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A kind of flupentixol melitracen pharmaceutical composition and preparation method thereof

A technology for flupentixol and melitracen tablets, applied in the field of pharmaceutical preparations, can solve problems such as poor fluidity and compressibility, and achieve the effects of avoiding a moist-heat drying process, and having good production process reproducibility and stability.

Active Publication Date: 2019-10-29
SICHUAN HAISCO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Flupenthixol hydrochloride and melitracen hydrochloride have poorer fluidity and compressibility than granules, so the formula of flupenthixol and melitracen tablets prepared by wet granulation is difficult to be directly used for direct powder compression

Method used

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  • A kind of flupentixol melitracen pharmaceutical composition and preparation method thereof
  • A kind of flupentixol melitracen pharmaceutical composition and preparation method thereof
  • A kind of flupentixol melitracen pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of flupentixol melitracen pharmaceutical composition

[0048] prescription:

[0049]

[0050] The preparation method is prepared according to the following steps:

[0051] (1), flupentixol hydrochloride and hydroxypropyl cellulose were mixed in equal amounts three times, and passed through an 80-mesh sieve to obtain the mixture ①;

[0052] (2), the mixture ① and melitracen hydrochloride were mixed twice in equal amounts, and passed through an 80-mesh sieve to obtain the mixture ②;

[0053] (3), mix the mixture ② with microcrystalline cellulose PH12 in an equal amount, and pass through a 40-mesh sieve to obtain the mixture ③;

[0054] (4), put the mixture ③, spray-dried lactose, and the remaining microcrystalline cellulose PH12 into a multi-directional motion mixer, pre-mix for about 15 minutes at 10 rpm, then add stearic acid and silicon dioxide and mix for about 10 minutes, Get the mixture ④;

[0055] (5), the mixture ④ is directly compress...

Embodiment 2

[0057] Example 2 Preparation of flupentixol melitracen pharmaceutical composition

[0058] prescription:

[0059]

[0060] The preparation method is prepared according to the following steps:

[0061] (1), flupenthixol hydrochloride and carboxymethyl starch sodium are carried out three equal volumes of incremental mixing, cross 80 mesh sieves, and obtain the mixture ①;

[0062] (2), the mixture ① and melitracen hydrochloride were mixed twice in equal amounts, and passed through an 80-mesh sieve to obtain the mixture ②;

[0063] (3), mix the mixture ② with microcrystalline cellulose PH12 in an equal amount, and pass through a 40-mesh sieve to obtain the mixture ③;

[0064] (4), put the mixture ③, mannitol, and remaining microcrystalline cellulose PH12 into a multi-directional motion mixer, pre-mix for about 15 minutes at 10 rpm, then add magnesium stearate and talcum powder and mix for about 10 minutes to obtain Mixture ④;

[0065] (5), the mixture ④ is directly compress...

Embodiment 3

[0067] Example 3 Preparation of flupentixol melitracen pharmaceutical composition

[0068] prescription:

[0069]

[0070]

[0071] The preparation method is prepared according to the following steps:

[0072] (1), flupenthixol hydrochloride and cross-linked polyvinylpyrrolidone are mixed three times in equal amounts, and passed through an 80-mesh sieve to obtain the mixture ①;

[0073] (2), the mixture ① and melitracen hydrochloride were mixed twice in equal amounts, and passed through an 80-mesh sieve to obtain the mixture ②;

[0074] (3), mix the mixture ② with microcrystalline cellulose PH102 in an equal amount, and pass through a 40-mesh sieve to obtain the mixture ③;

[0075] (4) Put the mixture ③, pregelatinized starch, and remaining microcrystalline cellulose PH102 into a multi-directional motion mixer, pre-mix for about 15 minutes at 10 rpm, then add stearic acid and sodium stearyl fumarate to mix About 10 minutes, the mixture ④ was obtained;

[0076] (5), t...

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Abstract

The invention relates to a tablet composition of antidepressant flupentixol and melitracen and a preparation method of the tablet composition. The composition comprises flupentixol (the particle size distribution D90 is smaller than 150mu m), melitracen, a filling agent, a disintegrating agent, an adhesive and a lubricating agent. The tablet composition is prepared from full-powder in a direct tabletting manner; and the method comprises the following steps: mixing step by step; tabletting; and coating and the like. The manufacturing process is simple; pelletizing and drying are avoided; energy and time are saved; the stability of active components is protected; the disintegration property and the dissolution rate of the tablet are improved; and the prepared tablet composition of antidepressant flupentixol and melitracen is stable in quality, low in impurity content, safe and good in effectiveness.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a flupentixol melitracen pharmaceutical composition and a preparation method thereof. Background technique [0002] Flupentixol (flupentixol) is a thiaxanthene atypical antipsychotic drug, which acts by blocking dopamine receptors in the mesencephalic-limbic system and midbrain-cortical system. Its chemical name is: α-trifluoromethyl- 9-{3-[4-(2-Hydroxyethyl)-1-diethylenediamine]-propane}-thioxanthene, the structure is shown in formula Ⅰ: [0003] [0004] Melitracen (melitracen) is a tricyclic (heterocyclic) antidepressant drug that inhibits the reuptake of norepinephrine and serotonin and increases the concentration of these two transmitters in the synaptic cleft. Its chemical name is: 3-[10,10-dimethyl-9(10H)-anthracene]-N,N-dimethyl-1-propanamine, and its structure is shown in formula II: [0005] [0006] Because flupenthixol may produ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/20A61K9/36A61K47/38A61P25/24A61P25/22A61P25/00A61K31/135
CPCA61K31/135A61K31/496A61K2300/00
Inventor 任东冯卫陈九龙汪顺洪
Owner SICHUAN HAISCO PHARMA CO LTD
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