注射用奥扎格镭钠细菌内毒素检查方法学研究

文档编号:ZY028    文档字数:13009,页数:27

摘要：本文档研究注射用奥扎格镭钠细菌内毒素检查方法，确定注射用奥扎格镭钠细菌内毒素检查方法及内毒素检查限值。对武汉海特生物制药股份有限公司、扬子江药业集团有限公司和宜昌人福药业有限责任公司生产的4批注射用奥扎格镭钠进行了干扰试验。样品采用灵敏度为0.25EU/mL和0.03EU/mL的鲎试剂经干扰试验，结果表明注射用奥扎格镭钠对细菌内毒素检查无干扰作用，可进行细菌内毒素检查。依法检查（中华人民共和国药典2005年版二部附录Ⅺ E），每1mg注射用奥扎格雷钠（按奥扎格镭钠计）中含内毒素的量应小于0.625EU。结果显示检验出其限值为0.625 EU/mg，符合要求。
关键词:细菌内毒素检查；鲎试剂；注射用奥扎格镭钠；干扰试验

Abstract : The objective of the research is to study on the test for Bacterium Endotoxins
 of Ozagrel Sodium Injection and to confirm test limit. The inhibition and enhancement test is studied with different products of Ozagrel Sodium Injection. Tachypleus amebocyte lysate which sensitivity are 0.25EU/mL  and 0.03EU/mL  had been used. The test was not disturbed by Ozagrel Sodium Injection. So the test for bacterial endotoxin of Ozagrel Sodium Injection can be carried out. According to inspection (People's Republic of China Pharmacopoeia 2005 version 2 Ⅺ Appendix E), The concentration of toxins in Ozagrel Sodium injection should be less than 0.625 EU /mg. The result was 0.625 EU /mg.It
accord with the criterion.
Keywords:  Ozagrel Sodium for Injection; bacterial endotoxin test; tachypleus amebocyte lysate; Interference test

 目  录
 
 中文摘要  ………………......................................Ⅰ
 英文摘要  …………………………………………………………………………Ⅱ
 目录  ………………………………………………………………………………Ⅲ
 1.绪论  ……………………………………………………………………………1
 1.1  细菌内毒素  ………………………………………………………………...…1
 1.2  鲎试剂………………………………………………………………………….2
  1.3 细菌内毒素检查法方法  …………………………………………………5
 2. 实验部分  ………………………………………………………………………11
 2.1 实验准备及材料  …………………………………………………...………11
 2.2 实验方法 ……………………………………………………………………12
 3. 结果与讨论 ……………………………………………………………………17
    3.1 结果 ………………………………………………………………………17
    3.2 讨论 ………………………………………………………………………17
 4. 总结与展望 ……………………………………………………………………20
      4.1 总结 ………………………………………………………………………….20
      4.2 展望 ………………………………………………………………….………20
 致谢  ………………………………………………………………………………21
 参考文献  …………………………………………………………………………22

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