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聚维酮碘膜剂的制备及质量控制
引用本文:田睿,李勤耕,徐启贵.聚维酮碘膜剂的制备及质量控制[J].中国药房,2006,17(6):430-431.
作者姓名:田睿  李勤耕  徐启贵
作者单位:重庆医科大学药学系,重庆市,400016
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。

关 键 词:聚维酮碘膜剂  制备  质量控制  稳定性
文章编号:1001-0408(2006)06-0430-02
收稿时间:09 30 2005 12:00AM
修稿时间:10 31 2005 12:00AM

Preparation and Quality Control of PVP- I Film
TIAN Rui,LI Qingeng,XU Qigui.Preparation and Quality Control of PVP- I Film[J].China Pharmacy,2006,17(6):430-431.
Authors:TIAN Rui  LI Qingeng  XU Qigui
Institution:Dept. of Pharmacy, Chongqing University of Medical Sciences, Chongqing 400016,China
Abstract: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.
Keywords:PVP-I film  Preparation  Quality control  Stability
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