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目的:制备显示义齿组织面压通点的新型压力指示剂并建立其质量控制方法。方法:以羊毛脂、白凡士林等为辅料制备新型压力指示剂,并考察其性状、涂展性、不易黏附黏膜程度。测定锥入度,采用干燥失重法测定其中的水分含量;进行耐热、耐寒、离心、长期试验等稳定性考察。结果:制备的新型压力指示剂为淡黄色、非透明、质地均匀的半固体制剂,具有良好的颜色遮盖度,涂展性好,不易黏附口腔黏膜且容易去除,锥入度平均值为173.50单位(RSD=2.22%,n=6)。水分回收率试验平均回收率为100.28%(RSD=0.608%,n=5)。样品平均水分含量为45.42%(RSD=0.337%,n=5);耐热和耐寒试验未见油水分离;离心试验未见分层;长期试验未见酸败、异臭、变硬、油水分离、分层现象发生;其含量亦无变化。结论:新型压力指示剂具有良好的性能,制备工艺简单,稳定性良好,质量可控。
OBJECTIVE: To prepare a new type of pressure indicator showing the pressure point of denture tissue surface and to establish its quality control method. Methods: A new type of pressure indicator was prepared with lanolin and white petrolatum as excipient, and its traits, spreadability and adhesion to mucosa were not observed. Determination of cone penetration, using the dry weight loss method to determine the moisture content; for heat, cold, centrifugation, long-term tests and other stability inspection. Results: The new pressure indicator prepared was a light yellow, non-transparent and homogeneous semi-solid formulation with good color coverage, good spreadability, easy adherence to the oral mucosa and easy removal with an average cone penetration of 173.50 units (RSD = 2.22%, n = 6). The average recovery of water recovery test was 100.28% (RSD = 0.608%, n = 5). The average moisture content of the sample was 45.42% (RSD = 0.337%, n = 5). No oil-water separation was observed in the heat-resistant and cold-tolerant tests. No delamination was observed in the centrifuge test. Stratification occurs; its content also does not change. Conclusion: The new pressure indicator has good performance, preparation process is simple, good stability, quality control.