中国药典2015年版中药中有害物残留检测的质量控制新动向

Quality Control Requirements for Harmful Residues Analysis in Chinese Herbs in Chinese Pharmacopoeia (2015 Edition)

摘要: 目的介绍中国药典2015年版在痕量残留分析过程中的质量控制要求。方法分别从干扰与污染、样品制备、准确度、分析校准、结果确证等方面探讨中国药典2015年版中的质量控制要求。结果中国药典2015年版提出了较为系统的质量控制要求。结论中国药典2015年版质量控制要求可有效地保证检测结果的准确性。

Abstract: OBJECTIVE To introduce the technical requirements of the quality control on trace analysis in Chinese Pharmacopoeia (2015 Edition). METHODS The quality control were discussed by the classification as contamination and interference, sample preparation, accuracy, analytical calibration and confirmation. RESULTS It build the requirements of the quality control systematically in the Chinese Pharmacopoeia (2015 Edition). CONCLUSION It can ensure the accuracy of the results more effectively in the Ch.P 2015.