天舒片变更辅料工艺优化

Technology Optimization of Excipients Changing for Tianshu Tablets

目的对天舒片辅料变更进行工艺优化。方法以软材性状、颗粒收率、颗粒吸湿率为评价指标,筛选辅料加入种类;以颗粒收率、素片硬度、崩解时间为评价指标,用Minitab软件对混合辅料配比和制剂工艺条件进行优化,并进行工艺验证和稳定性考察。结果最佳工艺条件是用微晶纤维素和二氧化硅代替糖粉,以干浸膏粉-辅料(5∶1),微晶纤维素-二氧化硅(3∶1),85%乙醇为润湿剂,加入量为干膏粉的20%。经热稳定性和加速稳定性考察,新配方工艺制备的天舒片没有渗油情况,其他指标与原工艺没有明显变化。结论优选的辅料可显著改善药片渗油现象,且成型工艺稳定合理,为天舒片工业化生产提供参考。

Objective To optimize the technology of excipients changing for Tianshu Tablets.Methods Taking characters of soft materials,particles yield and absorption rate as indexes,the varieties of excipients added prescription was screened.Taking particles yield,hardness of tablets and disintegration time as indexes,the ratio of excipients and molding process condition were optimized by using Minitab,and process validation and stability investigation were carried out.Results The optimal excipients were microcrystalline cellulose and silica,the optimal molding technology was as follows:extract powder-excipients(5∶1),excipient for themicrocrystalline cellulose-silica(3:1),with 85%ethanol as wetting agent which accounted 20%of the extract powder.The results of thermal stability and accelerated stability showed that there was no oil leakage in Tianshu Tablets prepared by the new formulation process,and other indexes had no obvious changes with the original process.Conclusion The optimized excipients can significantly improve the oil leakage of the tablets.The molding technology is stable and feasible,which can provide basis for the industrial production of TianshuTablets.