CAJ | 학술논문

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。
목적：근거은정성연구，수개처방공예；수정 H ＋총량、전화전화갑적함량측정방법。방법건립갑선도제적신적제비방법。적정법측정 H ＋총량、전화전화갑적함량，병차고찰료해방법적중현성、정밀도화회수솔。장수정전여수정후적측정결과진행료비교。결과갑선도제단기내은정성량호，가계속고찰장기은정성；H ＋총량적회수솔분별위99．1％、100．2％、99．7％，전적회수솔위99．8％、99．8％、99．9％，전화갑적회수솔위100．1％、100．1％、100．3％。타문적정밀도、중현성、은정성야균부합요구。결론거도원처방중용해수양산적을순화병동，이용이갑기아풍용해수양산，이보증제제적은정성；수정후적적정법측정 H ＋총량、전화전화갑적함량，적정종점령민，역우관찰，유리우경호적공제갑선도제적질량。
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 ob-served for quality control of this preparation.