CN105147627A - Medicine composition containing pramipexole dihydrochloride and preparation method thereof - Google Patents
Medicine composition containing pramipexole dihydrochloride and preparation method thereof Download PDFInfo
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- CN105147627A CN105147627A CN201510512655.1A CN201510512655A CN105147627A CN 105147627 A CN105147627 A CN 105147627A CN 201510512655 A CN201510512655 A CN 201510512655A CN 105147627 A CN105147627 A CN 105147627A
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- pramipexole dihydrochloride
- silica gel
- magnesium stearate
- micropowder silica
- microcrystalline cellulose
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Abstract
The invention relates to medicine composition containing pramipexole dihydrochloride and a preparation method thereof. The composition is orally disintegrating tablets and comprises components in percentage by weight in the specification. The preparation process of the pramipexole dihydrochloride orally disintegrating tablets is simple, and the pramipexole dihydrochloride orally disintegrating tablets taste good, have better compliance for medicine taking by comparison with products on the current market and are especially suitable for the special population such as the old, people who have difficulty in swallowing and the like.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, be specifically related to a kind of pharmaceutical composition containing body of Pramipexole dihydrochloride and preparation method thereof.
Background technology
Body of Pramipexole dihydrochloride is a kind of dopamine-receptor stimulant.
Chemical formula is as follows:
S amino-4,5,6, the 7-tetrahydrochysene-6-propylamine-benzothiazoles of ()-2-, molecular formula is C
10h
19c
l2n
3s.H
2o, molecular weight is 302.27.
Conventional body of Pramipexole dihydrochloride one hydration two hydrochloric acid in preparation.
Body of Pramipexole dihydrochloride is pharmacologically being full agonist and is having receptor-selective to the dopamine D 2 family of dopamine receptor.Be used for the treatment of the disease such as parkinson and restless legs syndrome.At present, listing dosage form has ordinary tablet and slow releasing tablet, listing specification is more, ordinary tablet has multiple specification such as 0.125mg, 0.25mg, 0.5mg, 0.75mg, 1mg and 1.5mg, and body of Pramipexole dihydrochloride slow releasing tablet has multiple specification such as 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg and 4.5mg.Listing oral solid formulation is conventional tablet and slow releasing tablet.
Parkinsonian gerontal patient, ubiquity swallows the comparatively difficult problem of medicine, so need the tablet of swallowed whole to have inconvenience in gerontal patient's drug administration process.Oral cavity disintegration tablet compared with ordinary tablet, without the need to water also without the need to chewing, be placed in by medicine on tongue, running into saliva rapid disintegrate can become fine particle, enters stomach along with swallowing saliva.Drug-eluting speed is fast, so have rapid-action, that bioavailability is high characteristic.
At present, not yet have the open source information of body of Pramipexole dihydrochloride oral cavity disintegration tablet, the present inventor attempts body of Pramipexole dihydrochloride to be prepared into oral cavity disintegration tablet, but finds in preparation process, and the poor compatibility of many adjuvants and body of Pramipexole dihydrochloride cannot reach formulation requirements.For this reason, the present inventor screens the adjuvant related to, and has found that a kind of formula is particularly suitable for body of Pramipexole dihydrochloride oral cavity disintegration tablet unexpectedly, and gained oral cavity disintegration tablet can fater disintegration in 30 seconds.
Summary of the invention
The invention provides a kind of pharmaceutical composition of body of Pramipexole dihydrochloride, and be prepared into oral cavity disintegration tablet further, improve body of Pramipexole dihydrochloride dissolution rate in an aqueous medium, and oral cavity disintegration tablet is difficult to swallow the parkinson of full wafer medicine moderate or severe symptomatic or the most preferred dosage form of parkinsonism patient.
