| 摘要: |
| 目的：以高效液相色谱(HPLC)指纹图谱结合含量测定方法，为科学评价脑得生丸的质量提供理论依据。方法：采用HPLC建立脑得生丸的指纹图谱，色谱柱为 Inertsil ODS-SP（4.6 mm×250 mm，5μm）；流动相为乙腈-0.1%甲酸溶液，梯度洗脱；柱温 30℃；检测波长为254 nm；流速为1 ml/min。采用HPLC方法测定脑得生丸中人参皂苷 Rg1，色谱柱为 HypersilODS2（4.6 mm×250 mm，5μm）；流动相为乙腈-0.05%磷酸（19∶81），等度洗脱；检测波长为 203 nm；流速为 1.0 ml/min；进样量为10 μl。基于指纹图谱和含量测定结果，对脑得生丸的质量进行评价。结果：建立了脑得生丸的指纹图谱，确定了11个共有峰，15批脑得生丸样品相似度均大于0.97。人参皂苷 Rg1的线性方程为 y=13600x-9.5581，线性范围是 19.2 μg/ml～1.920 mg/ml，相关系数是0.9992。15批脑得生丸中有5批样品为过期产品，仅批次为161003样品（过期5个月）含量检测不合格，其他均符合质量标准要求。结论：该方法简便、准确、重复性好，为脑得生丸质量的有效评价与整体控制提供了实验依据。 |
| 关键词: 指纹图谱 含量测定 脑得生丸 质量评价 |
| DOI： |
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| Quality assessment of Naodesheng pills based on fingerprint and content determination |
| LI Linmei,DENG Yun,TANG Juanli |
| (Hunan Tianjicaotang Pharmaceutical Co.，Ltd.，Changsha 410205，Hunan，China) |
| Abstract: |
| Objective：To investigate the value of high-performance liquid chromatography (HPLC) fingerprint combined with content determination in the quality assessment of Naodesheng pills，and to provide a theoretical basis for the scientific quality assessment of Naodesheng pills.Methods：HPLC was used to establish the fingerprint of Naodesheng pills on an Inertsil ODS-SP column (4.6 mm×250 mm，5 μm) with a mobile phase of acetonitrile-0.1% formic acid for gradient elution at a column temperature of 30℃，a detection wavelength of 254 nm，and a flow rate of 1 ml/min.HPLC was used to measure the level of ginsenoside Rg1 in Naodesheng pills on a HypersilODS2 column (4.6 mm×250 mm，5 μm) with a mobile phase of acetonitrile-0.05% phosphoric acid (19∶81) for isocratic elution at a detection wavelength of 203 nm，a flow rate of 1 ml/min，and a sample size of 10 μl.The quality of Naodesheng pills was assessed based on the results of fingerprint and content determination.Results：The fingerprint of Naodesheng pills was established，with a total of 11 common peaks identified，and 15 batches of Naodesheng pills had a similarity of >0.97.Ginsenoside Rg1 had a linear equation of y=13600x-9.5581，with a linear range of 19.2 μg/ml to 1.920 mg/ml and a correlation coefficient of 0.9992.Among the 15 batches of Naodesheng pills，5 were expired products，and only the batch 161003 (expired for 5 months) was tested unqualified；the other batches met the quality standard.Conclusion：This method is simple and accurate with good repeatability and provides an experimental basis for the quality assessment and overall quality control of Naodesheng pills. |
| Key words: fingerprint content determination Naodesheng pills quality assessment |
