Medicinal composition and preparation method and application thereof

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

Active Publication Date: 2019-07-09
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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  • Medicinal composition and preparation method and application thereof
  • Medicinal composition and preparation method and application thereof
  • Medicinal composition and preparation method and application thereof

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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PUM

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Abstract

The invention provides a medicinal composition. The composition consists of a water-insoluble antipsychotic, polyethylene glycol fatty acid ester, sorbitan ester and an aqueous intermedium; the medicinal composition forms an aqueous and injectable suspension. The water-insoluble antipsychotic drug is an aripiprazole prodrug, namely lauroyl aripiprazole, and the medicinal composition which is proper in particle size and is prepared according to a specific prescription proportion is used for preparing a clinical suspension injection which has high stability, meets the requirements for the release degree and particularly has high safety and an extremely 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 Applications(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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