儿咳灵糖浆质量控制研究  

Quality control of Erkeling syrup

作　　者：伏东宁 邵杰[2] FU Dongning;SHAO Jie(Department of Pharmacy,Lianyungang Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine,Lianyungang 222004,Jiangsu,China;Jiangsu Kanion Pharmaceutical Co.,Ltd,Lianyungang 222001,Jiangsu,China)

机构地区：[1]南京中医药大学附属连云港市中医院药学部,江苏连云港222004 [2]江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《上海中医药杂志》2020年第4期97-101,共5页Shanghai Journal of Traditional Chinese Medicine

基　　金：江苏省连云港市卫生计生科技项目(ZD1803)

摘　　要：目的修订完善儿咳灵糖浆的质量标准。方法采用TLC鉴别浙贝母;采用HPLC测定盐酸麻黄碱、苦杏仁苷和黄芩苷的含量,色谱柱为Kromasil C18柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液,梯度洗脱,流速为1.0 mL/min,检测波长为210 nm(盐酸麻黄碱、苦杏仁苷)、280 nm(黄芩苷),柱温30℃。结果浙贝母的TLC鉴别法专属性强,色谱斑点清晰,阴性对照无干扰。盐酸麻黄碱在1.050~10.500 mg/L范围内与峰面积线性关系良好(r=0.999 4),平均加样回收率为99.1%(RSD=1.50%,n=9);苦杏仁苷在5.220~52.200 mg/L范围内与峰面积线性关系良好(r=0.999 0),平均加样回收率为98.6%(RSD=0.81%,n=9);黄芩苷在20.050~200.500 mg/L范围内与峰面积线性关系良好(r=0.999 5),平均加样回收率为98.4%(RSD=0.94%,n=9)。结论该方法准确、重复性好,可作为儿咳灵糖浆的质量控制标准。Objective To improve the quality standard of Erkeling syrup. Methods Bulbus Fritillariae Thunbergii was identified by TLC.The contents of ephedrine hydrochloride,amygdalin and baicalin were analyzed by HPLC on Kromasil C18 column(250 mm × 4.6 mm,5 μm) with the mobile phase of acetonitrile-0.1% phosphate by gradient elution.The flow rate was 1.0 mL/min and the detection wavelength was set at 210 nm for ephedrine hydrochloride and amygdalin,280 nm for baicalin. The column temperature was 30 ℃. Rseults TLC identification method of Bulbus Fritillaria thunbergii had strong specificity. The spots in TLC were clear, and the negative samples showed no interference. Ephedrine hydrochloride had a good linear relationship with peak area in the range of 1.050 to 10.500 mg/L(r=0.999 4), and the average recovery rate was 99.1%(RSD=1.50%, n=9). In the range of 5.220-52.20 mg/L, amygdalin had a good linear relationship with peak area(r=0.999 0), and the average recovery rate was 98.6%(RSD=0.81%, n=9). Baicalin showed a good linear relationship with peak area in the range of 20.050-200.500 mg/L(r=0.999 5), with an average sample recovery of 98.4%(RSD=0.94%, n=9). Conclusion The method is accurate and repeatable,and can be used as the quality control of Erkeling syrup.

关 键 词：儿咳灵糖浆 盐酸麻黄碱 苦杏仁苷 黄芩苷 TLC HPLC 

分 类 号：R286.0[医药卫生—中药学]