CN105997916A - Carbamazepine tablet and preparation method thereof - Google Patents
Carbamazepine tablet and preparation method thereof Download PDFInfo
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- CN105997916A CN105997916A CN201610569411.1A CN201610569411A CN105997916A CN 105997916 A CN105997916 A CN 105997916A CN 201610569411 A CN201610569411 A CN 201610569411A CN 105997916 A CN105997916 A CN 105997916A
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- Prior art keywords
- carbamazepine
- low viscosity
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- methyl
- tablets
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a carbamazepine tablet which is a slow-release tablet. The carbamazepine tablet is prepared by uniformly mixing medicine-containing granules and pharmaceutically acceptable auxiliary materials to obtain a mixture, and directly tabletting the mixture. The medicine-containing granules are obtained by adding carbamazepine into low-viscosity hydroxypropyl methylcellulose and an ethanol solution of alpha-methyl-L-tyrosine to form a suspension, and performing heating, drying by distillation and screening in sequence. According to the preparation disclosed by the invention, the use amount of a slow-release material is reduced; granule coating and granulation are completed in one step; medicines are released steadily; the carbamazepine tablet is suitable for industrial production.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, in particular to a kind of Carbamazepine Tablets and preparation method thereof.
Background technology
Carbamazepine is a kind of common spirituality medicine.Carbamazepine has convulsion and prosopalgic pharmacological action,
Being used clinically for: 1, epilepsy, to complex partial seizures, secondary epilepsy is most effective, to constitutional grand mal,
Simplicial subdivision outbreak and mixed type epilepsy are the most effective；2, alleviate trigeminal neuralgia and glossopharyngeal neuralgia, prevent or treat double
Tropism manic depressive illness, central component diabetes insipidus.All things considered, patient's medication every day is more frequent, again due to essence
Godhead patient needs long-term prescription, and it is the most inconvenient and painful to bring to patient and family members.
Summary of the invention
In prior art, using gelatum skeleton material as slow-release material, there is problems of early stage release fast, the later stage releases
Put not exclusively；Use insoluble framework material, it is difficult to well Drug controlled release, medicine or be difficult to discharge, or
Release is rapidly；With insoluble material coating, controlling release by coating, industrialization difficulty, differences between batches are big.
For the deficiencies in the prior art, the purpose of inventor is to study prescription and technique, it is provided that a kind of tablet weight is little,
The Carbamazepine Tablets that release is steadily, slow-release material consumption is few, for slow releasing tablet.
Specifically, the present invention is achieved through the following technical solutions:
A kind of carbamazepine sustained-release tablet, described carbamazepine sustained-release tablet is mixed with pharmaceutically acceptable adjuvant by medicine-containing particle
Even rear direct compression forms, and described medicine-containing particle is that carbamazepine joins low viscosity hypromellose, α-first
Forming suspension in the ethanol solution of base-TYR, heating is sieved after being evaporated and is obtained.
Described carbamazepine sustained-release tablet, carbamazepine and low viscosity hypromellose, the weight of alpha-Methyl-L-tyrosine
Amount amount ratio is 1-5:0.5-0.8:0.8-1.2, and the viscosity of low viscosity hypromellose is 2000-5000mPa s.
Described carbamazepine sustained-release tablet, carbamazepine and low viscosity hypromellose, the weight of alpha-Methyl-L-tyrosine
Amount amount ratio is 2:0.6:1, and the viscosity of low viscosity hypromellose is 4000mPa s.
Described carbamazepine sustained-release tablet, described pharmaceutically acceptable adjuvant includes filler and lubricant.
Described carbamazepine sustained-release tablet, described filler is selected from microcrystalline Cellulose, lactose and pregelatinized Starch
Plant or multiple.
Described carbamazepine sustained-release tablet, described lubricant one in magnesium stearate, micropowder silica gel and Pulvis Talci
Or it is multiple.
The preparation method of described carbamazepine sustained-release tablet, it is characterised in that comprise the steps:
(1) carbamazepine was pulverized 200 mesh sieves, standby；
(2) low viscosity hypromellose, alpha-Methyl-L-tyrosine are dissolved in ethanol, standby；
(3), under stirring condition, carbamazepine fine powder is joined low viscosity hypromellose, Alpha-Methyl-L-cheese ammonia
In the ethanol solution of acid, being heated by this suspension, after being evaporated, sieve, the granule after sieving is with pharmaceutically acceptable
Adjuvant mix homogeneously, tabletting.
In the present invention, inventor creative by granule coating technology with prepare granule technology and be combined, utilize medicine in difference
In solvent, the difference of dissolubility, prepares super-fine medicament particles, simultaneously by the granule coating of preparation, well controls medicine
Release.
Compared with prior art, The present invention reduces the consumption of slow-release material, granule coating and a step of pelletizing are completed, medicine
Thing release steadily, is suitable to industrialized production.
