苍鹅鼻炎滴鼻剂质量标准研究

摘要

Objective To estabtish the quatity standard of Cang'e Biyan nasat drop. Methods Thin tayer chromatography ( TLC ) was apptied to identify Seutettaria Baieatensis, inspissatum Fet Suis, Chtorphenamine Mateate and Sodium Ilouttuyfonate in Cang'e Biyan nasat drop. High performanee tiquid chromatography ( IIPLC) was apptied to determine the content of Baieatin and Chtorphenamine Mateate in Cang'e Biyan nasat drop. Resutts Seutettaria Baieatensis, Inspissatum Fet Suis,Chtorphenamine Mateate and Sodium ttouttuyfonate eoutd be identified by TtC. Baieatin was tinear in the range of 0.099 6 -0.996 0 g,r =0.999 9,the average recovery was 100.34% ,RSD =0.52%. Chtorphenamine Mateate was tinear in the range of 0.082 4 -0. 824 0 g, r = 0.999 7, the average recovery was 100.40% ,RSD = 1.61 %. Conctusion The estabtished method is simpte,convenient, and reproducibte,and it can be used for the quatity controt of Cang'e Biyan nasat drop.%目的 建立苍鹅鼻炎滴鼻剂的质量标准.方法 采用薄层色谱法(TLC)对制剂中的黄芩、猪胆膏、马来酸氯苯那敏、鱼腥草素钠进行鉴别,采用高效液相色谱法(HPLC)对制剂中的黄芩苷、马来酸氯苯那敏进行含量测定.结果 TLC法可检出黄芩、猪胆膏、马来酸氯苯那敏、鱼腥草素钠.黄芩苷在0.099 6～0.996 0 mg范围内线性关系良好,相关系数为r=0.999 9,平均回收率为100.34%,RSD=0.52%.马来酸氯苯那敏在0.082 4～0.824 0 mg范围内线性关系良好,相关系数为r=0.999 7,平均回收率为100.40%,RSD=1.61%.结论 本法简便、快速、重复性好,可作为本品的质量控制指标.