A kind of flupenthixol melitracen pharmaceutical composition and its preparation

A technology for melitracen and pharmaceutical preparations, applied in the field of flupentixol melitracen pharmaceutical compositions and preparations thereof, can solve problems such as inability to guarantee product stability, achieve product safety and effectiveness, reduce Impurity level, effect of enhancing stability

Active Publication Date: 2021-10-08
GUANGDONG SCI FINDER PHARMA TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the production process is simple in this invention, the stability of the product during preparation and storage cannot be guaranteed because it does not contain stabilizer ingredients.
[0012] None of the above-mentioned prior art is based on the stability characteristics of flupenthixol and melitracen to select prescription ingredients

Method used

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  • A kind of flupenthixol melitracen pharmaceutical composition and its preparation
  • A kind of flupenthixol melitracen pharmaceutical composition and its preparation
  • A kind of flupenthixol melitracen pharmaceutical composition and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A pharmaceutical composition of flupenthixol and melitracen, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride and antioxidant are 0.48%, 9.30% and 0.08% respectively. The content of each component of the tablet prepared from the pharmaceutical composition is shown in Table 1.

[0030] The preparation method of tablet described in the present embodiment is:

[0031] (1) Preparation of Flupenthixol Granules

[0032] Dissolve flupenthixol hydrochloride and dibutyl hydroxytoluene in 80% ethanol-water solution, stir until clear; put anhydrous lactose, microcrystalline cellulose, and hydroxypropyl cellulose into a high-speed stirring granulator, add hydrochloric acid 80% ethanol-water solution of flupenthixol and dibutyl hydroxytoluene, stirring and shearing granulation; fluidized bed drying, granulation to obtain flupenthixol granules;

[0033] (2) Preparation of melitracen granules

[0034] Put melitracen hydrochloride, anhydrous lacto...

Embodiment 2

[0041] A pharmaceutical composition of flupenthixol and melitracen, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride and antioxidant are respectively 0.48%, 9.19%, and 0.82%. The content of each component of the tablet prepared from the pharmaceutical composition is shown in Table 1.

[0042] The preparation method of tablet described in the present embodiment is:

[0043] (1) Preparation of Flupenthixol Granules

[0044] Dissolve flupenthixol hydrochloride and propyl gallate in 75% ethanol-water solution, stir until clear; put anhydrous lactose, starch, and hydroxypropyl cellulose into a high-speed stirring granulator, add flupenthixol hydrochloride With 75% ethanol-water solution of propyl gallate, stirring and shearing granulation; fluidized bed drying, granulation to obtain flupentixol granules;

[0045] (2) Preparation of melitracen granules

[0046] Put melitracen hydrochloride, anhydrous lactose, starch, and hydroxypropyl cellulose...

Embodiment 3

[0049] A pharmaceutical composition of flupenthixol and melitracen, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride and antioxidant are respectively 0.48%, 9.20%, and 0.65%. The content of each component of the tablet prepared from the pharmaceutical composition is shown in Table 1.

[0050] The preparation method of tablet described in the present embodiment is:

[0051] (1) Preparation of Flupenthixol Granules

[0052] Dissolve flupentixol hydrochloride and tert-butyl p-hydroxyanisole in 75% ethanol-water solution, stir until clear; put calcium hydrogen phosphate, microcrystalline cellulose, and hypromellose into a high-speed stirring granulator , adding flupenthixol hydrochloride and 75% ethanol-water solution of tert-butyl-p-hydroxyanisole, stirring and shearing to granulate; fluidized bed drying, granulation to obtain flupentixol granules;

[0053] (2) Preparation of melitracen granules

[0054] Put melitracen hydrochloride, calcium...

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Abstract

The invention relates to a flupentixol melitracen pharmaceutical composition and a preparation thereof, belonging to the technical field of pharmaceutical preparations. The pharmaceutical composition of flupentixol and melitracen of the present invention comprises flupentixol hydrochloride, melitracen hydrochloride and an antioxidant. The flupenthixol melitracen pharmaceutical composition of the present invention can effectively enhance the stability of the flupenthixol melitracen compound preparation by adding an antioxidant, and can effectively control the degradation of flupentixol to produce Lu28-159 , trifluoromethylthioxanthone and other impurities, reduce the level of impurities, and ensure product safety and effectiveness; flupentixol and melitracen tablets prepared according to the present invention have similar in vitro dissolution behavior and Bioequivalence.

Description

technical field [0001] The invention relates to a flupentixol melitracen pharmaceutical composition and a preparation thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Usually, the stability of a pharmaceutical composition is a very important consideration during the design, manufacture, and storage of the pharmaceutical composition. Drugs with poor stability may be degraded into certain degradation products, causing unnecessary side effects or reducing the efficacy or bioavailability of the drug itself, making it difficult to achieve satisfactory results. [0003] Flupenthixol hydrochloride is the hydrochloride form of flupenthixol, an atypical antipsychotic drug. It is a thioxanthene derivative, which has a powerful effect of blocking dopamine receptors, and has anxiolytic and antidepressant effects in small doses. Its chemical name is: 2-[4-[3(EZ)-(2-trifluoromethylthioxanthene-9-yllidene)propyl]piperazin-1-yl]ethanol...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/28A61K47/10A61K31/496A61K31/135A61P25/24A61P25/22
CPCA61P25/22A61P25/24A61K9/2013A61K9/2054A61K9/28A61K31/135A61K31/496A61K2300/00A61K9/2059A61K9/2018A61K9/2009A61K9/2027
Inventor 卜水陈运万杨宇东郑伟国胡功允许礼贵王端统张炎
Owner GUANGDONG SCI FINDER PHARMA TECH CO LTD
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