人参总皂苷渗透泵控释片的片芯处方研究

Study on the Core Prescription of Gensenosides Osmotic Pump Tablets

目的:以中药人参的有效部位人参总皂苷为模型药物,进行人参总皂苷渗透泵片的片芯处方研究,以确定其最终片芯处方。方法:采用单因素考察法,从制剂的成型和体外释药特征角度,对人参总皂苷渗透泵片片芯的稀释剂、黏合剂、渗透活性物质和润滑剂进行了筛选。结果:人参总皂苷渗透泵片的最终片心处方为:人参总皂苷提取物100mg,乳糖235mg,淀粉118mg,氯化钠33mg,滑石粉3%～6%。结论:该片心处方辅料来源广泛,利于片心成型,并具有较好的体外释药行为,为人参总皂苷渗透泵控释片的进一步研究打下了基础。

Objective： To develop the core formulation of gensenosides osmotic pump tablets. Methods： Different attenuants, adhesive osmotic active compounds and lubricant were screened out for the formulation of the gensenosides osmotic pump tablet cores by the single factor experiment from two aspects, the dosage form and release character in vitro. Results： The core formulation was screened out consisting 100 mg gensenosides extract, 235 mg lactose. 118 mg starch, 70 mg sodium chloride and 3%-6% tale. Conclusions： The adjuvants of the core formulation have extensive source and good moldability. This study is the foundation of further research of gensenosides osmotic pump tablets.