盐酸左氧氟沙星分散片的制备及其质量研究

Study on the Preparation and Quality of Levofloxacin Hydrochloride Dispersible Tablets

目的:进行盐酸左氧氟沙星分散片处方、制备工艺及其主要质量指标的研究,开发其新型制剂以适用于临床。方法:根据处方组分的理化性质,设计了制备工艺路线。实验以崩解时限等为指标,筛选处方中崩解剂、填充剂、助悬剂等最佳辅料种类;通过正交实验,确定最佳处方并制备盐酸左氧氟沙星分散片;并对样品的外观、性状、硬度、脆碎度、崩解时限、分散均匀性、含量测定、溶出度等质量指标进行了研究。结果:通过筛选的优化处方为:盐酸左氧氟沙星104.60g、PVPP 22.50g、L-HPC 22.50g、MCC 112.50g、EC 12.50g、乳糖3.62g、润滑剂1.20g,共制1000片;崩解时限为62s。其他各项质量指标均符合规定。结论:本研究所得处方合理,制备工艺简便,检测方法准确可靠,药品质量可控。

Objective:Study of levofloxacin hydrochloride dispersible tablets prescription,preparation technology and its main quality indexes,the model formulation for clinical.Methods: According to the physicochemical properties of prescription composition, preparation process route design. Experiment with disintegration time as index,screening of disintegrants,filler,the suspending agent is the best accessories category; through orthogonal experiment, the best prescription and preparation of levofloxacin hydrochloride dispersible tablets; and the appearance,properties,hardness,friability,disintegration time,dispersible uniformity, content determination,stripping of the quality index is studied. Results: The formulation was optimized by screening for: levofloxacin hydrochloride 104.60g,PVPP 22.50g,L-HPC 22.50g,MCC 112.50g,EC 12.50g,lactose 3.62g,lubricant 1.20g,a total of 1000 tablets; disintegration time as 62s. All other quality indicators are in line with the provisions of.Conclusion: In this study,the prescription is reasonable,the preparation process is simple,accurate and reliable detection method,the drug quality control.