| 邓双炳*，王章伟▲，刘芳芳▲，刘地发，钟仁清，陈文北.创新药枳实总黄酮片的元素杂质研究及控制策略[J].中国医药科学,2024,14(11):46-50 基金项目:江西省重点研发计划项目（20212BBG73038；20212BBG73025）；江西省科技创新平台组建项目（20194AFD45002）；江西省重大科技成果熟化与工程化研究项目（20232AEI92004） |
| 创新药枳实总黄酮片的元素杂质研究及控制策略 |
| Research on the element impurities of the innovative Citrus aurantium total flavonoid tablets and its control strategy |
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| DOI： |
| 中文关键词: 中药；元素杂质；控制策略；枳实总黄酮片；电感耦合等离子体质谱 |
| 英文关键词:Chinese materia medica; Elemental impurities; Control strategy; Citrus aurantium total flavonoid tablets; Inductively coupled plasma mass spectrometry |
| 作者 | 单位 | | 邓双炳*，王章伟▲，刘芳芳▲，刘地发，钟仁清，陈文北 | 江西青峰药业有限公司，江西赣州 341000 |
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| 中文摘要: |
| [摘要] 目的 以枳实总黄酮片研发、生产全产业链的元素杂质研究为例，论述中药元素杂质控制策略。 方法 采用电感耦合等离子体质谱（ICP-MS）法测定枳实总黄酮片的7个元素杂质，经风险评估后，采用《中华人民共和国药典》的重金属检查法测定中间体、饮片的重金属。 结果 ICP-MS法的专属性、定量限、线性、精密度、准确度等均符合验证要求。测得四批成品的各元素杂质残留量均小于限度的30%；四批枳实提取物的重金属结果均小于10×10-6 mg/kg；三批枳实饮片的重金属结果均小于30×10-6 mg/kg。 结论 建立了一套适合中药研发、生产全产业链的元素杂质控制策略。 |
| 英文摘要: |
| [Abstract] Objective To discuss the control strategy of elemental impurities in Chinese materia medica by taking the research of elemental impurities in the whole industrial chain of R&D and production of Citrus aurantium total flavonoid tablets as an example. Methods 7 elemental impurities in Citrus aurantium total flavonoid tablets were determined by inductively coupled plasma mass spectrometry(ICP-MS). After risk assessment, heavy metals in intermediates and decoction pieces were determined by heavy metal inspection method in Pharmacopoeia of the People’s Republic of China. Results The specificity, quantitative limit, linearity, precision, and accuracy, etc. of ICP-MS method all met the verification requirements. The residual amount of impurities in four batches of finished products was all less than 30% of the limit. The results of heavy metals in four batches of Fructus Aurantii Immaturus extracts were all less than 10×10-6 mg/kg. The results of heavy metals in three batches of Fructus Aurantii Immaturus decoction pieces were all less than 30×10-6 mg/kg. Conclusion A set of elemental impurities control strategies suitable for the whole industrial chain of R&D and production in Chinese materia medica is established. |
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