中国药物警戒 ›› 2023, Vol. 20 ›› Issue (5): 514-518.
DOI: 10.19803/j.1672-8629.20211101

• 基础与临床研究 • 上一篇    下一篇

柴胡舒肝丸光释光法辐射筛查研究

王赵1, 赵剑锋2, 于新兰3, 金红宇1, 马双成1,*   

  1. 1中国食品药品检定研究院,北京 102629;
    2国家药典委员会,北京 100061;
    3新疆维吾尔自治区药品检验研究院,新疆 乌鲁木齐 830004
  • 收稿日期:2021-12-27 出版日期:2023-05-15 发布日期:2023-05-16
  • 通讯作者: *马双成,男,博士,研究员,中药质量控制。E-mail：masc@nifdc.org.cn
  • 作者简介:王赵,女,硕士,助理研究员,中药质量控制。
  • 基金资助:
    国家科技重大专项重大新药创制（2018ZX09735006）

Radiation screening of Chaihu Shugan pills via photostimulated luminescence

WANG Zhao1, ZHAO Jianfeng2, YU Xinlan3, JIN Hongyu1, MA Shuangcheng1,*   

  1. 1National Institutes for Food and Drug Control, Beijing 102629, China;
    2Chinese Pharmacopoeia Commission, Beijing 100061, China;
    3Xinjiang Institute for Food and Drug Control, Urumqi Xinjiang 830004, China
  • Received:2021-12-27 Online:2023-05-15 Published:2023-05-16

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摘要： 目的 采用光释光法建立柴胡舒肝丸的辐射筛查方法,为柴胡舒肝丸的质量控制和安全用药提供参考。方法 结合国家药品评价性抽验工作样品,参照欧盟标准（EN）13751：2009,样品经简单研粉、压饼处理后,利用SURRC PPSL辐照食品筛查系统,直接检测样品的辐射情况。结果 所建立方法经方法学考察可行,测定值可反映样品是否经过辐射,阴性对照无干扰。对10家企业102批次样品辐射情况进行检测,其中6家企业生产的26批次样品辐射筛查阳性,存在被辐射杀菌处理的情况,占总抽检批次的25.5%。结论 所建立方法无需复杂的样品前处理即可快速定性分析样品辐射情况,操作简便、快速、经济,可为柴胡舒肝丸的质量控制和安全用药提供参考。

关键词: 柴胡舒肝丸, 光释光, 辐射筛查, 质量控制

Abstract: Objective To establish a photostimulated luminescence (PSL) method for radiation screening of Chaihu Shugan pills so as to provide reference for quality control and safe use of these pills. Methods Combined with the national drug evaluation sampling test and in line with the European Standard (EN) 13751:2009, a radiation screening method of Chaihu Shugan pills was established by using the SURRC PPSL irradiation food screening system after the samples were crushed or laminated. Results This method proved to be feasible after methodological investigation. The measured values could reflect whether the sample had been irradiated. The negative control was free of interference. A total of 102 batches of samples from 10 enterprises were tested for radiation. The results showed that 26 of these batches of samples by 6 enterprises were positive for radiation screening and had been treated by radiation sterilization, accounting for 25.5% of the total. Conclusion The established method can quickly screen the irradiation residues without complex pretreatment, which is simple, rapid and economical, and can provide reference for quality control and safe use of Chaihu Shugan pills.

Key words: Chaihu Shugan pills, photostimulated luminescence (PSL), radiation screening, quality control

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