A compound of anti-infective drug and its preparation method

Abstract

The invention belongs to the technical field of medicine and particular relates to a novel compound of an anti-infection drug and a preparation method thereof. According to the compound, characteristic peaks are displayed at diffraction angles of 3.5 degrees, 4.6 degrees, 8.4 degrees, 12.5 degrees, 13.8 degrees, 16.2 degrees, 19.0 degrees, 19.5 degrees, 20.0 degrees, 21.1 degrees, 27.1 degrees and 33.1 degrees in an X-ray powder diffraction pattern obtained through measurement by Cu-KAlpha rays. The invention further relates to powder injection containing 100% cefazedone sodium. The new crystal from of the compound is different from that in the prior art, through experimental verification, it is surprised to find that compared with the prior art, the powder injection obtained by direct subpackage of the compound of the novel crystal form does not need any auxiliary material and is good in liquidity, the content of impurities and moisture is reduced effectively, the safety of products is good, and the stability is high.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a novel compound of an anti-infection drug and a preparation method thereof. Specifically, it relates to a cefazedone sodium crystal compound and a preparation method thereof. Background technique [0002] Infectious diseases are a common and frequently-occurring disease in clinical practice. According to the report of the World Health Organization (WHO), the number of deaths from infectious diseases is as high as 33.3% of the total number of deaths from various causes. Cephalosporins are the most widely used first-line drugs in clinical practice. In recent years, due to the abuse of antibiotics, many "super bacteria" have emerged, and the problem of bacterial drug resistance has become increasingly serious. The "Administrative Measures for the Clinical Application of Antibacterial Drugs" officially implemented by the state restricts the clinical application of the third-generat...

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Problems solved by technology

[0005] For example, in CN 101584671A, the cefazedone sodium solid is dissolved in water, after activated carbon decolorization and filtration, acetone crystallization is added to the filtrate, and the crystals are filtered and dried to obtain cefazedone sodium crystals. This method is only through conventional drying. There are problems such as low drying efficiency and difficulty in reproducing moisture control in different batches of products.

[0006] CN 102924482A discloses a preparation method of low-water-content cefazedone sodium, which has the following disadvantages: (1) sodium methoxide is used as a salt-forming solvent, and the alkalinity is too strong, so that the cefazedone β-lactam ring is easily destroyed, High impurity content, strong corrosiveness, and large pollution; (2) Isopropanol is used as the crystallization solvent, which has a high boiling point and low volatility, and is easy to remain in the product, increasing the impurity content; (3) The crystallization process uses Seed crystal generation by ultrasonic oscillation seeding method

This preparation method is loaded down with trivial details operation, high to equipment requirement, pollution is big, cost is also high, and the obtained product impurity content is high, and yield is low; (4) preparation method yield is low, only 85%

[0007] CN 104119361A discloses a method for refining an antibiotic compound. First, cefzidone and sodium isooctanoate are placed in anhydrous methanol to form a salt, and then a mixed solvent of acetone and ethyl acetate is used for crystallization and crystal growth, and the obtained cefzidone sodium The high-quality goods have low moisture content, low impurity content, high stability, but poor fluidity

[0008] CN104086571A discloses a preparation method of an anti-infective drug. First, cefozione and sodium sodium acetate are placed in anhydrous methanol to form a salt, and then ethanol and acetone are used for crystallization and crystal growth respectively, and the obtained cefozione sodium fine-quality water Low content, low impurity content, high stability, but poor fluidity

Although the stability of the obtained cefazedone sodium powder injection of the present invention is relatively good, the content of related substances is still relatively high, and needs to be further reduced.

[0010] Patent CN101584671A discloses a cefzidone sodium powder injection, which is prepared by crushing and bottling the single main drug cefzidone sodium. The content is high, and the change is obvious after long-term storage, which affects the safety of the drug

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