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Clonazepam tablet and preparation method thereof

A technology of clonazepam tablets and nitrazepam tablets, which is applied in the field of clonazepam tablets and its preparation, can solve the problems of weak chemical stability, long disintegration time of tablets, poor formability, etc., and achieve Avoid the incidence of adverse reactions, improve the safety and effectiveness of medication, and have good molding effects

Active Publication Date: 2019-11-08
HUNAN DONGTING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] It is known that the dissolution rate and chemical stability of active ingredients are the most important quality indicators of pharmaceutical preparations. However, during the research and development process, it was found that the existing clonazepam pharmaceutical preparations on the market still face poor formability, Dissolution is not enough and the chemical stability is not strong, the disintegration time limit of tablet is longer and other defects, there is greater room for improvement and improvement in these properties, therefore, develop new technology and method to prepare clonazepam tablet It is very important for this field to further improve the quality of clonazepam

Method used

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  • Clonazepam tablet and preparation method thereof
  • Clonazepam tablet and preparation method thereof
  • Clonazepam tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] The preparation of clonazepam tablet prepares following raw material: 1.2kg clonazepam, the first filler of 30kg, the second filler of 20kg, 0.1kg binder, the first lubricant of 0.1kg, the second lubricant of 0.1kg and Appropriate amount of purified water.

[0035] Among them, the first filler is composed of lactose and microcrystalline cellulose, and the mass ratio of lactose and microcrystalline cellulose is 0.8:1.0; the second filler is composed of corn starch and pregelatinized starch, corn starch and pregelatinized starch The mass ratio of starch is 1.0:0.8; the binder is composed of corn starch and hypromellose, and the mass ratio of corn starch and hypromellose is 0.9:1.2.

[0036] This amount is used to prepare 500,000 clonazepam tablets.

[0037] The preparation method of clonazepam tablet comprises the steps:

[0038] 1) Weighing: Weigh each raw material in proportion for subsequent use;

[0039] 2) Mixing: Put the first filler and the second filler into th...

Embodiment 2

[0045] The preparation of clonazepam tablet prepares following raw material: 1.0kg clonazepam, the first filler of 25kg, the second filler of 5kg, 0.05kg binder, the first lubricant of 0.05kg, the second lubricant of 0.05kg and Appropriate amount of purified water.

[0046] Among them, the first filler is composed of lactose and microcrystalline cellulose, and the mass ratio of lactose and microcrystalline cellulose is 1:1.2; the second filler is composed of corn starch and pregelatinized starch, corn starch and pregelatinized starch The mass ratio of starch is 1.2:1.0; the binder is composed of corn starch and hypromellose, and the mass ratio of corn starch and hypromellose is 1:1.5.

[0047] This amount is used to prepare 500,000 clonazepam tablets.

[0048] The preparation method of clonazepam tablet comprises the steps:

[0049] 1) Weighing: Weigh each raw material in proportion for subsequent use;

[0050] 2) Mixing: Put the first filler and the second filler into the ...

Embodiment 3

[0056] The preparation of clonazepam tablet prepares following raw material: 1.5kg clonazepam, the first filler of 50kg, the second filler of 50kg, 1.5kg binder, the first lubricant of 1kg, the second lubricant of 0.5kg and purified Appropriate amount of water.

[0057] Among them, the first filler is composed of lactose and microcrystalline cellulose, and the mass ratio of lactose and microcrystalline cellulose is 0.5:0.8; the second filler is composed of corn starch and pregelatinized starch, corn starch and pregelatinized starch The mass ratio of starch is 0.8:0.6; the binder is composed of corn starch and hypromellose, and the mass ratio of corn starch and hypromellose is 0.8:1.0.

[0058] This amount is used to prepare 500,000 clonazepam tablets.

[0059] The preparation method of clonazepam tablet comprises the steps:

[0060] 1) Weighing: Weigh each raw material in proportion for subsequent use;

[0061] 2) Mixing: Put the first filler and the second filler into the ...

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Abstract

The invention relates to a clonazepam tablet. The clonazepam tablet is prepared from the following raw materials in parts by weight: 0.5-1.5 parts of clonazepam, 25-50 parts of a first filling agent,5-50 parts of a second filling agent, 0.05-1.5 parts of a binding agent, 0.05-1 part of a first lubricating agent, 0.05-0.5 part of a second lubricating agent and appropriate amount of purified water;the first lubricating agent is talcum powder, and the second lubricating agent is magnesium stearate. The preparation process comprises the working procedures of raw material weighing and preparation, material mixing, mucilage dispensing, wet granulation, straightening granulation, total mixing, tableting, packaging and the like. According to the clonazepam tablet and the preparation method thereof, the preparation method is suitable for large-scale and industrial generalizing and production, a prepared product is better in compactibility, better in dissolution rate, higher in chemical stability, and the safety of drug use and the effectiveness are effectively improved.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a clonazepam tablet and a preparation method thereof. Background technique [0002] The chemical name of clonazepam is 1,3~dihydro~7~nitro~5~(2~chlorophenyl)~2H~l,4~benzodiazepine ~2 ketones, the molecular structure formula is as follows: [0003] [0004] Clonazepam tablets prepared with clonazepam are long-acting benzodiazepine sedative drugs, which have the functions of controlling various types of epilepsy, sedative hypnosis, anticonvulsant, anti-anxiety, depression, and controlling mental excitement, restlessness, etc. Multiple functions, especially suitable for absence seizures, infantile spasms, myoclonic, akinetic seizures and Lennox-Gastaut syndrome. [0005] It is known that the dissolution rate and chemical stability of active ingredients are the most important quality indicators of pharmaceutical preparations. However, during the research and development proce...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/38A61K47/36A61K31/5513A61P25/20A61P25/08A61P25/22A61P25/24A61P21/02A61P25/14
CPCA61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/5513A61P21/02A61P25/08A61P25/14A61P25/20A61P25/22A61P25/24
Inventor 侯奇伟石磊何平樊文操唐菲
Owner HUNAN DONGTING PHARMA
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