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Flupentixol and melitracen tablets and preparation method thereof

A technology of melitracen tablets and flupenthixol, which is applied in the field of pharmaceutical preparations, can solve the problems of not containing stabilizers and cannot guarantee product stability, so as to reduce the level of impurities, ensure product safety and effectiveness, The effect of enhancing stability

Active Publication Date: 2019-05-21
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 a stabilizer.
[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 tablets and preparation method thereof
  • Flupentixol and melitracen tablets and preparation method thereof
  • Flupentixol and melitracen tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] A flupenthixol melitracen tablet, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride, antioxidant, filler, disintegrant, binder, and lubricant are respectively 0.48 %, 9.30%, 0.08%, 82.69%, 1.49%, 4.96%, 0.99%, the quality of each component is shown in Table 1.

[0055] The preparation method of tablet described in the present embodiment is:

[0056] (1) Preparation of Flupenthixol Granules

[0057] 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;

[0058] (2) Preparation of melitracen granules

[0059] Put melitracen hydrochloride, anhydrous lactose, microcrystall...

Embodiment 2

[0066] A flupenthixol melitracen tablet, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride, antioxidant, filler, disintegrant, binder, and lubricant are respectively 0.48 %, 9.19%, 0.82%, 81.68%, 1.96%, 4.41%, 1.47%, the quality of each component is shown in Table 1.

[0067] The preparation method of tablet described in the present embodiment is:

[0068] (1) Preparation of Flupenthixol Granules

[0069] 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;

[0070] (2) Preparation of melitracen granules

[0071] Put melitracen hydrochloride, anhydrous lactose, starch, and hydroxypropyl cellulose into a high-speed...

Embodiment 3

[0074] A flupenthixol melitracen tablet, wherein the mass percentages of flupenthixol hydrochloride, melitracen hydrochloride, antioxidant, filler, disintegrant, binder, and lubricant are respectively 0.48 %, 9.20%, 0.65%, 81.81%, 1.96%, 4.42%, 1.47%, the quality of each component is shown in Table 1.

[0075] The preparation method of tablet described in the present embodiment is:

[0076] (1) Preparation of Flupenthixol Granules

[0077] 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;

[0078] (2) Preparation of melitracen granules

[0079] Put melitracen hydrochloride, calcium hydrogen phosphat...

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Abstract

The invention relates to flupentixol and melitracen tablets and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The flupentixol and melitracen tabletsare prepared from, by mass, 0.3-1.0% of flupentixol dihydrochloride, 5.78-19.26% of melitracen hydrochloride, 0.01-10% of an antioxidant, 60-88% of a filler, 0.5-6% of a disintegrating agent, 2-6% ofan adhesive and 0.2-3% of a lubricant. According to the flupentixol and melitracen tablets, by adding the antioxidant, the stability of the flupentixol and melitracen tablets can be effectively enhanced, flupentixol can be effectively controlled to be degraded to generate impurities such as Lu28-159 and trifluoromethyl thiodone, the impurity level is lowered, and product safety and effectiveness are guaranteed; the flupentixol and melitracen tablets prepared through the method has the similar in-vitro dissolution behavior and bioequivalence as original tablets Deanxit.

Description

technical field [0001] The invention relates to a flupenthixol melitracen tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] In general, the stability of pharmaceutical formulations is a very important consideration during the design, manufacture, and storage of pharmaceutical compositions. 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 dihydrochlor...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/10A61K47/14A61K47/22A61K47/38A61K31/496A61K31/135A61P25/18A61P25/22A61P25/24A61P25/00
CPCA61P25/24A61P25/22A61P25/00A61P25/18A61K31/496A61K9/2013A61K9/2054A61K9/2059A61K9/2018A61K9/2009A61K9/2027A61K31/137A61K2300/00A61K9/20A61K9/28A61K31/135A61K47/10A61K47/14A61K47/22A61K47/38
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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