摘要
目的:建立慈航丸的质量分析检测方法。方法:采用显微鉴别方法定性鉴别制剂中的益母草、当归和川芎的显微特征;采用薄层色谱鉴别制剂中的当归、川芎;利用氧化铝-活性炭层析柱测定盐酸水苏碱的含量,色谱柱为强阳离子交换(SCX)色谱柱,流动相为(0.15%磷酸与0.04%三乙胺)磷酸二氢钾流动相为15 mmol·L-1,检测波长为192 nm。结果:显微特征明显;薄层色谱鉴别,斑点清晰,无干扰。盐酸水苏碱的浓度在99.00~9900.24μg·m L-1范围与峰面积线性关系良好(r=0.9999);加样回收率为97.27%,RSD为1.1%(n=6)。结论:本方法简单、快速、准确、重现性好,可为全面评价和控制慈航丸制剂质量提供检测依据。
Objective:To establish a quality detection for Ci-hang pills.Methods:Microscope was used for identification of Motherwort、Chinses Angelica and Rhizome.Thin-layer chromatography(TLC)method was used for the qualitative identification of Chinses Angelica and Rhizome of Chuanxiong.Alumina-activated carbon column was used to determine the content of Stachydrine hydrochloride by High performance liquid chromatography(HPLC).The determination was performed on strong cation exchange column-HPLC(SCX-HPLC)with mobile phase of 15 mmol·L-1 potassium dihydrogen phosphate solution(containing 0.04%triethylamine and 0.15%phosphoric acid).The detection wavelength was 192 nm.Results:The microscopic feature was obvious.TLC spots were clear and well-separated without negative interference.Stachydrine hydrochloride had a good linear range between 99.00 and 9900.24μg·mL-1(r=0.9999).The average recovery was 97.27%,(RSD 1.1%).Conclusion:The method was simple,rapid,accurate and reproducible,which provides a reference for the quality control of Cihang pills.
作者
赵艳
赵明会
赵磊
ZHAO Yan;ZHAO Ming-hui;ZHAO Lei(Siping Institute food and Drug Control,Jilin Siping 136000,China;Jilin Institute food and Drug Control,Jilin Jilin 132000,China)
出处
《中国药物评价》
2018年第1期27-29,共3页
Chinese Journal of Drug Evaluation
关键词
慈航丸
显微鉴别
薄层色谱
盐酸水苏碱
高效液相色谱
质量检测
Cihang pills
Microscopic features
Thin-layer chromatography(TLC)
Stachydrine hydrochloride
High performance liquid chromatography(HPLC)
Quality detection
作者简介
赵艳，女，主任药师，研究方向：药品与食品质量管理。;[通讯作者] 赵磊，男，副主任药师，硕士研究生，研究方向：药物分析。
