The effect of ozone sterilization technology on the quality of Ganmaoling Granule based on HPLC fingerprint, chemometric analyses and multi-component content determination

Ganmaoling Granule (GMLG) is one of the most effective Chinese Patent Medicines (CPMs) which is applied to relieve the uncomfortable symptoms caused by the common cold. In this study, high-performance liquid chromatography (HPLC) combined with chemometric analyses and multi-component content determination were performed to preliminary investigate the effect of ozone sterilization technology on the quality of GMLG. The methodology validation and similarity analysis results showed that the analytical method was capable of complying with the demand of HPLC fingerprints, and 80 batches of GMLGs before and after ozone sterilization in four process stages had a high degree of similarity based on the values of similarity analysis (SA) was greater than 0.98. The results of hierarchical cluster analysis (HCA) and principal component analysis (PCA) showed that the GMLGs before and after ozone sterilization were divided into two categories, and the same batch of GMLGs was clustered into the same group. Meanwhile, the contents of linarin, caffeine, chlorpheniramine maleate and acetaminophen between 24 batches of GMLGs before and after ozone sterilization had no statistically significant differences (P > 0.05), which met the requirements of “Drug Standard of the People’s Republic of China”. In conclusion, the ozone sterilization technology had no obvious influence on the quality of GMLGs in four process stages, which provided a reference for the quality control of GMLG and other Chinese-western medicine compound preparations.