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Amitriptyline hydrochloride preparation composition and preparation method thereof

A technology of amitriptyline hydrochloride and amitriptyline hydrochloride tablets, which is applied in the field of amitriptyline hydrochloride preparation compositions and amitriptyline hydrochloride tablets, can solve the cumbersome production process of tablet cores, prone to sticking or punching Fragments, unfavorable environmental protection requirements and other issues, to reduce management and inspection costs, rapid release, and beneficial to the stability of the preparation

Active Publication Date: 2022-02-11
CHANGZHOU NO 4 PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] CN108721240A discloses a kind of 25mg amitriptyline hydrochloride sheet and preparation method thereof, mentioned amitriptyline hydrochloride sheet prescription, wherein used calcium hydrogen phosphate dihydrate, cornstarch, lactose, microcrystalline cellulose, Anhydrous silica gel, stearic acid, magnesium stearate and other excipient materials, in the production process of the tablet core, it is first necessary to wet granulate part of the granulation solution prepared with cornstarch and purified water. After drying, sieving and granulation, it is then pre-mixed with the remaining materials except the coating powder, and then dry granulated, compressed and coated, so the production process of the tablet core is very cumbersome; in addition, in the coating process , the organic solvent isopropanol is used, which is not conducive to environmental protection requirements, but also has certain safety hazards
And the amitriptyline hydrochloride sheet that prior art makes has the defect of unsteady stripping, or related substances are higher, poorer in stability, and sticking punches or splitting phenomenon occurs easily in tableting process, so amitriptyline hydrochloride Forest slices and their production technology still need to be improved

Method used

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  • Amitriptyline hydrochloride preparation composition and preparation method thereof
  • Amitriptyline hydrochloride preparation composition and preparation method thereof
  • Amitriptyline hydrochloride preparation composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037]Embodiment 1 Amitriptyline hydrochloride tablet (specification 25mg)

[0038]

[0039] Preparation Process:

[0040] (1) Grind amitriptyline hydrochloride and sieve it, the sieve aperture is 0.6mm, and measure the particle size, control D50≤150μm.

[0041] (2) Weigh amitriptyline hydrochloride, microcrystalline cellulose, anhydrous lactose, pregelatinized starch, hydroxypropyl cellulose and magnesium stearate in turn according to the prescription ratio in the above table, add them to the mixing tank, and carry out pre-treatment. Mix (10rpm / min*10min).

[0042] (3) Put the premixed material into the granulator for dry granulation. The side seal pressure is about 2.2MPa, the roller speed is 15rpm, and the sieve for granulation at the bottom of the equipment is a 20-mesh steel sieve. The granulation process controls the roller pressure to be about 1.8MPa. .

[0043] (4) Add the dry granulated granules together with the added magnesium stearate into the mixing tank fo...

Embodiment 2

[0046] Embodiment 2 Amitriptyline hydrochloride tablet (specification 25mg)

[0047] Composition according to Example 1, wherein microcrystalline cellulose PH101 was replaced by microcrystalline cellulose PH301. Amitriptyline hydrochloride tablets were obtained by the preparation process of Example 1.

Embodiment 3

[0048] Embodiment 3 Amitriptyline Hydrochloride Tablets (Specification 25mg)

[0049] According to the component composition of Example 1, wherein microcrystalline cellulose PH101 is replaced by microcrystalline cellulose KG802. Amitriptyline hydrochloride tablets were obtained by the preparation process of Example 1.

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Abstract

The invention provides an amitriptyline hydrochloride preparation composition, in particular to composition of amitriptyline hydrochloride tablets and a preparation method thereof, and the amitriptyline hydrochloride tablets are prepared from amitriptyline hydrochloride, microcrystalline cellulose, lactose anhydrous, pregelatinized starch, hydroxypropyl cellulose, magnesium stearate, a film coating premix and other raw and auxiliary materials. The preparation method comprises the steps of premixing, dry granulation, total mixing, tabletting, coating and the like. The amitriptyline hydrochloride preparation has the characteristics of quick dissolution and quick effect taking, is extremely low in content of related substances and very good in stability, and ensures the effectiveness and safety of the medicine; the production process is simple and easy to control, is suitable for industrial continuous production, does not use organic solvents in the production process, and is safe and environment-friendly.

Description

Technical field [0001] The present invention relates to an amitriptyline hydrochloride preparation composition, especially amitriptyline hydrochloride tablets, and a preparation method thereof. It belongs to the technical field of pharmaceutical preparations. Background technique [0002] Amitriptyline hydrochloride is N,N-dimethyl-3-[10,11-dihydro-5H-dibenzo[a,d]cycloheptatriene-5-ylidene]-1-propylamine hydrochloride Salt is a traditional tricyclic antidepressant. It has the strongest sedative effect among tricyclic antidepressants. It can significantly improve the mood of depressed patients. It is mainly used to treat anxiety or irritable depression. Its function is to inhibit the reuptake of 5-hydroxytryptamine and norepinephrine, the inhibition of 5-hydroxytryptamine reuptake is stronger, and the sedative and anticholinergic effects are also stronger. Anticholinergic reactions may occur in the early stage of treatment, such as excessive sweating, dry mouth, blurred vis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/135A61K47/38A61K47/36A61K47/26A61K47/12A61K47/04A61K9/20A61K9/28A61P25/24
CPCA61K9/2018A61K9/2013A61K9/2059A61K9/2054A61K9/2009A61K9/28A61K31/135A61P25/24
Inventor 沈征葛纪龙黄琳达雅静房燕冬杨京华屠永锐
Owner CHANGZHOU NO 4 PHARMA FACTORY
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