软脉灵颗粒剂的成型工艺研究

Study on Molding Process of Ruanmailing Granules

目的优选软脉灵颗粒剂最佳的制剂成型工艺。方法考察不同比例的干膏粉、糊精和可溶性淀粉分别制粒后对颗粒剂的成型性、流动性、溶化性和颗粒合格率的影响,优化软脉灵颗粒剂最佳赋形剂比例;考察矫味剂的用量,优化矫味剂的配比。结果软脉灵颗粒剂最佳的赋形剂比例为干膏粉:糊精:可溶性淀粉4:1:2,外加0.05%甜菊糖,90%乙醇适量,所制得的颗粒成型性、流动性、溶化性较好,颗粒合格率最高,于相对湿度(80±2)%,温度(25±1)℃的条件下放置12h,其吸湿率低于6%。结论优选出的软脉灵颗粒剂成型工艺稳定、科学合理,所制得的颗粒各项指标表现较好,并且符合《中国药典》对颗粒剂剂相应的质量要求。

Objective Optimizing Ruanmailing granules pellet the best preparation for molding process. Methods Different proportion of the dry extract powder, dextrin and soluble starch respectively after granulating formability of granules, liquidity, the influence of the melt and particles percent of pass, optimize Ruanmailing granules pellet best excipient. Results Ruanmailing granules best excipient proportion to dry paste powder： dextrin soluble starch 4：1：2, plus 0.05% stevia sugar, 90% alcohol is right amount, the formability of particles, good liquidity, melt fraction particles is highest, In relative humidity （80±2）%, Temperature is （25±1）℃ is placed under the condition of 12 h, the moisture absorption rate below 6%. Conclusion Optimizing Ruanmailing granules pellet molding process is stable, scientific and reasonable, made by the particles tend to do well the indicators and comply with the ＂Chinese pharmacopoeia＂ and corresponding quality requirements of the granules.