颗粒剂中丹皮酚掩味技术探索

Investigation of Taste Masking Technology of Paeonol in Granules

目的：掩盖丹皮酚不良味道,制备丹皮酚共融物颗粒,并考察其体外溶出度。方法：以山嵛酸甘油酯为掩味材料,采用熔融骤冷法制备共融物颗粒。选择丹皮酚与山嵛酸甘油酯的用量比、聚乙二醇6000加入量和颗粒大小为考察因素,以掩味效果和60 min溶出度为综合评价指标,通过正交试验优化丹皮酚共融物颗粒的处方工艺。利用紫外分光光度法测定丹皮酚溶出量,检测波长274 nm。结果：丹皮酚共融物颗粒的最佳处方工艺为丹皮酚-山嵛酸甘油酯（1∶3.5）,聚乙二醇6000用量占丹皮酚与山嵛酸甘油酯总量的13%,颗粒大小80-100目。丹皮酚共融物颗粒的大小对掩味效果及溶出度具有显著性影响,60 min时丹皮酚溶出度〉70%。结论：优选的处方工艺简单、方法可行,丹皮酚共融物颗粒具有良好的口感。

Objective： To cover up bad taste of paeonol and prepare paeonol common melting substance granules,and then investigate in vitro dissolution of this granules. Method： Taking glyceryl behenate as masking material,common melting substance granules were prepared by melting quenching method. With proportion of paeonol and glyceryl behenate,the amount of PEG6000 and particle size as factors,orthogonal test was adopted to optimize formulation technology by taking taste masking effect and dissolution in 60 min as comprehensive evaluation index. Dissolution of paeonol was determined by UV spectrophotometry. Result： The best formulation process of paeonol common melting substance granules was as following： paeonol-glyceryl behenate（1∶ 3. 5）,the amount of PEG6000 accounted for 13% of total content of paeonol and glyceryl behenate,particle size of 80-100 mesh. Particles size had a significant impact for taste masking effect and dissolution of paeonol common melting substance granules,dissolution of paeonol in 60 min was more than 70%. Conclusion： Paeonol common melting substance granules has good taste masking effect. This optimized process is simple and feasible.