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| 基于5-羟甲基糠醛含量测定的知柏地黄丸质量评价研究 |
| Quality Evaluation Study of Zhibai Dihuang Pills Based on the Determination of 5-Hydroxymethylfurfural Content |
| 投稿时间：2024-09-19 修订日期：2024-10-27 |
| DOI： |
| 中文关键词: 关键词 知柏地黄丸 5-HMF 高效液相色谱法 质量标准提升 |
| 英文关键词: Keywords: Zhibai dihuang pills 5-hydroxymethylfurfural High-performance liquid chromatography (HPLC) Quality standard improvement |
| 基金项目: |
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| 中文摘要: |
| 摘要：目的 探索知柏地黄丸的质量相关问题，提升知柏地黄丸质量标准，为监督管理提供参考。方法 随机抽取市售知柏地黄丸61批，针对法定标准项目不完善的问题，采用高效液相色谱法（HPLC），以5-羟甲基糠醛（5-HMF）作为指标成分进行定量测定。结果 通过方法学考察显示，5-HMF在1.9~96.9 μg/mL（r=1.000 0）浓度范围内与峰面积呈良好的线性关系，精密度相对标准偏差（RSD）为1.1%，稳定性RSD为0.4%，重复性RSD为0.6%（n=6），5-HMF的平均加样回收率为96.6%（RSD为1.7%，n=9）。通过统计分析5-HMF含量测定结果分布情况，分布区间为0.3~6.3 mg/g，均高于药典该杂质限度0.04mg/g。结论 通过方法学考察表明建立的HPLC法用于5-HMF的含量测定准确、灵敏、可靠。从分析结果看药品质量控制和检验标准有待提高，所建立的方法可为知柏地黄丸的质量评价及控制提供科学依据。 |
| 英文摘要: |
| Abstract:Objective To investigate quality-related issues of zhibai dihuang pills, improve their quality standards, and provide a reference for regulatory supervision.Method A total of 61 batches of commercially available zhibai dihuang pills were randomly sampled. Given the inadequacies in the statutory standards, high-performance liquid chromatography (HPLC) was employed to quantitatively determine the content of 5-hydroxymethylfurfural as an indicator component.Results Through methodological examination,5-hydroxymethylfurfural showed a good linear relationship with peak area within the concentration range of 1.9-96.9 μg/mL (r=1.0000). The precision RSD was 1.1%, the stability RSD was 0.4%, and the repeatability RSD was 0.6% (n=6). The average recovery rate of 5-hydroxymethylfurfural was 96.6% (RSD=1.7%, n=9). Through statistical analysis of the distribution of 5-HMF content determination results, the distribution interval was 0.3 -6.3 mg/g, all of which were higher than the impurity limit of 0.04 mg/g in the pharmacopoeia..Conclusion: The methodological investigation indicates that the established HPLC method for the determination of 5-HMF content is accurate, sensitive and reliable. Judging from the analysis results, the quality control and inspection standards of pharmaceuticals need to be improved. The established method can provide a scientific basis for the quality evaluation and control of zhibai dihuang pills. |
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