Novel crystal form for temozolomide, method for preparing temozolomide and medicinal composition of temozolomide

Abstract

The invention provides a novel crystal form for temozolomide, a method for preparing the temozolomide and a medicinal composition of the temozolomide. The novel crystal form for the temozolomide is characterized in that: Cu is used for radiation, and diffraction peaks of 2 theta represented by degrees exist at 8.2+ / -0.2 and 6.0+ / -0.2 in an X-ray diffraction pattern. The invention has the advantages that: a temozolomide crystal-shaped object which is suitable for industrialized production is provided; and the problems in the prior art are solved. The preparation process is simple and easy to operate, the industrialized production is convenient to operate, the quality is controllable, and the yield is stable. The crystal-shaped object obtained by the preparation process can remarkably improve the appearance and color and luster of products; the temozolomide M crystal-shaped object prepared by the method has high stability and can be stored for a long time; and in the method, the crystal-shaped object is prepared by using an organic solvent with lower toxicity, so the potential influence effect of the positioning of organic residue on human bodies is reduced to a certain degree. The advantages ensure that the invention is beneficial to the remarkable improvement on the quality of the products and is more suitable for industrialized production.

Description

technical field

[0001] The invention relates to a new crystal form of temozolomide, a preparation method and a composition thereof, belonging to the technical field of medicine. Background technique

[0002] The chemical name of Temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, and its chemical structure is:

[0003]

[0004] Temozolomide (trade name Temodal TM ) was developed by M..F.G Stevens, E.S Newlands, etc., and was transferred to Schering-Plough in 1992 for production. In October 1997, it was approved under the unanimous recommendation of the EU CPMP, and temozolomide capsules were launched in Europe in 1998. In January 1999, the US FDA expert advisory group unanimously recommended to speed up the approval of temozolomide, and it was approved by the FDA on August 11, 1999 to be marketed in the United States. At the same time, the company has applied for listing in 16 countries including Canada, Australia, New Zealand, Swi...

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