基于CCD-RSM联用D-最优混料设计优化抗下肢静脉血栓颗粒制剂工艺的研究  

Optimization of Preparation Technology of Anti Lower Limb Venous Thrombosis Granules by CCD-RSM Combined with D-Optimal Mixture Design

作　　者：仲瑞雪 程子为 杨曼宁 唐雨 万军[2] 吴传红[1] 段小云[1] ZHONG Rui-xue;CHENG Zi-wei;YANG Man-ning;TANG Yu;WAN Jun;WU Chuan-hong;DUAN Xiao-yun(Sichuan Provincial Orthopedic Hospital,Chengdu 610041,China;School of Life Science and Engineering,Southwest Jiaotong University,Chengdu 610031,China)

机构地区：[1]四川省骨科医院,四川成都610041 [2]西南交通大学生命科学与工程学院,四川成都610031

出　　处：《食品与药品》2024年第4期289-294,共6页Food and Drug

基　　金：四川省科技计划项目(编号:2022NSFSC1598);四川省科技计划项目(编号:2021YFS0257);中央高校基本科研业务费专项资金(编号:2022106130081);四川省骨科医院临床研究面上项目(编号:2021MS03)。

摘　　要：目的 采用星点设计-效应面法(CCD-RSM)联用D-最优混料设计,优化抗下肢静脉血栓颗粒的制剂工艺。方法 以溶媒用量、煎煮时间为主要考察因素,以有效成分丹酚酸B和多糖含量及干膏收率的总评归一值(OD)为评价指标,采用CCD-RSM确定最佳提取工艺;以颗粒吸湿率为评价指标,结合溶化性、成型率、休止角等,利用D-最优混料设计优选最佳成型工艺。结果 最佳提取工艺:采用8倍量水提取2次,每次100 min。成型工艺为浸膏与辅料比例1:2,辅料间比例为可溶性淀粉:糊精:蔗糖=0.452:0.518:0.030。结论 优选的制剂工艺条件稳定、可行,可为抗下肢静脉血栓颗粒的生产提供依据。Objective To optimize the preparation process of Anti Lower Limb Venous Thrombosis Granules using central composite design(CCD)-response surface methodology(RSM) combined with D-optimal mixture design.Methods Taking the solvent dosage and decoction time as the main investigation factors and using the normalized value(OD) of the contents of salvianolic acid B and polysaccharide and the yield of dry extract as the evaluating indicator,the CCD-RSM was used to determine the optimal extraction process.Using the hygroscopicity,solubility,formability of particles and angle of repose as the evaluating indicator,the D-optimal mixture design was used to investigate the optimal forming process.Results The optimal extraction process was as follows:the material was extracted twice with 8 times of solvent,100 min for each time.The optimal forming process was as follows:the ratio of the extract to the excipients was 1:2,and the ratio of the excipients was soluble starch:dextrin:sucrose=0.452:0.518:0.030.Conclusion The optimized preparation process is stable and feasible,which can provide a basis for the production of Anti Lower Limb Venous Thrombosis Granules.

关 键 词：抗下肢静脉血栓颗粒 星点设计-效应面法 D-最优混料设计 提取工艺 成型工艺 

分 类 号：R943[医药卫生—药剂学]