Quality evaluation and research of Huoxuezhitong preparations / 中国药学杂志

ABSTRACT

OBJECTIVE: To evaluate and analyze the quality status of Huoxuezhitong powders and Huoxuezhitong capsules, providing reference for standards improvement, quality supervision and regulated production of related drugs. METHODS: Samples were tested according to the statutory standards. And exploratory study were carried out concerning safety, effectiveness, homogeneity and stability, using TLC, HPLC, UPLC, GC, LC-MS, ICP-MS, NIR and other techniques. New methods were established and adopted to investigate the quality of the preparations and their raw materials. RESULTS: All the samples met the requirements of the current specifications while the exploratory study could reflect the quality of the drugs in a more comprehensive way. CONCLUSION: The results suggest that the quality standards for Huoxuezhitong powders/capsules need to be improved and unified, and the manufacturers should pay attention to the quality of raw materials like olibanum, Eupolyphaga Steleophaga, pyritum, and borneolum syntheticum.