影响亲水凝胶骨架片凝胶强度的骨架材料性质和工艺参数研究  

Investigation on Matrix Material Properties and Process Parameters Influencing Gel Strength of Hydrophilic Matrix Tablets

作　　者：高谐 黄大唯 任沁 刘怡 GAO Xie;HUANG Dawei;REN Qin;LIU Yi(Ashland(China)Holding Co.,Ltd.,Shanghai 200233)

机构地区：[1]亚什兰(中国)投资有限公司,上海200233

出　　处：《中国医药工业杂志》2023年第3期383-394,461,共13页Chinese Journal of Pharmaceuticals

摘　　要：该研究利用以质构仪测定负荷-距离曲线的方法,考察了采用双螺杆湿法制粒(TSWG)或高剪切湿法制粒(HSWG)工艺,以羟丙甲纤维素(HPMC)为骨架材料制备的亲水凝胶骨架片的凝胶强度。结果表明,HPMC的甲氧基含量和相对分子质量升高、粒径下降对于凝胶强度具有正向贡献作用。同时,通过Box-Behnken设计考察了TSWG工艺参数(液/固比、进料速率、螺杆转速)和HSWG工艺参数(制粒时间、搅拌桨转速、剪切刀转速)对亲水凝胶骨架片凝胶层厚度、片芯内部耐润湿性能的影响,结合颗粒粒径和片剂形态分析了制粒工艺对凝胶强度的潜在影响,以期为亲水凝胶骨架片更全面的研发路径提供参考。In this study,texture analysis method of load-distance curve was applied to evaluate the gel strength of hydroxypropyl methylcellulose(HPMC)-based hydrophilic matrix tablets prepared by twin-screw wet granulation(TSWG)or high shear wet granulation(HSWG).The results revealed that the increase of methoxy(MeO)substitution degree and relative molecular weight of HPMC,and the decrease of particle size have positive contributions to gel strength of matrix tablets.Moreover,TSWG process parameters(liquid/solid ratio,feeding rate,screw speed)and HSWG process parameters(granulating time,impeller speed,chopper speed)on the thickness of surface gel layer and anti-wettability of inner cores were investigated through Box-Behnken design.The potential influence of granulation process on gel strength was analyzed in combination with particle size and tablet morphology,hoping to provide some references for a more comprehensive development pathway for hydrophilic matrix tablets.

关 键 词：亲水凝胶骨架片 凝胶强度 羟丙甲纤维素 双螺杆湿法制粒 高剪切湿法制粒 影响因素 

分 类 号：R944.4[医药卫生—药剂学]