Cefixime composition and preparation method thereof

Abstract

The invention relates to the field of medicines, and particularly relates to a cefixime composition and a preparation method thereof. The cefixime composition comprises the following components in parts by weight: 360-440 parts of cefixime, 10-20 parts of liquid paraffin, 10-50 parts of magnesium stearate and 1100-1500 parts of dry starch. In the cefixime composition provided by the invention, the liquid paraffin has the effects of improving the stability of the composition, reducing the content of impurities in the composition and also promoting the dispersion of the cefixime, so that the dissolution rate of an oral preparation is increased. Experiments show that after the cefixime composition provided by the invention is prepared into the oral preparation, the dissolution rate is above 97% at the thirtieth minute and can be above 99%; an acceleration experiment and a long-term experiment show that the oral preparation prepared from the cefixime composition provided by the invention has small content changes after being preserved for six months, so the composition is proved to be stable in nature.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a cefixime composition and a preparation method thereof. Background technique [0002] Cefixime, the English name is Cefixime, the Chinese aliases are acetioxime cephalosporin, Shifusu granules, and the CAS number is 79350-37-1. It is a third-generation cephalosporin antibiotic and is absorbed through the gastrointestinal tract when taken orally. Finally, it can prevent the synthesis of bacterial cell walls and play an antibacterial effect, which is safe, efficient and resistant to enzymes. Cefixime is white to light yellow crystalline powder, bitter and slightly specific odor, unstable to damp heat, easily soluble in methanol and dimethyl sulfoxide, slightly soluble in acetone, hardly soluble in ethanol, almost insoluble in water, Ethyl acetate, ether, hexane. [0003] At present, oral preparations of cefixime mainly include tablets, dispersible tablets, dry suspensions and capsules. ...

AI Technical Summary

Problems solved by technology

For wet granulation, due to the instability of cefixime to heat and humidity, cefixime is often degraded during the preparation process, resulting in an increase in the content of related substances, which affects the safety of the drug

However, dry granulation can make the material not well mixed, and the particle size of the oral preparation is not uniform, resulting in a decrease in dissolution rate

In addition, there are currently other schemes for preparing cefixime oral preparations: for example, some technical schemes take raw materials and mix and pulverize them and then directly fill them into capsules, but this scheme usually leads to uneven content due to the difficulty in controlling the capsule loading, while some Technical solution During the preparation process, organic solvents such as methanol are used to dissolve cefixime, but there will be residues of organic solvents in the prepared product, which will affect the safety of the drug.

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