Study on the extraction method of Cefuroxime Axetil Tablets system

Cefuroxime axetil is Cefuroxime Axetil Tablets orally absorbed via the gastrointestinal tract, the decomposition in the esterase, belonging to the beta lactam antibiotics, exists in the structure of the instability of the beta lactam ring, water, alcohol, high heat, damp heat degradation may have. By the wet granulation process in the production process, the main grain process by damp heat has great influence in the granulation and dry, extremely easy to cause decreased and related substances exceed the standard. Dry granulation is the powder mixed evenly, drug and excipients using dry granulating machine pressed into cakes or plate, and then through the pellet machine finishing, a preparation method of selection of the desired diameter particles powder screening machine. The method by mechanical compression on the binding force between particles produced, without adding any binder, suitable for heat sensitive, in water or alcohol to drop drug granulation, the key point is to control the good three elements, namely, hydraulic pressure, extrusion speed, feeding speed. In recent years, with the continuous innovation of dry granulation equipment, dry granulation tabletting method gradually attracted the attention of pharmaceutical enterprises.

Methods: with the particle size, liquidity and yield as indexes, the process conditions of screening dry granulating, and check their quality and stability study.

Results: the determination of dry granulation of three elements of hydraulic pressure respectively 2.5~3MPa, 15~20r, min-1 extrusion speed, feeding speed

200~300g min-1, the control pressure cake thickness 1~2mm. Qualified particle circulating dry granulating (16~30 mesh) can reach 90% to

On the angle of repose, about 30 degrees, smooth flow, compression rate of finished products of about 94%, by the accelerated test and long-term stability test, the indicators meet the 2005 edition of "Pharmacopoeia" the relevant provisions of Chinese.

Conclusion: the process parameters after screening and after fine tuning of the prescription can adapt to the dry granulating requirements, product stability is better than wet sample process, good reproducibility, shortening production cycle.