聚维酮碘膜剂的制备及质量控制

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。

Preparation and Quality Control of PVP- I Film

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.