鼻炎通窍喷雾剂的质量标准研究

Study on the quality standard of Biyan Tongqiao Spray

目的:建立鼻炎通窍喷雾剂的质量标准。方法:采用薄层色谱法对麻黄、黄芩、白芷进行定性鉴别;用高效液相色谱法测定盐酸麻黄碱和黄芩苷的含量。结果:麻黄、黄芩、白芷的薄层色谱图斑点清晰,阴性无干扰。盐酸麻黄碱进样量在0.0798μg^1.1172μg浓度范围内与峰面积线性关系良好,平均回收率为97.26%,RSD为2.33%(n=6);黄芩苷进样量在0.1364μg^2.046μg浓度范围内与峰面积线性关系良好,平均回收率为98.15%,RSD值为2.03%(n=6)。结论:所用方法专属性强,灵敏度高,重现性好,可用于鼻炎通窍喷雾剂的质量控制。

Objective： To establish the quality standard of Biyan Tongqiao Spray. Method： TLC was used for the qualitative identification of Ephedra Herb, Scutellariae Radix and Angelicae Dahuricae Radix in Biyan Tongqiao Spray. HPLC was used to simultaneously determine the contents of ephedrine and baicalin. Result： TLC spots were clear without negative interference. HPLC experiment showed good linear relationship at the ranges of 0.0798μg～1.1172μg for ephedrine and 0.1364μg-2.046μg for baicalin. The average recoveries were 97.26% with RSD of 2.33% （n=6） for ephedrine and 98.15% with RSD of 2.03% for baicalin （n=6）.Conelusion： The method has characters of good specificity, sensitivity and reproducibility, so it can be used for the quality control of Biyan Tongqiao Spray.