复方玉红栓的质量标准研究

Study on quality standard of compound Yuhong suppository

目的建立复方玉红栓的质量标准。方法采用TLC法对白芷、松香和苦参3种中药材进行定性鉴别;采用HPLC-二极管阵列检测法同时测定磺胺嘧啶和盐酸达克罗宁含量,以甲醇-0.02 mol/L磷酸二氢钾溶液(用磷酸调节pH值至3.3)为流动相,梯度洗脱,于280 nm波长处检测磺胺嘧啶和盐酸达克罗宁。结果所建立的3种药材TLC鉴别法专属性良好,斑点清晰;磺胺嘧啶和盐酸达克罗宁分别在12.40~99.20μg/ml(r=0.9999)、2.56~20.48μg/ml(r=0.9999)范围内线性关系良好,平均回收率为(99.21±0.43)%(n=9)、(99.54±0.68)%(n=9)。结论本研究所建立的方法准确、灵敏,重现性好,所建标准可用于复方玉红栓的质量控制。

Objective To establish the quality standard of compound Yuhong suppository.Methods Angelica dahurica,colophony and Sophora flavescens Alt.were identified by thin layer chromatography(TLC)method.The contents of sulfadiazine and dyclonine hydrochloride were determined by HPLC with diode array detection method.The mobile phase was methanol-0.02 mol/L potassium dihydrogen phosphate(adjusted to pH 3.3 with phosphoric acid)for gradient elution.The detection wavelength was 280 nm for sulfadiazine and dyclonine hydrochloride.Results The three Chinese traditional medicines were identified by TLC with clear spots.The linear ranges of sulfadiazine and dyclonine hydrochloride were good in 12.40-99.20μg/ml(r=0.9999)and 2.56-20.48μg/ml(r=0.9999).The average recovery was(99.21±0.43)%(n=9)and(99.54±0.68)%(n=9).Conclusion This method is accurate,sensitive,and reproducible.It can be used as a standard method for the quality control of compound Yuhong suppository.