消炎止咳胶囊的标准提升  

Quality Standard Improvement for Xiaoyan Zhike Capsules

作　　者：彭啟丽 王丹丹 刘志海 金昭 PENG Qili;WANG Dandan;LIU Zhihai;JIN Zhao(Guizhou Province Qianxinan Institution for Tnspection and Testing Center,Xingyi 562400,China)

机构地区：[1]贵州省黔西南州检验检测中心,贵州兴义562400

出　　处：《中国民族民间医药》2025年第5期43-47,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：贵州省药品监督管理局,《贵州省2022年度省级药品探索性研究课题》。

摘　　要：目的:建立消炎止咳胶囊中吗啡的薄层色谱鉴别方法、盐酸麻黄碱和盐酸伪麻黄碱的含量测定方法。方法:薄层色谱鉴别条件以吗啡为对照品,以甲苯-丙酮-乙醇-浓氨试液(2∶8∶1∶0.75)为展开剂,喷以稀碘化铋钾试液,置日光下检视;含量测定色谱条件:以SuperLu C 18色谱柱(250 mm×4.6 mm,5μm)为分离柱,以乙腈-0.1%磷酸溶液(含0.1%三乙胺)(3∶97)为流动相,等度洗脱,检测波长为210 nm。结果:薄层色谱鉴别中,供试品色谱在与吗啡对照品色谱相应的位置上,显相同颜色的斑点;含量测定结果中,盐酸麻黄碱的浓度在3.360~33.604μg/mL(r=0.9999)范围内与峰面积线性关系良好,平均加样回收率为99.69%(RSD=1.33%),盐酸伪麻黄碱的浓度在3.293~32.926μg/mL(r=0.9999)范围内与峰面积线性关系良好,平均加样回收率为99.07%(RSD=1.05%);结论:本研究方法稳定可靠,检验结果准确,重复性好,能有效控制该制剂的质量。Objective To establish a TLC method of morphine,Content determination method of ephedrine hydrochloride and pseudoephedrine hydrochloride in Xiaoyan Zhike Capsules.Methods The identification conditions of TLC were as follows:Morphine was used as the reference substance,toluene-acetone-ethyl alcohol-ammonia solution(2∶8∶1∶0.75)was used as the developing agent,spray with dilute bismuth potassium iodide solution,observed under sunlight.Chromatographic conditions for content determination:SuperLu C 18 column(250 mm×4.6 mm,5μm)was used as separation column,acetonitrile-0.1%phosphoric acid solution(added in 0.1%triethylamine solution)(3∶97)was used as mobile phase,isocratic elution,detection wavelength of 210 nm.Results In TLC identification,The chromatogram of the sample for test showed the same color speckle at the corresponding position as that of the morphine reference substance.In the content determination results,the concentration of ephedrine hydrochloride in the range of 3.360-33.604μg/mL(r=0.9999)showed good linear relationships with the peak area,the average recovery rate was 99.69%(RSD=1.33%);the concentration of pseudoephedrine hydrochloride in the range of 3.293-32.926μg/mL(r=0.9999)showed good linear relationships with the peak area,the average recovery rate was 99.09%(RSD=1.05%)Conclusion The method is stable and reliable,the test results are accurate,with good repeatability,and the quality of the preparation can be effectively controlled.

关 键 词：消炎止咳胶囊 盐酸麻黄碱 盐酸伪麻黄碱 吗啡 薄层色谱 高效液相色谱 

分 类 号：R284.1[医药卫生—中药学]