注射用奧扎格鐳鈉細菌內毒素檢查方法學研究

制藥工程論文編號:ZY028    論文字數:13009,頁數:27

 目  錄
 
 中文摘要  ………………......................................Ⅰ
 英文摘要  …………………………………………………………………………Ⅱ
 目錄  ………………………………………………………………………………Ⅲ
 1.緒論  ……………………………………………………………………………1
 1.1  細菌內毒素  ………………………………………………………………...…1
 1.2  鱟試劑………………………………………………………………………….2
  1.3 細菌內毒素檢查法方法  …………………………………………………5
 2. 實驗部分  ………………………………………………………………………11
 2.1 實驗準備及材料  …………………………………………………...………11
 2.2 實驗方法 ……………………………………………………………………12
 3. 結果與討論 ……………………………………………………………………17
    3.1 結果 ………………………………………………………………………17
    3.2 討論 ………………………………………………………………………17
 4. 總結與展望 ……………………………………………………………………20
      4.1 總結 ………………………………………………………………………….20
      4.2 展望 ………………………………………………………………….………20
 致謝  ………………………………………………………………………………21
 參考文獻  …………………………………………………………………………22

摘要：本論文研究注射用奧扎格鐳鈉細菌內毒素檢查方法，確定注射用奧扎格鐳鈉細菌內毒素檢查方法及內毒素檢查限值。對武漢海特生物制藥股份有限公司、揚子江藥業集團有限公司和宜昌人福藥業有限責任公司生產的4批注射用奧扎格鐳鈉進行了干擾試驗。樣品采用靈敏度為0.25EU/mL和0.03EU/mL的鱟試劑經干擾試驗，結果表明注射用奧扎格鐳鈉對細菌內毒素檢查無干擾作用，可進行細菌內毒素檢查。依法檢查（中華人民共和國藥典2005年版二部附錄Ⅺ E），每1mg注射用奧扎格雷鈉（按奧扎格鐳鈉計）中含內毒素的量應小于0.625EU。結果顯示檢驗出其限值為0.625 EU/mg，符合要求。
關鍵詞:細菌內毒素檢查；鱟試劑；注射用奧扎格鐳鈉；干擾試驗

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