For this reason, the invention provides a kind of body of Pramipexole dihydrochloride pharmaceutical composition, the percentage by weight of each component is as follows:
Wherein, described filler is selected from: lactose, mannitol, microcrystalline Cellulose, pregelatinized Starch one or several; Described disintegrating agent is selected from: one or several of low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium; Described lubricant is magnesium stearate; Described fluidizer is micropowder silica gel; Described correctives is selected from: aspartame, steviosin.
Preferably, pharmaceutical composition of the present invention, the percentage by weight of each component is as follows:
The present invention also provides the preparation method of pharmaceutical composition of the present invention, and comprise preparation method A and B, particular content is as follows:
Described preparation method A, particular content is as follows:
(1) each material is crossed 80-200 mesh sieve respectively;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with filler;
(3) optional disintegrating agent, correctives, fluidizer are joined in the mixture of step (2), mix homogeneously;
(4) added by optional lubricant in the mixture of step (3), mix homogeneously, tabletting, to obtain final product.
Described preparation method B, particular content is as follows:
(1) each material is crossed 80-200 mesh sieve respectively;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with filler;
(3) optional filler, disintegrating agent, correctives are joined in the mixture of step (2), mix homogeneously;
(4) mixture of step (3) is granulated by dry granulating machine, after granulation, add fluidizer, mix lubricant is even, tabletting, obtained body of Pramipexole dihydrochloride oral cavity disintegration tablet.
Particularly preferred pharmaceutical composition of the present invention, composed as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.125 |
| Lactose | 50 |
| Microcrystalline Cellulose | 35 |
| Cross-linking sodium carboxymethyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Aspartame | 1 |
| Make altogether | 1000 |
。
Or
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.25 |
| Mannitol | 50 |
| Microcrystalline Cellulose | 30 |
| Cross-linking sodium carboxymethyl cellulose | 5 |
| Low-substituted hydroxypropyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Aspartame | 1 |
| Make altogether | 1000 |
。
Or
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.5 |
| Mannitol | 50 |
| Microcrystalline Cellulose | 30 |
| Polyvinylpolypyrrolidone | 5 |
| Low-substituted hydroxypropyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Steviosin | 1 |
| Make altogether | 1000 |
。
Or
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.75 |
| Pregelatinized Starch | 40 |
| Microcrystalline Cellulose | 40 |
| Low-substituted hydroxypropyl cellulose | 12 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
| Make altogether | 1000 |
。
Or
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 1 |
| Lactose | 40 |
| Microcrystalline Cellulose | 40 |
| Polyvinylpolypyrrolidone | 3 |
| Low-substituted hydroxypropyl cellulose | 7 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
。
Or
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 1.5 |
| Lactose | 45 |
| Microcrystalline Cellulose | 35 |
| Carboxymethyl starch sodium | 5 |
| Low-substituted hydroxypropyl cellulose | 12 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
| Make altogether | 1000 |
。
Most preferred pharmaceutical composition of the present invention, composed as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.5 |
| Mannitol | 50 |
| Microcrystalline Cellulose | 30 |
| Polyvinylpolypyrrolidone | 5 |
| Low-substituted hydroxypropyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Steviosin | 1 |
| Make altogether | 1000 |
。
The present invention relates to the specification of body of Pramipexole dihydrochloride, comprise all listing specifications of body of Pramipexole dihydrochloride sheet, multiple specification such as such as 0.125mg, 0.25mg, 0.5mg, 0.75mg, 1mg and 1.5mg etc.
The body of Pramipexole dihydrochloride oral cavity disintegration tablet that the present invention relates to, has carried out medicine and the research of selecting the adjuvant compatibility.The lactose used in prescription, mannitol, microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium are mixed homogeneously than the ratio being respectively (5:1) with principal agent; Magnesium stearate, micropowder silica gel, aspartame, steviosin mix than the ratio being respectively (1:20) with principal agent, illumination be 4500Lx ± 500Lx, 40 DEG C and 60 DEG C of calorstats, relative humidity 75%, relative humiditys 92.5% place 10 days, in sampling in 5 and 10 days; Measure lactose, mannitol, microcrystalline Cellulose, pregelatinized Starch, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, magnesium stearate, micropowder silica gel, aspartame by prescription, steviosin mix homogeneously makes blank full adjuvant and principal agent compares for 5:1, mix homogeneously, place 10 days under the same conditions, in sampling in 5 and 10 days; Separately get body of Pramipexole dihydrochloride to place under the same conditions, observe outward appearance, measure related substance (with area normalization method calculate), and with crude drug 0 day results contrast.The results are shown in Table 1-table 14.
