摘要
目的 优化银丹活血通瘀颗粒的成型工艺,并对所制备颗粒的质量进行评价。方法 以成型率、休止角、水分、吸湿率、溶化率为评价指标,通过单因素实验结合Plackett-Burman设计筛选关键工艺参数,利用层次分析法-熵权法结合Box-Behnken响应面法优化银丹活血通瘀颗粒的成型工艺,并进行工艺验证。通过相对均齐指数、松密度、振实密度、豪斯纳比、休止角、水分、吸湿率7个二级物理指标对10批银丹活血通瘀颗粒进行物理指纹图谱研究,以评价颗粒质量的一致性。结果 在固定辅料为甘露醇、药辅比1∶1(m/m)、干燥时间1 h的条件下,银丹活血通瘀颗粒的最优成型工艺为90%乙醇用量32%,干燥温度70℃;验证实验的综合评分均值为97.45分,与预测值97.18分接近。10批按最优成型工艺制备的银丹活血通瘀颗粒的物理指纹图谱与对照物理指纹图谱的相似度均高于0.99。结论 该成型工艺稳定、可行,所制备的银丹活血通瘀颗粒质量稳定、可控。
OBJECTIVE To optimize the forming process of Yindan huoxue tongyu granules,and evaluate the quality of the granules.METHODS Taking forming rate,angle of repose,moisture,moisture absorption rate and dissolution rate as indexes,single factor experiment combined with Plackett-Burman design was adopted to screen key process parameters;analytic hierarchy process combined with entropy weight method and Box-Behnken response surface method were used to optimize the molding process of Yindan huoxue tongyu granules,and the forming process was verified.The relative homogeneity index,bulk density,vibration density,Hausner ratio,angle of repose,moisture and hygroscopicity were used as secondary physical indexes to establish the physical fingerprints of 10 batches of Yindan huoxue tongyu granules to evaluate particle quality consistency.RESULTS The optimal molding process of Yindan huoxue tongyu granules was as follows:mannitol as the fixed excipient,the drug-assisted ratio was 1∶1(m/m)and the drying time was 1 h;90%ethanol was used as wetting agent and the amount of it was 32%,the drying temperature was 70℃.The results of validation tests showed that the average comprehensive score was 97.45,which was close to the predicted value of 97.18.The similarities between the physical fingerprints of 10 batches of Yindan huoxue tongyu granules prepared by the optimal molding process and the reference physical fingerprint were all higher than 0.99.CONCLUSIONS The molding process is stable and feasible,and the quality of Yindan huoxue tongyu granules produced is stable and controllable.
作者
王单单
陈雪平
白淑贤
吴作敏
董敬远
于晓涛
WANG Dandan;CHEN Xueping;BAI Shuxian;WU Zuomin;DONG Jingyuan;YU Xiaotao(Dept.of Pharmacy,Luohe Central Hospital,Henan Luohe 462300,China)
出处
《中国药房》
北大核心
2025年第11期1329-1334,共6页
China Pharmacy
基金
河南省科技攻关项目(No.242102310544)
河南省中医药科学研究专项课题(No.2023ZY3032)
漯河市重大科技创新专项(揭榜挂帅)项目(No.漯科〔2022〕45号)。
