Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (5): 519-523.
DOI: 10.19803/j.1672-8629.20220387

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Effects of 60Co-γ ray irradiation sterilization on quality of Buthus martensii Karsch powder

MA Yun1,2, HAN Zhenming1,2, ZHANG Wei1,2, MA Jian1,2, GUAN Yongxia1,2, ZHANG Guimin2,3,*   

  1. 1Lunan Houpu Pharmaceutical Co., Ltd., Linyi Shandong 276006, China;
    2State Key Laboratory of Generic Manufacture Technology of Traditional Chinese Medicine, Linyi Shandong 276006, China;
    3Lunan Pharmaceutical Group Co., Ltd., Linyi Shandong 276006, China
  • Received:2022-07-08 Online:2023-05-15 Published:2023-05-16

Abstract: Objective To study the effects of different doses of 60Co-γ ray radicidation on the composition and hygienic indexes of Buthus martensii Karsch powder, and to provide data for improvement of the sterilization process. Methods The Buthus martensii Karsch powder was irradiated with different doses of 60Co-γ rays, and pharmacopoeia-required test items, such as moisture, total ash, acid-insoluble ash, aflatoxin, acid-soluble leaches, heavy metals and harmful elements, were determined before and after sterilization of the samples. Such hygienic indicators as microbial contents were determined, and the contents of Buthus martensii Karsch powder sterilized by 4, 6, 8 and 10 kGy of 60Co-γ ray were analyzed. Results There was no significant difference in contents of moisture, total ash, acid-insoluble ash, aflatoxin, acid-soluble extract, heavy metals or harmful elements in the powder before and after irradiation with different doses of 60Co-γ. Before and after radicidation, the difference in hygiene indexes between the test groups was significant. The dynamic irradiation with 60Co-γ rays at the dose of 4 kGy or above could effectively kill microorganisms, and the sterilization effect of 6 kGy and above was good. There was no significant difference in the contents of five nucleoside components or seventeen amino acids before and after sterilization, as was determined by HPLC, and the quality was stable Conclusion 60Co-γ ray irradiation can effectively kill microorganisms in Buthus martensii Karsch powder. The doses of 6 to 10 kGy are the most effective. There is no obvious difference in the pharmacopoeia-required test items before and after radicidation. The quality of the powder after irradiation is better.

Key words: 60Co-γ rays, radicidation, Buthus martensii Karsch, quality

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