Table 1 body of Pramipexole dihydrochloride related substance measurement result
The compatibility determination of related substances result of the full adjuvant of table 2 and principal agent
The compatibility determination of related substances result of table 3 lactose and principal agent
The compatibility determination of related substances result of table 4 mannitol and principal agent
The compatibility determination of related substances result of table 5 microcrystalline Cellulose and principal agent
The compatibility determination of related substances result of table 6 pregelatinized Starch and principal agent
The compatibility determination of related substances result of table 7 low-substituted hydroxypropyl cellulose and principal agent
The compatibility determination of related substances result of table 8 polyvinylpolypyrrolidone and principal agent
The compatibility determination of related substances result of table 9 cross-linking sodium carboxymethyl cellulose and principal agent
The compatibility determination of related substances result of table 10 carboxymethyl starch sodium and principal agent
The compatibility determination of related substances result of table 11 micropowder silica gel and principal agent
The compatibility determination of related substances result of table 12 aspartame and principal agent
The compatibility determination of related substances result of table 13 steviosin and principal agent
The compatibility determination of related substances result of table 14 magnesium stearate and principal agent
The body of Pramipexole dihydrochloride oral cavity disintegration tablet that the present invention relates to, comprise the screening that component all carries out supplementary material compatibility test, prescription kind and consumption screening in table 15, the selection result is in table 16.
Table 15 prescription consumption screens
Table 16 prescription screening result
The prescription of the body of Pramipexole dihydrochloride oral cavity disintegration tablet that the present invention relates to, wherein optimizing prescriptions 6 ~ prescription 11.
Body of Pramipexole dihydrochloride oral cavity disintegration tablet disclosed by the invention has the advantage of at least one aspect following:
(1) rapid disintegrate dispersion in mouth, and without obvious grittiness;
(2) ifs vitro disintegration is rapid, is uniformly dispersed in 20 seconds;
(3) dissolution rate is fast, and dissolution is high, and 5min dissolution reaches more than 90%;
(4) preparation technology is simple, and cost is lower, is applicable to suitability for industrialized production.
Detailed description of the invention
By following examples, the invention will be further elaborated in the present invention, but be not limited to following embodiment.
The tablet of following embodiment compacting, all carries out tabletting with the tablet machine of same model.
The preparation of embodiment 1 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 0.125mg, and its prescription is
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.125 |
| Lactose | 50 |
| Microcrystalline Cellulose | 35 |
| Cross-linking sodium carboxymethyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Aspartame | 1 |
| Make altogether | 1000 |
Preparation technology:
(1) respectively lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, magnesium stearate, micropowder silica gel and aspartame are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with lactose;
(3) microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, micropowder silica gel, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) magnesium stearate added in the mixture of step (3), mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 2 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 0.25mg, and its prescription is as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.25 |
| Mannitol | 50 |
| Microcrystalline Cellulose | 30 |
| Cross-linking sodium carboxymethyl cellulose | 5 |
| Low-substituted hydroxypropyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Aspartame | 1 |
| Make altogether | 1000 |
Preparation technology:
(1) respectively mannitol, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, micropowder silica gel and aspartame are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with mannitol;
(3) microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, micropowder silica gel, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) magnesium stearate added in the mixture of step (3), mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 3 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 0.5mg, and its prescription is as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.5 |
| Mannitol | 50 |
| Microcrystalline Cellulose | 30 |
| Polyvinylpolypyrrolidone | 5 |
| Low-substituted hydroxypropyl cellulose | 10 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1.5 |
| Steviosin | 1 |
| Make altogether | 1000 |
Preparation technology:
(1) respectively mannitol, microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, magnesium stearate, micropowder silica gel and steviosin are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with mannitol;
(3) microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, micropowder silica gel, steviosin are joined in the mixture of step (2), mix homogeneously;
(4) magnesium stearate added in the mixture of step (3), mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 4 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 0.75mg, and its prescription is as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 0.75 |
| Pregelatinized Starch | 40 |
| Microcrystalline Cellulose | 40 |
| Low-substituted hydroxypropyl cellulose | 12 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
| Make altogether | 1000 |
Preparation technology:
(1) respectively 80 mesh sieves are crossed in pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica gel, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with pregelatinized Starch;
(3) microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) mixture of step (3) is carried out granulation and granulate by dry granulating machine.
