世界中医药

目的：以对照药材技术要求为基础，以等量同质为原则，利用现代的提取制备技术，制备成质量稳定、均匀性好的苦杏仁对照提取物。通过考察不同的薄层系统，建立薄层鉴别用对照提取物的质量标准，供中药标准中薄层鉴别使用。并对其主要药效成分进行方法学考察，确保今后制备的对照提取物的一致性。方法：采用不同薄层色谱系统对苦杏仁对照提取物可替代对照药材进行定性研究；并用高效液相色谱法测定苦杏仁对照提取物中苦杏仁苷的含量。结果：在苦杏仁对照提取物薄层色谱中，展开剂：为甲苯-甲酸乙酯-甲醇-甲酸-水(6∶2∶0.4∶0.1∶0.1)，在与对照药材色谱相应位置上，显相同颜色的斑点。HPLC测定苦杏仁对照提取物中苦杏仁苷含量，苦杏仁苷线性范围461.7~15.39 mg/L(r=0.999 5)，平均回收率为101.1%（RSD=2.15%），该方法准确、可靠、专属性强，重复性好。结论：苦杏仁对照提取可替代对照药材进行定性鉴别。

English Summary:

On the basis of the control reference drug technical requirements and the principle of equivalent homogeneity,using modern extraction and preparation technology to prepare a stable quality and good uniformity of Semen Armeniacae Amarum reference substance.By investigating the thin layer of different system,to establish the quality standards of thin layer identification with reference extract,for the use of thin layer identification in traditional Chinese medicine (TCM) standard.To investigate methodology and its main efficacy components to ensure the consistency.Methods：Different thin layer chromatographic system for Semen Armeniacae Amarum reference substance qualitative alternative was used to the reference drug research.An HPLC method for content determination of amygdalin in Semen Armeniacae Amarum reference substance was established.Results：In Semen Armeniacae Amarum reference substance in thin layer chromatography,the mobile phase was consisted of toluene- ethyl formate- methanol- formic acid and water (6∶2∶0.4∶0.1-0.1),and chromatographic corresponding to the position,the same color spots.To establish an HPLC method for content determination of amygdalin in Semen Armeniacae Amarum reference substance,the linear range of amygdalin was from 461.7 to 15.39 mg/L (r = 0.999 5),and the average recovery was 101.1% (RSD = 2.15%),The method was accurate,reliable,strong specialization and good repeatability．Conclusion：Semen Armeniacae Amarum reference substance can replace Semen Armeniacae Amarum reference drug for qualitative identification.

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