直接压片工艺在低剂量药物制剂中的应用研究

Research on Application of Direct Compression Technique in Low-dosage Drug

目的:研究直接压片工艺在低剂量药物制剂中的应用。方法:选用苯磺酸氨氯地平片(5mg)为研究药物,直压甘露醇、微晶纤维素、磷酸氢钙为辅料,采用直接压片工艺,混合、压片,并考察所制得的片芯的可压性、脆碎度、含量均匀度和溶出曲线。结果:所得的片剂具有良好的可压性、脆碎度和含量均匀度,药物的溶出曲线达到一致。结论:直接压片工艺适用于低剂量药物制剂中。

Objective:To study of the application of direct compression technique in low-dosage drug. Methods:Choose amlodipine besylate tablets as the study drug,directly compressible mannitol,MCC and cal-cium hydrogen phosphate as the excipients,use the direct compression technique,mixed and compression, And study the compressible active,friability,content uniformity and the releasing curve of the tablets.Re-sults:The tablets contained good compressible active,friability,content uniformity and releasing curve.Con-clusino:Direct compression technique can be used in low-dosage drug.