滴通鼻炎喷涂凝胶剂质量标准的研究

Study on the quality standards of Ditong Biyan spray gel

目的建立滴通鼻炎喷涂凝胶剂的质量控制方法。方法采用薄层色谱(TLC)法,分别对滴通鼻炎喷涂凝胶剂中的蒲公英、黄芩、麻黄、石菖蒲和白芷等药材进行鉴别。采用高效液相色谱(HPLC)法,以甲醇-1%(体积分数)乙酸(体积比50∶50)为流动相,在278 nm处测定黄芩苷质量分数;以乙腈-0.1%H 3PO 4水溶液(体积比5∶95)为流动相,在210 nm处测定盐酸麻黄碱质量分数。结果蒲公英、黄芩、麻黄、石菖蒲和白芷的薄层色谱鉴别方法专属性强、阴性无干扰。黄芩苷、盐酸麻黄碱分别在0.06528~1.04448μg(r=1)、0.0422~0.6752μg(r=0.9999)范围内,线性关系良好。平均回收率分别为101.13%、97.74%(n=6)。结论本研究建立的方法稳定、重复性好,可用于滴通鼻炎喷涂凝胶剂的质量控制。

Objective To establish a new method for the quality control of Ditong Biyan spray gel.Methods TLC was used to identify dandelion,scutellaria baicalensis,ephedra,acorus tatarinowii and angelica dahurica.The content of baicalin was determined by HPLC at the wavelength of 278 nm with methanol-1%acetic acidlutior(50∶50)as mobile phase.The content of ephedrine hydrochloride was determined by HPLC at the wavelength of 210 nm with acetonitrile-0.1%phosphoric acid(5∶95)as mobile phase.Results The TLC method for the identification of dandelion,scutellaria baicalensis,ephedra,acorus tatarinowii and angelica dahurica was good,specialized,and no interference from negative control.The levels of baicalin and ephedrine hydrochloride acetate had a good linear relationship within the range of 0.06528~1.04448μg(r=1)、0.0422~0.6752μg(r=0.9999),respectively.The average recoveries were 101.13%and 97.74%(n=6),respectively.Conclusion The methods is stable and reproducible,which can be used for the quality control of Ditong Biyan spray gel.