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Flupentixol and melitracen medicinal composition and preparation thereof

A technology of melitracen and flupentixol, applied in the field of pharmaceutical preparations, can solve problems such as inability to guarantee product stability, and achieve the effects of ensuring product safety and effectiveness, reducing impurity levels, and enhancing stability

Active Publication Date: 2019-04-26
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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  • Flupentixol and melitracen medicinal composition and preparation thereof
  • Flupentixol and melitracen medicinal composition and preparation thereof
  • Flupentixol and melitracen medicinal composition and preparation thereof

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 and melitracen medicinal composition and a preparation thereof, and belongs to the technical field of pharmaceutical preparations. The flupentixol and melitracenmedicinal composition is prepared from flupentixol dihydrochloride, melitracen hydrochloride and an antioxidant. The flupentixol and melitracen medicinal composition disclosed by the invention has the advantages that by adding the antioxidant, the stability of a flupentixol and melitracen compound preparation can be effectively enhanced, and impurities such as Lu28-159 and trifluoromethyl thioxanthone produced by degrading flupentixol can be effectively controlled, so that impurity level is reduced and the safety and the effectiveness of a product are ensured; flupentixol and melitracen medicinal tablets prepared by the preparation method disclosed by the invention have similar in-vitro dissolution behavior and bioequivalence with original research tablets Deanxit.

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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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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