Novel dronedarone hydrochloride crystal form and preparation method thereof
By mixing with an organic solvent under heating conditions and cooling to crystallize, a new crystal form of dronedarone hydrochloride was obtained, which solved the problems of insufficient stability and solubility of the existing crystal form and achieved high-quality preparation production. and simple preparation process.
CN103694206AActive Publication Date: 2014-04-02FUJIAN COSUNTER PHARMA CO LTD
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Patent Information
- Application Number
- CN201310655184.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2013-12-05
- Publication Date
- 2014-04-02
- Estimated Expiration
- 2033-12-05
AI Technical Summary
Technical Problem
The existing crystal form of dronedarone hydrochloride has deficiencies in stability and solubility, making it difficult to meet pharmaceutical needs.
Method used
Dronedarone hydrochloride is mixed with 15 to 20 parts by weight of organic solvent under heating conditions, 40 to 60% of the solvent is evaporated, and dronedarone hydrochloride II type crystal nuclei are induced, cooled and crystallized, and separated and dried. New crystal forms with excellent physical and chemical parameters were obtained.
Benefits of technology
Dronedarone hydrochloride crystal form II with excellent stability and high dissolution was obtained, which is suitable for making high-quality oral preparations, simplifying operations and improving industrial production efficiency.
✦ Generated by Eureka AI based on patent content.
Abstract
The invention relates to a novel dronedarone hydrochloride crystal form and a preparation method thereof. Characteristic absorption peaks are formed at the diffraction angles (2theta) which are 8.0, 15.7, 16.7, 21.8, 24.2 and 30.9+ / -0.2 degrees in an X-ray powder diffraction diagram of the crystal. The invention also provides a preparation method and use of the crystal form. The crystal form is good in stability, low in cost of a preparation technology and applicable to industrial production.
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