Preparation method of sertraline hydrochloride crystal form I

A technology of sertraline hydrochloride and crystal form, which is applied in the field of preparation of sertraline hydrochloride, can solve problems such as complex preparation, and achieve the effects of improving fit and transparent and complete appearance.

Pending Publication Date: 2021-03-26
SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The main purpose of the present invention is to provide a preparation method of sertraline hydrochloride crystal form I, to solve the complex problem of preparation of sertraline hydrochloride crystal form I in the prior art

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  • Preparation method of sertraline hydrochloride crystal form I
  • Preparation method of sertraline hydrochloride crystal form I
  • Preparation method of sertraline hydrochloride crystal form I

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preparation example Construction

[0025] Based on the above findings, the present application provides a preparation method of sertraline hydrochloride crystalline form I, the preparation method comprising: heating sertraline hydrochloride ethanol in absolute ethanol above 65°C, and the obtained solid Liquid mixed system, the solid suspension in the solid-liquid mixed system is sertraline hydrochloride with sertraline hydrochloride crystal form I.

[0026] The preparation method of the present application has relatively broad requirements on the preparation conditions, and there is no need to limit the high vacuum conditions. It is only necessary to heat the acid sertraline ethanolate in absolute ethanol at a temperature above 70°C. During this process, the hydrochloric acid Crystal transformation occurs after the sertraline ethanolate is dissolved, and sertraline hydrochloride of sertraline hydrochloride crystal form I is obtained. The obtained product was tested, and the X-ray powder diffraction pattern show...

Embodiment 1

[0040] Add 300g of sertraline hydrochloride ethanolate and 300ml of absolute ethanol prepared above into a 1L reaction bottle, adjust the rotation speed to 100rpm, raise the temperature of the water bath to 75°C, keep it warm for 2 hours, and filter while it is hot. After the filter cake is dried, you can get sertraline hydrochloride The finished product of Lin Jing type I is about 244g, the yield is 92%, and the crystal appearance is transparent.

Embodiment 2

[0042]Add 300g of sertraline hydrochloride ethanolate and 450ml of absolute ethanol prepared above into a 1L reaction bottle, adjust the rotation speed to 100rpm, raise the temperature of the water bath to 75°C, keep it warm for 2 hours, and filter while it is hot. After the filter cake is dried, you can get sertraline hydrochloride The finished product of Lin Jing type I is about 219g, the yield is 83.0%, and the crystal appearance is transparent.

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Abstract

The invention provides a preparation method of a sertraline hydrochloride crystal form I. The preparation method comprises the following steps: heating a sertraline hydrochloride ethanol compound in absolute ethyl alcohol at the temperature of 70 DEG C or above to obtain a solid-liquid mixed system, and taking sertraline hydrochloride with a sertraline hydrochloride crystal form I as a solid in the solid-liquid mixed system. The preparation method has wide requirements for preparation conditions, high vacuum conditions do not need to be limited, only the sertraline hydrochloride ethanol compound needs to be heated in absolute ethyl alcohol at the temperature of 70 DEG C or above, in the process, crystal transformation occurs after the sertraline hydrochloride ethanol compound is dissolved,and sertraline hydrochloride of the sertraline hydrochloride crystal form I is obtained. The crystal grain obtained by the preparation method is large and transparent and complete in appearance, andis different from the sertraline hydrochloride crystal form I which is opaque in appearance due to the fact that the crystal is too small to form a block mass in the prior art. The larger the crystalgrain is, the better the dissolution rate of the sertraline hydrochloride preparation is controlled, and the fitting degree of the dissolution curve of the sertraline hydrochloride preparation and theoriginal preparation is significantly improved.

Description

technical field [0001] The invention relates to the technical field of preparation of sertraline hydrochloride, in particular to a preparation method of sertraline hydrochloride crystal form I. Background technique [0002] Sertraline hydrochloride, a selective serotonin reuptake inhibitor antidepressant, is mainly used for the treatment of severe depression in adults, and also for the treatment of obsessive-compulsive disorder, panic disorder and social phobia in children or adults. Sertraline hydrochloride can exist in different crystal forms and polymorphs, which are different in stability, physical properties, spectral data and preparation methods, and have the following chemical structural formula: [0003] [0004] Patent US5248699 discloses four polymorphs I, III, IV and V. Characterization by single crystal x-ray analysis, powder x-ray diffraction, infrared spectroscopy and differential scanning calorimetry. According to this patent, the preferential formation o...

Claims

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Application Information

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IPC IPC(8): C07C209/84C07C211/42
CPCC07C209/84C07B2200/13C07C2602/10C07C211/42Y02A50/30
Inventor 沈杞容王冬冬陶颉孙小燕贾佩骞李俊峰赵志良
Owner SHANXI C&Y PHARMACEUTICAL GROUP CO LTD
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