A kind of flupenthixol melitracen tablet 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
CN109771386BActive Publication Date: 2021-10-08GUANGDONG SCI FINDER PHARMA TECH CO LTD +1
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
GUANGDONG SCI FINDER PHARMA TECH CO LTD
Publication Date
2021-10-08

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Abstract

The invention relates to a flupenthixol melitracen tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The flupentixol melitracen tablet of the present invention comprises the following components in mass percentage: 0.3% to 1.0% of flupentixol hydrochloride, 5.78% to 19.26% of melitracen hydrochloride, and 0.01% to 10% of antioxidant %, filler 60%-88%, disintegrant 0.5%-6%, binder 2%-6%, lubricant 0.2%-3%. The flupenthixol melitracen tablet of the present invention can effectively enhance the stability of the flupenthixol melitracen tablet by adding an antioxidant, and can effectively control the degradation of flupentixol to produce Lu28‑159, Impurities such as trifluoromethylthioxanthone 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 biological properties as the original tablet Deanxit. equivalence.
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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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