摘要
目的优化脑血康分散片的制备工艺。方法采用水提醇沉方法从水蛭中提取浸膏,以微晶纤维素作为主要辅料制备脑血康分散片,并对三批中试放大试验样品进行考察。结果平均成品率为97.25%,平均片重为0.3690g,平均崩解时间为50s,含氮量为5.45mg/片,分散均匀性、重量差异及微生物限度均符合规定。结论本制剂工艺设备简单,操作方便,制成的制剂符合分散片质量标准。
Objective To optimize preparation process of Naoxuekang dispersible tablets. Method The method of water distill and the alcohol precipitates was adopted to withdraw the ointments from the Hirudo, the microcrystaline cellulose being used in manufacturing Naoxuekang dispersible tablets, and review three batch sampler. Results The average product rate is 97.25%, the average tablet heavy is 0.3690 g, average collapse time is 50 second, contain nitrogen is 5.45 mg/tablet, the scattering about even, weight difference and micro organism limits to all meet the provision. Conclusion This product craft equipments is simple, the operation is convenient, the product accord with the dispersible tablets quantity standard.
出处
《药品评价》
CAS
2006年第3期198-200,共3页
Drug Evaluation
关键词
脑血康
水蛭
分散片
微晶纤维素
Naoxuekang
Hirudo
dispersible tablets
Microcrystaline cellulose