压力指示剂的制备及质量控制

Preparation and Quality Control of Pressure Indicator

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 new type pressure indicator for showing denture tissue surface tenderness and to establish the method for its quality control. METHODS： Lanolin and petrolatum were used as the main adjuvant material to prepare new pres- sure indicator. The property, spreadable property and the degree of difficulty to adhere to mucous membrane of the indicator were investigated. Cone penetration was determined, and the moisture determination study was conducted by weightlessness method. The stabilities of heat-resistant, cold-resistant, centrifugation and long-term tests were evaluated. RESULTS： The prepared new pressure indicator was yellowish, non-transparent and homogeneous semi-solid preparation, with good color cover coverage and viscosity. The prepared indicator was not easy to adhere to oral mucosa and could be removed easily. The cone penetration was 173.50 units in average （RSD=2.22%, n=6）. The average recovery test of moisture was 100.28% （RSD=0.608%, n=5）. Average moisture capacity of the optimized pressure indicator was 45.42% （RSD=0.337%, n=5）. No water-oil separation was found in heat-resis- tant test and cold-resistant test; no layering occurred in centrifugal test; rancidity, foreign odor, brinelling, water-oil separation and layering were not observed in long-term test; the content of pressure indicator had no difference. CONCLUSIONS： The new pressure indicator has good performance. The preparation process is simple. The property of optimized pressure indicator is stable and controllable in quality.