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Method for preparing terbutaline sulphate crystal form B meeting medicinal requirements

A technology of terbutaline sulfate and crystal form, which is applied in the field of medicine, can solve problems such as the method for preparing terbutaline sulfate crystal form B that has not been clearly disclosed, and achieve the effect of stable chemical and physical properties

Inactive Publication Date: 2009-07-08
李勤耕
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there are reports about terbutaline sulfate crystal form B, there is no clear disclosure of the method for preparing terbutaline sulfate crystal form B so far

Method used

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  • Method for preparing terbutaline sulphate crystal form B meeting medicinal requirements
  • Method for preparing terbutaline sulphate crystal form B meeting medicinal requirements
  • Method for preparing terbutaline sulphate crystal form B meeting medicinal requirements

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 0.5 g of non-B crystalline terbutaline sulfate was stirred in 10 ml of aqueous ethyl acetate (saturated with water) at 25° C. for 24 hours, and then the resulting suspension was dried at 50° C. under nitrogen flow to constant weight. Terbutaline sulfate crystal form B was obtained.

Embodiment 2

[0034]0.5 g of non-B crystalline terbutaline sulfate was stirred in 10 ml of aqueous ethyl acetate (water half-saturated) at 25°C for 24 hours, and then the resulting suspension was dried at 50°C under nitrogen flow to constant weight. Terbutaline sulfate crystal form B was obtained.

Embodiment 3

[0036] 0.5 g of non-B crystalline terbutaline sulfate was stirred in 10 ml of aqueous ethyl acetate (saturated with water) at 35° C. for 24 hours, and then the resulting suspension was dried at 50° C. under nitrogen flow to constant weight. Terbutaline sulfate crystal form B was obtained.

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Abstract

The invention provides a method for preparing terbutaline sulphate B crystal form. The method comprises: selecting a solvent, dissolving 1-(3,5-dibenzyloxy phenyl)-2-n-tert-butyl aminoethanol into the solvent, removing benzyl groups through hydrogenolysis by a general method, obtaining terbutaline free alkali, and adding sulfuric acid into the terbutaline free alkali to form terbutaline sulphate of crystal form B; or dissolving terbutaline sulphate of non-crystal form B into the solvent, stirring the terbutaline sulphate of the non-crystal form B in the solvent at a certain temperature until the terbutaline sulphate of the non-crystal form B is converted into the terbutaline sulphate B crystal form through dissolution and lixiviation, and reclaiming the leached terbutaline sulphate B crystal form. The method has the advantage of obtaining the terbutaline sulphate B crystal form which has stable chemical and physical properties and meets the requirements of medical preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1), terbutaline sulfate crystal form B. Background technique [0002] α-[(tert-butylamino)methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (terbutaline sulfate in this article) CAS number is 23031-32-5, molecular formula is (C 12 h 19 NO 3 ) 2 ·H 2 SO 4 and has the following structure: [0003] [0004] Terbutaline sulfate can selectively excite β2 adrenergic receptors, relax bronchial smooth muscle, inhibit the release of endogenous spasmogens, and inhibit the edema caused by endogenous transmitters and mucociliary clearance. Its bronchodilation effect is similar to salbutamol. The antiasthmatic effect of 2.5mg of this product is equivalent to that of 25mg ephedrine. In vitro experiments on animals or humans have confirmed that it has very little effect on cardiac ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C215/30C07C213/10A61P11/06
Inventor 李勤耕郭彬田睿周辉罗绪王涛全继平徐少杰
Owner 李勤耕
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