氟[^18F]化钠注射液细菌内毒素检查及无菌检查方法建立  

Establishment of Bacterial Endotoxin Test and Sterility Test of Sodium Fluoride [^18F] Injection

作　　者：孙祥敏 骆丹 杜建冬 吴艳丽 张云 郭飞虎 SUN Xiangmin;LUO Dan;DU Jiandong;WU Yanli;ZHANG Yun;GUO Feihu(HTA CO.,LTD,Beijing 102413,China)

机构地区：[1]原子高科股份有限公司,北京102413

出　　处：《同位素》2020年第4期234-240,I0003,共8页Journal of Isotopes

摘　　要：为建立氟[^18F]化钠注射液的细菌内毒素检查方法及无菌检查方法,本研究依据《中国药典》2015年版四部进行实验,其中细菌内毒素检查采用凝胶限度法,无菌检查采用直接接种法。实验结果表明,将供试品稀释10倍,选用两个厂家的鲎试剂同时进行细菌内毒素干扰实验,均无干扰,该方法适用于细菌内毒素检查检验。采用接种0.2 mL供试品至7.5 mL培养基的检验方式对药典规定的6株实验菌均无抑菌性,各实验菌生长良好,表明此检验方法适用于无菌检查。以上结果表明,氟[^18F]化钠注射液可以采用凝胶限度法进行细菌内毒素检查,采用直接接种法进行无菌检查,方法适用、准确可靠,且操作简单、快速、经济,产生放射性废物量小,既能确保用药安全,又经济、环保。To establish the methods for the bacterial endotoxin test and the sterility test of Sodium Fluoride[^18F] Injection. The Gel-clot method and the direct inoculation method was carried out according to the 2015 version of Chinese Pharmacopoeia(Vol.Ⅳ). The interferencing factors of bacterial endotoxin test were determined with two lachypleus amebocyte lysate from different producers. The interference can be eliminated after the sample was diluted to 10 times. The suitability test of sterility test indicated that the direct inoculation method can be used with 0.2 mL samples inoculated into 7.5 mL medium to conduct the sterility analysis. The results indicate that the Gel-clot method and the direct inoculation method could be used for the quality contral of Sodium Fluoride[^18F] Injection. The methods are applicable, accurate, easy operated, rapid, economical and less-productive of radioactive waste.

关 键 词：氟[^18F]化钠注射液 细菌内毒素检查 无菌检查 

分 类 号：TL923[核科学技术—核燃料循环与材料] R817[医药卫生—影像医学与核医学]