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Low-dosage atypical antipsychotic drug composition

An antipsychotic drug and atypical technology, applied in the field of medicine, can solve the problems of patients with residual negative symptoms, reduce patient compliance, shorten life expectancy, etc., achieve the effect of reducing medical costs, reducing cardiac side effects, and eliminating negative symptoms

Inactive Publication Date: 2018-12-07
FIRST HOSPITAL OF SHANXI MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] More than 50% of diagnosed SCZ patients have long-term intermittent psychotic symptoms, and most patients have residual negative symptoms, cognitive deficits, poor social function and even mental disability, and their life expectancy is shortened by 10 to 20 years
Dose increases may result in more serious side effects, which in turn may reduce patient compliance

Method used

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  • Low-dosage atypical antipsychotic drug composition
  • Low-dosage atypical antipsychotic drug composition
  • Low-dosage atypical antipsychotic drug composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] According to the conventional capsule preparation method, 62.5g of ziprasidone, 125g of sertraline hydrochloride, 300g of cornstarch, 300g of hydroxypropyl cellulose, 120g of magnesium oxide, 60g of talcum powder, and 32.5g of micropowder silica gel were mixed to form granules, and The filling amount of each 200 mg is packed into capsules to make 5000 capsule preparations, each capsule preparation contains 12.5 mg of ziprasidone and 25 mg of sertraline hydrochloride.

Embodiment 2

[0050] Adopt conventional preparation method, ziprasidone 40g, sertraline hydrochloride 40g, cornstarch 80g, carboxymethyl starch sodium 100g, talcum powder 20g, magnesium stearate 10g, microcrystalline cellulose 10g are mixed to make powder, use The powder was compressed by a rotary tablet press to make 2000 tablets, each 150 mg, containing 20 mg of ziprasidone and 20 mg of sertraline hydrochloride.

Embodiment 3

[0052] Screen and collect 468 cases of schizophrenia patients meeting the inclusion criteria and exclusion criteria to evaluate the effect of the clinical trial of the pharmaceutical composition of the present invention, and divide the subjects into an experimental group and a control group at random, with 234 cases in each group.

[0053] Inclusion criteria: 1) Meet the diagnostic criteria for schizophrenia in DSM-IV; 2) Educational years ≥ 9 years, right-handed, Han nationality, 3) Age 18-60 years old; 4) Have not received any medical treatment 2 weeks before enrollment 5) half a year ≤ total disease duration ≤ 30 years; 6) PANSS score ≥ 60 points; 7) signed the informed consent.

[0054]Exclusion criteria: 1) Those who are known to be allergic to the drugs used, those who have recent pregnancy plans or breastfeeding; 2) Recent acute myocardial infarction, decompensated heart failure, and a history of prolonged QT interval (including congenital long QT interval 3) Those who ...

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Abstract

The invention relates to a low-dosage atypical antipsychotic drug composition. The low-dosage atypical antipsychotic drug composition comprises active components, i.e., ziprasidone and sertraline hydrochloride with the weight ratio being 0.5:1-2:1, and the active components with the dosage being 120-150mg / d, in which the dosage of the ziprasidone is 40-100mg / d, is applied to treatment of SCZ (Schizophrenia). In the low-dosage atypical antipsychotic drug composition, low-dosage ziprasidone and sertraline hydrochloride have good synergistic effect, and compared with use of the ziprasidone with medium-high dosage to treat the SCZ, not only is the effect for eliminating positive symptoms equivalent, but also the effect for eliminating negative symptoms and affective symptoms is more obvious and the social function of SCZ patients is improved; simultaneously, the QTc interval prolongation of electrocardiogram due to the ziprasidone with medium-high dosage is greatly reduced, and the occurrence probability of other adverse cardiovascular events such as TdP (Torsades De Pointes) risk and sudden death and the like is reduced.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to a pharmaceutical composition, in particular to an antipsychotic pharmaceutical composition, which can effectively treat schizophrenia with a low dose of the pharmaceutical composition of the invention. Background technique [0002] Schizophrenia (SCZ) is a chronic severe mental illness with high recurrence rate, high disability rate, high mortality rate and high disease burden, which is extremely harmful to human health, and its etiology is unknown so far. 1%. [0003] The main symptoms of SCZ include positive symptoms, negative symptoms, affective symptoms and cognitive symptoms. Positive symptoms mainly include hallucinations, delusions, disorganized speech and behavior, nervous or agitated behavior; negative symptoms mainly include emotional bluntness or incoordination, reduced social interaction, withdrawn and withdrawn, lack of speech and interest, decreased willpower, lazy l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61K31/137A61P25/18A61P25/24A61P25/22A61P25/28
CPCA61K31/496A61K31/137A61P25/18A61P25/22A61P25/24A61P25/28A61K2300/00
Inventor 郎小娥李鸿博闫欣宋苗薛晓燕侯鑫何潇柴娜任变林
Owner FIRST HOSPITAL OF SHANXI MEDICAL UNIV
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