Pharmaceutical cefotiam composition for treating infectious diseases

Abstract

The invention relates to a pharmaceutical cefotiam hydrochloride composition for treating infectious diseases, belonging to the technical field of medicine. The composition is composed of cefotiam hydrochloride and anhydrous sodium carbonate. The cefotiam hydrochloride is a crystal, and can obtain an X-ray powder diffractogram disclosed as Figure 1 by using Cu-Kalpha ray measurement. The cefotiam hydrochloride new crystal form provided by the invention is different from the crystal form structure in the prior art. The experimental verification surprisingly detects that the crystal compound has the advantages of high purity, favorable flowability, favorable stability, low polymer content and no hygroscopicity; and the solution, which is prepared by mixing the powder injection, a 0.9% sodium chloride injection, a 5% glucose injection and a 5% glucose sodium chloride injection and standing at room temperature for 4 hours, has favorable stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug cefotiam composition for treating infectious diseases. Background technique [0002] Cefotiam hydrochloride is a widely used cephalosporin in clinical practice. During storage, especially at high temperature (>50°C), it often undergoes degradation and polymerization reactions, resulting in a decrease in the content of active ingredients in the drug. The color is enhanced and the content of polymer impurities is increased. In addition, cefotiam hydrochloride that has expired, due to long storage time, often reduces the content of active ingredients of the drug, darkens the color, and has a particularly high polymer content. When the polymer content is high, it is easy to cause allergic reactions in the human body. [0003] Although the prior art has solved its purity problem to a certain extent, it has been found through further research that degradation and polymerizati...

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Problems solved by technology

[0004] However, the structure of cefotiam hydrochloride contains an unstable β-lactam ring, which is prone to hydrolysis and rearrangement reactions, resulting in the destruction of the structure and the loss of antibacterial activity. Some degradation products may cause allergic reactions. The stability in the

[0005] However, the literature "Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions" [Luo Xiaoru, Wei Liping, et al. Study on the Compatibility Stability of Cefotiam Hydrochloride for Injection and Three Kinds of Infusions, Journal of Pharmaceutical Sciences of PLA [J], 2013, 29 (4): 354-356] After investigating the compatibility stability of cefotiam hydrochloride for injection with 0.9% sodium chloride injection, 5% glucose injection and 5% glucose sodium chloride injection, Its result shows that under room temperature condition, cefotiam hydrochloride for injection is all unstable in above-mentioned 3 kinds of solutions

However, none of the new crystal compounds of the prior art solves the problem

[0006] And, the fluidity of cefotiam hydrochloride is also relatively poor, makes when preparing cefotiam hydrochloride for injection and the mixing homogeneity of auxiliary material is poor

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