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Gamma-crystalline form of landiolol hydrochloride, preparation method of same and pharmaceutical composition containing same

A technology for landiolol hydrochloride and crystal form, which is applied in the field of γ-crystal form of landiolol hydrochloride, its preparation and pharmaceutical composition containing it, can solve the problem of low yield and purity of landiolol hydrochloride. The problem is not high, and the effect of easy industrial scale production is achieved.

Inactive Publication Date: 2009-11-04
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Yet the purity of the Landisolol hydrochloride that this comparative document recrystallization method obtains is not high, and yield is not high either

Method used

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  • Gamma-crystalline form of landiolol hydrochloride, preparation method of same and pharmaceutical composition containing same
  • Gamma-crystalline form of landiolol hydrochloride, preparation method of same and pharmaceutical composition containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Get 36g of landyrolol hydrochloride crude product prepared by JP3072475 method, add 360ml acetone, 3.6g gac. Heat to reflux for 15 minutes. Filtrate hot to remove activated carbon. Crystallize below 10°C for 2 hours. Suction filtration, the solid was washed with 80ml acetone. Dry under reduced pressure at 40°C for 6 hours to obtain 29.6 g of γ-crystalline form of landisolol hydrochloride, with a melting point of 124.3°C to 125.7°C and a yield of 82.2%.

[0024] X-ray powder diffraction pattern:

[0025] Determine the X-ray powder diffraction spectrum under the following test conditions:

[0026] Instrument model: Japan Rigaku D / max-rC type anode turning target X-ray instrument

[0027] Conditions: 40kV, 50mA, ray wavelength CuKa DS=SS=1°, RS=0.3mm, scanning range 0-40.0°, scanning rate 5.0° / min.

[0028] The X-ray powder diffraction pattern of Landisolol Hydrochloride γ-crystalline form is given by the important spectral lines organized in the following table: ...

Embodiment 2

[0031] The formula for preparing 1000 lyophilized preparations each containing 50mg landipolol hydrochloride:

[0032] Gamma-crystalline form of Landisolol Hydrochloride 50g

[0033] Mannitol 50g

[0034] Appropriate amount of sodium hydroxide

[0035] Add water for injection to 2000ml

[0036] Prepared according to the conventional process, that is.

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Abstract

The invention relates to a gamma-crystalline form of landiolol hydrochloride shown in a general formula (I), a preparation method of the same and a pharmaceutical composition containing the same.

Description

technical field [0001] The present invention relates to the γ-crystal form of landiolol hydrochloride of general formula (I), its preparation method and pharmaceutical composition containing it. [0002] Background technique [0003] Landisolol hydrochloride is a selective β1 receptor blocker, which mainly antagonizes the β1 receptors present in the heart, and improves tachycardia arrhythmia by inhibiting the increase in heart rate caused by catecholamines. Clinically, it can be used for the emergency treatment of tachycardia arrhythmia (including atrial fibrillation, atrial flutter, sinus tachycardia) during operation; under the dynamic monitoring of the circulation after operation, the tachycardia arrhythmia ( Includes emergency treatment for atrial fibrillation, atrial flutter, sinus tachycardia). [0004] Patent JP3072475 discloses the preparation method and therapeutic use of landisolol and its addition salt formed with a pharmaceutically acceptable acid. [0005] ...

Claims

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Application Information

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IPC IPC(8): C07D317/24A61K31/5377A61P9/06
Inventor 李明丽李清涛李大涛
Owner CISEN PHARMA
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