口腔修复用压力指示剂的处方优化研究

Formulation Optimization of Pressure Indicator for Prosthodontics

目的以制剂的涂展性、不易黏附黏膜程度、去除难易程度等为考察指标,对压力指示剂处方组成及各组分含量进行优化,设计出新型压力指示剂的最优处方。方法以综合评分法对处方材料进行筛选。以正交试验方法对处方配比进行优化。对优选处方进行耐热、耐寒试验;离心试验等稳定性研究。结果以羊毛脂为主要成分的新型压力指示剂本身具有良好的颜色遮盖度,且在一定的黏度下能够达到既易涂布又不易黏附于口腔黏膜。正交试验结果显示羊毛脂与水的比例为影响压力指示剂性能的主要因素。优选出的处方稳定。结论优化后的压力指示剂具有良好的性能,临床反应良好。且制备工艺简单,稳定性良好,质量可控。

OBJECTIVE To optimize the formulation of pressure indicator based on spreadability, nonadhesion to oral mueosa, and difficulty of removal. METHODS The formulation components were screened by colligation score, the optimal formulation was designed by orthogonal test, and the heat-resistance, cold-resistance, and stabilily of the optimal formulation were evaluated. RESULTS The optimized pressure indicator using lanolin as the main ingredient had good color coverage and suitable viscosity which allowed easy coating of the internal surfaces of dentures and no adherence to the oral mucosa at the same time. And it could be removed easily. The results of orthogonal test showed that the ratio of lanolin and water was the main factor affecting the performance of the pres- sure indicator. The optimized formulation was stable. CONCLUSION The optimized pressure indicator has good performance and good clinical response. The preparation process is simple. The property of optimized pressure indicator is stable and the quality can be controlled.