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文章摘要
He Yan.Research of Bacterial Endotoxin Test Method for Raw Medicine Peramivir Trihydrate[J].中国药物评价,2019,36(3):175-178
帕拉米韦三水合物细菌内毒素检查法的研究
Research of Bacterial Endotoxin Test Method for Raw Medicine Peramivir Trihydrate
投稿时间:2019-02-20  修订日期:2019-04-02
DOI:
中文关键词: Ⅰ类新药  帕拉米韦三水合物  原料药  干扰试验  细菌内毒素检查  凝胶法
英文关键词: Class I new drug  Peramivir Trihydrate  Raw medicine  Interference test  Bacterial endotoxin test  Gel method
基金项目:
作者单位E-mail
何燕 河南省食品药品审评查验中心 1420918564@qq.com 
张伟奇 河南省食品药品审评查验中心  
徐晓月 河南省食品药品审评查验中心  
何波 商丘市药品不良反应监测中心  
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中文摘要:
      目的:研究并建立原料药帕拉米韦三水合物的细菌内毒素(凝胶法)检查法。方法:取批量生产的,连续批号的原料药帕拉米韦三水合物,参考该原料制剂注射液的用法用量,计算出该原料药的细菌内毒素限值;制备不同浓度的系列溶液;应用两个不同生产厂家的鲎试剂,进行凝胶法干扰预试验和干扰试验。之后,依据确定的限值及最大不干扰浓度,取不同批号的供试品进行细菌内毒素检查。结果:原料药帕拉米韦三水合物在浓度为0.5 mg·mL-1时对鲎试剂与细菌内毒素的凝集反应无干扰作用,细菌内毒素限值可设定为0.5 EU·mg-1。结论:帕拉米韦三水合物可采用细菌内毒素检查法(凝胶法)作为质量控制方法,该方法简便可行。
英文摘要:
      Objective: To study and establish a bacterial endotoxin test (gel method) method for the raw medicine Peramivir Trihydrate. Methods: The batch production of continuous batch Paramivir Ttrihydrate was used in the experiment. According to the usage and dosage of the injection, the bacterial endotoxin limit of the raw medicine was calculated. We prepared different concentrations of series of solutions, then we used two different manufacturers of limulus lysate to carry out the gel interference Pre test and interference test. According to the determined limit and maximum non-interference concentration, bacterial endotoxin test was taken on different batches of samples. Results: Palamivir trihydrate had no interference on the agglutination reaction of tachypleus amebocyte lysate and bacterial endotoxin at the concentration of 0.5 mg·mL-1 . The bacterial endotoxin limit can be set at 0.5 EU·mg-1. Conclusion: The bacterial endotoxin test (gel method) can be used as a quality control method for Peramivir Trihydrate. The method is simple and feasible.
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