中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 519-523.
DOI: 10.19803/j.1672-8629.20220387

• 基础与临床研究 • 上一篇    下一篇

60Co-γ射线辐照灭菌对全蝎药粉品质的影响研究

马云1,2, 韩振明1,2, 张微1,2, 马健1,2, 关永霞1,2, 张贵民2,3,*   

  1. 1鲁南厚普制药有限公司,山东 临沂 276006;
    2中药制药共性技术国家重点实验室,山东 临沂 276006;
    3鲁南制药集团股份有限公司,山东 临沂 276006
  • 收稿日期:2022-07-08 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *张贵民,男,硕士,研究员,药物研发。E-mail:lunanzhangguimin@163.com
  • 作者简介:马云,女,硕士,工程师,中药新药研发与质量控制。
  • 基金资助:
    国家科技重大专项重大新药创制(2018ZX09201010); 临沂市兰山区科技创新发展计划专项(1811); 临沂市自主创新重大专项(2019ZDZX001)

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

摘要: 目的 研究不同剂量60Co-γ射线辐照灭菌对全蝎药粉成分及卫生学指标的影响,为全蝎灭菌工艺提升提供依据。方法 使用4、6、8、10 kGy 60Co-γ射线对全蝎药粉进行辐照灭菌,对灭菌前后样品的水分、总灰分、酸不溶性灰分、黄曲霉毒素、酸溶性浸出物、重金属及有害元素等药典要求检查项进行测定,以及对微生物含量等卫生学指标进行测定,并对不同剂量60Co-γ射线辐照灭菌的全蝎药粉进行HPLC成分含量分析。结果 不同剂量60Co-γ射线辐照前后全蝎药粉中的水分、总灰分、酸不溶性灰分、黄曲霉毒素、酸溶性浸出物、重金属及有害元素无明显差异;全蝎药粉在不同剂量60Co-γ射线辐照灭菌前后,各试验组之间卫生学指标差异极显著,4 kGy及以上的60Co-γ射线动态辐照可对微生物进行有效杀灭,6 kGy及以上的剂量灭菌效果好;高效液相色谱测定灭菌前后5种核苷类成分及17种氨基酸含量无显著差异,灭菌前后质量稳定。结论 60Co-γ射线辐照可有效杀灭全蝎药粉中微生物,6~10 kGy的剂量效果最佳,辐照灭菌前后药粉药典检查项无明显差异,辐照后的药粉品质更优。

关键词: 60Co-γ射线, 辐照灭菌, 全蝎, 品质

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

中图分类号: