基于星点设计-效应面法联用正交设计优选抗骨质疏松颗粒的制剂工艺

Optimization the preparation process of Anti-osteoporosis Granules based on CCD-RSM and orthogonal experimental design

目的用星点设计-效应面法(CCD-RSM)联用正交实验设计优选抗骨质疏松颗粒的制剂工艺。方法以溶媒用量、煎煮时间为考察因素,以有效成分补骨脂素、异补骨脂素总量和干膏收率的总评“归一值”(optical density,OD)为评价指标,用CCDRSM确定最佳提取工艺;以颗粒溶化性、吸湿率、水分、成型率、休止角为评价指标,用正交实验优选最佳成型工艺。结果最佳提取工艺为加水量12倍,提取2次,每次130 min;成型工艺为浸膏与辅料的比例为1∶2,可溶性淀粉与糊精的比例为1∶3,用体积分数为90%的乙醇制粒,75℃干燥,过16目筛整粒,即得。结论优选的制剂工艺条件稳定、可行,可为抗骨质疏松颗粒的实际生产提供依据。

Objective To optimize the preparation process of Anti-osteoporosis Granules by central composite design-response surface method(CCD-RSM)and orthogonal experimental design.By taking solvent dosage and decocting time as the factors,the total concentration of effective components(the sum of psoralen and isopsoralen)and the overall desirability value(OD)of dry extract as the evaluation index,the optimal extraction process was determined by CCD-RSM.By taking solubility,moisture absorption rate,moisture,molding rate,and the angle of repose as the evaluation index,the best formalizing process was optimized by orthogonal experiment.Results The optimal extraction process was determined as follows:solvent dosage 12 times,extracted for 2 times and the decocting time 130 minutes;the optimal molding process was determined as follows:extract∶excipient=1∶2,soluble starch∶dextrin=1∶3,granulated with 90%vol ethanol,dried at 75℃,and sieved with a 16 mesh sieve again.Conclusion The optimized preparation process is stable and feasible,which can provide the basis for the actual production of Anti-osteoporosis Granules.