| 严华,麻思宇,程显隆,陈佳,魏锋,马双成.中药对照药材的稳定性及期间核查[J].中国药事,2017,(9):1012-1016 |
| 中药对照药材的稳定性及期间核查 |
| Interval Monitoring on the Stability of Traditional Chinese Medicine Reference Material |
| 投稿时间：2017-03-02 |
| DOI：10.16153/j.1002-7777.2017.09.009 |
| 中文关键词: 中药对照药材 稳定性 稳定性期间核查 |
| 英文关键词: traditional Chinese medicine reference material stability interval monitoring on the stability |
| 基金项目: |
|
| 摘要点击次数: 1068 |
| 全文下载次数: 548 |
| 中文摘要: |
| 目的：为保证中药对照药材的质量稳定和质量可追溯性，使其在国家食品药品监管工作中切实有效地发挥技术支持作用，探讨研究中药对照药材稳定性期间核查的方法及方法的可行性。方法：介绍中药对照药材的特性及影响中药对照药材质量稳定性的主要因素，依据中国合格评定国家认可委员会（CNAS）发布的CNAS-CL01（即ISO/IEC 17025：2005）《检验和校准实验室能力认可准则》、《国家药品标准物质管理办法》，建立基于薄层色谱鉴别方法的稳定性期间核查技术方案及评价方法。结果：核查方案及评价方法取得了良好的稳定性评价结果，能够发现并及时处理相关问题，提高了中药对照药材的研制效率。结论：稳定性期间核查工作，是保证中药对照药材质量的重要措施。新建立的核查方法操作简捷，行之有效。 |
| 英文摘要: |
| Objective:To ensure the quality stability and traceability of traditional Chinese medicine reference material (TCMRM), so as to play a practical and effective technical support function in national food and drug supervision, a method for the interval monitoring (IM) of TCMRM and its feasibility were studied. Methods:The qualitative attribute of TCMRM and the factors that affect the quality stability of TCMRM were discussed. A protocol of IM and evaluation method were established based on the TLC method according to the CNASCL01 (ISO/IEC 17025, 2005) Testing and Calibration Laboratory Accreditation Standards and National Pharmaceutical Standard Material Management Measures released by CNAS. Results:The verification protocol and the evaluation method for TCMRM achieved good stability evaluation results and could find and timely deal with the unstable problem, which improved the work efficiency of developing TCMRM. Conclusion:IM is an important measure to ensure the quality of TCMR. The newly established protocol and method of IM were simple and effective. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |