聚维酮碘泡腾栓剂的制备及质量控制

摘要

OBJECTIVE To analyze the method of preparation of povidone iodine suppositories ,explore effec-tive measures of quality control.METHODS Using povidone iodine ,sodium bicarbonate ,citric acid,duckbill sup-positorymold preparation of povidone iodine effervescent suppository ,titration method was used to examine the iodine content of povidone ,product stability was observed.RESULTS The product was red brown suppository with good water solubility ,The pH value was 6.6 ,degradation reaction was first order reaction ,the effect of iodine content not in low temperature storage ,valid for up to 432 d.CONCLUSION The simple preparation of povidone iodine efferves-cent suppository preparation ,strong stability and convenient for quality control.%目的：分析聚维酮碘泡腾栓剂的制备方法，探讨有效质量控制措施。方法利用聚维酮碘、碳酸氢钠、枸橼酸、鸭嘴形栓剂模制备聚维酮碘泡腾栓，采取滴定法对聚维酮碘含量进行检测，对成品稳定性进行观察。结果本品是棕红色栓剂，具有良好水溶性，pH值为6.6，降解反应是一级反应，在低温贮藏时不会影响碘含量，有效期长达432d。结论聚维酮碘泡腾栓制备工艺简单，稳定性强且便于质量控制。