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
季欧 1范依霖 2骆巧媚 2洪冉 2孙小丽 2仲瑞雪 1段小云1
作者信息
- 1. 四川省骨科医院药学部,成都 610041
- 2. 西南交通大学生命科学与工程学院,成都 610031
- 折叠
摘要
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CCD-RSM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.
Abstract
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 con-centration 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,mois-ture,molding rate,and the angle of repose as the evaluation index,the best formalizing process was optimized by orthogonal experi-ment.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,granu-lated 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.
关键词
抗骨质疏松颗粒/补骨脂素/异补骨脂素/星点设计-效应面法/正交实验设计Key words
Anti-osteoporosis Granules/psoralen/isopsoralen/central composite design-response surface method/orthogonal design引用本文复制引用
基金项目
四川省中医药局科学技术研究专项(2020JC0101)
出版年
2024
NETL
NSTL
万方数据