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Atypical antipsychotic medicinal 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, poor social function, etc., so as to reduce medical costs, improve compliance, and reduce the incidence of serious toxic and side effects. Effect

Inactive Publication Date: 2018-12-04
FIRST HOSPITAL OF SHANXI MEDICAL UNIV
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  • 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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  • Atypical antipsychotic medicinal composition
  • Atypical antipsychotic medicinal composition
  • Atypical antipsychotic medicinal composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] According to the conventional capsule preparation method, 10g of risperidone, 250g of sertraline hydrochloride, 300g of corn starch, 250g of hydroxypropyl cellulose, 100g of magnesium oxide, 70g of talcum powder, and 20g of micropowdered silica gel were mixed to form granules, and each capsule was 100mg The loading amount of the above is packed into capsules, and 10000 capsule preparations are made, each capsule preparation contains risperidone 1mg, and sertraline hydrochloride 25mg.

Embodiment 2

[0048] Using a conventional preparation method, 8 g of risperidone, 100 g of sertraline hydrochloride, 150 g of sodium carboxymethyl starch, 20 g of talcum powder, 10 g of magnesium stearate, and 12 g of microcrystalline cellulose were mixed to make powder, and a rotary tablet press was used to The powder was compressed into 4000 tablets, each 75 mg, containing 2 mg of risperidone and 25 mg of sertraline hydrochloride.

Embodiment 3

[0050] Screen and collect 184 cases of schizophrenia patients who meet the inclusion 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 92 cases in each group.

[0051] Inclusion criteria: 1) meet the diagnostic criteria for schizophrenia in DSM-Ⅳ; 2) years of education ≥ 9 years, right-handed, Han nationality, 3) age 18-60; 4) did not receive 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.

[0052] Exclusion criteria: 1) patients who are known to be allergic to risperidone or any ingredients in the drug used, pregnant and lactating women; 2) suffering from cardiovascular diseases (such as heart failure, myocardial infarction, conduction abnormalities, dehydration, blood loss or cerebral palsy) 3) Those wi...

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Abstract

The invention relates to an atypical antipsychotic medicinal composition. The medicinal composition contains active components risperidone and sertraline hydrochloride according to a weight ratio of 0.04:1 to 0.08:1, and is applied to the treatment of SCZ when the dosage of risperidone in the active components is 2-4 mg / d. Low-dosage risperidone and sertraline hydrochloride in the medicinal composition have excellent synergistic effects; and compared with medium and high dosage risperidone, the medicinal composition has the advantages of equivalent positive symptom elimination effect, significant elimination of negative symptoms and emotion symptoms, and improvement of the social function of SCZ patients when used in the treatment of SCZ. The medicinal composition greatly reduces the occurrence probability of medium and high dosage risperidone induced hyperprolactinemia, severe extrapyramidal symptoms and other adverse drug events.

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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IPC IPC(8): A61K31/519A61K31/137A61P25/18A61P25/24A61P25/22A61P25/28
CPCA61K31/519A61K31/137A61P25/18A61P25/22A61P25/24A61P25/28A61K2300/00
Inventor 郎小娥李鸿博薛晓燕宋苗何潇侯鑫闫欣李建中柴娜
Owner FIRST HOSPITAL OF SHANXI MEDICAL UNIV
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