首页|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

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

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

Anti Lower Limb Venous Thrombosis GranulesCCD-RSMD-optimal mixture designpreparation technologyextraction process

仲瑞雪、程子为、杨曼宁、唐雨、万军、吴传红、段小云

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四川省骨科医院,四川 成都 610041

西南交通大学 生命科学与工程学院,四川 成都 610031

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

四川省科技计划项目中央高校基本科研业务费专项资金四川省科技计划项目四川省骨科医院临床研究面上项目

2022NSFSC159820221061300812021YFS02572021MS03

2024

10.3969/j.issn.1672-979X.2024.04.001

食品与药品
山东省生物药物研究院

食品与药品

CSTPCD
影响因子：0.537
ISSN：1672-979X
年,卷(期)：2024.26(4)
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