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金港榄香烯与榄香烯脂质体注射液的指纹图谱研究 |
谢恬1,2,3, 李铖璐3, 徐淑媛1, 王宇2, 杨友剑2, 赵宏2, 刘兴元2, 于丽红2, 张涤菲2, 曾昭武3
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1.杭州创新中药标准化研究所有限公司, 杭州 310053;2.大连华立金港药业有限公司, 大连 116000;3.杭州师范大学, 杭州 310012
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摘要: |
[目的] 通过检测金港榄香烯与榄香烯脂质体注射液的指纹图谱,考察它们的质量稳定性。[方法] 分别对10批金港榄香烯与榄香烯脂质体注射液,采用气相色谱法检测其指纹图谱,采用中药指纹图谱相似度计算软件计算相似度。[结果] 采用气相色谱法检测它们的指纹图谱稳定可靠,发现榄香烯和榄香烯脂质体注射液都有6个共有特征峰,各批次榄香烯和榄香烯脂质体注射液的相似度都不低于0.995.[结论] 建立的金港榄香烯和榄香烯脂质体注射液指纹图谱符合要求,为不同批次产品的质量稳定性提供了保证。 |
关键词: 榄香烯 脂质体 注射液 气相色谱 指纹图谱 |
DOI:10.11656/j.issn.1672-1519.2014.05.17 |
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Study on fingerprint of Kingkong Elemene and Elemene liposomal injection |
XIE Tian1,2,3, LI Cheng-lu3, XU Shu-yuan1, WANG Yu2, YANG You-jian2, ZHAO Hong2, LIU Xing-yuan2, YU Li-hong2, ZHANG Di-fei2, ZENG Zhao-wu3
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1.Hangzhou Innovation TCM Standardization Research Institute Co., Ltd., Hangzhou 310053, China;2.Dalian Holley Kingkong Pharmaceutical Co., Ltd., Dalian 116000, China;3.Hangzhou Normal University, Hangzhou 310012, China
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Abstract: |
[Objective] To detect the fingerprint of Kingkong Elemene and Elemene liposomal injection for observing their quality stability. [Methods] The fingerprints of 10 batches of Kingkong Elemene and Elemene liposomal injection were detected by gas chromatography(GC), and their similarity was calculated by the fingerprint similarity calculation software of traditional Chinese medicine (TCM). [Results] The GC method for detecting their fingerprint was stable and reliable. Six common characteristic peaks were all found in Kingkong Elemene and Elemene liposomal injection. The fingerprint similarity of these batches of Kingkong Elemene or Elemene liposomal injection was not lower than 0.995. [Conclusion] The resulted fingerprint of Kingkong Elemene and Elemene liposomal injection meet the requirements, and provide a guarantee for the quality stability of different batches of the product. |
Key words: Elemene liposome injection gas chromatography fingerprin |