Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (4): 200-202.

Previous Articles     Next Articles

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

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

CLC Number: