The Quality and Preparation of Levofloxacin Film-Coated Tablets
The consistency of the quality between the self-crafted and original preparations can ensure the clinical effect of the two prepara-tions to a greater extent.Therefore,the particle forming,fragility,and in vitro dissolution was used as the evaluation indicators,the prescrip-tion of self-developed formulations by screened and optimized experiments of the types of wetting agents,fillers and disintegrants,lubri-cants,adhesives,and coating powders.The optimum prescription of levofloxacin film-coated tablet contained Levofloxacin 512.5mg,micro-crystalline cellulose 70mg,calcium carboxymethyl cellulose 30mg,hydroxypropyl cellulose 3.75mg and sodium stearate 27mg.Coating ma-terial 3-5%was the optimal weight of levofloxacin tablets.Conduct quality inspection on the film coated tablets prepared by the selected pre-scription and compare them with the original research formulation,the self-developed drug and reference listed drug,when dissolved in four media-phosphate buffer solution(pH 6.8),hydrochloric acid(pH 1.0),acetate buffer solution(pH 4.5),and water-all had dissolution rates higher than 85%for 15 minutes,suggesting a similar dissolution behavior.Same crystal form and content;there was no significant change in the sample control indicators after 6 months of accelerated tested compared to 0 days.It is proved that the formulation and technology of self-developed levofloxacin tablets are stable and feasible,and the quality was consistent with the original preparation.
万方数据
维普
