and this patent improves the compressibility of tablet by preferred mannitol-D.We prepare tablet with the mannitol that domestic routine uses according to method described in patent, there is poor compressibility, not the shortcoming of easy-formation in tableting processes.In addition the patent that the said firm also applies for has: " comprise the prolongation release tablet of pramipexole or its acceptable salts, and preparation method thereof " (publication number: CN101005830A), " comprising prolongation release pellet formulation, the Its Preparation Method And Use of pramipexole or its acceptable salts " (publication number: CN101022788A; US2009130197A1), " transdermal therapeutic system containing pramipexole activating agent " (publication number: CN1826113A).
2, pramipexole is used for the treatment of parkinson disease, user mostly is old people, forgetful or the situation of dysphagia may be there is for old people, therefore the body of Pramipexole dihydrochloride slow releasing preparation developed is also relatively many, except the preparation that above-mentioned Boehringer Ingelheim Pharma KG develops, also has Pharmacia Corp's " dosage form once a day of pramipexole " (publication number: CN1671381A in addition; US2005175691A1), " sustained-release tablet composition of pramipexole " (publication number: CN1671382A; US2005226926A1), Tianheng Medicinal Inst., Beijing " body of Pramipexole dihydrochloride osmotic pump type controlled release tablets " (application publication number: CN102670550A), Shenzhen Haiwang Pharmaceutical Co., Ltd " body of Pramipexole dihydrochloride slow releasing tablet and preparation method thereof " (application publication number: CN102406626A).Hyundai pharmaceutical Co. Ltd " SUSTAINED-RELEASE PHARMACEUTICAL COMPOSITION COMPRISING PRAMIPEXOLE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF HAVING IMPROVED STABILITY " (KR20120003278A), LUPIN LTD company of India " EXTENDED RELEASE FORMULATION OF PRAMIPEXOLE " (WO2011148243A1).The patent of pramipexole dispersible tablet has Beijing DeZhong Wanquan Drug Technology Development Co., Ltd's " comprising the pharmaceutical composition that can disperse in mouth of pramipexole " (application publication number: CN101766605A), Beijing Cheng Chuankang rhythm Pharmaceutical Technology Co., Ltd " pramipexole orally disintegrating tablets and preparation method thereof " (publication number: CN101401796A), SANOVEL ILAC SANAYI VE TICARET A S " Orally disintegrating compositions of pramipexole " (TR20090007554).
No matter above-mentioned patented invention is the hypromellose, ethyl cellulose, the carbomer that use in slow releasing tablet, or the adjuvant such as superdisintegrantes cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone generally used in dispersible tablet depends on import all in a large number, not only increase pharmaceutical production cost, cause selling price to remain high, and product adjuvant source in large-scale production process can be made to be subject to a definite limitation.
Patent EP2462925A1 provides a kind of method preparing conventional pramipexole tablet, adjuvant used is identical with the patent CN101505734A that Boehringer Ingelheim Pharma KG applies in China, preparation method is similar, has done more detailed requirement in the grain shape only after fluid bed drying.Patent " pramipexole preparation and preparation method thereof " (application publication number: CN102772403A) of Zhejiang Jingxin Pharmaceutical Co., Ltd's application provides the preparation method of a kind of conventional pramipexole tablet and capsule, for tablet in inventor's embodiment prescription, introduce microcrystalline Cellulose, by the ratio of adjustment mannitol, pregelatinized Starch and microcrystalline Cellulose, improve compression molding.High spot reviews sample is at 25 DEG C, under relative humidity 75% condition, the situation of sample moisture absorption weightening finish in 10 days, show sample moisture absorption degree is lower than Sen Fuluo, place under accelerated test condition 4 weeks compared with 0 day sample size, related substance, dissolution all there is not significant change, and inventor determines, and the average sheet of sample is heavy, tablet weight variation does not detect the uniformity of dosage units of sample.
But above-mentioned patent does not mention an importance, the i.e. uniformity problems of content, because body of Pramipexole dihydrochloride content is in the formulation extremely low, therefore to preparation method, particularly mixing homogeneity requires high, existing hybrid technology is difficult to reach Chinese Pharmacopoeia requirement, and the present invention, through research, finds a kind of preparation method of hydrochloric acid pramipexole capsule.
Although the hydrochloric acid pramipexole capsule prepared through the inventive method overcomes homogeneity question, but the thing followed is that the dissolution of product is not ideal enough, the granule simultaneously prepared is frangible, poor stability, the present invention is through screening, find to add the dissolution that a certain amount of polylactic acid can increase capsule, solve the problem of the frangible and poor stability of granule simultaneously.
Summary of the invention
The object of the present invention is to provide a kind of preparation method of hydrochloric acid pramipexole capsule, for small dimension preparation, uniformity of dosage units is the key evaluation index of this product in preparation process, and hydrochloric acid pramipexole capsule prepared by this method possesses technique simple and stable advantage with low cost.
