脑安片粉末直接压片新工艺研究

Study on direct powder compression of Naoan tablet

使用新型的直接压片辅料,筛选出可压性和流动性均好的稀释剂,建立脑安片粉末直接压片的新工艺.新工艺制备的脑安片比湿法制粒老工艺制备的脑安片一次合格率提高30%.经影响因素试验、加速试验及室温贮存考察,检测制备的脑安片的性状、质量分数、片重差异.考察结果本工艺制备的脑安片稳定性良好,符合法定质量标准要求.该工艺简单易行,稳定可行,适合工业化生产.

To establish a new method to make Naoan tablets by directly squashing main medicinal powder and excipients powder. Chooses new excipients which can be directly squashed and have good fluidity, mix with main medicinal powder and directly squash the mixed powder to produce Naoan tablets. Naoan tablets of direct powder compression compared with wet method manufacture pellet, product qualified rate enhances 30%. under stress test , room temperature environment , the following Naoan tablets＇ properties were assessed ： appearance, Naoan＇ s quality score,weight variation. The results showed that Naoan tablets have good stability, the properties are correspondent with the requirements of legal quality standard. The new direct powder compression method is simple, repeatable and adapt to industrial production.