中国药物警戒 ›› 2015, Vol. 12 ›› Issue (4): 200-202.

• 柴胡药材、有效成分及制剂的“毒-效”及质量评价专栏 • 上一篇    下一篇

基于“效-毒”相关模式的柴胡注射液质量研究与思考

徐男1,孙蓉1*,李晓宇1,王玉团2,时海燕3   

  1. 1山东省中医药研究院，山东 济南，250014;
    2 山东省食品药品检验研究院，山东 济南 250101;
    3山东省千佛山医院，山东 济南 250014
  • 收稿日期:2015-03-31 出版日期:2015-04-08 发布日期:2015-07-27
  • 通讯作者: 孙蓉，女，博士，研究员?博导，中药药理与毒理。
  • 作者简介:徐男，男，博士，助理研究员，中药新药开发与药效物质研究。
  • 基金资助:
    国家重点基础研究发展计划（973），中医基础理论专项资助项目（2009CB522802），山东省科技平台建设项目课题（2008GG2NS02021），山东省自主创新和成果转化项目（2014ZZCX02104）。

Bupleurum Injection Quality Study and Reflection Based on"Effection - Toxicity " Related Patterns

XU Nan1,SUN Rong1*,LI Xiao-yu1,WANG Yu-tuan2,SHI Hai-yan3   

  1. 1Shandong Academy of Chinese Medicine, Shandong Jinan 250014, China;
    2Shandong Institute for Food and Drug Control, Shandong Jinan 250101, China;
    3Qianfoshan Hospital Affiliated to Shandong University, Shandong Jinan 250014, China
  • Received:2015-03-31 Online:2015-04-08 Published:2015-07-27

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摘要： 目的 通过评价柴胡注射液质量现状和开展指纹图谱研究，为提升本品的质量标准、保证药品的安全性和有效性及开展柴胡注射液“效-毒”物质基础研究提供依据。方法 依据现行卫生部部颁标准，采用气相色谱法测定不同厂家及批次柴胡注射液的糠醛含量；比较不同厂家及批次柴胡注射液特征指纹图谱的差异。结果 不同厂家及批次的柴胡注射液糠醛含量有不同程度的差异；柴胡注射液指纹图谱在19 min前所含色谱峰的数目和峰面积上存在显著差异。结论 目前柴胡注射液的糠醛含量基本符合现行标准要求，方法可用于测定不同来源的柴胡注射液色谱指纹图谱，但有必要进一步加强柴胡注射液的毒性物质基础研究，为构建“效-毒”关联评价的柴胡注射液综合质量控制体系奠定基础。

关键词: 柴胡注射液, 糠醛, 指纹图谱, 质量

Abstract: Objective By evaluation of the quality of Bupleurum injection and study on its fingerprints, to provide evidence to enhance the quality standards of the product, ensure safety and efficacy and carry out material basis research of "toxicity-effection" for Bupleurum injection. Methods Under the current Ministry of Health ministerial standards, using gas chromatography to determinate Bupleurum injection's furfural content of different manufacturers and batches, compare the differences of Bupleurum injection fingerprint characteristics of different manufacturers and batches. Results Bupleurum injection furfural content of different manufacturers and batches is different. The number of peaks and the peak area before the 19 minutes in Bupleurum injection fingerprints exist significant differences.Conclusion Currently furfural content of Bupleurum injection conform with the current standard, Bupleurum injection chromatographic fingerprint method can be used to determine the different sources. To lay the foundation of the evaluation of Bupleurum injection for the construction of a comprehensive quality control system on "effection-toxicity" related patterns, it's necessary to further strengthen the toxic material basis research for Bupleurum injection.

Key words: Bupleurum injection, furfural, fingerprints, quality

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