CN112168792A - Carbamazepine tablet and preparation method thereof - Google Patents

Carbamazepine tablet and preparation method thereof Download PDF

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Publication number
CN112168792A
CN112168792A CN202011047883.3A CN202011047883A CN112168792A CN 112168792 A CN112168792 A CN 112168792A CN 202011047883 A CN202011047883 A CN 202011047883A CN 112168792 A CN112168792 A CN 112168792A
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China
Prior art keywords
carbamazepine
parts
tablet
mixing
additive
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
CN202011047883.3A
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Chinese (zh)
Inventor
蒋锋
周健
王顺
扶文君
侯珂兰
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JIANGSU PENGYAO PHARMACEUTICALS Inc
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JIANGSU PENGYAO PHARMACEUTICALS Inc
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Priority to CN202011047883.3A priority Critical patent/CN112168792A/en
Publication of CN112168792A publication Critical patent/CN112168792A/en
Withdrawn legal-status Critical Current

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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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention discloses a carbamazepine tablet which comprises the following components in parts by weight: 100 parts of carbamazepine, 5-10 parts of sodium carboxymethyl starch, 5-10 parts of low-substituted cellulose and 3-5 parts of additive. Meanwhile, the invention also discloses a preparation method of the carbamazepine tablet. The taste of the carbamazepine tablet is adjusted by adding the additive, so that the carbamazepine tablet is more acceptable to users; the solubility of the carbamazepine tablet is reduced by adding sodium carboxymethyl starch and low-substituted cellulose, so that the carbamazepine tablet can be dissolved and absorbed after reaching the gastrointestinal tract, the blood concentration is improved, and the treatment effect is improved.

Description

Carbamazepine tablet and preparation method thereof
Technical Field
The invention belongs to the field of medicines, and particularly relates to a carbamazepine tablet and a preparation method thereof.
Background
Carbamazepine is mainly used for treating epilepsy, is also commonly used for treating diseases such as peripheral neuralgia, manic depression, arrhythmia and the like, and is generally used as a first choice medicament for treating epilepsy in clinic. The mechanism of its treatment of epilepsy is not clear, and it may be combined with its ability to increase the sodium channel inactivation potency, to restrict postsynaptic neurons and to block presynaptic Na+The channel is used for limiting the sending of the action potential of the pre-synaptic and post-synaptic neurons, blocking the release of excitatory neurotransmitter, reducing the excitability of nerve cells and achieving the anti-epileptic effect; the action mechanism of resisting peripheral neuralgia is probably related to Ca2+The channel modulation is relevant.
The traditional carbamazepine tablet is formed by extruding a carbamazepine raw material through an extruder, the taste of the carbamazepine tablet is bitter due to the process method, and the carbamazepine raw material drug has higher solubility and loses part of content before entering gastrointestinal tracts, so that the blood concentration is often lower than the standard.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to provide a carbamazepine tablet which has good mouthfeel and can ensure that most of main components are absorbed by stomach and intestine aiming at the defects of the prior art.
Another object of the present invention is to provide a process for preparing the above carbamazepine tablet.
The technical scheme is as follows: in order to achieve the above object, the present invention is specifically realized as follows: the carbamazepine tablet comprises the following components in parts by weight: 100 parts of carbamazepine, 5-10 parts of sodium carboxymethyl starch, 5-10 parts of low-substituted cellulose and 3-5 parts of additive.
Wherein the additive is one or more of magnesium stearate, vitamin D3 and D-glucosamine potassium sulfate.
A process for preparing the above carbamazepine tablet comprising the steps of:
(1) weighing the components according to a formula for later use;
(2) respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 20-40 minutes;
(3) adding the material and the additive obtained in the step (2) into carbamazepine, and mixing for 1-2 hours at normal temperature in a centrifugal stirrer;
(4) and (4) adding the material obtained in the step (3) into a granulator for granulation.
Has the advantages that: compared with the prior art, the invention has the following advantages:
(1) the taste of the carbamazepine tablet is adjusted by adding the additive, so that the carbamazepine tablet is more acceptable to users;
(2) the solubility of the carbamazepine tablet is reduced by adding sodium carboxymethyl starch and low-substituted cellulose, so that the carbamazepine tablet can be dissolved and absorbed after reaching the gastrointestinal tract, the blood concentration is improved, and the treatment effect is improved.
Detailed Description
Example 1:
taking 100 parts by weight of carbamazepine, 5 parts by weight of sodium carboxymethyl starch, 5-10 parts by weight of low-substituted cellulose and 3 parts by weight of additive for standby, wherein the additive is magnesium stearate. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 30 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 1 hour at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 2:
taking 100 parts by weight of carbamazepine, 6 parts by weight of sodium carboxymethyl starch, 8 parts by weight of low-substituted cellulose and 4 parts by weight of additive for standby. The additive is magnesium stearate, vitamin D3, and D-glucosamine potassium sulfate. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 40 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 2 hours at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 3:
taking 100 parts by weight of carbamazepine, 7 parts by weight of sodium carboxymethyl starch, 6 parts by weight of low-substituted cellulose and 5 parts by weight of additive for standby, wherein the additive is vitamin D3. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 20 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 1 hour at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 4:
taking 100 parts by weight of carbamazepine, 8 parts by weight of sodium carboxymethyl starch, 7 parts by weight of low-substituted cellulose and 3 parts by weight of additive for standby, wherein the additive is D-glucosamine potassium sulfate. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 30 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 1.5 hours at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 5:
taking 100 parts by weight of carbamazepine, 9 parts by weight of sodium carboxymethyl starch, 8 parts by weight of low-substituted cellulose and 4 parts by weight of additive for standby, wherein the additive is magnesium stearate and vitamin D3 which are mixed. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 40 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 1 hour at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 6:
100 parts of carbamazepine, 10 parts of sodium carboxymethyl starch, 9 parts of low-substituted cellulose and 5 parts of additive are taken for standby application, wherein the additive is formed by mixing vitamin D3 and D-glucosamine potassium sulfate. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 20-40 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 1-2 hours at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.
Example 7:
100 parts of carbamazepine, 8 parts of sodium carboxymethyl starch, 10 parts of low-substituted cellulose and 3 parts of additive are taken for standby application, and the additive is magnesium stearate and D-glucosamine potassium sulfate which are mixed. Respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 20 minutes; adding the mixed materials and additives into carbamazepine, and mixing for 2 hours at normal temperature in a centrifugal stirrer; and adding the mixture into a granulator for granulation.

