应用感应压片机研究直接压片辅料的形变行为和成型性  

Deformation Mechanisms and Compactibility of Directly Compressible Excipients Using Induction Tablet Press

作　　者：李晓海[1] 赵立杰[2,3] 阮克萍 李美黛[5] 冯怡[2,3] 徐德生[1] 阮克锋[2,3] 

机构地区：[1]上海中医药大学附属曙光医院,上海200021 [2]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [3]上海张江中药现代制剂技术工程研究中心,上海201203 [4]上海强生制药有限公司,上海200245 [5]上海中医药大学基础医学院,上海201203

出　　处：《中国药学杂志》2014年第10期849-857,共9页Chinese Pharmaceutical Journal

基　　金：上海市自然科学基金资助项目(10ZR1439200);上海市教委重点学科(J50302)

摘　　要：目的应用感应压片机研究直接压片辅料的形变行为。方法选择18种常用直接压片辅料作为研究对象,以数学模型、压缩功和快速弹性松弛等作为评价方法,考察这些物质在压缩过程中的形变行为和成型性。结果纤维素类物质和共聚维酮有较低的屈服应力值和弹性系数,处于高抗张强度区;淀粉类物质有较低的屈服应力值,较高弹性松弛和塑性常数,弹性系数高于纤维素类,处于低抗张强度区;多元醇和乳糖类物质的塑性常数和屈服应力与纤维素类物质相似,但弹性系数高于后者,多处于中抗张强度区;矿物质盐类物质有非常高的屈服应力值和弹性系数,处于低抗张强度区。结论共聚维酮和纤维素类辅料是典型的塑性形变物质,有很好成型性;淀粉类物质具有良好的塑性形变,但也具有很高的弹性松弛,成型性相对较差;多元醇和乳糖类物质压缩过程中易于发生破碎,但前者的成型性相对较好;坚硬的矿物质盐类物质很难发生破碎,并具有很高的弹性复原能力。OBJECTIVE To study deformation behaviors of directly compressed materials using induction tableting machine. METHODS Eighteen types of materials,which were widely used in tablet production,were selected and compressed. Their deformation behaviors and compactability were investigated by applying classic methods involving compression models,mechanical energy and elastic stretch. RESULTS Cellulose and copovidone with lower Pyand E were ranked in high TS interval; starches with lower Py, high FES and Esp,and larger E values than cellulose,were ranked in inferior TS interval; polyols and lactose materials resembling cellulose powders in appearance of Esp and Py,were of higher E values than that of the latter and mostly ranked in intermediate interval; mineral materials with highest Pyand E were ranked in inferior TS interval. CONCLUSION Copovidone and cellulose derivatives display good plastic deformation and compactability whereas Ac-Di-Sol SD711 mainly deform elastically; starch derivatives primarily undergo plastic deformation during compaction but with high FES and relatively poor compactability; polyols and lactose materials exhibit brittle characteristics during loading and the former consolidating better; mineral materials show great resistance to break and deform and have relatively high elastic recovery.

关 键 词：直接压片辅料 形变行为 成型性 

分 类 号：R944[医药卫生—药剂学]