Hydrochloric acid pramipexole capsule of the present invention, is characterized in that every hydrochloric pramipexole 0.125mg ~ 0.5mg, starch 20mg ~ 50mg, mannitol 40mg ~ 70mg, polylactic acid 5mg ~ 10mg, PVP K30 1.5mg ~ 3mg, silicon dioxide 0.5mg ~ 2mg, magnesium stearate 0.5mg ~ 2mg.
The preparation method of hydrochloric acid pramipexole capsule, is made up of following steps successively:
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, add after dissolving after body of Pramipexole dihydrochloride dissolves and obtain binder solution.
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved and is granulated or fast Speed mixer.
(4) by step (3) wet granular in 55-60 DEG C dry 1 ~ 4 hour, or fluid bed airpillow-dry.
(5) get dry rear granule and cross 16 mesh sieve granulate, add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule.
In the preparation process of above-mentioned hydrochloric acid pramipexole capsule, in step (2), polyvidone k30 water dissolution is made into the aqueous solution of polyvidone k30, and its concentration is 5%-10%.In step (2), in binder solution, principal agent body of Pramipexole dihydrochloride concentration is 0.5% ~ 4%(m/v), in step (2), the weight of binder solution is 20% ~ 40% of mixed grain weight amount in step (1).
The inlet temperature 50 DEG C ~ 60 DEG C of fluid bed airpillow-dry in step (4), temperature of charge 30 DEG C ~ 50 DEG C.
Specification of the present invention has 0.125mg, 0.25mg and 0.5mg.Require according to Chinese Pharmacopoeia version in 2010: unless otherwise specified, tablet, hard capsule or injectable sterile powder, each labelled amount is not more than 25mg or drug content is not more than 25% of each weight; The soft capsule of the non-uniform solution of content, the oral administration mixed suspension of unit dose package, logical skin patch, inhalant and suppository, all should check uniformity of dosage units.Good in order to show according to hydrochloric acid pramipexole capsule uniformity of dosage units of the present invention, we carry out uniformity of dosage units detection to the hydrochloric acid pramipexole capsule that embodiment 1 and embodiment 2 obtain, reference preparation is commercially available product body of Pramipexole dihydrochloride sheet, while carrying out uniformity of dosage units investigation, the present inventor has also carried out multinomial contrast effect experiment to capsule of the present invention, and regarding assay result is as follows:
Experiment one, uniformity of dosage units are investigated:
The hydrochloric acid pramipexole capsule adopting high performance liquid chromatography to obtain embodiment 1 ~ 6 and commercially available body of Pramipexole dihydrochloride sheet carry out Determination of Content Uniformity.
Chromatographic condition and system suitability: be filler with octadecylsilane chemically bonded silica: with acetonitrile-ammonium carbonate buffer (pH10.0) (20:80) for mobile phase; Determined wavelength is 262nm, and theoretical cam curve presses the calculating of body of Pramipexole dihydrochloride peak should lower than 2000.
Algoscopy: get this product 1 intragranular tolerant, put in 25ml volumetric flask (0.125mg specification) or 50ml volumetric flask (0.25mg specification) or 100ml volumetric flask (0.5mg specification), add phosphate buffer (pH3.0) appropriate, jolting makes disintegrate, jolting 15min makes body of Pramipexole dihydrochloride dissolve again, is diluted to scale, shakes up with phosphate buffer (pH3.0), centrifugal, get supernatant as need testing solution.Precision measures 20 μ l, injection liquid chromatography, record chromatogram, and precision takes body of Pramipexole dihydrochloride reference substance in right amount in addition, makes the solution of about hydrochloric pramipexole 5 μ g in every 1ml, be measured in the same method with phosphate buffer (pH3.0).By external standard method with calculated by peak area, both obtained this product every content, parallel assay 10 times, content results is as shown in table 1.
Table 1 uniformity of dosage units result
Result is as implied above, and the capsule content uniformity in embodiment 1 ~ 6 is better than reference preparation.
Experiment two, dissolution are investigated
Get this product, measure according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex X C first methods), with citrate/Lin acid Yan Huan Red liquid (pH6.8) 500ml for dissolution medium, rotating speed is 50 turns per minute, operate in accordance with the law, respectively when 5min, 10min, 20min, 30min, 45mim and 60min, get solution appropriate, filter, get subsequent filtrate as need testing solution; It is appropriate that another precision takes body of Pramipexole dihydrochloride reference substance, make in every 1ml about containing 0.25 μ g(0.125mg specification with citrate/Lin acid Yan Huan Red liquid (pH6.8)) or 0.5 μ g(0.25mg specification) or 1 μ g(0.5mg specification) solution, product solution in contrast.Except sample size is 500 μ l, measure by the chromatographic condition of Determination of Content Uniformity item, calculate the stripping quantity of every.Result is as shown in table 2.
