丁香苦苷亲水凝胶骨架片的研制及其释药影响因素的研究

Study on Preparation of the Syingopicroside Hydrophilic Matrix Tablet and the Factors Affecting Dissolution Rate

目的制备丁香苦苷亲水凝胶骨架片,并对其释药影响因素进行了研究。方法采用羟丙甲基纤维素HPMC为骨架材料,以湿法制粒压片法制备丁香苦苷亲水凝胶骨架片。根据《中国药典》2005年版所载的溶出度测定方法测定其释放度。结果丁香苦苷缓释片释药行为符合H iguch i方程。HPMC在片剂中的含量升高或粒度减小,释药速度变慢。MCC、乳糖的加入(每片HPMC的含量不变)均加快丁香苦苷释药速率,且加入量不同其释药速率间具有显著差异。片剂大小、制粒方法对丁香苦苷释药速率均有影响。结论HPMC的型号、HPMC的用量、填充剂及压力的调节和控制等为影响丁香苦苷亲水凝胶骨架片释放速度的主要因素。

Objective To make Singopicroside hydrophilic gel matrix tablets and to examine the factors affecting their dissolution rates.Methods With HPMC as the matrix,the Singopicroside hydrophilic matrix tablets were prepared by a wet granulation compression method.According to the ＂Chinese Pharmacopoeia＂ contained in the 2005 edition of the dissolution test method was used to determine its release.Results The Syinggopicroside hydrophilic matix tablets conformed to Higuchi equation.The dissolution rates became slow with the increase of HPMC content or the decrease of HPMC particle size.Hydrophilic additives of starch,MCC,lactose,could accelerate the Singopicroside release from the tablets and the changes of their amount in this test range significantly affected the drug release.Conclusion Syingopicroside hydrophilic matix tablets conformed to Higuchi equation,and its release rate can be affed by many factors,such as HPMC models,HPMC the amount,bulking agent,and the pressure regulation and control.