提高感冒疏风丸质量标准的研究  

Study on the improvement of quality standard of Ganmao Shufeng Pills

作　　者：杨深应 刘常逊 王洪云[2] 陶明宝 曹朴琼 丁国瑜[2] 杨麒[2] 赵兴蕊 YANG Shenying;LIU Changxun;WANG Hongyun;TAO Mingbao;CAO Puqiong;DING Guoyu;YANG Qi;ZHAO Xingrui(Baoshan Inspection and Testing Center for Food and Drug,Baoshan 678000,China;Baoshan College of Traditional Chinese Medicine,Baoshan 678000,China)

机构地区：[1]保山市食品药品检验检测中心,保山678000 [2]保山中医药高等专科学校,保山678000

出　　处：《西北药学杂志》2022年第2期16-21,共6页Northwest Pharmaceutical Journal

基　　金：云南省教育厅科学研究基金项目(编号:2021J1133);保山中医药高等专科学校百名中青年学术技术带头人项目(编号:2020x001)。

摘　　要：目的提升感冒疏风丸的质量标准。方法选取薄层色谱法(thin layer chromatography,TLC)对感冒疏风丸中麻黄绒(炙)、桂枝、紫苏叶、甘草和独活进行定性鉴别;采用高效液相色谱法(high performance liquid chromatography,HPLC)测定麻黄绒(炙)药材中盐酸麻黄碱、盐酸伪麻黄碱的含量。结果TLC斑点清晰且阴性样品无干扰;盐酸麻黄碱、盐酸伪麻黄碱质量浓度分别在4.40~87.94μg·mL^(-1)(r=0.9999)、2.12~42.40μg·mL^(-1)(r=0.9999)范围内与其峰面积呈良好的线性关系,精密度、重复性、稳定性实验的RSD值均小于2.0%(n=6);平均加样回收率分别为98.62%、95.97%(RSD=1.17%、0.69%,n=6)。结论该方法操作简便、准确可靠、专属性强,可用于感冒疏风丸的定性鉴别和含量测定,有效提高该制剂的质量控制标准。Objective To improve the quality standard of Ganmao Shufeng Pills.Methods Thin layer chromatography(TLC)was used to qualitatively identify Ephedrae Herba Velvet(roast),Cinnamomi Ramulus,Perillae Folium,Glycyrrhizae Radix Et Rhizoma and Angelicae Pubescentis Radix in Ganmao Shufeng Pills.High performance liquid chromatography(HPLC)was used to determine the content of ephedrine hydrochloride and pseudoephedrine hydrochloride in the medicinal materials of Ephedrae Herba Velvet(roast).Results The TLC spots were clear and the negative samples showed no interference.The linear ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride were within 4.40-87.94μg·mL^(-1)(r=0.9999)and 2.12-42.40μg·mL^(-1)(r=0.9999),respectively.The RSDs of precision,reproducibility,stability tests were all less than 2.0%(n=6).The average recoveries were 98.62% and 95.97%(RSD=1.17%,0.69%,n=6),respectively.Conclusion The method is simple,accurate and reliable with strong specificity,and can be used for the qualitative identification and content determination of Ganmao Shufeng Pills,therefore effectively improve the quality control standard of the preparation.

关 键 词：感冒疏风丸 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R282[医药卫生—中药学]