| 引用本文: | 王赵,孙彩林,于新兰,孙磊,马双成.乳香杂质检查方法的建立及其杂质限度研究[J].中国现代应用药学,2020,37(3):288-291. |
| WANG Zhao,SUN Cailin,YU Xinlan,SUN Lei,MA Shuangcheng.Study on Impurity Detection Method of Olibanum and Its Impurity Limit[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(3):288-291. |
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| 摘要: |
| 目的 建立乳香杂质检查方法并制定合理的杂质限度。方法 对样品取样方式、取样量、提取溶剂、提取方法等进行考察及方法学验证，并对随机收集的15批埃塞俄比亚乳香样品进行杂质测定，最后结合国内外现有乳香标准，提出合理的国内药用乳香杂质限度。结果 建立了适合乳香的杂质检查方法，收集的15批乳香样品杂质范围为0.5%~9.3%，建议国内药用乳香的杂质限度为乳香珠不得>2%，原乳香不得>5%。结论 本研究建立的乳香杂质检查方法简便、准确、耐用性好，可用于乳香杂质检查。 |
| 关键词: 乳香 杂质检查 杂质限度 树脂类药物 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.03.006 |
| 分类号:R917 |
| 基金项目:国家药典委员会2017年度国家药品标准提高课题（494） |
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| Study on Impurity Detection Method of Olibanum and Its Impurity Limit |
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WANG Zhao1, SUN Cailin1, YU Xinlan2, SUN Lei1, MA Shuangcheng1
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1.National Institutes for Food and Drug Control, Beijing 100050, China;2.Xinjiang Institute for Food and Drug Control, Urumqi 830004, China
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| Abstract: |
| OBJECTIVE To establish an impurity detection method and set a reasonable impurities limit of olibanum. METHORDS The influence factors including sampling method, sampling quantity, extraction solvent and extraction method of samples were investigated and methodological verification was carried out. Then, 15 batches of Ethiopia olibanum samples that collected randomly were determined for the impurity detection. Finally, a reasonable limit of impurities in domestic medicinal olibanum was put forward based on the existing standards of medicinal olibanum at home and abroad. RESULTS A suitable method was established for the impurities detection of olibanum, and the impurities of 15 batches of olibanum were ranged from 0.5% to 9.3%. It was recommended that the impurity limit of domestic medicinal olibanum should not >2% and original olibanum should not >5%. CONCLUSION It is proven that the proposed method can be a simple, accurate and durable tool for impurity detection of olibanum. |
| Key words: olibanum impurity detection impurity limit resinous drugs |