Accompanying drawing explanation
Fig. 1 is carbamazepine Cumulative release profile figure in slow releasing tablet prepared by embodiment 1.
Fig. 2 is carbamazepine Cumulative release profile figure in slow releasing tablet prepared by embodiment 2.
Fig. 3 is carbamazepine Cumulative release profile figure in slow releasing tablet prepared by embodiment 3.
Fig. 4 is carbamazepine Cumulative release profile figure in slow releasing tablet prepared by comparative example 1.
Detailed description of the invention
Following example further describe preparation process and the beneficial effect of the present invention, and embodiment is only used for the purpose of illustration,
Not limiting the scope of the invention, those of ordinary skill in the art are obviously changed according to what the present invention made and repair simultaneously
Within decorations are also contained in the scope of the invention.
Embodiment 1 carbamazepine sustained-release tablet and preparation method thereof
Take carbamazepine 500g, viscosity is the low viscosity hypromellose 150g of 5000mPa s, Alpha-Methyl-L-cheese
Propylhomoserin 250g, ethanol 600g, microcrystalline Cellulose 100g, magnesium stearate 7g, the carbamazepine weighing recipe quantity is pulverized
Cross 200 mesh sieves, weigh the low viscosity hypromellose of recipe quantity, alpha-Methyl-L-tyrosine dissolving in ethanol；Stir
Under the conditions of mixing, carbamazepine powder is joined the ethanol solution of low viscosity hypromellose, alpha-Methyl-L-tyrosine
In, this suspension being heated to 80 DEG C, after being slowly evaporated, crosses 20 mesh sieves, the granule after sieving is micro-with recipe quantity
Crystalline cellulose, magnesium stearate mix homogeneously, tabletting.
Embodiment 2 carbamazepine sustained-release tablet and preparation method thereof
Take carbamazepine 500g, viscosity is the low viscosity hypromellose 250g of 5000mPa s, Alpha-Methyl-L-cheese
Propylhomoserin 400g, ethanol 600g, microcrystalline Cellulose 150g, magnesium stearate 10g, the carbamazepine weighing recipe quantity is pulverized
Cross 200 mesh sieves, weigh the low viscosity hypromellose of recipe quantity, alpha-Methyl-L-tyrosine dissolving in ethanol；Stir
Under the conditions of mixing, carbamazepine powder is joined the ethanol solution of low viscosity hypromellose, alpha-Methyl-L-tyrosine
In, this suspension being heated to 80 DEG C, after being slowly evaporated, crosses 20 mesh sieves, the granule after sieving is micro-with recipe quantity
Crystalline cellulose, magnesium stearate mix homogeneously, tabletting.
Embodiment 3 carbamazepine sustained-release tablet and preparation method thereof
Take carbamazepine 500g, viscosity is the low viscosity hypromellose 80g of 5000mPa s, Alpha-Methyl-L-cheese
Propylhomoserin 120g, ethanol 600g, microcrystalline Cellulose 150g, magnesium stearate 10g, the carbamazepine weighing recipe quantity is pulverized
Cross 200 mesh sieves, weigh the low viscosity hypromellose of recipe quantity, alpha-Methyl-L-tyrosine dissolving in ethanol；Stir
Under the conditions of mixing, carbamazepine powder is joined the ethanol solution of low viscosity hypromellose, alpha-Methyl-L-tyrosine
In, this suspension being heated to 80 DEG C, after being slowly evaporated, crosses 20 mesh sieves, the granule after sieving is micro-with recipe quantity
Crystalline cellulose, magnesium stearate mix homogeneously, tabletting.
Comparative example 1 carbamazepine sustained-release tablet and preparation method thereof
Referenced patent (application number 201410162639.X Carbamazepine Tablets and preparation method thereof) prepares carbamazepine
Sheet.
The release of embodiment 4 carbamazepine sustained-release tablet is investigated
Drug release determination method: with reference to Chinese Pharmacopoeia two annex XD drug release determination the first methods of version in 2010, uses
The device of two annex XC dissolution determination the second methods of version in 2010,900mL water is release medium, and rotating speed is
50r min-1, temperature is 37 DEG C, operates in accordance with the law.In the separately sampled 2mL of 2h, 4h, 6h, 8h, 12h and 24h,
Add equivalent release liquid simultaneously, and be centrifuged immediately, take supernatant, carry out HPLC analysis, calculate the accumulative release of medicine
Amount.Dissolution of sustained-release tablets measurement result prepared by embodiment 1-3 is shown in accompanying drawing 1-3, the slow releasing tablet of comparative example 1 preparation
Drug release determination result is shown in accompanying drawing 4.
The result of the test of 1-4 understands with reference to the accompanying drawings, and carbamazepine sustained-release tablet release prepared by embodiment of the present invention 1-3 is steadily
(seeing Fig. 1-3)；Comparative example 1 pelletizes after being mixed with pregelatinized Starch etc. by carbamazepine, due to the granule of preparation
Middle carbamazepine is not fully wrapped up, therefore discharges too fast (seeing Fig. 4).
