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发明公开
CN104072497A 一种多尼培南新结晶及其制备方法 有权 转让

一种多尼培南新结晶及其制备方法
摘要：
本发明公开了一种多尼培南或其水合物的新结晶及其制备方法。本发明的多尼培南或其水合物的新结晶的粉末X-射线衍射在2θ为：6.5±0.2°、16.0±0.2°、16.7±0.2°、24.0±0.2°、26.1±0.2°、29.1±0.2°处有特征峰，其中，16.0±0.2°处的特征峰的相对峰强度为100%，24.0±0.2°和26.1±0.2°处的特征峰的相对峰强度不低于30%，6.5±0.2°、16.7±0.2°和29.1±0.2°处的特征峰的相对峰强度不低于10%。本发明的多尼培南或其水合物的新结晶性质稳定、晶型稳定、溶解性好、制备方法简便且适合工业化，更适合于作为原料药贮存和使用，为多尼培南药物的制备提供了一种新途径。
摘要（英）：

The invention discloses a doripenem novel crystal and a preparation method thereof. The X-ray powder diffraction spectrum represented by the degree of 2 theta of novel crystal of doripenem or doripenem hydrate has characteristic peaks at 6.5+/-0.2 degree, 16.0+/-0.2 degree, 16.7+/-0.2 degree, 24.0+/-0.2 degree, 26.1+/-0.2 degree, and 29.1+/-0.2 degree, the relative peak strength of the characteristic peak at 16.0+/-0.2 degree is 100%, the relative peak strength of the characteristic peaks at 24.0+/-0.2 degree and 26.1+/-0.2 degree is not less than 30%, and the relative peak strength of the characteristic peaks at 6.5+/-0.2 degree, 16.7+/-0.2 degree, and 29.1+/-0.2 degree is not less than 10%. The novel crystal of doripenem or doripenem hydrate has the advantages of stable properties, stable crystal form, good solubility, and convenient preparation method, which is suitable for industrial production, and can be used as the bulk drug which is more convenient to store and use. A novel way is provided for the preparation of doripenem drugs.

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