| 精制橄榄油细菌内毒素检查的可行性研究 |
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| 引用本文： | 潘卫松,肖瑛. 精制橄榄油细菌内毒素检查的可行性研究[J]. 中国医药科学, 2011, 0(8): 10-11,16 |
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| 作者姓名： | 潘卫松 肖瑛 |
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| 作者单位： | 广州市药品检验所;暨南大学药学院;暨南大学中药药效物质基础及创新药物研究广东省高校重点实验室 |
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| 基金项目： | 广东省广州市食品药品监督管理局科技计划项目(2010GZFDA006);广东省中医药局科技计划项目(2010124);暨南大学211项目资助 |
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| 摘 要： | 目的对精制橄榄油进行凝胶法干扰试验,建立精制橄榄油细菌内毒素的检查方法。方法按2010年版《中国药典》(二部)"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的精制橄榄油分别进行干扰试验。结果精制橄榄油稀释至浓度83.4mg/mL或以下稀释浓度的溶液对细菌内毒素检查法无干扰作用。结论精制橄榄油注射液进行细菌内毒素检查是可行的。
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| 关 键 词： | 精制橄榄油 细菌内毒素检查法 干扰试验 药用辅料 质量控制 |
Study on the Test Method of Bacterial Endotoxin in Refined Olive Oil |
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| PAN Weisong,XIAO Ying. Study on the Test Method of Bacterial Endotoxin in Refined Olive Oil[J]. China Medicine and Pharmacy, 2011, 0(8): 10-11,16 |
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| Authors: | PAN Weisong XIAO Ying |
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| Affiliation: | 2,3 1.Institute for Drug Control of Guangzhou,Guangzhou 510160,China;2.College of Pharmacy,Ji’nan University,Guangzhou 510632,China;3.Key Lab of Guangdong College for TCM Bioactivity Material Foundation and Brand New Drug Research,Ji’nan University,Guangzhou 510632,China |
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| Abstract: | Objective To establish a bacterial endotoxin test for refined olive oil injection.Methods According to the bacterial endotoxins test in Chinese Pharmacopoeia 2005.Different batches of refined olive oil injection from different TAL manufacturers were underwent the interference tests.Results There was no interference in the bacterial endotoxins test when the concentration of refined olive oil is less than or equal to the detection limit 83.4mg/mL.Conclusion Carrying out the bacterial endotoxin test for refined olive oil injection is feasible. |
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| Keywords: | Refined olive oil injection Bacterial endotoxins test method Interference experiment Pharmaceutical excipients Quality control |
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