止汗贴质量标准的建立

Establishment of quality standard for antiperspirant paste

目的:完善制剂止汗贴的质量标准,更好地保障制剂的稳定性。方法:建立止汗贴方中郁金、五倍子的薄层鉴别法;建立姜黄素的高效液相测定法,姜黄素的含量以乙腈-水-冰醋酸(45:55:6)为流动相,检测波长254 nm。结果:止汗贴薄层色谱与郁金、五倍子对照药材色谱和相应的位置上,显相同颜色的斑点,且阴性样品无干扰。姜黄素的含量鉴别方法专属性强,姜黄素在0.10~0.80 mg/mL范围内的线性关系良好,r=0.9997,加样回收率为100.28%,RSD为0.91%(n=6)。结论:新建立的检测方法可行,专属性强,可作为止汗贴质量控制的方法。

Objective:To improve the quality standard of preparation antiperspirant paste,and to better guarantee the stability of preparation.Methods:To establish the thin layer identification method of turpentine and gallnut in antiperspirant paste recipe.A HPLC method for the determination of curcumin was established.Acetonitrile-water-glacial acetic acid(45:55:6)was used as the mobile phase,and the detection wavelength was 254 nm.Results:THE TLC OF ANTIperspirant PATCHES SHOWED the same color spots ON THE chromatograms of TURpentINE and GALLA chinENSIS AND THE corresponding positions,and the negative samples had no interference.The curcumin content identification method was specific,and the linear relationship was good in the range of 0.10~0.80 mg/mL(r=0.9997).The recovery was 100.28%,RSD was 0.91%(n=6).Conclusion:The newly established detection method is feasible and specific,and can be used as a quality control method.