夏振民, 顾淑琴, 何欣若, 王振山, 范广誉, 许文福, 刘端华, 丁友玲. 鲎试验检测放射性药品热原的研究J. 药学学报, 1981, 16(2): 122-126.
引用本文: 夏振民, 顾淑琴, 何欣若, 王振山, 范广誉, 许文福, 刘端华, 丁友玲. 鲎试验检测放射性药品热原的研究J. 药学学报, 1981, 16(2): 122-126.
Xia Zhenmin , Gu Shuqin, He Xinruo, Wang Zhenshan , Fan GuangyuXu Wenfu, Liu Duanhua, , Ding Youling, . STUDIES ON THE LIMULUS TEST FOR DETECTION OF ENDOTOXIN(PYROGEN) IN RADIOPHARMACEUTICALSJ. Acta Pharmaceutica Sinica, 1981, 16(2): 122-126.
Citation: Xia Zhenmin , Gu Shuqin, He Xinruo, Wang Zhenshan , Fan GuangyuXu Wenfu, Liu Duanhua, , Ding Youling, . STUDIES ON THE LIMULUS TEST FOR DETECTION OF ENDOTOXIN(PYROGEN) IN RADIOPHARMACEUTICALSJ. Acta Pharmaceutica Sinica, 1981, 16(2): 122-126.

鲎试验检测放射性药品热原的研究

STUDIES ON THE LIMULUS TEST FOR DETECTION OF ENDOTOXIN(PYROGEN) IN RADIOPHARMACEUTICALS

  • 摘要: 各国药典规定的药品热原检查法为家兔升温试验,由于放射性药品中放射核素半衰期及射线的生物效应的限制,采用规定的方法遇到很多困难。鲎试验是利用一种低等海洋动物“鲎”的血细胞溶解物与微量细菌内毒素(热原的主要来源)起凝胶化反应从而检测出微量内毒素的一种实验技术。本文报道了用东方鲎(Tachypleus tridentatus)提取的鲎血细胞溶解物,以微量载玻片鲎试验法,考核了国产放射性药品共13种50批,并与家兔法进行了比较。其中38批两法结果一致,占76%。结果认为,鲎试验可作为检测放射性药品热原的一种方法,具有灵敏、快速、简便的特点。

     

    Abstract: Pyrogen testing is one of the most difficult problems encountered in quality control of radiopharmaceuticals. The increased use of short-life radiopharmaceuticals presents formidable problems in pyrogen testing by the official method because of the rapier physical decay of most radionuclides, the large volume of required test solution, the radiation exposure and waste-disposing problems.The Limulus test is a rapid, sensitive and simple method for detection of bacterial endotoxin (pyrogen).We prepared amebocytes lysate from Horseshoe crab of China i. e. Tachypleus tridentatus. Its sensitivity was found to be 1~10 ng/ml for E. coli O111B4 endotoxin. An improved micromethod of slide test was used as a modified Limulus test in our laboratory. In testing 50 batches of radiopharmaceuticals for pyrogen by rabbit and Limulus methods, the results of 38 batches were in agreement with each other.Preliminary results indicate that the Limulus test is a rapid, sensitive and simple method for detection of pyrogen in radiopharmaceuticals.

     

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