| 刘 园,张华峰,宋 青,等.甲癣涂剂的制备及主要成分含量测定方法的研究[J].安徽医药,2015,19(10):1881-1884. |
| 甲癣涂剂的制备及主要成分含量测定方法的研究 |
| Preparation and determination method for content in paint for onychomycosis |
| 投稿时间：2015-05-15 |
| DOI： |
| 中文关键词: 甲癣涂剂 制备 H+总量 碘 碘化钾 |
| 英文关键词: paint for onychomycosis preparation volume dose of H+ iodine potassium iodide |
| 基金项目: |
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| 摘要点击次数: 2904 |
| 全文下载次数: 180 |
| 中文摘要: |
| 目的 根据稳定性研究,修改处方工艺；修订H+总量、碘和碘化钾的含量测定方法。方法 建立甲癣涂剂的新的制备方法。滴定法测定H+总量、碘和碘化钾的含量,并且考察了该方法的重现性、精密度和回收率。将修订前与修订后的测定结果进行了比较。结果 甲癣涂剂短期内稳定性良好,可继续考察长期稳定性；H+总量的回收率分别为99.1%、100.2%、99.7%,碘的回收率为99.8%、99.8%、99.9%,碘化钾的回收率为100.1%、100.1%、100.3%。它们的精密度、重现性、稳定性也均符合要求。结论 去掉原处方中溶解水杨酸的乙醇和丙酮,利用二甲基亚砜溶解水杨酸,以保证制剂的稳定性；修订后的滴定法测定H+总量、碘和碘化钾的含量,滴定终点灵敏,易于观察,有利于更好的控制甲癣涂剂的质量。 |
| 英文摘要: |
| Objective To improve formula technology based on the findings of stability research,and to revise the method for content determination of volume dose of H+,iodine and potassium iodide.Methods A new preparation method of paint for onychomycosis was adopted. The content of volume dose of H+,iodine and potassium iodide were determined by titrimetric method,and the recovery rate,precision,reproducibility were inspected. The determination results prior to the revision were compared with the revised one.Results Paint for onychomycosis was stabile within a short period and its long-term stability could be investigated.The recovery rates of H+ were 99.1%,100.2%,99.7%. The recovery rates of iodine were 99.8%,99.8%,99.9%. The recovery rates of potassium iodide were 100.1%,100.1%,100.3%. The precision,reproducibility and stability of the volume dose of H+,iodine and potassium iodide were consistent with the request.Conclusions It is proposed to remove the alocohol and acetone from pro-prescription,and guarantee the stability of this preparation by dissolving salicylic acid in dimethyl sulfoxide. The titrating termination was sensitive and easy to be observed for quality control of this preparation. |
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