Investigation On Biological Quality Control Of Traditional Chinese Medicine – Cerebralcare Granule As An Example

Quality control is one of the biggest issues for the modernization of traditional Chinese medicine (TCM). It is the bottleneck of bringing TCM to the global world. Bioassay has been considered as a desirable quality control technique for drugs, especially TCM, which consists of complex substances and difficult to be determined using regular physical and chemical methods. Cerebralcare granule (CG), which has effective and widespread applications, was taken as a practical example. Utilizing zebrafish as animalmodel, protection efficiency of nerve cells was measured to assess the quality of Cerebralcare granule. By comparing different batches CG products, and study the necessity and feasibility in quality specification of CG through establishing bioactivity assay. This method exhibited excellent precision (intra-day RSD = 2.2 – 3.7%, inter-day RSD = 1.2%), reproducibility (RSD = 4.9%) and stability (RSD = 8.4%); and the method met the requirements of guiding principles of the biological activity determination. According to the results of the protection efficiency of nerve cells, CG in different batches showed significantly differences in bioactivity. This novel method could reflect the pharmacological effects on neuroprotective effect and be helpful for the quality control of CG. This study provides reference for the bio-evaluation of the quality control of TCM.

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