丹皮酚-β-环糊精包合物处方工艺研究

Optimization on the Formulation Technology of Paeonol-β-cyclodextrin Inclusion Compound

目的:优选丹皮酚-β-环糊精包合物的处方工艺。方法:以β-环糊精用量、固-液比例(β-环糊精∶丹皮酚乙醇液)、包封液乙醇的浓度为因素进行正交试验,对超声时间进行单因素考察,以利用率和包封率为评价指标,筛选丹皮酚-β-环糊精包合物制备的最佳处方工艺条件,并进行验证试验。结果:最佳处方工艺为β-环糊精8g,固-液比例1∶3,乙醇浓度40%,超声40min。验证试验结果表明4批样品的标示含量约为90%。结论:该处方工艺简单、合理,可用于制备丹皮酚-β-环糊精包合物。

OBJECTIVE： To optimize the formulation technology of paeonol-β-cyclodextrin inclusion compound. METHODS： The formulation technology of paeonol-β-cyclodextrin inclusion compound was optimized by performing or-thogonal experiment with the amount of β-cyclodextrin, the solid - liquid ratio （ratio of β-cyclodextrin to paeonol alcohol solution）, the concentration of the envelop liquid （alcohol） as factors and the ultrasonic time was studied by single factor test and with the utilization ratio and entrapment efficiency of paeonol as indexes for evaluation. Meanwhile, a verification test was performed. RESULTS： The optimal formulation technology was as follows： the amount of β-cyclodextrin was 8g; the solid-liquid ratio was 1： 3; the concentration of the alcohol was 40% and the ultrasounding time was 40 rain. The verification test revealed that the labeled contents were about 90% for all samples （4 batches）. CONCLUSION： The optimized formulation technology is simple and reasonable, and it is applicable for the preparation of paeonol-β-cyclodextrin inclusion compound.