小儿青香外洗散剂质量标准研究

Research on the Quality Standard of Xiaoer Qingxiang External Washing Powder

目的 建立小儿青香外洗散剂的质量控制方法,为小儿青香外洗散剂的生产提供质量控制依据。方法 参照2020年版《中华人民共和国药典(四部)》通则中的方法对小儿青香外洗散剂的粒度、水分、装量差异、外观均匀度等进行测定;采用薄层色谱法(TLC)对小儿青香外洗散剂中的苍术进行定性鉴别研究;采用显微鉴别法对方中苍术、香薷的主要显微特征进行鉴别。结果 小儿青香外洗散剂的粒度为最细粉;水分含量不超过9.0%;装量差异及外观均匀度均符合标准规定;散剂中苍术和香薷的显微特征明显;薄层色谱图中,苍术的色谱斑点清晰、特征明显、分离度好,且阴性对照溶液不存在干扰。结论 此实验所建立的小儿青香外洗散剂质量控制方法重复性好、专属性强,可对小儿青香外洗散剂质量进行控制。

Objective To establish the quality control method for Xiaoer Qingxiang external washing powder,and provide quality control basis for the production of Xiaoer Qingxiang external washing powder.Methods The determination of particle size,moisture,loading variation and uniformity of appearance of Xiaoer Qingxiang external washing powder was carried out with reference to the methods in the general rules of the 2020 edition of the Chinese Pharmacopoeia(Part IV).Results The particle size of Xiaoer Qingxiang external washing powder was the finest powder.The moisture content did not exceed 9.0%.The loading variation and uniformity of appearance were in accordance with the standard.The microscopic features of Atractylodes macrocephala and Elsholtzia sp.in the powder were obvious.In the thin layer chromatogram,the chromatographic spots of Atractylodes macrocephala were clear,distinct and well separated,and there was no interference from the negative control solution.Conclusion The established method for quality control of Xiaoer Qingxiang external washing powder has good repeatability and specificity,and can control the quality of Xiaoer Qingxiang external washing powder.