交联淀粉碘微球软膏的处方筛选和质量评定

Formula Screen and Quality Evaluation of Crosslinked Starch Iodine Microspheres Ointment

目的筛选交联淀粉碘微球乳膏的处方,获得质量稳定的交联淀粉碘微球乳膏。方法以体外释放量为考察指标,筛选交联淀粉碘微球软膏的处方,以软膏外观、均匀度和粒度、含量、酸碱度、离心稳定性评价软膏质量;同时用硫代硫酸钠滴定测定微球中碘的含量。结果最优处方组成为聚乙二醇400-泊洛沙姆188-交联淀粉碘微球(2.2 g:0.8 g:2.0 g),软膏中的碘的有效含量为(1.9±0.1)%。结论按照最佳处方配比制备的淀粉碘微球软膏进行了初步质量评定,发现软膏外观良好,含量符合要求,稳定性较高。

To screen the formulas of crosslinked starch microspheres ointment in order to obtain a stablecrosslinked starch microspheres ointment. METHODS The formula of crosslinked starch iodine microspheres ointment was screened according to the release quantity in vitro. The ointment quality was evaluated according to appearance, uniformity and granularity, content,acidity or alkalinity,and centrifugal stability. RESULTS The optimal formula was that consisted of 2. 2 g PEG400,0. 8 g Poloxamer188 and 2 g crosslinked water-soluble-starch microspheres. The content of effective iodine in ointment was （ 1.9± 0. 1 ）%. CONCLUSION The preliminary quality assessment of ointment with optimal formula is conducted, and the ointment shows good appearance, desirable content and high stability.