电子束辐照对肉豆蔻药材质量及灭菌效果的影响  

Influence of Electron Beam Irradiation on the Quality of Myristicae Semen and Sterilization Effect

作　　者：戈雅倩 谢和兵 尼玛次仁 白玛旦增 GE Yaqian;XIE Hebing;NIMA Ciren;BAIMA Danzeng(School of Pharmacy,Anhui University of Chinese Medicine,Hefei,Anhui,China 230012;Yangtze Delta Drug Advanced Research Institute,Nantong,Jiangsu,China 226133;Jiangsu Shenhou Pharmaceutical Research Co.,Ltd.,Nantong,Jiangsu,China 226133;Tibet Shenhou Pharmaceutical Co.,Ltd.,Shigatse,Tibet,China 857000)

机构地区：[1]安徽中医药大学药学院,安徽合肥230012 [2]江苏省南通市海门长三角药物高等研究院,江苏南通226133 [3]江苏神猴医药研究有限公司,江苏南通226133 [4]西藏神猴药业有限责任公司,西藏日喀则857000

出　　处：《中国药业》2023年第16期90-93,共4页China Pharmaceuticals

基　　金：西藏自治区科技厅区域科技协同创新专项项目[QYXTZX-RKZ2022-07]。

摘　　要：目的探讨电子束辐照对肉豆蔻药材质量及灭菌效果的影响。方法采用电子加速器对肉豆蔻药材粉末样品进行电子束辐照灭菌,辐照剂量分别为0,2,4,6,8,10 kGy。比较辐照前后样品的高效液相色谱(HPLC)图(并进行相似度评价),以及去氢二异丁香酚、总黄酮含量,细菌、霉菌和酵母菌、大肠菌群总数的变化。结果不同剂量电子束辐照样品的HPLC图相似度均不低于0.998。与空白对照样品(0 kGy)比较,不同剂量电子束辐照样品去氢二异丁香酚和总黄酮含量变化不显著(P>0.05)。样品在辐照前后均未检出大肠菌群;随着辐照剂量的增加,细菌、霉菌和酵母菌总数均显著降低(P<0.05),当辐照剂量为8 kGy时,微生物总数符合2020年版《中国药典》规定,当辐照剂量为10 kGy时,细菌、霉菌和酵母菌均未检出。结论不同剂量的电子束辐照灭菌对肉豆蒄药材质量无显著影响,且辐照剂量为8 kGy时灭菌效果良好。Objective To investigate the influence of electron beam irradiation on the quality of Myristicae Semen and sterilization effect.Methods Electron accelerator was used to sterilize Myristicae Semen powder samples by the electron beam irradiation,with the irradiation doses of 0,2,4,6,8,10 kGy,respectively.The changes of high-performance liquid chromatography(HPLC)chromatograms of the samples(similarity evaluation was performed in the study),the contents of dehydrodiisoeugenol,total flavonoids,the total count of bacteria,molds,yeasts and coliforms before and after irradiation were compared.Results The similarity of HPLC chromatograms of samples irradiated by different doses of electron beams was not lower than 0.998.Compared with those in the blank reference sample(0 kGy),there was no significant change in the contents of dehydrodiisoeugenol and total flavonoids in the samples irradiated by different doses of electron beams(P>0.05).No coliform was detected in the samples before and after irradiation.As the irradiation dose increased,the total count of bacteria,molds and yeasts significantly decreased(P<0.05).When the irradiation dose was 8 kGy,the total count of microorganisms met the requirements of the Chinese Pharmacopoeia(2020 Edition),and when the irradiation dose was 10 kGy,no bacterium,mold and yeast was detected in the samples.Conclusion Different doses of electron beam irradiation have no significant influence on the quality of Myristicae Semen,and the sterilization effect is good when the irradiation dose is 8 kGy.

关 键 词：肉豆蔻 高效液相色谱法 含量测定 微生物限度检查 

分 类 号：R917[医药卫生—药物分析学] R932[医药卫生—药学]