(5) add in the mixture of step (3) by micropowder silica gel, magnesium stearate, mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 5 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 1mg, and its prescription is as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 1 |
| Lactose | 40 |
| Microcrystalline Cellulose | 40 |
| Polyvinylpolypyrrolidone | 3 |
| Low-substituted hydroxypropyl cellulose | 7 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
Preparation technology:
(1) respectively lactose, microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, magnesium stearate, micropowder silica gel and aspartame are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with lactose;
(3) microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) mixture of step (3) is carried out granulation and granulate by dry granulating machine.
(5) add in the mixture of step (3) by micropowder silica gel, magnesium stearate, mix homogeneously, tabletting, to obtain final product.
The preparation of embodiment 6 body of Pramipexole dihydrochloride oral cavity disintegration tablet
In 1000 dosage units, and each dosage unit contains the body of Pramipexole dihydrochloride of 1.5mg, and its prescription is as follows:
| Components Name | Consumption (g) |
| Body of Pramipexole dihydrochloride | 1.5 |
| Lactose | 45 |
| Microcrystalline Cellulose | 35 |
| Carboxymethyl starch sodium | 5 |
| Low-substituted hydroxypropyl cellulose | 12 |
| Magnesium stearate | 1.5 |
| Micropowder silica gel | 1 |
| Aspartame | 1 |
| Make altogether | 1000 |
Preparation technology:
(1) respectively lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, micropowder silica gel and aspartame are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with lactose;
(3) microcrystalline Cellulose, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, micropowder silica gel, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) mixture of step (3) is carried out granulation and granulate by dry granulating machine.
(5) add in the mixture of step (3) by micropowder silica gel, magnesium stearate, mix homogeneously, tabletting, to obtain final product.
Test example 1: the disintegration of oral cavity disintegration tablet checks
Get 2ml water (37 DEG C) and be placed in 5ml test tube, add body of Pramipexole dihydrochloride oral cavity disintegration tablet, start timing, independently fine particle is shattered into all collapsing, completely by 30 mesh sieves, record disintegration time, shaking test tube is not wanted in disintegrating procedue, get 6 to detect, get its meansigma methods, disintegration the results are shown in Table 15 at every turn.
Test example 2: the friability inspection of oral cavity disintegration tablet
Test under " tablet friability inspection technique " item according in Chinese Pharmacopoeia 2010 editions two annex XG.Friability result table 15.
Test example 3: stripping curve measures
Measure according to the second method in dissolution method (" Chinese Pharmacopoeia " 2010 editions two annex XC), be specially:
(1) dissolution medium: pH6.8 citrate/phosphate buffer: 500mL; (2) temperature: 37 DEG C ± 0.5 DEG C;
(3) slurry processes: rotating speed is 50 revs/min.(4) determined wavelength: 230nm; (5) sample point: 5,10,15 and 30min.Stripping curve the results are shown in Table 17.
