壮药前列舒外洗剂质量标准研究

Study on Quality Standard of Zhuang Medicine Qianlieshu External Lotion

目的:建立壮药前列舒外洗剂质量标准,并进行洗剂的常规检查。方法:对壮药前列舒外洗剂进行最低装量及微生物限度检查;采用薄层色谱法鉴别壮药前列舒外洗剂中姜黄、三叉苦;采用紫外可见分光光度法测定壮药前列舒外洗剂总黄酮的含量。结果:壮药前列舒外洗剂最低装量、微生物限度检查均符合2020年版《中国药典》的相关规定;薄层色谱中,姜黄、三叉苦的特征斑点显色清晰,分离效果好,阴性对照无干扰;以HCl-Mg法显色,芦丁为对照品,282 nm波长条件下测定,芦丁在22.18~133.08μg/mL浓度间呈良好的线性关系好(R^(2)=0.9995,n=6),样品平均回收率98.14%(RSD=1.04%,n=6)。结论:所建立的质量标准操作简单、重复性好,可用于壮药前列舒外洗剂的质量控制。

Objective To establish the quality standard of Zhuang Medicine Qianlieshu lotion and to conduct routine examination of the lotion.Methods The minimum quantity and microbial limit of Qianlieshu lotion were examined,and the turmeric and Trischia in Qianlieshu lotion were identified by Thin layer chromatography The content of total flavonoids in Qianlieshu lotion was determined by UV-Vis Spectrophotometer.Results the minimum loading and microbial limit of Qianlieshu lotion were in accordance with the relevant regulations of Chinese pharmacopoeia(2020 edition),and the characteristic spots of turmeric and trisporia were clearly displayed in TLC,HCl-Mg method was used for the determination of rutin at 282 nm wavelength,rutin showed a good linear relationship between the concentrations of 22.18-133.08μg/mL(R^(2)=0.9995,n=6),and the average recovery was 98.14%(RSD=1.04%,n=6),it can be used for quality control of Qianlieshu lotion.