益心酮渗透泵片的制备及体外释放度考察

Preparation and in-vitro release of Yixintong osmotic pump tablets

目的:制备益心酮渗透泵片,并对其体外释药影响因素进行考察。方法:建立释放度测定方法,采用单因素试验优化益心酮渗透泵片的双层片芯处方和包衣处方,以f2相似因子法评价释药曲线相似性。结果:益心酮渗透泵片的释药行为受助推层聚氧乙烯、氯化钠用量以及包衣增重等因素影响显著;而受含药层处方及体外释放条件影响较小。优化处方制得的渗透泵片体外释药行为符合零级特征,释药方程为:Q=6.304 1t+5.937 2(r=0.993 1)。结论:采用渗透泵技术制备的益心酮渗透泵片释药行为达到控释要求,可用于益心酮缓控释制剂研究,也为中药剂型现代化提供了新思路。

OBJECTIVE To study the preparation and in-vitro release of Yixintong osmotic pump tablets. METHODS The method for determination of drug release was established. The single factor test that affected drug release in vitro was estab- lished. The single factor test that affected drug release in vitro was investigated to optimize the prescriptions of two-layer core and coated member, respectively. The similarity factors f2 were used to evaluate the similarities of the drug release profiles. RESULTS Drug release profiles in vitro were obviously affected by the content of PEO and NaC1 in the push layer and mem- brane thickness, but relatively lesser with agents in the drug layer and the release conditions in vitro. The drug release profile in vitro of optimized prescription of Yixintong osmotic pump tablets fits zero- order model. The equation was; Q = 6. 304 It ＋ 5. 937 2 （r = 0. 993 1 ）. CONCLUSION The prepared Yixintong osmotic pump tablets with osmotic pump technique was promi- nent in the characteristics of controlled release, not only could it be used for the study of preparation of Yxintong controlled re- lease,but also provided a new idea for the modernization of Chinese traditional drug formulation.