Abstract:
OBJECTIVE To determine the best sterilization method of Notoginseng Radix et Rhizoma medicinal materials.
METHODS A multi-dimensional quality evaluation system of “microorganism-physicochemical” was established based on microbial limits, traits, fingerprint similarity, percentage difference between extract and content and difficulty of sterilization operation, and the weight coefficient was determined by analytic hierarchy process by comparing the sterilization effects of humid heat sterilization, ethanol sterilization, high temperature instantaneous sterilization and electron beam irradiation sterilization.
RESULTS The four sterilization methods all met the microbial limit requirements of Notoginseng Radix et Rhizoma medicinal materials, However, ethanol sterilization and moist heat sterilization altered the appearance color, the content of extracts, and the total content of ginsenoside Rg1, ginsenoside Rb1, and notoginsenoside R1 to varying degrees, and the similarity of the fingerprint spectra was relatively low. There was no significant change in the physical and chemical indexes of Notoginseng Radix et Rhizoma before and after high-temperature instantaneous sterilization and electron beam irradiation sterilization, and the similarity of fingerprints was above 0.997, but the high-temperature instantaneous sterilization operation reduced the production efficiency of enterprises.
CONCLUSION Electron beam irradiation sterilization is selected as the sterilization method for Notoginseng Radix et Rhizoma medicinal materials, and the tentative irradiation dose is 9.0 kGy. This study provides a practical basis for the application of electron beam irradiation sterilization in the pretreatment of traditional Chinese medicine before the use of Notoginseng Radix et Rhizoma powder before entering the drug.