芦丁渗透泵片片芯的处方组成研究

Prescription Form of Core of Rutin Osmotic Pump

目的探讨芦丁渗透泵片的片芯处方组成。方法以体外释药行为和工艺成型的难易程度为指标,采用单因素法对低分子促渗剂、高分子促渗剂、黏合剂、稀释剂、崩解剂、阻滞剂的种类与用量进行考察。结果确定了芦丁渗透泵片片芯处方中低分子促渗剂为蔗糖,稀释剂为药用淀粉,黏合剂为10%聚乙烯吡咯烷酮(PVP)-乙醇,润滑剂为硬脂酸镁;常用高分子促渗剂聚氧乙烯(PEO)及阻滞剂羟丙甲纤维素(HPMC)、阿拉伯胶均会严重阻滞芦丁渗透泵片的体外释药;崩解剂微晶纤维素(MCC)对片芯高分子辅料黏性的改善效果不佳。结论单室单层型难溶性药物渗透泵片的常用片芯辅料种类不适合芦丁渗透泵片的制备,其片芯辅料还有待进一步的筛选和优化。

Objective To study the prescription form for core of rutin osmotic pump. Methods Single-factor method was applied to study the types and doses of infihration promoter with low and high-molecular-weight polymers, adhesive agent, diluting agent, disintegrating agent and blocker, by using in vitro drug release, as well as the molding process as indicators. Results The prescription form for rutin osmotic pump was composed as： sugar as low-molecular-weight infiltration promoter, medicinal starch as diluting agent, 10% PVP-ethanol as adhesives, stearate magnesium as lubricant; the common used PEO and HPMC retarded drug release in vitro; MCC was not good enough for adhesion. Conclusion The conventional core accessories for osmotic pump with insoluble drugs as a single-room and single-layer model are not suitable for rutin osmotic pump, proper ones of which need to be further screened and optimized.