温控型胰岛素液体肛门栓药剂学研究

Pharmaceutical studies on thermos sensitive insulin anal liquid suppository

目的温控型胰岛素液体肛门栓药剂学性质的研究。方法采用正交试验法,以形成凝胶时间、胶凝强度、生物黏附力、黏度、胶凝温度作为评价指标,对处方中的泊洛沙姆407和泊洛沙姆188的比例、壳聚糖质量分数和pH值3个因素进行考察,确定最优处方工艺;测定最优处方液体栓剂的胶凝强度、生物黏附力、黏度、胶凝温度。结果泊洛沙姆407∶泊洛沙姆188(15∶25),壳聚糖质量分数0.4%,pH值为5±0.2。结论经验证结果良好,液体栓剂强度及生物黏附力良好。

Objective To study the pharmaceutical quality of the thermos sensitive insulin anal liquid suppository .Meth-ods Orthogonal test method was used ,the forming of a gelatum time ,gel strength ,bio-adhesive force ,viscosity ,gelation temperature were taken as the evaluation index ,the prescription of poloxamer 407 and poloxamer 188 ,the proportion of chi-tosan and pH were investigated ,in order to determine the best optimized prescription and measure what was the best choice of the gel strength ,biological adhesion force ,suppository viscosity ,gelation temperature for the final prescription of liquid sup-pository .Result The best combination of the prescription were 15% of poloxamer 407 ,25% of poloxamer 188 and 0 .4% of chitosan with the pH of 5 ± 0 .2 .Conclusion The test proved to be equitable with the good intensity and bio-adhesive force of the liquid suppository .