论文部分内容阅读
目的考察影响罗氟司特片溶出度的关键工艺参数。方法采用正交试验及单因素法考察不同因素对罗氟司特片溶出度的影响。结果在诸多因素中,原料药的粒径对罗氟司特片溶出度的影响最为关键。结论原料药的粒径是影响罗氟司特片溶出度的关键工艺参数,需控制粒径D90<10μm。
Objective To investigate the key process parameters that affect the dissolution of roflumilate tablets. Methods The effects of different factors on the dissolution of roflumilate tablets were investigated by orthogonal test and single factor test. Results Among many factors, the influence of the particle size of the drug substance on the dissolution of roflumilate tablets is the most important. Conclusion The particle size of API is the key process parameter that affects the dissolution of roflumilate tablets, and the particle size D90 <10μm should be controlled.