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目的:考察热敏型酸缓冲避孕凝胶(Ace-Acidgel)的稳定性。方法:酸碱滴定法测量热敏型酸缓冲避孕凝胶中冰醋酸的含量,分别于光照、低温、冻融和长期(12个月)留样条件下放置,于规定时间内,观察本品外观性状、pH、含量、黏度、胶凝温度及相变时间限度的变化。结果:本品外观性状、pH、含量、黏度、胶凝温度及相变时间限度在光照、低温、冻融和长期留样条件下基本无变化。结论:热敏型酸缓冲避孕凝胶稳定性较好,可在常温阴凉处保存。
Objective: To investigate the stability of heat sensitive Ace-Acidgel. Methods: The content of glacial acetic acid in the heat-sensitive acid-labile contraceptive gel was measured by acid-base titration. The contents of glacial acetic acid were placed under light, low temperature, freeze-thaw and long-term (12 months) Appearance traits, pH, content, viscosity, gelation temperature and the change of the time limit of the transformation. Results: The appearance, pH, content, viscosity, gelation temperature and the time limit of phase transformation were basically unchanged under light, low temperature, freeze-thaw and long-term retention. Conclusion: The heat-sensitive acid buffer contraceptive gel has good stability and can be stored in the shade at room temperature.