摘要
目的建立粉末直接压片法制备制霉素片的新工艺,解决生产过程中含量下降的问题。方法选用新型直接压片用辅料,采用正交实验法筛选处方。结果以流动性和可压性均好的Celldone102CG的微晶纤维素作为填充剂与药物混合后压成的片,生产过程中含量未下降,片重差异符合要求,素片脆碎度为0,包衣后崩解时间24min结论该处方工艺制备的制霉素片符合质量要求,且稳定性好。
Objective To establish the new formulation of preparing nysfungin tables by direct compression, and to solve the problem of content decrease during producing. Methods New direct compression excipient was chosen. The formulation was optimized based on the orthogonal design. Results The tablets with Celldone102CG MCC as the excipient had quality profiles as follows: the content did not decrease, the weight variation met the requirement, and the fragility was 0, and the disintegration after coating was 24 min. Conclusion The nysfungin tablets with this formulation complies with the quality criteria.
出处
《中南药学》
CAS
2008年第2期184-185,共2页
Central South Pharmacy
关键词
制霉素片
粉末直接压片法
正交实验
nysfungin tablet
direct compression
orthogonal design