苦黄栓的制备与刺激性评价

The preparation and irritation evaluation of Kuhuang suppository

关键词:  妇科栓剂  基质  大鼠阴道黏膜  刺激性  中药制备  评价

Key words:  Gynaecology suppository  matrix  vaginal mucosa of SD rats  irritation  preparation  evaluation

摘要:

[目的]制备中药妇科栓剂苦黄栓，并进行初步刺激性评价。[方法]以融变时限为指标，筛选了水溶性基质与油溶性基质，并进行苦黄栓儿茶的薄层色谱鉴别。以健康雌性SD大鼠为模型动物，考察SUPPOCIRE NAS50基质苦黄栓的大鼠阴道黏膜刺激性。[结果]SUPPOCIRE基质栓剂偏硬，融变时限符合药典规定。S40基质栓剂与PEG1500基质栓剂的融变时限偏长。综合考虑，采用SUPPOCIRE NAS50作为苦黄栓的基质；在与对照品色谱和对照药材色谱相应的位置上，供试品色谱显相同颜色的荧光斑点，阴性无干扰，大鼠阴道解剖前后直观结果与病理切片分析结果表明，SUPPOCIRE NAS50基质苦黄栓给药组与空白组间无显著性差异。[结论]选择SUPPOCIRE NAS50作为苦黄栓的基质；SUPPOCIRE NAS50基质苦黄栓对大鼠阴道黏膜无刺激，安全性好，可用于阴道炎的治疗。

Abstract:

[Objective] To study the preparation and safety of HS Shuan,a gynecological disease preparation.[Methods] Screen matrix of HS Shuan,investigate the effect of different matrix (water soluble matrix and oil soluble matrix) on melting time. Observe and study the irritation to vaginal mucosa of female SD rats.[Results] The melting time of oil soluble matrix prepared suppositories was short,while that of water soluble matrix prepared was long. At last,we choose oil soluble matrix to prepare HS Shuan. HS Shuan prepared by oil soluble matrix had no irritation to vaginal mucosa of female SD rats.[Conclusion] The process is steady to prepare HS Shuan from oil soluble matrix. HS Shuan has no irritation to vaginal mucosa of female SD rats. HS Shuan can be used to treat vaginitis.