Study And Evaluation Of Contaminants In Traditional Chinese Medicine: Application Of Celebral Care Granule As An Example

Recently, the developed countries introduced more strict regulations on contaminants (such as pesticide residues, heavy metals, etc.) which severely threaten the safety of herbal products. Such a tendency may restrict the globalization of traditional Chinese medicine (TCM) to some extent. Therefore, it's necessary to improve the safety standard of TCM to keep up with the times by multi-dimension quality control. Cerebral care Granule (CG) is a Chinese herb compound preparation that has been approved by the China State Food and Drug Administration in 1996 for treatment of headache and dizziness associated with cerebrovascular diseases [1]. We take CG as an example, a series of research work around the contaminants has been done, including the QuEChERS-based method for the analysis of 227 pesticide residues by GC-MS/MS and LC-MS/MS, a method for simultaneous determination of 15 heavy metals by ICP-MS, and a method for simultaneous determination of 4 aflatoxins using immunoaffinity columns and LC-MS/MS. The developed methods were applied to the analysis of CG. The residue levels of these contaminants in 20 batches of CG all meet the requirements of the European and American standards. This work is expected to help ensure the safety of CG for clinical use, at the same time to provide an advisory strategy for quality control of other TCMs.

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Acknowledgement: This work was supported by National Key Special Project of Science and Technology for Innovation Drug of China (Grant No. 2013ZX09402202).

Reference: [1] Kai Sun, Qin Hu, Chang-Man Zhou, et al. (2010) Journal of Ethnopharmacology, 130: 398 – 406.