Test example 4: related substance is investigated
Be filler (150mm × 4.6mm, 5 μm) with octadecylsilane chemically bonded silica; Mobile phase A is potassium phosphate buffer (pH3.0) (takes 5.0g perfluoroetane sulfonic acid sodium-hydrate and 9.1g potassium dihydrogen phosphate to put in 900ml water and dissolve, by phosphoric acid adjust ph 3.0, be diluted with water to 1000ml); Mobile phase B is acetonitrile-potassium phosphate buffer (pH3.0) (50:50), gradient, and flow velocity is 1.5ml/min; Determined wavelength is 264nm; Column temperature 40 DEG C ± 5 DEG C, sample size 100 μ l.Related substance the results are shown in Table 18.
Disintegration of table 17 body of Pramipexole dihydrochloride oral cavity disintegration tablet, friability and stripping curve measurement result
The determination of related substances result of table 18 body of Pramipexole dihydrochloride oral cavity disintegration tablet
Claims (10)
1. a body of Pramipexole dihydrochloride pharmaceutical composition, is characterized in that, the percentage by weight of each component is as follows:
Its preparation method, step is as follows:
(1) each material is crossed 80-200 mesh sieve respectively;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with filler;
(3) disintegrating agent, correctives, fluidizer are joined in the mixture of step (2), mix homogeneously;
(4) added by lubricant in the mixture of step (3), mix homogeneously, tabletting, to obtain final product;
Wherein, described filler is selected from: lactose, mannitol, microcrystalline Cellulose, pregelatinized Starch one or several; Described disintegrating agent is selected from: one or several of low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium; Described lubricant is magnesium stearate; Described fluidizer is micropowder silica gel; Described correctives is selected from: aspartame, steviosin.
2. pharmaceutical composition as claimed in claim 1, it is characterized in that, the percentage by weight of each component is as follows:
3. pharmaceutical composition as claimed in claim 1, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
4. pharmaceutical composition as claimed in claim 1, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
5. pharmaceutical composition as claimed in claim 1, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
6. pharmaceutical composition as claimed in claim 2, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
7. pharmaceutical composition as claimed in claim 2, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
8. pharmaceutical composition as claimed in claim 2, it is characterized in that, described oral cavity disintegration tablet is composed as follows:
。
9. the arbitrary pharmaceutical composition as described in claim 3-5, is characterized in that, described Orally disintegrating piece preparation method is as follows:
(1) respectively mannitol, microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, magnesium stearate, micropowder silica gel and steviosin are crossed 80 mesh sieves, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with mannitol;
(3) microcrystalline Cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, micropowder silica gel, steviosin are joined in the mixture of step (2), mix homogeneously;
(4) magnesium stearate added in the mixture of step (3), mix homogeneously, tabletting, to obtain final product.
10. the arbitrary pharmaceutical composition as described in claim 3-5, is characterized in that, described Orally disintegrating piece preparation method is as follows:
(1) respectively 80 mesh sieves are crossed in pregelatinized Starch, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate and micropowder silica gel, body of Pramipexole dihydrochloride crosses 200 mesh sieves;
(2) by even for each mixing of materials.During mixing, body of Pramipexole dihydrochloride is mixed by the equivalent method of progressively increasing with pregelatinized Starch;
(3) microcrystalline Cellulose, low-substituted hydroxypropyl cellulose, aspartame are joined in the mixture of step (2), mix homogeneously;
(4) mixture of step (3) is carried out granulation and granulate by dry granulating machine.
(5) add in the mixture of step (3) by micropowder silica gel, magnesium stearate, mix homogeneously, tabletting, to obtain final product.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107789327A (en) * | 2016-09-07 | 2018-03-13 | 成都康弘药业集团股份有限公司 | A kind of pharmaceutical composition containing hydrobromic acid Wo Saiting and preparation method thereof |
| CN107789327B (en) * | 2016-09-07 | 2020-06-02 | 成都康弘药业集团股份有限公司 | Pharmaceutical composition containing vortioxetine hydrobromide 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 |
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