摘要
目的:制备聚维酮碘新制剂并建立其质量控制方法。方法:制备独立包装的聚维酮碘片剂及缓冲溶液,采用电位滴定法测定混合后制剂中碘的含量,同时考察其稳定性。结果:所制制剂固相为棕红色片剂,液相为pH约5.8的无色澄清溶液;混合后制剂溶液中平均有效碘含量为95.24mg;稳定性考察中,10h内有效碘含量测定结果平稳。结论:本制剂制备工艺简单可行,质量稳定可控。
OBJECTIVE： To prepare and establish the quality standards for new povidone iodine preparation. METHODS： Povidone iodine tablets with independent package and its buffer solution were prepared. Electrolytic titration was applied to determine the content of iodine in the solution, meanwhile the stability of the preparation was investigated as well. RESULTSi The solid phase of the preparation was brownish red tablet, and the liquid phase was colorless clarified solution with pH = 5.8. The active content of iodine in the mixture was 95.24 mg on average. The active content of iodine within 10 h was stable. CONCLUSION ： The preparation is simple and feasible in technology, and its quality is stable and controllable.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第1期48-49,共2页
China Pharmacy
基金
中国人民解放军海军医学研究所基金资助(07K301)
关键词
聚维酮碘
含量测定
鉴别
电位滴定法
质量标准
Povidone iodine
Content determination
Identification
Electrolytic titration
Quality standard
