巴洛沙星胃内漂浮缓释片的制备与评价

目的制备巴洛沙星胃内漂浮缓释片,并对其体外释药性能进行评价。方法以体外释放度试验为手段,通过单因素试验和正交试验设计考察并优化巴洛沙星胃内漂浮缓释片的处方及工艺,并对其释药机制进行初步研究。结果以巴洛沙星200 mg,CaCO340 mg,羟丙基甲基纤维素K4M/十八醇（1∶1）调节片质量至400 mg,硬度为10 kgf压片,所得片剂在15 min内起漂,且能维持8 h以上,药物释放曲线符合Hixson-Crowell溶蚀方程和Ritger-Peppas方程,以溶蚀机制为主。结论该制剂具有明显的漂浮和缓释性能,且工艺简单。

Preparation and evaluation of balofloxacin gastric floating sustained release tablets

Objective To prepare the balofloxacin gastric floating sustained release tablets,and to evaluate drug release properties in vitro.Methods By means of the single-factor tests and orthogonal design,formulations and process factors of balofloxacin gastric floating sustained release tablets were investigated and optimized by drug release tests,and the release mechanism was also studied.Results The optimized tablets prepared with balofloxacin 200mg,CaCO3 40 mg,HPMC K4M 80mg and octadecanol 80mg could float within 15 min and maintain over 8.0 h.The release profile of balofloxacin from the tablets followed the Hixson-Crowell equation and Ritger-Peppas equation,which indicated that drug release mechanism was mainly by erosion.Conclusion The prepared sustained release tablets with a simple preparation process show obvious floating and sustained-release performance.