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Flupentixol-melitracen pharmaceutical composition and preparation method thereof

A technology of melitracen and flupentixol, applied in the field of pharmaceutical preparations, can solve the problems of increased safety risk, decreased stability, increased degradation impurities, etc., and achieves good process reproducibility and stability. , the effect of low content of related substances

Inactive Publication Date: 2018-09-07
CHONGQING SHENGHUAXI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Studies have shown that the stability of flupentixol hydrochloride and melitracen hydrochloride is reduced under the humid heat conditions of the wet granulation and tableting process, and the degraded impurities tend to increase, which will increase the safety risk

Method used

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  • Flupentixol-melitracen pharmaceutical composition and preparation method thereof
  • Flupentixol-melitracen pharmaceutical composition and preparation method thereof
  • Flupentixol-melitracen pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Prescription: The specifications are: flupenthixol hydrochloride (calculated as flupentixol) 0.2mg; melitracen hydrochloride (calculated as melitracen) 5mg (10,000 tablets in batches)

[0043]

[0044] The preparation method is:

[0045] (1) Ingredients: take the flupentixol hydrochloride and melitracen hydrochloride of the prescribed amount, pass through a 100-mesh sieve, and set aside;

[0046] (2) Granulation: The weighed melitracen hydrochloride, lactose, starch, and polyethylene glycol 6000 are put into a high-efficiency wet mixing granulator, stirred and mixed at a low speed for about 5 minutes to obtain a mixture 1; take povidone K30 , added to medicinal ethanol, stirred and dissolved to prepare a 3% povidone K30 solution; weighed flupenthixol hydrochloride, and added it to the prepared adhesive solution to obtain mixture 2; Soft materials made in the mixture 1 of the mixed granulator; passed through a 20-mesh nylon screen, and the oscillating granulator was us...

Embodiment 2

[0052] Prescription: The specifications are: flupenthixol hydrochloride (calculated as flupentixol) 0.9mg; melitracen hydrochloride (calculated as melitracen) 15mg (10,000 tablets)

[0053]

[0054] Prepared by the same preparation method as in Example 1.

Embodiment 5

[0056] Flupentixol and melitracen coated tablets were prepared according to Example 5 of CN103877088A;

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Abstract

The invention designs an anti-depression drug flupentixol-melitracen pharmaceutical composition and a preparation method thereof, wherein the composition comprises flupentixol hydrochloride, melitracen hydrochloride, a filler, a binder, a lubricant and a stabilizer, and is prepared by using wet granulation tableting, and the method comprises: granulation, drying, granulation and total mixing, tableting, film coating, and other steps. According to the present invention, the process effectively solves the problems of dissolution and content uniformity due to the high difference in the contents of the two main drugs, and further protects the stability of the active ingredient; and the prepared flupentixol-melitracen tablet has characteristics of stable quality, safety and good effectiveness.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a flupentixol melitracen pharmaceutical composition and a preparation method thereof, in particular to a coating formulation pharmaceutical composition containing flupentixol hydrochloride and melitracen hydrochloride. Background technique [0002] Flupentixol hydrochloride (flupentixol) belongs to the atypical antipsychotic drugs of the thioxanthene class, which acts by blocking dopamine receptors in the midbrain-limbic system and midbrain-cortical system. [3-[2-(trifluoromethyl)-9H-thioxanthene-9-ylidene]propyl]-1-piperazine ethanol dihydrochloride, its structural formula is as follows: [0003] [0004] Melitracen hydrochloride (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. , and its chemical name is: 3-[10,10-d...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/10A61K9/36A61K31/496A61K31/135A61P25/24A61P25/22A61P15/12A61P25/32A61P25/36
CPCA61K9/2031A61K9/2095A61K9/2866A61K31/135A61K31/496A61K2300/00
Inventor 周莲钟声荣
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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