摘要
目的研制巴洛沙星胶囊并利用溶出度试验来严格控制产品的质量。方法采用单因素试验筛选巴洛沙星胶囊的处方、工艺,采用不同pH的溶出度试验条件检验处方的合理性。结果所研制的产品符合要求,在不同pH下,60min的溶出度达75%以上。结论制备工艺简单易行,药品溶出度较高。
Objective To prepare Balofloxacin Capsules and to control the product quality strictly through the dissolution rate tests. Methods The mono-factor test was adopted to screen the formulation and preparation techniques, and the formulation was verified by the dissolution tests under different pH conditions. Results The obtained capsules met the pharmaceutical requirements. The dissolution rates of balofloxacin capsules under different pH conditions achieved above 75% after 60 min. Conclusion The preparation process is simple and easy for operation. The dissolution rates are higher in different pH conditions.
出处
《中国药业》
CAS
2009年第12期53-54,共2页
China Pharmaceuticals
关键词
巴洛沙星胶囊
制备
酸碱度
溶出条件
溶出度试验
Balofloxacin Capsules
preparation
pH
dissolution conditions
dissolution rate test