VE醋酸酯微乳凝胶的质量评价及初步稳定性研究

目的:对VE醋酸酯微乳凝胶进行质量评价及初步稳定性考察。方法:考察3批样品的性状、pH值、黏度、失水百分率和含量及其在高温、高湿、强光照射、高速离心和室温下的初步稳定性。结果:3批样品外观均呈均匀、细腻、黏稠适宜的乳白色半固体凝胶,pH值约为6.5,黏度约为16mPa·s,失水百分率<20%,主药含量约为10mg·g-1(占标示量95%～100%),均符合相关规定;稳定性试验中除强光下含量略有下降外,其余指标均无明显变化。结论:VE醋酸酯微乳凝胶质量可控、初步稳定性良好,建议避光贮存。

Quality Evaluation and Preliminary Stability Test of VE Acetic Ester Microemulsion-based Gels

OBJECTIVE： To investigate the quality and preliminary stability of VE acetic ester microemulsion-based gels. METHODS： The property, pH value, viscosity, water loss property and content of 3 batches of samples were investigated, and the preliminary stability of VE acetic ester microemulsion-based gels was tested by exposing to high temperature, high humidity, high light, high speed centrifugation and room temperature. RESULTS： The appearances of 3 batches of samples were ivory semi- solid gels that were uniformed, fine and smooth, pH value was about 6.5 and viscosity was nearly 16 mPa.s, the ratio of water loss was lower than 20%, the content of main component was 10 mg.g ~ （95% ~100% of labelled amount）, which were all in line with the standard. The content of samples decreased slightly under high light, and other index had no obvious change. CON- CLUSION： VE acetic ester microemulsion-based gels are controllable and stable in quality, and should be stored in dark place.