沉香舒郁片质量标准研究  

Study on the quality standard of Chenxiang Shuyu tablets

作　　者：贾浩然 黄涛[1] 佟若菲[1] 孙燕燕[1] Jia Haoran;Huang Tao;Tong Ruofei;Sun Yanyan(Tianjin Children's Hospital,Tianjin 300400)

机构地区：[1]天津市儿童医院,天津300400

出　　处：《天津药学》2023年第6期16-20,共5页Tianjin Pharmacy

摘　　要：目的:提高沉香舒郁片质量标准。方法:采用TLC法对沉香舒郁片中木香、沉香、厚朴进行薄层色谱定性鉴别;采用HPLC法同时对沉香舒郁片中陈皮及厚朴的有效成分进行定量测定。以乙腈(A)-0.2%磷酸溶液(B)为流动相,梯度洗脱;检测波长288 nm,柱温:40℃;流速:1.0 ml/min;进样量:10μl。结果:木香、沉香及厚朴的TLC色谱图斑点清晰,与杂质斑点可有效分离,阴性样品无干扰。在选定的色谱条件下,橙皮苷在8.13~81.28μg/ml范围内呈良好线性关系(r=0.9999,n=5),厚朴酚在9.86~98.56μg/ml范围内呈良好线性关系(r=0.9999,n=5),平均回收率分别为99.8%(RSD为0.6%)和99.7%(RSD为0.3%)。结论:本试验所拟定质量标准重现性好,专属性强,可有效控制沉香舒郁片质量。Objective:To establish a quality standard for Chenxiang Shuyu tablets.Methods:Thin-layer chromatography(TLC)was used to qualitatively identify Aucklandia Lappa Decne,Aquilariae Lignum Resinatum,and Magnolia officinalis in Chenxiang Shuyu tablets.High-performance liquid chromatography(HPLC)was used to quantitatively determine the active ingredients of Citrus reticulata pericarpium and Magnolia officinalis in Chenxiang Shuyu tablets at the same time.The separation was carried out using acetonitrile(A)-0.2%phosphoric acid solution(B)as the mobile phase with gradient elution;the detection wavelength was 288 nm,the column temperature was 40°C,the flow rate was 1.0 ml/min;and the injection volume was 10μl.Results:The spots of the TLC chromatograms of Aucklandia Lappa Decne,Aquilariae Lignum Resinatum,and Magnolia officinalis were clear,which could be efficiently separated from the spots of the impurities,and there was no interference with the negative samples.Under the selected chromatographic conditions,good linearity was observed in the range of 8.13~81.28μg/ml for hesperidin(r=0.9999,n=5)and 9.86~98.56μg/ml for magnolol(r=0.9999,n=5),with average recoveries of 99.8%(RSD was 0.6%)and 99.7%(RSD was 0.3%),respectively.Conclusions:The quality standard formulated in this study was reproducible and exclusive and can be used as a quality control method for Chenxiang Shuyu tablets.

关 键 词：沉香舒郁片 质量标准研究 木香 沉香 橙皮苷 厚朴酚 和厚朴酚 TLC法 HPLC法。 

分 类 号：R927.1[医药卫生—药学]