Table 2 dissolution investigates result
| Sample | 5min | 10min | 20min | 30min | 45min | 60min |
| Embodiment 1 | 61% | 87% | 95% | 101% | 104% | 103% |
| Embodiment 2 | 58% | 82% | 97% | 100% | 103% | 105% |
| Embodiment 3 | 70% | 88% | 96% | 98% | 102% | 101% |
| Embodiment 4 | 66% | 85% | 98% | 101% | 104% | 106% |
| Embodiment 5 | 60% | 87% | 97% | 99% | 99% | 101% |
| Embodiment 6 | 63% | 85% | 99% | 101% | 100% | 102% |
| Reference preparation | 50% | 75% | 83% | 88% | 92% | 100% |
| Reference substance | 46% | 68% | 79% | 86% | 94% | 99% |
From experimental result, the hydrochloric acid pramipexole capsule in embodiment 1 ~ 6 all reaches more than 90% at the accumulation stripping quantity of 20min, and when 30min, almost all strippings, are better than reference preparation and reference substance.
The investigation of experiment three, pellet hardness
Table 3
| Sample | |
| Embodiment 1 | Good |
| Embodiment 2 | Good |
| Embodiment 3 | Good |
| Embodiment 4 | Good |
| Embodiment 5 | Good |
| Embodiment 6 | Good |
| Reference preparation | Difference |
| Reference substance | Difference |
From experimental result, the granule obtained in the hydrochloric acid pramipexole capsule in preparation embodiment 1 ~ 6, is better than the granule obtained in reference preparation and reference substance preparation process.
Experiment four, study on the stability
Experimental technique: by each embodiment sample and reference substance simulation listing packaging (aluminum-plastic packaged), simultaneously carry out accelerated test investigation (temperature 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%) with reference preparation, respectively at 0,1,2,3,6 month sampling and measuring, result of the test such as following table shows:
Table 4
From experimental result, after hydrochloric acid pramipexole capsule in embodiment 1 ~ 6 places 6 months under acceleration conditions, the related substance of each sample does not have obvious variation tendency, and reference preparation and reference substance related substance significantly increase, content reduces, from result of the test, the stability of the hydrochloric acid pramipexole capsule in embodiment 1 ~ 6 is better than reference preparation and reference substance.
Detailed description of the invention
Following embodiment for illustration of the present invention, but is not used for limiting the scope of the invention.
The preparation of [embodiment 1] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, after the body of Pramipexole dihydrochloride added dissolves, obtain binder solution after dissolving.
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved granulation.
(4) by step (3) wet granular in 55 DEG C ~ 60 DEG C dry 3 hours.
(5) get dry rear granule and cross 16 mesh sieve granulate, add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of [embodiment 2] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, after the body of Pramipexole dihydrochloride added dissolves, obtain binder solution after dissolving.
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved granulation.
(4) by step (3) wet granular in 55 DEG C ~ 60 DEG C dry 3 hours.
(5) get dry rear granule and cross 16 mesh sieve granulate, add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of [embodiment 3] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, after the body of Pramipexole dihydrochloride added dissolves, obtain binder solution after dissolving.
(3) in the mixed powder of step (1), the binder solution in step (2) is added, fast Speed mixer.
(4) step (3) wet granular is placed in fluid bed airpillow-dry, keeps being about inlet temperature 55 DEG C, temperature of charge 45 DEG C, airpillow-dry 20min.
(5) get dry rear granule and add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of [embodiment 4] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, after the body of Pramipexole dihydrochloride added dissolves, obtain binder solution after dissolving.
(3) in the mixed powder of step (1), the binder solution in step (2) is added, fast Speed mixer.
(4) step (3) wet granular is placed in fluid bed airpillow-dry, keeps being about inlet temperature 55 DEG C, temperature of charge 45 DEG C, airpillow-dry 20min.
(5) get dry rear granule and cross 16 mesh sieve granulate, add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of [embodiment 5] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, add after dissolving after body of Pramipexole dihydrochloride dissolves and obtain binder solution.
(3) in the mixed powder of step (1), the binder solution in step (2) is added, fast Speed mixer.
(4) step (3) wet granular is placed in fluid bed airpillow-dry, keeps being about inlet temperature 55 DEG C, temperature of charge 45 DEG C, airpillow-dry 20min.
(5) get dry rear granule and add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of [embodiment 6] hydrochloric acid pramipexole capsule
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, polylactic acid, crosses mix homogeneously after 80 mesh sieves, obtains mixed powder;
(2) add polyvidone k30 in aqueous, add after dissolving after body of Pramipexole dihydrochloride dissolves and obtain binder solution.
