基于多指标考察桑白皮配方颗粒的制备工艺及质量评价

Examination of the Preparation Process and Quality Evaluation of Cortex Mori Formula Granules Based on Multiple Indicators

以桑白皮为主要研究对象,通过单因素和正交实验对桑白皮料液比、提取时间、提取次数3个方面进行优化,并结合颗粒制造工艺,从辅料麦芽糊精的用量、湿润剂的选择2个方面对桑白皮配方颗粒制备工艺进行优化。结果显示,桑白皮水煎法最佳提取工艺为料液比1∶10,提取1 h,提取3次,桑皮苷A的平均转移率为96.10%;最佳的颗粒剂制备辅料配比为干浸膏粉-麦芽糊精(5∶1),润湿剂为80%乙醇。实验表明,上述桑白皮配方颗粒的提取和制剂成型工艺稳定可靠,且生产的配方颗粒质量可控,各项指标符合药典标准。

Taking Cortex Mori as the main research object,its extraction process was optimized through single factor and orthogonal experiment in three aspects:material-liquid ratio,extraction time and number,and the preparation process of Cortex Mori formula granules was optimized in two aspects:the amount of maltodextrin and the selection of wetting agent for the excipients in combination with the manufacturing process of granules.The results showed that the best extraction process of Cortex Mori by water decoction was under the material-liquid ratio of 1∶10 for 1 h and three times,which showed that the average transfer rate of Mulberroside A was 96.10%;as for the best preparation process of granules,the ratio of excipients between dry extract powder and maltodextrin was 5∶1,and the wetting agent was 80%ethanol.The experiment suggests that the above-mentioned extraction and preparation processes of Cortex Mori formula granules are stable and reliable,and the quality of produced formula granules is controllable and their indexes were in accordance with the standards in Pharmacopoeia of the People′s Republic of China.