Claims (7)
1. a Carbamazepine Tablets, it is characterised in that: described Carbamazepine Tablets by medicine-containing particle with pharmaceutically acceptable
Auxiliary materials and mixing after direct compression form, described medicine-containing particle is that carbamazepine joins low viscosity hypromellose
Element, alpha-Methyl-L-tyrosine ethanol solution in form suspension, heating is sieved and is obtained after being evaporated.
Carbamazepine Tablets the most according to claim 1, it is characterised in that: carbamazepine is fine with low viscosity hydroxypropyl first
Dimension element, alpha-Methyl-L-tyrosine weight consumption ratio for 1-5:0.5-0.8:0.8-1.2, low viscosity hypromellose
Viscosity be 2000-5000mPa s.
Carbamazepine Tablets the most according to claim 2, it is characterised in that: carbamazepine is fine with low viscosity hydroxypropyl first
Dimension element, alpha-Methyl-L-tyrosine weight consumption ratio for 2:0.6:1, the viscosity of low viscosity hypromellose is
4000mPa·s。
4. according to the Carbamazepine Tablets described in any one of claim 1-3, it is characterised in that: described pharmaceutically can connect
The adjuvant being subject to includes filler and lubricant.
Carbamazepine Tablets the most according to claim 4, it is characterised in that: described filler is selected from microcrystalline cellulose
One or more in element, lactose and pregelatinized Starch.
Carbamazepine Tablets the most according to claim 4, it is characterised in that: described lubricant selected from magnesium stearate,
One or more in micropowder silica gel and Pulvis Talci.
7. the preparation method according to the Carbamazepine Tablets described in any one of claim 1-3, it is characterised in that include
Following steps:
(1) carbamazepine was pulverized 200 mesh sieves, standby；
(2) low viscosity hypromellose, alpha-Methyl-L-tyrosine are dissolved in ethanol, standby；
(3), under stirring condition, carbamazepine fine powder is joined low viscosity hypromellose, Alpha-Methyl-L-cheese ammonia
In the ethanol solution of acid, being heated by this suspension, after being evaporated, sieve, the granule after sieving is with pharmaceutically acceptable
Adjuvant mix homogeneously, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610569411.1A CN105997916A (en) | 2016-07-19 | 2016-07-19 | Carbamazepine tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610569411.1A CN105997916A (en) | 2016-07-19 | 2016-07-19 | Carbamazepine tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105997916A true CN105997916A (en) | 2016-10-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201610569411.1A Pending CN105997916A (en) | 2016-07-19 | 2016-07-19 | Carbamazepine tablet and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN105997916A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815126A (en) * | 2018-07-25 | 2018-11-16 | 江苏黄河药业股份有限公司 | A kind of Carbamazepine Tablets and preparation method thereof |
| CN110269845A (en) * | 2019-07-11 | 2019-09-24 | 上海复旦复华药业有限公司 | A kind of novel production prescription and technique of Carbamazepine Tablets |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5888545A (en) * | 1994-07-01 | 1999-03-30 | Arzneimittelwerk Dresden Gmbh | Carbamazepine medicament with retarded active substance release |
| CN101647787A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine controlled-release tablet and preparation method thereof |
| CN101647784A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine sustained-release tablet and preparation method thereof |
| CN103948560A (en) * | 2014-04-22 | 2014-07-30 | 青岛市中心医院 | Carbamazepine tablet and preparation method thereof |
-
2016
- 2016-07-19 CN CN201610569411.1A patent/CN105997916A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5888545A (en) * | 1994-07-01 | 1999-03-30 | Arzneimittelwerk Dresden Gmbh | Carbamazepine medicament with retarded active substance release |
| CN101647787A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine controlled-release tablet and preparation method thereof |
| CN101647784A (en) * | 2008-08-15 | 2010-02-17 | 北京科信必成医药科技发展有限公司 | Carbamazepine sustained-release tablet and preparation method thereof |
| CN103948560A (en) * | 2014-04-22 | 2014-07-30 | 青岛市中心医院 | Carbamazepine tablet and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 李新芳等: "《外科药物速查手册》", 31 December 2003 * |
| 沈志华: ""不同的处方与制备工艺对卡马西平缓释效果的研究"", 《海峡药学》 * |
| 程磊等: ""卡马西平缓释片的处方优化研究"", 《安徽卫生职业技术学院学报》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108815126A (en) * | 2018-07-25 | 2018-11-16 | 江苏黄河药业股份有限公司 | A kind of Carbamazepine Tablets and preparation method thereof |
| CN110269845A (en) * | 2019-07-11 | 2019-09-24 | 上海复旦复华药业有限公司 | A kind of novel production prescription and technique of Carbamazepine Tablets |
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| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
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| RJ01 | Rejection of invention patent application after publication | ||
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Application publication date: 20161012 |