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved granulation.
(4) by step (3) wet granular in 55 DEG C ~ 60 DEG C dry 3 hours.
(5) get dry rear granule and add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
The preparation of the reference substance in experiment:
Prescription forms
Preparation technology
(1) by prescription by mannitol, starch, cross mix homogeneously after 80 mesh sieves, obtain mixed powder;
(2) add polyvidone k30 in aqueous, after the body of Pramipexole dihydrochloride added dissolves, obtain binder solution after dissolving.
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved granulation.
(4) by step (3) wet granular in 55 DEG C ~ 60 DEG C dry 3 hours.
(5) get dry rear granule and cross 16 mesh sieve granulate, add silicon dioxide, magnesium stearate, mix homogeneously.
(6) fill capsule, to obtain final product.
Claims (7)
1. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.25mg of every capsules, starch 35mg, mannitol 50mg, polylactic acid 5mg, 30 POVIDONE K 30 BP/USP
302mg, silicon dioxide 0.7mg, magnesium stearate 0.7mg.
2. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.5mg of every capsules, starch 45mg, mannitol 70mg, polylactic acid 10mg, 30 POVIDONE K 30 BP/USP
303mg, silica 1 .2mg, magnesium stearate 1.2mg.
3. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.125mg of every capsules, starch 40mg, mannitol 30mg, polylactic acid 5mg, 30 POVIDONE K 30 BP/USP
301.5mg, silicon dioxide 0.5mg, magnesium stearate 0.5mg.
4. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.125mg of every capsules, starch 32mg, mannitol 44.7mg, polylactic acid 5mg, 30 POVIDONE K 30 BP/USP
301.6mg, silicon dioxide 0.8mg, magnesium stearate 0.8mg.
5. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.25mg of every capsules, starch 40mg, mannitol 45mg, polylactic acid 10mg, 30 POVIDONE K 30 BP/USP
302mg, silicon dioxide 0.7mg, magnesium stearate 0.7mg.
6. a hydrochloric acid pramipexole capsule, is characterized in that, the hydrochloric pramipexole 0.5mg of every capsules, starch 50mg, mannitol 65mg, polylactic acid 10mg, 30 POVIDONE K 30 BP/USP
302mg, silica 1 .2mg, magnesium stearate 1.2mg.
7. the preparation method of the hydrochloric acid pramipexole capsule of any one described in claim 1-6, is characterized in that, through following steps:
(1) take mannitol, starch, polylactic acid, sieve, mix homogeneously, obtain mixed powder;
(2) 30 POVIDONE K 30 BP/USP is added in aqueous
30, add body of Pramipexole dihydrochloride after dissolving, dissolve to obtain binder solution;
(3) in the mixed powder of step (1), add the binder solution in step (2), wet method is sieved granulation;
(4) by step (3) wet granular in 55-60 DEG C dry 1 ~ 4 hour, or fluid bed airpillow-dry;
(5) get dry rear granule and cross 60 mesh sieve granulate, add residue silicon dioxide, magnesium stearate, mix homogeneously;
(6) fill capsule.
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| CN104398485B (en) * | 2014-12-10 | 2017-05-10 | 哈药集团技术中心 | Olmesartan medoxomil tablet and preparation method thereof |
| CN106619514A (en) * | 2017-02-27 | 2017-05-10 | 佛山市弘泰药物研发有限公司 | Pramipexole dihydrochloride self-microemulsion preparation and preparing method thereof |
| CN108670959A (en) * | 2018-06-30 | 2018-10-19 | 郑州明泽医药科技有限公司 | A kind of ranitidine hydrochloride capsules and preparation method thereof |
| TW202400156A (en) * | 2022-05-16 | 2024-01-01 | 大陸商四川科倫藥物研究院有限公司 | Long-acting sustained-release pramipexole preparation and method for preparing same |
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| CN102772403A (en) * | 2011-05-10 | 2012-11-14 | 浙江京新药业股份有限公司 | Preparation method for pramipexole preparation |
| CN103070829A (en) * | 2012-12-21 | 2013-05-01 | 北京万全阳光医学技术有限公司 | Medicine composition including pramipexole and active ingredients of medicinal salt and preparation method thereof |
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| WO2007072497A2 (en) * | 2005-12-02 | 2007-06-28 | Alembic Limited | Stabilized pharmaceutical composition of pramipexole and method of preparation thereof |
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| CN102772403A (en) * | 2011-05-10 | 2012-11-14 | 浙江京新药业股份有限公司 | Preparation method for pramipexole preparation |
| CN103070829A (en) * | 2012-12-21 | 2013-05-01 | 北京万全阳光医学技术有限公司 | Medicine composition including pramipexole and active ingredients of medicinal salt and preparation method thereof |
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