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A kind of pharmaceutical composition and its preparation method and application

A composition and drug technology, applied in the field of medicine, can solve problems such as hemolysis

Active Publication Date: 2021-12-24
重庆仁泽医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the adjuvants used in the above-mentioned and other sustained-release injections in the prior art can cause adverse reactions such as hemolysis

Method used

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  • A kind of pharmaceutical composition and its preparation method and application
  • A kind of pharmaceutical composition and its preparation method and application
  • A kind of pharmaceutical composition and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-6

[0050] Embodiment 1-6 preparation method is as follows:

[0051] S1: Weigh according to the above ratio HS-15 and Span 20 were dissolved by adding an appropriate volume of water for injection to prepare a mixture of excipients; S2: Weighing sodium chloride, pH regulator disodium hydrogen phosphate and sodium dihydrogen phosphate according to the above ratio, and prepared into Water-based vehicle; S3: After fully mixing the auxiliary material mixture described in S1 and the water-based vehicle described in S2, add the main drug with a suitable particle size to prepare a medicinal solution, and then use a homogenizer to fully prepare the medicinal solution.

[0052] 3.3 Experimental results: Suspoemulsion can be formed without oily precipitation, and it can be suspended for a long time without irreversible sedimentation.

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Abstract

The invention provides a pharmaceutical composition, comprising the following components: water-insoluble antipsychotic drugs; polyethylene glycol fatty acid esters; sorbitan esters and aqueous vehicles; the pharmaceutical composition formed is aqueous, Injectable suspension. The water-insoluble antipsychotic drug is aripiprazole prodrug—lauroyl aripiprazole, and the pharmaceutical composition prepared by selecting appropriate particle size and specific prescription ratio is prepared to have good stability and meet the requirements of release, especially possesses It is a suspension injection for clinical use with good safety and high application value.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a pharmaceutical composition and its preparation method and application. Background technique [0002] Aripiprazole (Aripiprazole), chemical name: 7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3 4-dihydro-2- (lH)-quilinone, the molecular formula is C 23 h 27 N 3 o 2 Cl 2 , the molecular weight is 448.4, and the chemical structural formula is: [0003] [0004] Aripiprazole is a partial agonist of dopamine D2, serotonin 5-HT 1A Agonists and serotonin 5-HT 2A receptor antagonists. As an antipsychotic drug useful in the treatment of schizophrenia, bipolar disorder, depression and other CNS disorders. [0005] Aripiprazole lauroxil (Aripiprazole lauroxil) is a prodrug of aripiprazole, which is catalyzed and hydrolyzed by enzymes in vivo to form N-hydroxymethyl aripiprazole, which is then hydrolyzed into aripiprazole, and then plays an anti-inflammatory role. Schi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K47/14A61K31/496A61P25/18
CPCA61K9/10A61K9/0019A61K47/14A61K31/496A61P25/18
Inventor 许娟周于琳沈丹丹
Owner 重庆仁泽医药科技有限公司
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