摘要
目的:研制高水溶性聚维酮碘膜剂,并建立其质量控制方法。方法:用聚维酮碘、甘油、蒸馏水和水溶性成膜材料聚乙稀醇05-88制备膜剂;以电位滴定法测定聚维酮碘含量,并分别考察成品在棕色和无色玻璃瓶中的稳定性。结果:制备的膜剂完整光洁、色泽均匀、厚度一致;平均加样回收率为99.03%(RSD=0.75%);膜剂在棕色玻璃瓶中60d内外观和含量均无明显变化,而在无色玻璃瓶中含量明显降低,外观也变为淡黄色。结论:本制剂的制备工艺简便,质量控制方法准确可靠。
OBJECTIVE： To prepare PVP -Ⅰ film agent of high water solubility and to establish a method for its quality control. METHODS： The film was prepared by mixing PVP -Ⅰ, glycerol, distilled water and PVA05- 88. The content of povidone iodine was determined with electric titration. The stability of the preparation stored in brown glass and colorless glass was investigated.RESULTS： The prepared film was integrated, clear and even in color and size. The average recovery was 99.03% （RSD=0.75% ） . The film stored in brown glass showed no evident changes in appearance and content within 60d, while that in colorless glass was found to have a decrease in content and yellowish appearance. CONCLUSION： The preparation technology is simple and method of quality control is accurate and reliable.
出处
《中国药房》
CAS
CSCD
北大核心
2006年第6期430-431,共2页
China Pharmacy
