反流安无糖型混悬颗粒不同制备工艺制剂质量研究

Quality Study of Free-sugar Suspended Granules of Fanliuan of Different Preparation Process

目的比较反流安无糖型混悬颗粒不同制备工艺制剂质量,确定最佳制备工艺。方法对水提、醇提2种工艺按不同制粒配方制备的颗粒色泽、均匀度、味道、气味进行比较,确定浓浸膏-木糖醇-糊精的比例,并对颗粒的溶化性、粒度、流动性进行考察。分别采用薄层色谱法鉴别2种工艺制备的颗粒中的柴胡、白芍、枳实、延胡索,采用高效液相色谱法测定芍药苷和橙皮苷的含量,对水提和醇提效果进行比较。结果反流安无糖型混悬颗粒最佳制备工艺为:柴胡、枳实、白芍、甘草加12倍量80%乙醇浸泡30 min,提取1.5 h,药渣与生姜、竹茹、蒲公英、延胡索加8倍量水,提取2次,每次1.5 h,滤过,合并3次滤液,浓缩至膏状,按浓浸膏∶木糖醇∶糊精=1∶1∶3进行制粒。结论该方法操作简单,稳定,可行。

Objective To compare the quality of Free-sugar Suspended Granules of Fanliuan of different preparation technology, and optimize its preparation process. Methods The color, uniformity, taste and smell of particles of two kinds of extraction process were compared to optimize the proportion of drug, xylitol and dextrin of particle formation process, and dissolubility, size, liquidity of particles were investigated. Bupleuri radix, Aurantii fructus immaturus, Paeoniae radix alba and Rhizoma corydalis were identified by TLC, and paeoniflorin and hesperidin were determined by HPLC to compare the effect of water extraction and alcohol extraction. Results The best preparation process was as follows：Bupleuri radix, Aurantii fructus immaturus, Paeoniae radix alba and Glycyrrhizae radix et rhizoma were soaked with 12 times amount of 80%ethanol for 30 min, extracted for an hour and a half. Then the extract dreg and Zingiber officinale Rosc, Bamboo shavings, Taraxacum mongolicum, Corydalis rhizoma were extracted with 8 times amount of water for 2 times, 1.5 h for each time. After filtering, the filtrate was merged and concentrated to paste, the particle was formed as thick concrete∶xylitol∶dextrin=1∶1∶3. Conclusion The method is simple, stable and feasible.