Claims (3)

1. The carbamazepine tablet is characterized by comprising the following components in parts by weight: 100 parts of carbamazepine, 5-10 parts of sodium carboxymethyl starch, 5-10 parts of low-substituted cellulose and 3-5 parts of additive.
2. The carbamazepine tablet of claim 1, wherein the additive is one or more of magnesium stearate, vitamin D3, D-glucosamine potassium sulfate.
3. A process for preparing the carbamazepine tablet of claim 1 comprising the steps of:
(1) weighing the components according to a formula for later use;
(2) respectively sieving sodium carboxymethyl starch and low-substituted cellulose with a 400-mesh sieve, mixing at normal temperature, and mixing for 20-40 minutes;
(3) adding the material and the additive obtained in the step (2) into carbamazepine, and mixing for 1-2 hours at normal temperature in a centrifugal stirrer;
(4) and (4) adding the material obtained in the step (3) into a granulator for granulation.
CN202011047883.3A 2020-09-29 2020-09-29 Carbamazepine tablet and preparation method thereof Withdrawn CN112168792A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202011047883.3A CN112168792A (en) 2020-09-29 2020-09-29 Carbamazepine tablet and preparation method thereof

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Application Number Priority Date Filing Date Title
CN202011047883.3A CN112168792A (en) 2020-09-29 2020-09-29 Carbamazepine tablet and preparation method thereof

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113440531A (en) * 2021-07-08 2021-09-28 江苏鹏鹞药业有限公司 Carbamazepine pharmaceutical composition and preparation method and application thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113440531A (en) * 2021-07-08 2021-09-28 江苏鹏鹞药业有限公司 Carbamazepine pharmaceutical composition and preparation method and application thereof

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